chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: whole body myalgia; nasal congestion; The health professional administered the vaccine through a regular band aid, rather than an intended barrier bandage; burning pain at the injection site; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID vaccine (she took vaccine 3 weeks ago).   On 15-DEC-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 15-DEC-2024, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: burning pain at the injection site), nausea (Verbatim: nausea) and wrong technique in product usage process (Verbatim: The health professional administered the vaccine through a regular band aid, rather than an intended barrier bandage). On 16-DEC-2024, the patient experienced myalgia (Verbatim: whole body myalgia) and nasal congestion (Verbatim: nasal congestion). The patient was treated with ibuprofen (Advil). On 15-DEC-2024, the outcome of the nausea was resolved.  On 17-DEC-2024, the outcome of the myalgia was resolved (duration 1 day). The outcome of the injection site pain was not resolved and the outcome of the nasal congestion was resolved and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain, nausea, myalgia and nasal congestion to be related to Shingrix.     It was unknown if the company considered the injection site pain, nausea, myalgia and nasal congestion to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-DEC-2024 The health professional (pharmacist/vaccinator) administered the vaccine through a regular (opaque, gauze centered) band-Aid, rather than an intended barrier bandage, which led to wrong technique in product usage process. The patient immediately had burning pain at the injection site and immediately, briefly, had nausea. The patient believed the nausea may have been due to the intensity of the pain. The next day she had whole body myalgia and took Advil and the myalgia resolved after one day.  She had nasal congestion the day after vaccination. The patient did not know the batch number or expiration date. Nothing else was reported.
Sex: F
Vaccine: UNK
Symptoms: Influenza
Clinical narrative: Patient recently became infected with influenza virus following seasonal influenza vaccination; This spontaneous case, initially received on 07-Jan-2025, was reported by a health professional and concerns an Other female patient.  Patient's medical history and concomitant Medications were unknown.  Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for Active immunization against influenza disease. Dose regimen: Not reported, Route of Administration: Not reported, Anatomical location: Not reported, Lot number: No batch number available, and will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the Patient recently became infected with influenza virus following seasonal influenza vaccination (Medically significant, outcome: Unknown).  It was reported that, the patient recently became infected with influenza virus following seasonal influenza vaccination.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide seriousness and causality assessment. The event influenza upgraded to serious considering event's clinical significance; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association could not be completely ruled out in view of insufficient information, hence causality assessed as related.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Chills, Delivery, Exposure during pregnancy, Pre-eclampsia
Clinical narrative: Fever of 101.5 started 12 hours after receiving vaccine and lasted another 12 hours, had chills, stomachache. I was 36 weeks pregnant (2nd pregnancy) with an estimated due date of 7/14/24. I delivered at 38 weeks due to sudden onset of preeclampsia on 7/X/24 - healthy baby at 7 lbs 4 oz.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Fever of 101.5 started 12 hours after receiving vaccine and lasted another 12 hours, had chills, stomachache. I was 36 weeks pregnant (2nd pregnancy) with an estimated due date of 7/14/24. I delivered at 38 weeks due to sudden onset of preeclampsia on 7/X/24 - healthy baby at 7 lbs 4 oz.
Age: 52.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Culture stool, Full blood count, Influenza virus test, Malaise, Psittacosis
Clinical narrative: malaise; psittacosis; Initial information received on 13-Jan-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 52 years old male patient who experienced malaise and psittacosis after receiving Influenza trivalent recombinant vaccine [Flublok TIV] and Novavax covid-19 vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Citalopram (Citalopram) and Valaciclovir hydrochloride (Valtrex) for Product used for unknown indication.  On 15-Nov-2024, the patient received a dose 1 of suspect influenza trivalent recombinant vaccine lot number Solution for injection not reported via intramuscular route in unknown administration site for prophylactic immunization and received a dose 1 of suspect Novavax covid-19 vaccine not produced by Sanofi Pasteur lot number not reported via intramuscular route in unknown administration site (frequency, route, strength and expiration date: not provided) for prophylactic immunization.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On 22-NOV-2024 the patient developed malaise and psittacosis (latency- 7 days).   Relevant laboratory test results included: Culture stool - On an unknown date:  [unknown] Full blood count - On an unknown date:  [unknown] Influenza virus test - On an unknown date:  [unknown] SARS-CoV-2 test - On an unknown date:  [unknown]  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for both the events.
Age: 52.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test
Clinical narrative: malaise; psittacosis; Initial information received on 13-Jan-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 52 years old male patient who experienced malaise and psittacosis after receiving Influenza trivalent recombinant vaccine [Flublok TIV] and Novavax covid-19 vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Citalopram (Citalopram) and Valaciclovir hydrochloride (Valtrex) for Product used for unknown indication.  On 15-Nov-2024, the patient received a dose 1 of suspect influenza trivalent recombinant vaccine lot number Solution for injection not reported via intramuscular route in unknown administration site for prophylactic immunization and received a dose 1 of suspect Novavax covid-19 vaccine not produced by Sanofi Pasteur lot number not reported via intramuscular route in unknown administration site (frequency, route, strength and expiration date: not provided) for prophylactic immunization.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On 22-NOV-2024 the patient developed malaise and psittacosis (latency- 7 days).   Relevant laboratory test results included: Culture stool - On an unknown date:  [unknown] Full blood count - On an unknown date:  [unknown] Influenza virus test - On an unknown date:  [unknown] SARS-CoV-2 test - On an unknown date:  [unknown]  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for both the events.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: pentacel diluent was administered prior to reconstitution with no reported adverse event; Initial information received on 09-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6-month-old male patient whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] diluent was administered prior to reconstitution 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 rotavirus vaccine live reassort oral 5V (Rotateq); and pneumococcal vaccine conj 15V (CRM197) (Vaxneuvance) for Immunisation.  On 09-Jan-2024, a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection of lot UK044AA and expiry date: 31-Aug-2025 strength: standard frequency: once via intramuscular route in the left thigh for immunization diluent was administered prior to reconstitution with no reported adverse event (wrong technique in product usage process) (latency: on same day).   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.
Sex: F
Vaccine: FLU3
Symptoms: COVID-19, Dyspnoea
Clinical narrative: covid; shortness of breath; Initial information received on 09-Jan-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves an unknown age female patient who experienced covid and shortness of breath after receiving Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (Suspension for injection) lot UT481AB via unknown route in unknown administration site for Prophylactic vaccination (immunization) (strength, expiry date was unknown).  On an unknown date the patient developed covid (covid-19) and shortness of breath (dyspnoea) (unknown latency) following the administration of Influenza Usp Trival A-B Subvirion No Preservative Vaccine.  Reportedly "Caller wanted to know the ingredients of the vaccine that was injected to their sister on 2011 for them to avoid to see if there are other vaccines that could be given to the patient. "  Action taken was not applicable for all the events.  It was not reported if the patient received a corrective treatment for the events (shortness of breath, covid).  At time of reporting, the outcome was Unknown for the events shortness of breath and covid.
Age: 24.0
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccines.
Age: 21.0
Sex: F
Vaccine: COVID19, IPV, MMR, VARCEL
Symptoms: Asthenia, Eyelid function disorder, Facial paralysis
Clinical narrative: Weakness, paralysis of left side of her face. Unable to close left eye.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MNQ, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was accidentally given the Menvo MCV4 vaccination intended for patients over the age of 10. Patient is a 1-year-old. We spoke with the manufacturer and have attached the information that htey sent to us this morning. After discussing with the provider, she felt that there should not be any major side effects since there are exceptions that the vaccine can be given at a younger age. Provider has reached out to mother of child x2 with no response.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Nurse was attempting to give 1 year old vaccines MMR and Varicella. Nurse mistakenly grabbed ProQuad and Varicella resulting in the patient receiving a double dose of Varicella.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Limb discomfort, Mobility decreased, Painful respiration, Spinal pain
Clinical narrative: Patient, as the days went by, the effects worsened. On the first day I experienced general discomfort. On the second day there was a lot of discomfort in the arm but on the third day the patient stated that she could not move, pain in the spine that prevented her mobility and when breathing she also experienced pain in the spine. she feels like she's paralyzed
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Patient developed redness and itching
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Product lot number issue
Clinical narrative: PCV20 lot # was used in documentation for both the PCV20 and flu vaccine order.  Unable to confirm if pt did received first flu dose. Pt advised to repeat influenza vaccination.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: NO SIGNS OR SYMPTOMS OF ADVERSE.  VACCINE WAS GIVEN IM VERSES SUBCUTANOUS. DOCTOR NOTIFIED AND THIS DOSE COUNTS.  NO FURTHER ACTION NEEDED
Age: 0.08
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Incorrect dose administered
Clinical narrative: Pt ordered to received 50mg dose of Beyfortus based on weight. Pt was given 100mg dose based on lot number used in vaccine documentation.
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: HIB powder was mixed with a standard diluent instead of the diluent that is provided with vaccine.
Age: 30.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Extra dose administered, Product lot number issue
Clinical narrative: PCV20 lot # used for documentation of tdap vaccine.  Unable to determine if pt received tdap vaccine. Additionally, pt received PCV vaccine on 12/30/24, so pt received 2 doses of PCV.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness unilateral, Sudden hearing loss
Clinical narrative: I received the flu vaccine on the afternoon of 01/10/2025. In the early morning hours of 01/13/2025 I suddenly lost hearing in my left ear.  The hearing loss lasted about 16 hours.  Later during the evening of 01/13/2025 my hearing gradually returned. I haven't noticed any residual effects since.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired COVID vaccine. Vaccine has 60 life in fridge, given at 61 days.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Dyspnoea, Rash
Clinical narrative: Rash to abdomen that resolved with Hydrocortisone cream, Mild Shortness of breath -
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Colitis ulcerative, Diarrhoea, Haematochezia, Immediate post-injection reaction
Clinical narrative: I became very sick, flu like symptoms immediately after receiving shot. This included stomach pains and diarrhea.  Stomach issues never went away and within a few days I began to see blood in my stool for the first time in my life.  I've since been diagnosed with ulcerative colitis and being treated with remicaid.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: I became very sick, flu like symptoms immediately after receiving shot. This included stomach pains and diarrhea.  Stomach issues never went away and within a few days I began to see blood in my stool for the first time in my life.  I've since been diagnosed with ulcerative colitis and being treated with remicaid.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine that expired 1 day ago. Vaccine was administered on 1/10/25. Vaccine expired on 1/9/25.
Age: 56.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Pt was due for her 2 year booster.  Pt did note on initial series (11/21/2022 & 12/20/22)  significant vesicle development, induration and itching.   VAERS was submitted (VAERS E-report 918671 submitted on 12/01/22).  Patient is a Vet Pathologist who works with mpox in research lab.  Pt was due for booster.   Given patient Occupational Exposure risk, risk vs benefit of booster vaccination was discussed with patient including discussion if unknown if same/worsening side effects could occur again.  (serum testing for immunity not available at this time)    Patient decided to  proceed with Jynneos booster.  Booster given on 12/20/24.  Pt notes side effects were significant.  Photos submitted notes reddness from injection site 10 cm long with induration. Pt notes "flu like " symptoms from 12/21 to 12/23.  Pt had tissue reaction fairly significant by 12/22 -12/23 (day 2 and 3). Pt notes she managed symptoms with NSAIDS and benadryl.  Pt notes she took regular doses of Benadryl for 10 days to control symptoms of very intense itching at injection site . As of 1/3/25  nodular reaction was size of lima bean
Age: 1.0
Sex: F
Vaccine: DTPPVHBHPB, FLU3, MMR, UNK
Symptoms: Blood electrolytes normal, Contusion, Flow cytometry, Haemoglobin normal, Petechiae
Clinical narrative: Developed thrombocytopenia 2 weeks following vaccine administration.  Has mucosal purpura, limb bruising, petechiae.
Age: 1.0
Sex: F
Vaccine: DTPPVHBHPB, FLU3, MMR, UNK
Symptoms: Platelet count decreased, Purpura, Reticulocyte count normal, Smear test, Thrombocytopenia
Clinical narrative: Developed thrombocytopenia 2 weeks following vaccine administration.  Has mucosal purpura, limb bruising, petechiae.
Age: 1.0
Sex: F
Vaccine: DTPPVHBHPB, FLU3, MMR, UNK
Symptoms: White blood cell count normal
Clinical narrative: Developed thrombocytopenia 2 weeks following vaccine administration.  Has mucosal purpura, limb bruising, petechiae.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Pain, Paraesthesia
Clinical narrative: moderate/severe pain at/around site. Patient reported tingling that radiated down her left arm for a couple days. Pain described as sharp/burning. Since improved.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: About 1.5hrs after administration of vaccine, vial was noted to only have enough liquid for one additional COVID dose remaining (though it should have had 2 doses remaining in vial). Suspect that inadequate diluent was added to reconstitute the vaccine, resulting in administration of a more concentrated dose (unknown how concentrated) to the patient. Patient did not demonstrate any side effects.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site reaction, Pain, Pain in extremity
Clinical narrative: On the following day at around 7:30 AM on Wednesday January 15th client developed a whelp the size of a tennis ball at injection site and then had a 3 raised areas several inches below injection site that were the  size of half dollars. Her arm was very warm to touch and sore. Client also noticed left backside of shoulder had redness and warmth. Client left cheek also was reddened in appearance. She also experienced severe body chills and body aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: On the following day at around 7:30 AM on Wednesday January 15th client developed a whelp the size of a tennis ball at injection site and then had a 3 raised areas several inches below injection site that were the  size of half dollars. Her arm was very warm to touch and sore. Client also noticed left backside of shoulder had redness and warmth. Client left cheek also was reddened in appearance. She also experienced severe body chills and body aches.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: HER RIGTH ARM  WAS A LITTLE SWOLLEN, THE DAY BEFORE , ACCORDING TO THE PATIENT WAS MORE SWOLLEN AND HAD BEGUN TO GO DOWN
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Thigh and leg  pain. Pain in the front and back of thigh on the mostly the right side.  Some pain on front thigh left side.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Idiopathic angioedema, Lip swelling, Ophthalmic migraine, Swelling, Swelling face
Clinical narrative: Significant swelling of lip and face, visual migraine.  The swelling has occurred repeatedly afterwards.  At first, the severe facial swelling happened every few months, but then increased in frequency  and began occurring on other parts of the body, as well.  Swelling happened multiple times per week.  Was diagnosed as "idiopathic angioedema" one year ago and is controlled with daily allergy medication.  Swelling returns when medication is not taken.
Age: 3.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received single vial presentation rather than 2-vial presentation of Menveo. No signs or symptoms of adverse event.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Injection site pain, Insomnia, Pyrexia
Clinical narrative: fever, cold sweats, chills difficulty sleeping lasting 36 hours.  injection site soreness lasting 48 hours.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Immunization was incorrectly given as a first dose of DTaP and first dose of IPV.
Age: 9.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received single vial presentation instead of 2-vial presentation. No adverse events noted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The DTaP/IPV vaccine was incorrectly given to a patient as their first dose of DTaP and first dose of IPV.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Pain, Periarthritis, Product administered at inappropriate site
Clinical narrative: Administration was very high/superior, did not follow proper landmarks for deltoid administration, caused immediate extraordinary pain soon followed by impaired shoulder mobility (frozen shoulder for several days improved, but sharp pain with particular movements has persisted even now, months later), appears to have entered joint capsule rather than IM into deltoid, unknown at this time if injury/damage is permanent
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint injury
Clinical narrative: Administration was very high/superior, did not follow proper landmarks for deltoid administration, caused immediate extraordinary pain soon followed by impaired shoulder mobility (frozen shoulder for several days improved, but sharp pain with particular movements has persisted even now, months later), appears to have entered joint capsule rather than IM into deltoid, unknown at this time if injury/damage is permanent
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MMRV was incorrectly given to this patient at the age of 17 years
Age: 93.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient got a second dose of Arexvy after getting a dose on 12/16/23, Spoke with her on 1/17/25. She did not have any side effects that she was aware of since vaccination.
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received a DTaP vaccine in error, as based on their age they should have received the Tdap vaccine.
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Loss of consciousness, Presyncope
Clinical narrative: After leaving the immunization room and upon returning to the observation area the patient got light headed and passed out exhibiting signs of a vasovagal reaction to the vaccine. The patient came to almost immediately asking what occurred.  The patient had a friend with her. I spent some time with the patient. She was given water to sip on and stayed with us about 30 minutes longer. She stated she was feeling fine upon leaving.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalization with covid infection after vaccination
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Nos symptoms at this time
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalization for covid infection after vaccination
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalization for covid infection after vaccination
Age: 2.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event
Clinical narrative: No symptoms at this time
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received second fluzone trivalent vaccine for 24-25 season. Pt had no adverse reactions, immediately after injection nor any adverse symptoms reported by parents in the days after administration.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalization for covid infection after vaccination
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Neurological symptom
Clinical narrative: Chronic neurologic symptoms with normal neurology evaluation and laboratory testing
Age: 82.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Rash
Clinical narrative: Patient presents on 1/17/25, complaining of a sporadic rash on her arms. Upon RPh observation, absence of reaction at injection site was noted, however patient does appear to have  a handful of blemishes on her forearms bilaterally and one blemish underneath the left armpit. Patient was advised to address concern with her PCP, however she declined. Pharmacist then recommended to the patient to apply a mix of Benadryl and Hydrocortisone cream bid for 5 days, and if no improvement in symptoms, to seek medical care.  Patient demonstrated understanding.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalization for covid infection after vaccination
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalization for covid infection after vaccination
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis
Clinical narrative: Celluitus
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Prescriber sent prescription to the pharmacy for Shingrix vaccine to receive 1 dose, with a 2nd dose in 2-6 months. (state vaccine registry) was not verified prior to administration. Following vaccine administration upon logging in state vaccine registry it was discovered that patient had already completed the vaccine series in 2020. Patient did not experience any adverse outcomes besides pain at the injection site. Patient and prescriber were notified of the unnecessary administration of the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity, Pain of skin
Clinical narrative: pt says after getting the vaccine that every place on her body that she has scar tissue became sore. The pain was underneath the skin. It was painful to walk. Her left hip, knee, and shoulder became sore. Her right neck and hand became sore. The pain lasted about 2 to 3 days.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient developed Gullian-Barre'.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Undiluted dose given. Pt's mother does not report any symptoms. Manufacturer called. No treatment provided.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Aphasia, Blood immunoglobulin E normal, Dyskinesia, Mobility decreased, Neurological symptom
Clinical narrative: Developed neurologic symptoms (without altered mental status)- 2 days after immunization- stopped babbling,  less mobile (decreased in rolling over), developed 12  involuntary extremities movements episodes (without loss of consciousness, lethargy or altered mental status; usually lasting up to 1 minute).  Symptoms resolved after 1 month.   Also developed hives - 2 days after immunization - which lasted for a couple of weeks.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Urticaria
Clinical narrative: Developed neurologic symptoms (without altered mental status)- 2 days after immunization- stopped babbling,  less mobile (decreased in rolling over), developed 12  involuntary extremities movements episodes (without loss of consciousness, lethargy or altered mental status; usually lasting up to 1 minute).  Symptoms resolved after 1 month.   Also developed hives - 2 days after immunization - which lasted for a couple of weeks.
Age: 65.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given Twinrix 12 days before Pt was due for second dose. No adverse reactions. Just given vaccination too early.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event know. But, vaccine was given after use by date (1/13/25)
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High dose IMM ordered.  Pt not 65
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event known, dose given after use by date (01/13/25)
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient given Flublok for 18 yrs and older but there was no adverse event.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received first dose of Hep A 10/06/2024 and mistakenly received second dose today (01/17/2025) which is due on the 04/06/2025, along side with polio, VZV, and Hep B. Parents  and supervisor received notification of the error, Patient monitored for 45 minutes. No reaction noted and patient was stable and encouraged to stay hydrated. Parents encouraged  to continue to monitor.
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Protein urine present, Pyrexia, Seizure
Clinical narrative: At 2:22am on 1/17, she had a seizure and was febrile.  Was taken to the hospital in an ambulance. At around 12:20pm, she had another set of seizures and was febrile (temperature of 101.9). She has had 5 seizures in the 24 hours since receiving the vaccine.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Syncope episode. Patient was treated with Ice packs to the back of the neck and face, gave patient cold water to drink, and called patients husband to come pick her up. Patient had recovered upon leaving the pharmacy.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Developed redness, itching of the site, painful and swollen
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash, Rash erythematous
Clinical narrative: erythematous rash all over body, Benadryl given at home with no improvement noted.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Patient had localized swelling,  hives, itching and redness in a approximately 6 inch diameter at the injection site. Symptoms are subsiding slightly by still present 9 days after the injection.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient was given Undiluted 0.3ml.  Multidose vial with 3 doses, needs to be diluted.  Patient received whole vial.  Patient parents called by MD.  No adverse reaction noted.  Parents aware of s/s and plan of care. Parents declined office visit.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient reported on 1/2/2025 that pain persisted two weeks after vaccination. She has talked to her doctor's office and md suggested that she takes over-the-counter pain medication and see if it gets better in a few weeks. Her physical therapist suggested a couple exercises to see if they might help.  She described it as a dull ache at the site of injection. She reported that she has difficulty dressing and brushing hair since she can't move her arm much without it causing pain.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza virus test negative, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Chest congestion, prednisone, once every 12 hours for 5 days, feeling bettrr
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV1
Symptoms: Erythema multiforme, Viral rash
Clinical narrative: 1. Erythema multiforme (Primary) (Rash x2 days) - DDX is reaction for vaccine vs viral exanthem. No evidence of anaphylaxis.  - Given it was after vaccination, it is possible that the reaction was secondary to Beyfortus. There are some cases of similar rash with Beyfortus.  -  Also possible that it is a viral exanthem  - Not unsafe to given next vaccines but would appreciate recommendations from A&I.  Plan: - Supportive care with motrin, moisturizer. - Pediatric Allergy and Immunology. Stat referral for recommendations about 6 mo vaccines. - Counseled on return precautions.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient received Fluzone multi dose vial instead of preservative free Flu
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling at vaccine site
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE; Caller reported expired PROQUAD administered to a patient.  No other information provided.  No additional AEs/PQC reported.; This spontaneous report was received from an Other Health Professional and 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 therapies were not reported.  On 07-JAN-2025, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin(rHA) (PROQUAD) injection, 0.5 milliliter, lot #X018729, expiration date: 06-JAN-2025, administered intramuscularly for prophylaxis (strength was not provided) (Expired product administered). No additional adverse event was reported.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: GARDASIL 9 at 18 years old in 2018, and is now returning to gynecology's office today, 8JAN2025 at 25 years of age inquiring about third dose.; No symptoms or side effects reported; This spontaneous report was received from a nurse regarding a currently 25-year-old female patient.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2018 (also reported as when the patient was 18 years old), the patient was vaccinated with the first and second doses of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strengths, volume of injections, lot numbers, expiry dates, anatomical locations, and routes of administration were not provided). However, on 08-JAN-2025, she returned to gynecology's office at 25 years of age inquiring about the third dose, hence, the reported inquired about the interrupted dosing schedule and how to proceed (Inappropriate schedule of product administration). No symptoms or side effects reported.  Lot # is being requested and will be submitted if received.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms reported. No additional details provided. No other AE/PQC reported; Nurse calling to report the inadvertent administration of PROQUAD to a 16 year old on 11/13/2024.; This spontaneous report was received from a nurse referring to a 16-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-NOV-2024, the patient inadvertently received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, lot #Y010930, expiration date: 14-DEC-2025, administered for prophylaxis (strength, dose and route of administration were not provided) (Product administered to patient of inappropriate age). Operator of device was health professional. No symptoms reported.  No other adverse event (AE) reported (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Pharmacist reported that an expired MMR II (Lot X000178 exp 1/2/2025) was administered on 1/11/2025. No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 11-JAN-2025, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot # X000178, expiration date 02-JAN-2025 (dose and route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: HIBV, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; ROTATEQ, VAXNEUVANCE (PFS), PEDVAX HIB were administered during the T/E to 1 patient. T/E occurred on 1/11/2025; This spontaneous report was received from a Nurse and referred 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 13-JAN-2025, the patient received the dose with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection lot #X028615, expiration date: 09-JUL-2026, administered for prophylaxis (strength, dose and route of administration were not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid lot #Y003753, expiration date: 18-OCT-2025, administered orally for prophylaxis (strength, dose was not provided); and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection lot #X026480, expiration date: 12-JAN-2026, administered for prophylaxis (strength, dose and route of administration were not provided) after a temperature excursion to 30.2 degree F for 17 hours (Product storage error). There was no previous temperature excursion. No adverse event was reported.
Age: 0.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Merck employee called on behalf of an office staff that reported that VARIVAX was inadvertently administered to a two-month-old patient on 14JAN2025. No additional information was known by reporter. Limited reporter demographics were known. No additi; This spontaneous report was received from an office staff referring to a 2-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.   On 14-JAN-2025, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.  Lot # is being requested and will be submitted if received.
Age: 37.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product communication issue
Clinical narrative: A HCP called to inquire about how to administer a second dose of GARDASIL 9 to a 38-year-old patient who's schedule was interrupted.  The HCP stated the patient received the first dose of GARDASIL 9 in July 2024 (exact date unknown) and came in toda; Patient's confusion on when second dose should have been administered was identified; The patient did not report any additional adverse event issue or reaction; This spontaneous report was received from a pharmacist and refers to a 38 year old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date in July 2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL (lot # 1965045, expiration date: 19-JAN-2026) (route of administration, anatomical location not provided) as prophylaxis.   On 14-JAN-2025 (also reported as today), the patient went to the pharmacy to receive the second dose of the vaccine; therefore, he missed the second dose according to the recommended product information (PI) timeframe/schedule (inappropriate schedule of product administration). It was identified that the patient was confused on when the second dose should had been administered (product communication issue). The patient did not report any additional adverse issue or reaction.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Additional AE. No PQC.; HCP calling to report patient inadvertently received expired dose of VARIVAX on 1/15/2025 after its labeled expiry date of 1/9/2025.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age an gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-JAN-2025, the patient inadvertently was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose (valid lot number X001000, expiration date: 09-JAN-2025), administered for prophylaxis (dose, dose number, and route of administration were not provided) (expired product administered).  No additional adverse event (AE ).
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Neuropathy peripheral
Clinical narrative: it gave me Gillian Bree syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: it gave me Gillian Bree syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     The company considered the guillain barre syndrome to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient was given the shot and it gave him/her Guillain Barre syndrome. He/she would never took it but doctor told him/her to had it. It would help him/her but instead, it caused a side effect called Guillain Barre syndrome which caused neuropathy.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: MENB
Symptoms: Confusional state, Product administered to patient of inappropriate age
Clinical narrative: Mental confusion; Drug administered to patient of inappropriate age; This non-serious case was reported by a non-health professional and described the occurrence of mental confusion in a 62-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included apixaban (Eliquis).   On 10-DEC-2024, the patient received Bexsero. On 10-DEC-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Drug administered to patient of inappropriate age). On 11-DEC-2024, the patient experienced mental confusion (Verbatim: Mental confusion). The outcome of the mental confusion was not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the mental confusion to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the mental confusion to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 21-DEC-2024 The reporter reported that the patient received 1st dose of Bexsero and experienced mental confusion. The patient was 62 years old when received the vaccine which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; came down with shingles; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: came down with shingles). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JAN-2025 The reporter reported that friend of him/her had just come down with shingles.  She was in the Shingrix trial - active arm. The reporter want to ask that it might be time to consider the need for a booster shot especially since shingles was worse. She had been given Valtrex and do not know if she was taking other drugs that suppress her immune system, she did not say about it. She was a nurse so medically savvy. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.