chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This RN in charge today, 12/21/23, at medical facility today and realized we had some private Covid 12+ vaccines that expired on 12/18/23 (based on the 10 week expiration date from coming out of the deep freezer). This RN reviewed private vaccine Covid 12+ doses given on 12/19 and 12/20/23 and found that one patient received a private dose of Covid 12+ on 12/19/2023, with same expiration and lot number as expired vaccines in refrigerator (HF9300, expiration 1/30/25).
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Decreased appetite, Malaise, Myalgia, Pain
Clinical narrative: Pt reports that early in the morning he started to feel achey all over, it hurt to sit up or stand up. He did not feel like eating breakfast. He states that all of his muscles hurt and he felt "like crap". However, his left arm where he received the injection, did not hurt. He reports that he felt this way after receiving the Novavax vaccine on 11/29/23 and Prevnar20 vaccine on 09/27/2023 (also got FLUAD quadrivalent that day). He has received 5 Moderna vaccines, an annual flu vaccine for years, and the Shingrix vaccine series in 2021. He did not feel this uncomfortable after any vaccines he has previously received. He is very active, works out with heavy weights several times a week. He reports not having done a heavy workout in the past few days - "I've been working on my back and core lately"
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Blood glucose increased, Cerebral venous sinus thrombosis, Chest pain, Headache, Jugular vein thrombosis
Clinical narrative: Pfizer - BioNTech COVID-19 Vaccine.  I had a seizure on 6/17, went to a hospital by EMT, told me my sugar was high and to take Metformin. Next day around 1 pm, I had another seizure.  Went to hospital by EMT.  Stayed for 8 days in the hospital because I  had two blood clots on my brain.  Venus sinus thrombosis, one in the back and one in the jugular.  The one in the jugular is still there and now I am having chest pains.  I am scheduled for ECHO Testing to figure out my chest pains.  My Hematologist took me off Xarelto because they cannot figure out why I am getting the blood clots, but I keep having headaches especially when I wake up in the am.   Since I had the shots, I have seen 6 doctors and continue to be on this hunt for recovery.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Laboratory test, Seizure
Clinical narrative: Pfizer - BioNTech COVID-19 Vaccine.  I had a seizure on 6/17, went to a hospital by EMT, told me my sugar was high and to take Metformin. Next day around 1 pm, I had another seizure.  Went to hospital by EMT.  Stayed for 8 days in the hospital because I  had two blood clots on my brain.  Venus sinus thrombosis, one in the back and one in the jugular.  The one in the jugular is still there and now I am having chest pains.  I am scheduled for ECHO Testing to figure out my chest pains.  My Hematologist took me off Xarelto because they cannot figure out why I am getting the blood clots, but I keep having headaches especially when I wake up in the am.   Since I had the shots, I have seen 6 doctors and continue to be on this hunt for recovery.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMRV, PNC15
Symptoms: Ear infection, Injection site mass, Pyrexia, Rash macular, Viral infection
Clinical narrative: Mother states that a day after vaccination, the pt was running a fever. 4 days after the vaccination occurred, mother took pt into PCP with c/o a fever off and on for past 3 days. The mother states that she has given the pt acetaminophen for the fever. The mother states that the pt was dx with an ear infection and prescribed amoxicillin. The mother states that there is a lump on the pt's left leg where vaccination occurred, and skin is red and splotchy all over the pt's body. The pt's PCP told the mother that "it was probably a viral infection".
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Tremor, Vomiting
Clinical narrative: Patient experienced vomiting, chills, body aches and shaking that developed within a few hours of receiving vaccines
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headaches, unspecified
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient was given dose of meningococcal group B to early. spoke with Dr. who said patient will be completely fine, he just received a dose to early so he'll need to still get this done at the time he's supposed to (16-18 years). patients mother was informed and she understood and had no further questions.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Below the injection site about one inch, the day after the upper arm swelled significantly, had a band of redness about one inch wide and four inches long.  The actual site of injection bruised.  The upper arm has remained sore and is still sore 5 days later.  The redness has changed to more of a bruised appearance, and there are raised bumps in the red zone, very small blisters of fluid.  The area of red is extremely itchy.  The left hand is sore at the wrist, and fingers are hard to flex - feels numb.   There were no effects from the original dose. #1 at all, same clinic.  I always do my left arm as I am a side sleeper on my right side.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Below the injection site about one inch, the day after the upper arm swelled significantly, had a band of redness about one inch wide and four inches long.  The actual site of injection bruised.  The upper arm has remained sore and is still sore 5 days later.  The redness has changed to more of a bruised appearance, and there are raised bumps in the red zone, very small blisters of fluid.  The area of red is extremely itchy.  The left hand is sore at the wrist, and fingers are hard to flex - feels numb.   There were no effects from the original dose. #1 at all, same clinic.  I always do my left arm as I am a side sleeper on my right side.
Age: 37.0
Sex: M
Vaccine: FLUC4, IPV, TDAP, TYP
Symptoms: Dizziness, Hyperhidrosis, Malaise, Pallor, Syncope
Clinical narrative: Client became lightheaded, pale, and diaphoretic. Verbalized not feeling well, then fainted for approx 3 seconds. Shook Clients shoulder and called his name. He immediately came to. Client was placed supine on the floor with legs elevated in the chair for 10 mins. Color returned to his face and stated felt he felt fully recovered after approx 4 minutes. Was given cool water and hard candy. Patient recovered at office.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eye swelling, Pyrexia
Clinical narrative: Parent called and reported the patient developed a low-grade fever, and swelling around the eyes and lips the morning after receiving the Hepatitis A, MMR, and Varicella vaccines the afternoon before. Provider advised to treat symptoms with 6.25mg of diphenhydramine q6 hours and watch for any worsening  symptoms. Provider also advised parent to go the emergency room should patient develop difficulty breathing. Patient has not developed any respiratory distress; patient is able to eat and drink without vomiting.
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Exposure during pregnancy, Headache, Pain
Clinical narrative: Headache, chills, body aches 14 hours after injection. Currently 32 weeks pregnant, estimated due date 2/12/24.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time abnormal, Atrial fibrillation, Blood magnesium, Blood thyroid stimulating hormone, Cardiac pacemaker insertion
Clinical narrative: One day after receiving the Pfizer COVID-19 booster, I began to feel short of breath while walking, and began having short dizzy spells. Approximately one week after the vaccination, I began to intermittently feel my pulse throbbing in my head and neck.  On November 18th, while trying to sleep, my heart pounded in my chest so hard that it shook my whole body. Upon waking, I found that my watch had recorded three alarms stating that my heart rate had fallen below 40 for greater than 10 minutes three times during the night. On November 19th, the same thing happened, but this time my watch had five alarms indicating that my heart rate had fallen below 40 for greater than 10 minutes. I was admitted to the hospital on November 20th, 2023, with atrial fibrillation, and on November 21, 2023, a Medtronic pacemaker was implanted in my chest to regulate my heart rate.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Differential white blood cell count, Dizziness, Dyspnoea exertional, Echocardiogram
Clinical narrative: One day after receiving the Pfizer COVID-19 booster, I began to feel short of breath while walking, and began having short dizzy spells. Approximately one week after the vaccination, I began to intermittently feel my pulse throbbing in my head and neck.  On November 18th, while trying to sleep, my heart pounded in my chest so hard that it shook my whole body. Upon waking, I found that my watch had recorded three alarms stating that my heart rate had fallen below 40 for greater than 10 minutes three times during the night. On November 19th, the same thing happened, but this time my watch had five alarms indicating that my heart rate had fallen below 40 for greater than 10 minutes. I was admitted to the hospital on November 20th, 2023, with atrial fibrillation, and on November 21, 2023, a Medtronic pacemaker was implanted in my chest to regulate my heart rate.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Fibrin D dimer, Full blood count, Heart rate decreased, International normalised ratio
Clinical narrative: One day after receiving the Pfizer COVID-19 booster, I began to feel short of breath while walking, and began having short dizzy spells. Approximately one week after the vaccination, I began to intermittently feel my pulse throbbing in my head and neck.  On November 18th, while trying to sleep, my heart pounded in my chest so hard that it shook my whole body. Upon waking, I found that my watch had recorded three alarms stating that my heart rate had fallen below 40 for greater than 10 minutes three times during the night. On November 19th, the same thing happened, but this time my watch had five alarms indicating that my heart rate had fallen below 40 for greater than 10 minutes. I was admitted to the hospital on November 20th, 2023, with atrial fibrillation, and on November 21, 2023, a Medtronic pacemaker was implanted in my chest to regulate my heart rate.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test abnormal, N-terminal prohormone brain natriuretic peptide, Palpitations, Prothrombin time, Pulse pressure abnormal
Clinical narrative: One day after receiving the Pfizer COVID-19 booster, I began to feel short of breath while walking, and began having short dizzy spells. Approximately one week after the vaccination, I began to intermittently feel my pulse throbbing in my head and neck.  On November 18th, while trying to sleep, my heart pounded in my chest so hard that it shook my whole body. Upon waking, I found that my watch had recorded three alarms stating that my heart rate had fallen below 40 for greater than 10 minutes three times during the night. On November 19th, the same thing happened, but this time my watch had five alarms indicating that my heart rate had fallen below 40 for greater than 10 minutes. I was admitted to the hospital on November 20th, 2023, with atrial fibrillation, and on November 21, 2023, a Medtronic pacemaker was implanted in my chest to regulate my heart rate.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin T
Clinical narrative: One day after receiving the Pfizer COVID-19 booster, I began to feel short of breath while walking, and began having short dizzy spells. Approximately one week after the vaccination, I began to intermittently feel my pulse throbbing in my head and neck.  On November 18th, while trying to sleep, my heart pounded in my chest so hard that it shook my whole body. Upon waking, I found that my watch had recorded three alarms stating that my heart rate had fallen below 40 for greater than 10 minutes three times during the night. On November 19th, the same thing happened, but this time my watch had five alarms indicating that my heart rate had fallen below 40 for greater than 10 minutes. I was admitted to the hospital on November 20th, 2023, with atrial fibrillation, and on November 21, 2023, a Medtronic pacemaker was implanted in my chest to regulate my heart rate.
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported, patient tolerated the vaccines. Error recognized and parent informed, as well as escalation up to the chain of command
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Anxiety, Pallor, Syncope
Clinical narrative: Menquadfi administered in right deltoid. Bexsero then administered in left deltoid. Patient became pale and fainted as writer was applying bandage following Bexsero administration.  Did not fall/no injury. Patient was sitting on exam table, held upright and laid back by writer and immunization assistant. Regained consciousness as she was being laid back.  Recovered quickly. Laid on exam table for several minutes with cool washcloth. Assisted to sitting position and given snack.  Normal coloring returned. HR 82 BP 112/62.  Patient reports she was very anxious about receiving immunizations and also had not eaten yet today.  Reported feeling "fine" and that she "feels normal" prior to leaving office.  No further distress observed. Normal, steady gait observed when leaving office.  Patient left with mother.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Fatigue, Headache, Impaired driving ability
Clinical narrative: dizziness, fatigue, brain fog, nausea, headaches lasting over a month. reported that she has almost gotten into a car accident today and she believes this to be due to the dizziness from the covid shot 12/15
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: dizziness, fatigue, brain fog, nausea, headaches lasting over a month. reported that she has almost gotten into a car accident today and she believes this to be due to the dizziness from the covid shot 12/15
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated with 1 booster
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pruritus
Clinical narrative: RSV vaccine on 12/14/23 to right arm.  Red dots to both arms, back and face and is spreading since Saturday.  Some itching, took Benadryl past 2 days.  No fever, no blisters, no red streaks, no pain, no purple or blood colored rash.  No new foods or soaps or lotions.
Age: 8.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Fall, Feeling hot, Nausea, Vomiting
Clinical narrative: Pt became nauseous post injection within 10-15minutes.  parents caught her prior to falling .  Alerted her and continued to talk to her.  Patient stated she was hot and vomited.  Cold compress was place on head until ambulance arrived.  Assessment done by paramedics and patient was given permission to go home.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with booster
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with booster
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Autopsy, Death
Clinical narrative: Death - no prior medical concerns of athlete. Found in bedroom, no signs of foul play or self-harm. Went to sleep and never woke up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events.  Patient had forgotten that he had received a Comirnaty Pfizer COVID-19 vaccination on 11/20/23, and asked for another one on 12/21/2023.  He received the vaccine without incident.  Upon speaking with the patient in the afternoon, it was discovered that he had already received the vaccine and was not eligible for a second dose.  He experienced no ill effects from the vaccine.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Approximately 10 hours after receiving vaccine patient developed urticaria of his left thigh. Patient went back to bed and urticaria had resolved when he woke in the morning.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Tic
Clinical narrative: facial tick, referral to Neurology today 12/21/23
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received blue cap Pfizer COVID-19 vaccine for ages 5 to <12y. She is 54 and was meant to be given a dose of 12y+ Pfizer COVID-19 vaccine. I have contacted the patient and she is not experiencing any adverse effects.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Tremor
Clinical narrative: After giving Pt this vaccine, she began to fall back and shake, but her eyes were opened the whole time. Her mom assisted me with sitting her back up then i ran out for help.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: In an attempt to be prompt with patient I negated to ensure the patient had not been vaccinated for this, yet, learning after from the doctor that he had already been administered this vaccine by another team member that showed in his chart, at a previous visit. It was our intention to catch him this visit for his Pnuemo 20 vaccine, of which he had declined last visit, per the doctors note. Patient tends to only allow a certain amount of care before becoming overwhelmed and walking out.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine positive, Death
Clinical narrative: Resident Expired on 12/16/23
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pain and redness localized to R thigh, treated with tylenol as needed as well as ice packs as needed - started a couple of days after vaccine given and worsened over a couple days before self resolving
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received inappropriate age vaccine. patient is 12 yrs of age and received pfizer 5 yr -11 yr vaccine.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the patient came into the pharmacy and asked for a flu shot, it was entered into the system. The pt is 80 years old and after the shot stated she wanted the covid shot. The pt had the fluad 65 high dose at the  doctor's office also back in October , therefore she got 2 flu shots within a few months.  She said she did not have any reactions as of yet and it occurred on 12/19/2023  .  I contacted the doctor, and they noted it in the patients  records.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine past its expiration date which is 8/29/2023.  The doctor was informed of this and no action was taken per his order.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident Expired
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Contusion
Clinical narrative: PER PT, THE ADVERSE EVENT STARTED A FEW DAYS AFTER THE VACCINE AND STAYED FOR 2 MONTHS.   "BLACK AND BLUE BRUISE ON HIS ARM, NOT PAINFUL" RESOLVED ON ITS OWN AFTER 2 MONTHS
Age: 75.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Cough, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient reports about 3 days after vaccinations she began feeling tired and started coughing. These symptoms lasted for approximately 1 month. She also reports a vaccine site reaction on the right arm of redness, swelling, and pain.
Sex: U
Vaccine: VARZOS
Symptoms: Immunisation reaction, Inappropriate schedule of product administration, Pruritus, Ulcer
Clinical narrative: Multiple small ulcers with itch; Itch; The 2nd dose of shingles (8/15/22); This non-serious case was reported by a other health professional via call center representative and described the occurrence of ulcer in a patient who received Herpes zoster (Shingles vaccine) (batch number 3BD53, expiry date 07-JUL-2023) and (batch number 9R4N2, expiry date 07-JUL-2023) for prophylaxis.   Previously administered products included Shingrix (on 06-APR-2018, the patient received 1st dose).   On 15-AUG-2022, the patient received the 2nd dose of Shingles vaccine. On 15-AUG-2022, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: The 2nd dose of shingles (8/15/22)). On an unknown date, the patient experienced ulcer (Verbatim: Multiple small ulcers with itch) and pruritus (Verbatim: Itch). The outcome of the ulcer and pruritus were not resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the ulcer and pruritus to be related to Shingles vaccine.     The company considered the ulcer and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was a Risk Control Coordinator. The patient received 2nd dose of Shingles that caused multiple small ulcers with itch, that was everyday worst.  The reporter requested copy of medication insert / literature on the shingles vaccine and to confirm if there were any re-calls to this specific lot. The patient received the 2nd dose of Shingles vaccine later than recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP called to report that about two weeks ago ( exact dates unknown) a patient older that 12 years of age was inadvertently given a dose of PROQUAD.  The HCP did not have access to any patient information and could not provide the lot number or expir; No adverse event; This spontaneous report was received from a nurse prescriber refers to a patient of unknown exact age (reported as older than 12 years of age). The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), formulation: injection, 0.5 milliliter for prophylaxis (lot #, expiration date, route of administration and anatomical location were not reported) (product administered to patient of inappropriate age). No additional adverse event reported (no adverse event).
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No Adverse Event; A HBP called to report that an expired dose of RECOMBIVAX HB (Lot #W016842; expiration 11/19/2023) was inadvertently administered to a patient earlier today (12/07/2023) by a medical assistant (MA). The were no adverse issues or side effects reported; This spontaneous report was received from an office manager refers to a 5-week-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-DEC-2023, the patient was vaccinated with expired dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), formulation: intramuscular Injection, lot# W016842, expiration date: 19-NOV-2023, 0.5 milliliter (once) for prophylaxis by medical assistant (route of administration and anatomical location were not provided) (expired product administered). No additional adverse event reported (no adverse event).
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Vaccine administered on 21-JUL-1993; Vaccine administered on 17-NOV-1992; Vaccine administered on 29-SEP-1992; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet and Medical Records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2311USA000042), concerning a currently 31-year-old female patient. Concomitant therapies included: polio vaccine live oral (reported as POL-OPV (Polio, live virus)). There was no information about the patient's concurrent conditions or medical history provided.  On 30-JUN-1992, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as HIB PRP-OMP (Haemophilus influenzae b)) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis.  On 29-SEP-1992, she was vaccinated with the next dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as HIB PRP-OMP (Haemophilus influenzae b)) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  On 17-NOV-1992, she was vaccinated with the next dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as HIB PRP-OMP (Haemophilus influenzae b)) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  On 21-JUL-1993, she was vaccinated with the next and last dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as HIB PRP-OMP (Haemophilus influenzae b)) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (extra dose administered).  Other vaccinations included: DTP (Diphtheria, Tetanus, Pertussis), HAV ped (Hepatitis A), HAV ped/adol 2 dose sch (Hepatitis A), HBV ped/adol, 3dose sch (Hepatitis B), HPV4 (Human papillomavirus, quadrivalent), influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT), INFs (Influenza split virus), INFs pres free 3yrs-adult (Influenza), influenza vaccine inact split 3v (AFLURIA), MENcn-ACYW (Meningococcal conjugate, groups ACYW-135), MMR (Measles, Mumps, Rubella), Tdap (ADACEL) (Tetanus, diphtheria, acellular pertussis), Tdap (ADACEL) (Tetanus, diphtheria, acellular pertussis), VAR (Varicella, chickenpox) and td 7yrs-adult (tetanus, diphtheria), adsorber.  This is one of the few reports concerning the same patient.; Sender's Comments:  US-009507513-2312USA003370: US-009507513-2312USA003367: US-009507513-2312USA003369:
Age: 52.0
Sex: M
Vaccine: HEP, HEPA, HEPAB
Symptoms: Interchange of vaccine products
Clinical narrative: No adverse event; Interchange of vaccine products; This spontaneous report was received from a pharmacist refers to a 52-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 18-MAY-2023, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA), formulation: intramuscular injection, lot# W017819, expiration date: 27-DEC-2023, 1 milliliter (once), route of administration reported as injection, (anatomical location was not reported); and the first dose of creatine, galantamine hydrobromide, royal jelly, sodium phytate(ENERGIX) lot# reported as: K9HS5, expiration date: 18-MAR-2024, 1 milliliter (once), route of administration reported as injection, (formulation and anatomical location were not reported) for immunisation. On 20-JUN-2023, the patient was vaccinated with the second dose of creatine, galantamine hydrobromide, royal jelly, sodium phytate (ENERGIX) lot# reported as: K9HS5, expiration date: 18-MAR-2024, 1 milliliter (once), route of administration reported as injection, (formulation and anatomical location were not reported) for immunisation. On 06-DEC-2023, the patient was vaccinated with hepatitis a vaccine inact, hepatitis b vaccine rhbsag (yeast)(TWINRIX) lot# reported as: 797R9, expiration date reported as: 30-DEC-2025, 1 milliliter (once), route of administration reported as injection, (formulation and anatomical location were not reported) for immunization (interchange of vaccine products). The patient did not report any side effects or issues with the administration of any of the vaccines (no adverse event).
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 07-DEC-2001 vaccination with Hepatitis B; On 26-MAR-2001 vaccination with Hepatitis B; This spontaneous report has been received from a lawyer, via a Memo and Medical Records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (2310USA011688), concerning a currently 32-year-old female patient. Her historical vaccines included: diphtheria vaccine toxoid, pertussis vaccine, tetanus vaccine toxoid (reported as DTP) and measles vaccine, mumps vaccine, rubella vaccine (reported as MMR). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-SEP-2000, the patient was vaccinated with hepatitis b vaccine (recombinant) vaccine (manufacturer unknown) (reported as Hepatitis B) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis.  On 26-MAR-2001, she was vaccinated with the next dose of hepatitis b vaccine (recombinant) vaccine (manufacturer unknown) (reported as Hepatitis B) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). On 07-DEC-2001, she was vaccinated with the next dose of hepatitis b vaccine (recombinant) vaccine (manufacturer unknown) (reported as Hepatitis B) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). Other vaccinations included: hepatitis A; diphtheria vaccine toxoid, tetanus vaccine toxoid (reported as Td); quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL); meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA); "PPD" and influenza vaccine inact split (reported as influenza (split)).  This is one of the few reports concerning the same patient.; Sender's Comments:  US-009507513-2312USA005493:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC; HBP called to report inadvertent administration of expired GARDASIL 9 to a patient. Product expired on 15-AUG-2023 and was administered to a patient on 13-DEC-2023.; This spontaneous report has been received from a health business professional (HBP) (also reported as type "other") regarding a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions, and concomitant medications were not reported.  On 13-DEC-2023, the patient was inadvertently vaccinated with an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose number, dosage, vaccination scheme frequency, route of administration, anatomical site of application, and lot number were not provided; expiration date was reported as 15-AUG-2023) (expired product administered).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; inadvertent administration of expired MMR-II to a patient on 12/7/2023; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 07-DEC-2023, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (recombinant Human albumin), 0.5 milliliter, lot #W009105, expiration date: 04-DEC-2023, administered for prophylaxis (anatomical location, strength, and route of administration were not provided) (expired product administered). No additional AE was reported.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE; patient received an expired MMR II; This spontaneous report was received from pharmacist and refers to a 2-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 15-DEC-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) injection, (1 dose, lot #w009107, expiration date: 04-DEC-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No additional adverse events (AEs) were reported (No adverse event). No further information provided. No product quality complaint (PQC).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, COVID-19, Cough, Fine motor skill dysfunction, SARS-CoV-2 test positive
Clinical narrative: (M.D.) Physician Specialty:  NEUROSURG TRAUMA/COMPLEX SPINE Progress Notes    Signed  Signed       Neurosurgery   Patient tested positive for COVID on screening test yesterday.  She did endorse a mild cough over the weekend which was self-limited and has been asymptomatic since then. I discussed with her that she has spinal cord compression with cord signal and has already been postponed once for cardiac clearance; she subjectively feels like her balance has worsened as well as the dexterity of her hands. Given the potential of worsening of her myelopathic symptoms, we discussed proceeding which she agrees to.  We discussed there is still a potential for worsening perioperative events which she understands.   MD      Note Details  Author (M.D.) File Time 11/21/2023  7:41 AM Author Type Physician Status Signed Last Editor (M.D.) Specialty NEUROSURG TRAUMA/COMPLEX SPINE Hospital Acct #  Admit Date 11/21/2023
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal cord compression
Clinical narrative: (M.D.) Physician Specialty:  NEUROSURG TRAUMA/COMPLEX SPINE Progress Notes    Signed  Signed       Neurosurgery   Patient tested positive for COVID on screening test yesterday.  She did endorse a mild cough over the weekend which was self-limited and has been asymptomatic since then. I discussed with her that she has spinal cord compression with cord signal and has already been postponed once for cardiac clearance; she subjectively feels like her balance has worsened as well as the dexterity of her hands. Given the potential of worsening of her myelopathic symptoms, we discussed proceeding which she agrees to.  We discussed there is still a potential for worsening perioperative events which she understands.   MD      Note Details  Author (M.D.) File Time 11/21/2023  7:41 AM Author Type Physician Status Signed Last Editor (M.D.) Specialty NEUROSURG TRAUMA/COMPLEX SPINE Hospital Acct #  Admit Date 11/21/2023
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Vasovagal Syncope. Pt passed out twice
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Dysstasia
Clinical narrative: After HPV was given patient stated was feeling lightheaded, unable to standing alone, feeling palw, was placed by MA on decubitus supinus and the symptoms were subsiding in several minutes. VS were taken after the incident showing BP and HR within normal limits. On questioning she states a hx of needles fear. Pt denies any palpitations, chest pain, shortness of breath.  Observed 30 minutes, patient was stable.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture negative, Death
Clinical narrative: Resident Expired
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Device leakage, Underdose
Clinical narrative: When giving vaccine, plunger was pulled to aspirate, then plunger was pushed in to administer the vaccine. The contents of the syringe squirted out the sides between the needle hub and luer lock of the syringe. Possible manufacturer error.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal distension, Amnesia, Arthralgia, Back pain, Blood test
Clinical narrative: Chronic headaches, menstrual irregularities, and persistent fatigue. The situation worsened after my third dose on October 30, 2023, with symptoms including tachycardia, dizziness, shortness of breath, nausea, extreme fatigue, decreased appetite, early fullness, back pain, joint pain, exercise intolerance, headaches, temperature intolerance, chest pain, palpitations, muscle twitching, insomnia, inability to concentrate, short-term memory loss, severe constipation, and bloating. After an extensive battery of blood and cardiac tests, I was diagnosed with POTS on December 6, 2023
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Cardiac function test, Cardiac monitoring abnormal, Chest pain, Constipation, Decreased appetite
Clinical narrative: Chronic headaches, menstrual irregularities, and persistent fatigue. The situation worsened after my third dose on October 30, 2023, with symptoms including tachycardia, dizziness, shortness of breath, nausea, extreme fatigue, decreased appetite, early fullness, back pain, joint pain, exercise intolerance, headaches, temperature intolerance, chest pain, palpitations, muscle twitching, insomnia, inability to concentrate, short-term memory loss, severe constipation, and bloating. After an extensive battery of blood and cardiac tests, I was diagnosed with POTS on December 6, 2023
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Echocardiogram normal, Exercise tolerance decreased
Clinical narrative: Chronic headaches, menstrual irregularities, and persistent fatigue. The situation worsened after my third dose on October 30, 2023, with symptoms including tachycardia, dizziness, shortness of breath, nausea, extreme fatigue, decreased appetite, early fullness, back pain, joint pain, exercise intolerance, headaches, temperature intolerance, chest pain, palpitations, muscle twitching, insomnia, inability to concentrate, short-term memory loss, severe constipation, and bloating. After an extensive battery of blood and cardiac tests, I was diagnosed with POTS on December 6, 2023
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Insomnia, Menstruation irregular, Muscle twitching
Clinical narrative: Chronic headaches, menstrual irregularities, and persistent fatigue. The situation worsened after my third dose on October 30, 2023, with symptoms including tachycardia, dizziness, shortness of breath, nausea, extreme fatigue, decreased appetite, early fullness, back pain, joint pain, exercise intolerance, headaches, temperature intolerance, chest pain, palpitations, muscle twitching, insomnia, inability to concentrate, short-term memory loss, severe constipation, and bloating. After an extensive battery of blood and cardiac tests, I was diagnosed with POTS on December 6, 2023
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Palpitations, Postural orthostatic tachycardia syndrome, Tachycardia, Temperature intolerance
Clinical narrative: Chronic headaches, menstrual irregularities, and persistent fatigue. The situation worsened after my third dose on October 30, 2023, with symptoms including tachycardia, dizziness, shortness of breath, nausea, extreme fatigue, decreased appetite, early fullness, back pain, joint pain, exercise intolerance, headaches, temperature intolerance, chest pain, palpitations, muscle twitching, insomnia, inability to concentrate, short-term memory loss, severe constipation, and bloating. After an extensive battery of blood and cardiac tests, I was diagnosed with POTS on December 6, 2023
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX  w008711  3/14/2024 Temperature: -13.8 Ti; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 10-NOV-2023 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W008711 and expiration date 14-MAR-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided). Temperature excursion lasted for 12 minutes in temperature of -13.8 (units not provided) (product storage error and no adverse event).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: The medical assistant gave Pentacel and Quadracel in error at same visit instead of giving Quadracel and Proquad.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Device connection issue, Immunisation, Underdose, Wrong technique in product usage process
Clinical narrative: No distinct adverse event, but due to small bore needle use, and pressure exerted on syringe, needle became disconnected from syringe at time of delivery of flu vaccine and none or minimal dose entered patient intramuscularly. Clinical judgement exercised to administer additional dose.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: There was large swelling and redness at the injection site (left arm) below shoulder.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Dyskinesia, Eye movement disorder, Fall, Musculoskeletal stiffness
Clinical narrative: Patient was given Gardasil and Tdap on left arm and then MCV and flu-zone on right arm, right after needle was taken out the arm patient fell back, eyes also rolled back. Patient began to have erratic movements on arms and legs with stiffness. I then opened the door and shouted for Dr. down the hall, before provider came in patient had come back to her senses, lasted about 5-10 seconds.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Patient was given Gardasil and Tdap on left arm and then MCV and flu-zone on right arm, right after needle was taken out the arm patient fell back, eyes also rolled back. Patient began to have erratic movements on arms and legs with stiffness. I then opened the door and shouted for Dr. down the hall, before provider came in patient had come back to her senses, lasted about 5-10 seconds.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose administered; This spontaneous report was received from Health Care Professional (HCP, a Registered Nurse) and refers to a patient of an unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 14-DEC-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) formulation reported as injection, upon internal review, established as prefilled syringe, 0.5 milliliter (lot #W015900, expiration date: 20-OCT-2023), administered intramuscularly for prophylaxis (strength and vaccination schedule were not provided) (Expired product administered). No additional adverse events (AEs) or Product Quality Complaint (PQC) were reported (No adverse event).
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: his wife received PNEUMOVAX 23 and shortly after, the HCP's office contacted her to let her know that the vaccine that she received expired in October of 2023; No additional AE; This spontaneous report was received from a patient's husband and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, expiration date: 15-OCT-2023, administered for prophylaxis (anatomical location, strength, lot #, and route of administration were not provided) (expired product administered). No additional adverse events occurred.
Sex: U
Vaccine: FLUN4
Symptoms: Death, Influenza
Clinical narrative: COMMENT ON SOCIAL MEDIA ABOUT CHILD RECEIVING FLUMIST YEARS AGO AND DYING FROM THE FLU; A spontaneous report has been received from a consumer concerning a child of unknown gender of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: NASK.     No concomitant products were reported.    On an unknown date, the patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) once/single administration, via nasal route.     On an unknown date, the patient experienced comment on social media about child receiving flumist years ago and dying from the flu (preferred term: Influenza).      The action taken with flumist quadrivalent is not applicable.    The patient died from the event on an unspecified date.    An autopsy was not performed. The cause of death was comment on social media about child receiving flumist years ago and dying from the flu.     The reporter assessed the event of comment on social media about child receiving flumist years ago and dying from the flu to be serious due to fatal outcome.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect     Minor correction 19-Dec-2023: Reporter name( Vaccination facility) added on product and dosing. Tick removed from Include in E2B.Narrative updated.; Sender's Comments: Fatal event of Influenza is not listed in company core data sheet of Q/LAIV. Due to limited information on complete patient?s demographics, suspect start date with indication, event onset date,  circumstances leading to event, clinical course, treatment details, concomitant medications, risk factors, medical history (congenital abnormalities, cardio-pulmonary disorders), birth history, maternal gynecological and obstetrics history, relevant family history, detailed etiological and diagnostic work up(complete blood count, imaging studies, infection workup), the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the event and the suspect drug. ; Reported Cause(s) of Death: COMMENT ON social media ABOUT CHILD RECEIVING FLUMIST YEARS AGO AND DYING FROM THE FLU
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: fever; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a female 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 fever (Verbatim: fever). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Arexvy.     It was unknown if the company considered the fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-DEC-2023 The patient reported that she received  RSV shot.  She did not knew which one she received.  She reported that the general adverse effects including fever. The reporter did not consent to follow up.