chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Off label use, Therapeutic response unexpected
Clinical narrative: resolution without side effects; recurrent SCCIS of the penis successfully treated with systemic and intralesional 9-valent human papillomavirus (HPV) vaccine; effective off-label treatment for cutaneous SCCs; recurrent SCCIS of the penis successfully treated with systemic and intralesional 9-valent human papillomavirus (HPV) vaccine; effective off-label treatment for cutaneous SCCs; This literature marketed report has been received from the authors of a published article titled as stated below and refers to an adult male patient. Patient's medical history included circumcision and anogenital Herpes simplex virus (HSV) infection. Concurrent conditions included non-Hodgkin lymphoma in remission, type 2 diabetes mellitus, human immunodeficiency virus (HIV) with an undetectable viral load on highly active antiretroviral therapy (HAART).  The patient also had recurrent squamous cell carcinoma in situ (SCCIS) of the penis treated over 13 years with more than 10 surgeries. On an unknown date, patient presented with a painful, ulcerated plaque on his penis. Biopsy was consistent with SCCIS. He declined additional surgical excision or a repeat course of imiquimod and elected to receive the systemic hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), his first ever, on 03-MAR-2016, 21-APR-2016, and 29-SEP-2016 (lot#, dose, route of administration and anatominal location were not reported) (off label use), which resulted in clinical and histologic resolution.   The SCCIS recurred 21 months after clearance, confirmed with biopsy on 23-MAR-2018. The patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) booster on 29-MAR-2018. Magnetic resonance imaging (MRI) of the pelvis with and without contrast showed a signal abnormality in the distal corpus spongiosum as well as thickening and enhancement of the distal penis. The patient again elected to receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), this time intralesionally. Four doses of the 0.5 ml hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were administered undiluted intralesionally on 27-SEP-2019, 05-DEC-2019, 16-JAN-2020, and 10-MAR-2021 (off label use). The patient experienced resolution without side effects and has not had a clinical recurrence in 20 months.   A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reporting temperature excursion. One dose was administered.; This spontaneous report was received from the office manager and refers to a patient of an unknown age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2023, the patient was vaccinated with an improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 ml, lot #X002291, expiration date: 21-JUL-2024, administered as prophylaxis (strength,  vaccination scheme, anatomical location of administration and route of administration were not provided) following a temperature excursion of -14 degree Celsius (C)  to -10.3 C for 1 hour 6 minutes, it was stated that no previous temperature excursion occurred (Improper storage of product in use).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported.; Caller reported vaccine administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.        ?    Names of vaccines involved (including lot/exp) ROTATEQ 1918229  3/15/2024        ?    Temperature 11; This spontaneous report as received from a nurse 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 04-DEC-2023, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot number 1918229, expiration date 15-MAR-2024 oral (dose not reported) for prophylaxis (product storage error). No adverse events was reported.  The vaccine underwent a temperature excursion of 11.4 degrees Celsius for 4 hours. No previous excursions were reported.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AE/no PQC.; HCP accidentally administered VARIVAX instead of MENVEO; HCP accidentally administered VARIVAX instead of MENVEO on 12/1/2023; the child has already received two doses of VARIVAX in the past; This spontaneous report was received from a medical assistant, referring to an 11-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 01-DEC-2023, the patient was accidentally vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X010523 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 25-APR-2024, but upon internal validation established as 11-APR-2025, 0.5 milliliter (strength and route of administration were not provided) and sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (lot # and expiry date were unknown) (strength and route of administration were not provided), 0.5 milliliter, instead of meningococcal vaccine a/c/y/w conj (crm197) (MENVEO), administered by health professional as prophylaxis (wrong product administered). Health care professional (HCP) confirmed that it was not due to packaging or product confusion, it was just a mistake. HCP reported that the patient had already received two doses of varicella virus vaccine live (oka/merck) (VARIVAX) in the past (extra dose administered). No side effects were reported. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: No side effects reported/No additional AE/PQC; HCP calling to report AE for patient who received MMRII/Patient has a history of rheumatoid arthritis, fibromyalgia, and immunosuppression; This spontaneous report was received from  a nurse and refers to a patient of a not reported age or gender. The patient's medical history was not reported. The patient's concurrent conditions included  rheumatoid arthritis,  fibromyalgia, and immunosuppression. Concomitant therapies included tofacitinib citrate (XELJANZ).  On 13-DEC-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, lot #X012185, which was found as a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date not reported but validated as: 03-JUN-2024, administered as prophylaxis (strength, vaccination scheme, anatomical location of administration and route of administration were not provided) (Contraindicated product administered). No side effects reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse called to report an expired dose of ROTATEQ was administered on 12/12/2023 that expired on 12/9/2023. Confirmed no symptoms or side effects reported. Confirmed no history of temperature excursions. Dose was supported per the Post Expiry Memo, s; This spontaneous report was received from a nurse and refers to a unknown patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-DEC-2023, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1918231, expiration date: 09-DEC-2023, administered orally for prophylaxis (strength was not provided) (Product storage error). There was no history of temperature excursion No additional adverse event was reported.  This is non valid case due to lack of patients identifiers.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Additional AE; expired VAQTA, was inadvertently given to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 20-DEC-2023, the patient was vaccinated with the second dose of Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (25U/0.5ml, lot number: W017343, expiration date: 13-DEC-2023; dose, and route of administration was not reported) inadvertently by a health professional for prophylaxis (expired product administered). No temperature excursion (T/E) occurred. No additional adverse events (AE) were reported (no adverse event).
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Blood culture positive, Central venous catheterisation, Chills, Diarrhoea
Clinical narrative: his manager called 911 to take him to the hospital because he looked so bad/was treated in the ER and admitted to hospital; he 'looked yellow'; diarrhea; fever/his fever hit 105 F; chills; vomiting; he is still weak; has swelling in his legs; Hospital lab checked blood cultures that tested positiv for Haemophilus influenzae; This spontaneous report has been received from a male consumer of unknown age, referring to himself. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 04-DEC-2023, at 13:30, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, route of administration reported as injection, for prophylaxis (dose, anatomical location of vaccination, lot number and expiration date were not provided).  On that same date, at 21:00, the patient experienced fever (pyrexia), chills, vomiting and diarrhea, which lasted several days. He also looked yellow (jaundice). On 06-DEC-2023, the patient went to work, where his manager called 911 to take him to the hospital because he looked so bad (malaise). Caller was treated in the Emergency Room (ER) and admitted to hospital. His fever hit 105 Fahrenheit (F). On 19-DEC-2023, the patient was discharged from the hospital with a peripherally inserted central catheterization (PICC) line to receive home treatments of intravenous (IV) antibiotics (unspecified); he also received IV fluids (unspecified) as part of the treatment of the events. Additionally, it was reported that the hospital laboratory checked blood cultures tested positive for Haemophilus influenzae (Haemophilus test positive). At the reporting time, the patient was still weak (asthenia) and had swelling in his legs (peripheral swelling). The outcome of all events was reported as recovering.  The causality assessment between malaise, jaundice, Haemophilus test positive, diarrhea, peripheral swelling, pyrexia, asthenia, chills and vomiting and the suspect vaccine was not provided.  Upon internal review, malaise was determined to be medically significant due to a central venous catheterization was performed.
Sex: M
Vaccine: PPV
Symptoms: General physical condition abnormal, Haemophilus test positive, Impaired work ability, Jaundice, Malaise
Clinical narrative: his manager called 911 to take him to the hospital because he looked so bad/was treated in the ER and admitted to hospital; he 'looked yellow'; diarrhea; fever/his fever hit 105 F; chills; vomiting; he is still weak; has swelling in his legs; Hospital lab checked blood cultures that tested positiv for Haemophilus influenzae; This spontaneous report has been received from a male consumer of unknown age, referring to himself. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 04-DEC-2023, at 13:30, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, route of administration reported as injection, for prophylaxis (dose, anatomical location of vaccination, lot number and expiration date were not provided).  On that same date, at 21:00, the patient experienced fever (pyrexia), chills, vomiting and diarrhea, which lasted several days. He also looked yellow (jaundice). On 06-DEC-2023, the patient went to work, where his manager called 911 to take him to the hospital because he looked so bad (malaise). Caller was treated in the Emergency Room (ER) and admitted to hospital. His fever hit 105 Fahrenheit (F). On 19-DEC-2023, the patient was discharged from the hospital with a peripherally inserted central catheterization (PICC) line to receive home treatments of intravenous (IV) antibiotics (unspecified); he also received IV fluids (unspecified) as part of the treatment of the events. Additionally, it was reported that the hospital laboratory checked blood cultures tested positive for Haemophilus influenzae (Haemophilus test positive). At the reporting time, the patient was still weak (asthenia) and had swelling in his legs (peripheral swelling). The outcome of all events was reported as recovering.  The causality assessment between malaise, jaundice, Haemophilus test positive, diarrhea, peripheral swelling, pyrexia, asthenia, chills and vomiting and the suspect vaccine was not provided.  Upon internal review, malaise was determined to be medically significant due to a central venous catheterization was performed.
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Vomiting, Yellow skin
Clinical narrative: his manager called 911 to take him to the hospital because he looked so bad/was treated in the ER and admitted to hospital; he 'looked yellow'; diarrhea; fever/his fever hit 105 F; chills; vomiting; he is still weak; has swelling in his legs; Hospital lab checked blood cultures that tested positiv for Haemophilus influenzae; This spontaneous report has been received from a male consumer of unknown age, referring to himself. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 04-DEC-2023, at 13:30, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, route of administration reported as injection, for prophylaxis (dose, anatomical location of vaccination, lot number and expiration date were not provided).  On that same date, at 21:00, the patient experienced fever (pyrexia), chills, vomiting and diarrhea, which lasted several days. He also looked yellow (jaundice). On 06-DEC-2023, the patient went to work, where his manager called 911 to take him to the hospital because he looked so bad (malaise). Caller was treated in the Emergency Room (ER) and admitted to hospital. His fever hit 105 Fahrenheit (F). On 19-DEC-2023, the patient was discharged from the hospital with a peripherally inserted central catheterization (PICC) line to receive home treatments of intravenous (IV) antibiotics (unspecified); he also received IV fluids (unspecified) as part of the treatment of the events. Additionally, it was reported that the hospital laboratory checked blood cultures tested positive for Haemophilus influenzae (Haemophilus test positive). At the reporting time, the patient was still weak (asthenia) and had swelling in his legs (peripheral swelling). The outcome of all events was reported as recovering.  The causality assessment between malaise, jaundice, Haemophilus test positive, diarrhea, peripheral swelling, pyrexia, asthenia, chills and vomiting and the suspect vaccine was not provided.  Upon internal review, malaise was determined to be medically significant due to a central venous catheterization was performed.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Injection site erythema, Migraine, Myalgia, Nausea
Clinical narrative: Itchy, swollen, red injection site reaction. Wide-spread muscle aches. Migraine lasting 2 hours. Nausea all day (12+ hrs).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy, swollen, red injection site reaction. Wide-spread muscle aches. Migraine lasting 2 hours. Nausea all day (12+ hrs).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Circumstance or information capable of leading to medication error, Wrong patient received product, Wrong product administered
Clinical narrative: Patient was 1 of 3 young children with appointments. Mother had difficulty understanding language. She was also alone with a total of 4 young children. Mother had trouble with all the patient's full names and date of births. I had all papers on my desk and the patient's paper got pushed aside and mixed in with his brother's. I inadvertently gave Pediarix to this patient. I immediately told my supervisor and I told Mother. I repeated the incident using the translator device.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Pain, Periorbital swelling, Swelling face
Clinical narrative: body and joint aches; headache; facial swelling especially around the eyes.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Muscular weakness, Nervousness, Rash
Clinical narrative: seconds after vaccine pt. reports she felt dizzy, shaky, and weak and reports her husband had to lower her to the ground because her legs were weak. Her symptoms lasted minutes and then resolved. Pt had no respiratory distress. She reports a rash developed on the right side of her neck that was red and itchy but resolved. Pt reports she did not take any benadryl or antihistamines after the incident and has no symptoms today 12/28/2023.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: seconds after vaccine pt. reports she felt dizzy, shaky, and weak and reports her husband had to lower her to the ground because her legs were weak. Her symptoms lasted minutes and then resolved. Pt had no respiratory distress. She reports a rash developed on the right side of her neck that was red and itchy but resolved. Pt reports she did not take any benadryl or antihistamines after the incident and has no symptoms today 12/28/2023.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine Spikevax was given outside of the date of use. The vaccine had been out of the recommedned storage temperature for 6 days. Manufacturer notified advised to not readminister. Patient notified of this event.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE GIVEN AFTER VIABILITY DATE.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine Spikevax was given outside of the date of use. The vaccine had been out of the recommedned storage temperature for 6 days. Manufacturer notified advised to not readminister. Patient notified of this event.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine Spikevax was given outside of the date of use. The vaccine had been out of the recommedned storage temperature for 6 days. Manufacturer notified advised to not readminister. Patient notified of this event.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine Spikevax was given outside of the date of use. The vaccine had been out of the recommedned storage temperature for 6 days. Manufacturer notified advised to not readminister. Patient notified of this event.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine Spikevax was given outside of the date of use. The vaccine had been out of the recommedned storage temperature for 6 days. Manufacturer notified advised to not readminister. Patient notified of this event.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Cough, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Sore throat, headache, dizzy, congestion, coughing, diarrhea weakness, fatigue
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Sore throat, headache, dizzy, congestion, coughing, diarrhea weakness, fatigue
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine Spikevax was given outside of the date of use. The vaccine had been out of the recommedned storage temperature for 6 days. Manufacturer notified advised to not readminister. Patient notified of this event.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Chest X-ray normal, Chills, Full blood count normal, Metabolic function test normal, Oxygen saturation decreased
Clinical narrative: Patient oxygen level dropped had to be put on oxygen, experienced chills, patient recovered from symptoms overnight
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial test negative, Laboratory test normal, Lumbar puncture normal, Magnetic resonance imaging head normal, Magnetic resonance imaging neck
Clinical narrative: Patient developed sudden onsent blurry vision in the left eye about 2wks after administration. Exam consistent with Unilateral papilledema consistent with optic neuritis. Extensive testing (MRI/MRV of head/neck/spine, viral/bacterial serologies, MS testing, lumbar puncture all negative.  Treated with high dose steroids with improvement but not full recovery in the left eye vision.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal normal, Optic neuritis, Papilloedema, Serology negative, Venogram normal
Clinical narrative: Patient developed sudden onsent blurry vision in the left eye about 2wks after administration. Exam consistent with Unilateral papilledema consistent with optic neuritis. Extensive testing (MRI/MRV of head/neck/spine, viral/bacterial serologies, MS testing, lumbar puncture all negative.  Treated with high dose steroids with improvement but not full recovery in the left eye vision.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Viral test negative, Vision blurred
Clinical narrative: Patient developed sudden onsent blurry vision in the left eye about 2wks after administration. Exam consistent with Unilateral papilledema consistent with optic neuritis. Extensive testing (MRI/MRV of head/neck/spine, viral/bacterial serologies, MS testing, lumbar puncture all negative.  Treated with high dose steroids with improvement but not full recovery in the left eye vision.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Fatigue, Injection site pain, Lethargy, Nausea
Clinical narrative: Awoken in middle of night with nausea and vomiting, rt arm severe pain at injection site. In Am was tired with no energy whatsoever , entire body hurt as if had the Flu. Continued all day, fatigue, pain, lethargy.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Sleep disorder, Vomiting
Clinical narrative: Awoken in middle of night with nausea and vomiting, rt arm severe pain at injection site. In Am was tired with no energy whatsoever , entire body hurt as if had the Flu. Continued all day, fatigue, pain, lethargy.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Chest X-ray, Dyspnoea, Full blood count normal, Metabolic function test normal, Use of accessory respiratory muscles
Clinical narrative: Accessory muscle use when breathing, SOB and wheezing, placed on oxygen to help with breathing, ordered duoneb treatments and vistaril
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Wheezing
Clinical narrative: Accessory muscle use when breathing, SOB and wheezing, placed on oxygen to help with breathing, ordered duoneb treatments and vistaril
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine Spikevax was given outside of the date of use. The vaccine had been out of the recommedned storage temperature for 6 days. Manufacturer notified advised to not readminister. Patient notified of this event.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was 63 years in age and received flu vaccine for >65 years. Hand written vaccine consent form had illegible age written.  No adverse events noted at administration of vaccine or following. No adverse events reported by patient.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine Spikevax was given outside of the date of use. The vaccine had been out of the recommedned storage temperature for 6 days. Manufacturer notified advised to not readminister. Patient notified of this event.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine Spikevax was given outside of the date of use. The vaccine had been out of the recommedned storage temperature for 7 days. Manufacturer notified advised to not readminister. Patient notified of this event.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide increased, Cardiac failure acute, Cardiac failure congestive, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Participant received COVID vaccination with Spikevax at the Clinic on December 15th, noted to be in her usual state of health at that time.  She went to the emergency room the following day for shortness of breath that began in the morning, she was brought there by her daughter.  Had oxygen saturation of 93% on 2 L of nasal cannula along with expiratory wheezes and increased work of breathing, which improved following nebulizer and parenteral steroids.  She was admitted to the hospital and discharged on December 19th with final diagnosis of acute on chronic CHF exacerbation and concurrent COPD exacerbation.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Participant received COVID vaccination with Spikevax at the Clinic on December 15th, noted to be in her usual state of health at that time.  She went to the emergency room the following day for shortness of breath that began in the morning, she was brought there by her daughter.  Had oxygen saturation of 93% on 2 L of nasal cannula along with expiratory wheezes and increased work of breathing, which improved following nebulizer and parenteral steroids.  She was admitted to the hospital and discharged on December 19th with final diagnosis of acute on chronic CHF exacerbation and concurrent COPD exacerbation.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine Spikevax was given outside of the date of use. The vaccine had been out of the recommedned storage temperature for 7 days. Manufacturer notified advised to not readminister. Patient notified of this event.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, state registry, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient work up at 0630 on 21 December and notice hives and rashes all over body. Rashes were more severe on right side of body, particularly upper right arm where vaccine was administered. Patient was not hot and did not have a fever. Patient did not take benadryl . Patient presents today at work (28 December 2023) and still presents with hives.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Bone pain, Chest discomfort, Headache
Clinical narrative: Felt healthy with no respiratory or cold symptoms prior to the shot.  Back pain began within an hour or two, becoming more severe by 9pm. No other muscle aches, no redness at injection site. Site was warm. Friday morning woke with a stiff neck and growing muscle pains and stiffness. Headache began by early afternoon, with low fever and nausea. Site still warm, no redness, slight swelling. By Friday 3pm could no longer work at my desk, had to lay down, body aches and bone pain felt up entire back, across shoulders chest and neck, across hips and pelvis, and in both knees and upper legs.  I could barely move, had significant pain even laying still, my breathing was affected. My chest felt constrained and very heavy. Symptoms continued Saturday. Sunday the pain subsided, and I was able to breathe easier. Today still have rib/lung soreness.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site warmth, Mobility decreased, Musculoskeletal chest pain, Musculoskeletal stiffness
Clinical narrative: Felt healthy with no respiratory or cold symptoms prior to the shot.  Back pain began within an hour or two, becoming more severe by 9pm. No other muscle aches, no redness at injection site. Site was warm. Friday morning woke with a stiff neck and growing muscle pains and stiffness. Headache began by early afternoon, with low fever and nausea. Site still warm, no redness, slight swelling. By Friday 3pm could no longer work at my desk, had to lay down, body aches and bone pain felt up entire back, across shoulders chest and neck, across hips and pelvis, and in both knees and upper legs.  I could barely move, had significant pain even laying still, my breathing was affected. My chest felt constrained and very heavy. Symptoms continued Saturday. Sunday the pain subsided, and I was able to breathe easier. Today still have rib/lung soreness.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Felt healthy with no respiratory or cold symptoms prior to the shot.  Back pain began within an hour or two, becoming more severe by 9pm. No other muscle aches, no redness at injection site. Site was warm. Friday morning woke with a stiff neck and growing muscle pains and stiffness. Headache began by early afternoon, with low fever and nausea. Site still warm, no redness, slight swelling. By Friday 3pm could no longer work at my desk, had to lay down, body aches and bone pain felt up entire back, across shoulders chest and neck, across hips and pelvis, and in both knees and upper legs.  I could barely move, had significant pain even laying still, my breathing was affected. My chest felt constrained and very heavy. Symptoms continued Saturday. Sunday the pain subsided, and I was able to breathe easier. Today still have rib/lung soreness.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pelvic pain, Pulmonary pain, Pyrexia, Respiratory disorder
Clinical narrative: Felt healthy with no respiratory or cold symptoms prior to the shot.  Back pain began within an hour or two, becoming more severe by 9pm. No other muscle aches, no redness at injection site. Site was warm. Friday morning woke with a stiff neck and growing muscle pains and stiffness. Headache began by early afternoon, with low fever and nausea. Site still warm, no redness, slight swelling. By Friday 3pm could no longer work at my desk, had to lay down, body aches and bone pain felt up entire back, across shoulders chest and neck, across hips and pelvis, and in both knees and upper legs.  I could barely move, had significant pain even laying still, my breathing was affected. My chest felt constrained and very heavy. Symptoms continued Saturday. Sunday the pain subsided, and I was able to breathe easier. Today still have rib/lung soreness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTREAD OF REFRIGERATED
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Severe Vomiting  (10:30pm-3:00am/night 1), upper abdominal pain,  nausea.  Less  severe night 2. Eating soup/toast to until I can tolerate food.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Oropharyngeal pain
Clinical narrative: Cough, sore throat, chills, diarrhea, body aches, fatigue
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Cough, sore throat, chills, diarrhea, body aches, fatigue
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 17.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given MMRV intead of MMR and Varicella
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 14.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Same day of injections, pt experienced pain which became severe to left arm. denied numbness or tingling.  Pain limited movement of the left arm.  The following day she developed redness and swelling which increased over the next few days. She was seen in clinic on 12-27-23 with Dr. Noted to still have pain in left arm, some limitations to full movement due to persisting  pain and swelling.  Size of induration at visit was noted to be 10 cm x 10 cm, not erythematous.  She is to be seen on 12-29-23 for follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Headache, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat, headache, cold symptoms
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The COVID vaccine given in December was outside of the date of use. The manufacturer was contacted and recommended not re-administration. PCP, Agency, risk management has been notified of the event. Staff training and education has been completed to avoid reoccurrence.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt had already received flushot. No reported adverse effects
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Fatigue, Myalgia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose, congestion, fatigue, cough, myalgias
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Runny nose, congestion, fatigue, cough, myalgias
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Muscle spasms, Paraesthesia, Sensory disturbance, Vaccination site induration, Vaccination site pain
Clinical narrative: 12/22/23: Patient reports weird feeling in arm when driving home from facility after getting vaccine. Arm felt diminisheed/tingly. It started to worsen over the next couple days. 12/27/23: muscle spasms 30 seconds at a time throughout the day. Tingling all 5 fingers of right arm. 12/28/23: Slight induration at vaccine site. Vaccine induration and tenderness noted to be appropriate site for vaccine, provider notes vaccine administration appropriate without concerns to administration procedure. Provider advised on ibuprofen, moving extremity, rest.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Discomfort, Injection site pain, Insomnia, Joint noise
Clinical narrative: Patient notified clinic via message on 12/28 that since her vaccination, she's been having R shoulder/arm aching, tenderness, some difficulty sleeping related to the discomfort, weakness to that arm, and cracking to her shoulder when stretching a certain way followed by pain after the crack. Did mention the vaccine was more painful than usual also.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity, Tenderness
Clinical narrative: Patient notified clinic via message on 12/28 that since her vaccination, she's been having R shoulder/arm aching, tenderness, some difficulty sleeping related to the discomfort, weakness to that arm, and cracking to her shoulder when stretching a certain way followed by pain after the crack. Did mention the vaccine was more painful than usual also.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, body chills, body ache, tender injection site, fatigue
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The 3 year old patient in office and due for the seasonal dose of Pfizer, 6mo-4yrs  dose.  The patient received the dose of 0.3ml and later discovered that the dose was past its use by date of 12/19/23.  Management was notified and the Immunization Department.  I as the department coordinator contacted the manufacture for stability guidance.  A company variance was completed as part of our policy and case will be reviewed by the Nursing Director for action.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Reported sore arm a month after injection. No treatment.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Lymphadenopathy, Scan with contrast abnormal
Clinical narrative: Swollen lymph nodes on right side of neck and shoulder.  First noticed on 12/3/2023.  Was not able to get an initial doctors appointment until 12/11/2023.  Dr. requested a CT scan which was done on 12/12/2023.  He then referred me to an ENT specialist whom I saw on 12/20/2023.  The ENT doctor decided he could not do a needle biopsy himself and referred me to another specialist for the needle biopsy.  I am currently awaiting the biopsy specialist to agree they can do the requested procedure and then schedule me for it.
Age: 19.0
Sex: M
Vaccine: HPV9, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Patient presented with redness, swelling, pain, itching and warm to touch in the back of the Right arm (triceps area) which is where the Varicella Vaccine was administered. The suspected localized reaction measured 11x13cm, Administered 25mg of Benadryl orally and applied ICE to the area for 20 minutes.
Age: 19.0
Sex: M
Vaccine: HPV9, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Patient presented with redness, swelling, pain, itching and warm to touch in the back of the Right arm (triceps area) which is where the Varicella Vaccine was administered. The suspected localized reaction measured 11x13cm, Administered 25mg of Benadryl orally and applied ICE to the area for 20 minutes.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The 85 year old patient in office and due for the seasonal dose of Comirnaty 12yrs+  dose.  The patient received the dose of 0.3ml on 12/27/23 and later discovered that the dose was past its use by date of 12/25/23.  Management was notified and the Immunization Department.  I as the department coordinator contacted the manufacture for stability guidance.  A company variance was completed as part of our policy and case will be reviewed by the Nursing Director for action.