chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: HEP, UNK, UNK, UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in left arm when moving it around
Age: 59.0
Sex: F
Vaccine: HEP, UNK, UNK, UNK
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in left arm when moving it around
Age: 79.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Chills, Migraine, Pyrexia, Vomiting
Clinical narrative: Patient reported vomiting, migraine headache, fever/chills, and weakness lasting about 2 days
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Multiple sclerosis relapse, Walking aid user
Clinical narrative: The patient received an unknown COVID booster shot at an unknown time. After receiving the booster he had a relapse of his multiple sclerosis symptoms. The patient now uses a walker.
Age: 21.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Syncope
Age: 21.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Nausea, Syncope
Clinical narrative: Syncope
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event occurred.  Patient received extraneous dose of Varicella.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: Splotchy rash, with hives Bilaterial arm/face/cheeks and neck, no distress, no difficulty breathing
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chills, Condition aggravated, Headache, Injection site pain
Clinical narrative: On 9/11/2024, in the evening muscle soreness developed in left injection arm site, felt headache starting.  At 2:30 am woke with bad headache and shivering. Took Tylenol 500mg.  At 7 am headache much improved, took losartan, vitamind3 and AREDS-2. Normal low salt DASH diet and beverages throughout day. Between 1-3 pm began worse headache, Temp 100.2, irregular pulse (missing a beat every 5 beats which I have had occasionally this year after having COVID 12/2023), BP 165/105 (high for me since began daily BP medication Jan/2024), and seem to have urge to urinate much more frequently as in every hour. Took tylenol 500mg for second time. At 6 pm, headache better, BP 142/82, Temp 98.2. On 9/13/2024, am, no headache, BP 132/72, Temp 98.4.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Memory impairment, Nightmare
Clinical narrative: Extremely vivid nightmares, brain fog (forgetful with common tasks, forgetful with "in the moment" plans.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: redness and warm area
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No symptoms reported by patient or family.  Writer has left several messages with patient's mother but no calls have been returned.  Medication Error via wrong route.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC20
Symptoms: Irritability, Pyrexia, Rash maculo-papular, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: fever 102.2F, maculopapular rash, runny nose/congestion, fussy/irritable about 3 days after vaccine was administered. symptoms persisting x 3 days.
Age: 7.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: DTAP DOSE GIVEN IN LIEU OF TDAP ACCORDING TO AGE GUIDELINES OF THE CATCH-UP SCHEDULE
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Developed muscle pain from above shoulder (in neck area) down entirety of right arm starting 4 days after vaccination.  Continues to have pain at injection site and when lifting the arm above the shoulder 2 weeks after vaccination.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient started symptoms within hours of receiving a covid vaccine to the right deltoid, from pharmacy. Patient presents with cellulitis. Since that time, her arm is red, swollen, hot to touch, and itching from elbow to shoulder.
Age: 10.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Syncope, Tremor
Clinical narrative: Patient became syncopal immediately after vaccination. Patient stated he felt lightheaded. Patient initially had tremors in both the hands and the upper body. I advised the patient to place his head between his knees and got a cold compress. I applied the cold compress and advised the patient to keep breathing normally. The patient received a  drink. After eating and drinking, the patient's symptoms resolved. The patient did not require emergency care or urgent care. The patient's symptoms resolved through intervention at the pharmacy.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Lymphadenopathy, Pain, Swelling
Clinical narrative: Symptoms- worsening of swelling, redness & pain. right arm after vaccine. sing of cellulitis (+), Axillary lymphadenopathy. Presented to the clinjc at the 3rd day of vaccine given, symptoms started the same day evening with a mild swelling erythema.
Age: 10.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Meniere's disease, Vertigo
Clinical narrative: Development of Meniere?s Disease. Vertigo and loss of hearing in the right ear.
Age: 9.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Clumsiness, Dysgraphia, Fall, Fine motor skill dysfunction
Clinical narrative: Following the initial pfizer covid vaccine on 8/13/2021, our son complained of "not feeling right".  Based on what he said, we thought he was just having the typical aches and pains associated with any vaccine.  After his 2nd shot on 9/3/2021, we knew something was wrong.  He complained of a pressure in his chest and he said his hands, feet, arms and legs felt funny, as if he couldn't really feel them any more.  One of his calves appeared swollen where he said it didn't feel right.  We took him to the hospital, because we were worried.  They did all manner of testing.  They ruled out endocarditis, myocarditis and a bunch of other problems.  After they determined it was not life threatening, we were sent on to a pediatric neurologist who determined that the vaccine injury resulted in neuoropathy.  In our son's case, it was limited to glove and stocking syndrome.  The first year after the vaccine it was more severe.  He took a terrible fall at school and twisted his ankle severely because he couldn't feel his foot placement.  He had to sit out of sports.  By the second year after injury, he was having more sensation in his limbs, but suffered another poor foot placement partially due to the neuorpathy and had a severe sprain as well as a fracture of his foot.  Fast forward to three years since injury and he is doing much better.  He still does not have the fine motor skills and full sensation that he should have; however, it is much better than it was.  We have hope that there will come a day when he has full sensation in his limbs, hands and feet.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Foot fracture, Gait disturbance, Hypoaesthesia, Immunisation reaction, Injury
Clinical narrative: Following the initial pfizer covid vaccine on 8/13/2021, our son complained of "not feeling right".  Based on what he said, we thought he was just having the typical aches and pains associated with any vaccine.  After his 2nd shot on 9/3/2021, we knew something was wrong.  He complained of a pressure in his chest and he said his hands, feet, arms and legs felt funny, as if he couldn't really feel them any more.  One of his calves appeared swollen where he said it didn't feel right.  We took him to the hospital, because we were worried.  They did all manner of testing.  They ruled out endocarditis, myocarditis and a bunch of other problems.  After they determined it was not life threatening, we were sent on to a pediatric neurologist who determined that the vaccine injury resulted in neuoropathy.  In our son's case, it was limited to glove and stocking syndrome.  The first year after the vaccine it was more severe.  He took a terrible fall at school and twisted his ankle severely because he couldn't feel his foot placement.  He had to sit out of sports.  By the second year after injury, he was having more sensation in his limbs, but suffered another poor foot placement partially due to the neuorpathy and had a severe sprain as well as a fracture of his foot.  Fast forward to three years since injury and he is doing much better.  He still does not have the fine motor skills and full sensation that he should have; however, it is much better than it was.  We have hope that there will come a day when he has full sensation in his limbs, hands and feet.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Ligament sprain, Limb injury, Loss of personal independence in daily activities, Neuropathy peripheral
Clinical narrative: Following the initial pfizer covid vaccine on 8/13/2021, our son complained of "not feeling right".  Based on what he said, we thought he was just having the typical aches and pains associated with any vaccine.  After his 2nd shot on 9/3/2021, we knew something was wrong.  He complained of a pressure in his chest and he said his hands, feet, arms and legs felt funny, as if he couldn't really feel them any more.  One of his calves appeared swollen where he said it didn't feel right.  We took him to the hospital, because we were worried.  They did all manner of testing.  They ruled out endocarditis, myocarditis and a bunch of other problems.  After they determined it was not life threatening, we were sent on to a pediatric neurologist who determined that the vaccine injury resulted in neuoropathy.  In our son's case, it was limited to glove and stocking syndrome.  The first year after the vaccine it was more severe.  He took a terrible fall at school and twisted his ankle severely because he couldn't feel his foot placement.  He had to sit out of sports.  By the second year after injury, he was having more sensation in his limbs, but suffered another poor foot placement partially due to the neuorpathy and had a severe sprain as well as a fracture of his foot.  Fast forward to three years since injury and he is doing much better.  He still does not have the fine motor skills and full sensation that he should have; however, it is much better than it was.  We have hope that there will come a day when he has full sensation in his limbs, hands and feet.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Sensory disturbance, Sensory loss
Clinical narrative: Following the initial pfizer covid vaccine on 8/13/2021, our son complained of "not feeling right".  Based on what he said, we thought he was just having the typical aches and pains associated with any vaccine.  After his 2nd shot on 9/3/2021, we knew something was wrong.  He complained of a pressure in his chest and he said his hands, feet, arms and legs felt funny, as if he couldn't really feel them any more.  One of his calves appeared swollen where he said it didn't feel right.  We took him to the hospital, because we were worried.  They did all manner of testing.  They ruled out endocarditis, myocarditis and a bunch of other problems.  After they determined it was not life threatening, we were sent on to a pediatric neurologist who determined that the vaccine injury resulted in neuoropathy.  In our son's case, it was limited to glove and stocking syndrome.  The first year after the vaccine it was more severe.  He took a terrible fall at school and twisted his ankle severely because he couldn't feel his foot placement.  He had to sit out of sports.  By the second year after injury, he was having more sensation in his limbs, but suffered another poor foot placement partially due to the neuorpathy and had a severe sprain as well as a fracture of his foot.  Fast forward to three years since injury and he is doing much better.  He still does not have the fine motor skills and full sensation that he should have; however, it is much better than it was.  We have hope that there will come a day when he has full sensation in his limbs, hands and feet.
Age: 3.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 6.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was due for Tdap vaccine, inadvertently received Td vaccine instead. No adverse reaction noted. No plans to revaccinate at this time.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Myocarditis, Pericarditis, Troponin increased
Clinical narrative: chest pain, elevated troponin, myocarditis and pericarditis
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 11.0
Sex: M
Vaccine: COVID19-2, FLU4, HPV9, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: 5 areas on the body, 2 on the right face, 1 on the left at chin, 1 upper left of spine below nape, 1 on left side of buttock. Raised red areas some itch all are red , raised and rough. I thought skin cancer basal cell, except too many erupted with hours and or days. I called Dr to eval, no apt until Oct 1 thinking skin cancer.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Urticaria
Clinical narrative: Pt developed fine hives to bilateral feet within 5 minutes of receiving vaccine. Administered 1.25mL of Diphenhydramine 12.5mg/5mL. 20 minutes after diphenhydramine rash resolved. No respiratory symptoms. VSS. HR 156. O2 95% RA.
Age: 4.0
Sex: M
Vaccine: COVID19-2, DTAPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 74.0
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: I was on site for a clinic and pt. asked for 3 shots Spikevax, Fluzone HD and Arexvy. I didn't have access to system that i gave it to him and when i run this thru insurance then that i learned he also had this vaccine last year. I called him & informed him that its only recommended once in a lifetime for now.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Diagnosed Pityriasis Rosea rash on stomach, arms, legs and back.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm was red and swollen at the injection site. It hurt to touch and slightly warm. Going to apply ice to site and take some pain reliever. She is also going to contact her dr.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting.  Recommend temporarily eliminating lactose from diet until symptoms resolve     Recommend encouraging fluid intake, advance diet as tolerated
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PT HAS NO ADVERSE EFFECT. PT  IS UNDER 12 YEARS OF AGE AND RECEIVED COMIRNITY COVID 24-25.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Hives (Dr. said to take Zyrtec during the day and Benedryl at night. No improvement four days later), diarrhea
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Biopsy skin abnormal, Dermatitis, Eczema, Parakeratosis, Rash
Clinical narrative: Severe rash, hives, sores (Dermatitis / Eczema) on entire body except for face and private area.   Took a three (3) week course of Prednisone.   Followed after one (1) week with a two (2) week course of Clobetasol Propionate.  Symptoms were reduced but did not go completely away.   Currently took initial two (2) doses of Dupixent (300mg) on 09/10/2024.  Will require a dose every two (2) weeks in the future.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Skin disorder, Urticaria
Clinical narrative: Severe rash, hives, sores (Dermatitis / Eczema) on entire body except for face and private area.   Took a three (3) week course of Prednisone.   Followed after one (1) week with a two (2) week course of Clobetasol Propionate.  Symptoms were reduced but did not go completely away.   Currently took initial two (2) doses of Dupixent (300mg) on 09/10/2024.  Will require a dose every two (2) weeks in the future.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: patient called and reported numbness and tingling in the arm she received the vaccine
Age: 33.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Pruritus, Rash
Clinical narrative: 9/13/24- Employee called & reported generalized "itching" on 9/9/24 night after receiving the flu shot and Hep B booster (dose #4) in the afternoon.   Then, she reported a "rash" all over the body except her face, starting 9/10/24; she denies any breathing problem. Symptoms are not improved as of 9/13/24.  She was sent to a local occupational health clinic; Clinic address: with telephone , for further evaluation and treatments.  Note that this employee previously had a documented flu shot in 2027 and a series of 3 doses of Hepatitis B shots in 1992 & 1993 with non-immune titer on 8/28/24.
Sex: U
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pt received Arexvy on 10/2/23.   Pt requested and received Arexvy on 9/13/24
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient came in and requested an RSV vaccine. We administered the vaccine and as we entered her information into the state database found that she had already received a dose back in December 2023.
Age: 7.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 12.0
Sex: F
Vaccine: COVID19-2, HPV9, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Severe joint pain of both knees, toes, shoulders, hips, neck, hands. Pain  in one shoulder and both knees continues for 12 days so far.
Age: 85.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: patient noticed the next day 9/12/24 that around the injection site, her arm is swollen and warm to touch. she also has redness the size of a baseball per patient. per patient , arm is not too sore or painful, only hurst when she says on arm on her left side.  patient has taken acetaminophen and plans to use an ice pack. she feels her arm feels a little better today (9/13/24 ) than yesterday. she will reach out to her doctor if arm is not getting better or if gets worse.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 19 year old Patient was given Moderna 6 months to 11 year old 0.25 ml dose. No immediate adverse reaction noted.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Patient has received two Fluad Trivalent vaccines for the season of 2024 due to staff error
Age: 10.0
Sex: F
Vaccine: COVID19-2, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 73.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Fatigue, Influenza like illness, Insomnia, Myalgia, Nausea
Clinical narrative: Patient called via phone three days after vaccinations complaining of fatigue, aching muscles, nausea, trouble sleeping, and flu like symptoms. Patient was advised to rest at home and contact their doctor or seek urgent care if symptoms persist or worsen.
Age: 40.0
Sex: F
Vaccine: COVID19, FLUR4, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching on the back of the right arm
Age: 1.67
Sex: M
Vaccine: COVID19-2, DTAP, HEPA, HIBV, PNC20
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 11.0
Sex: M
Vaccine: COVID19-2, HPV9, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD for vaccine. Outcome will be recommend to receive the covid 19 2024-25 vaccine when available in the fall.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: product dispensing error; A HCP called to inquire about GARDASIL 9 in which a 12 year old may have inadvertently received an extra dose. The 12-year patient came into the clinic today (08/14/2024) with accompanied by their father and no shot record.  The previous record was r; Rash; This spontaneous report has been received from a clinical nurse and refers to a 12-year-old female patient. The patient's concurrent conditions included tricuspid but functionally bicuspid aortic valve. Previous allergies and pdrugs reactions were not provided. Nonprevious illness at time of vaccination. Concomitant therapies included meningococcal MCV40 vaccine and Tdap vaccine.   On 08-JUN-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # W033611 has been verified to be valid for with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)  expiration date not provided but upon internal validation established as: 08-JAN-2025) administered for prophylaxis (dose, route of administration, anatomical location were not provided). On 09-FEB-2024, received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis, 0.5 milliliter, once (lot #1965035, has been verified to be valid, expiration date reported and established as 20-SEP-2025; route of administration not provided). On 14-AUG-2024, she was vaccinated with the third dose of the vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (Inappropriate schedule of product administration) (reported also as: inadvertently received an extra dose) at a dose of 0.5 milliliter, once, intramuscular in left deltoid as prophylaxis (lot #2032274 has been verified to be valid, expiration date reported and established as 19-JAN-2026). All doses given by a health professional. It was reported that it was a dispensing error on the same date (14-AUG-2024) (product dispensing error).   The patient's mother stated that the only symptom the patient presented was a diffuse rash since an unknown date in August 2024. No other symptoms were noted. No product quality complaints. The outcome of rash was not provided.  The causality assessment between the event rash and vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired PROQUAD to a patient; This spontaneous report has been received from a nurse, referring to a 4-year-old patient of unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 19-AUG-2024, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) at a dose of 0.5 mL, lot# X004370, expiry date 07-AUG-2024 (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No temperature excursions were confirmed. No symptomatic adverse events were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AE. No PQC.; HCP reports patient may have received expired dose of PROQUAD.  Caller states product was administered on 11/27/2012 with expiration documented as 1/14/2006.  OMC unable to confirm expiration date so filing precautionary AE.  No other information pro; This spontaneous report was received from a consumer refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 27-NOV-2012 the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin satatus: rHA) lot # H015642 and expiration date established as 06-JAN-2014 (discrepant information, it was reported that patient was vaccinated with expired dose, upon lot validation it was established that the expiration was as reported above but stated that expiration date was documented as 14-JAN-2006) for prophylaxis (exact dose, dose number, route and site of administration were not provided) (experienced expired product administered).
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose, and Have Not Had The Second Dose; Initial report received on 26-Aug-2024.  A consumer reported that he, a male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose yet.  Medical history and concomitant medications were not reported.   On 26-Oct-2022, the patient received the first dose of HEPLISAV-B (lot # 937782, NDC # 43528-002-01, expiration date, route, and site not reported). At the time of reporting, the patient has not received the second dose of HEPLISAV-B yet.    No other information is available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Haematemesis, Headache
Clinical narrative: vomiting blood; inability to stand; severe headache; This serious case was reported by a consumer and described the occurrence of vomiting blood in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number TF9HE, expiry date 19-JUN-2026) for prophylaxis.   On 06-SEP-2024, the patient received Shingrix .5 ml. On 06-SEP-2024, less than a day after receiving Shingrix, the patient experienced vomiting blood (Verbatim: vomiting blood) (serious criteria GSK medically significant), difficulty in standing (Verbatim: inability to stand) and headache (Verbatim: severe headache). The outcome of the vomiting blood, difficulty in standing and headache were not resolved.   It was unknown if the reporter considered the vomiting blood, difficulty in standing and headache to be related to Shingrix.     The company considered the vomiting blood to be unrelated to Shingrix. It was unknown if the company considered the difficulty in standing and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-SEP-2024 The reporter reported besides all the common symptoms listed, severe headache vomiting blood, inability to stand and all the events required intervention. The patient definitely won't be getting the 2nd dose.; Sender's Comments: Haematemesis is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; have them in small patches; 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: have them in small patches). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-SEP-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine and regret it everyday. The patient had Shingles in small patches quite often. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: she experienced a rash from her chin all the way down her torso; severe allergic reaction; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (highly allergic to most antibiotics).   On 30-AUG-2024, the patient received the 1st dose of Shingrix (left arm). On 01-SEP-2024, 2 days after receiving Shingrix, the patient experienced allergic reaction (Verbatim: severe allergic reaction). On an unknown date, the patient experienced rash (Verbatim: she experienced a rash from her chin all the way down her torso). The patient was treated with diphenhydramine hydrochloride (Benadryl). Shingrix was discontinued. On 04-SEP-2024, the outcome of the rash was resolved. The outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the rash and allergic reaction to be related to Shingrix.     It was unknown if the company considered the rash and allergic reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-SEP-2024 The patient self-reported this case. The patient received Shingrix and experienced a severe allergic reaction. The patient experienced a rash from her chin all the way down her torso. Consumer reports she took Benadryl(unknown form, dose) to stop the allergic reaction. The patient did consult her healthcare professional (HCP)who advised her not to had a second dose of Shingrix due to this reaction. The patient stated as of 04-SEP-2024 the rash was mostly resolved. As of interest, the consumer did report that she was highly allergic to most antibiotics but not to vaccines. The patient stated that she had pictures that she could provide to GSK showing the extent of the allergic reaction.
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Incorrect preparation/just had dosed the liquid without reconstituting the powder component; we had an incident where just had dosed the liquid without reconstituting the powder component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Incorrect preparation/just had dosed the liquid without reconstituting the powder component) and inappropriate dose of vaccine administered (Verbatim: we had an incident where just had dosed the liquid without reconstituting the powder component). The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   Additional Information: GSK Receipt Date: 05-SEP-2024 The pharmacist reported about the menveo vaccine, they had an incident where just had dosed the liquid without reconstituting the powder component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This case had been link with US2024110786, reported by the same reporter.; Sender's Comments:  US-GSK-US2024110786:Same reporter/ different patient
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Engerix-B adult dose administered to an adolescent; Engerix-B adult dose administered to an adolescent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 17-year-old female patient who received HBV (Engerix B adult) (batch number Y5X9T, expiry date 30-SEP-2026) for prophylaxis.   On 23-JUL-2024, the patient received the 2nd dose of Engerix B adult. On 23-JUL-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Engerix-B adult dose administered to an adolescent) and adult product administered to child (Verbatim: Engerix-B adult dose administered to an adolescent). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 05-SEP-2024 The director of nursing reported that an adolescent patient received Engerix-B second dose adult formulation, which led to overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 at 15:15 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Known allery: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LOSARTAN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 31Aug2024 at 08:00, outcome "recovering", described as "Injection site pain". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: patient did not receive any other vaccines on the same date, patient did not receive any other vaccines within 4 weeks PRIOR to the BNT162b2 omicron (kp.2).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vaccination site pain
Clinical narrative: Started to feel sore arm around 10pm on 04Sep2024; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 04Sep2024 as dose 1, singel), in left arm. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Sep2024 at 22:00, outcome "recovering", described as "Started to feel sore arm around 10pm on 04Sep2024". Therapeutic measures were not taken as a result of vaccination site pain. Additional information:The patient did not receive any other vaccines within 4 weeks prior to the suspected vaccine(s) and did not take any other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy
Clinical narrative: Chills and swollen lymph nodes; Chills and swollen lymph nodes; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2024 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), CHILLS (non-serious) all with onset 06Sep2024 at 16:00, outcome "not recovered" and all described as "Chills and swollen lymph nodes". Therapeutic measures were not taken as a result of lymphadenopathy, chills. Additional information: patient did not receive any other vaccines on the same date, patient did not receive any other vaccines within 4 weeks PRIOR to the BNT162b2 omicron (kp.2).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site dryness
Clinical narrative: In my injection site it developed dry brown spots and it's doesn't heal; In my injection site it developed dry brown spots and it's doesn't heal; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE DRYNESS (non-serious), outcome "not recovered" and all described as "In my injection site it developed dry brown spots and it's doesn't heal".  Additional information: The patient stated "I have Pfizer vaccines for Covid. 3 different injections site. I am going to see a dermatologist about this issue. Any recommendations or advice."  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400119331 same patient/product, different dose;US-PFIZER INC-202400254625 same patient/product, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria
Clinical narrative: Chronic idiopathic urticaria; This is a spontaneous report received from a Pharmacist from medical information team.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC SPONTANEOUS URTICARIA (non-serious), outcome "not recovered", described as "Chronic idiopathic urticaria".  Additional information: Reporter was asking if there is information on the vaccine and chronic urticaria involving the 2021 formula of the vaccine. Patient received the Pfizer COVID vaccine in early 2021 and 3.5 years later, they are still experiencing chronic idiopathic urticaria. HCP requested further research regarding chronic urticaria.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Allergy test positive, Anaphylactic reaction, Urticaria
Clinical narrative: she had a severe reaction, as hive of 11mm; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Shingrix, for immunisation, reaction(s): "hive". The following information was reported: URTICARIA (medically significant), outcome "unknown", described as "she had a severe reaction, as hive of 11mm". Clinical course: Reporter states that she developed an anaphylactic reaction after getting Prevnar 13. Requester stated she had a kind of an anaphylactic reaction and her doctor suggested to get a test for it, so she took up the Prevnar 20 and got it tested in the allergist office and she had a severe reaction, as hive of 11mm and it was the same with the Shingrix because she was afraid if she took that one, she would have the same reaction. Caller is wondering about the ingredients of the Abrysvo and the other ones.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 1.0
Sex: U
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from an Other HCP from medical information team, Program ID.  A 12-month-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Sep2024 as dose number unknown, 0.5ml single (Lot number: HH9322, Expiration Date: 30Jun2025) at the age of 12 months intramuscular, in right thigh for immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing); "anemia" (ongoing). Concomitant medication(s) included: CETIRIZINE oral taken for hypersensitivity; LIQUID IRON oral taken for anaemia, start date: 10Sep2024 (ongoing). The following information was reported: PYREXIA (non-serious) with onset Sep2024, outcome "unknown", described as "fever".  Additional information: the patient was prescribed with ibuprofen 5.5ml as needed for fever after the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400254613 same reporter/drug/event, different patient;
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: Stinging upon injection; body aches; tender to touch at injection site with arm swelling; tender to touch at injection site with arm swelling and turning red in a 3 inch by 2 inch area; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Sep2024 as dose 1, single (Lot number: ML2215) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VESTURA. Past drug history included: Amoxicillan, reaction(s): "Hypersensitivity"; Cefzil, reaction(s): "Hypersensitivity". Vaccination history included: Bnt162b2 (DOSE 1), administration date: 2021, for covid-19 immunization; Bnt162b2 (DOSE 2), administration date: 2021, for covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER)), administration date: 2021, for covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER)), administration date: 2022, for covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Sep2024 at 16:30, outcome "not recovered", described as "Stinging upon injection"; PAIN (non-serious) with onset 09Sep2024 at 16:30, outcome "recovered" (10Sep2024 at 16:30), described as "body aches"; PERIPHERAL SWELLING (non-serious) with onset Sep2024, outcome "not recovered", described as "tender to touch at injection site with arm swelling"; VACCINATION SITE ERYTHEMA (non-serious) with onset Sep2024, outcome "not recovered", described as "tender to touch at injection site with arm swelling and turning red in a 3 inch by 2 inch area". Therapeutic measures were taken as a result of pain.  Additional Information: Stinging upon injection; body aches starting about 12 hours after shot and lasting 24 hours; within 24 hours of injection, tender to touch at injection site with arm swelling and turning red in a 3 inch by 2 inch area; within 48 hours of injection, still tender to touch and red/swollen, which the patient did not experience with previous Pfizer covid-19 vaccines (3x 2021, 1x 2022). The patient did not receive any other vaccines on the same date and within 4 weeks prior as the reported vaccine. The patient took Tylenol to help with body aches.