chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, X-ray normal
Clinical narrative: The patient claims that 3 to 4 days after receiving the flu vaccine at our vaccination center, her arm began to swell and hurt. She states that she went to her primary care physician and was given pain medication, but saw no improvement. Her husband came to the pharmacy and was recommended to take (Aleve "Naproxen"). Naproxen provided a lot of relief, but time passed and the patient still has pain, inflammation, and feels that the pain is reaching her leg. The patient had to go to the emergency room yesterday, January 2, 2025. The patient has been in this situation for over a month now. She was prescribed Ultracet, Indometacin, and Medrol dose pack. At the pharmacy, she was recommended that if the treatment is not effective, she should visit a physiatrist.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Cough, sore throat x3 weeks
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection after vaccination
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Cough, Nasal congestion, Pain, SARS-CoV-2 test
Clinical narrative: Cough, chest aches, dry cough, nasal congestion, body aches
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection after vaccination
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Exposure during pregnancy, Heart rate irregular
Clinical narrative: 33 weeks pregnant at time of vaccine. Due date Feb 16 2025. Uncomplicated. Adverse event was irregular heart rhythm and breathlessness starting at 1130 PM   Lasted for about 30-45 minutes. I verified irregular heart rhythm with my Omren blood pressure cuff and it picked it up as well. Heart rate was normal. Once my heart was back in rhythm nothing else happened. I had an OB appt the next day and brought it up.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt got Boostrix in 01/31/24 and received another vaccine on 01/03/25. Pt is fine, he is okay and has had no adverse reaction
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic dilatation, Cardiomegaly, Computerised tomogram heart abnormal, Laboratory test
Clinical narrative: Pt says on 8/1/24 she was getting her calcium scoring and there was an indidental finding that it was low. She was asked if she had shortness of breath or trouble breathing. She had mulitple test and was dx with mild cardiomegaly aortic ectasia of the ascending aorta measuring up to 4.2 centameters. She was prescibed lisinapril. This is all new dx for her since being vaccinated. She will follow up after taking up medication after taking this mediciation after a month and will have more of these test in july or aug 2025. She is hoping that she has started treament early enough to have not caused permanent damage.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Pain, Pain in extremity
Clinical narrative: He started feeling pain in his arm that radiated to his wrist and hand, which continued for 30 hours. He took so Ibuprofen and it relieved the pain some what. He has no symptoms or anything now.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received second dose of RSV vaccine.  First dose received in Oct 2023
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pediatric dose was administered to adult in error.
Age: 0.67
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Fatigue, Lethargy, Pallor
Clinical narrative: Fatigued in the afternoon. Episode of increased lethargy and pale skin around 7:30. Patients lips turned white.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: pt says about 10 days after getting vaccine she was itching and developed hives. She had already started weining herself off the bromelain papain natural supplement and noticed she was starting to itch but then after the vaccine she now has the hives. She started using oatmeal wash in her bath to help ease the itch. She had red welps on her left side of her torso that she was treating with aloe and lotion.  After going to bed it erupted on the right side of her torso.  Her symptoms are worse at night. She went to see her doctor and was prescribed hydroxyzine. She will follow up after taking meds if needed.
Age: 67.0
Sex: F
Vaccine: IPV, TYP
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site erythema, Pain
Clinical narrative: Patient noted a quarter sized bruise at injection side and red area approx. 3? in same location that continued to get worse causing limited mobility of arm.  Client saw Urgent Care on 12/27/24 and began a 5 day course of Prednisone.  Patient followed up with primary care physician on 01/03/2025 and reported to this provider that PCP determined there was not a frozen shoulder or infection noted at this time.  The patient reports gradual improvement of pain, bruising and redness.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Tinnitus, Constant Ringing and Muffled Sound in Right Ear, Varies in Volume
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patient stated they had redness and swelling to the size of "a golf ball" at the site
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: stated arm is still sore since September
Age: 76.0
Sex: F
Vaccine: FLU3, PNC20, RSV
Symptoms: Arthralgia, Arthritis, Neck pain, Pain in extremity
Clinical narrative: Patient has Arthritis. Patient took RSV ,Prevnar 20,and Flu vaccines at the same day , same arm. patient suffered from  arm , shoulder , and neck pain
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: the pharmacist that administered the vaccine only gave the patient two vials of the adjuvant instead of the active component of the vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Blood test, Electromyogram abnormal, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Pt  had a EMG where they found a blockage in his neck and then had surgery on Dec 5th 2021.  After his extensive rehab period his doctor referred him to other doctors for further treatment and testing. He started loosing the muscle between the index fingers and the thumbs on both hands. DX was muscle atrophy and is now on active treatment for ALS. (motor neuron disease) He continues to pursue doctors for treatment and to confirm other diagnosis. He will be going to clinic on Jan 22 for an further eval.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle atrophy, Spinal operation
Clinical narrative: Pt  had a EMG where they found a blockage in his neck and then had surgery on Dec 5th 2021.  After his extensive rehab period his doctor referred him to other doctors for further treatment and testing. He started loosing the muscle between the index fingers and the thumbs on both hands. DX was muscle atrophy and is now on active treatment for ALS. (motor neuron disease) He continues to pursue doctors for treatment and to confirm other diagnosis. He will be going to clinic on Jan 22 for an further eval.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Head injury, Headache, Loss of consciousness
Clinical narrative: Vaccination was given. Pt left the treatment area and went to nursing station to make a follow up appointment. Per mom, she signaled to her that she was going to pass out, then she went down. She hit her head on the floor. She came around quickly with no need to use any inhalants. Cold pack was applied to head. No open wounds noted. CNP on staff notified and she examined pt. She was given juice and sat up  on her own. She then stood up and said she was fine but her head hurt. Tylenol samples given to mom for future use. Instructed to go to ER if further complications, ie continued HA or vomiting.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Arexvy vaccine on 1/2/25. Patient had previously received vaccine on 12/29/2023. Patient had no reaction or any complication.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site swelling, Injection site warmth, Ocular hyperaemia, Pruritus
Clinical narrative: 12-02-24, the evening of the immunization, the left deltoid swelled-up, warm to touch and low fever for 1 day . There were some itchy splotches on the face .  When examined 2 days later, 12-04-24, there was no shortness of breath and no edema.  Treatment included discussing care at length, ordered Benadryl and Tylenol as needed for fever or pain. Ice to arm.  Follow-up 2 days later, on 12-06-2024, there was redness of eyes, some hives on neck, decreased swelling and redness on arm.  Patient was still taking Benadryl at this time.  Patient had no previous adverse events with vaccinations.  Referral made to allergy/immunology and has appointment scheduled for 02-19-2025.  On 01-03-2025, parent reports that there is no longer any issues from this adverse event and patient is fin.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Urticaria
Clinical narrative: 12-02-24, the evening of the immunization, the left deltoid swelled-up, warm to touch and low fever for 1 day . There were some itchy splotches on the face .  When examined 2 days later, 12-04-24, there was no shortness of breath and no edema.  Treatment included discussing care at length, ordered Benadryl and Tylenol as needed for fever or pain. Ice to arm.  Follow-up 2 days later, on 12-06-2024, there was redness of eyes, some hives on neck, decreased swelling and redness on arm.  Patient was still taking Benadryl at this time.  Patient had no previous adverse events with vaccinations.  Referral made to allergy/immunology and has appointment scheduled for 02-19-2025.  On 01-03-2025, parent reports that there is no longer any issues from this adverse event and patient is fin.
Age: 1.08
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Pyrexia
Clinical narrative: Difficulty Breathing, Cough, & Low-Grade Fever about 10 Hours after the vaccine was administered.  Treated with humidifier, saline mist 3 days after the vaccine required a nebulizer treatment and oral prednisone. Symptoms significantly improved on day 4. By day 5 her cough, fever, & respiratory distress resolved.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal discomfort, Headache
Clinical narrative: Pt. reports a headache  treated with Tylenol, upset stomach that was made better by eating something.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is 63, received high dose flu shot
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: LOCALIZED SWELLING OF INJECTION SITE
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse affect. Patient received first dose on 12/24/24 in this office. Patient vomited immediatly after getting the oral vaccine. Patient was brought back in today for another dose.  After completing the dose, talked with employee at the health department and was educated that even with vomiting that another dose should not have been administered.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient asked for a flu shot at the pharmacy on 1/2/25. On 1/3/25, it was discovered that the patient already received a dose this season on 9/20/24. Patient was not experiencing any adverse reactions for the additional vaccine per her phone call with the pharmacist today.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already received this vaccine in October 2023. Patient was unaware that only one vaccination for RSV is needed. Patient received an additional RSV vaccine on 12/30/24. Patient was notified on 01/02/25 and has not had any adverse reactions from receiving additional dose.
Age: 50.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Mobility decreased, Pain, Skin warm, Swelling
Clinical narrative: Patient had vaccine Saturday, felt pain initially, and increased in swelling and soreness on Sunday. By Monday, he states he could not lift his arm without pain. Wednesday redness and swelling increasing. Friday at MD appt, MD said warm to touch and was concerned about infection, prescribed antibiotic.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt came in for vaccines, nurse was in hurry and did not pay attention that 4th dose of polio was not due at time because child was only 1. Pt was given Pentacel, MMR, Varicella,  and PCV. Pt had with no reaction, no issues, dose did not count, just given too soon.
Age: 50.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Arthralgia, Contusion, Pain in extremity, Peripheral swelling
Clinical narrative: The patient called the pharmacy to report side effects. Patient describes dime size bruising on injection arm, soreness, the area feeling swollen, and joint pain. The patient said the onset happened shortly after administration and is continuing. The patient was instructed to use an ice pack and to go into their provider or seek other medical attention if no relief, bothersome, or worsening symptoms.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The high dose influenza vaccine was administered instead of the regular dose. Patient had no symptoms when he left the clinic and when called to inform him of the incident he was still asymptomatic.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Arexvy dispensed to a 35 year old female pt who was 32 weeks pregnant. Arexvy is not indicated by the FDA for this use, the product Abrysvo should have been administered in its place
Age: 57.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Agraphia, Alexia, Aphasia, Atrial fibrillation, Cardiac ablation
Clinical narrative: Left temporal CVA.  Right arm flaccid, aphasia.  I still have word searching, and reading and writing comprehension is still an issue, however improved.  I went into afib, and I have since had an ablation.  I had an inflammatory response after the 2nd dose causing orbital swelling, 3 days after injection
Age: 57.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Cerebrovascular accident, Hypotonia, Inflammation, Magnetic resonance imaging, Orbital swelling
Clinical narrative: Left temporal CVA.  Right arm flaccid, aphasia.  I still have word searching, and reading and writing comprehension is still an issue, however improved.  I went into afib, and I have since had an ablation.  I had an inflammatory response after the 2nd dose causing orbital swelling, 3 days after injection
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: pt was pregnant, was given Arexvy instead of Abrysvo
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Incorrect dose given for age
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Administered to a pateint during a potential temperature excursion due to a shipping issue; Administered to a pateint during a potential temperature excursion due to a shipping issue; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 05-DEC-2024, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). The shipment of the product hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was received on the same day. The shipment might have been delayed in transit and the vaccine may no longer be viable (Product storage error; Product distribution issue). There was no additional adverse event (AE) or product quality complaint (PQC) reported.   Follow up information was received from the nurse practitioner on 18-DEC-2024.  This spontaneous report was regarding a 19-year-old female patient. There was no illness at time of vaccination. On 05-DEC-2024, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #Y007322, expiration date: 18-AUG-2026, administered intramuscularly in the deltoid for prophylaxis (strength was not provided) then after they were noticed of temperature excursion during delivery (also reported as temperature not maintained during delivery)
Sex: M
Vaccine: VARZOS
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This serious case was reported by a consumer and described the occurrence of pericarditis in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAY-2024, the patient received Shingrix. On 05-MAY-2024, 2 days after receiving Shingrix, the patient experienced pericarditis (Verbatim: Pericarditis) (serious criteria hospitalization and GSK medically significant). On 09-MAY-2024, the outcome of the pericarditis was resolved with sequelae.   It was unknown if the reporter considered the pericarditis to be related to Shingrix.     The company considered the pericarditis to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 20-DEC-2024 The case was self reported by patient. The patient received Shingrix vaccine and experienced pericarditis.; Sender's Comments: Pericarditis is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: RVX
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of fatigue in a 74-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included cardiovascular syncope. Concomitant products included diltiazem.   On 06-DEC-2024, the patient received RSV vaccine. In DEC-2024, an unknown time after receiving RSV vaccine, the patient experienced fatigue (Verbatim: Extreme fatigue). The outcome of the fatigue was resolving.   It was unknown if the reporter considered the fatigue to be related to RSV vaccine.     It was unknown if the company considered the fatigue to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 08-DEC-2024 The case was reported by the patient. The patient experienced extreme fatigue. The symptoms were not treated.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Headache, Herpes zoster, Pruritus
Clinical narrative: shingles on the left side of my nose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of facial herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced facial herpes zoster (Verbatim: shingles on the left side of my nose). The patient was treated with aluminium sulfate, calcium acetate (Domeboro). The outcome of the facial herpes zoster was resolving.   It was unknown if the reporter considered the facial herpes zoster to be related to Shingles vaccine.     It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-DEC-2024  The case was received from the patient via interactive digital media. The reporter reported that got the first shot but before it was time for the second shot he/she got shingles on the left side of my nose.  The reporter went to the physician the next day.  The physician gave reporter something for the shingles and told me to get Domeboro.  The reporter reported, maybe he/she got a mild case or the Domeboro did its job.  As soon as the reporter started using that the itching mostly stopped and the blisters were drying up.  The reporter reported that the after effects were that he/she get headaches on the left side and were killer.  The physician told the reporter that he/she didn't need to get the second shot at the time of reporting.  The reporter said the reporter must had gotten stressed recently and that caused him/her to get the shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Depressed mood, Pain
Clinical narrative: it hurts/it makes you feel achy; it makes you feel  droopy; This non-serious case was reported by a consumer and described the occurrence of pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: it hurts/it makes you feel achy) and feeling down (Verbatim: it makes you feel  droopy). The outcome of the pain and feeling down were resolved.   The reporter considered the pain and feeling down to be related to Shingrix.     The company considered the pain and feeling down to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-DEC-2024 The reporter reporting that while discussing the Shingrix vaccine the patient stated that It was a hot vaccine, it hurts, it makes you feel achy and droopy. The patient reported that she received the vaccine in the Spring of 2021, exact date was unknown. No additional details were provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 20-DEC-2024 This case was reported by a patient via interactive digital media. Reporter reported that he/she had both shots and still got Shingles.  He/she was in his/her 3rd month of pain. This case was considered as suspected vaccination failure as details regarding completion of time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.  The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Incorrect dose administered, Occupational exposure to product
Clinical narrative: Occupational exposure (eye and mouth contact); Occupational exposure (eye and mouth contact); Occupational exposure (eye and mouth contact); Incomplete dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inadvertent exposure to vaccine in a 30-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-DEC-2024, the patient received Shingrix. On 04-DEC-2024, an unknown time after receiving Shingrix, the patient experienced inadvertent exposure to vaccine (Verbatim: Occupational exposure (eye and mouth contact)), exposure via eye contact (Verbatim: Occupational exposure (eye and mouth contact)), exposure via skin contact (Verbatim: Occupational exposure (eye and mouth contact)) and incomplete dose administered (Verbatim: Incomplete dose administered). The outcome of the inadvertent exposure to vaccine, exposure via eye contact, exposure via skin contact and incomplete dose administered were unknown.   Additional Information: GSK Receipt Date: 04-DEC-2024 A Pharmacist reported that he/she was administering a vaccination, and withdrawing the Shingrix vaccine, and then reconstitute it and then essentially, while after withdrawing it and mixed it using a new syringe to withdraw the mixed product, and then essentially they was trying to get the air bubble blew out, when doing that had pushed too much and then a little bit of the vaccine went into eye and mouth, which led to inadvertent exposure to vaccine, exposure via skin contact, exposure via eye contact. It was on right eye and then my mouth. Did not consent to follow-up. The pharmacist (the reporter) had an occupational exposure while handling the Shingrix vaccine, he let us know that this situation occurred, and set the same date on suspect vaccine section, however this did not mean that he get the vaccine, which led to incomplete dose administered.
Sex: U
Vaccine: RSV
Symptoms: Intercepted product prescribing error
Clinical narrative: Doctor's prescription for RSV vaccine second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose of RSV vaccine last year in 2023).   On an unknown date, the patient did not receive the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product prescribing error (Verbatim: Doctor's prescription for RSV vaccine second dose). The outcome of the intercepted product prescribing error was unknown.   Additional Information: GSK Receipt Date: 04-DEC-2024 The pharmacist reported that, a patient who had received an RSV (Arexvy) vaccine last year, the physician wrote a RX (prescribed) for another RSV, which led to an intercepted product prescribing error. The reporter wanted to know was it a onetime dose, or could it be given yearly. The vaccine administration facility was the same as primary reporter. This case was linked with case US2020039862 from the same reporter.; Sender's Comments:  US-GSK-US2020039862:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: muscle pain was and she said it was mostly my right leg and hip and a little bit: lower left leg; soreness of injected arm; it did keep her from sleeping/which made it difficult to sleep; This non-serious case was reported by a consumer via call center representative and described the occurrence of myalgia of lower extremities in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-DEC-2024, the patient received the 1st dose of Shingrix (unknown arm). In DEC-2024, less than a day after receiving Shingrix, the patient experienced myalgia of lower extremities (Verbatim: muscle pain was and she said it was mostly my right leg and hip and a little bit: lower left leg), pain in arm (Verbatim: soreness of injected arm) and difficulty sleeping (Verbatim: it did keep her from sleeping/which made it difficult to sleep). The outcome of the myalgia of lower extremities and difficulty sleeping were unknown and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the myalgia of lower extremities, pain in arm and difficulty sleeping to be related to Shingrix.     It was unknown if the company considered the myalgia of lower extremities, pain in arm and difficulty sleeping to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-DEC-2024 The reporter reported that the patient received a Shingrix shot on Monday and experienced muscle pain, extreme muscle pain. It was at night mostly as patient relax.  Patient did not know what was causing the pain but it happened monday night and a little less frequent on tuesday night. The reporter specify the muscle pain was mostly in right leg and hip and a little bit on lower left leg. The pain was not keeping her from doing her normal daily activities but it did keep her from sleeping because turning over in bed was painful.  Reporter also mentioned that the injected arm is sore, but not painful.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This non-serious case was reported by a other health professional via sales rep and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: allergic reaction). The outcome of the allergic reaction was not resolved.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     It was unknown if the company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-DEC-2024 Reporter informed they had a patient that claimed that she was continued to experience an allergic reaction from Shingrix a year later.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product preparation error
Clinical narrative: reconstituted with sterile water and not the adjuvant component; This non-serious case was reported by a other health professional via sales rep and described the occurrence of intercepted product preparation error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product preparation error (Verbatim: reconstituted with sterile water and not the adjuvant component). The outcome of the intercepted product preparation error was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2024 The reporter asked how to proceed with a Shingrix dose that has been reconstituted with sterile water and not the adjuvant component which led to intercepted product preparation error. The dose was not administered to a patient. The reporter asked if the vaccine needs to be discarded. No further details provided by field rep who submitted inquiry.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Exposure via mucosa, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; She mistakenly got a little bit of Shingrix in her eye and her mouth; Shingrix in her eye and her mouth; Shingrix in her mouth; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number 9C5T4, expiry date 26-OCT-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration), inadvertent exposure to vaccine (Verbatim: She mistakenly got a little bit of Shingrix in her eye and her mouth), exposure via eye contact (Verbatim: Shingrix in her eye and her mouth) and exposure via oral mucosa (Verbatim: Shingrix in her mouth). The outcome of the inappropriate age at vaccine administration, exposure via eye contact and exposure via oral mucosa were unknown and the outcome of the inadvertent exposure to vaccine was unchanged.   Additional Information: GSK Receipt Date: 06-DEC-2024 The reporter was the healthcare professional, medical assistant. The reporter was also the patient. The patient was mistakenly got a little bit of Shingrix in her eye and her mouth which led to Inadvertent exposure to vaccine, Exposure via eye contact and Exposure via oral mucosa. The patient was irrigated her eye and rinsed her mouth. The patient was asymptomatic. Nothing else was reported. The patient was 26 years old which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Injection site swelling, Nausea
Clinical narrative: injection site swelling.; Extreme nausea; dizziness; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a definite number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site swelling (Verbatim: injection site swelling.), nausea (Verbatim: Extreme nausea) and dizziness (Verbatim: dizziness). The outcome of the injection site swelling, nausea and dizziness were resolved.   It was unknown if the reporter considered the injection site swelling, nausea and dizziness to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site swelling, nausea and dizziness to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 06-DEC-2024 Physician reported that she had 5 patients in the past month who had experienced extreme side effects from Bexsero and they were refusing to get the 2nd dose. The side effects were extreme nausea, dizziness, and injection site swelling. These symptoms had sometimes lasted up to a week long. Reporter stated lot numbers on the packages for these patients were different as well, so it did not sound like just a bad box. Physician had been using Bexsero since it came out and had not ever experienced this so she was curious to what was going on.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose (Shingrix) , like 5 to 10 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 to 10 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received 1st dose (Shingrix) , like 5 to 10 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-DEC-2024 The pharmacist reported that a patient received 1st dose of Shingrix like 5 to 10 years ago and asked if they have to be revaccinate or how did that worked. The reporter asked was there any information or anything. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received her 1st Shingrix dose 3 years ago; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received her 1st Shingrix dose 3 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-DEC-2024 The reporter reported that they had a patient that received her 1st Shingrix dose 3 years ago. The reporter did reviewed the prescribing information, but just wanted to verify that restarting the series was still not recommended even though it had been 3 years. The Vaccine Administration Facility was the same as Primary Reporter Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: chronic urticaria; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA CHRONIC (chronic urticaria) in a 34-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 22-Dec-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced URTICARIA CHRONIC (chronic urticaria). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at a dose of UNK, bid. At the time of the report, URTICARIA CHRONIC (chronic urticaria) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient chronic urticaria every day and it appeared after 12 days from the booster dose. There was research linking it to Spikevax and that it was a confirmed side effect. Patient was taking Benadryl twice a day to relieve the hives and dermatographia. Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms/events.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Another patient that died from the the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Another patient that died from the the Moderna vaccine) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was not performed.        For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-777341 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-777341:Case for different Patient; Reported Cause(s) of Death: Another patient that died from the the Moderna vaccine
Sex: U
Vaccine: RSV
Symptoms: Device malfunction
Clinical narrative: Abrysvo vaccine malfunction (Unknown if administered to any patient); This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "Abrysvo vaccine malfunction (Unknown if administered to any patient)".  Causality for "abrysvo vaccine malfunction (unknown if administered to any patient)" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: fever; we did not feel very well; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; MALAISE (non-serious), outcome "unknown", described as "we did not feel very well".  Additional information: When the reporter and the patient got home after their first shot, they experienced fever and did not feel very well.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400326172 same reporter/ drug, different patient;
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Paralysis
Clinical narrative: right hip replacement; had no strength in her body; paralyzed her; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in arm for covid-19 immunisation. The patient can't recall which arm. The reporter informed that the vaccination facility type was Pharmacy. The patient's relevant medical history included: "cervical myelopathy surgery", start date: 2021 (unspecified if ongoing), notes: probably 3 years ago; "glaucoma" (ongoing); "Asthma" (ongoing); "cervical myelopathy" (ongoing), notes: still had compression in neck for too long. MRI and radiology and 1 doctor said she didn't have it. The patient's family history included: "osteoarthritis" (ongoing); "Osteoporosis" (ongoing). Concomitant medications included: TRAVOPROST ophthalmic taken for glaucoma (ongoing); DULERA resp inhalation taken for asthma (ongoing). The patient also took other concomitant therapy. The patient started taking travaprost a couple years ago and started taking formoterol fumarate, mometasone furoate years ago. The patient was taking supplements. Vaccination history included: Shingle vaccine (dose 1, unknown manufacturer), for immunization; Shingle vaccine (dose 2, unknown manufacturer), for immunization; Flu vaccine (dose number unknown, manufacturer unknown), for immunization; Pneumonia vaccine (dose number unknown, manufacturer unknown), for immunization. The following information was reported: HIP ARTHROPLASTY (medically significant) with onset 12Apr2024, outcome "unknown", described as "right hip replacement"; ASTHENIA (non-serious) with onset Apr2024, outcome "unknown", described as "had no strength in her body"; PARALYSIS (medically significant) with onset Apr2024, outcome "unknown", described as "paralyzed her". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Computerised tomogram: Unknown results; radiology report: Unknown results; Magnetic resonance imaging: didn't have it. The patient's first one was in Apr2024 before 12Apr2024, didn't have exact date to provide. She had right hip replacement 12Apr2024, so it was a week before that. She had a reaction which paralyzed her the next day. She was flat on her back for 2 days with a severe reaction. She got up to go to the bathroom and couldn't get off her bed or on her bed. She slid to the floor and spent the day on the floor waiting to call someone to help her. It was an incredible experience. She thought if she slid to the floor, she could hoist herself, but she had no strength in her body. The outcome was that she got over it rather completely she thought. She didn't know because she had hip surgery so not sure.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400334632 same  patient/vaccine, different dose/AE;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". Additional information: During an inbound call from a patient seeking financial assistance, the patient states, "I have COVID, and I was prescribed Paxlovid, and they told me that it was (Withheld), and this other thing is (Withheld). I don't have either one of those." The agent clarifies the reason for the call. The patient continued later in the call and stated, "Everything's fine. It's just the coughing is so bad I think that's a part of it's respiratory I never had it. I really escaped it all these years, you know, and then the last COVID shot gave me a heart attack, so I can't take COVID shots, so apparently, I shouldn't try." The patient stated "Should I be scared of this drug or what? Is it new, and do they know anything about it? I mean I took the Pfizer shot."  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400170313 same reporter/patient, different dose/event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: heart attack; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". Additional information: During an inbound call from a patient seeking financial assistance, the patient states, "I have COVID, and I was prescribed Paxlovid, and they told me that it was (Withheld), and this other thing is (Withheld). I don't have either one of those." The agent clarifies the reason for the call. The patient continued later in the call and stated, "Everything's fine. It's just the coughing is so bad I think that's a part of it's respiratory I never had it. I really escaped it all these years, you know, and then the last COVID shot gave me a heart attack, so I can't take COVID shots, so apparently, I shouldn't try." The patient stated "Should I be scared of this drug or what? Is it new, and do they know anything about it? I mean I took the Pfizer shot."  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400170313 same reporter/patient, different dose/event;