chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Patient presented to clinic stating she needed a Tdap vaccination, reports she is required to have another as she works in childcare. Patient is also pregnant currently and is going in for induction in 3 days. Patient signed into the clinic registration as also needing a Tdap vaccination. Patient signed vaccine consent form for Tdap vaccination. APRN confirmed with patient prior to giving the vaccination that she was there for a Tdap vaccine. After vaccination administration, patient states "Last time I had the Tdap they put it in the lower part of my arm. Did they change it?" It was at that time, the APRN realized she needed a PPD and NOT a Tdap Vaccination. Patient admits to incorrectly and unknowingly asking and confirming the wrong procedure. PPD also performed at time of visit.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: The on half of my legs has completely stopped growing since vaccinated and I experience swelling in feet and ankles. Seems like it created a circulation issue.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient was to receive Quadracel IM in left arm. Patient instead received Quadracel SC in left arm. After vaccination, and after patient left clinic, patient mother was informed, denies any reactions at this time.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient was injected with a Covid Comirnaty prefilled syringe ages 12 and up on 05/07/2024 that expired on 05/04/2024.  No adverse reaction happened to the patient.  The patient was notified Pfizer was called, and stated no safety concerns, and no need to re-vaccinate.  Staff have been re-educated.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported. No PQC reported.; Medical assistant reported ROTATEQ was administered after a temperature excursion to patient. Date of administration: 4/22/2024 Names of vaccines involved (including lot/exp): ROTATEQ (1968392 5/24/2024) Temperature: 32.9°F Time frame: 3 hours 18 mi; This spontaneous report was received from a medical assistant 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 22-APR-2024 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968392 and expiration date 24-MAY-2024 for prophylaxis (exact dose, dose number and route of administration were not provided). The temperature excursion lasted for 3 hours and 18 minutes in temperature of 32.9 Fahrenheit degrees (product storage error and no adverse event).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Mobility decreased, Myalgia, Nasal congestion, Nasopharyngitis
Clinical narrative: The following day, she had really bad cold symptoms.  Stuffed nose, etc. Lasted 3 to 4 days.  A week later after the cold symptoms subsided, she said her arm hurt.  Muscular pain in the arm.  She had trouble lifting it.  She also got a rash at the injection site at this time as well.  To this day, remnants of the rash remain at the injection site.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The following day, she had really bad cold symptoms.  Stuffed nose, etc. Lasted 3 to 4 days.  A week later after the cold symptoms subsided, she said her arm hurt.  Muscular pain in the arm.  She had trouble lifting it.  She also got a rash at the injection site at this time as well.  To this day, remnants of the rash remain at the injection site.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt stated about 3 days after receiving his 2nd shingles vaccine he got swelling, erythema, to left forearm area of the same arm where he received the vaccine. he has been taking benadryl and rash appeared to be getting better.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Pt developed redness, swelling, and itching at the injection site. It started with pain in her arm. She took ibuprofen and put cold compress on it.  Consulted her on taking benadryl and monitor symptoms, and call doctor if it worsens.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Nurse drew up the green top vial of Adjuvant Suspension Component and administered it to the patient without first mixing the adjuvant with the Lypholized gE antigen component.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given MMRV @ 15 YO
Age: 16.0
Sex: F
Vaccine: COVID19, FLU4, MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: On 5/06/2024 patient got administered a COVID19 ( Pfizer-Biontech) vaccine that expired on 5/04/2024. No adverse reactions after vaccination.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Central vision loss, Retinal haemorrhage, Retinal oedema, Retinogram abnormal, Vascular occlusion
Clinical narrative: Vascular occlusion in the right eye with subsequent blurring and loss of central vision.  Currently under treatment.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Vascular occlusion in the right eye with subsequent blurring and loss of central vision.  Currently under treatment.
Age: 36.0
Sex: F
Vaccine: HEPAB, HPV9, MMR
Symptoms: Cold sweat, Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: patient got lite headed, nausea, headache and hot/clammy.  she sat herself on the ground (about 1210pm), then laid herself down.  we gave her ice packs and kept her talking, she was not feeling better.  we called a code white and ems at 1213. by 1226 paramedics took over.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Blood test normal, Dizziness, Impaired driving ability, Magnetic resonance imaging head normal
Clinical narrative: Within 8 hours I started to feel dizzy. By 24 hours I was so dizzy I could not drive. By 48 hours I was mostly sitting due to being so dizzy and if I walked any amount of time I would start to get sick to my stomach. At 72 hours I went to urgent care which sent me to the hospital emergency room. Due to being busy, i had to wait 12 hours to be seen. By the time went back my dizziness had started to improve. The hospital did a brain MRI to rule out stroke and cancer. Both were negative. I was sent home with  Meclizie tablets for motion sickness. Within 24 hours I was able to drive and return to work. Occasionally I still experience mild dizziness or unsteady on my feet.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Motion sickness, Nausea
Clinical narrative: Within 8 hours I started to feel dizzy. By 24 hours I was so dizzy I could not drive. By 48 hours I was mostly sitting due to being so dizzy and if I walked any amount of time I would start to get sick to my stomach. At 72 hours I went to urgent care which sent me to the hospital emergency room. Due to being busy, i had to wait 12 hours to be seen. By the time went back my dizziness had started to improve. The hospital did a brain MRI to rule out stroke and cancer. Both were negative. I was sent home with  Meclizie tablets for motion sickness. Within 24 hours I was able to drive and return to work. Occasionally I still experience mild dizziness or unsteady on my feet.
Age: 1.25
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MMRV Vaccine was given in the accelerated time period and not the recommended time period.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: After the 2nd vaccine on 12/30/2022, my left upper arm still was very sore and continues to be sore to this day 5/7/24.  It feels like I was hit by a baseball and It became more intense over time   I received the first vaccine on 10/11/22.  Normally I have the usual very minor sore feeling that might last no longer than 1 day.
Age: 61.0
Sex: M
Vaccine: SMALL, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Adverse effect is Patient receiving a Second dose of Prevnar 20 when already received a dose on 4/8/24 -- discovered after administration and when paperwork being completed.  Mistake by myself, when I quickly reviewed prior vaccines and did not catch he had already received.  I contacted patient 2 days after vaccination, informed him, asked if any adverse effects, and none were reported.   He noted his sugar was elevated (about 300), which is about the same he told it was the morning of his administration (before the shots were given)- so no change.  Dr. office also informed.  Again, no adverse effects reported.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia, Pain
Clinical narrative: Patient reported burning, shooting pain down arm, "in muscle," "whenever engaging muscle"
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: There was no reaction to the vaccine.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; RECOMBIVAX HB was administered after a temperature excursion to patient; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-APR-2024, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (1 dose, lot #X002469 was valid for formulation vial, expiration date: 22-MAY-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Temperature excursion (TE) of 32.9 degrees Fahrenheit (F) for 3 hours and 18 minutes. No previous TE. No further information provided. No additional AE reported (No adverse event). No PQC reported.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: On 01/17/24, the patient was given the Moderna SpikeVax vaccine designated for ages 12 and up. The child was 10 years of age at the time of the vaccine. No symptoms have been reported since the vaccine was administered.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Barium double contrast, Intussusception
Clinical narrative: INTUSSUSCEPTION -- required air enema reduction
Age: 34.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received 3 vaccines on left arm on 5/03/2024. Patient came to clinic with a painful erythema and swelling on her left arm on 5/07/2024, she described that the night before she was feeling fever.  Patient was evaluated by Clinic Nurse Practitioner and encourage to go to Urgent Care.
Age: 7.0
Sex: M
Vaccine: FLU4, IPV
Symptoms: Anxiety, Eye movement disorder, Heart rate irregular, Hypopnoea, Loss of consciousness
Clinical narrative: Child, mother, interpreter at the DOH for vaccinations;    Child was very anxious during the shots; he sat in the immune room for 2 minutes following vaccination, without issue. The family was taken to room as she was to process payment within a minute child displayed signs that he would faint; she quickly moved him to a chair and called for assistance. When I entered the room, he was seated, he was pale, his eyes rolled back and staff was attempting to revive him with a sternal rub. A call for assistance was given; the Oximeters placed with his O2 level reading 98%; respiration rapid and shallow. He revived after less than 60 seconds. Blood pressure/temperature/Heart Rate/O2 levels taken for the next 30 minutes. Child's color improved with food and juice. He experienced no further dizziness and was stable in standing and walking afterwards without issue. Family had been instructed by myself to wait for the shot record but left after leaving office.   Timeline: 1638 shots administered child sitting in chair 1642 Child stands, confirmation he feels no symptoms, family walked into office 1644 Staff calls for assistance after placing child in chair, beginning sternal rub 1645 vitals begin Vitals:     BP 83/55; HR 68; Temp 97.2; O2 Sat 98% on room air; heart rate irregular; coat taken off  breathing shallow     BP 69/49 HR 76 O2 sat 98% heart rate regular; breathing even; color improved     BP 69/49 HR 76 O2 sat 98%     BP 82/48  HR     Temp 97.7F, O2 sat 98% 1715 family leaves       1745-1820 Call with mom using interpreter #1254; mom reports child is doing "fine", he has no dizziness/nausea; he is active. I went over side effects and allergic reactions again; mom denies he has any. I explained the reaction he had in the office most likely was due to anxiety and his lack of having eaten/hydrated prior; it may have also been fainting syndrome as he was very anxious prior to the vaccinations. Mom's anxiety at that time appeared to contribute to child's.  I advised that if he had any further reaction, she should seek immediate medical assistance then let us know. She had no additional questions/concerns; I arranged to call her to check on the child again tomorrow. We scheduled the next IPV for 6/13/24. -RN  6/7/24 Call with mom through interpreter #14374; Child is doing well today, no symptoms from yesterday, no side effects. Advised her to seek medical attention if he has any further symptoms. Child was not in school today but she will send him tomorrow. -RN
Age: 7.0
Sex: M
Vaccine: FLU4, IPV
Symptoms: Pallor, Respiratory rate increased
Clinical narrative: Child, mother, interpreter at the DOH for vaccinations;    Child was very anxious during the shots; he sat in the immune room for 2 minutes following vaccination, without issue. The family was taken to room as she was to process payment within a minute child displayed signs that he would faint; she quickly moved him to a chair and called for assistance. When I entered the room, he was seated, he was pale, his eyes rolled back and staff was attempting to revive him with a sternal rub. A call for assistance was given; the Oximeters placed with his O2 level reading 98%; respiration rapid and shallow. He revived after less than 60 seconds. Blood pressure/temperature/Heart Rate/O2 levels taken for the next 30 minutes. Child's color improved with food and juice. He experienced no further dizziness and was stable in standing and walking afterwards without issue. Family had been instructed by myself to wait for the shot record but left after leaving office.   Timeline: 1638 shots administered child sitting in chair 1642 Child stands, confirmation he feels no symptoms, family walked into office 1644 Staff calls for assistance after placing child in chair, beginning sternal rub 1645 vitals begin Vitals:     BP 83/55; HR 68; Temp 97.2; O2 Sat 98% on room air; heart rate irregular; coat taken off  breathing shallow     BP 69/49 HR 76 O2 sat 98% heart rate regular; breathing even; color improved     BP 69/49 HR 76 O2 sat 98%     BP 82/48  HR     Temp 97.7F, O2 sat 98% 1715 family leaves       1745-1820 Call with mom using interpreter #1254; mom reports child is doing "fine", he has no dizziness/nausea; he is active. I went over side effects and allergic reactions again; mom denies he has any. I explained the reaction he had in the office most likely was due to anxiety and his lack of having eaten/hydrated prior; it may have also been fainting syndrome as he was very anxious prior to the vaccinations. Mom's anxiety at that time appeared to contribute to child's.  I advised that if he had any further reaction, she should seek immediate medical assistance then let us know. She had no additional questions/concerns; I arranged to call her to check on the child again tomorrow. We scheduled the next IPV for 6/13/24. -RN  6/7/24 Call with mom through interpreter #14374; Child is doing well today, no symptoms from yesterday, no side effects. Advised her to seek medical attention if he has any further symptoms. Child was not in school today but she will send him tomorrow. -RN
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient should have received Prevnar 20 as catch up vaccine, patient was given Pneumovax 23. Patient's guardian did not report  any high risk conditions for patient.  There was no adverse event following the medication error.
Age: 34.0
Sex: M
Vaccine: HEPA, MMR, TDAP, TYP, YF
Symptoms: Confusional state, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Pt experienced syncopal episode post Vx. This RN and another RN managed episode according to protocol. Pt recovered fully prior to leaving clinic, this RN walked pt and wife to their car. Pt and wife were advised to contact PCP about episode and education was given on S/S to watch for over the next few days. VAERS report will be submitted for this event.  Prior to Vx this nurse had Pt eat an energy bar and drink a health drink because Pt had not eaten breakfast this morning and Pt was anxious about Vx. After completion of Vx today Pt stated that he was feeling a bit lightheaded, this nurse had him rest his head/back against the wall where he was seated. Pt requested water and this nurse provided him some. Pt had a few sips of water leaned over his knees and lost consciousness momentarily. When this happened, this nurse called for other nurse to assist the Pt to a laying position on the bench where he was seated (no head strike occurred). When in the laying position the Pt regained consciousness and was confused about why he was laying down. This nurse had Pt remain in laying position while another nurse gathered to initiate VS. First set of VS were as follows- B/P- 138/70, O2- 97, HR- 54, RR- 16, Pt was diaphoretic. VS were monitored for the next 45 min to establish normal heart rate and appropriate level of consciousness. VS did trend to WLN and Pt was walked to the front w/ wife to check out.
Age: 91.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: Patient reporting severe injection site pain and nausea and vomiting that started several hours after vaccination and lasted through the next day
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Comirnaty 2023-2024 12 yr+ was administered instead of the Pfizer BioNTech 2023-2024 5-11yr.  No adverse reaction noted.
Age: 0.17
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; HCP called to report MMRII inadvertently administered on 5/2/24 to a 2 month old patient.  No symptoms reported.  No additional information provided by HCP. No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 02-MAY-2024 the patient was vaccinated at inappropriate age with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin tatus: rHA) lot # X011431 and expiration date 19-APR-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was given an expired Covid Vaccine exp date: 5/4/2024 NO Symptoms. Called Pfzier and was informed  Expiration Date ? Stability data demonstrated no impact to vaccine quality attributes for up to 7 days beyond the printed expiration date as long as prefilled syringes were stored at appropriate storage conditions throughout their entire shelf life. Vaccine will count patient will not need to return for a repeated.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Biopsy skin abnormal, Granuloma annulare
Clinical narrative: Developed biopsy proven granuloma annulare 2 weeks after vaccination
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site discomfort, Urticaria
Clinical narrative: Mother reported patient developed injection site discomfort and urticaria on right buttocks.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: The patient claims that 5 days after she experienced a rash that was similar to the symptoms of having shingles
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site vesicles
Clinical narrative: The patient claims that 5 days after she experienced a rash that was similar to the symptoms of having shingles
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pruritus, Varicella
Clinical narrative: The patient claims that 5 days after she experienced a rash that was similar to the symptoms of having shingles
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Arterial catheterisation abnormal, Coronary artery disease, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: Myocarditis, pericarditis, NSTEMI,  heart failure with reduced ejection fraction.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Heart failure with reduced ejection fraction, Myocarditis, Pericarditis, Troponin I increased, Troponin T increased
Clinical narrative: Myocarditis, pericarditis, NSTEMI,  heart failure with reduced ejection fraction.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Patient experienced immediate pallor with syncope occurring about 90 seconds later.  Pharmacist responded to pallor by re-seating the patient in the armed immunization seat. Patient nodded once, seemed to regain consciousness almost immediately and then nodded again, also regaining consciousness nearly immediately. Patient felt confused for 3-4 minutes and remained at the pharmacy until EMS arrived. They evaluated and released him to leave with his partner.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC20
Symptoms: Breath holding, Crying, Eye movement disorder, Loss of consciousness
Clinical narrative: Patient lost consciousness for no more than 5 seconds. He was crying and holding his breath. He then went silent, and his eyes rolled back so after a few seconds he started moving again and started crying.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Dyskinesia, Electric shock sensation, Laboratory test normal, Muscle twitching, Tremor
Clinical narrative: I starting trembling, shaking, got electric like shoots in my arms, my legs were jumping, a lot of muscle twitching and jerkiness.  It was horrible..  I still have some of the symptoms.. much better now. I was tested for Parkinsons, but it was ruled out by 2 Doctors. They simple cold not diagnose me, but told me not to get a tetanus shot again...  I have had them all of my life, as I worked in the yard,, rode horses etc and never had a problem before
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt. described continued soreness in left arm and limited movement of the left arm. Symptoms have continued since they started after the vaccination
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported VAQTA was administered after a temperature excursion to patient.; This spontaneous report was received from medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-APR-2024, the patient was vaccinated after a temperature excursion with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, valid lot #X025342 with expiration date: 12-MAY-2025, administered for prophylaxis (dose, strength, and route of administration were not provided) (product storage error). Temperature excursion was with temperature of 32.9 F, time frame of 3 hours and 18 minutes. There was no previous temperature excursion.  No further information was provided.and no additional adverse event (AE) was reported reported.
Age: 18.0
Sex: F
Vaccine: IPV, IPV, TDAP, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt. did not experience any s/e from getting double dose.. RN grabbed vaccine from the wrong tray. Pt was receiving 7 vaccines and tdap and Polio had already been given on the other arm from the correct tray.  As of  the time of the report pt had not experienced any issues. RN will plan to follow-up with pt to make sure she is okay. Pt was also given information on how to report any issues she was having after receiving the vaccine.
Age: 45.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: tonic colonic seizure
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported VAQTA was administered after a temperature excursion to patient. Date of administration: 4/30/2024.  Names of vaccines involved (including lot/exp): VAQTA (X025342 5/12/2025) Temperature: 32.9°F Time frame: 3 hours 18 minu; This spontaneous report was received from the Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 30-APR-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once, lot #X025342, verified as valid for formulation prefilled syringe, expiration date: 12-MAY-2025, administered once for prophylaxis (anatomical location, strength, and route of administration were not provided), after a temperature excursion; temperature: 32.9 F degrees, time frame: 3 hours 18 minutes (np previous temperature excursion) (Product storage error). No additional adverse events reported.
Age: 59.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Cerebrovascular accident, Influenza like illness, Mental status changes, Pain, Urinary retention
Clinical narrative: Possible stoke was reported as worsened.; Inability to urinate; Patient was in hospital for Started with flu like symptoms; Altered mental state; Severe pain with a medication required; This serious case was reported by a physician via sales rep and described the occurrence of worsening of stroke in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number X5j23, expiry date 25-JAN-2026) for prophylaxis.   Co-suspect products included Tetanus vaccine for prophylaxis.   On 16-APR-2024, the patient received the 1st dose of Shingrix and Tetanus vaccine. On 16-APR-2024, less than a day after receiving Shingrix, the patient experienced worsening of stroke (Verbatim: Possible stoke was reported as worsened.) (serious criteria hospitalization and GSK medically significant), unable to urinate (Verbatim: Inability to urinate) (serious criteria hospitalization and GSK medically significant), influenza-like symptoms (Verbatim: Patient was in hospital for Started with flu like symptoms) (serious criteria hospitalization), mental status changes (Verbatim: Altered mental state) (serious criteria hospitalization) and pain (Verbatim: Severe pain with a medication required) (serious criteria hospitalization). The outcome of the worsening of stroke, unable to urinate, influenza-like symptoms, mental status changes and pain were not resolved.   The reporter considered the worsening of stroke, unable to urinate, influenza-like symptoms, mental status changes and pain to be related to Shingrix.     The company considered the worsening of stroke, unable to urinate, influenza-like symptoms, mental status changes and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-APR-2024 The physician reported that the patient was received 1st dose of Shingrix vaccine and patient was hospitalized for started with flu like symptoms, severe pain with a medication required, inability to urinate, hospitalization, altered mental state and possible stroke was reported as worsened. The patient got a tetanus shot on same day. On 16-APR-2024, less than a day after receiving Tetanus vaccine, the patient experienced worsening of stroke, unable to urinate, influenza-like symptoms, mental status changes and pain. The reporter considered the worsening of stroke, unable to urinate, influenza-like symptoms, mental status changes and pain to be related to Tetanus vaccine. The reporter consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: experience after getting the shot and said it was painful; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site pain 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 injection site pain (Verbatim: experience after getting the shot and said it was painful). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-APR-2024 This report was submitted via the online direct entry reporting system.  The health care professional shared her own experienced after getting the shot and said it was painful. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I have a patient who got a shingles shot (Shingrix) in 2021, but never got a 2nd dose.; This non-serious case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I have a patient who got a shingles shot (Shingrix) in 2021, but never got a 2nd dose.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-APR-2024 The patient who got a shingles shot (Shingrix) in 2021, but never got a 2nd dose, which led to incomplete course of vaccination. The reporter wanted to know if she needed to start over with the series or just got the 2nd one as soon as per.
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero instead of Menquadfi; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero instead of Menquadfi). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-APR-2024 The pharmacist called to inform about a situation where Bexsero was given instead of Menquadfi, according to reporter, there were 'a couple of different doses' given to an unknown number of patients that were between the ages of 11 to 13 years old, which led to wrong vaccine administered. The reporter did not had information on dates of administration. The reporter agreed to provide more details upon follow up by safety team. The case was linked with US2024AMR057555 via E2B Linked Report considering the Same reporter and different patient.; Sender's Comments:  US-GSK-US2024AMR057555:Same reporter and different patient.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: made him feel bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: made him feel bad). The outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-APR-2024 The reporter called and mentions that her nephew had received the complete dose of Shingrix and the second vaccination made him felt bad. No further information was known about patient demographics, dates of Shingrix injections, lot numbers of vaccinations. The reporter provided information that she heard about, no consent given or any PCP demographics. This case has been linked to the case US2024052740 reported by the same reporter.; Sender's Comments:  US-GSK-US2024052740:2/2 report
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt bad after the dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: felt bad after the dose). The outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.   It was unknown if the company considered the feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-APR-2024 The consumer called and mentioned a lady at her church had the first dose of Shingrix and felt bad after the dose. No further information was known about patient demographics, date of vaccination, arm vaccinated, how long the consumer felt bad. The consumer provided information that she heard about, no consent given or any demographics. This case has been linked to the case  US2024052739 reported by the same reporter.; Sender's Comments:  US-GSK-US2024052739:2/2 report
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Maladministration of Hiberix after the expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received Hib (Hiberix) (batch number 74YN7, expiry date 30-DEC-2023) for prophylaxis.   On 23-APR-2024, the patient received Hiberix. On 23-APR-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Maladministration of Hiberix after the expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-APR-2024 The medical assistant reported that the patient received Hiberix vaccine expired dose The reporter did not consent to follow up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed
Clinical narrative: having trouble with her periods/her period not coming on time; trouble with her period/ Pain and like she was saying like sharp pain in her stomach; This is a spontaneous report received from a Nurse from a sales representative and product quality group.  A female patient in her 40's received BNT162b2 (BNT162B2), in Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 5 decade for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for covid-19 immunisation. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset Dec2021, outcome "unknown", described as "having trouble with her periods/her period not coming on time"; DYSMENORRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "trouble with her period/ Pain and like she was saying like sharp pain in her stomach".  Additional information: Pfizer representative stated, patient had her fourth booster shot and this was done in Dec2021, two weeks later she got covid and she has been having trouble with her periods ever since. She was saying like sharp pain in her stomach and her period not coming on time. Patient did not mention any regarding medical conditions and concomitant medications. Reported vaccine was given to prevent covid. No information provided about facility details, dose, site of administration and route of administration. Patient didn't mention "no" when asked about treatment.  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-202400101079 same patient/vaccine, different events;
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: having trouble with her periods/her period not coming on time; trouble with her period/ Pain and like she was saying like sharp pain in her stomach; This is a spontaneous report received from a Nurse from a sales representative and product quality group.  A female patient in her 40's received BNT162b2 (BNT162B2), in Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 5 decade for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for covid-19 immunisation. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset Dec2021, outcome "unknown", described as "having trouble with her periods/her period not coming on time"; DYSMENORRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "trouble with her period/ Pain and like she was saying like sharp pain in her stomach".  Additional information: Pfizer representative stated, patient had her fourth booster shot and this was done in Dec2021, two weeks later she got covid and she has been having trouble with her periods ever since. She was saying like sharp pain in her stomach and her period not coming on time. Patient did not mention any regarding medical conditions and concomitant medications. Reported vaccine was given to prevent covid. No information provided about facility details, dose, site of administration and route of administration. Patient didn't mention "no" when asked about treatment.  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-202400101079 same patient/vaccine, different events;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed
Clinical narrative: Two weeks later she got covid; Two weeks later she got covid; This is a spontaneous report received from a Nurse from a sales representative and product quality group.  A female patient in her 40's received BNT162b2 (BNT162B2), in Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "Two weeks later she got covid".; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202400100445 Same patient/same product, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Two weeks later she got covid; Two weeks later she got covid; This is a spontaneous report received from a Nurse from a sales representative and product quality group.  A female patient in her 40's received BNT162b2 (BNT162B2), in Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "Two weeks later she got covid".; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202400100445 Same patient/same product, different dose/event;
Sex: F
Vaccine: PNC20
Symptoms: Headache
Clinical narrative: had a really bad headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 70-year-old 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. The following information was reported: HEADACHE (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "had a really bad headache". Therapeutic measures were taken as a result of headache. Additional information: The caller recently had her pneumonia vaccine but was not sure which one she received. She stated she is pretty sure it was Prevnar 20. She had never had a pneumonia vaccine (before this). She got the one time vaccine on Monday. On Thursday she had a really bad headache so she took Tylenol on yesterday (in May2024) for that. She didn't think it was a symptom of the vaccine. The patient had the vaccine before, and the doctor said she needed one. The agent confirmed the medication was Prevnar.  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: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2021 at 12:00 as dose 3 (booster), single (Lot number: 331308A) at the age of 57 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 23Apr2024 to 27Apr2024, Lot number: HF4637).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Neuropathy peripheral" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID 19"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient was treated with Paxlovid from 01May2024 to 06May2024 for COVID-19.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy is affected by various factors. The association between the event lack of effect (COVID-19) with COMIRNATY 2023-2024 Formula can not be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: she lost all hearing in her right ear after a Covid booster shot.; This is a spontaneous report and received from Consumer or other non HCPs.  A 58-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: DEAFNESS (medically significant), outcome "unknown", described as "she lost all hearing in her right ear after a Covid booster shot.".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Medical Assistant reported that an expired dose of MMR II was administered to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown).   On 25-APR-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (rHA),  lot #W028732, expiration date: 06-APR-2024, administered for prophylaxis (strength and route of administration were not provided) that was expired. It was noted that the vaccine did not experience temperature excursions prior to administration.  No adverse event was reported.