chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Got the shot years ago now got shingles/ suspected vaccination failure; Shingles on back; Very painful; Itchy; My back is all scarred; Awful; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot years ago now got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on back), pain (Verbatim: Very painful), pruritus (Verbatim: Itchy), scar (Verbatim: My back is all scarred) and feels awful (Verbatim: Awful). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not reported and the outcome of the scar and feels awful were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus, scar and feels awful to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, pruritus, scar and feels awful to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine years ago and now experienced shingles. The patient stated that it was very painful, itchy and now shingles on his or her back and it was now all scarred which was never had prior to having shingles and it was awful. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine and got severe shingles / Suspected vaccination failure; Severe 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 patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine and got severe shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Severe 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: 09-APR-2023 This case was reported by the patient via interactive digital media.  The reporter stated that the he/she knewa number of folks who had got the vaccine and had got severe shingles multiple times afterwards. The reporter had shingles and did not get the vaccine and it was mild and was managed without a single pharmaceutical. 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. Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Vaccination failure
Clinical narrative: Had two shingles shots and still got shingles/ suspected vaccination failure; Shingles; Numbness outside hip area; Pain; 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: Had two shingles shots and still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), numbness (Verbatim: Numbness outside hip area) and pain (Verbatim: Pain). The patient was treated with magnesium, lysine, ascorbic acid (Vitamin C) and vitamin d. The outcome of the vaccination failure was unknown and the outcome of the shingles, numbness and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, numbness and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, numbness and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two Shingles vaccine and still experienced shingles. The patient reported that physician stated that happened but it came in milder way. The physician stated three signs of shingles, 1. rash of any kind, small bumps, pimples, red spots and bumps. 2. Pain or flu symptoms and 3. numbness The patient stated his or her shingles felt like a sword went in through his or her back above his or her hip and through his or her colon and front below belly button it can effect the digestive system. The patient had numbness in the part of the outside hip area, the physician stated that was the tip off for him. The patient stated that no one knows how this shingles felt until you had it. The patient received magnesium gel which was applied to spot it was stings at first but will ease the pain for hours. Patient received lysine in large doses and vitamin c and vitamin d as a treatment. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Stress, Vaccination failure
Clinical narrative: had 3 shots broke out/suspected vaccination failure; broke out on legs, back, neck, face; stress; pain; Extra dose administered; 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: had 3 shots broke out/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: broke out on legs, back, neck, face), stress (Verbatim: stress), pain (Verbatim: pain) and extra dose administered (Verbatim: Extra dose administered). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles, stress and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, stress and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles, stress and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient had three shingles shots. The reporter stated that huge pills and pills. The reporter stated that shingles broke out on his/her legs. The patient had four different times shingles on back, neck and face. The reporter stated that stress brought it on and was painful. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient had three shingles shots, which led to extra dose administered. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got them after taking shot/Suspected vaccination failure; 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: Got them after taking shot/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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: 08-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she got shingles even after taking the Shingle vaccine 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccine didn't work for me/suspected vaccination failure; vaccine didn't work for me; 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: vaccine didn't work for me/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: vaccine didn't work for me). 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: 18-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that the vaccine did not work for him or her. 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
Symptoms: Burning sensation, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Had shot had shingles/ suspected vaccination failure; Shingles; Burned; Itched; 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 had shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), burning sensation (Verbatim: Burned) and pruritus (Verbatim: Itched). The outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, burning sensation and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAR-2023/ 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles twice. The patient stated that the shingles were not as bad and did not blister it was just burned and itched. The patient stated that you can experience shingles more than once even after received Shingles vaccine years ago. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: second time was after having the Shingles Vaccine/Suspected Vaccination Failure; second time was after having the Shingles 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.   The patient's past medical history included shingles (had shingles before vaccination) and pain.   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: second time was after having the Shingles Vaccine/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: second time was after having the Shingles Vaccine). The outcome of the vaccination failure was unknown and the outcome of the shingles was 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: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles two times and first time before vaccination. The reporter stated that it took 4 years before symptoms completely subsided. The doctor tried many types of treatments and none worked. That included pain management after medications did not work. The second time shingles was after having the shingles vaccine and was extremely less severe and gone within weeks. Both time it was treated with a viral treatment upon recognition. The reporter highly recommended the shingles vaccine. 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: Got shingles from the vaccine/ 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: Got shingles from the vaccine/ 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.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     The company considered the vaccination failure and shingles to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles from the vaccine. 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. According to narrative verbatim the causality was conservatively captured as possible. 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 shot and had small case of 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 shot and had small case of 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: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced small case of shingles and it was very painful and they are horrible. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: received injection and got shingles/suspected vaccine failure; received injection and got 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.   Concurrent medical conditions included diabetes and immunocompromised (was immunocompromised because of diabetes).   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 injection and got shingles/suspected vaccine failure) (serious criteria GSK medically significant), shingles (Verbatim: received injection and got shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was recovered/resolved (duration 3 days).   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the pain to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient received his or she injection and got a light case of shingles only because he or she got the injection. The patient stated that but he or she could told in the small areas where the shingles was it was painful, the pain lasted three days because of additional medication. 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
Symptoms: Back pain, Herpes zoster, Neuralgia, Pain, Vaccination failure
Clinical narrative: had the vaccine and Shingles/Suspected Vaccination Failure; shingles; terrible burning pain on right side and back area/pain; apparently, it centered on one nerve forever/terrible burning pain; 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 vaccine and Shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pain (Verbatim: terrible burning pain on right side and back area/pain) and nerve pain (Verbatim: apparently, it centered on one nerve forever/terrible burning pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported and the outcome of the nerve pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve pain to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles, pain and nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient actually had shingles vaccine a few years prior.  The patient went to emergency room . The reporter stated that three years ago in such pain. It was shingles and went around his/her and was treated but he/she continued to have the terrible burning pain on his/her right side and back area. The reporter stated that apparently, it centered on one nerve forever. 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: Incomplete course of vaccination
Clinical narrative: 1st dose 17Jan2022, 2nd not yet; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17-JAN-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: 1st dose 17Jan2022, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:04-APR-2023 The patient was scheduled for a heart procedure and the doctor did not want him/her to get the second dose until after the heart procedure.  The patient's doctor then went in for a hip replacement, and was not conducting office hours. The office manager did not call him/her when the doctor returned to her practice.  As lot of time has passed since shingrix 1st dose, the patient wanted to know if he/she had to do start all over with the first dose, or could he/she receive the second dose of the vaccine. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache
Clinical narrative: she has the worst headache; Felt like was hung over the next day; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: she has the worst headache) and feeling abnormal (Verbatim: Felt like was hung over the next day). The outcome of the headache was unknown and the outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the headache and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the headache and feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient:  US2023050866   Additional Information: GSK Receipt date: 06-APR-2023 The reporter was the consumer.  The reporter reported that she had her first Shingrix vaccination administered that she had the worst headache and she felt like she was hungover the next day. The reporter was consented to followup.; Sender's Comments:  US-GSK-US2023050866:Same reporter US-GSK-US2023050865:Same reporter - husband case
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Arm where the injection felt like I got hit with a baseball/was not near the pain of shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Arm where the injection felt like I got hit with a baseball/was not near the pain of shingles). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient had two kids all natural and patient would do it again to not have shingles. The patient stated that, bought her/his doctor a gift for giving relief from the pain. The patient couldn't wait to get the shingles vaccine even though her/his arm where the injection felt like he/she got hit with a baseball, it wasn't anything near the pain of shingles. The patient used baby powder on the shingles area which she/he think helped them from spreading and the blisters bursting as the powder helped them dry up and not burst or spread. The follow-up could not be possible as no contact details were available.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: I received the fourth dose of the Moderna Bivalent COVID-19 vaccine on 10/3/2022. Within a week or so, I developed small, itchy areas on various parts of my body. They were usually on my hands, arms, stomach, or the bottoms of my feet. The itch wasn't severe, but it was annoying. I went to my PCP on 11/18/2022, and he didn't know what was causing the itching, so he referred me to a dermatologist. On 2/14/2023, I saw the dermatologist. I explained my symptoms to her, and she thought that it was likely caused either by COVID-19 or by the COVID-19 vaccine. She prescribed triamcinolone (0.1%) cream, which I was to use as needed. I think I have only used it once. The dermatologist said that the itch should resolve on its own and that it just takes time. I have also noticed that taking oral Benadryl every once in a while has provided some relief. At the time of this writing, I haven't noticed any itching in about a month, so I think it has largely resolved itself.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: patient had no reaction while waiting for the 15mins wait time after the vaccine was administered  the MA that administered the vaccine to the patient called parents of the patient to inform them about the incident and that  patient needs to get re vaccinated dad understood about the situation and we asked if they wanted to come back and get the patient re vaccinated dad said we rather wait and will find a different place to get vaccinated. MA gave dad our contact information if they have and questions or concerns.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Pain
Clinical narrative: Sinus Pain, cough, some hives, diarrhea, vomiting, aches, chills, no fever started 3/28 - peaked 3/29 - slowly decreased over 7 days.  Ending with a sinus infection.  Worth noting that i had started with a cold March 10, that progressed to strep throat the following week.  Was on antibiotics at that time.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pharyngitis streptococcal, SARS-CoV-2 test positive, Sinus pain, Sinusitis, Urticaria
Clinical narrative: Sinus Pain, cough, some hives, diarrhea, vomiting, aches, chills, no fever started 3/28 - peaked 3/29 - slowly decreased over 7 days.  Ending with a sinus infection.  Worth noting that i had started with a cold March 10, that progressed to strep throat the following week.  Was on antibiotics at that time.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Sinus Pain, cough, some hives, diarrhea, vomiting, aches, chills, no fever started 3/28 - peaked 3/29 - slowly decreased over 7 days.  Ending with a sinus infection.  Worth noting that i had started with a cold March 10, that progressed to strep throat the following week.  Was on antibiotics at that time.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient received Trumenba and Men Quad-Fi.  Syncopal episode <1min. LOC, immediately following vaccinations. Lay flat on exam table for recovery, vitals recorded, cool cloth to forehead. Apple juice given when able to sit up. Left office ~15 mins later
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NONE
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Mechanical urticaria, Pain, Pruritus
Clinical narrative: I have itching everywhere on my body. When I itch it, it burns and stings. I believe it is an allergy thing that I never had before. I went to my dermatologist and they said it might be an autoimmune disorder. The doctor also said it was dermatographia. I was prescribed me Zyrtec and it does help.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: pt complained of pain in the arm starting 2 days after the vaccine was administered and difficulty moving the arm
Age: 51.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing, shortness of breath
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient was given a second Bivalent booster prior to indication for this and was given within 6 months of previous dose
Age: 66.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Muscle spasms
Clinical narrative: generalized spasm of shoulder approximately 4 inches proximal to injection site, starting 2 days after injection and persisting as of 4/13/23.
Age: 66.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Fear, Muscle spasms, Muscle strain, Musculoskeletal stiffness, Pain
Clinical narrative: generalized spasm of shoulder approximately 4 inches proximal to injection site, starting 2 days after injection and persisting as of 4/13/23.
Age: 66.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Periarthritis
Clinical narrative: generalized spasm of shoulder approximately 4 inches proximal to injection site, starting 2 days after injection and persisting as of 4/13/23.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Nurse administered Tdap Vaccine as requested for school entry. Provider order to administer vaccine. Allergies assessed NKA , VIS and consent given. Tdap administered IM at LD at 1710. Nurse back into to room at 1720 patient reports slight rash to chest, patient assessed denies SOB no difficulty swallowing. Vital signs assessed, WNL Provider notified and in room with patient. Patient in room for 20 min, rash appeared to resolve and patient had no further complaints. Patient to discharge with medications ordered by provider.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received bivalent vaccine instead of the monovalent vaccine as the first dose in the vaccine series in error
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: swelling noted at 1 day, on exam 48 hours after administration, warm and tense with well demarcated erythema not responsive to Benadryl consistent with celullitis
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: none. Covid vaccine expired. 10/25/2022. Given 01/16/2023
Age: 5.0
Sex: F
Vaccine: DF
Symptoms: Expired product administered
Clinical narrative: none. Expired vaccine 10/25/2022. Given on 01/13/2023
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 2 days.  The same as his other vaccinations.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: none, expired vaccine given
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: The patient was given the Pfizer bivalent vaccine on 4/4/23 and the medication expired on 3/31/23.  When the medication was placed in the refrigerator the expiration date of the frozen vaccine was placed on the container.  The patient had a sore arm for a couple days as with previous vaccinations.
Age: 21.0
Sex: M
Vaccine: JEV1
Symptoms: Incorrect dose administered
Clinical narrative: Encephalitis vaccine inactivated doesn't have clear markings for 0.25 ml dose for 2 month to 35 month old child dose.  Patient received full dose of syringe 0.5 ml.
Age: 1.67
Sex: U
Vaccine: UNK
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: allergic reaction - HIVES
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: After having Janssen COVID 19 vaccine less than one month developed a DVT (extensive) throughout right lower extremity from common femoral vein through the calf veins. Patient was seen and given eliquis (blood thinner).
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Diabetic ketoacidosis, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Pt is a hospitalized breakthrough case but is not hospitalized for non COVID-19 reasons. Was admitted to Hospital on 6/5/21 for diabetic ketoacidosis and was there diagnosed a second time with COVID-19. His inital was positive was on 1/22/21. Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination: bamlanivimab, aspirin, calcium carb and citrate-vitD3, finasteride, pantoprazole, pyridostigmine, ramipril, vitamin B-12, vitamin D3, insulin.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Muscle disorder, Rhinorrhoea, Sleep disorder
Clinical narrative: I've never had allergies in the past, ever.  - Now I have to take a cetirizine daily to quell the sneezing/runny nose  All of my joints (knees, hips and shoulders) feel like the muscles or tendons or something is disintegrating. My shoulders are especially bad, Terrible pain that messes with my sleep.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing, Tendon disorder
Clinical narrative: I've never had allergies in the past, ever.  - Now I have to take a cetirizine daily to quell the sneezing/runny nose  All of my joints (knees, hips and shoulders) feel like the muscles or tendons or something is disintegrating. My shoulders are especially bad, Terrible pain that messes with my sleep.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain
Clinical narrative: I started to feel fatigued, and I developed a cough, and sore throat. I did not have a fever. I checked my oxygen with my pulse oximeter, and it did not go below 93. I took a COVID-19 test on 10/23/2022 and it was positive.  That day I called my doctor, and they prescribed me Paxlovid.  My symptoms lasted about 2 days and I felt better. I continued to take the medication for the full 5 days.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had a breakthrough case of Covid-19 I had a runny nose and sore throat sneezing I felt feverish and had a lot of fatigue with brain fog hard to focus.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Brain fog, COVID-19, Disturbance in attention, Fatigue, Oropharyngeal pain
Clinical narrative: I had a breakthrough case of Covid-19 I had a runny nose and sore throat sneezing I felt feverish and had a lot of fatigue with brain fog hard to focus.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing, Vaccine breakthrough infection
Clinical narrative: I had a breakthrough case of Covid-19 I had a runny nose and sore throat sneezing I felt feverish and had a lot of fatigue with brain fog hard to focus.
Age: 22.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Dyspnoea, Feeling hot, Flushing, Urticaria
Clinical narrative: Anaphylaxis requiring EpiPen 30 minutes following vaccination
Age: 22.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Allergy to vaccine, Anaphylactic reaction, Blood immunoglobulin E abnormal
Clinical narrative: Anaphylaxis requiring EpiPen 30 minutes following vaccination
Age: 43.0
Sex: M
Vaccine: JEV1, JEV1
Symptoms: CSF protein increased, Change in sustained attention, Computerised tomogram head normal, Confusional state, Electroencephalogram abnormal
Clinical narrative: Encephalitis- presented twice to the ER, once starting 3/8/2023 and again on 3/16/2023 with right sided numbness of face and arm and aphasia.
Age: 43.0
Sex: M
Vaccine: JEV1, JEV1
Symptoms: Encephalopathy, HIV test negative, Laboratory test abnormal, Lumbar puncture abnormal, Magnetic resonance imaging head normal
Clinical narrative: Encephalitis- presented twice to the ER, once starting 3/8/2023 and again on 3/16/2023 with right sided numbness of face and arm and aphasia.
Age: 43.0
Sex: M
Vaccine: JEV1, JEV1
Symptoms: Mental status changes, Somnolence
Clinical narrative: Encephalitis- presented twice to the ER, once starting 3/8/2023 and again on 3/16/2023 with right sided numbness of face and arm and aphasia.
Age: 43.0
Sex: M
Vaccine: JEV1, JEV1
Symptoms: Aphasia, Cytotoxic lesions of corpus callosum, Encephalitis, Hypoaesthesia, Magnetic resonance imaging head abnormal
Clinical narrative: Encephalitis- presented twice to the ER, once starting 3/8/2023 and again on 3/16/2023 with right sided numbness of face and arm and aphasia.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nervous system disorder
Clinical narrative: Muscle pain; Twitching; Lump; Neurological problems; Anatomical site of injection: SQ, left arm; This is a spontaneous report received from contactable reporters (Consumer or other non-HCP and Physician), Program ID:  The reporter is the patient.  A 50-year-old patient received BNT162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 1, single (Lot number: EL3249, Expiration Date: 31May2021) subcutaneous, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "HTN" (ongoing); "COVID-19", start date: Nov2020 (unspecified if ongoing). Concomitant medication included: LISINOPRIL oral taken for hypertension, start date: 2014 (ongoing). The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Feb2021, outcome "unknown", described as "Anatomical site of injection: SQ, left arm"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "Twitching"; MASS (non-serious), outcome "unknown", described as "Lump"; NEUROLOGICAL SYMPTOM (non-serious), outcome "not recovered", described as "Neurological problems". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient reported that his/her primary care physician (PCP) had questions as there was muscle pain, twitching, lump noted, and ongoing neurological problems after the 1st dose.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Mass, Muscle twitching, Myalgia, Neurological symptom
Clinical narrative: Muscle pain; Twitching; Lump; Neurological problems; Anatomical site of injection: SQ, left arm; This is a spontaneous report received from contactable reporters (Consumer or other non-HCP and Physician), Program ID:  The reporter is the patient.  A 50-year-old patient received BNT162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 1, single (Lot number: EL3249, Expiration Date: 31May2021) subcutaneous, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "HTN" (ongoing); "COVID-19", start date: Nov2020 (unspecified if ongoing). Concomitant medication included: LISINOPRIL oral taken for hypertension, start date: 2014 (ongoing). The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Feb2021, outcome "unknown", described as "Anatomical site of injection: SQ, left arm"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "Twitching"; MASS (non-serious), outcome "unknown", described as "Lump"; NEUROLOGICAL SYMPTOM (non-serious), outcome "not recovered", described as "Neurological problems". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient reported that his/her primary care physician (PCP) had questions as there was muscle pain, twitching, lump noted, and ongoing neurological problems after the 1st dose.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Muscle pain; Twitching; Lump; Neurological problems; Anatomical site of injection: SQ, left arm; This is a spontaneous report received from contactable reporters (Consumer or other non-HCP and Physician), Program ID:  The reporter is the patient.  A 50-year-old patient received BNT162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 1, single (Lot number: EL3249, Expiration Date: 31May2021) subcutaneous, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "HTN" (ongoing); "COVID-19", start date: Nov2020 (unspecified if ongoing). Concomitant medication included: LISINOPRIL oral taken for hypertension, start date: 2014 (ongoing). The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Feb2021, outcome "unknown", described as "Anatomical site of injection: SQ, left arm"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "Twitching"; MASS (non-serious), outcome "unknown", described as "Lump"; NEUROLOGICAL SYMPTOM (non-serious), outcome "not recovered", described as "Neurological problems". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient reported that his/her primary care physician (PCP) had questions as there was muscle pain, twitching, lump noted, and ongoing neurological problems after the 1st dose.
Age: 2.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Recieved Moderna Monovalent for first and second dose. Given Pfizer Bivalent for third dose on 3/14/23. No adverse outcome.
Age: 2.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: Recieved Moderna Monovalent for first and second dose. Given Pfizer Bivalent for third dose on 3/14/23. No adverse outcome.
Age: 0.5
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: Pt given COVID19 Bivalent Pfizer vaccine instead of Monovalent Pfizer.  No adverse outcome.
Age: 0.5
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt given COVID19 Bivalent Pfizer vaccine instead of Monovalent Pfizer.  No adverse outcome.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: idiopathic Transverse Myelitis; This is a literature report. This is a literature report based on a Health Authority database analysis.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 12Feb2021, for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 05Mar2021, outcome "unknown", described as "idiopathic Transverse Myelitis". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging spinal: Normal. Clinical courses: Headache, cramping after 2nd injection; chills, fatigue, leg pain and difficulty walking by the second day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: This is a literature report based on a Health Authority database analysis.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event transverse myelitis  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;