chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Approximately 12 hours after each Covid vaccine (regardless of manufacture - Moderna, Pfizer or J&J - I?ve had all 3) I had the following reactions: Headache, fever, chills (shaking), nausea and rapidly, pounding heartbeats.  I did not go to an immediate care center or sought any medical attention as I was not informed that an abnormal heart-beat was a serious side effect that would require immediate medical attention/documentation.  Having a fever and very bad headache, I wasn?t able to think clearly, so my main concern was to take something to alleviate my headache and nausea.  I took advil and drank small sips of gingerale.  It was hours before my heartbeat returned to normal - unfortunately I did not write down the exact hours. Even after returning to it?s normal beat, it would sometimes flutter or skip beats. This lasted for a few days.  The headache and nausea last for a few days.  The fever subsided after the first full day following the vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Sensory disturbance
Clinical narrative: Covid shot Nov 18 Armour 60mg 6:30 am Took Tylenol at night Nov 19  No thyroid med Tylenol again Chest Pain light left side Nov 20 Chest pain on the left side, light burning, followed by something like a butterflies or like buzzing sensación in my heart. After 10 Pm Nov 21 6:49 am 8:30 am 3:00Pm 815 PM 9:10 PM 9:21 PM Nov22 - more frequent Continues to today but light less intense
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient never presented adverse events to the vaccine, the vaccine was expired
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient never presented adverse events to the vaccine, the vaccine was expired
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: patient was given the pfizer covid vaccine for the age group <5 and patient is 5 years of age. Not sure of number in covid series of shots
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: PATEINT WAS IN FOR IMMUNIZATIONS,  DID NOT GIVE ANY INDICATION OF POSSIBLE PREGNANCY,  FOSTER MOTHER INFORMED CLINIC ON 11/30/23 THAT THE PATIENT IS PREGNANT,  UNKNOWN EDC.  HAS ULTRASOUND SCHEDULED FOR 12/5/23.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient never presented adverse events to the vaccine, the vaccine was expired
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pentacel vaccine was inadvertently given.  Family was notified.  No adverse reactions observed.
Age: 48.0
Sex: F
Vaccine: COVID19, HEP, IPV, MMR, TDAP
Symptoms: Asthenia, Decreased appetite, Headache, Menstruation irregular, Nausea
Clinical narrative: Reports headache, nausea, no appetite, weakness, irregular menstruation. Symptoms started the day after vaccination and have been intermittent and recurring  in the month since vaccination.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient never presented adverse events to the vaccine, the vaccine was expired
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient never presented adverse events to the vaccine, the vaccine was expired
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram head, Echocardiogram abnormal, Electrocardiogram, Laboratory test, Visual impairment
Clinical narrative: I was looking at the time on my cell phone and realized the left side of my visual field was blank.  I could see the :12 but not the 9 or the rest of the left side of the cell phone when the time was 9:12 am.  I shut my eyes one at a time and it was the same in both eyes.  The episode lasted about 5 minutes or so and the vision gradually started to improve.  The whole episode was no more than 10 minutes.  I did not have any pain, weakness, or other symptom.  The episode took place between November 4 and 7.  I'm not sure which day it was.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: TDAP Vaccine expired on 10/27/23. PARENT WILL BE NOTIFIED. LOCAL TEAM NOTIFIED
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Rash, Swelling
Clinical narrative: Patient developed s/s consistent with an allergic response after receiving IM injection of Fluzone.  Reaction began approximately 15 min post injection.  Patient states she had some swelling and a rash after receiving vaccine.  Patient states she took OTC Benadryl and it resolved the symptoms.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: sore arm,shoulder and neck
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Blood test, Joint range of motion decreased, Neck pain, Pain in extremity
Clinical narrative: sore arm,shoulder and neck
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dysgraphia, Gait disturbance, Hypoaesthesia
Clinical narrative: Acute dizziness, numbness, tingling hands and feet, disorientation, inability to walk alone, difficulty with mentation, writing, speaking
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Paraesthesia, Speech disorder
Clinical narrative: Acute dizziness, numbness, tingling hands and feet, disorientation, inability to walk alone, difficulty with mentation, writing, speaking
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Dad came in and we completed well child, patient was due for a few vaccines. dad only wanted to do one today and checked TDAP. we dont have DTAP here so i mistaking gave a TDAP not realizing the child was younger then 12. Was checked by other MA and not caught, Gave vaccine and went to place in system and realized she was supposed to get a DTAP instead due to age. Child did well with vaccine no reaction in clinic.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: I was pulled in as a second nurse to administer vaccinations. The vaccine coordinator and the primary nurse had looked over records to determine what vaccines were needed by the patient. Vaccinations were drawn up and ready to give as I entered the room. I double checked what vaccines I would be giving with the other nurse. I administered prepared vaccinations. When entering the data into the computer, the primary vaccination nurse noted that the Hepatitis A vaccine was determined to not be valid. Upon investigation by the vaccine coordinator, it was determined the dose of Hepatitis A that I gave on this day was given too soon, and was given only 1 month after the primary dose instead of 6 months. Patient's father was contacted today and information was relayed to him about the incident. Father states patient has not had any adverse reactions or symptoms of anything being wrong. He knows that the patient will need another dose of Hepatitis A in 6 months, which will be after May 28, 2024. He verbalizes understanding of the incident and who to contact in case of any questions or concerns.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU4, PNC20
Symptoms: No adverse event
Clinical narrative: PCP and Pt made aware. No ill effects Noted.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired MMR vaccine on 11/13/23. Medication expired 10/18/23. No harm was done. Patient contacted. Primary care provider contacted. Health department contacted.
Age: 60.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Adverse Event:  Pain after COVID vaccination. Gradual pain with gradual loss of lateral movement, progressed down to elbow, then numbness in fingers. Treatment: Steroid shot on 11/28 230pm per pt.  Temporary relief but gradual worsening again.  OTC treatments include Tylenol, Advil, and Dramamine for sleep.  Some relief with pain but not loss of movement.  Patient says next step with prescriber may be referral for therapeutic massage.
Age: 0.58
Sex: F
Vaccine: PNC20
Symptoms: Urticaria, Vaccination site erythema
Clinical narrative: Redness around vaccinated area and hives on legs
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cutaneous vasculitis
Clinical narrative: Leukocytoclastic vasculitis.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Tongue pruritus
Clinical narrative: The patient was given the immunization. Afterward she was waiting for the recommended 15 minutes in our waiting area. Within 5-10 minutes she reported that her face and tongue felt itchy. She also reported that her lips were swollen. I could not visibly see any rash, but her lips did look a bit puffy. She reported having similar reactions in the past to foods that she was allergic to. She does not carry an Epipen, and has not used one in the past. I monitored the patient closely. I offered Benadryl to the patient, but she did not want to take it. I also suggested an Epipen or calling 911, but she wanted to wait and see how things progressed. Over the next 15-20 minutes her symptoms were similar, not really progressing or fading. The patient called her mother to come pick her up. Mom arrived about 45 minutes after vaccination and took her to the ER. The patient called back 8 days later to update me on how she was doing. Per the patient she was given Benadryl, an  Epipen and a course of 4 days of steroids to treat her reaction. She states that she feels back to normal now.
Age: 47.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Underdose
Clinical narrative: This adult client  received a dose of COVID -19 Moderna 6m-11yo 2023-2024 vaccine.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Injection site pain, Speech disorder, Swelling face
Clinical narrative: Patient had no symptoms until nearly 24 hours post injection. Patient complains of pain at injection site, facial swelling, difficulty talking, tiredness and dizziness
Age: 50.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Headache, nausea, fatigue
Age: 60.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site dryness, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported redness and swelling "like a balloon" at injection site of Spikevax vaccine for several days following administration. She stated she took an antihistamine orally and symptoms reduced over a few days. States she is now experiencing dry, itchy skin around injection site.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient reported to pharmacy to receive RSV vaccine and was given shingles instead of Arexvy.  She has already received 2 doses of the shingles vaccine.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: Patient has had diarrhea starting today (the day after administration).  Patient says it is not continuous, but has been occurring throughout the day on several occasions.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Pruritus
Clinical narrative: Started having itching on left breast.  Diagnosed with breast cancer
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Condition aggravated, Dehydration, Electric shock sensation
Clinical narrative: Evening post injection: headache, chills, injection site pain. Acetaminophen taken to curb symptoms without success. Insomnia, treated with high dose melatonin.  Day 1 post injection: extreme chills, fatigue, global body and joint aches and worse than normal muscle spasms. Unable to function well; dehydration may have contributed to spasms. Injection site pain worsened to inability to lift right arm or use right shoulder. Joint (throbbing in PIP and DIP) and nerve pain (zapping feeling running to fingertips) in fingers.  Acetaminophen, cyclobenzaprine, rest, heated blanket utilized.  Day 2: extreme chills, fatigue, global body and joint aches have subsided. Right arm pain persists, though have regained some function--able to lift and movie objects. Nerve pain in fingers improving--feels more like nibbling than zapping. Viral rash noted around neck and under breasts.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Evening post injection: headache, chills, injection site pain. Acetaminophen taken to curb symptoms without success. Insomnia, treated with high dose melatonin.  Day 1 post injection: extreme chills, fatigue, global body and joint aches and worse than normal muscle spasms. Unable to function well; dehydration may have contributed to spasms. Injection site pain worsened to inability to lift right arm or use right shoulder. Joint (throbbing in PIP and DIP) and nerve pain (zapping feeling running to fingertips) in fingers.  Acetaminophen, cyclobenzaprine, rest, heated blanket utilized.  Day 2: extreme chills, fatigue, global body and joint aches have subsided. Right arm pain persists, though have regained some function--able to lift and movie objects. Nerve pain in fingers improving--feels more like nibbling than zapping. Viral rash noted around neck and under breasts.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Neuralgia, Pain, Pain in extremity
Clinical narrative: Evening post injection: headache, chills, injection site pain. Acetaminophen taken to curb symptoms without success. Insomnia, treated with high dose melatonin.  Day 1 post injection: extreme chills, fatigue, global body and joint aches and worse than normal muscle spasms. Unable to function well; dehydration may have contributed to spasms. Injection site pain worsened to inability to lift right arm or use right shoulder. Joint (throbbing in PIP and DIP) and nerve pain (zapping feeling running to fingertips) in fingers.  Acetaminophen, cyclobenzaprine, rest, heated blanket utilized.  Day 2: extreme chills, fatigue, global body and joint aches have subsided. Right arm pain persists, though have regained some function--able to lift and movie objects. Nerve pain in fingers improving--feels more like nibbling than zapping. Viral rash noted around neck and under breasts.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Evening post injection: headache, chills, injection site pain. Acetaminophen taken to curb symptoms without success. Insomnia, treated with high dose melatonin.  Day 1 post injection: extreme chills, fatigue, global body and joint aches and worse than normal muscle spasms. Unable to function well; dehydration may have contributed to spasms. Injection site pain worsened to inability to lift right arm or use right shoulder. Joint (throbbing in PIP and DIP) and nerve pain (zapping feeling running to fingertips) in fingers.  Acetaminophen, cyclobenzaprine, rest, heated blanket utilized.  Day 2: extreme chills, fatigue, global body and joint aches have subsided. Right arm pain persists, though have regained some function--able to lift and movie objects. Nerve pain in fingers improving--feels more like nibbling than zapping. Viral rash noted around neck and under breasts.
Age: 71.0
Sex: F
Vaccine: COVID19-2, RSV, UNK
Symptoms: Asthenia, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Muscular weakness
Clinical narrative: The RSV vaccine immediately gave me a painful lump the size of an orange.  It remained swollen for 3-4 days and painful to touch for just over a week.   The problem is, that since that shot, my left arm is weak and at night I can't sleep in the positions I used to because that arm falls asleep, has no strength, and sometimes just aches where the shot was given. I can often feel a lump below the skin where the large lump used to be and putting pressure on it helps me to stop the weakness and tingling. My daughter thought the lingering effects might be due to the vaccine, so that is why I am reporting it now.
Age: 71.0
Sex: F
Vaccine: COVID19-2, RSV, UNK
Symptoms: Pain, Paraesthesia, Sleep disorder, Swelling, Tenderness
Clinical narrative: The RSV vaccine immediately gave me a painful lump the size of an orange.  It remained swollen for 3-4 days and painful to touch for just over a week.   The problem is, that since that shot, my left arm is weak and at night I can't sleep in the positions I used to because that arm falls asleep, has no strength, and sometimes just aches where the shot was given. I can often feel a lump below the skin where the large lump used to be and putting pressure on it helps me to stop the weakness and tingling. My daughter thought the lingering effects might be due to the vaccine, so that is why I am reporting it now.
Age: 12.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient already received a Flu vaccine this season. Patient received Flucelvax Quad lot #370659  in left arm, IM injection on 9/27/23. Patient has had no symptoms.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Blood glucose increased
Clinical narrative: Patient states his blood glucose is normally around 160 but it got up to 360 within 24 hours of the vaccine. He states he has not changed anything about his diet, exercise, or medications. He states that his blood glucose is trending back down to normal using his medications and regular diet and exercise.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: Pfizer Covid 19 vaccine was diluted with 0.7ml  sterile water and the contents of the vial was administered.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: SHE HAD A 8 CM RED ROUND  HARD SPOT ON HER LEG AT INJECTION  SITE. dR. IS TREATING HER WITH SULFAMETHOXAZOLE-TRIMETHOPRIM.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Fatigue, Myalgia
Clinical narrative: The patient received a second dose of Fluzone vaccine on the same day.  In the next 24 hours the patient reported significant fatigue and myalgias, which resolved approximately after 24 hours.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccine positive rechallenge
Clinical narrative: Pre-filled syring of diluent was administered without being reconstituted with MMR vaccine powder.
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Acrochordon, Heart rate increased, Heart rate irregular, Injection site pain, Injection site swelling
Clinical narrative: Health care provider injected the shot into forarm instead of of upper arm, large and painful sore, followed by irregular speeding heartbeat, hives, and now permanent skin tags left close to the eye.
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product administered at inappropriate site, Urticaria
Clinical narrative: Health care provider injected the shot into forarm instead of of upper arm, large and painful sore, followed by irregular speeding heartbeat, hives, and now permanent skin tags left close to the eye.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Full blood count, Pruritus, Rash, Skin lesion
Clinical narrative: Rash and pruritus that presented approximately 24-48 hours after vaccination on the arm that the vaccine was administered to. No redness or erythema around the actual vaccination site, The violaceous, flat lesions appeared inferior to vaccination site and extended from deltoid to wrist, then 2 days later, appeared on the opposite arm. The pruritus and rash appear to be improving. Patient took Benadryl and ibuprofen for the discomfort.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face, Urticaria
Clinical narrative: Patient had delayed onset reaction of urticaria following administration of Spikevax for the 2023/2024 season. Reaction began 3 days after administration.  Reaction was localized but later spread to the majority of the body.  10 days after injection, patient had facial swelling and facial numbness and reported to emergency room for treatment.   Patient was treated with steroids at the emergency room and was discharged with prescriptions for prednisone 20mg (2 tablets by mouth once daily for 5 days), famotidine 20mg (1 tablet by mouth twice daily for 7 days), and diphenhydramine 25mg (1 tablet by mouth every 4 hours while symptoms persist).
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product preparation issue
Clinical narrative: Prefilled syringe of diluent was administered without being reconstituted with MMR powder.
Age: 74.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Arthralgia, Burning sensation, Condition aggravated, Gait disturbance, Inflammation
Clinical narrative: Inflammatory issues started 11/13+/- with stiffness in walking pain in left hand, and index finger burning.. I became slower in gait and hip pain and shoulder pain reported to Rheumatologist office as Flare given Prednisone 5 mg X 7 days and then Prednisone 2.5 mg X 5 days  out of 7 ordered (started 11/14 . Called the on call rheumatologist on Sunday 11/26 with burning in left arm and flare of PMR increased pain left shoulder and hips.  Started on Prednisone 10 mg for 5 days to reduce to 5 mg for 5 days.
Age: 74.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Musculoskeletal stiffness, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: Inflammatory issues started 11/13+/- with stiffness in walking pain in left hand, and index finger burning.. I became slower in gait and hip pain and shoulder pain reported to Rheumatologist office as Flare given Prednisone 5 mg X 7 days and then Prednisone 2.5 mg X 5 days  out of 7 ordered (started 11/14 . Called the on call rheumatologist on Sunday 11/26 with burning in left arm and flare of PMR increased pain left shoulder and hips.  Started on Prednisone 10 mg for 5 days to reduce to 5 mg for 5 days.
Age: 95.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: 2nd 2023 - 2024 FluAD was administered. Patient did not report that she received the Flu vaccine earlier that month already.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: The vaccination site in the upper portion of arm began to itch. It has degree of severity and same itch occurs over body. Both arms and trunk. Tried cortisone itch cream with limited relief.
Age: 32.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Injection site haemorrhage, Syncope
Clinical narrative: Patient fainted after seeing blood at the site of injection.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient involved has not reported any medical concerns or symptoms related to the administration of MMR II and VARIVAX from 10/17/2023.; Medical Assistant reporting that a patient in their care was inadvertently administered a third dose of both MMR II and VARIVAX.; This spontaneous report has been received from a Medical Assistant, referring to a 13-year-old patient of unspecified gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-AUG-2011, the patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 02-DEC-2016, the patient received the second dose varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 17-OCT-2023, the patient was inadvertently vaccinated a third dose of both varicella virus vaccine live (oka/merck) (VARIVAX)  0.5 milliliter, for prophylaxis (lot # W021743; expiration date: 10-JUL-2024) (strength and route of administration were not provided) and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, administered for prophylaxis (lot # W001519; expiration date: 13-JAN-2024 ) (strength and route of administration were not provided) (Extra dose administered). No additional adverse events were reported.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects were reported / No adverse reaction noted; Expired dose of PNEUMOVAX 23 that was administered to a patient on 31OCT2023. Product expired on 01OCT2023.; Initial and follow up information have been received from a physician and a nurse, respectively, referring to a 71-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 31-OCT-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #W021636, expiration date on 01-OCT-2023, for prophylaxis (dose and route of administration were not provided) (expired product administered). No side effects or adverse reactions were reported. No temperature excursions were reported for the product and no other medical information was known.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: No adverse effects were reported; HCP called to report inadvertent concomitant administration of PROQUAD and VARIVAX instead of MMR II and VARIVAX.  No adverse effects were reported. Request case reference 02501947. Consent to contact is yes. No additional AE/No PQC.; This spontaneous report was received from a physician referred to a 12-months-old patient. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On 02-NOV-2023, the patient was vaccinated (by a Health Professional) with varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 ml, lot number X010525, expiration date 11-MAY-2025, (strength, route, anatomical location, and scheme were not reported), as prophylaxis. On the same date, the patient was vaccinated (by a Health Professional) with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) albumin status of rHA (recombinant human albumin) lot # X011983, expiration date 22-OCT-2024, 0.5 ml, (strength, route, anatomical location, and scheme were not reported), for prophylaxis; the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was administered as "inadvertent concomitant administration," instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) (this vaccine was not administered) (interchange of vaccine products). No adverse event was reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: There were no side effects; TE for GARDASIL 9; This spontaneous report was received from office manager and refers to a 12-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-NOV-2023, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 mL, lot #1957405 was valid for formulation pre-filled syringe, expiration date 11-NOV-2025, route od administration and anatomical location were not provided) for prophylaxis (Product storage error).  On 18-NOV-2023, the temperature excursion (TE) details were a low temp of 33.15 F for 1 hour 8 minutes with zero previous excursions and an evaluation outcome that was supported. There were no side effects or unexpected reactions experienced by the patient (No adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Painful/ Stabbing pain; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful/ Stabbing pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 5 weeks) and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-Nov-2023 This case was reported by a patient via (social media) interactive digital media. The patient reported that he or she received Shingles vaccine 4 years ago. The patient experienced shingles for 5 weeks and this was his or her third time he or she experienced Shingles. The patient stated that it was very painful and stabbing pain. The physician prescribed him or her white pills and patient received those pills but the pain continues. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have it not very intense, but very annoying; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have it not very intense, but very annoying). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 21-NOV-2023 This case was reported by patient via (social media) interactive digital media. The patient reported that he or she had it and he/she vaccinated, not very intense, but very annoying. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of expired vaccine used in a male patient who received Herpes zoster (Shingles vaccine) (batch number 2Kl4K, expiry date 09-NOV-2023) for prophylaxis.   In NOV-2023, the patient received Shingles vaccine. In NOV-2023, an unknown time after receiving Shingles vaccine, the patient experienced expired vaccine used (Verbatim: Expired vaccine used). The outcome of the expired vaccine used was unknown.   Additional Information: RA Receipt date: 21-NOV-2023 A reporter reported that a medical assistant gave the vaccine then realized it was expired on 9th Nov 2023 which led to expired vaccine used. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Peripheral swelling
Clinical narrative: arm was swollen; arm was red; Discomfort; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced discomfort (Verbatim: Discomfort), swelling arm (Verbatim: arm was swollen) and erythema (Verbatim: arm was red). The outcome of the discomfort was resolved (duration 1 day) and the outcome of the swelling arm and erythema were not reported.   It was unknown if the reporter considered the discomfort, swelling arm and erythema to be related to Shingles vaccine.     It was unknown if the company considered the discomfort, swelling arm and erythema to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-NOV-2023 This case was reported by a patient via interactive digital media. The case was reported by patient's parent. The reporter stated that his/her daughter had worst adverse reaction. The patient experienced discomfort lasted one day, and the patient's arm was swollen, and red.  The reporter stated that it was still better to get vaccinated. This case had been linked with-US2023AMR162011. Follow-up would not possible no contact details were available.; Sender's Comments:  US-GSK-US2023AMR162011:Case created for parent
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had her first vaccination of HAVRIX on October 23, 2023 and her second vaccination of HAVRIX on 11/20/2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 33-year-old female patient who received HAV (Havrix adult) (batch number 55m72, expiry date 13-DEC-2024) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix adulti).   On 20-NOV-2023, the patient received the 2nd dose of Havrix adult. On 20-NOV-2023, an unknown time after receiving Havrix adult, the patient experienced drug dose administration interval too short (Verbatim: had her first vaccination of HAVRIX on October 23, 2023 and her second vaccination of HAVRIX on 11/20/2023). The outcome of the drug dose administration interval too short was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 20-NOV-2023 The consumer was the reporter.   The patient stated she had her 1st dose of Havrix on 23rd October 2023 and her 2nd dose on 20th November 2023, which led to shortening of vaccination schedule. The reporter consented to follow up.Contact:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The third dose was given at 5 months after the first; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received the first two doses on schedule) and Engerix B. Concurrent medical conditions included hemodialysis.   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: The third dose was given at 5 months after the first). The outcome of the drug dose administration interval too long 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 stated that a patient on the adults on hemodialysis schedule for Engerix-B received the first two doses on schedule. The third dose was given at 5 months after the first. No other information was known. The reporter did not consent to follow-up. The patient received 3rd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Feeding disorder, Feeling hot, Headache, Paraesthesia
Clinical narrative: Tingling face and lips; Swollen tongue; Tummy swollen; Ringing in her ears; Face gets hot; Weight loss of 10 pounds since receiving Shingrix dose 1; Headaches; Loss of appetite; Tingling face and lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-NOV-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-NOV-2023, 10 min after receiving Shingrix, the patient experienced tingling (Verbatim: Tingling face and lips), swollen tongue (Verbatim: Swollen tongue), local swelling (Verbatim: Tummy swollen), ringing in ears (Verbatim: Ringing in her ears), feeling of warmth facial (Verbatim: Face gets hot), weight loss (Verbatim: Weight loss of 10 pounds since receiving Shingrix dose 1), headache (Verbatim: Headaches), appetite lost (Verbatim: Loss of appetite) and tingling lips (Verbatim: Tingling face and lips). The outcome of the tingling, swollen tongue, local swelling, ringing in ears, feeling of warmth facial, headache, appetite lost and tingling lips were not resolved and the outcome of the weight loss was unknown.   It was unknown if the reporter considered the tingling, swollen tongue, local swelling, ringing in ears, feeling of warmth facial, weight loss, headache, appetite lost and tingling lips to be related to Shingrix.     It was unknown if the company considered the tingling, swollen tongue, local swelling, ringing in ears, feeling of warmth facial, weight loss, headache, appetite lost and tingling lips to be related to Shingrix.   Additional Information: GSK Receipt Date - 21-NOV-2023 The reporter reported that patient received first dose of shingrix and started symptoms 10 minutes after receiving dose. The reported that she had tingling in her face and lips and a swollen tongue.  The pharmacy used an epi pen on her and the symptoms subsided. The reporter stated that patient get went to the home and the symptoms(swollen tongue and tingling) started up again, so she went to the emergency room. The reported that patient administered some steroid as a treatment and the symptoms subsided. The patient ended up back at the emergency room later that night for the symptoms (swollen tongue and tingling) again. The reporter stated that the had been a week since receiving the vaccine and symptoms are still occurring The reported that patient had tingling in face and lips, headache, ringing in ears, face feeling hot, she has lost 10 lbs where she is unable to eat, swollen tummy. The reporter consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Swollen tongue, Tinnitus, Weight decreased
Clinical narrative: Tingling face and lips; Swollen tongue; Tummy swollen; Ringing in her ears; Face gets hot; Weight loss of 10 pounds since receiving Shingrix dose 1; Headaches; Loss of appetite; Tingling face and lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-NOV-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-NOV-2023, 10 min after receiving Shingrix, the patient experienced tingling (Verbatim: Tingling face and lips), swollen tongue (Verbatim: Swollen tongue), local swelling (Verbatim: Tummy swollen), ringing in ears (Verbatim: Ringing in her ears), feeling of warmth facial (Verbatim: Face gets hot), weight loss (Verbatim: Weight loss of 10 pounds since receiving Shingrix dose 1), headache (Verbatim: Headaches), appetite lost (Verbatim: Loss of appetite) and tingling lips (Verbatim: Tingling face and lips). The outcome of the tingling, swollen tongue, local swelling, ringing in ears, feeling of warmth facial, headache, appetite lost and tingling lips were not resolved and the outcome of the weight loss was unknown.   It was unknown if the reporter considered the tingling, swollen tongue, local swelling, ringing in ears, feeling of warmth facial, weight loss, headache, appetite lost and tingling lips to be related to Shingrix.     It was unknown if the company considered the tingling, swollen tongue, local swelling, ringing in ears, feeling of warmth facial, weight loss, headache, appetite lost and tingling lips to be related to Shingrix.   Additional Information: GSK Receipt Date - 21-NOV-2023 The reporter reported that patient received first dose of shingrix and started symptoms 10 minutes after receiving dose. The reported that she had tingling in her face and lips and a swollen tongue.  The pharmacy used an epi pen on her and the symptoms subsided. The reporter stated that patient get went to the home and the symptoms(swollen tongue and tingling) started up again, so she went to the emergency room. The reported that patient administered some steroid as a treatment and the symptoms subsided. The patient ended up back at the emergency room later that night for the symptoms (swollen tongue and tingling) again. The reporter stated that the had been a week since receiving the vaccine and symptoms are still occurring The reported that patient had tingling in face and lips, headache, ringing in ears, face feeling hot, she has lost 10 lbs where she is unable to eat, swollen tummy. The reporter consent to follow up.
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Flulaval to a 12 month old child on 08NOV2023 and again on 21NOV2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 12-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 993AM, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT).   On 21-NOV-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 21-NOV-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced drug dose administration interval too short (Verbatim: Flulaval to a 12 month old child on 08NOV2023 and again on 21NOV2023). The outcome of the drug dose administration interval too short was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt date: 21-NOV-2023 Patient had no vaccination history in previous flu season. The reporter requested data on the administration of Flulaval to a patient who administered the second dose early, which led to shortening of vaccinations schedule. The reporter consented to follow up.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Knee operation, Pruritus, Rash
Clinical narrative: she has had itching all over her body; rash on both legs; left knee surgery; This serious case was reported by a consumer via call center representative and described the occurrence of knee operation in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sjogren's (diagnosed with Sjogrens in 2001).   On 29-AUG-2023, the patient received the 1st dose of Shingrix. On 17-OCT-2023, 49 days after receiving Shingrix, the patient experienced knee operation (Verbatim: left knee surgery) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced pruritus (Verbatim: she has had itching all over her body) and rash (Verbatim: rash on both legs). The patient was treated with menthol;pramocaine hydrochloride (Store brand Medicated Anti Itch). The outcome of the knee operation was resolved and the outcome of the pruritus and rash were not resolved.   It was unknown if the reporter considered the knee operation, pruritus and rash to be related to Shingrix.     It was unknown if the company considered the knee operation, pruritus and rash to be related to Shingrix.   Additional Information: GSK receipt date: 21-NOV-2023 The reporter stated that after she received a dose of Shingrix, she had left knee surgery. The reporter stated that after her surgery she had itching all over her body and also rashes on both legs. She stated that she had been used store brand itch cream but unsuccessfully. She also mentioned that she was diagnosed with Sjogrens. The reporter did not consent follow up.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: They dont believe the adjuvant were administered alone to a patient.; Inappropriate dose of vaccine administered; 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) 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: They dont believe the adjuvant were administered alone to a patient.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 21-NOV-2023 The pharmacist reported that the 2 vials of powder was found without the liquid portion accompanying.   The pharmacist don't believe the adjuvant were administered alone to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. Consent to follow up.