chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: The patient came in for the Moderna Spikevax +12 vaccine and was asked to wait in the waiting room for 15 after the injection. The patient left without adverse event. The patient returned to the clini at 6 PM 11/14/2023 with four red whelps bilaterally under her chin; she denied itching or shortness of breath. The patient stated that she took benadryl at home. The patient was instructed to go the the emergency room if her symptoms worsened, or if she became short of breath. The patient left the clinic in no distress. The patient was called vis the phone 11/15/2023 at 8:40 AM and reported that her symptoms resolved withiin an hour of taking Benadryl; she voiced no other complaints.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Cough, Dyspnoea exertional
Clinical narrative: The patient has a history of Type II Diabetes and COPD, on 2 L O2 at baseline. He was seen in the ED on 10/12/23 for evaluation of dyspnea on exertion, dry cough, sore throat, sinus congestion, and headaches for the past day. A COVID PCR test resulted positive in the ED. Ultimately, the patient was admitted 10/12/23 - 10/14/23 for acute COPD exacerbation secondary to COVID-19 infection, among other diagnoses.   Of note, the patient has received 3 doses of the Pfizer Monovalent COVID vaccine (given 3/13/2021, 4/3/2021, 5/3/2022) and one dose of the Pfizer Bivalent COVID vaccine (given 9/20/2022).
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Oropharyngeal pain, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: The patient has a history of Type II Diabetes and COPD, on 2 L O2 at baseline. He was seen in the ED on 10/12/23 for evaluation of dyspnea on exertion, dry cough, sore throat, sinus congestion, and headaches for the past day. A COVID PCR test resulted positive in the ED. Ultimately, the patient was admitted 10/12/23 - 10/14/23 for acute COPD exacerbation secondary to COVID-19 infection, among other diagnoses.   Of note, the patient has received 3 doses of the Pfizer Monovalent COVID vaccine (given 3/13/2021, 4/3/2021, 5/3/2022) and one dose of the Pfizer Bivalent COVID vaccine (given 9/20/2022).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No  treatment , no side effects known from patient.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient given  0.5ml  dose of Moderna 6-11 y.  No adverse reaction from this.  Contacted Agency who in turn contacted CDC and I was told patient did not need another dose of vaccine.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Underdose
Clinical narrative: Pt received wrong dose of Hep B, Pt receive pediatric dose.  Called manufacture advised CDC recommended another 0.5 dose of ped hep b to complete the dose if it was on the same day.  2nd dose administered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: redness in the area about 4 centimeters in diameter
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Contusion
Clinical narrative: Bruising
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, COVID-19, COVID-19 pneumonia, Cough
Clinical narrative: The patient was brought to the ED by EMS on 10/13/23 for cough and generalized weakness. She was found to be hypoxic by EMS with O2 sats at 88% so was placed on 3L O2. A COVID PCR test was performed in the ED which resulted positive. Ultimately the patient was admitted 10/13/23 - 10/18/23, with discharge diagnoses including acute respiratory failure with hypoxia due to COVID-19 pneumonia. She was discharged to TCU, however returned to the ED on 10/19/23 and ultimately was admitted 10/19/23 - 11/4/23 with discharge diagnoses including acute respiratory failure with hypoxemia and pneumonia due to COVID-19 infection, among other diagnoses.   Of note, the patient has received three doses of the Pfizer Monovalent COVID Vaccine (given 2/24/21; 3/16/21; and 9/28/21).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, SARS-CoV-2 test positive
Clinical narrative: The patient was brought to the ED by EMS on 10/13/23 for cough and generalized weakness. She was found to be hypoxic by EMS with O2 sats at 88% so was placed on 3L O2. A COVID PCR test was performed in the ED which resulted positive. Ultimately the patient was admitted 10/13/23 - 10/18/23, with discharge diagnoses including acute respiratory failure with hypoxia due to COVID-19 pneumonia. She was discharged to TCU, however returned to the ED on 10/19/23 and ultimately was admitted 10/19/23 - 11/4/23 with discharge diagnoses including acute respiratory failure with hypoxemia and pneumonia due to COVID-19 infection, among other diagnoses.   Of note, the patient has received three doses of the Pfizer Monovalent COVID Vaccine (given 2/24/21; 3/16/21; and 9/28/21).
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Nausea, Pain in extremity
Clinical narrative: Patient was administered a Fluzone HD Vaccine on 10/24/23 per her request. Resident had already received a Fluzone HD vaccine on 9/27/23. Error was related to patient  and  PCP on 10/15/23. Patient reported on symptoms as sore arm and minor nausea on 10/25/23.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Cough, SARS-CoV-2 test positive, Sepsis
Clinical narrative: The patient was brought to the ED by EMS on 10/16/23 for weakness and a cough. In the ED, patient was found to be borderline febrile with a temperature of 100 F. A rapid COVID PCR test performed in the ED resulted positive. Ultimately, the patient was admitted 10/16/23 - 10/26/23. Discharge diagnoses included suspected sepsis secondary to UTI and COVID positive, among other diagnoses.   Of note, the patient has received the Pfizer Monovalent COVID vaccine (given 3/7/2021; 4/4/2021; 12/6/2021; 8/16/202) and the Pfizer Bivalent COVID vaccine (given 12/7/2022).
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urinary tract infection
Clinical narrative: The patient was brought to the ED by EMS on 10/16/23 for weakness and a cough. In the ED, patient was found to be borderline febrile with a temperature of 100 F. A rapid COVID PCR test performed in the ED resulted positive. Ultimately, the patient was admitted 10/16/23 - 10/26/23. Discharge diagnoses included suspected sepsis secondary to UTI and COVID positive, among other diagnoses.   Of note, the patient has received the Pfizer Monovalent COVID vaccine (given 3/7/2021; 4/4/2021; 12/6/2021; 8/16/202) and the Pfizer Bivalent COVID vaccine (given 12/7/2022).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Anal incontinence, Blood test, Lumbar puncture, Magnetic resonance imaging, Myelitis transverse
Clinical narrative: Transverse Myelitis bowel and bladder incontinent
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary incontinence
Clinical narrative: Transverse Myelitis bowel and bladder incontinent
Age: 12.0
Sex: F
Vaccine: DTAP, FLU4, HEP, IPV, MMR
Symptoms: Wrong product administered
Clinical narrative: Dad brought in daughter for vaccinations. He agreed to have her receive: MMR, Hep B, Flu, Polio, and Tdap. I inadvertently drew up and administered Dtap instead of Tdap vaccine, after administering all 5 vaccines, I then discovered the error and immediately notified my nursing supervisor. After reviewing protocol, I went and spoke with dad and daughter. I advised them of the error, and that the dose doesn't require repeat vaccination. Dad and daughter both verbalized understanding and they were both ok with it.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: nurse drew up covid vaccine with diluent, when giving vaccine to patient, nurse did not realize that the vaccine just given was 3 total doses of vaccine 0.9 ml instead of 0.3.  notified patients mother immediately and primary provider.  checked on patient multiple times that day afterward. denies any side effects or symptoms of anything.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received vaccine to soon for recommended time frame.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Arrhythmia, Chills, Headache, Lethargy
Clinical narrative: The patient began to experience chills, headache, lethargy, and arrythmia. The patient experienced these symptoms for about 3 days, and then they went away.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Tdap/adacel was indivertibly given to a child of 2 years old. No adverse reactions. Follow up made two days and seven days after administered. Parents reported no side effects.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Patient reported that during the night post vaccine, he developed hives and shortness of breath. He used home oxygen and felt better. Symptoms resolved on own without additional treatment. He went to his PCP approximately one week later.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Abdominal discomfort, Hypersomnia, Muscle spasms, Pain, Vomiting
Clinical narrative: upset stomach, pain and severe cramps, vomiting, sleeping
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Road traffic accident, Seizure, Seizure like phenomena
Clinical narrative: The patient, received two doses of the primary series of the Pfizer COVID-19 vaccines at pharmacy. The first dose of the series was given on 9/24/2021 by CPhT, under the supervision of RPh. The vaccine was administered in the left arm, had a lot number of FE3592, and expiration of 11/30/2021. The second dose of the series was given on 10/15/2021 by CPhT, under the supervision of RPh. The vaccine was administered in the left arm, had a lot number of 30145BA, and expiration of 08/31/2022.   On November 3rd, 2023, around 9:45 AM, the spouse of patient, contacted us via phone at pharmacy. She stated that her husband had received two COVID-19 vaccines from us in 2021 and developed a seizure disorder around 6 weeks after, which they believed to be an adverse effect of the vaccines. Patient saw Dr., a neurologist at medical facility, but now sees NP. She stated that NP was going to report the incident but told her to reach out to our pharmacy to report it as well. I told her that we would get in touch with NP for more details and may need to call her back for more information prior to reporting the incident. She was very pleasant and stated that she understood completely. She asked about reaching out to Pfizer about it; I told her she could, but if she wanted to get any kind of compensation from them, she would likely need a lawyer. She did not show much interest in this idea; it seemed that she simply wanted to make everyone aware of the issue. I told her thank you for reaching out to let us know and was extremely sympathetic when she talked about how hard it had been since he had his first seizure. She thanked me again for my kindness and willingness to report the incident, and that was the extent of our conversation. I filed an incident report per our company's protocol on this same day.    On Monday, November 6th, 2023, at 10:39 AM, I reached out to NP, for more information about this incident. She stated that spouse and patient felt strongly that the COVID-19 vaccines he received from us were the cause of his seizure disorder, but she told them that there was not enough data to say one way or another. NP said that on 11/30/2021, the patient had a loss of consciousness and showed seizure-like activity at home. He was transported to hospital via ambulance and was started on levetiracetam 1,000 mg twice daily. This was his first and last known seizure; he has been treated prophylactically ever since. He followed up with Dr., a neurologist at medical facility, on 12/15/2021.  In March of 2022, he started seeing NP and stayed on the levetiracetam until June 29, 2022, when they started to titrate his dose down to start him on lamotrigine. He is still taking lamotrigine for this indication. NP did state that the patient had a motor vehicle accident in July of 2021, during which he had a ?close-hit injury? and flipped his jeep. She said he followed up with his primary care provider, following the wreck and the only note she saw was that he had a broken finger.  NP also added that this patient works at agency.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart issues
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Patient stated redness and swelling that is spreading on her arm. There appears to be a bump at the injection site, per patient. No puss or fever at this time, but area is warm to the touch. Advised patient to use a cold compress and to take Benadryl. If symptoms do not improve after 2-3 days to report to providers office (patient did speak to provider prior to calling pharmacy)
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Erythema of eyelid, Periorbital swelling, Swelling of eyelid, Tenderness
Clinical narrative: Puffy, tender and red eyelid and around the eye.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Flushing, Headache
Clinical narrative: 2-3 days after the vaccine I felt tired and felt a strange malaise feeling and I had a low grade fever. I had the fever for about a 1-1.5 weeks. I feel flushed now but no fever. I feel irritable and fatigued. I have headaches with sharp pain in the side of my head that is mild to moderate. I take Tylenol and aspirin to get rid of it. Body/muscle aches. It has been 2 weeks of this now. Very dizzy and unsteady.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: 2-3 days after the vaccine I felt tired and felt a strange malaise feeling and I had a low grade fever. I had the fever for about a 1-1.5 weeks. I feel flushed now but no fever. I feel irritable and fatigued. I have headaches with sharp pain in the side of my head that is mild to moderate. I take Tylenol and aspirin to get rid of it. Body/muscle aches. It has been 2 weeks of this now. Very dizzy and unsteady.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, COVID-19 pneumonia, Dizziness, Leukopenia
Clinical narrative: The patient was seen in the ED on 10/17/23 for dizziness and generalized weakness. Additionally, in the ED she was found to be mildly febrile. A COVID PCR test performed in the ED resulted positive. Ultimately, she was admitted 10/17/23 - 10/20/23. Discharge diagnoses included generalized weakness secondary to COVID+; COIVD pneumonia ruled out; and leukopenia, moderate, likely secondary to COVID. During her admission, the patient was not started on steroids as she was non-hypoxic.   Of note, the patient has received four doses of the Moderna Monovalent COVID vaccine (given 2/12/21; 3/12/21; 11/16/21; and 4/27/22) and one dose of the Moderna Bivalent COVID vaccine (given 11/29/22).
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: The patient was seen in the ED on 10/17/23 for dizziness and generalized weakness. Additionally, in the ED she was found to be mildly febrile. A COVID PCR test performed in the ED resulted positive. Ultimately, she was admitted 10/17/23 - 10/20/23. Discharge diagnoses included generalized weakness secondary to COVID+; COIVD pneumonia ruled out; and leukopenia, moderate, likely secondary to COVID. During her admission, the patient was not started on steroids as she was non-hypoxic.   Of note, the patient has received four doses of the Moderna Monovalent COVID vaccine (given 2/12/21; 3/12/21; 11/16/21; and 4/27/22) and one dose of the Moderna Bivalent COVID vaccine (given 11/29/22).
Age: 1.33
Sex: F
Vaccine: COVID19, DTAP, FLU4, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error, Underdose
Clinical narrative: 16-month-old female given covid-19 pfizer vaccine for ages 5-11 years of age 0.3ml not diluted.  No reaction or adverse event has occurred from this incorrect dose. No changes to health as reported by parent at time of event and follow up call today 11/15/23 parent reports no concerns.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient had full body rash one day after vaccination that went away 2 days after appearing. 15 days later, patient developed a 1.5 cm diameter erythematous region at the injection site with two raised areas.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Headache, Injection site swelling, Nausea, Peripheral swelling
Clinical narrative: Fever, headache, swelling around injection site (arm/neck/shoulder), nausea, brain fog
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever, headache, swelling around injection site (arm/neck/shoulder), nausea, brain fog
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: Vaccine was administered too low on the deltoid muscle, resulting in large redness and pain at the injection site for 5+ days
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received incorrect vaccine at vaccine clinic. Patient was scheduled to received a covid vaccine, but received a flu vaccine. Patient had already received his flu vaccine a month prior on 10/12.; received extra dose
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat irritation, Urticaria
Clinical narrative: After waiting the 15 minute observation period the patient, informed that her throat was feeling itchy. The provider, DNP, was notified and noticed that the patient was also developing hives on her chest. The provider then ordered 125mg of Solu-Medrol and 50mg of Diphenhydramine to be administered to the patient via injection. The provider also okayed water to be given to the patient. Patient was then observed for an additional 20 minutes.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative
Clinical narrative: I am reaching out as I have a relative who recently mentioned that she got a MMR titer that showed no immunity for measles or mumps; I am reaching out as I have a relative who recently mentioned that she got a MMR titer that showed no immunity for measles or mumps; This spontaneous report was received from a company representative and refers to a 47-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (dose, route of administration, anatomical location, lot # and expiration date were not provided). On an unknown date, the patient got Measles, Mumps and Rubella (MMR) titer test that showed no immunity for measles or mumps (measles antibody negative; mumps antibody test negative). Outcome of the events was unknown.  Causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA000897:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse calling to report that a dose of PNEUMOVAX 23 was administered after its labeled expiration date.; This spontaneous report was received from a nurse regarding a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-OCT-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, (lot number W007035 has been verified to be a valid lot number, expiration date reported and validated as 20-OCT-2023) (expired product administered) administered for prophylaxis (vaccination scheme, anatomical location and route of administration were not provided). The product did not undergo a temperature excursion and there was no adverse event.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of expired MMR-II to a patient. Product expired on 23SEPT2023 and was administered on 02NOV2023.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-NOV-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) injection, therapy type: rHA, valid lot #U029793, expiration date: 23-SEP-2023, administered for prophylaxis (strength and route of administration were not provided) (Expired product administered). No additional adverse event was reported (No adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: There are no side effects or symptoms/No further AE information; PNEUMOVAX 23 was given 10/23/2023. The dose Expired on 10/20/2023; This spontaneous report was received from a pharmacist and refers to a patient of a not reported age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of  0.5ml, lot #W007035, expiration date: 20-OCT-2023, administered as prophylaxis (strength, and route of administration were not provided) (Expired vaccine used ). It was reported that there were no side effects or symptom.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported.; The nurse is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 24-OCT-2023, the patient received a improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot #x019553, expiration date: 19-JAN-2025) administered for prophylaxis (strength, and route of administration were not provided) (Improper storage of product in use). The administered dose of the vaccine was stored at a temperature of -9.2 degrees Celsius (C), for a time frame of 1 hour and 7 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient involved did not report any symptoms or medical concerns related to the administration of the expired PNEUMOVAX 23.; Medical Assistant calling to report expired administration of PNEUMOVAX 23.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 13-NOV-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (0.5 mL / once, lot#: W015900, expiration date: 20-OCT-2023; strength and route of administration were not reported) by a health professional for prophylaxis (expired product administered). The patient was aware the expired problem told by the physician. The patient involved did not report any symptoms or medical concerns related to the administration of the expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23). No additional information provided regarding this adverse event (no adverse event).
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: ATRIAL FIBRILLATION; This 70-year-old female subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, right deltoid) .5 ml on 07-OCT-2023, for prophylaxis. The subject received the 1st dose of Hz/su + AS01B (intramuscular, right deltoid) .5 ml on 07-OCT-2023, for prophylaxis.   The subject's past medical history included diastasis of muscle, neurofibroma (LEFT FOOT), uterine fibroid, chronic suppurative otitis media, inguinal hernia, tonsillectomy, adenoidectomy, cesarean section (CEASEAN), cesarean section, subtotal hysterectomy (PARTIAL), neurofibroma (LEFT FOOT REMOVAL), inguinal hernia repair, tummy tuck and mastopexy (BREAST LIFT). Concurrent medical conditions included hypocholesteremia, herpes simplex type ii, asthma, bronchospasm (ALLERGY RELATED), cataract (BILATERAL), osteoarthritis (BILATERAL KNEES AND HANDS) and seasonal allergy. Concomitant products included fluticasone furoate + vilanterol trifenatate (Breo Ellipta), montelukast, pravastatin, levocetirizine, fluticasone, meloxicam, fexofenadine, cetirizine hydrochloride (Cetrizine) and salbutamol (Albuterol Inhaler).   On 31-OCT-2023, 24 days after receiving RSVPreF3 vaccine + AS01E and Hz/su + AS01B, the subject developed atrial fibrillation (Verbatim: ATRIAL FIBRILLATION). Serious criteria included hospitalization. The subject was treated with flecainide, apixaban (Eliquis), moxifloxacin and prednisone. The action taken with RSVPreF3 vaccine + AS01E and Hz/su + AS01B was no change. The outcome of atrial fibrillation was resolved on 31-OCT-2023.   It was unknown if the investigator considered the atrial fibrillation to be related to RSVPreF3 vaccine + AS01E and Hz/su + AS01B.   The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. It was unknown if the company considered the atrial fibrillation to be related to Hz/su + AS01B.   GSK receipt date: 10-NOV-2023; Sender's Comments: Company Clinical Comment: The company considers that there was no reasonable possibility that the pancreatitis may have been caused by the study drug. The patient's medical history/risk factors could be considered as confounding factors.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: pain at injection site; Fatigue for two days following administration, pain at injection site for two days; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-SEP-2023, the patient received the 1st dose of Shingrix. On 01-SEP-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site) and fatigue (Verbatim: Fatigue for two days following administration, pain at injection site for two days). On 03-SEP-2023, the outcome of the injection site pain and fatigue were resolved (duration 2 days).   The reporter considered the injection site pain and fatigue to be related to Shingrix.     The company considered the injection site pain and fatigue to be related to Shingrix.   Additional Information: GSK receipt date:05-NOV-2023 The reporter reported that seriousness for fatigue for two days after administration, pain at injection site for two days was non serious. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I got both of mine painful but not as painful as the Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2023AMR118278.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: I got both of mine painful but not as painful as the Shingles).  Rechallenge with Shingrix was positive. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR118278   Additional Information: GSK Receipt Date: 29-AUG-2023 The case was received from the patient via interactive digital media. The patient received both her Shingrix vaccine which was painful. It was not as painful as Shingles. She stated that the people she knew had shingles were like it was so painful. The patient asked to get vaccinated.  The follow-up would not required per process; Sender's Comments:  US-GSK-US2023AMR118278:Same patient / Shingrix dose 1st
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Decreased appetite, Feeling abnormal
Clinical narrative: stomach was very upset; stomach painful; I am weak; nausea; loss of appetite; Sick with nausea; felt a little bad; This non-serious case was reported by a consumer and described the occurrence of upset stomach in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st July 2023 and felt cruddy but no stomach issues refer linked case US2023AMR157970).   On 01-NOV-2023, the patient received the 2nd dose of Shingrix. On 01-NOV-2023, less than a day after receiving Shingrix, the patient experienced feeling bad (Verbatim: felt a little bad). On 02-NOV-2023, the patient experienced upset stomach (Verbatim: stomach was very upset), stomach pain (Verbatim: stomach painful), weakness (Verbatim: I am weak), nausea (Verbatim: nausea), appetite lost (Verbatim: loss of appetite) and sickness (Verbatim: Sick with nausea). The outcome of the upset stomach, stomach pain, sickness and feeling bad were not reported and the outcome of the weakness, nausea and appetite lost were not resolved.   It was unknown if the reporter considered the upset stomach, stomach pain, weakness, nausea, appetite lost, sickness and feeling bad to be related to Shingrix.     It was unknown if the company considered the upset stomach, stomach pain, weakness, nausea, appetite lost, sickness and feeling bad to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR157970   Additional Information: GSK Receipt Date: 05-Nov-2023 and 07-Nov-2023 The patient was self-reported this case. The patient reported that he received 2nd dose of Shingrix vaccine on last Wednesday and on the same day in afternoon and in night he felt a little bad and then from the next day and every day he experienced stomach was very upset and painful usually in the evening after he eat.  Patient cannot eat very much at all so he was weak. The patient stated that on 2nd November 2023, 1 day after received Shingrix vaccine experienced felt sick with nausea and loss of appetite which was unresolved. Patient was planning a long flight on Tuesday and he was not sure he can go if he still feel this way.  The reporter wanted to know if is this normal, and how long will this last. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR157970:Same Patient Same reporter Different Dose
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Nausea
Clinical narrative: stomach was very upset; stomach painful; I am weak; nausea; loss of appetite; Sick with nausea; felt a little bad; This non-serious case was reported by a consumer and described the occurrence of upset stomach in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st July 2023 and felt cruddy but no stomach issues refer linked case US2023AMR157970).   On 01-NOV-2023, the patient received the 2nd dose of Shingrix. On 01-NOV-2023, less than a day after receiving Shingrix, the patient experienced feeling bad (Verbatim: felt a little bad). On 02-NOV-2023, the patient experienced upset stomach (Verbatim: stomach was very upset), stomach pain (Verbatim: stomach painful), weakness (Verbatim: I am weak), nausea (Verbatim: nausea), appetite lost (Verbatim: loss of appetite) and sickness (Verbatim: Sick with nausea). The outcome of the upset stomach, stomach pain, sickness and feeling bad were not reported and the outcome of the weakness, nausea and appetite lost were not resolved.   It was unknown if the reporter considered the upset stomach, stomach pain, weakness, nausea, appetite lost, sickness and feeling bad to be related to Shingrix.     It was unknown if the company considered the upset stomach, stomach pain, weakness, nausea, appetite lost, sickness and feeling bad to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR157970   Additional Information: GSK Receipt Date: 05-Nov-2023 and 07-Nov-2023 The patient was self-reported this case. The patient reported that he received 2nd dose of Shingrix vaccine on last Wednesday and on the same day in afternoon and in night he felt a little bad and then from the next day and every day he experienced stomach was very upset and painful usually in the evening after he eat.  Patient cannot eat very much at all so he was weak. The patient stated that on 2nd November 2023, 1 day after received Shingrix vaccine experienced felt sick with nausea and loss of appetite which was unresolved. Patient was planning a long flight on Tuesday and he was not sure he can go if he still feel this way.  The reporter wanted to know if is this normal, and how long will this last. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR157970:Same Patient Same reporter Different Dose
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Erythema
Clinical narrative: erythema/redness; discomfort; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 3 days after receiving Shingrix, the patient experienced erythema (Verbatim: erythema/redness) and discomfort (Verbatim: discomfort). The outcome of the erythema and discomfort were resolved.   It was unknown if the reporter considered the erythema and discomfort to be related to Shingrix.     It was unknown if the company considered the erythema and discomfort to be related to Shingrix.   Additional Information: GSK Receipt Date- 06-NOV-2023 The physician reported that he had erythema and discomfort 3 days after first Shingrix vaccine administration. Redness and discomfort resolved without intervention in both cases. This case was linked with US2023AMR154563 reported by the same reporter for different patient. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2023AMR154563:Same Reporter
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: vaccine by mistake- she is 34 weeks pregnant; This non-serious prospective pregnancy case was reported by a consumer via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: vaccine by mistake- she is 34 weeks pregnant). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 07-NOV-2023 The case was reported by patient's husband. The patient received Arexvy. The patient received vaccine by mistake and she was 34 weeks pregnant. She received from the pharmaceutical information which showed there was a clinical study done on pregnant woman.  The reporter needed the results of that study to know what other side effects and they need to look out for.  The reporter had called multiple times. The reporter wanted information for his wife's sake and his unborn daughters sake and asked to get that information.  The reporter just want to know what to look out for concerning the wrong vaccine and what side effects to consider, how this would impact birth, lactation and the child's health. The reporter wanted this information to be passed that his wife had doctor appointment the day after reporting and he was hoping some answers to get then.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Should I do about getting the second dose now; 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 (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: Should I do about getting the second dose now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-Nov-2023 The patient was self-reported this case. The reporter reported that he or she received first dose of Shingles vaccine but they had no recollection of it in their data. The patient did not know if it was been longer than six months or not. The reporter asked what should he or she do about receiving the second dose now. Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Injection site swollen; Injection site red; knuckles and wrist and became very sore; painful; traveling down her arm into her phalanges between knuckles; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-SEP-2023, the patient received the 1st dose of Shingrix (left arm). In SEP-2023, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: painful) and radiating pain (Verbatim: traveling down her arm into her phalanges between knuckles). On an unknown date, the patient experienced injection site swelling (Verbatim: Injection site swollen), injection site erythema (Verbatim: Injection site red) and wrist pain (Verbatim: knuckles and wrist and became very sore). The outcome of the injection site swelling and injection site erythema were unknown and the outcome of the injection site pain, radiating pain and wrist pain were resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, radiating pain and wrist pain to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site erythema, injection site pain, radiating pain and wrist pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-NOV-2023 The consumer was the reporter stated that had her 1st Shingrix vaccination.    The reporter stated the injection site was swollen, red and painful.   Reported that 3 days after receiving the Shingrix vaccine the injection site pain began traveling down her arm into her phalanges between knuckles and wrist and became very sore.   The pain resolved about one month later. The consumer declined to provide any demographics or any information for her physician. The reporter did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Respiratory disorder
Clinical narrative: Respiratory issues; This serious case was reported by a physician via sales rep and described the occurrence of respiratory disorder in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced respiratory disorder (Verbatim: Respiratory issues) (serious criteria hospitalization). The outcome of the respiratory disorder was unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Arexvy.     It was unknown if the company considered the respiratory disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-NOV-2023 An GSK sales representative called on behalf of healthcare professional (MD). The healthcare professional reported that a couple of patients were hospitalized with respiratory issues after receiving the RSV vaccine (Unknown manufacturer). Adverse event filed with limited information. The reporter did not consent to follow-up. The healthcare professional provided very limited information. The reporter did not know which RSV vaccine the patients received (GSK or Pfizer). The healthcare professional did not wish to follow up with Safety.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient received a dose of Hiberix which had expired on August 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Hib (Hiberix) (expiry date 31-AUG-2023) for prophylaxis.   On 06-NOV-2023, the patient received Hiberix. On 06-NOV-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: patient received a dose of Hiberix which had expired on August 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 7-NOV-2023 A pharmacy intern reported that patient received a dose of Hiberix in unknown facility and the dose had expired on August 2023. There was no patient data available just that the patient would be getting a splenectomy done. The reporter did not consent to follow up. The patient received an expired dose of Hiberix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Possible extra dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years ago) and Shingrix (2nd dose received 5 years ago).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Possible extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 07-NOV-2023 The pharmacist reported on November 7th 2023 that male patient might have received 2 doses of Shingrix in the past (around 5 years ago) but was not sure about it and would like to know what safety information was available after the administration of a 3rd dose. The vaccine administration facility was the same as primary reporter. No patient's identifiers other than male over 65 years of age were provided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got her first shot of Shingrix over 3 years ago; 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 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TA92, expiry date 29-SEP-2025) for prophylaxis.   Previously administered products included Shingrix (first shot of Shingrix over 3 years ago).   On 07-NOV-2023, the patient received the 2nd dose of Shingrix. On 07-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: got her first shot of Shingrix over 3 years ago). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 07-NOV-2023 The patient that got her 1st shot of Shingrix over 3 years ago.   No further details available about patient restarting of the 2nd dose. Reporter stated the patient told her this happened at the time of the COVID-19 pandemic and when patient called the pharmacy where patient had received the first dose, they saying they did not have any Shingrix in stock eventually the patient stopped calling. The patient received the 2nd dose after the vaccination period, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: HEPAB, HEPAB, HEPAB
Symptoms: Hepatitis A antibody negative
Clinical narrative: antibody titer for Hep A did not worked; This non-serious case was reported by a nurse via call center representative and described the occurrence of hepatitis a antibody negative in a 66-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included HAB (Twinrix adult) for prophylaxis and HAB (Twinrix adult) for prophylaxis.   On 26-SEP-2023, the patient received the 3rd dose of Twinrix adult. On 20-APR-2023, the patient received the 2nd dose of Twinrix adult. On 20-MAR-2023, the patient received the 1st dose of Twinrix adult. On an unknown date, more than a month after receiving Twinrix adult, more than 6 months after receiving Twinrix adult and between 7 and 8 months after receiving Twinrix adult, the patient experienced hepatitis a antibody negative (Verbatim: antibody titer for Hep A did not worked). The outcome of the hepatitis a antibody negative was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 07-NOV-2023 The registered nurse called to inquire that at 12 months, can we give the Hep A or how to proceed. The registered nurse reported a patient received the first, second and third dose of Twinrix. and stated that they ran labs and the antibody titer measures showed Hepatitis B worked and the Hep A did not. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the first dose of Shingrix on September 19th 2023 and the second dose was administered on October 12th 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number Y2229, expiry date 16-SEP-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 12-OCT-2023, the patient received the 2nd dose of Shingrix. On 12-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received the first dose of Shingrix on September 19th 2023 and the second dose was administered on October 12th 2023.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 07-NOV-2023 The pharmacist reported that a patient received the 1st dose of Shingrix and the 2nd dose was administered on. The vaccine administration facility was the same as primary reporter. The patient received the 2nd dose earlier than the schedule, which led to shortening of vaccination schedule.  The reporter did not consent to follow-up.