chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Abasia, Diplegia, Nuclear magnetic resonance imaging
Clinical narrative: This medically confirmed, Health Authority report (initial receipt 21-Aug-2013) involves a patient (no patient identifiers reported). On an unreported date, the patient received AFLURIA (batch number: 073492211A, batch number provided not for AFLURIA). On an unreported date, the patient developed paralysis of both legs resulting in inability to walk/abasia. The patient received an nuclear magnetic resonance imaging (MRI) and was treated with steroids. The patient was discharged from hospital on 11-Jan-2013. The patient continued to receive ongoing therapy. Outcome for the events was not yet recovered (the patient still cannot walk).
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pyrexia
Clinical narrative: Pt received FLUZONE at 1:45 on 9-17-13. Pt began running fever and coughing evening of 9-20-13. Pt had TESSALON and Ibuprofen on hand and took those over weekend. Reported to pharmacy on 9-23-13.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, female patient. The relevant history and concomitant drugs of patient were not reported. The patient has been receiving nasal FLUMIST. FLUMIST started on 07-Nov-2012. The Health Professional reported that the patient has Influenza A virus infection which started on 16-Jan-2013 after administration of FLUMIST by the nurse. She was treated with TAMIFLU. The nurse commented that the lot for this patient's FLUMIST vaccination did not seem right. The patient recovered from the event of tested positive for Flu A on an unspecified date. The reporter considered the event of tested positive for Flu A to be non-serious. Summary of follow-up information received on 11-Feb-2013: reporter last name was added, new lot number and expiration date was added.
Age: 1.37
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Small urticarial rash on forehead and back of neck. No angioedema, airway compromise or rash anywhere else. Recommended topical BENADRYL to help decrease itching. Reviewed signs of respiratory distress or anaphylaxis like sx and when to go to ER.
Age: 1.23
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Autism, Eye colour change
Clinical narrative: After receiving this vaccination - my son stopped speaking completely. He began showing signs of autism after that and was diagnosed with autism 3 months later. Eyes changed color to full blue from crystal blue. Speaks in full sentences but I refused anti psychotics and anti depressants at 3 years old and was made to look insane because of this.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Mild erythema around injection site and severe progression muscle pain around the site. This pain increased for 2 days then gradually decreased over 2 days. NSAIDs were used during this time. The pain was completely incapacitating.
Age: 21.0
Sex: M
Vaccine: IPV
Symptoms: Catatonia, Drug screen negative, Electroencephalogram normal, Full blood count normal, Incoherent
Clinical narrative: Catatonia-like symptoms - started approximately 2 d post vacc. - incoherent speech.
Age: 21.0
Sex: M
Vaccine: IPV
Symptoms: Lumbar puncture normal, Metabolic function test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Catatonia-like symptoms - started approximately 2 d post vacc. - incoherent speech.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: Pt called pharmacy on Thursday 9/19/2013 at approximately 6:15pm to complain of severe headache and nausea and denied vomiting. Pt later went to ER that night as advised by pharmacist. Pt said Flu shot gave her the flu - was later advised at ER she did not have the flu.
Age: 66.0
Sex: U
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea after 1st dose.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Pyrexia, Tremor
Clinical narrative: Chills, shaking, low grade fever. Coughing--onset 9/17/13.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Worsening redness, swelling, warmth, pain at site of injection, right deltoid.  Intermittent numbness to right hand/fingers.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Large red welt size of 50 cent piece at the injection site (left upper arm) very tender. Next day welt became rectangular 2 1/2 x 3 1/2 in size --took 400 mg ibuprofen to try and reduce swelling also took Benadryl.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Insomnia, Malaise, Pain
Clinical narrative: Site soreness, fever, chills, pain, malaise, insomnia.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Site soreness, fever, chills, pain, malaise, insomnia.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient had swelling, redness at injection site, itching of left arm only.  Swelling of arm can be attributed to previous removal of lymph nodes in same arm.  Patient forgot to tell Pharmacist prior to time of injection.  As of 9/18/13, patient has no redness or itching and swelling was minimal.  Patient refused seeing MD to confirm diagnosis.  No fever was noted by patient at any time.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Rapid heart rate.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: PAIN REDNESS, AND SWELLING OF RIGHT ARM.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Coordination abnormal, Muscle fatigue, Muscle rigidity, Muscle tightness, Myalgia
Clinical narrative: Symptoms began with tingling to both shoulders and arms with decreased sensation to both, several hours later after initial onset both legs had decreased sensation and tingling and muscle rigidity began with tightening of the jaw muscles first then moved downward with rigidity to arms and legs with feelings of uncoordination. The following day there were still residual intermittent tingling sensation to all extremities and muscle fatigue, rigidity had lessened.  To this date there is still residual muscle fatigue with random tingling sensations and muscle pain the pain being mostly in the both legs. Employee Health contacted on Friday morning 9/20/2013 to report event.  Primary Care Physician notified Monday 9/22/2013.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Sensory disturbance
Clinical narrative: Symptoms began with tingling to both shoulders and arms with decreased sensation to both, several hours later after initial onset both legs had decreased sensation and tingling and muscle rigidity began with tightening of the jaw muscles first then moved downward with rigidity to arms and legs with feelings of uncoordination. The following day there were still residual intermittent tingling sensation to all extremities and muscle fatigue, rigidity had lessened.  To this date there is still residual muscle fatigue with random tingling sensations and muscle pain the pain being mostly in the both legs. Employee Health contacted on Friday morning 9/20/2013 to report event.  Primary Care Physician notified Monday 9/22/2013.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Syncope
Clinical narrative: Pt reaction was 2 hours post vaccination. She fainted. Couldn't breathe. Had to be on an inhaler and HD prednisone. Pt was doing better the next day. Pt received FLUZONE HD 49281-0393-65 lot U4717AA exp 04/04/2014.
Age: 48.0
Sex: F
Vaccine: DTAP
Symptoms: Aortic aneurysm, Asthma, Biopsy skin, Blood test, Diarrhoea
Clinical narrative: EXTREME fatigue, nausea, vomiting, abdominal pain, diarrhea, diaphoresis, fever from 5/25 - 5/26; then developed severe itching, skin eruptions, scabs and scarring diagnosed as eczema. Oral and topical steroids (multiple courses) antihistimines, other topical ointments/sprays, occasional asthma (new onset requiring inhalers), blood work, skin biopsy, avoidance of dairy, soy, and peanuts. Was advised never to receive DTaP again. This vaccine was given as part of my pre-employment physical and is required for me to work in the neonatal intensive care unit.
Age: 48.0
Sex: F
Vaccine: DTAP
Symptoms: Eczema, Fatigue, Hyperhidrosis, Nausea, Pruritus
Clinical narrative: EXTREME fatigue, nausea, vomiting, abdominal pain, diarrhea, diaphoresis, fever from 5/25 - 5/26; then developed severe itching, skin eruptions, scabs and scarring diagnosed as eczema. Oral and topical steroids (multiple courses) antihistimines, other topical ointments/sprays, occasional asthma (new onset requiring inhalers), blood work, skin biopsy, avoidance of dairy, soy, and peanuts. Was advised never to receive DTaP again. This vaccine was given as part of my pre-employment physical and is required for me to work in the neonatal intensive care unit.
Age: 48.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Rash, Scab, Scar, Vomiting
Clinical narrative: EXTREME fatigue, nausea, vomiting, abdominal pain, diarrhea, diaphoresis, fever from 5/25 - 5/26; then developed severe itching, skin eruptions, scabs and scarring diagnosed as eczema. Oral and topical steroids (multiple courses) antihistimines, other topical ointments/sprays, occasional asthma (new onset requiring inhalers), blood work, skin biopsy, avoidance of dairy, soy, and peanuts. Was advised never to receive DTaP again. This vaccine was given as part of my pre-employment physical and is required for me to work in the neonatal intensive care unit.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, tired, sore throat.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest X-ray normal, Cough, Dizziness, Headache
Clinical narrative: High fever sudden onset extreme weakness dizziness headache cough still fever 103.7 Monday after urgent care Sunday states RXN to shot.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Pyrexia
Clinical narrative: High fever sudden onset extreme weakness dizziness headache cough still fever 103.7 Monday after urgent care Sunday states RXN to shot.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Erythema, Local swelling, Skin warm
Clinical narrative: Swollen, uncomfortable, red, warm @ 3in X 2in area.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, uncomfortable, red, warm @ 3in X 2in area.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, pain and heat at injection site.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: Sore arm, next day very sore and rash.  Also total body ache.
Age: 60.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: Fever, excruciating pain radiating from jaw, through shoulder, down arm, right side.  Tried aspirin.  Every time I moved, I ended up involuntarily screaming out in pain.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Mom noticed some red spots on left thigh that seem tender.  These are new.  no associated fever. Had Prevnar and varicella in that thigh 10 days ago.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Pt had already received MMR # 2 and Varicella #2 in 8/6/13. The immunizations were not in NVSIIS.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Localized papular rash to bilateral thighs. No treatment.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash, Swelling, Visual acuity reduced
Clinical narrative: Between 9/20-9/21 - patient developed unilateral rash on right back radiating/spread to armpit and chest. He has decreased vision in R eye. He has pain, swelling, redness at rash. He is following up with family doctor today 9/23/13.
Age: 47.0
Sex: F
Vaccine: FLUN4
Symptoms: Balance disorder, Dizziness, Paraesthesia, Respiratory tract congestion
Clinical narrative: Patient had vaccine 29 Aug 13, 4 days later she contacted (MD) to report a reaction. Patient reported being off balance for 2 days, lightheadedness, some congestion, and a feeling of being sunburned on her left side of her face. Patient reported all signs disappeared 2 days after the vaccination (31 Aug 13).
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a licensed practical nurse concerning a 20 year old female patient. On 29-JUL-2013, the patient was vaccinated with the third dose of, 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly while the patient was approximately 21 weeks pregnant at the time of report. No concomitant therapy was reported. No adverse effects were reported. No treatment was given. The patient did not seek any medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients. On unknown dates the patients were vaccinated with dose of RECOMBIVAX HB (lot #, expiration date and dose unspecified) that were exposed to 8/5 degree centigrade to 12 degree centigrade for 158.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients. On unknown dates the patients were  vaccinated with doses of VAQTA (lot #, expiration date and dose unspecified) that were exposed to 8.5 degree centigrade to 12 degree centigrade for 158.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients. On unknown dates the patients were vaccinated with doses of ROTATEQ, injection, (lot #, expiration date and dose unspecified) that were exposed to 8.5 degree centigrade to 12 degree centigrade for 158.5 hours which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports from same source. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site swelling, Injection site warmth, Local swelling, Respiratory tract congestion
Clinical narrative: Received flu vaccine approximately 845. My arm began to feel heavy. Within a few hours I developed a headache. The next day arm swollen from elbow up to neck on side vaccine administered. Congestion, warmth at site continue swelling decreasing.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of heaviness
Clinical narrative: Received flu vaccine approximately 845. My arm began to feel heavy. Within a few hours I developed a headache. The next day arm swollen from elbow up to neck on side vaccine administered. Congestion, warmth at site continue swelling decreasing.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX23, (lot #, expiration date and dose unspecified) that were exposed to 8.5 degree centigrade to 12 degree centigrade for 158.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 2 month old patient of unknown gender. On 17-SEP-2013, the patient ws vaccinated with a dose of PNEUMOVAX23 (lot#, expiry not reported) instead of PREVNAR. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. It was reported that the patient received two doses of ZOSTAVAX, 19400 PFU 0.65 ml, subcutaneous. One dose of ZOSTAVAX was administered on an unspecified date "last week" (unknown date in 2013). The date of vaccination with the other dose was not provided. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other licensed practical nurse refers to a patient of unknown age. On 13-SEP-2013 the patient was in the office for vaccination with GARDASIL dose 2 (dose and route not provided). It was reported that the first dose of GARDASIL was administered over a year ago, on an unspecified date. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 23-OCT-2008 the patient was vaccinated with the first dose of GARDASIL dose, route, lot number and expiration date not reported). The nurse stated that at the time of the report on 19-SEP-2013 (also reported as now) the patient was in the office to receive dose 2 of GARDASIL (route, dose, lot number and expiration date not provided) which would be late. No symptoms were reported. The patient's outcome was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Injection site nodule, Injection site swelling, Pyrexia
Clinical narrative: (R) arm swollen from chicken pox vaccine injection site down to elbow. Knot (quarter size) noted to chicken pox injection site. Fever of 102 started this am.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date the patient missed a dose of PNEUMOVAX23 lot # not specified, because 5 dose vial was under filled. No adverse effect was reported. The patient's outcome was unknown. Product Quality Complaint (PQC) was filled. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to female patient who in her seventies with no known allergies. The patient's medical history included shingles. On 13-SEP-2013 the patient ws vaccinated with ZOSTAVAX vial 0.65 ml once, subcutaneously. The patient was feeling "tingling" at an unspecified time on 13-SEP-2013 and reported an outbreak of shingles on 14-SEP-2013. The patient contacted unspecified physician and also contacted pharmacy about outbreak. The patient was prescribed valacyclovir and Zovirax cream which started on 14-SEP-2013. None lab diagnostics studies performed. When patient had shingles prior, acyclovir was prescribed. Pharmacist stated patient was "doing better since she's received treatment". Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site nodule, Milia, Pyrexia, Rash erythematous
Clinical narrative: Pt was vaccinated on 8/26/13 on 8/28/13 pt mother called health dept stating pt was running fever and small nodule and redness noted where DTap was given. Instructed mom symptoms normal to administer fever reducer and apply cold pack to injection site. 8-30-13 mother called and stated child still has fever and now has a generalized rash. States it is red with small whiteheads, appears measle like. Informed mom to call PCP and make appt. Since child has had such a hard time. Rash could be normal as described or VIS.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Pt was vaccinated on 8/26/13 on 8/28/13 pt mother called health dept stating pt was running fever and small nodule and redness noted where DTap was given. Instructed mom symptoms normal to administer fever reducer and apply cold pack to injection site. 8-30-13 mother called and stated child still has fever and now has a generalized rash. States it is red with small whiteheads, appears measle like. Informed mom to call PCP and make appt. Since child has had such a hard time. Rash could be normal as described or VIS.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Eye pruritus, Lacrimation increased
Clinical narrative: This spontaneous report was received from a female registered pharmacist who is the patient. The patient's medical history included chickenpox as a child. The patient, who was not wearing gloves while disposing a vial of ZOSTAVAX had right eye exposure to reconstituted ZOSTAVAX by rubbing her eye with her hand. She did not irrigate the eye at the time of the exposure. The pharmacist stated the right eye 'was a little itchy and watery'. No treatment was provided for the event. Laboratory diagnostic studies were not performed for the events. The patient did not seek medical attention. The events did not resolve at the time of this report. Causality was not reported for the events. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Fall, Gaze palsy, Tremor, Urinary incontinence
Clinical narrative: 5 mins after the injections were given child was notice by medical assistant falling off table; eyes rolled; shaking; became incontinence of urine. Child transported to hospital by ambulance.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 16-SEP-2013 (reproted as yesterday), the patient was vaccinated with a dose of expired PNEUMOVAX23 (lot # 1418AA, 25-MAY-2013). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients. On unknown dates the patients were vaccinated with doses of M-M-R II, injection, (lot # , expiration date and dose unspecified) that were exposed to 8.5 degree centigrade to 12 degree centigrade for 158.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Borrelia test negative, Epstein-Barr virus test negative, Eye pain, Fatigue, Headache
Clinical narrative: Immediately following vaccine, left leg felt numb and painful. 2 days later developed right leg pain. Developed eye pain and headache. Fatigue. On 8/23/13 developed Bells Palsy.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Nuclear magnetic resonance imaging normal, Pain in extremity, VIIth nerve paralysis
Clinical narrative: Immediately following vaccine, left leg felt numb and painful. 2 days later developed right leg pain. Developed eye pain and headache. Fatigue. On 8/23/13 developed Bells Palsy.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. On an unknown date of unspecified number of patients might have received a dose of PNEUMOVAX23 (Lot#, dose and route not reported). PNEUMOVAX23 was reported to have a temperature excursion on 06-SEP-2013 by the pharmacist and the excursion was not supported. The pharmacist was calling in for recommendations for revaccination for patients who might have been administered the unsupported product. Follow-up information was received from the pharmacist to approximately 7 adult patients of unknown age. The pharmacist stated approximately 7 adult patients were vaccinated improperly stored PNEUMOVAX23. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Approximately 24 hrs after vaccine administration pt's left upper arm became red, edematous, and gender. Temp of 101.8. Pt. returned to healthcare clinic on 9/15/13 placed on antibiotics, steroids, and antihistamine. Follow-up phone call 9/16/13. Pt's arm is improviing.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 19-SEP-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (dose, dose # and route not reported) (Lot # reported as G007814, Exp. Date: 10-AUG-2013). No adverse effects were reported. The outcome and action taken were unknown. No PQC (product quality complaint) involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients. On unknown dates, the patients were vaccinated with doses of GARDASIL, injection (lot #, expiration date and dose unspecified) that were exposed to 8.5 degree centigrade to 12 degree centigrade for 158.5 hours, which was an excursion  that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, MMRV
Symptoms: Injection site erythema, Injection site swelling, Skin infection
Clinical narrative: Vaccines administered on 9/6/13. Patient returned to clinic on 9/8/13 with a skin infection near injection site: redness and swelling on (R) inner thigh.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Oral herpes, Pyrexia, Viral infection
Clinical narrative: Viral illness with fever began on 9/11/13 (2 days after vaccine). Pt later developed herpetic stomatitis.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: About 4 or 5 hours after injections arm became swollen, red and painful. Arm was a little warm. Pt went to see MD 9/23/13 AM. MD said not infected.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: Patients entire arm was in pain, with numbness and tingling down the arm. Painful to touch or move and keeping the patient up at night. Patient is taking OTC pain relievers, which are not helping. Patient is going to see a doctor today. This is in right arm only.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Paraesthesia
Clinical narrative: Patients entire arm was in pain, with numbness and tingling down the arm. Painful to touch or move and keeping the patient up at night. Patient is taking OTC pain relievers, which are not helping. Patient is going to see a doctor today. This is in right arm only.
Age: 46.0
Sex: F
Vaccine: FLUX, MEN, PPV
Symptoms: Axillary pain, Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: Pain, swelling to Lt arm, unable to lift arm. Also pain/swelling under arm.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Syncope
Clinical narrative: Pt fainted a few minutes after receiving shot then said arm hurt.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Stridor, Vomiting, Vomiting projectile
Clinical narrative: Vomiting, stridor onset - 6 hours after vaccination. Projectile x 4. Perioral rash. Resolved after ER visit given albuterol md. at home, ZOFRAN in ER.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness / swelling from elbow to shoulder on arm receiving PNEUMOVAX injection.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness / swelling from elbow to shoulder on arm receiving PNEUMOVAX injection.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Laboratory test abnormal
Clinical narrative: Redness / swelling from elbow to shoulder on arm receiving PNEUMOVAX injection.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: 8:50 AM Flu shot given (R) arm. 12:15 P rash noted to neck and chest - sl. red maculopapular fine rash to neck and torso - arms and legs without rash. 12:45 P seen at health clinic.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Pt woke up next am with diffuse hives and swelling of eyes and cheeks. Seen at walk-in, given prednisone taper. F/up at our office 9/16 with no improvement in hives - covering arms, legs, trunk, back and feet. No improvement in itching. Continue prednisone SINGULAIR, add TAGAMET.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Rash macular
Clinical narrative: Patient received FLUZONE Intradermal vaccine on 9/10/13 at 11am. On evening of 9/11/13 patient starting getting symptoms of swollen lips and macular rash. On 9/12/13 MD prescribed Prednisone. Later that evening symptoms started to get better.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity
Clinical narrative: There is a pinching sensation in the right arm about 2-3 inches below the shoulder.  She can not reach all the way up and extending the arm out can cause stiffness and pain.  She reports having a sore muscle the first day and then the pinching pain since then.  She has not sought the care of a physician but has tried ibuprofen, aspirin, cream, heat patches and a brace.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance
Clinical narrative: There is a pinching sensation in the right arm about 2-3 inches below the shoulder.  She can not reach all the way up and extending the arm out can cause stiffness and pain.  She reports having a sore muscle the first day and then the pinching pain since then.  She has not sought the care of a physician but has tried ibuprofen, aspirin, cream, heat patches and a brace.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site exfoliation, Vaccination site rash
Clinical narrative: Redness, itching rash at vaccination site.  Itch went away after 1.5 weeks. Red spot drying up and flaking after aprox 3 weeks.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Rash and hives.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Vaccine 09/12/13. 9/13/13 noted 2 inch area of erythema and color. 9/14/13 with 10cm x 6cm hot red area. Required 80mg DEPO-MEDROL and prednisone taper as well as antihistamine treatment.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Grand mal convulsion, Impaired driving ability, Mobility decreased, Nasopharyngitis
Clinical narrative: Within 4 hours I had extreme tiredness, cold like symptoms (congestion, runny nose, acheness).  The symptoms stayed for over 5 weeks, getting out of bed only for food, etc.  A few days after getting up, on 3/10/2013, I had a Grand Mal seizure.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Nervous system disorder, Pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Within 4 hours I had extreme tiredness, cold like symptoms (congestion, runny nose, acheness).  The symptoms stayed for over 5 weeks, getting out of bed only for food, etc.  A few days after getting up, on 3/10/2013, I had a Grand Mal seizure.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender (no demographic details were provided). The medical history of the patients was unknown. On an unknown date, the patients received LIQUID PEDVAXHIB, intramuscular that was exposed to 31F for four hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender (no demographic details were provided). The medical history of the patients was unknown. On an unknown date, the patients received GARDASIL, intramuscular that was exposed to 31F for four hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a clinical medical assistant who refers to a patient of unknown age and gender. On 09-SEP-2013 the patient received less than the recommended first dose of GARDASIL (route not reported, lot number reported as J006879, exp. 04-DEC-2015) due to leaking GARDASIL prefilled syringe. No adverse effect reported. POC has been already involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling
Clinical narrative: Patient's arm swelled up a lot. She went to urgent care where they started her on BENADRYL. According to patient, they did not think it was an allergic response, but rather a possible punctured blood vessel. She states she has gotten pneumonia vaccine in the past without event. Her arm swelling is going again when I spoke with her 2 days later and she feels good.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, pruritis injection site. Treated with ice and antihistamines.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Swelling
Clinical narrative: All over swelling hands, feet.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash
Clinical narrative: Large raised rash on her arm, approximately 2 inches wide by 3 inches long around injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Malaise, Pain in extremity, Varicella
Clinical narrative: Pt's daughter called pharmacy on 9/10/13 stating pt. had received shingles vaccine on 6/17 13 and arm was still hurting. Stated pt. was sick for 3 weeks after shot and broke out w/ chicken pox. States she can not wash her air in shower b/c can't raise arm. Ask pt. to seek advice from MD. No PCP. So went to ER 9/10.Will call back 9/18. She felt Dr. "wouldn't touch her". She felt he "acted disgusted with her".
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Dysgeusia, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Patient received FLUVIRIN on 9/19/13 at 8PM. Approximately one hour later, patient complained of a bad taste in mouth (metallic) and nausea. At approx. 9:30PM she complained of heaviness/burning/pressure in chest. She had on/off pain starting in the right shoulder and moving to the left shoulder. She left for the hospital at 10:15PM. She took a nitroglycerin tablet while in route but it helped only slightly. She was admitted at 10:45PM. I spoke with patient who was at home, she is doing fine (no symptoms).
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Patient received FLUVIRIN on 9/19/13 at 8PM. Approximately one hour later, patient complained of a bad taste in mouth (metallic) and nausea. At approx. 9:30PM she complained of heaviness/burning/pressure in chest. She had on/off pain starting in the right shoulder and moving to the left shoulder. She left for the hospital at 10:15PM. She took a nitroglycerin tablet while in route but it helped only slightly. She was admitted at 10:45PM. I spoke with patient who was at home, she is doing fine (no symptoms).
Age: 55.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dysgeusia
Clinical narrative: Patient called office after leaving and headed home with complaints of a terrible metallic taste. Metallic taste increased as patient returned home. Drank Sunny Delight and metallic taste was resolved. Patient was given FLUVIRIN Tdap vaccines. No treatment given to patient.
Age: 35.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Fatigue, Pain in extremity, Pruritus generalised
Clinical narrative: R arm erythremia, painful, itching over entire body. Fatigue.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Vaccines received Monday 9/16/13. Child complained of itchiness on 9/17/13, woke with hives all over body on 9/18/13. Seen in clinic.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Left arm red, swollen, tender onset yesterday a few hours after immunization.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Feeling hot, Lacrimation increased, Sensation of foreign body
Clinical narrative: Received vaccine on 09-12-13 around 11:45AM. A couple hours later patient began to experience a "severe lump in throat", she was hot, hoarse, her eyes watered and she reported having troubles breathing. She went home and to bed and reported feeling better in a few hours.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Golf-sized, reddened and warm area noted to injection site. Area tender to touch and with ROM.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Fall, Gait disturbance, Head injury, Wheelchair user
Clinical narrative: 24 hrs. after flu shot - patient had difficulty walking - balance affected as well. He fell cut his head, went to ER and returned - still not walking w/out help - is in wheelchair. Assume this was caused from flu shot.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Trismus
Clinical narrative: Lock jaw reported.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness and swelling on her arm located about 4 in below injection site. Patient stated it was the size of a tennis ball and lasted about 3 days.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Moderate swelling and pain at influenza vaccine injection site.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Contusion, Erythema, Muscular weakness, Pain
Clinical narrative: Swelling, bruising, weakness in limb, muscle weakness, redness, pain, chills.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Swelling, bruising, weakness in limb, muscle weakness, redness, pain, chills.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Blood came from the site of injection. The site became swollen - about the size of a marble. Pt stated no pain.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose, Electrocardiogram, Feeling abnormal
Clinical narrative: Patient returned to site where flu shots being administered saying did not feel right.  Pulse in 130's.  Waves of feeling a little better then bad again.  No respiratory difficulty or skin rash.  Ambulance called when continued to feel poorly.  Pulse rate improved, but ambulance crew recommended patient be checked out; proceeded to nearby Emergency Department.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin reaction, Swelling
Clinical narrative: Single erythematous 12cm x 8 cm slightly raised patch.
Age: 0.83
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Severe hives, still getting hives today.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Complains of rash on both arms and cheeks.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Feeling abnormal, Headache, Somnolence
Clinical narrative: 30 minutes after receiving the vaccine I started with a severe headache, which continued to get worse in the next 24 hours, as well as a sensation of my throat closing up, which lasted for a little over the next 24 hours after injection. I have not felt right since getting the vaccination. Tired and needing to sleep a lot, now having a scratchy throat and cough.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Throat tightness
Clinical narrative: 30 minutes after receiving the vaccine I started with a severe headache, which continued to get worse in the next 24 hours, as well as a sensation of my throat closing up, which lasted for a little over the next 24 hours after injection. I have not felt right since getting the vaccination. Tired and needing to sleep a lot, now having a scratchy throat and cough.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Pyrexia
Clinical narrative: Chills, sweats, 101.9 fever, diarrhea.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram normal, Convulsion, Depressed level of consciousness, General physical health deterioration, Hypertension
Clinical narrative: At approximately 5:45 pm I did not feel well.  Could not say why.  I deteriorated from there and my husband took me to the hospital.  My LOC was greatly diminished and my blood pressure went very high.  No stroke noted.  It was then decided that I had a seizure related to the flu shot.  Saw my neurologist the next day and she agreed it was a seizure and started me on Gabapentin.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test normal, Malaise
Clinical narrative: At approximately 5:45 pm I did not feel well.  Could not say why.  I deteriorated from there and my husband took me to the hospital.  My LOC was greatly diminished and my blood pressure went very high.  No stroke noted.  It was then decided that I had a seizure related to the flu shot.  Saw my neurologist the next day and she agreed it was a seizure and started me on Gabapentin.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching to posterior neck, bilateral axillas, waist, bilateral hips.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Developed redness and itchy spot around the area where she rec'd the vaccination.  She used some anti-itch cream to help.  She felt that it traveled down the arm.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticarial rash on chin, face, trunk in patches; Benadryl 50mg dose every 6 hours as needed for rash recommended.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Initially, localized hives specific to the arm where the injection was given.  This spread in 24 hrs. across the midline to all four extremities and face.  No airway involvement. The hives are pruritic but manageable with Benadryl and an H2 blocker (Pepcid).
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Initially, localized hives specific to the arm where the injection was given.  This spread in 24 hrs. across the midline to all four extremities and face.  No airway involvement. The hives are pruritic but manageable with Benadryl and an H2 blocker (Pepcid).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Malaise, Nausea, Pain
Clinical narrative: Fever, chills, achiness, nausea, malaise, exhaustion.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, chills, achiness, nausea, malaise, exhaustion.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eye swelling, Urticaria
Clinical narrative: Whelps on left arm, left eye was swollen.  1 Benadryl for treatment.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Fatigue, Mobility decreased, Musculoskeletal pain
Clinical narrative: Chills, sore arm at shoulder.  Continued severe pain and could not raise arm at all.  Took Motrin for relief. Very weak and tired.  Should have gone to emergency room at onset.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Aphasia, Asthenia, Hypoaesthesia, Lethargy
Clinical narrative: Couldn't stay awake, couldn't hold my head up, nor talk, nor put words together, was very lethargic, arms and body were not working with me. Couldn't make a sentence or function at all. Took me quite some time to get back home fom my grandsons school. My kids asked what was wrong, they could see I was in bad shape, I went to lay down for a few hrs. before I could even get back up. Felt as if my feet had been cut of and all blood drained out. But was wose than I've had before, but the worst was the inability to function, so to speak.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Posture abnormal, Somnolence, Speech disorder
Clinical narrative: Couldn't stay awake, couldn't hold my head up, nor talk, nor put words together, was very lethargic, arms and body were not working with me. Couldn't make a sentence or function at all. Took me quite some time to get back home fom my grandsons school. My kids asked what was wrong, they could see I was in bad shape, I went to lay down for a few hrs. before I could even get back up. Felt as if my feet had been cut of and all blood drained out. But was wose than I've had before, but the worst was the inability to function, so to speak.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother noticed swelling and redness right deltoid area.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pruritus, Pruritus generalised
Clinical narrative: Prickly itching starting near the injection site and spreading across my body.
Age: 0.34
Sex: M
Vaccine: DTAP, PNC13, RV5
Symptoms: Abdominal pain, Decreased appetite, Gastric disorder, Screaming
Clinical narrative: Symptoms - violent screaming, lack of appetite, intense abdominal pain. Child would barely eat 1/4 of his normal amount of food. Screaming and pain would last anywhere from 20 minutes to over an hour. Child would bring legs to chest and try to curl up into a ball during these times of pain. When admitted into the hospital the doctor there had us put him on nothing but Pedialyte so his stomach could have a break to help things move through. It took 2 days to get him back onto food. We still have stomach issues today that were not there before the vaccine was given.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased
Clinical narrative: Pt showed big red patch 12 x 9 cm wide spreading entire upper arm. Reported to Dr. Dr told pt to report to us: Pt got both shots in same arm: stated other arm could not be used.