chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Myalgia, Pain, Pain in extremity
Clinical narrative: She got her vaccine, very painful arm.  Last night she broke out with shingles on her back side, blisters, painful.  She has been having a lot of pain, muscle pain in her legs over the last couple of weeks that she did not have before.  It hurts to get up.  She has not gone to the doctor again.
Age: 4.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Day 7 booster dose of rabies vaccine. She developed tingling of bilateral feet, fever 100.7, vomiting x 1 episode and abdominal pain. Was evaluated in primary care clinic.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  Pt contacted, no known health complications.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Carotid artery stenosis, Coronary artery disease, Gangrene, Hypoxia
Clinical narrative: R09.02 HYPOXEMIA 5/3/2023 BILAT CAROTID ARTERY STENOSIS R09.02 HYPOXEMIA 5/3/2023 GANGRENE R09.02 HYPOXEMIA 5/3/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Age: 3.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Child is age 3 and recommended vaccine is Dtap.  She was given Tdap. State response when reported is that if dose 4 or 5-it can be considered valid and does not need to be repeated. (if dose 1,2, or 3-it would not count and need to be repeated) She has already received 4 doses of Dtap and this is dose #5. It  is a valid dose and the child is protected. It will count as 5th dose and is now completed.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Neuropathy peripheral, Pulmonary embolism
Clinical narrative: G62.9 NEUROPATHY 4/27/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I26.99 ACUTE PULMONARY EMBOLISM 4/25/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: localized welling and redness reported on 7/12/2023, reports more redness and swelling yesterday. Denies any drainage, or bleeding. Denies any fever or any other symptoms. no shaking or chills, no vomiting or severe abdominal or flank pain. Patient has not problems with immune system or kidney failure. none other concerns reported, patient prescribed medication to treat localized area or swelling and redness. patients mother reports no change in playing/activity or eating.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Diabetic nephropathy
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 DM 2 W RENAL MANIFESTATION
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Adenocarcinoma pancreas, Biliary obstruction, Hypotension
Clinical narrative: I95.9 HYPOTENSION 4/25/2023 BILE DUCT OBSTRUCTION I95.9 HYPOTENSION 4/25/2023 ABDOMINAL PAIN I95.9 HYPOTENSION 4/25/2023 ADENOCARCINOMA, HEAD OF PANCREAS
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone increased, Weight increased
Clinical narrative: Dose 1 received 07/30/2021. Dose 2 received 08/20/2021. Dose 3 (booster) received 05/11/2022.  Prior to my first dose, my thyroid (TSH) was slightly elevated at 7.84.  After Dose 1 and 2, at my next test a few months later, my TSH had nearly tripled to 20  never been that high.  Nothing else had changed in my diet or routines.  My appetite was the same, but I gained 4 lbs (138 to 142).  The further I've gotten from my booster, by late 2022, my weight returned to 138, and my TSH has been dropping back toward acceptable range.  At the very minimum, if the Pfizer vax did not cause the TSH spike, it at least magnified what might have been a small spike from something else.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  Pt contacted, no known health complications.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Embolic stroke, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt reported an irregular roundish red, warm area at injec
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.   No known health complications.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angioedema
Clinical narrative: ANGIOEDEMA, SUBSEQ
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Embolic stroke, Lacunar stroke
Clinical narrative: ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  No known health complications.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram normal, Blood test normal, Computerised tomogram normal, Diplopia, Dizziness
Clinical narrative: Initially, suffered a severe migraine.  I believed that I was having a stroke.  It was followed by vertigo, blurred and double vision, and dizziness.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture normal, Magnetic resonance imaging normal, Migraine, Myasthenia gravis, Vertigo
Clinical narrative: Initially, suffered a severe migraine.  I believed that I was having a stroke.  It was followed by vertigo, blurred and double vision, and dizziness.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Initially, suffered a severe migraine.  I believed that I was having a stroke.  It was followed by vertigo, blurred and double vision, and dizziness.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt was given the age +12 year COVID Pfizer vaccine instead of the age appropriate. Pt had no side effects, no complication.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Symptom recurrence, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA 2/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Embolic stroke
Clinical narrative: ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Asthenia, COVID-19, Chest X-ray abnormal, Dyspnoea
Clinical narrative: Patient is a 86 y.o. female with a history of COPD, HTN, and HLD who presented to RMH 5/1/2023 with dyspnea. Patient found to be COVID positive requiring oxygen on discharge.    1. COVID Infection: without pneumonia. Presented with four days of generalized weakness, congestion and not positive test date 5/1/23. Fully vaccinated. CXR with minimal hazy interstitial opacity in the left lung base with trace left pleural effusion. Remdesivir discontinued. Decadron continued on discharge.  2. Acute Hypoxic Respiratory Failure: required 2L NC on admission with initial oxygen saturation of 87% per ED notes. Endorsed she has needed O2 in the setting of COPD but was never arranged. Patient qualified for home oxygen and arranged per CM on discharge.  3. COPD: per history. Not in exacerbation. Suspect will need chronic home oxygen, arranged on discharge. Inhalers initiated.  4. Malnutrition: moderate malnutrition without cachexia. BMI 21 on admission. Encouraged PO intake.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lung opacity, Malnutrition, Pleural effusion, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Patient is a 86 y.o. female with a history of COPD, HTN, and HLD who presented to RMH 5/1/2023 with dyspnea. Patient found to be COVID positive requiring oxygen on discharge.    1. COVID Infection: without pneumonia. Presented with four days of generalized weakness, congestion and not positive test date 5/1/23. Fully vaccinated. CXR with minimal hazy interstitial opacity in the left lung base with trace left pleural effusion. Remdesivir discontinued. Decadron continued on discharge.  2. Acute Hypoxic Respiratory Failure: required 2L NC on admission with initial oxygen saturation of 87% per ED notes. Endorsed she has needed O2 in the setting of COPD but was never arranged. Patient qualified for home oxygen and arranged per CM on discharge.  3. COPD: per history. Not in exacerbation. Suspect will need chronic home oxygen, arranged on discharge. Inhalers initiated.  4. Malnutrition: moderate malnutrition without cachexia. BMI 21 on admission. Encouraged PO intake.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Provider ordered Pentacel, only the liquid was given.  Patient family is aware to return to the office for ActHIB.  Reeducation was given to staff members
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Malaise
Clinical narrative: Presented to the ED to be evaluated for covid like sx onset 6 weeks ago; admitted for COVID-19 pna; tx w/abx, Vit C, zinc, O2; pt weaned off of O2 and dc'd home
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Hypotension
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN HYPOTENSION
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, SEQUELA
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Per mother patient has bumps to face and thighs. Did telehealth for patient was sent Triamcinolone and Cetirizine to pharmacy.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dyspnoea
Clinical narrative: Presented to the ED c/o of worsening SOB; admitted for COVID-19 pna; tx w/abx, remdesivir, steroids, O2 therapy; weaned to RA and dc'd home
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary embolism, Respiratory failure
Clinical narrative: ACUTE PULMONARY EMBOLISM RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Human chorionic gonadotropin negative, Injection site pain
Clinical narrative: patient received the vaccine around 10:45AM and  initially experienced soreness at the injection site and general malaise throughout the day.  At 2 AM woke with reports of shortness of breath and that she felt lightheaded.  She then had a syncopal event that was about 30 seconds long- had possible seizure like activity and was taken to the emergency room.  At that time had swelling at the injection site as well as continued soreness.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Malaise, Metabolic function test normal, Syncope
Clinical narrative: patient received the vaccine around 10:45AM and  initially experienced soreness at the injection site and general malaise throughout the day.  At 2 AM woke with reports of shortness of breath and that she felt lightheaded.  She then had a syncopal event that was about 30 seconds long- had possible seizure like activity and was taken to the emergency room.  At that time had swelling at the injection site as well as continued soreness.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, COVID-19 pneumonia, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w/ c/o weakness; EMS report pt tested COVID-19+ x 3 days ago; admitted for COVID-19 pna w/hypoxic resp failure; tx w/abx, Vit C, zinc, O2 therapy; NC weaned to RA; dc'd back to NH
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Blood test abnormal, Haemolytic anaemia
Clinical narrative: Extreme leg pain and couldn?t get around very well.  Previously an active 16 yr old girl who ran cross country and played high school soccer.  Extreme anemia that wasn?t helped with iron infusions? hemolytic anemia and hospitalized after blood work led to ANCA associated vasculitis diagnosis.   After treatment for 10 days in hospital, currently receiving Rituximab  infusions every 6 months and has returned to all normal activities including long distance running and soccer.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Infusion, Loss of personal independence in daily activities, Mineral supplementation, Mobility decreased, Pain in extremity
Clinical narrative: Extreme leg pain and couldn?t get around very well.  Previously an active 16 yr old girl who ran cross country and played high school soccer.  Extreme anemia that wasn?t helped with iron infusions? hemolytic anemia and hospitalized after blood work led to ANCA associated vasculitis diagnosis.   After treatment for 10 days in hospital, currently receiving Rituximab  infusions every 6 months and has returned to all normal activities including long distance running and soccer.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: Extreme leg pain and couldn?t get around very well.  Previously an active 16 yr old girl who ran cross country and played high school soccer.  Extreme anemia that wasn?t helped with iron infusions? hemolytic anemia and hospitalized after blood work led to ANCA associated vasculitis diagnosis.   After treatment for 10 days in hospital, currently receiving Rituximab  infusions every 6 months and has returned to all normal activities including long distance running and soccer.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive
Clinical narrative: Presented to the ED c/o generalized weakness onset 3 days ago; admitted for severe sepsis; COVID test positive 1/7, pt developed COVID-19 pna w/acute resp failure; tx w/O2 therapy, remdesivir, abx; pt weaned to RA, dc'd home
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Presented to the ED c/o generalized weakness onset 3 days ago; admitted for severe sepsis; COVID test positive 1/7, pt developed COVID-19 pna w/acute resp failure; tx w/O2 therapy, remdesivir, abx; pt weaned to RA, dc'd home
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Dyspnoea
Clinical narrative: Presented to ED w/SOB; admitted w/acute resp failure d/t COVID-19 pna; tx w/abx, remdesivir, O2, steroids, zinc; dc'd home w/O2.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise
Clinical narrative: Presented to ED c/o covid-like symptoms progressively getting worse.  Admitted for COVID-19 infection w/o resp failure; provided supportive care w/zinc & mag sulfate.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, COVID-19 pneumonia, Death
Clinical narrative: Presented to the ED via mobile health care c/o SOB. Pt is COVID positive for 11 days. Admitted for COVID-19 pna w/acute resp failure; aggressive care needed w/intubation, vasopressors, CRRT d/t acute renal failure; pt went into PEA 1/21 and unable to obtain ROSC and expired
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Haemofiltration, Pulseless electrical activity, SARS-CoV-2 test positive
Clinical narrative: Presented to the ED via mobile health care c/o SOB. Pt is COVID positive for 11 days. Admitted for COVID-19 pna w/acute resp failure; aggressive care needed w/intubation, vasopressors, CRRT d/t acute renal failure; pt went into PEA 1/21 and unable to obtain ROSC and expired
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Haemodynamic instability, Neck pain, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w/neck pain; pt hemodynamically unstable and admitted; COVID+ on 1/10; tx w/remdesivir, steroids, zinc, O2; weaned to RA for d/c.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cough, Dyspnoea, Respiratory tract congestion
Clinical narrative: Presented to the ED c/o dyspnea x 2 days. Pt was 88% on RA in triage. Associated symptoms include cough, congestion; admitted for acute hypoxemic resp failure d/t COVID-19; tx w/remdesivir, steroids, abx, Vit C, zinc, O2 therapy; weaned to room air; home w/HHC
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Dyspnoea, Mental status changes
Clinical narrative: Presented to ED w c/o AMS, w/cough & SOB; COVID PCR positive; admitted for pneumonia d/t COVID-19 & metabolic encephalopathy; tx w/abx, steroids, remdesivir, zinc. DC'd home on hospice.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic encephalopathy, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w c/o AMS, w/cough & SOB; COVID PCR positive; admitted for pneumonia d/t COVID-19 & metabolic encephalopathy; tx w/abx, steroids, remdesivir, zinc. DC'd home on hospice.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Coagulopathy, Obstructive sleep apnoea syndrome
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE OBSTRUCTIVE SLEEP APNEA
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Dyspnoea
Clinical narrative: Presented to ED w/SOB; admitted for COVID-19 pna & acute resp failure w/hypoxia; tx w/02, steroids, abx, zinc; dc home w/O2
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Mental status changes
Clinical narrative: Presented to ED w/AMS; admitted for COVID-10 pna; did not require O2 therapy; tx w/abx, melatonin, zinc. Regarding the patient's COVID infection, the patient's clinical course was mild. He was not hypoxic and did not require supplemental oxygen throughout his hospitalization. He completed a course of intravenous ceftriaxone and intravenous azithromycin. No further isolation is required post-hospitalization as he is greater than 10 day from date of diagnosis.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Cough, Death
Clinical narrative: Presented to ED w c/o SOB, cough; reports testing COVID+ 4 days prior but symptoms not improving; admitted for COVID-19 pna & acute resp faillure w/hypoxia; tx w/ abx, steroids, remdesivir, O2; continued to need more O2 support & was intubated 1/17 and then trached on 2/9. Pt continued to deteriorate and transitioned to comfort care and expired 2/19.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Endotracheal intubation, General physical health deterioration, SARS-CoV-2 test positive, Tracheostomy
Clinical narrative: Presented to ED w c/o SOB, cough; reports testing COVID+ 4 days prior but symptoms not improving; admitted for COVID-19 pna & acute resp faillure w/hypoxia; tx w/ abx, steroids, remdesivir, O2; continued to need more O2 support & was intubated 1/17 and then trached on 2/9. Pt continued to deteriorate and transitioned to comfort care and expired 2/19.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Fatigue, Nausea
Clinical narrative: Presented to ED w c/o nausea, fatigue x 2 days; COVID+ 1/6 but Z-pak, steroids & Tessalon Perles ineffective; admitted for acute resp failure w/hypoxemia d/t COVID-19 pna; tx w/steroids, zinc, remdesivir, O2; weaned to RA prior to dc.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Presented to ED w c/o nausea, fatigue x 2 days; COVID+ 1/6 but Z-pak, steroids & Tessalon Perles ineffective; admitted for acute resp failure w/hypoxemia d/t COVID-19 pna; tx w/steroids, zinc, remdesivir, O2; weaned to RA prior to dc.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Dyspnoea, SARS-CoV-2 test positive, Suspected COVID-19
Clinical narrative: Presented to ED w/SOB; admitted for acute resp failure w/hypoxia & suspect COVID; COVID test +, tx w/ O2, abx & steroids; dc'd home w/ O2.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Mental status changes
Clinical narrative: Admitted w/AMS & weakness; found to have COVID-19 pna; tx w/ abx & zinc; did not need O2 therapy
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cough, Mental status changes, Pyrexia
Clinical narrative: Presented to ED w/cough, fever, & AMS; admitted for COVID-19 pna; tx w/abx, steroids, remdesivir, O2 therapy; pt weaned from O2/NC to RA; dc'd home
Age: 50.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Cough, Electrocardiogram, Pharyngeal swelling, Throat clearing
Clinical narrative: Patient given vaccine during appointment around 0930. Around 0935 patient reported feeling of throat swelling and was coughing/clearing throat. Medical response was called. Patient was assessed, vitals taken and given 1 dose of Epinephrine - 0.3 mg IM. Epi was given at 0943. EMS was called and arrived around 0954. Patient transferred to ER for further evaluation. In ER was treated with Methylprednisolone, diphenhydramine and famotidine, at 1050. Discharged from ER.
Age: 50.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Hypersensitivity, Pharyngeal swelling
Clinical narrative: Patient given vaccine during appointment around 0930. Around 0935 patient reported feeling of throat swelling and was coughing/clearing throat. Medical response was called. Patient was assessed, vitals taken and given 1 dose of Epinephrine - 0.3 mg IM. Epi was given at 0943. EMS was called and arrived around 0954. Patient transferred to ER for further evaluation. In ER was treated with Methylprednisolone, diphenhydramine and famotidine, at 1050. Discharged from ER.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Swelling face
Clinical narrative: RASH AND FACIAL SWELLING WITHIN 24 HOURS OF VACCINE ADMINISTRATION
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, COVID-19 pneumonia, Cough, Groin pain
Clinical narrative: Chief c/o cough and pain in left lower abdomen/groin; admitted for COVID-19 pna; tx w/abx, steroids, zinc; was not hypoxic
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Pyrexia
Clinical narrative: Presented to ED w c/o fever; admitted for acute resp failure d/t COVID-19 pna; tx w/abx, remdesivir, Vit C, steroids, melatonin, zinc, O2. Weaned to RA for dc.
Age: 8.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was administered incorrect vaccine by medical assistant staff from what was ordered by doctor. No adverse events have been reported by patient's mother.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: swelling and redness . went to urgent care and was told she had cellulitis. got cephalexin 500mg qid for 10 days,  and Bactrim ds   BID for 10 days.   she is doing better today Tuesday the 18th of July 2023.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Dyspnoea, Oxygen saturation decreased
Clinical narrative: Presented to ED from NH where he was recovering from COVID-19 (dx at recent hospital stay) w c/o SOB & decreased O2 saturation; admitted for peristent COVID-19 pna; tx w/abx, O2, steroids, zinc; dc'd to LTAC d/t continuing need for high O2.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Productive cough, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w c/o productive cough; home COVID-19 test positive; pt admitted for COVID-19 pna, acute on chronic resp failure; tx w/steroids, remdesivir, zinc, O2; dc'd to home on RA
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea
Clinical narrative: Presented to ED w c/o SOB, cough, & weakness x 3 days; tx as COVID PUI; tx w/steroids, remdesivir, abx & O2; weaned to RA for dc.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Dyspnoea
Clinical narrative: Presented to ED w c/o SOB; is on home O2 and reports having to increase O2; admitted for COVID-19 pna w/ acute resp failure; tx w/remdesivir, abx, steroids, zinc, O2; weaned to home baseline O2 prior to dc home
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis
Clinical narrative: Left arm cellulitis
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Death, Endotracheal intubation
Clinical narrative: Admitted for COVID-19 pna; tx w/abx, steroids, zinc; pt needed intubation; despite aggressive tx, pt didn ot improve and subsequently expired.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dyspnoea
Clinical narrative: Presented to ED c/o worsening SOB; admitted w/ COVID-19 pna; tx w/abx, remdesivir, steroids, zinc, O2; weaned to RA for dc
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cough, Dyspnoea, Urinary tract infection
Clinical narrative: Presented to ED w/progressive cough & SOB X 1 week; admitted for COVID-19 pna & UTI; tx w/abx, steroids, zinc; did not need O2 therapy; dc'd home
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Urinary tract infection
Clinical narrative: Presented to ED w/ generalized weakness; admitted for COVID-19 pna & UTI; tx w/abx, remedesivir, Vit C, zinc; did not require O2 therapy; dc'd to SNF
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Bursitis, Joint range of motion decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Patient developed left arm pain several hours after vaccine that has persisted until today and associated with reduced range of motion on exam and no signs of infection (no fevers, redness, swelling). I suspect a bursitis/SIRVA and am referring to physicla therapy today with follow up afterward.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Dyspnoea, Hypoxia
Clinical narrative: Presented to ED w/SOB, hypoxia; admitted w/ COVID-19 pna and acute hypoxic resp failure; tx w/steroids, abx, O2, Vit C, Remdesivir, zinc; dc'd to rehab w/O2.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Confusional state, Fatigue
Clinical narrative: Presented to ED w c/o CP, fatigue, mild confusion; admitted for COVID-19 pna; tx w/redemsivir, abx, steroids, zinc; did not need O2 therapy
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Headache, Injection site rash, Nausea
Clinical narrative: Rash at site plus headache/dizzy/nausea (improving)
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  Pt contacted, no known health complications.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  Pt contacted, no known health complications.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  Pt contacted, no known health complications.
Age: 60.0
Sex: M
Vaccine: PPV, PPV, TDAP
Symptoms: Injection site erythema, Pain, Peripheral swelling
Clinical narrative: Arm swelling, pain, and redness began shortly after injection. Does not appear to be infected as the entire arm is rapidly swollen to elbow
Age: 60.0
Sex: M
Vaccine: PPV, PPV, TDAP
Symptoms: Immunisation reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm swelling, pain, and redness began shortly after injection. Does not appear to be infected as the entire arm is rapidly swollen to elbow
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: CHILD PRESENTED WITH GRANDFATHER FOR SWELLING OF ARM WHERE VACCINES WERE GIVEN THE DAY BEFORE.  REDNESS AND WARMTH TO THE AREA OF THE RIGHT DELTOID MUSCLE,  ABOUT 50MM IN DIAMETER WITH LOCALIZED SWELLING TO THE SAME AREA. SKIN UNAFFECTED TO THE SUBCUTANEOUS AREA WHERE THE PROQUAD WAS GIVEN.  NO FEVER PRESENT.  CHILD COMPLAINS OF SORENESS TO THE ARM BUT IS CHILD'S DEMENOUR AND ACTIVITY LEVEL UNAFFECTED.   VACCINES WERE STATE SUPPLIED VACCINES
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiogenic shock, Hypotension, Hypoxia
Clinical narrative: CHRONIC HYPOTENSION HYPOXIA CARDIOGENIC SHOCK
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  Pt contacted, no known health complications.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Acute respiratory failure, Chronic respiratory failure, Deep vein thrombosis, Pulmonary embolism
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE DVT, UNSPECIFIED VEIN ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/30/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory failure, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE DVT, UNSPECIFIED VEIN ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/30/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypotension
Clinical narrative: HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/23/2023  --  PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Pt was administered expired vaccine-reported to GSK.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient given PCV 20 too soon first dose 08/03/2022 and  2nd dose 07/18/2023.
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: She got her vaccine, had no reaction right away, then probably about 3:00 PM she had slight aching in her upper arm.  She took 2 Tylenol for that.  Then she was OK until later that evening and that's when she got chills, aching, and the headache.  Throughout the night she had the chills most of the night, and at 3:00 AM she fell asleep.  When she got up in the morning she felt much better.  The arm never hurt her at all.  She was very very tired and slept almost all of Sunday afternoon.  She then noticed some pimples popping up and every day there was 1-2 more.  She went to the UC and they told her that she had small vesicular rash noted.  This was most likely related to the shingles vaccine. She got a topical cream called Betamethasone Dipropionate 0.5%.  She used it just about an hour ago and it is supposed to help the itching as it was just awful.  She was told to FU with her doctor.  She did call her doctor and told the receptionist what she had done, and that she went to the UC, and she said that she would relay the message to her doctor.  She has also been taking Benadryl for the itching but has not taken it as she was given this new medication.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pruritus, Rash vesicular
Clinical narrative: She got her vaccine, had no reaction right away, then probably about 3:00 PM she had slight aching in her upper arm.  She took 2 Tylenol for that.  Then she was OK until later that evening and that's when she got chills, aching, and the headache.  Throughout the night she had the chills most of the night, and at 3:00 AM she fell asleep.  When she got up in the morning she felt much better.  The arm never hurt her at all.  She was very very tired and slept almost all of Sunday afternoon.  She then noticed some pimples popping up and every day there was 1-2 more.  She went to the UC and they told her that she had small vesicular rash noted.  This was most likely related to the shingles vaccine. She got a topical cream called Betamethasone Dipropionate 0.5%.  She used it just about an hour ago and it is supposed to help the itching as it was just awful.  She was told to FU with her doctor.  She did call her doctor and told the receptionist what she had done, and that she went to the UC, and she said that she would relay the message to her doctor.  She has also been taking Benadryl for the itching but has not taken it as she was given this new medication.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate increased, Hypertension, Pulmonary thrombosis
Clinical narrative: Blood clots in lungs, Afib, high blood pressure and heart rate
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Injection was administered low and resulted in erythema, bruising and swelling at injection site
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: HYPOXIA 3/4/2023  &  1/29/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Developed heart condition
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: patient reports a tingling, burning pain, has no issues with mobility
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Parotitis
Clinical narrative: Parotitis - right parotid gland - subsided on its own within a couple days
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetic nephropathy, Hypotension
Clinical narrative: I95.9 HYPOTENSION 4/22/2023 DM 2 W RENAL MANIFESTATION
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Care team inadvertently gave a duplicate varicella vaccine. CDC vaccine hotline consulted and care expectations given to parent.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Pallor, Vomiting
Clinical narrative: At 1238 after vaccinating patient (14 y.o. female) with patient sat down in chair and reported feeling "dizzy". LVN gave water to patient and patient was able to drink water. PHN noted diaphoresis and pale skin. Patient reported she ate strawberries for breakfast. PHN took vital signs at 1240 and were BP 70/50, HR 76 and O2 98%. Patient vomited and reported she felt "better". Patient was assisted to sit in anti-gravity chair. PHN took vital signs at 1245 and were BP 91/69, HR 76, and O2 99%. Patient reported she feels "good". PHN Supervisor entered room and was notified of the situation. Patient's mother offered emergency medical services. Patient's mother agreed. PHN contacted emergency medical services at 1248. PHN took vital signs at 1250 and were BP 92/67, HR 73, and O2 100%. At 1302 emergency medical services arrived on scene and assumed care. At 1314, patient's mother declined hospital transportation and reported they will go to primary care doctor for follow up. At 1323, patient's mother signed and emergency medical services left the scene. Patient denied symptoms and was alert and oriented to person, place, time and situation. PHN educated patient to let her mother know if she doesn't feel well again. At 1326, patient left facility with mother and family.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Lip swelling, Urticaria
Clinical narrative: Symptoms Patient received Men B vaccine on 7/10 -- and then had hives on 7/14/2023 after going out to dinner.  Mother gave patient allegra on the 7/14 -- then benedryl the next day and had about 75 % resolution of hives.  Mother has added some pepcid as well.  Patient did have swollen lips about 2 days after the initial hives, but no swelling inside of mouth/throat.  Patient has been taking benedryl about every 6 hours.  Last benedryl was at about 8:30 a.m. today.  Mother had a similar reaction to the covid vaccine.  This patient and her sister did not have any issues with covid vaccines.  Patient hasn't had any new products or foods prior to the hives.  No fever, cough, congestion, emesis, diarrhea..
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: This injection was given SQ instead of IM
Age: 62.0
Sex: F
Vaccine: YF
Symptoms: Aphasia, Back pain, Cognitive disorder, Confusional state, Headache
Clinical narrative: 5/26/23  Ischemic Stroke with Aphasia - no cause determined; intermittent severe pain (and occasional numbness) in the upper left quadrant of back, upper left arm, neck and  head Symptoms:  confusion; aphasia; inability to read & comprehend Hospitalization:  5/26/23-5/31/23
Age: 62.0
Sex: F
Vaccine: YF
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Ischaemic stroke, Neck pain
Clinical narrative: 5/26/23  Ischemic Stroke with Aphasia - no cause determined; intermittent severe pain (and occasional numbness) in the upper left quadrant of back, upper left arm, neck and  head Symptoms:  confusion; aphasia; inability to read & comprehend Hospitalization:  5/26/23-5/31/23
Age: 62.0
Sex: F
Vaccine: YF
Symptoms: Reading disorder
Clinical narrative: 5/26/23  Ischemic Stroke with Aphasia - no cause determined; intermittent severe pain (and occasional numbness) in the upper left quadrant of back, upper left arm, neck and  head Symptoms:  confusion; aphasia; inability to read & comprehend Hospitalization:  5/26/23-5/31/23
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac murmur, Echocardiogram normal, Electrocardiogram abnormal, Heart rate irregular, Wolff-Parkinson-White syndrome
Clinical narrative: My son had a normal ECG at age 5 as well as normal physical exam. His last physical exam at age 9 was normal. He did not have an annual physical at age 10. On his 11 year annual exam he was noted to have a heart murmur and later that night noted to have an irregular heart rate. He had a cardiology appointment with a normal echo but incidental finding of Wolff Parkinson's White Syndrome on ECG. This will now require an ablation to correct.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  Pt contacted, no known health complications.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.  This is one of several reports received from the same source.; Sender Comments: US-009507513-2306USA011972:
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient received an extra dose of GARDASIL 9; No additional AE; This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with an extra dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose description, lot #, expiry date, route of administration, and indication were not provided) (extra dose administered). The nurse did not report that patient had any symptoms and did not provide any further information on when extra dose was received. No additional adverse event (no adverse event) and no product quality complaint (PQC) was involved.
Sex: U
Vaccine: HPV4
Symptoms: Dental caries
Clinical narrative: 2 cavities in 15 years, followed by 10 cavities in the first year following her daughter's Gardasil vaccination/increased dental carries; This spontaneous report was received from Consumer and refers to an unknown number of patients.  The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  Asignificant number of parents reported increased dental carries, including one parent who reported 2 cavities in 15 years, followed by 10 cavities in the first year following her daughter's vaccination. Outcome of the event , onset date and causality were not reported..
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; HBP calling to report an administration of PEDVAXHIB  following a temperature excursion.; This spontaneous report was received from an other and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W034363, expiration date: 14-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). On 13-JUL-2023, this vaccine underwent temperature excursion (Product storage error). No additional adverse events were reported.
Age: 52.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I decided to get vaccinated for HPV at age 52; This spontaneous report was received from a physician refers herself a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of the Company unidentified HPV vaccine, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.   It was reported that the patient received her first dose of vaccine, when she was 52 years old (product administered to patient of inappropriate age).
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post-herpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneou report was received from a lawyer regarding a case in litigation and referred to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around 01-DEC-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided). On unspecified dates (reported as subsequently), the patient experienced multiple outbreaks of herpes zoster and postherpetic neuralgia. On unspecified dates, the patient was treated by a healthcare providers for multiple outbreaks of the events. The outcome of multiple outbreaks of herpes zoster and postherpetic neuralgia was not reported. The lawyer considered the events of multiple outbreaks of herpes zoster and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: FLUN4
Symptoms: Nasal disorder
Clinical narrative: I TOOK A FLU MIST VACCINE IN COLLEGE AND IT RUINED MY LIFE, WHAT IS IT DOING TO MY NOSE, SO I CAN REVERSE IT?; I took a flu Mist vaccine in college and it ruined my life you. What is it doing to my nose, so I can reverse it?; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown), via nasal route, on an unknown date.     A Unknown administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced i took a flu mist vaccine in college and it ruined my life, what is it doing to my nose, so i can reverse it (preferred term: Nasal disorder).     At the time of reporting, action taken with Flumist Quadrivalent was not applicable.    The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect