chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was in the fridge longer than 30 days. Pt got expired vaccine but with no problems or symptoms reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 3/7/21 Lot# 030A21A;  Moderna 4/6/21 Lot# 018B21A;  Moderna 1/4/22 Lot# 059H21A
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No ADR Resident received her first primary dose as a Bi Valent dose on 12/8/2022.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer female, Mammogram
Clinical narrative: Positive for breast cancer November 15, 2022
Age: 96.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 1/28/21 Lot# 028L20A;  Moderna 2/25/21 Lot# 004M20A;  Moderna 10/5/22 Lot# 027E22A
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Chest X-ray normal, Computerised tomogram head normal, Fall
Clinical narrative: On 1/1/2023, patient presented to the emergency department with concerns for weakness and speech difficulties. She was promptly tested for COVID-19 which came back positive. Patient did have a mild fever, but her other vital signs were normal, and she was not hypoxic. There was no evidence of viral or bacterial pneumonia on chest x-ray or upon examination. Chest x-ray showed no acute cardiopulmonary findings. Treatment included IV fluids for hydration and Tylenol for a low-grade temperature of 100.4F. Patient was noted to have a fall earlier in the day at her assisted living residence. Therefore, she was evaluated for hemorrhagic versus ischemic CVA due to weakness in the left arm. Her stat head CT was unremarkable and showed no intracranial hemorrhage. Treatment for Ischemic CVA with tPA was considered but was deferred given the uncertainty of a CVA and the anticoagulation medication that the patient takes. Due to the patient's increased overall weakness, weakness in her left arm and possibility of a CVA, she was admitted to the hospital on 1/2/2023 for further treatment and evaluation. Her admission diagnoses were COVID-19 Infection, Generalized Weakness, and Questionable Left Sided Weakness (likely chronic in LUE).  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hemiparesis, Muscular weakness, Pyrexia, SARS-CoV-2 test positive, Speech disorder
Clinical narrative: On 1/1/2023, patient presented to the emergency department with concerns for weakness and speech difficulties. She was promptly tested for COVID-19 which came back positive. Patient did have a mild fever, but her other vital signs were normal, and she was not hypoxic. There was no evidence of viral or bacterial pneumonia on chest x-ray or upon examination. Chest x-ray showed no acute cardiopulmonary findings. Treatment included IV fluids for hydration and Tylenol for a low-grade temperature of 100.4F. Patient was noted to have a fall earlier in the day at her assisted living residence. Therefore, she was evaluated for hemorrhagic versus ischemic CVA due to weakness in the left arm. Her stat head CT was unremarkable and showed no intracranial hemorrhage. Treatment for Ischemic CVA with tPA was considered but was deferred given the uncertainty of a CVA and the anticoagulation medication that the patient takes. Due to the patient's increased overall weakness, weakness in her left arm and possibility of a CVA, she was admitted to the hospital on 1/2/2023 for further treatment and evaluation. Her admission diagnoses were COVID-19 Infection, Generalized Weakness, and Questionable Left Sided Weakness (likely chronic in LUE).  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
Age: 54.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Aphonia, Chest X-ray normal, Cough, Ear infection, Ear pain
Clinical narrative: My symptoms started on a Friday. I was having ear pain and a discharge from the ear. I had just returned from trip, and I started having sinus drainage from my nose and in my ear. I went the doctor after 1 day of severe drainage. A chest x-ray was completed to confirm I did not have pneumonia on February. The provider looked in my ear and determined that I had an ear infection in my left ear. I was given an antibiotic and some ear drops. My symptoms improved a little and then I returned to see my doctor and was still taking the antibiotic. It took a week and a half to get rid of the major congestion. The ear infection cleared up in less than a week. The coughing caused me to lose my voice. I took over the counter medication to treat the remaining symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Foreign travel, Otorrhoea, Paranasal sinus hypersecretion, Respiratory tract congestion
Clinical narrative: My symptoms started on a Friday. I was having ear pain and a discharge from the ear. I had just returned from trip, and I started having sinus drainage from my nose and in my ear. I went the doctor after 1 day of severe drainage. A chest x-ray was completed to confirm I did not have pneumonia on February. The provider looked in my ear and determined that I had an ear infection in my left ear. I was given an antibiotic and some ear drops. My symptoms improved a little and then I returned to see my doctor and was still taking the antibiotic. It took a week and a half to get rid of the major congestion. The ear infection cleared up in less than a week. The coughing caused me to lose my voice. I took over the counter medication to treat the remaining symptoms.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/5/21 Lot# EN6206;  Pfizer 3/26/21 Lot# ER8732;  Pfizer 11/14/21 Lot# FE3590
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction noted. Vaccine given prior to reccomended age.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Pneumonitis, Pyrexia, Respiratory tract congestion
Clinical narrative: My symptoms began on the 27th and I had a feeling like my lungs were inflamed. The next day it was a dry cough. I tested negative two days in a row. I tested positive with PCR on the 3rd day. I then had a fever and hacking cough and congestion and this lasted another 2 days. I started PAXLOVID on the 28th. As of March 4th I felt better and tested negative on Tuesday the 7th and tested positive again two days later. With the rebound case I have had horrible congestion and fever came back. I am feeling better as of now.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: My symptoms began on the 27th and I had a feeling like my lungs were inflamed. The next day it was a dry cough. I tested negative two days in a row. I tested positive with PCR on the 3rd day. I then had a fever and hacking cough and congestion and this lasted another 2 days. I started PAXLOVID on the 28th. As of March 4th I felt better and tested negative on Tuesday the 7th and tested positive again two days later. With the rebound case I have had horrible congestion and fever came back. I am feeling better as of now.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderrna 3/13/21 Lot# 001B21A;  Moderna 4/0/21 Lot# 016B21A;  Moderna 11/11/21 Lot# 004F21A;  Moderna 8/26/22 Lot# 052B22A
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Headache, Hyperhidrosis
Clinical narrative: I had a headache, fever, chills, sweats, cough, and body aches. I tested positive for COVID-19. I already had Paxlovid on hand. So, I took that and Tylenol. I contacted my doctor afterwards because it was the holidays. He said that it was fine. After taking Paxlovid I tested negative on day 5 and on day 6 I was symptomatic again and tested positive for COVID-19. I had the same symptoms and just as bad. I took Tylenol to manage the fever and body aches.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Malaise, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had a headache, fever, chills, sweats, cough, and body aches. I tested positive for COVID-19. I already had Paxlovid on hand. So, I took that and Tylenol. I contacted my doctor afterwards because it was the holidays. He said that it was fine. After taking Paxlovid I tested negative on day 5 and on day 6 I was symptomatic again and tested positive for COVID-19. I had the same symptoms and just as bad. I took Tylenol to manage the fever and body aches.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of consciousness, Mobility decreased, Syncope
Clinical narrative: Syncopal episode after taking a bath. I could not stand or raise my head off floor for 15-20 min without passing out.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal discolouration, Oropharyngeal pain, Sexually transmitted disease test, Streptococcus test negative, Treponema test negative
Clinical narrative: On December 23, 2022, I woke up with a sore throat which was accompanied with white spots in the back of my throat. It persisted for eight to nine days, then went away. It was resistant against all medication. It came back in January and also in February. The time it came back in February it lasted for two to three weeks.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Influenza, Nasopharyngitis
Clinical narrative: I went to the doctor because I had multiple negative and positive results. I went to the doctor just to get a decent result. It felt it like a headache. I had Flu the week before contracting COVID-19. It was like a head cold and a blur. I had congestion in the head and cough. But that could have been from the flu.  It was extremely mild, very mild. The shot that I got though, this arm from this shot was super sore. I had never had that before.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I went to the doctor because I had multiple negative and positive results. I went to the doctor just to get a decent result. It felt it like a headache. I had Flu the week before contracting COVID-19. It was like a head cold and a blur. I had congestion in the head and cough. But that could have been from the flu.  It was extremely mild, very mild. The shot that I got though, this arm from this shot was super sore. I had never had that before.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: MEDICAL ASST ADMINISTERED VACCINE BEFORE VACCINE WAS DILUTED
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hydrocholecystis, Palpitations, Urinary incontinence
Clinical narrative: I have been having heart palpitations and my bladder has dropped to vaginal opening which has cause urinary incontinence. These symptoms have been present since my second Pfizer covid vaccine.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was administered the Pfizer Bivalent 12+ vaccine instead of the Pediatric Pfizer Bivalent 5-11Y vaccine. Mother was informed. Patient was monitored for 15 minutes post vaccination. No signs and symptoms of any side effects or adverse reactions observed. Mother was provided education on signs and symptoms to monitor for. Mother verbalized understanding.
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Patient states approximately 1 week after the shot he developed pain in his left arm and armpit.  He states it bothers him mostly when he is laying down trying to sleep.  It seems to be better when he is moving it around. Recommended seeing a doctor for this pain.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Headache, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I had a scratchy throat, a headache for a day, and fatigue. I tested positive for COVID-19 at home. I went to the urgent care and they prescribed me PAXLOVID. I don't if it helped or not because I wasn't that sick. But I wasn't sick for a long time. I still have fatigue.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature increased, COVID-19, Chills, Malaise, Oropharyngeal pain
Clinical narrative: I begin experiencing symptoms of Covid 03/10/2023 sore throat elevated body temperature, no fever runny nose mild congestion and chills.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I begin experiencing symptoms of Covid 03/10/2023 sore throat elevated body temperature, no fever runny nose mild congestion and chills.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a third dose of Zoster Recombinant. There was no adverse event.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Asthenia, Endoscopy, Haematemesis, Nasopharyngitis
Clinical narrative: I had my last booster in September, which was Pfizer, and all the other vaccines were Moderna. I started having very mild cold symptoms. I took a COVID-19 test on Tuesday and then Thursday I took a COVID-19 at home test. On this day I called my doctor, and I was given PAXLOVID, and I took it for five days, and then on Christmas Day I had a belly ache. I started to vomit blood in big amounts then this happened repeatedly for the next 4-5 hours and then I stopped. The next day I was very weak, so I called my doctor that was listed but nobody was in the office because of the holiday. I called the doctor and reached them on December 27, I was then sent to have endoscopy surgery. I then started the recovery process.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test, Surgery
Clinical narrative: I had my last booster in September, which was Pfizer, and all the other vaccines were Moderna. I started having very mild cold symptoms. I took a COVID-19 test on Tuesday and then Thursday I took a COVID-19 at home test. On this day I called my doctor, and I was given PAXLOVID, and I took it for five days, and then on Christmas Day I had a belly ache. I started to vomit blood in big amounts then this happened repeatedly for the next 4-5 hours and then I stopped. The next day I was very weak, so I called my doctor that was listed but nobody was in the office because of the holiday. I called the doctor and reached them on December 27, I was then sent to have endoscopy surgery. I then started the recovery process.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy breast abnormal, Breast calcifications, Breast cancer female, Breast conserving surgery, Breast enlargement
Clinical narrative: In late October, I felt some warmth in my left breast. It also appeared larger. I wasn't in any pain, and I had a mammogram coming up on 10/27/2022. They said that they saw some calcification that didn't look normal, so they wanted me to come back for a diagnostic mammogram on 11/16/2022. The result of that was that something abnormal was going on and they wanted to follow up with a biopsy on 12/06/2022. I found out later that day that I had a condition called DCIS in stage zero. I met with a surgeon on 12/23/2022. I was told I could do a lumpectomy or mastectomy. I elected the lumpectomy and had that on 01/19/2023. I had to have a second surgery on 02/07/2023 because one of the margins did not come clean. I am now receiving radiation treatment. Today was day 7 of 20.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling hot, Intraductal proliferative breast lesion, Mammogram abnormal, Radiotherapy
Clinical narrative: In late October, I felt some warmth in my left breast. It also appeared larger. I wasn't in any pain, and I had a mammogram coming up on 10/27/2022. They said that they saw some calcification that didn't look normal, so they wanted me to come back for a diagnostic mammogram on 11/16/2022. The result of that was that something abnormal was going on and they wanted to follow up with a biopsy on 12/06/2022. I found out later that day that I had a condition called DCIS in stage zero. I met with a surgeon on 12/23/2022. I was told I could do a lumpectomy or mastectomy. I elected the lumpectomy and had that on 01/19/2023. I had to have a second surgery on 02/07/2023 because one of the margins did not come clean. I am now receiving radiation treatment. Today was day 7 of 20.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Dyspnoea
Clinical narrative: I had a lot of fatigue with a headache, sore throat and mild cold symptoms. I also had a mild cough. I contacted my doctor on the day I got the positive test results. She started me on PAXLOVID which I started on the 17th since my daughter was positive for COVID-19 and I am considered high. My symptoms remained mild. I had a low-grade fever. I continued to have mild symptoms until February 22, 2023. For 12 days I thought I had completely recovered even though I continued to have positive antigen test. I believe that I had a rebound case started on March 087, 2023. The symptoms were worse. I completely lost my taste and smell and I felt very fatigued. I never had a fever this time. I am still having symptoms like when they peaked on March 11, 2023. I do have some trouble breathing when I lie down. I have an appointment for Thursday with my primary care provider. I also had a yeast infection during this time which started around March 01, 2023. I think I still have it. I treated with MONISTAT, and it seemed to get better but now feels like it's worse.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Fungal infection, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I had a lot of fatigue with a headache, sore throat and mild cold symptoms. I also had a mild cough. I contacted my doctor on the day I got the positive test results. She started me on PAXLOVID which I started on the 17th since my daughter was positive for COVID-19 and I am considered high. My symptoms remained mild. I had a low-grade fever. I continued to have mild symptoms until February 22, 2023. For 12 days I thought I had completely recovered even though I continued to have positive antigen test. I believe that I had a rebound case started on March 087, 2023. The symptoms were worse. I completely lost my taste and smell and I felt very fatigued. I never had a fever this time. I am still having symptoms like when they peaked on March 11, 2023. I do have some trouble breathing when I lie down. I have an appointment for Thursday with my primary care provider. I also had a yeast infection during this time which started around March 01, 2023. I think I still have it. I treated with MONISTAT, and it seemed to get better but now feels like it's worse.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had a lot of fatigue with a headache, sore throat and mild cold symptoms. I also had a mild cough. I contacted my doctor on the day I got the positive test results. She started me on PAXLOVID which I started on the 17th since my daughter was positive for COVID-19 and I am considered high. My symptoms remained mild. I had a low-grade fever. I continued to have mild symptoms until February 22, 2023. For 12 days I thought I had completely recovered even though I continued to have positive antigen test. I believe that I had a rebound case started on March 087, 2023. The symptoms were worse. I completely lost my taste and smell and I felt very fatigued. I never had a fever this time. I am still having symptoms like when they peaked on March 11, 2023. I do have some trouble breathing when I lie down. I have an appointment for Thursday with my primary care provider. I also had a yeast infection during this time which started around March 01, 2023. I think I still have it. I treated with MONISTAT, and it seemed to get better but now feels like it's worse.
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Pain, Peripheral swelling, Pruritus
Clinical narrative: Day after vaccination, arm was swollen in  area the size of a mason jar, pain and itching associated
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MNQ, PNC13, RV1
Symptoms: Death
Clinical narrative: notified at approximately 3pm on Friday, March 6, 2023 infant passed away that day
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Fatigue, Feeling abnormal
Clinical narrative: I had a mild fever and chills, fatigue, muscle aches, sinus pressure, runny nose, and runny eyes. I also had phlegm drainage in the chest and a cough. This was the worst I had felt in a long time. I took a home antigen test and got a positive result. We called the doctor, and I was prescribed Paxlovid. I took the Paxlovid for five days. It wasn't about the seventh day that I noticed an improvement, though I still had some COVID-19 symptoms. On the eighth day, I felt markedly better and was able to get up and move around.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lacrimation increased, Malaise, Mobility decreased, Myalgia, Paranasal sinus discomfort
Clinical narrative: I had a mild fever and chills, fatigue, muscle aches, sinus pressure, runny nose, and runny eyes. I also had phlegm drainage in the chest and a cough. This was the worst I had felt in a long time. I took a home antigen test and got a positive result. We called the doctor, and I was prescribed Paxlovid. I took the Paxlovid for five days. It wasn't about the seventh day that I noticed an improvement, though I still had some COVID-19 symptoms. On the eighth day, I felt markedly better and was able to get up and move around.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Productive cough, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Secretion discharge
Clinical narrative: I had a mild fever and chills, fatigue, muscle aches, sinus pressure, runny nose, and runny eyes. I also had phlegm drainage in the chest and a cough. This was the worst I had felt in a long time. I took a home antigen test and got a positive result. We called the doctor, and I was prescribed Paxlovid. I took the Paxlovid for five days. It wasn't about the seventh day that I noticed an improvement, though I still had some COVID-19 symptoms. On the eighth day, I felt markedly better and was able to get up and move around.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Impaired work ability, Malaise
Clinical narrative: Around 2AM I awoke with a headache, sore throat not feeling well. I took two TYLENOL and went back to sleep. I awoke again at 6AM not feeling any better, I had a runny nose. I took a home COVID-19 test that came back positive. I called my doctor and had a telehealth visit. I was prescribed PAXLOVID, advised to take zinc 50mg, vitamin C 500mg, vitamin D 500mcg iu once a day. I was feeling better and back to work in five days as long as I wore my mask. My cough lingered for a bit but I felt much better.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Sleep disorder
Clinical narrative: Around 2AM I awoke with a headache, sore throat not feeling well. I took two TYLENOL and went back to sleep. I awoke again at 6AM not feeling any better, I had a runny nose. I took a home COVID-19 test that came back positive. I called my doctor and had a telehealth visit. I was prescribed PAXLOVID, advised to take zinc 50mg, vitamin C 500mg, vitamin D 500mcg iu once a day. I was feeling better and back to work in five days as long as I wore my mask. My cough lingered for a bit but I felt much better.
Sex: U
Vaccine: VARZOS
Symptoms: Nerve injury, Occipital neuralgia
Clinical narrative: Occipital Nerve Damage; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of occipital neuralgia 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 occipital neuralgia (Verbatim: Occipital Nerve Damage). The outcome of the occipital neuralgia was not reported.   It was unknown if the reporter considered the occipital neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the occipital neuralgia to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 This case was reported bya patient via interactive digital media. The patient had ocipital nerve damage from Shingles vaccine. The follow-up could not be possible as no contact details were available.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Tremor
Clinical narrative: redness all over body; hands shaky; feels generaly weak; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-JAN-2023, the patient received the 1st dose of Shingrix (intramuscular, right deltoid) .5 ml. On 07-FEB-2023, 33 days after receiving Shingrix, the patient experienced weakness (Verbatim: feels generaly weak). On 14-FEB-2023, the patient experienced tremor of hands (Verbatim: hands shaky). On 25-FEB-2023, the patient experienced erythema (Verbatim: redness all over body). The patient was treated with benadryl (nos) (Benadryl) and ambiguous medication nos (Claritin (Nos)). On 26-FEB-2023, the outcome of the erythema was recovered/resolved (duration 1 day). The outcome of the tremor of hands and weakness were not recovered/not resolved.   It was not reported if the reporter considered the erythema, tremor of hands and weakness to be related to Shingrix.     It was not reported if the company considered the erythema, tremor of hands and weakness to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-FEB-2023 The reporter was the patient. There was redness all over the patient's body, she went to the emergency room and the doctor gave her Benadryl and Claritin and sent her home. The redness on her body resolved by Sunday morning. The reporter mentioned that, for the past two weeks (from the reporting date) her hands were shaky and past few weeks she felt generally weak. The shaky hands and general weakness had not resolved. The reporter gave permission for GSK to contact her doctor. The reporter consented to follow up. Time to onset of tremor of hands was 40 days and erythema was 51 days with Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Myalgia
Clinical narrative: muscle aches; weakness; flu-like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included immunoglobulins nos (Ivig).   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 muscle pain (Verbatim: muscle aches), weakness (Verbatim: weakness) and influenza-like symptoms (Verbatim: flu-like symptoms). The outcome of the muscle pain, weakness and influenza-like symptoms were recovered/resolved.   It was not reported if the reporter considered the muscle pain, weakness and influenza-like symptoms to be related to Shingrix.     It was not reported if the company considered the muscle pain, weakness and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-02-2023 The caller stated her husband received dose 1 of Shingrix 2 months before date of reporting.  He experienced muscle aches and weakness and flu-like symptoms for 2 days. She stated he was immunocompromised and receives IVIG.  He would be getting dose 2 of Shingrix next month.  The caller did not want to provide any patient identifiers or demographics.  The reporter did not consent to follow-up. No additional information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema
Clinical narrative: Redness at injection site; Feel bad; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included peripheral neuropathy.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site) and feeling bad (Verbatim: Feel bad). The outcome of the injection site erythema and feeling bad were unknown.   It was not reported if the reporter considered the injection site erythema and feeling bad to be related to Shingrix.     It was not reported if the company considered the injection site erythema and feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-02-2023 HCP called on behalf of herself for information regarding if Shingrix was contraindicated in people who had peripheral Neuropathy.  During the call she mentioned that many of her colleagues usually feel bad or had redness at the injection site after receiving the Shingrix.  No additional information provided.  She just mentioned this during the conversation.  The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Neuralgia, Pain in extremity, X-ray normal
Clinical narrative: arm pain (shoulder to elbow), worse when moving arm; pain in her shoulder; Constant nerve pain (PT); Injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included knee injury.   On 27-JAN-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 27-JAN-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain). On an unknown date, the patient experienced pain in arm (Verbatim: arm pain (shoulder to elbow), worse when moving arm), shoulder pain (Verbatim: pain in her shoulder) and nerve pain (Verbatim: Constant nerve pain (PT)). The patient was treated with non-drug therapy (Physical Therapy). The outcome of the injection site pain was not recovered/not resolved and the outcome of the pain in arm, shoulder pain and nerve pain were not reported.   It was unknown if the reporter considered the injection site pain, pain in arm, shoulder pain and nerve pain to be related to Shingrix.     It was unknown if the company considered the injection site pain, pain in arm, shoulder pain and nerve pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2023 The reporter was the patient.  The patient received first dose of Shingrix vaccine. The patient experienced injection site pain. The pain had not lessened and worsened when she tried to move her arm. Sometimes it hurts from her shoulder to her elbow.  She described it as a constant nerve pain.  She saw her orthopedic doctor for a pre existing knee problem and mentioned the pain in her shoulder and arm.  The doctor took an x-ray that was normal.  The orthopedic doctor recommended physical therapy which was began on day of reporting.  No other information was reported.  The reporter did not consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: 2nd dose a month after 1st; administered subcutaneously; arm hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ms and crohn's disease. Concomitant products included cyanocobalamin (Vitamin B12) and ustekinumab (Stelara).   On 28-FEB-2023, the patient received the 2nd dose of Shingrix (intramuscular). On 28-JAN-2023, the patient received the 1st dose of Shingrix (subcutaneous, right arm). On 28-JAN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered subcutaneously). On 28-FEB-2023, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose a month after 1st). On an unknown date, the patient experienced pain in arm (Verbatim: arm hurt). The outcome of the pain in arm was recovered/resolved (duration 6 days) and the outcome of the intramuscular formulation administered by other route and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-Feb-2023 The reporter was the patient.  The patient's right arm hurt for 6 days after receiving the 1st Shingrix shot. Vitamin B12 was given intramuscular in the other arm that day also.  The patient received his second dose of Shinrix intramuscular on date of reporting, which led to shortening of vaccination schedule. The first dose was administered in his right arm and was administered subcutaneously, which led to  The patient gave consented to follow up. This might be the reason for a 1-month dosing interval.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Part of dose leaked from syringe; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Part of dose leaked from syringe). The outcome of the incomplete dose administered was not reported.   Additional Information: GSK receipt date: 28-FEB-2023 The pharmacist reported that the part of a dose of Shingrix leaked from syringe while administering the medication. The reporter did not consent to follow up. The reporter declined to provide more information. While administering the Shingrix the part of a dose of Shingrix leaked from syringe, which led to incomplete dose administered.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Third dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FE44) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (SHINGRIX).   On 28-FEB-2023, the patient received the 3rd dose of Shingrix. On 28-FEB-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Third dose administered). The outcome of the extra dose administered was not reported.   Additional Information: GSK Receipt Date: 28-FEB-2023 A medical assistant called to inform that a patient received a third dose of Shingrix earlier that day.  The second dose of Shingrix had been administered on 24 February 2023.  The vaccine administration facility was the same as primary reporter. The reporter had consent to follow-up. At the time of reporting, the patient had received his third dose of Shingrix vaccine, which had led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Malaise
Clinical narrative: This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included covid vaccines. Concurrent medical conditions included guillain-barre syndrome and multiple sclerosis. On an unknown date, the patient received the 1st dose of SHINGRIX (left arm). On an unknown date, an unknown time after receiving SHINGRIX, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms), fatigue (Verbatim: Fatigue), pain in arm (Verbatim: Intensely sore arm), feeling unwell (Verbatim: Felt sick), headache (Verbatim: Headache), shivering (Verbatim: Shivering) and muscle pain (Verbatim: Muscle Aches). The outcome of the influenza-like symptoms, fatigue, feeling unwell, headache, shivering and muscle pain were unknown and the outcome of the pain in arm was recovered/resolved (duration 5 days). It was not reported if the reporter considered the influenza-like symptoms, fatigue, pain in arm, feeling unwell, headache, shivering and muscle pain to be related to SHINGRIX. It was not reported if the company considered the influenza-like symptoms, fatigue, pain in arm, feeling unwell, headache, shivering and muscle pain to be related to SHINGRIX. Additional Information: GSK Receipt Date: 28-Feb-2023. The reporter was the patient. The patient received his first dose of SHINGRIX 1 month ago. The patient experienced muscle Aches, headache, shivering, flu-like symptoms, fatigue, felt sick, and had an intensely sore arm for 5 days. The reporter did not consent to follow-up. The patient did not wish to provide his date of birth but provided age as 73 years old. The follow up was not granted, but patient might be contacted. Sender's Comments: US-GSK-US2023033389: Same reporter; US-GSK-US2023033391: Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included covid vaccines. Concurrent medical conditions included guillain-barre syndrome and multiple sclerosis. On an unknown date, the patient received the 1st dose of SHINGRIX (left arm). On an unknown date, an unknown time after receiving SHINGRIX, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms), fatigue (Verbatim: Fatigue), pain in arm (Verbatim: Intensely sore arm), feeling unwell (Verbatim: Felt sick), headache (Verbatim: Headache), shivering (Verbatim: Shivering) and muscle pain (Verbatim: Muscle Aches). The outcome of the influenza-like symptoms, fatigue, feeling unwell, headache, shivering and muscle pain were unknown and the outcome of the pain in arm was recovered/resolved (duration 5 days). It was not reported if the reporter considered the influenza-like symptoms, fatigue, pain in arm, feeling unwell, headache, shivering and muscle pain to be related to SHINGRIX. It was not reported if the company considered the influenza-like symptoms, fatigue, pain in arm, feeling unwell, headache, shivering and muscle pain to be related to SHINGRIX. Additional Information: GSK Receipt Date: 28-Feb-2023. The reporter was the patient. The patient received his first dose of SHINGRIX 1 month ago. The patient experienced muscle Aches, headache, shivering, flu-like symptoms, fatigue, felt sick, and had an intensely sore arm for 5 days. The reporter did not consent to follow-up. The patient did not wish to provide his date of birth but provided age as 73 years old. The follow up was not granted, but patient might be contacted. Sender's Comments: US-GSK-US2023033389: Same reporter; US-GSK-US2023033391: Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Two years later January 2023 they both received dose 2 of Shingrix.; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose around October 2020.).   In JAN-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Two years later January 2023 they both received dose 2 of Shingrix.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 01-MAR-2023 The patient received Shingrix dose 1 around October 2020 and after two years later in January 2023 the patient received dose 2 of Shingrix. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule. The reporter did not want to provided any additional information. The reporter did not consent to follow up. This case is linked with US2023033410, reported by same reporter.; Sender's Comments:  US-GSK-US2023033410:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose after 4 years of 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1 st dose received more than a 4 year ago).   In DEC-2022, the patient received the 2nd dose of Shingrix. In DEC-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose after 4 years of 1st). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 02-MAR-2023 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Seizure
Clinical narrative: seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Patient had a seizure the next day after vaccine. No treatment medications was reported.  This case contains information about patient-11 out of 63 patients.  Company comment:This is a spontaneous case concerning a 80 years old female patient, with no medical history,  who experienced the unexpected serious (medically significant) AESI event of seizure, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 bivalent BA.4/ BA.5 vaccination. At the time of reporting of the outcome of the event is unknown. No further information for medical review. The benefit-risk relationship of mRNA-1273 bivalent BA.4/ BA.5 vaccination is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis
Clinical narrative: DVT in my leg; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (DVT in my leg) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT in my leg) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (DVT in my leg) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     It was reported that patient had DVT in leg 10 days after and had to visit emergency room (ER) hospital.  No treatment medications were reported.  This case contains information for the 21st of 63 patients described by the reporter.  Company comment: This spontaneous case concerns an 83 year old female patient with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Deep vein thrombosis (reported as DVT in my leg) after receiving a dose of mRNA-1273.222 bivalent vaccine. It was reported that patient had DVT in leg 10 days after and had to visit emergency room (ER) hospital. No information on risk factors, investigations, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case