chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Dyskinesia, Infantile spitting up, Somnolence, Tremor
Clinical narrative: Mother report that approximately 4 hours after vaccine was given infant had an adverse reaction. While infant was breastfeeding the infant pulled away and limbs began to shake(jerk). This event lasted 30 seconds. The infant did spit up. Afterwards the infant was very sleepy. Mother denies any fevers.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine best if used by 2/8/24. Expiration 12/31/24. Vaccine administered 4 days after best by date. No adverse effects noted by patient or mom.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose Hepatitis A vaccine 1 month earlier than specified interval of 6 months by CDC in error. Hep A Dose 1 given on 09/22/2023 and second dose given on 02/22/2024 (5 month interval). No treatment was required. Patient's Parents were contacted, both mother and father were explained that this 2nd dose of Hepatitis A was given 1 month earlier in error and this will not harm the child, no treatment is required but a decreased immune response may occur when a dose of the vaccine is administered earlier than the recommended interval, therefore an additional dose of Hepatitis should be given 6 months from 2nd dose to ensure an optimal immune response to Hepatitis A virus. Both Mother and Father verbalized their understanding.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Fatigue, Head injury, Headache
Clinical narrative: The above vaccines administered without incident. Nurse walked with patient and MOC to checkout without incident. At the checkout, patient fainted, the fall resulting in him hitting the back of his head. Patient woke within seconds, responded appropriately verbally, VS assessed. BB 96/78, Pulse 69. Pupils equal and reactive, no blurry vision reported. Patient assisted to a sitting position, ice pack place on back of head/neck and juice given. After approximately 20 minutes, patient continued to pain of headache and dizziness and fatigue and a "tingly" right arm. 911 called. After EMS assessed patient, recommendation made to take child to ER. MOC chose to transport him to ER via personal vehicle. EMS to help patient to personal vehicle.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU4, HPV9, MNQ, TDAP
Symptoms: Paraesthesia, Syncope
Clinical narrative: The above vaccines administered without incident. Nurse walked with patient and MOC to checkout without incident. At the checkout, patient fainted, the fall resulting in him hitting the back of his head. Patient woke within seconds, responded appropriately verbally, VS assessed. BB 96/78, Pulse 69. Pupils equal and reactive, no blurry vision reported. Patient assisted to a sitting position, ice pack place on back of head/neck and juice given. After approximately 20 minutes, patient continued to pain of headache and dizziness and fatigue and a "tingly" right arm. 911 called. After EMS assessed patient, recommendation made to take child to ER. MOC chose to transport him to ER via personal vehicle. EMS to help patient to personal vehicle.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: HIVES-PEPCID SINGULAIR - SENT TO ER FOR FURTHER EVAL DUE TO NOT HAVING EPI IN CLINIC
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient was given Proquad in place of Varivax.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine given past the recommend 12 hours after dilution in pre-drawn up syringe and kept stored in fridge. Manufacturer contacted for viability of vaccine, confirmed stable and no additional doses needed to be given.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC15, RV5
Symptoms: Extra dose administered
Clinical narrative: BOTH PENTACEL AND PEDIARIX VACCINES ADMINISTERED ON SAME DATE AND TIME.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine best if used by 12/25/2023. Vaccine expiration 04/30/2024. Vaccine administered on 1/23/24. No adverse events reported by mom.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Hypoaesthesia, Laboratory test, Postmenopausal haemorrhage
Clinical narrative: Post menopausal bleeding.   Has gotten worse in the past month with the possibility of having to have a hysterectomy.   NEVER had these problems before.     Left hand, left side numbness and weakness.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine best by date 12/25/2023. Expiration of vaccine 04/30/2024. Administered on 01/31/2024- over 1 month past the best by date. No adverse event reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at site of injection
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine best by dat 12/25/2023. Vaccine expiration date 04/30/2024. Vaccine administered after the best by date on 2/6/2024. No adverse events reported.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Pain
Clinical narrative: Patient reports continued, throbbing/burning pain in the deltoid at the site of the injection, 9 days post-injection with worsening of her symptoms.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine best by date 2/8/2024. Vaccine expiration date 047/31/2024. Vaccine administered past best by date on 2/15/2024. No adverse events reported.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Injection site mass, Injection site swelling, Nausea, Pain
Clinical narrative: Swelling with a 3x3x3 Inch  lump in my muscle at the injection site, minimal joint rotation, rquires surgery. Am getting scheduled in for an MRI. Have had an Ultra Sound. Nausea, Constant Aching, Swelling, Burning that feels like it is traveling into my left breast and left lung, both on left side. Right Shoulder experincing the same thing, with a lump at injection site. It seams to be growing. Not as severe as the left but is growing in size.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling, Ultrasound scan
Clinical narrative: Swelling with a 3x3x3 Inch  lump in my muscle at the injection site, minimal joint rotation, rquires surgery. Am getting scheduled in for an MRI. Have had an Ultra Sound. Nausea, Constant Aching, Swelling, Burning that feels like it is traveling into my left breast and left lung, both on left side. Right Shoulder experincing the same thing, with a lump at injection site. It seams to be growing. Not as severe as the left but is growing in size.
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine best by date 01/17/2024. Vaccine expiration date 07/31/2024. Vaccine administered after best by date on 01/30/2024. No adverse events reported.
Age: 84.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Blood pressure increased, Dysarthria, Speech disorder, Transient ischaemic attack
Clinical narrative: Patient presented to ER 2/13 between 530 and 6pm with slurred speech and talking nonsensically. Reported elevated blood pressure and was sent to Hospital later as no room in clinic for observation. Patient was discaharged following day 2/13/24 and reported suspected TIA.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None.                     Report completed due to age of patient 9 years old.                 Parent aware of vaccine administration. Child doing well. Dose shows as valid Tdap in EMR and the system.
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction. Dose given was expired
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine best by date 01/17/2024. Vaccine expiration date 07/31/2024. Vaccine administered after best by date on 2/2/24. No adverse events reported.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already received flu shot at dr office in december. Pt got another dose. No side effects reported
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Swollen arm that turned hard, painful and itchy and swelling and redness grew over 48 hours and doesn?t appear to be getting better
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine best by date 1/17/2024. Vaccine expiration date 07/31/2024. Vaccine administered past best by date on 2/14/2024. No adverse events reported.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Child received an expired dose on 02/22/24; dose expired on 02/19/2024
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine best by date 01/17/2024. vaccine expiration date 07/31/2024. Vaccine administered after best by date on 02/16/2024.No adverse events reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt received Pfizer vaccine on 12/15/2023 with a BUD of 12/13/2023. Due to the vaccine BUD being expired by two days, CDC and Pfizer recommended repeating the dose as there is "no stability data" by the manufacturer. Per CDC, "If the manufacturer does not have data to support the stability of the vaccine, repeat the dose immediately (no minimum interval."
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt received flu vaccine already at clinic on 12/12/2023- no side effects reported
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine best by date 01/17/2024. Vaccine expiration date 07/31/2024. Vaccine administered past best by date on 2/19/2024. No adverse events reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cardiac disorder, Cardiac murmur, Computerised tomogram thorax normal, Dyspnoea
Clinical narrative: vaccine received 6/18/21 while ~33 weeks pregnant.  While seated (no recent activity) felt sudden shortness of breath with tachycardia.  BP was elevated.  Went to ER, evaluated for PE, none on CT.  Symptoms did not improve. EKG did not pick up any abnormalities outside of tachycardia. Not evaluated for myocarditis or pericarditis. But to this day 2/23/24 continue to have episodes of cardiac events with SOB, increasing fatigue and more cardiac related symptoms that cannot be determined to be any other cause.  Murmur heard as well that was not noticed prior.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Exposure during pregnancy, Fatigue, Tachycardia
Clinical narrative: vaccine received 6/18/21 while ~33 weeks pregnant.  While seated (no recent activity) felt sudden shortness of breath with tachycardia.  BP was elevated.  Went to ER, evaluated for PE, none on CT.  Symptoms did not improve. EKG did not pick up any abnormalities outside of tachycardia. Not evaluated for myocarditis or pericarditis. But to this day 2/23/24 continue to have episodes of cardiac events with SOB, increasing fatigue and more cardiac related symptoms that cannot be determined to be any other cause.  Murmur heard as well that was not noticed prior.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Pt received a dose of covid19 pfizer vaccine on 12/15/2023 with a BUD of 12/13/2023. Due to the BUD being expired by two days, and Pfizer not having stability data beyond the recommended storage timeframe of 10 weeks in the refrigerator, CDC recommends revaccination immediately.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: During our inventory check yesterday before the end of the shift, Staff found out that the box of Moderna pediatric dose vaccine was inadvertently dispensed with written BUD 02/11/24(Expiration Date: 6/7/24) We've been receiving the same batch of box daily since past the BUD. As soon as we noticed the oversight I've gone through past daily reports from 2/11 up to present and discovered that vaccine was administered to 1 patient after its recommended Best Used Date.  Reached out and spoken with the mother and addressed the issue comprehensively.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Dermatitis, Exfoliative rash, Papule, Pruritus, Pustule
Clinical narrative: . Scaly rash on skin to bilateral feet. Chest, torso, back and shoulders with Vesicular rash on to torso and back- inflamed papules and/or pustules. + pruritis
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Rash, Rash vesicular
Clinical narrative: . Scaly rash on skin to bilateral feet. Chest, torso, back and shoulders with Vesicular rash on to torso and back- inflamed papules and/or pustules. + pruritis
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Pain
Clinical narrative: Patient has been experiencing muscle soreness in a 4 inch diameter around his injection site. I did confirm verbally with him that the soreness was not in his shoulder joint and the injection was not administered in his shoulder joint. He said it is a dull ache that gets worse when he is working out or lifting weights. He said he has applied Biofreeze to aid in relieving the soreness but once it wears off after a few hours, the soreness returns. He spoke with the nurse at his primary care physician's office and she stated that she has heard of this issue with a few other patients as well. I have not confirmed this myself with her.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated.
Age: 15.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Contracted varicella after vaccination.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient was given vaccine after the 30day window from being removed from a frozen status due to a shipping error from supplier. We obtained a new supply and revaccinated patient.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: I expected a sore arm and some aches the next day.   Plus those I had fever, headache, fatigue for 2 days followed by fatigue and headache for 5 days and it continues. This is the 8th day.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: contracted varicella after vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: It was brought to my attention by a coworker on 1/30/2024 that the patient received extra doses of the HPV vaccine. The incident occurred on 6/6/2023 and on 8/16/2023. No treatment needed; vaccine did not harm the patient.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 15.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Contracted varicella after vaccination
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: about a 25mm raised circular welt. Red, warm.   Advised Benadryl and Nsaids, reports to Urgent care if no improvement in the next 12-24 hours.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: contracted varicella after vaccination.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I administered the  Spikevax Covid-19 for 12yrs and older to the patient thinking she was 12yrs of age but she is 11yrs old.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Diluted with 0.1 mL in lieu of 1.1 mL sterile saline solution.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Back pain, Chest pain, Discomfort, Injection site pain
Clinical narrative: Patient reports muscle soreness in deltoid, left side of chest and left back on and off since shortly after vaccine date, which is just over 2 months ago at this time.  Patient reports he went to the ER around New Years due to level of discomfort, but was discharged finding nothing wrong, advising him to take OTC tylenol to manage the pain.  Patient is following up with cardiologist soon, then possibly primary doctor after if cardiologist does not find anything.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue, Product storage error
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient accepted offer for re-vaccination which was completed on 2/19/24.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient accepted offer for re-vaccination which was completed on 2/20/2024.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient accepted offer for re-vaccination which was completed on 02/21/24.
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: Blood culture negative, CSF culture negative, Chest X-ray normal, Computerised tomogram head normal, Culture urine negative
Clinical narrative: Patient had a complex febrile seizure on 2/21/24 at home and transferred to hospital via EMS and there required intubation for airway support following administration of multiple doses of benzos and 20mg/kg of fosphenytoin,  Following intubation patient and cessation of seizure activity patient was also loaded keppra 60mg/kg. She was transferred to another Hospital ICU.  In the PICU patient had sepsis workup consisting of chest xray, MRI of brain, spinal tap, blood culture, and urine culture, and respiratory pathogen panel. EEG was negative. All cultures were negative. Patient had two fevers in the ICU, but no further seizure activity.  Patient was discharged to home.
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram normal, Endotracheal intubation, Febrile convulsion, Intensive care, Laboratory test normal
Clinical narrative: Patient had a complex febrile seizure on 2/21/24 at home and transferred to hospital via EMS and there required intubation for airway support following administration of multiple doses of benzos and 20mg/kg of fosphenytoin,  Following intubation patient and cessation of seizure activity patient was also loaded keppra 60mg/kg. She was transferred to another Hospital ICU.  In the PICU patient had sepsis workup consisting of chest xray, MRI of brain, spinal tap, blood culture, and urine culture, and respiratory pathogen panel. EEG was negative. All cultures were negative. Patient had two fevers in the ICU, but no further seizure activity.  Patient was discharged to home.
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Pyrexia
Clinical narrative: Patient had a complex febrile seizure on 2/21/24 at home and transferred to hospital via EMS and there required intubation for airway support following administration of multiple doses of benzos and 20mg/kg of fosphenytoin,  Following intubation patient and cessation of seizure activity patient was also loaded keppra 60mg/kg. She was transferred to another Hospital ICU.  In the PICU patient had sepsis workup consisting of chest xray, MRI of brain, spinal tap, blood culture, and urine culture, and respiratory pathogen panel. EEG was negative. All cultures were negative. Patient had two fevers in the ICU, but no further seizure activity.  Patient was discharged to home.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient accepted offer for re-vaccination which was completed on 02/21/24.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Brain fog, Diabetes mellitus, Dyspnoea, Myalgia
Clinical narrative: I am experiencing serious muscle pains in my chest (heart), heart palpitations, and shortness of breath, and brain fog
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: I am experiencing serious muscle pains in my chest (heart), heart palpitations, and shortness of breath, and brain fog
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given wrong dose of COVID vaccine, Due to age
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient accepted offer for re-vaccination which was completed on 02/21/24.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient accepted offer for re-vaccination which was completed on 02/20/2024.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient accepted offer for re-vaccination which was completed on 02/19/2024.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Circumoral swelling, Lip swelling, Pain
Clinical narrative: Patient received vaccines around 4p and later the same evening developed bodyaches and the next morning had swelling around her mouth.  She was given Benadryl with positive results (swelling decreased).  Seen in office for further evaluation with swelling noted to upper lip area, no distress, bodyaches or fever.  Benadryl prescibed Q6hr x 24hrs and advised to call EHS for difficulty breathing or significant lip swelling.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue, Product storage error
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient accepted offer for re-vaccination which was completed on 02/19/2024.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient accepted offer for re-vaccination which was completed on 02/16/2024.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: Vaso-vagal Reglex
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Patient was administered vaccines at 11:33 and while waiting the 15 minute observation time patient complained of itching on left arm. Assessed at 11:46 at time of complaint. Patient had localized redness and itching at injection site. Took a picture and sent to provider for evaluation. Patient was given 10 mL of Benadryl per provider. Patient was advised to apply cold compress 3 times a day for 15 minutes.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Recd shot 2/12 afternoon, by morning of 2/13 sent pic of red hard lump left thigh, instructed to give ibuprofen, by 2/14 AM more painful and bigger, saw patient that afternoon, diagnosed with left thigh cellulitis, started on cephalexin, improvement within 24 hrs
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was given influenza vaccine instead of Hep B.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration.; A HCP called to report a TE for GARDASIL 9 in which the vaccines had also been administered to a patient on 12/12/2023; This spontaneous report was received from a medical assistant referring to a 10-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-DEC-2023, a temperature excursion (TE) happened for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at 54.3F for 9 hours 32 minutes 0 seconds; on 05-DEC-2023, TE at 57.7F for 15 hours 30 minutes 0 seconds; on 06-DEC-2023, TE at 50.2F for 5 hours 43 minutes 0 seconds; on 07-DEC-2023, TE at 30.6F for 1 hour 55 minutes 0 seconds and 52.7F for 11 hours 3 minutes 0 seconds; on 11-DEC-2023, TE at 48.4F for 1 hour 47 minutes 0 seconds. No other reported current or previous temperature excursions.  On 12-DEC-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml / once, lot #X019196, expiration date: 25-APR-2025, administered for prophylaxis (strength, and route of administration were not provided).  The reporter called to report the vaccine which experienced TE was administered to the patient on that day (Product storage error). The patient did not report any adverse issues or side effects from the administration (No adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA015454: US-009507513-2401USA015463: US-009507513-2401USA015432:
Age: 53.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; A HCP called and reported that a 54 year old patient came in to request her second dose of GARDASIL 9 on 01/029/2024.  The HCP was uncomfortable administering the dose but reviewed the patient's prescription from her provider to administer a three d; This spontaneous report was received from a pharmacist and refers to a 53-year-old female. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were unknown.  On 27-NOV-2023, the patient received the first dose of vaccination of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe injection 0.5 ml once (Lot No. 1957407 has been verified to be a valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), expiration date was 23-JAN-2026, strength and route was not provided) for prophylaxis (inappropriate age at vaccine administration). The operator of the device was the health care professional. She had not experienced any adverse side effects or issues from the administered first dose (no adverse event). The patient came in to request her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) on 29-JAN-2024. The health care professional (HCP) was uncomfortable administering the dose but reviewed the patient's prescription from her provider to administer a three-dose series in which she had received the first dose previously. The HCP declined to administer the second dose to the patient. The reporter declined to provide full patient demographics. No additional adverse event information nor product quality complaint (PQC) was able to be provided during the call.
Age: 33.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called to report T/E for GARDASIL 9 and relayed 3 vaccines had been administered.; This spontaneous report was received from a registered nurse (RN) referring to 3 patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced temperature excursion, with temperature excursion 35.02 Fahrenheit (F) for 24 minutes on 28-NOV-2023; and temperature 35.01F for 25 minutes on an unknown date.       On unknown dates, 3 vaccines with temperature excursion of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection were administered to the patients (lot # X005579, expiration date 30-NOV-2024; strength, dose and route were not reported) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  Follow-up information has been received from the RN on 26-JAN-2024. This spontaneous report was referring to a 33-year-old male patient. On 29-NOV-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot# X004374, expiration date 02-JAN-2025, intramuscular at left right deltoid (strength and dose were not reported) for prophylaxis which had temperature excursion for a total of 49 minutes to a minimum low temperature of 35 F previously (Product storage error). No adverse events noted by patient during the vaccination (No adverse event). Patient denied any adverse reactions post injection. It was stated the current supply in this excursion of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was supported for continued use.  This case is valid since patient identifier was provided. This is one of 3 reports received from the same reporter.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called to report T/E for GARDASIL 9 and relayed 3 vaccines had been administered.; This spontaneous report was received from a registered nurse (RN) referring to 3 patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced temperature excursion, with temperature excursion 35.02 Fahrenheit (F) for 24 minutes on 28-NOV-2023; and temperature 35.01F for 25 minutes on an unknown date.       On unknown dates, 3 vaccines with temperature excursion of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection were administered to the patients (lot # X005579, expiration date 30-NOV-2024; strength, dose and route were not reported) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  Follow-up information has been received from the RN on 26-JAN-2024. This spontaneous report was referring to a 29-year-old trans-female patient. On an unknown date in 2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot# X004374, expiration date 02-JAN-2025 (also reported as 31-JAN-2025), intramuscular at left right deltoid (strength and dose were not reported) for prophylaxis which had temperature excursion for a total of 49 minutes to a minimum low temperature of 35 F previously (Product storage error). No adverse events noted by patient during the vaccination (No adverse event). Patient denied any adverse reactions post injection. It was stated the current supply in this excursion of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was supported for continued use.  This case is valid since patient identifier was provided. This is one of 3 reports received from the same reporter.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: a pregnant patient inadvertently received one dose of GARDASIL 9; no symptoms or side effects have been reported; This spontaneous prospective pregnancy report has been received from a physician via a company representative and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.      On an unknown date, the patient became pregnant. On 22-JAN-2024, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot # 1957407 has been verified to be a valid lot number, expiration date 23-JAN-2026; dose, route and strength were not provided) inadvertently for prophylaxis (exposure during pregnancy). No symptoms or side effects have been reported (no adverse event). The last menstrual period (LMP) and estimated delivery date (EDD) was not known. The pregnancy outcome was pending. The fetus outcome was unknown.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2402USA007944: US-009507513-2402USA007943: US-009507513-2402USA007945:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; ROTATEQ was administered after a supported TE; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-FEB-2024, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTAETQ) administered orally, lot # 1965644, expiration date 02-OCT-2024 (dose and anatomical location were not provided) for prophylaxis (improper storage of product in use). There was no additional adverse event reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: a pregnant patient inadvertently received one dose of GARDASIL 9; no symptoms or side effects have been reported; This spontaneous prospective pregnancy report has been received from a physician via a company representative and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.      On an unknown date, the patient became pregnant. On 02-FEB-2024, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot # 1957407 has been verified to be a valid lot number, expiration date 23-JAN-2026; dose, route and strength were not provided) inadvertently for prophylaxis (exposure during pregnancy). No symptoms or side effects have been reported (no adverse event). The last menstrual period (LMP) and estimated delivery date (EDD) was not known. The pregnancy outcome was pending. The fetus outcome was unknown.   This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-2402USA002045:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: a pregnant patient inadvertently received one dose of GARDASIL 9; no symptoms or side effects have been reported; This spontaneous prospective pregnancy report has been received from a physician via a company representative and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.      On an unknown date, the patient became pregnant. On 02-FEB-2024, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot # 1957407 has been verified to be a valid lot number, expiration date 23-JAN-2026; dose, route and strength were not provided) inadvertently for prophylaxis (exposure during pregnancy). No symptoms or side effects have been reported (no adverse event). The last menstrual period (LMP) and estimated delivery date (EDD) was not known. The pregnancy outcome was pending. The fetus outcome was unknown.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2402USA002045:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: a pregnant patient inadvertently received one dose of GARDASIL 9; no symptoms or side effects have been reported; This spontaneous prospective pregnancy report has been received from a physician via a company representative and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.      On an unknown date, the patient became pregnant. On 05-FEB-2024, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot # 1957407 has been verified to be a valid lot number, expiration date 23-JAN-2026; dose, route and strength were not provided) inadvertently for prophylaxis (exposure during pregnancy). No symptoms or side effects have been reported (no adverse event). The last menstrual period (LMP) and estimated delivery date (EDD) was not known. The pregnancy outcome was pending. The fetus outcome was unknown.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2402USA002045:
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Scratching; Have received 3 shingles shots; itch; Have received 3 shingles shots But I am getting what looks like shingles but no pain/suspected vaccination failure; Shingles without the pain just itch like I have chicken pox; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included red rash (Rash looks little bumps with almost tiny blisters dot of red) and blister (Rash looks little bumps with almost tiny blisters dot of red). Previously administered products included Shingrix (received first dose of shingles shot on unknown date), Shingrix (received second dose of shingles shot on unknown date) and cortisone. Concurrent medical conditions included blood pressure high and thyroid disorder.   On an unknown date, the patient received the 3rd dose of Shingrix. On 13-FEB-2024, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Have received 3 shingles shots But I am getting what looks like shingles but no pain/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles without the pain just itch like I have chicken pox) and pruritus (Verbatim: itch). On an unknown date, the patient experienced scratch (Verbatim: Scratching) and extra dose administered (Verbatim: Have received 3 shingles shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pruritus were not resolved and the outcome of the scratch was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, scratch and pruritus to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles, scratch and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-FEB-2024 The patient reported she received 3 shingles shots and had shingles without the pain and was just scratching and itch like she has chicken pox. The patient stated when she was a kid, she had rash which looked little bumps with almost tiny blisters dot of red. In middle she used cortisone cream but regular and prescription.  The patient used other product of thyroid medication and high blood pressure. The symptoms were not treated. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Vaccination failure; childbrth pain; Got three sht of shingles; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pain (Verbatim: childbrth pain) and extra dose administered (Verbatim: Got three sht of shingles). The patient was treated with lysine (L-Lysine). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was resolved (duration 10 weeks) and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-FEB-2024 This case was reported by a patient via interactive digital media. The patient reported that he/she had all of three shots and got shingles anyway which lasted 10 weeks and reminded patient of childbirth pain. The patient stated that luckily he/she had not been left with neuralgia and thought that started turning the corner when he/she began taking L-Lysin three a day until shingles was gone and one a day until now and stated that he/she thought would continue it as a form of maintenance. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.