chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound kidney, Ventricular extrasystoles, Vomiting, White blood cell count increased
Clinical narrative: Dec. 20, 2020 - respiratory illness, chest xray normal , given antibiotics and prednisone Dec 25, 2020- went to ER could not breath, chest Xray showed pneumonia, given IV medication, nebulizers, sent home with medication  January 2021 elevated WBC and Liver enzymes  July 2022 - had mild respiratory illness tehn diagnosed with pneumonia  , one week later , ascending shaking in legs, loss of relfexes wrist and knee, was given MRI with and without contrast brain and spine, ruled out MS, Parkinsons, tumors. Neurological symptoms of unsteady gait, loss of reflexes, and memory issues , severe fatigue August 2022- was given B12 injections to help with fatigue and nerve issues, 2 weeks later leg shaking resolved and fatigue somewhat  resolved Nov 2022- Mild respiratory infection, turned into pneumonia, 11/27-12/1 High WBCS and CRP legs shaking nad then felt chest pain , heart racing as well, resolved after about 4-6 wks January 26th, 2023 ? at work,legs felt week, stated to shake, then had tunnel vision , chest pain, went to urgent care then told to go to ER , went to hospital, CT scan no abnormalities, however high WBCs and CRP no cardiac event as per troponin levels  February 12th, 2023- felt fatigued all day, had a mild cold with congestion for a few days, went to sleep early, was awakened by my sick child , went down stairs to assist her, my husband asked if I was ok , I said yes just felt my heart racing, I was ashen gray, I turned to walk up the stairs my brain knew how to but my legs would not work, I crawled up on flight of stairs, then sat and turned around, I was completely grey, I flt numb from my legs and it went up, my heart was racing, my neck could not suppott my heads weight then I heard a gun shot in my head, I went backwards and was unconscious, EMS arrived, I was awake but couldn?t really talk, I was slurring, I was severely hypotensive and had tachycardia, I was taken to hospital and was given CT scan, all normal , WBC count was high and CRP .  I followed up with cardiolost who stated my heart and arteries are WNL but did have some PVCs and tachycardia.  On 2/26 and 3/1 more blood testing ordered still  WBCs and CRP increased from previous blood work. Legs began to shake and resolved after 4 weeks.  10/1/23 - felt hot, had high fever , went to urgent care next day 10/2 confirmed pnuemonia 10/18 my left pupil was dalltated and not constricting went to  primary physician on 10/18 eye doctor on 10/19  10/29 legs felt weak , started to shake, neck could not support my head, could not stay awake, was slurring words, taken to ER , told not a stroke or heart issue, reflexes were diminished, could not lift legs, could not swallow liquids  10/30 slept all day and do not recall any events that day 10/31 ataxia, mixing words up, could not keep head up, lift legs, swallow liquids, did not know if and when vomiting would occur ( already in mouth when it happened) legs shaking , unsteady gait again  Saw Neurologist 11/10 confirmed CIPD from vaccine
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Hives appeared Sunday evening. More hives on Monday morning and night. Hives and swollen lips Tuesday morning.  Had Decadron injected at urgent care. Was on Prednisone and Benadryl for more than a week.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient states that shortly after he received his flu vaccine he developed a rash inside of his right elbow and that it itched at first but no longer itches.  He states that the rash is no longer itching but is still persistant.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site. Applied ice and resolved in 24 hours
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient came in to receive the 5-11yo Pfizer vaccine (which was the product billed and entered). The patient was administered Comirnaty 12+ Pfizer vaccine. The mother of the patient was contacted as soon as the error was discovered later that evening after the patient had left. The mother reported no adverse effects at that time, though she was told to monitor and follow up with the child's PCP as the child has a history of epilepsy.
Age: 30.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Arthralgia, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: fever, muscle aches, joint pain: lasted for 4 days following the vaccination nausea and vomiting: occurred on days 2 and 3 following the vaccination fatigue: lasted for 5 days following the vaccination
Age: 30.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Vomiting
Clinical narrative: fever, muscle aches, joint pain: lasted for 4 days following the vaccination nausea and vomiting: occurred on days 2 and 3 following the vaccination fatigue: lasted for 5 days following the vaccination
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Immediate post-injection reaction, Pain in extremity, Wrong product administered
Clinical narrative: Requested a COVID shot.  Filled out paperwork/consent for a COVID shot.  Was accidentally given flu shot by the MA who was not paying attention.  Spoke to the pharmacist afterwards who was made aware of the mistake. Staff does not appear to see the gravity of the situation of giving a patient the wrong vaccination without consent.   During the injection, felt severe pain and burning in my left arm and numbness in my left hand.  Unable to tell if will have further adverse events as I just received the shot without my consent yesterday.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Atrioventricular block complete, Cardioversion, Dizziness, Intensive care, Nausea
Clinical narrative: On the same day the patient received the vaccine, developed dizziness and nausea, and went to Hospital, found to have complete heart block. Received IV epinephrine and then transferred to Hospital and admitted into the ICU. Cardiologists initiated IV isoproterenol which converted back into sinus rhythm.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Sinus rhythm
Clinical narrative: On the same day the patient received the vaccine, developed dizziness and nausea, and went to Hospital, found to have complete heart block. Received IV epinephrine and then transferred to Hospital and admitted into the ICU. Cardiologists initiated IV isoproterenol which converted back into sinus rhythm.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Lymphadenopathy, Tenderness
Clinical narrative: Breast and axillary area tenderness with lymph node swelling started on the day of the day I received the vaccine.  The swelling of my lymph nodes resolved after 4 weeks, but my breast and underarm are still tender.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Pain, Sleep disorder
Clinical narrative: Dose received at ~3pm. That night I woke up at ~1am with severe joint pain in fingers on both hands, ankle & elbow. I tried stretching & rotating joints with no relief of symptoms. Took 250mg acetaminophen and fell back asleep. Woke up at 5am with relief of joint pain but sensitivity to touch at injection site with some redness. Some pain while raising right arm above head to reach items.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient reports muscle arm pain and stiffness 5 days post immunization.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: redness and swelling with warmth to site. treated with loratadine and keflex
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a vaccine that was supposed to be for an older age.
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS, VARZOS
Symptoms: Erythema, Injection site pallor, Pain, Pruritus, Swelling
Clinical narrative: SWELLING  3 INCHES BY 2 INCHES, REDNESS, PAIN. FEVER OF 100 DEGREES THE DAY AFTER THE INJECTION, WITH TOTAL BODY ACHES. THE AREA IS STILL RED AND TENDER 3 WEEKS AND 2 DAYS LATER, BUT LESS SO. THERE'S ALSO A SMALL WHITE CIRCLE AROUND THE NEEDLE INSERTION SITE. SOME ITCHING.
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS, VARZOS
Symptoms: Tenderness
Clinical narrative: SWELLING  3 INCHES BY 2 INCHES, REDNESS, PAIN. FEVER OF 100 DEGREES THE DAY AFTER THE INJECTION, WITH TOTAL BODY ACHES. THE AREA IS STILL RED AND TENDER 3 WEEKS AND 2 DAYS LATER, BUT LESS SO. THERE'S ALSO A SMALL WHITE CIRCLE AROUND THE NEEDLE INSERTION SITE. SOME ITCHING.
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: SWELLING  3 INCHES BY 2 INCHES, REDNESS, PAIN. FEVER OF 100 DEGREES THE DAY AFTER THE INJECTION, WITH TOTAL BODY ACHES. THE AREA IS STILL RED AND TENDER 3 WEEKS AND 2 DAYS LATER, BUT LESS SO. THERE'S ALSO A SMALL WHITE CIRCLE AROUND THE NEEDLE INSERTION SITE. SOME ITCHING.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Current age = 11. Child given the 12+ dosage instead of the 5-11 dosage. No adverse reactions at time of injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: She had shingles outbreak right neck and arm 1 day after Shingrix vaccine 2nd dose.  Also had Tdap the same day on the right arm.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12+ vaccine given instead of the 6 months-11 year old vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient has a flat rash/red area that has grown in size in last 24 hours, is warm and accompanied by increasing soreness in the arm.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Pharmacist administered vaccine without reconstituting with the diluent. Pharmacist called mom to inform mom regarding the error. Patient does not live near the store and was going to come on a future date. It has been about one month and patient has not been back,
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Patient received Spikevax 12+ BPK 23-24 INJ on 10-23-23. Patient states she began having seizures on approximately 11-12-23. Was hospitalized for one week. Is now discharged and home. States previous to this she had no history of seizures. Does not know why she had seizures and patient is looking into all possibilities, including recent vaccines. States the hospitalists did not know what the seizures. According to State Registry, patient has had 3 previous Moderna Covid vaccines (this was her fourth covid vaccine). Has not had a reaction before.
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Was given Arexvy instead of FDA approved Abrysvo
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Chills, Oropharyngeal pain, Pyrexia, Stomatitis
Clinical narrative: Patient experienced fever/chills. Loss of taste. Mouth sores and a sore throat.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Aptyalism, Bell's palsy, Ear pain, Facial paresis
Clinical narrative: Patient experienced fever/chills. Loss of taste. Mouth sores and a sore throat.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeding disorder, Glossodynia, Oropharyngeal pain, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Patient experienced fever/chills. Loss of taste. Mouth sores and a sore throat.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Weight decreased
Clinical narrative: Patient experienced fever/chills. Loss of taste. Mouth sores and a sore throat.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Tinnitus
Clinical narrative: slight dizziness and right ear ringing noise
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Pyrexia
Clinical narrative: weakness - unable to stand - slight fever
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Allergy test, Urticaria
Clinical narrative: Random hives breakouts only on neck
Age: 46.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered expired Tdap vaccine. Patient had no adverse reactions.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt came in for 4 month vaccines on 7/10/23. Pt was due for Dtap, Hib, and Polio. Pt should have received a Pentacel but instead was given a Kinrix which is for 4 years and older. Pt has not had any reactions from this vaccine. This was found by billing. We will contact pt and they will be coming back to receive a hib vaccine. I have reported this to CDC which advised pt does not need to be revaccinated.
Age: 80.0
Sex: M
Vaccine: COVID19-2, FLUA4, RSV, VARZOS
Symptoms: Gait disturbance, Lethargy
Clinical narrative: Next day after receiving vaccine administration, patient stated having a "shuffle" step in his walk. Patient felt lethargic.
Age: 1.75
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: patient received 2nd flu vaccine in same year. Pt already had flu vaccine in 9/2023. Pt did not need 2nd dose. Already received 2 doses on 12/5/22 and 1/5/23 - as initial flu dose.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Moderna Spikevax vaccine for 12+ years old was administered to this 9 year old.  Family notified.  No known adverse effects.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: Rash appeared on left elbow then right elbow then near armpits, legs, hips, thighs ankles, abdomen and last breasts. All areas had varring levels of itching. Over the counter topical caladryl was able to reduce the itching. Red spots remain still. Rash was raised but not pustules occured.
Age: 45.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: "Pt reports R arm redness and swelling noted starting this morning. Also notes they had some vomiting yesterday following appointment and this morning, as well. They had the same issue with a shingles vaccine they received from Walmart 4-5 years ago. Reports 3/4 inch area of redness and swelling at injection site. This nurse recommended OTC Benadryl and increased monitoring of symptoms. Pt verbalizes understanding of symptoms concerning for ED visit."
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Back pain, Injection site pain, Myalgia
Clinical narrative: Low energy and muscular and joint pain in my neck and back, as well as pain at the injection site starting the day after the injection and ending Saturday morning.
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Induced labour, Premature delivery, Preterm premature rupture of membranes
Clinical narrative: PPROM - Water broke the next day at 34 weeks pregnant. I had to be induced because I wasn't dialated or having contractions. My son was born at 11:58 PM weighing 4 lbs 15 oz.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Muscle pain at injection site from time of injection. It is difficult to dress and undress. I talked to a pharmacist and he said it is unusual to have pain this far out from injection.
Age: 8.0
Sex: M
Vaccine: HPV9, IPV, MNQ
Symptoms: Wrong product administered
Clinical narrative: MA was about to give vaccinations to the patients. Translator stepped out of the room. MA verified name and DOB with patient's sister who MA was under the impression that she understood language but she did not. Wrong name and DOB was verified. When RN came into the room MA had verified pts name and DOB and told RN this patient was to get these shots. Pt was crying and screaming, RN and MA help father and sister give shots to the patient. Afterwards family said they though the patient was to only get 2 shots that is when MA looked at the order again and realized they had given the wrong vaccines to the patient. MD was notified and stated that the vaccines will not cause any medical harm to the patient, although he is not due for the three additional vaccines he received. Family was notified, MD sat when them and went over the vaccines and answered any questions that they had. Family verbalized understanding and stated they have no further questions or concerns regarding the matter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Chills, muscle aches and headache. Lasted  less than 24 hours
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU4, COVID19
Symptoms: Chest pain, Myocardial infarction
Clinical narrative: pt left the office and had chest pain within an hour, he went to the ER was told he had Myocardial infarction.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU4, COVID19
Symptoms: Blood test, Catheterisation cardiac, Electrocardiogram, Myocardial infarction
Clinical narrative: pt left the office and had chest pain within an hour, he went to the ER was told he had Myocardial infarction.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU4, COVID19
Symptoms: Myocardial infarction
Clinical narrative: pt left the office and had chest pain within an hour, he went to the ER was told he had Myocardial infarction.
Age: 79.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called the pharmacy on 11/27/2023 stating that his arm has been very sore since getting vaccinated on 10/31/2023. Patient has not been able to raise his arm above his head. Told patient to take tylenol , do stretches and alternate applying heat and ice to injection area. Advised patient that if pain did not resolve, patient would need to see a physician.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was ordered 10/11/2023 and was received 10/16/2023. Upon receiving vaccine, it was stored in the medication fridge (not freezer). Vaccine was given to patient on 11/27/2023 after the 30 days Beyond Use Date of thawed medication.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed that patient did not report any symptoms from administration of expired dose; administration of PNEUMOVAX-23 past expiration; HCP states that vaccine had a temperature excursion on 18-OCT-2023; This spontaneous report was received from a medical assistant and refers to a 74-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-NOV-2023, the patient was administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) formulation reported as injection, upon internal review, established as prefilled syringe, 0.5 milliliter/ once, lot #W007035, expiration date: 20-OCT-2023 (Expired product administered) (vaccination schedule, site and route of administration were not provided) for prophylaxis. The administered dose experienced a temperature excursion of 46.62 F for 15 minutes on 18-OCT-2023 (Product storage error). It was confirmed that patient did not report any symptoms from administration of expired dose and he felt fine. No additional information, no additional adverse event (AE).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions reported.; HBP calling on behalf of an HCP to report Expiry dose of ROTATEQ that was administered to patient.  No adverse reactions reported.  No PQC.; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions and concomitant medications was provided.  On 14-NOV-2023 the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # W004502 and expiration date 09-OCT-2023, for prophylaxis (exact dose, dose number and route of administration were not provided) (expired product administered and no adverse event).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: There were no side effects, adverse outcomes, or unexpected reactions experienced by the patient; A called to report a TE for PEDVAX HIB (Lot #W032686; expiration 06/12/2025) that had been administered to the patient on 11/27/2023.  The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous ex; This spontaneous report was received from an offer manager and refers to a 15-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-NOV-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, lot #W032686, expiration date: 12-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 33.15 Farenheit for 1 hours nad 8 minutes on 18-NOV-2023 with zero previous excursions (Product storage error). No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Breast feeding, No adverse event
Clinical narrative: Received Heplisav-B While Breastfeeding; Initial report received on 11-Sep-2023.  An advanced nurse practitioner (ANP) reported that a 29 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization who is breastfeeding.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 11-Sep-23, the patient received the first dose of HEPLISAV-B (Lot #943007, expiration date 30-Sep-25, and NDC # 43528-003-01) intramuscularly in the right arm.   On 11-Sep-23, the same day as having been vaccinated with HEPLISAV-B, the patient was noted to having been in the 7th month of breastfeeding post delivery of an infant. No adverse effects have been reported.  No additional information was reported.   Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received First Dose of Heplisav-B and Second Dose 8 Days Later; Initial report received on 29-Sep-2023  A nurse reported that a 35 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient received a second dose of Heplisav-B eight days later.  No relevant medical history was reported.   No relevant concomitant medications were reported.    On 21-Sep-23, the patient received the first dose of HEPLISAV-B (Lot # 941428, expiration date 30-Apr-2025, and NDC # 43528-003-01) in the left arm.  On 29-Sep-23, eight days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 943010, expiration date 31-Oct-2025, and NDC # 43528-003-01) in the left arm.  No additional information was reported.   Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: little painful when pressed for a few days; vaccination spot on my arm was swollen; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In NOV-2023, the patient received Shingles vaccine. In NOV-2023, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: little painful when pressed for a few days) and injection site swelling (Verbatim: vaccination spot on my arm was swollen). The outcome of the injection site pain and injection site swelling were resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain and injection site swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-NOV-2023 This case was reported by a patient via (social media) interactive digital media. The patient received the Shingles vaccine a week ago from reporting and the vaccination spot on the patient's arm was swollen and a little painful when pressed for a few days but now the patient was back to normal. The reporter reported that very minimal side effects.  Reporter highly recommended getting the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: The second dose hurts more; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of pain (received first dose of Shingles vaccine on an unknown date and first one hurts, refer case US2023AMR163010).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: The second dose hurts more). Rechallenge with Shingles vaccine was positive. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR163010   Additional Information: GSK Receipt Date: 20-NOV-2023 This case was reported by a consumer via (social media) interactive digital media. The patient already had Shingles vaccine because it repeated. The reporter stated that second hurts more. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR163010:case for first dose
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received his first dose and never came back for the 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix in July-2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received his first dose and never came back for the 2nd dose.). The outcome of the incomplete course of vaccination 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: 20-NOV-2023 The pharmacist reported that he had a patient who received his first dose of Twinrix  and never came back for the 2nd dose. The reporter consented to follow up via mail. Till the time of reporting, the patient did not receive 2nd dose of Twinrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Dr reported below temp excursions for vaccines: Bexsero, Flulaval, Havrix, Pediarix, Boostrix, Infanrix, Engerix-B; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified numbers of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   In OCT-2023, the patients received Bexsero, FluLaval Quadrivalent 2023-2024 season, Havrix, Pediarix, Boostrix, Infanrix and Engerix B. On an unknown date, an unknown time after receiving Bexsero, FluLaval Quadrivalent 2023-2024 season, Havrix, Pediarix, Boostrix, Infanrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Dr reported below temp excursions for vaccines: Bexsero, Flulaval, Havrix, Pediarix, Boostrix, Infanrix, Engerix-B). The outcome of the incorrect storage of drug 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: 20-NOV-2023 The reporter reported that below temperature excursions for vaccines Bexsero, Flulaval, Havrix, Pediarix, Boostrix, Infanrix, Engerix-B Low, 30.7 F. which led to incorrect storage of drug. The all vaccines were administered to patients between the 9th October 2023 and 23rd October 2023. The reporter was unable to provide exact number of patients or any demographic details at time of call. The reporter was consented to follow up.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Influenza like illness, Malaise, Seizure, Tic
Clinical narrative: seizures; Autonomic, autoimmune and neurological injuries and resulting sequelae; tics; Autonomic, autoimmune and neurological injuries and resulting sequelae; he received his first dosage of Gardasil on August and on november 21 2018 his second dose; Information has been received from a lawyer regarding a case in litigation concerning a 11 years old male patient. His concurrent conditions, medical history and concomitant therapies were not provided.  On 01-AUG-2017, the patient's health care provider, recommended that patient receive the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)vaccine, which was touted as a safe and effective vaccine for preventing cervical cancer. Then on the same date (01-AUG-2017), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   In light of patient's doctor's recommendations, the patient's mother consented to patient being injected with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). Then, on 21-NOV-2018, the patient received his second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).   After his second dose, on unspecified dates, the patient began experiencing general malaise, fatigue and flu-like symptoms. He later began experiencing face, jaw, neck tics, and later suffered a seizure. As the months progressed, so did patient's symptoms. He was seen by multiple physicians and specialists for his complaints which now included neck and facial tics and seizures. As a result of his post-Gardasil symptoms, patient has been unable to engage in activities that a normal young person would enjoy. The patient has anxiety about if and/or when he would have a seizure, especially if it happens in a social setting with his friends. He must take medication regularly to control his symptoms. He continued to have tics. Based upon his chronic and severe post-Gardasil symptoms, patient has been diagnosed with various medical conditions, including but not limited to, seizures and tics. The patient suffered and continued to suffer severe and permanent physical injuries and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. At the reporting time, the patient had not recovered from the adverse events.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.  The reporter considered all events to be disabling.
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old female patient was supposed to receive Boostrix vaccine but was inadvertently administered Kinrix instead; 11 year old female patient was supposed to receive Boostrix vaccine but was inadvertently administered Kinrix instead; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 20-NOV-2023, the patient received Kinrix. On 20-NOV-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: 11 year old female patient was supposed to receive Boostrix vaccine but was inadvertently administered Kinrix instead) and inappropriate age at vaccine administration (Verbatim: 11 year old female patient was supposed to receive Boostrix vaccine but was inadvertently administered Kinrix instead). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 20-NOV-2023 The office manager reported that a patient was supposed to receive Boostrix vaccine but was inadvertently administered Kinrix instead, which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Inadvertently administered only the adjuvant portion of Arexvy; Inadvertently administered only the adjuvant portion of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number BA332, expiry date 04-MAR-2025) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Inadvertently administered only the adjuvant portion of Arexvy) and inappropriate dose of vaccine administered (Verbatim: Inadvertently administered only the adjuvant portion of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-Nov-2023 Only adjuvant of Arexvy vaccine inadvertently administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter could not provided any patient demographics.  This case was 1 of 3 cases for the patient reported by same reporter. The reporter did consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient was administered just the adjuvant portion of Shingrix; patient was administered just the adjuvant portion of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: patient was administered just the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient was administered just the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 20-NOV-2023 The pharmacist reported that a patient was administered just the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The healthcare professional had no details at time of call. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: the usage of Arexvy in pregnant patients after a nurse accidentally administered a dose; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4L5M7) for prophylaxis.   On 10-NOV-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: the usage of Arexvy in pregnant patients after a nurse accidentally administered a dose). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 21-NOV-2023 The reporter was a OBGYN (obstetrics and gynaecology). The reporter inquired about Arexvy and what information was available about the usage of Arexvy in pregnant patients after a nurse accidentally administered a dose to patient.  The vaccine administration facility was the same as primary reporter. The healthcare professional was unsure if they could give consent for follow-up. This case was 1 of 5 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023161828:same reporter, Different patient US-GSK-US2023161829:same reporter, Different patient US-GSK-US2023161825:same reporter, Different patient US-GSK-US2023161830:same reporter, Different patient
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Administration to a pregnant patient; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4L5M7) for prophylaxis.   On 20-NOV-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Administration to a pregnant patient). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 20-NOV-2023 A OBGYN contacted GSK via phone inquiring about Arexvy and what information is available about the usage of Arexvy in pregnant patients after a nurse accidentally administered a dose to 5 patients. The healthcare professional was unsure if they could give consent for follow-up.  The vaccine administration facility is the same as primary reporter. Agreed to have call escalated to team. This case is one out of 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023161828:Different patient US-GSK-US2023161829:Different patient
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Gait disturbance, Inappropriate schedule of product administration, Pain
Clinical narrative: right side of body was sore and achy; lower back was sore; difficulty walking; 1st dose on Mar 2022 and 2nd dose on 17 Nov 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (on March 2022 received 1st dose).   On 17-NOV-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 17-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on Mar 2022 and 2nd dose on 17 Nov 2023). On 18-NOV-2023, the patient experienced general body pain (Verbatim: right side of body was sore and achy), sore back (Verbatim: lower back was sore) and walking difficulty (Verbatim: difficulty walking). The outcome of the general body pain, sore back and walking difficulty were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the general body pain, sore back and walking difficulty to be related to Shingrix.     It was unknown if the company considered the general body pain, sore back and walking difficulty to be related to Shingrix.   Additional Information: GSK Receipt date: 21-NOV-2023 The patient was self-reported. Patient stated about 10 hours receiving her vaccine she noticed she had difficulty walking and her right side of body was sore and achy and mentioned that her lower back was sore.  The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose given to adult; pediatric dose given to adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   Previously administered products included Engerix B (On an unspecified date the patient received 1st dose).   On an unknown date, the patient received the 2nd dose of Engerix B pediatric 10 ug. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: pediatric dose given to adult) and adult use of a child product (Verbatim: pediatric dose given to adult). The outcome of the underdose and adult use of a child product were 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: 22-NOV-2023 The reporter reported that he/she had a patient who completed the 3 dose Engerix series and upon review it was discovered that her second dose was a paediatric dose (10 mcg instead of 20) which led to adult use of a child product and underdose. He/she need for his/her quality team information on if this was dangerous to the patient or not emailed to him/her so he/she could place it in their chart and the reporter stated that if any recommendations GSK could provide would be great. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. No further details available.
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain, Prostatic disorder
Clinical narrative: lost my ability to use the arm; all of a sudden now my right leg has gone till bananas; my prostate has gone bananas; I have hurt so bad; This spontaneous case was reported by a patient and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (lost my ability to use the arm), LIMB DISCOMFORT (all of a sudden now my right leg has gone till bananas), PROSTATIC DISORDER (my prostate has gone bananas) and PAIN (I have hurt so bad) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (lost my ability to use the arm), LIMB DISCOMFORT (all of a sudden now my right leg has gone till bananas), PROSTATIC DISORDER (my prostate has gone bananas) and PAIN (I have hurt so bad). At the time of the report, INJECTED LIMB MOBILITY DECREASED (lost my ability to use the arm), LIMB DISCOMFORT (all of a sudden now my right leg has gone till bananas), PROSTATIC DISORDER (my prostate has gone bananas) and PAIN (I have hurt so bad) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant and treatment medications were not reported.  Reported that patient have had lots of problems since modern virus vaccine has been injection in his arm and lost his ability to use the arm. It's been 15 months all of a sudden now right leg has gone till bananas his prostate has gone bananas and somebody needs to fix it. Patient was tired of this and reported that he was hurt so bad and was concerned cutting his throat.
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy
Clinical narrative: Had a swollen axillary lymph node; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Had a swollen axillary lymph node) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced LYMPHADENOPATHY (Had a swollen axillary lymph node). At the time of the report, LYMPHADENOPATHY (Had a swollen axillary lymph node) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) (No recent changes in condition status (i.e. significant worsening or improvement; treatment changes, etc). Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), Sulfonamide allergy (Sulfa, Sulfer), Egg allergy, Allergy to antibiotic (Z-pack antibiotic) and Allergy to antibiotic.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Unknown date in 2022, Patient received third dose of Moderna covid-19 vaccine.  Treatment medication was not reported.