chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Nausea, Respiration abnormal, Restlessness, Skin warm
Clinical narrative: POST administration of COVID vaccine pt began to c/o nausea and not feeling well. Writer went to assess pt and noted to be a bit anxious and fidgeting, pt breathing heavily but unlabored, no wheezing audible, skin warm and stating "I have never felt this way."  Initial BP check - 80/45, HR 85, Pulse ox 100%. MD notified and arrived immediately to asses pt. Upon assessment requested NS bolus and EPI pen.   Epi pen and Benadryl were administered, BP and HR labile while waiting for code assist. 22G IV placed to R ac patent and intact. NS initiated.  Pt left w/code assist team and at that time skin was moist to touch, still hypotensive SBP 80?s, pt still alert and responsive and able to provide nurse w/ phone # of family member
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral abnormal, Asthenia, Computerised tomogram head abnormal, Demyelination, Headache
Clinical narrative: Beginning in June 2022 I began having dull/nagging headaches initiated by sexual activity/orgasm. The headaches increased in severity until I began experiencing debilitating thunderclap headaches with sexual activity/orgasm in July 2022. I spoke with my primary who referred me to neurology at Medical Center where I received an MRI on 11/21/22. It was discovered that I have sudden onset demyelination of the blood vessels in my brain. I was then sent for a CT Scan and CT Angiogram on 3/6/2023 which confirmed the demyelination.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Primary headache associated with sexual activity, Thunderclap headache
Clinical narrative: Beginning in June 2022 I began having dull/nagging headaches initiated by sexual activity/orgasm. The headaches increased in severity until I began experiencing debilitating thunderclap headaches with sexual activity/orgasm in July 2022. I spoke with my primary who referred me to neurology at Medical Center where I received an MRI on 11/21/22. It was discovered that I have sudden onset demyelination of the blood vessels in my brain. I was then sent for a CT Scan and CT Angiogram on 3/6/2023 which confirmed the demyelination.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: Received vaccine on 7/25/23; Patient passed out morning of 7/26/23, was found to have very low blood pressure and was admitted to hospital Wednesday 7/26/23 through Saturday 7/29/23; Patient blood pressure gradually increased during admission, reportedly the physicians at hospital thought vaccine could have lead to this adverse event and did not find anything else they felt was responsible for patient passing out.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hypoaesthesia, Muscle tightness, Paraesthesia
Clinical narrative: Patient received immunization and reported feeling faint. Incident witnessed by mom. Mom reports LOC for "a few seconds". Patient experiencing tightening of bilateral upper extremities with numbness and tingling of hands. Patient alert and oriented upon assessment. Vitals stable. Numbness, tingling, and tightening resolved soon after. Patient discharged after visit.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a higher dose than she was supposed to get for her age.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine past BUD
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No Adverse Event; Customer reported an AE for MMRII. The caller said she reported this to Merck previously, however original case was not able to be located. Company awareness date marked 7/12/2023. The caller said the patient received a dose of MMRII on 6/29/2023, af; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 29-JUN-2023, the patient was vaccinated with one dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number w039699, expiration date reported and validated as 25-MAY-2024) as prophylaxis, that experienced a temperature excursion (product storage error). No other adverse event.  The vaccine experienced a temperature excursion of 48.8 degrees Fahrenheit (F) for an unknown timeframe. It was unknown if there was a previous temperature excursion.; Sender's Comments:  US-009507513-2307USA006147:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HBP called to report that a dose of RECOMBIVAX HB was given after a TE.; This spontaneous report has been received from a consumer, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 24-JUL-2023, the patient was vaccinated by a health care professional with an improperly storage dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection, as prophylaxis (lot number: W038227, which was determined to be valid as vial formulation by the validation lot team, with an expiration date on 23-MAY-2025) (strength, dose, scheme, route and anatomical location of administration were not reported (Product storage error).  The administered dose underwent a temperature excursion above 47 degrees Fahrenheit (F) (63.5F) for 7 hours. No previous temperature excursion was reported.  No additional adverse event was reported.
Age: 0.58
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered with the PENTACEL liquid component alone without the Hib component with no reported adverse event; Initial information received on 25-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 7 months old male patient who was administered with the diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] liquid component alone without the hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine and Pneumococcal Vaccine for Prophylactic vaccination.  On 20-Jul-2023, the patient received 0.5 mL dose 3 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB (PRP/T) vaccine, suspension for injection (batch number: UJ807AA; expiry date: 01-Oct-2023) via intramuscular route in the left vastus lateralis for immunization with the pentacel liquid component alone without the hib component with no reported adverse event (product preparation error) (same day latency).  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event administered with the pentacel liquid component alone without the hib component with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: radiating pain in the arm
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Pateint received vaccine after BUD
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pateint received vaccine after BUD
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: patient came in for wcc and needed vaccines. provider had ordered vaccines needed. I went to get vaccines and asked staff to come and help. we got vaccines that were ordered and double checked each other, inadvertently got an extra polio dose and vaccines were given to patient. when mistake was found provider was notified and attempted to call parent, with no answer and left message. Dr was also notified.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 23.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: Patient fainted falling forward. Team went in and helped her lay down, took vital signs. Patient was stated she was very dizzy, waited in the room until dizziness went away
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Blisters on right side of forehead and scalp, saw healthcare professional on 7/31/2023 and we are treating it like shingles with Valacyclovir HCL 1 gra tablets 3x daily for 7 days and Desonide 0.05% cream.  I am reporting this because it is claimed that: "Can the Shingrix vaccine cause shingles? No. Shingrix contains only a small part of the varicella zoster virus that causes shingles. Shingrix does not contain any live varicella zoster virus."
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with an expired (past beyond use date) Pfizer bivalent vaccine that. The vaccine was received and moved to our fridge on 5/3/23. Beyond use date was 7/2/23 and the vaccine was administered to the patient on 7/27/23.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Pt complains of itching and burning at the injection site even after more than 2 weeks after the vaccine administration
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Patient stated that she had fever for 12 hours, sore arm, redness at injection site
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Fall, Magnetic resonance imaging, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: Collapse while walking. Legs do not respond and I fall. It happens while I?m out walking. It is lasting longer. I have been seen by go, neurologist and neurosurgeon, pt assessment, MRI s, blood work
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Muscular weakness, Red blood cell sedimentation rate
Clinical narrative: Collapse while walking. Legs do not respond and I fall. It happens while I?m out walking. It is lasting longer. I have been seen by go, neurologist and neurosurgeon, pt assessment, MRI s, blood work
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large raised red area below the injection site.  Also itching in this area.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Diarrhoea, Faeces discoloured, Gastrointestinal pathogen panel, Rotavirus test positive, Vomiting
Clinical narrative: Patient seen on 6/24/2023 c/o black, watery stool X3 weeks with csome vomiting after feedings Ordered GI Panel through test. Resutes came back 07/25/2023 positie ROTAVIORUS
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1, DTPPVHBHPB, PNC15, RV1
Symptoms: Erythema, Immediate post-injection reaction, Infant irritability, Pallor, Peripheral swelling
Clinical narrative: Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg. Got PCV 15 in Right leg right ager. Face and trunk became very pale, patient very fussy. No mouth swelling or audible wheezing, no respiratory distress. Vitals stable (BP, HR, pulse ox), given IM EpiPen Jr x 1, leg swelling resolved immediately. Vitals remained stable, taken to ED via ambulance. Will need allergist clearance before receiving any future vaccines. Will follow up recommendations from ED.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1, DTPPVHBHPB, PNC15, RV1
Symptoms: Erythema, Immediate post-injection reaction, Irritability, Pallor, Peripheral swelling
Clinical narrative: Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg. Got PCV 15 in Right leg right ager. Face and trunk became very pale, patient very fussy. No mouth swelling or audible wheezing, no respiratory distress. Vitals stable (BP, HR, pulse ox), given IM EpiPen Jr x 1, leg swelling resolved immediately. Vitals remained stable, taken to ED via ambulance. Will need allergist clearance before receiving any future vaccines. Will follow up recommendations from ED.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No Symptoms reported. No other AE details; One dose of VARIVAX that was involved in the TE was administered to a patient; This spontaneous report has been received from a registered nurse, concerning a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 26-JUL-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/once (lot number X006978 with expiration date reported as 07-MAR-2025), administered as prophylaxis (route of administration and anatomical location were not provided). The vaccine administered was involved in a temperature excursion (TE) of 5.5 degree Fahrenheit (F), during a time frame of 3 minutes, and did not suffered previous temperature excursions (Product storage error). No symptoms reported nor other adverse events (AEs) were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed that no symptomatic adverse event was reported / No additional AE; Inbound call from nurse calling to report TE for MMR-II. Caller states product was administered to patient on 7/26/2023; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 26-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) injection, 0.5 milliliter/once (lot number U031359 was verified to be valid, expiration date reported and confirmed as 07-OCT-2023), administered as prophylaxis (route of administration and anatomical location were not provided). The vaccine administered had had a temperature excursion of 9.6 degree Celsius (C), during a time frame of 16 minutes, and had a previous temperature excursion during 14 minutes with high of 8.6C. (Product storage error). No symptomatic adverse event was reported.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Face oedema, Pruritus, Urticaria
Clinical narrative: Mother reported that child was complaining of itching all afternoon the day of immunization. Next day child woke up with diffuse edema to mouth, face and hives all over body.  Mother provided antihistamine prior to arrival
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURES; This spontaneous report received from a consumer via a company representative via Communication concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients died from seizures. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20230754295- seizures. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: SEIZURES
Age: 73.0
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product colour issue, Product preparation error
Clinical narrative: used sterile water instead of the sterile diluent (normal saline solution) that comes with the Stamaril/color turned into rose-tinge color upon dilution/ was administered to a patient with no reported adverse event; Initial information was received on 26-May-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 73 years old and unknown gender patient for whom sterile water was used instead of the sterile diluent (normal saline solution) that comes with the stamaril/color turned into rose-tinge color upon dilution/ was administered to a patient with no reported adverse event for yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-May-2023 at 03:16 PM, the patient received a dose of 0.5 ml of suspect yellow fever vaccine (Solution for injection) (lot UJ820AB) (with an unknown strength and expiry date) via subcutaneous route in the left arm for Travel for which the sterile water was used instead of the sterile diluent (normal saline solution) that comes with the stamaril/color turned into rose-tinge color upon dilution/ was administered to a patient with no reported adverse event (product preparation error) (latency- same day).  Reportedly, there were no harmful effects and patient was revaccinated as advised 28 days later.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 25-Jul-2023 from other healthcare professional: age of the patient was added, vaccine administration details were added, product coding (trade name) was updated. Narrative amended accordingly.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Burning sensation, Colonoscopy, Constipation
Clinical narrative: Numbness left side of face with burning and numbness left arm and leg on May 4.  The right side arm and leg less numbness.  Burning and pain left and right side of hip (2021).  Difficult digestion end of 2021 and into 2022 with constipation.  Overactive bladder with sweating and redness in face at end of 2021 and into 2022.  Sweating when eating and brushing teeth with numbness going down body.  Problems swallowing late summer and through the fall 2022.  Trouble sleeping fall 2022 and into 2023.  Depression and anxiety starting  fall  2022 and into 2023.  Today still overactive bladder with numbness and some redness in face and left side with constipation and diarrhea on and off.  Diagnosis:  Small Fiber Neuropathy  Diagnosed through MRI February 2023
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Diarrhoea, Dyspepsia, Dysphagia, Endoscopy
Clinical narrative: Numbness left side of face with burning and numbness left arm and leg on May 4.  The right side arm and leg less numbness.  Burning and pain left and right side of hip (2021).  Difficult digestion end of 2021 and into 2022 with constipation.  Overactive bladder with sweating and redness in face at end of 2021 and into 2022.  Sweating when eating and brushing teeth with numbness going down body.  Problems swallowing late summer and through the fall 2022.  Trouble sleeping fall 2022 and into 2023.  Depression and anxiety starting  fall  2022 and into 2023.  Today still overactive bladder with numbness and some redness in face and left side with constipation and diarrhea on and off.  Diagnosis:  Small Fiber Neuropathy  Diagnosed through MRI February 2023
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hyperhidrosis, Hypertonic bladder, Hypoaesthesia, Insomnia
Clinical narrative: Numbness left side of face with burning and numbness left arm and leg on May 4.  The right side arm and leg less numbness.  Burning and pain left and right side of hip (2021).  Difficult digestion end of 2021 and into 2022 with constipation.  Overactive bladder with sweating and redness in face at end of 2021 and into 2022.  Sweating when eating and brushing teeth with numbness going down body.  Problems swallowing late summer and through the fall 2022.  Trouble sleeping fall 2022 and into 2023.  Depression and anxiety starting  fall  2022 and into 2023.  Today still overactive bladder with numbness and some redness in face and left side with constipation and diarrhea on and off.  Diagnosis:  Small Fiber Neuropathy  Diagnosed through MRI February 2023
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging abnormal, Oesophageal motility test, Small fibre neuropathy
Clinical narrative: Numbness left side of face with burning and numbness left arm and leg on May 4.  The right side arm and leg less numbness.  Burning and pain left and right side of hip (2021).  Difficult digestion end of 2021 and into 2022 with constipation.  Overactive bladder with sweating and redness in face at end of 2021 and into 2022.  Sweating when eating and brushing teeth with numbness going down body.  Problems swallowing late summer and through the fall 2022.  Trouble sleeping fall 2022 and into 2023.  Depression and anxiety starting  fall  2022 and into 2023.  Today still overactive bladder with numbness and some redness in face and left side with constipation and diarrhea on and off.  Diagnosis:  Small Fiber Neuropathy  Diagnosed through MRI February 2023
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Headache, Urticaria
Clinical narrative: 3" x 2" reddened raised welt area with significant headache the next day.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19 pneumonia, Coagulopathy, International normalised ratio increased, Metabolic encephalopathy
Clinical narrative: Admitted for acute metabolic encephalopathy, AKI and coagulopathy (INR was 8.76) due to Pneumonia due to COVID-19 virus; tx w/abx, remdesivir, steroids, zinc; did not require O2. D/c home w/HHC.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Presented w/generalized weakness and significant orthostatics despite IV fluids. Patient was also noted to be COVID-19 positive. Initially she was saturating well on room air however later became hypoxic requiring 2L supplemental oxygen. She was therefore started on remdesivir, empiric antibiotics and steroids. She remained on 2L supplemental oxygen throughout hospitalization. Dc to Rehab
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia
Clinical narrative: Admitted for acute hypoxic respiratory failure /Pneumonia due to COVID-19.  Received all treatments including tocilizumab, Remdesivir, high-dose steroids. Did not improve despite efforts. Pt dc'd to hospice.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, COVID-19 pneumonia, Faeces discoloured, Fall
Clinical narrative: Presented with chief complaint of frequent falls and black color stool patient was admitted for further management. patient did have a lengthy and complicated hospital course for over 15 day; pt also dx w/ acute hypoxic respiratory failure related to COVID-19 pneumonitis and tx w/dexamethasone Lovenox vitamin-C and zinc.  Patient was back to 2 L nasal cannula. D/C to SNF.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea
Clinical narrative: Presented to ER via EMS from home for evaluation of shortness of breath.  He lives with his brother, both were battling COVID-19 infection for the last few days. Tx w/abx, remdesivir, zinc, O2. Due to requiring high flo O2 still, pt dc'd to LTAC
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Lethargy, SARS-CoV-2 test positive, Surgery
Clinical narrative: Presented to the emergency department with shortness of breath and lethargy from skilled nursing for surgery.  She is found to be COVID-19 positive.  Tx w/ abx, remdesivir, O2, steroids. Weaned down to 2 L of nasal cannula.  Dc'd to SNF
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cellulitis, Pain in extremity, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Presented w c/o toe pain. Admitted for tx of sepsis d/t cellulitis; tested COVID positive on pre-procedural testing but asymptomatic
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: Presented to ER w/cold-like symptoms; cxr suggestive of COVID pna; COVID test returned positive. Pt remained on RA and did not require any specific treatment
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malnutrition, Physical deconditioning, SARS-CoV-2 test positive
Clinical narrative: Admitted for physical deconditioning and severe protein calorie malnutrition.  Also tested positive for COVID but remains asymptomatic
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia
Clinical narrative: Presents to the ED via EMS from independent living facility c/o 2 week worsening weakness, worsened over the last 3 days; dx w/COVID pna;  tx w/ abx; supportive tx w/zinc, VitC, melatonin; no O2 required; pt discharged home
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ammonia increased, Blood lactic acid increased, COVID-19, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: Presents with altered mental status.  Workup significant for for high ammonia and lactic acid.  Otherwise mostly unremarkable. Incidental COVID-19+, asymptomatic
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: Presented to the ED for confusion. Admitted for acute UTI. Tested positive for COVID-19 six days into stay but was asymptomatic
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Admitted with acute appendicitis and incidental finding of +covid 19
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache, Myalgia & NauseaVomiting Narrative:  dose 1- day 1-3- sorearm dose 2- day 1-2 sore arm; day 2-chills, fatigue, nausea, vomiting, ha
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Headache, Myalgia & NauseaVomiting Narrative:  dose 1- day 1-3- sorearm dose 2- day 1-2 sore arm; day 2-chills, fatigue, nausea, vomiting, ha
Age: 51.0
Sex: F
Vaccine: PNC15
Symptoms: Circumstance or information capable of leading to medication error, Dyspnoea, Gastrointestinal disorder, Life support, Recalled product administered
Clinical narrative: I am I'm 51 years old. At the department of health on June 14th I received a recalled vaccine Vaxneuvance by a CDC doctor who argued that vaccines have antibiotics and are live cell. This shot was Dr gave me the patient package insert from the printer room. She agreed with internet lies. Vaccines are created with a dead cell of the organism you are in ovulating against. The body creates its own individualized antibody. The patient leaflet says it's a dead cell vaccine. The name proves it's not. I am autoimmune Dr. should not be working for the CDC doh I challenge her credentials she should have known the shot was on recall by the FDA. There is no such thing as the disease pneumoniae is a bacteria requiring antibiotics. My bowels won't work good I am swelled up like a whale it's hard to breathe at times. I am allergic to penicillin and other illians. The antibiotics makes the shot illegal.she also scheduled me for the pneumococcal conjugate valent 23 polysaccharide on my dead Dad's birthday.just like the COVID-19 shots its says don't give if Autoimmune I am I have Hep C Provider is going to treat me for as long as I can validate the medicine myself. On 7)10 I was on life support and magnesium from Pool. The pool has mold spores and dead human beings in the trap. my shot record is inacc
Age: 51.0
Sex: F
Vaccine: PNC15
Symptoms: Swelling
Clinical narrative: I am I'm 51 years old. At the department of health on June 14th I received a recalled vaccine Vaxneuvance by a CDC doctor who argued that vaccines have antibiotics and are live cell. This shot was Dr gave me the patient package insert from the printer room. She agreed with internet lies. Vaccines are created with a dead cell of the organism you are in ovulating against. The body creates its own individualized antibody. The patient leaflet says it's a dead cell vaccine. The name proves it's not. I am autoimmune Dr. should not be working for the CDC doh I challenge her credentials she should have known the shot was on recall by the FDA. There is no such thing as the disease pneumoniae is a bacteria requiring antibiotics. My bowels won't work good I am swelled up like a whale it's hard to breathe at times. I am allergic to penicillin and other illians. The antibiotics makes the shot illegal.she also scheduled me for the pneumococcal conjugate valent 23 polysaccharide on my dead Dad's birthday.just like the COVID-19 shots its says don't give if Autoimmune I am I have Hep C Provider is going to treat me for as long as I can validate the medicine myself. On 7)10 I was on life support and magnesium from Pool. The pool has mold spores and dead human beings in the trap. my shot record is inacc
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Cardiac ablation, Palpitations
Clinical narrative: Received covid booster 10/16/22 end of October started having palpitations mild at first by December increasing in frequency eventually went to doctor diagnosed with atrial flutter and paroxsmal atrial fibrillation underwent ablation
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No side effects reported; GARDASIL 9 was administered after it experienced a temperature excursion; This spontaneous report was received from a medical assistant referring to a 13 years old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters (lot #W028573 and expiration date on 06-JAN-2025), administered for prophylaxis (strength, and route of administration were not provided) after it experienced a temperature excursion (product storage error).  No side effects were reported.   The dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was exposed to a temperature excursion of 50 degrees Fahrenheit (°F) during a time frame of 1 hour, 40 minutes, 0 seconds. There was no prior temperature excursion.        ?
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptoms reported; HCP reported inadvertent administration of expired MMR-II that was stored properly; This spontaneous report was received from a pharmacist, referring to a patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 28-JUL-2023, the patient was inadvertently vaccinated with expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live, rHA (M-M-R II) injection (1 dosage form, lot #U022175, expiration date 14-JUL-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No symptoms reported. No additional adverse event (AE)/ product quality complaint (PQC) (No adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Near death experience
Clinical narrative: that almost killed me; This serious case was reported by a nurse via sales rep and described the occurrence of near death experience in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced near death experience (Verbatim: that almost killed me) (serious criteria GSK medically significant). The outcome of the near death experience was not reported.   The reporter considered the near death experience to be related to Shingrix.     The company considered the near death experience to be related to Shingrix.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter quoted that Shingrix, that almost killed him/her and did not elaborate further. The reporter did not agreed to follow up with GlaxoSmithKline.
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Invalid dosing interval between dose 1 and dose 2; This non-serious case was reported by a nurse and described the occurrence of drug dose administration interval too short in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On 13-JUL-2023, the patient received the 2nd dose of Bexsero. On 13-JUL-2023, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Invalid dosing interval between dose 1 and dose 2). The outcome of the drug dose administration interval too short 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: 26-Jul-2023 The patient received dose 1 on June 29 2023 and dose 2 on July 13 2023, which led to shortening of vaccination schedule. The health care professional (HCP) did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm hurt). (Dechallenge was negative). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-JUL-2023 This case was reported by a patient via interactive digital media. The reporter reported that the Shingles vaccine was put in her arm and same for her husband. Her arm hurt only for 3 days but did not hurt her husband. The patient stated that there were two injections initially and second one was 2 months later she thought. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Influenza
Clinical narrative: first shot made me sick; had flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, burning sensation, pain, pruritus and sleeplessness.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: first shot made me sick) and influenza (Verbatim: had flu). The outcome of the sickness and influenza were not reported.   It was unknown if the reporter considered the sickness and influenza to be related to Shingles vaccine.     It was unknown if the company considered the sickness and influenza to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR101938   Additional Information: GSK receipt date: 22-JUL-2023 This case was reported by a patient via interactive digital media. It was reported that the patient had shingles before vaccination. The patient stated that it was no joke, the burning and the pain and itching were all at the same time which made it hard to sleep.  The reporter reported that as soon as the shingles went away, he/she got vaccinated. The first shot made the patient sick like he/she had the flu plus his/her arm for it. The patient stated that, but it was worth it because if you do not get vaccinated, even if you had Shingles, you could get it again. For tolerance of 2nd dose, refer case US2023AMR101938. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR101938:same patient, 1st dose