chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old patient. On 26-SEP-2013 the patient was vaccinated with M-M-R II (dose not reported, lot# reported as 0599AA, expired date: 26-APR-2013). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pruritus, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date recently, the patient was vaccinated with PNEUMOVAX23, 1 dose in the arm for an unknown indication. It was possible that the lot number was #J007786 Exp. 25-SEP-2015 because the pharmacist only had 1 other injection that was used from this box. The patient's relevant medical history, concomitant medications and past drug history were unknown. On an unknown date in the past week (approximately September 2013) the patient had edema at the injection site, the site swelled to the size of a silver dollar, some itching, and then the whole arm swelled like a balloon. It was unknown if there was any laboratory data. As of 29-SEP-2013 it was unknown if the patient would have another PNEUMOVAX23 injection and the outcome of the edema at the injection site, itching, and the whole arm being swollen were unknown. This pharmacist reports similar events for 4 patients. This was the fourth of 4 reports. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a currently 20 year old non-pregnant female patient. On 28-DEC-1993 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 22-JAN-1994 and the third dose was administered on 11-JUL-1994. The reporter stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Dialysis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 86 year old male patient with high blood pressure. The patient had no drug reactions/allergies 3 or 4 years ago, in approximately September 2010, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not provided). Concomitant therapies included nifedipine (manufacturer unknown) and metoprolol (manufacturer unknown). The pharmacist reported that a patient was on dialysis after receiving a dose of ZOSTAVAX. The pharmacist did not know when the patient was placed on dialysis or why the patient needed the dialysis. It was unknown if the patient was on dialysis when the ZOSTAVAX was administered 3 or 4 years ago or if the patient's condition changed after the administration of the ZOSTAVAX. This outcome of dialysis was unknown. The relationship between ZOSTAVAX and dialysis was not reported. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Vaccine given 9/25/13. Woke up 9/26/13 with swollen tender lymph node in right axilla. Today swelling has gone away. Still mildly tender.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No medical history or drug reactions were reported. On 25-SEP-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously as it was recommended by 3 physicians. On 26-SEP-2013, the patient experienced injection site redness, warmth, swelling and itchiness. The redness and itchiness had spread. Laboratory diagnostics studies performed were none. Patient sought medical attention: patient visited the pharmacist. The outcome of injection site redness, warmth, swelling and itchiness was reported as not recovered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female with no reproted medical history. On 22-SEP-2013 the patient was vaccinated with ZOSTAVAX dose 1 (date, route, dose and lot number unknown). No other suspect therapy or concomitant medication was reported. On 24-SEP-2013, 3 days after onset of therapy the patient developed redness and warmth at the injection site following the administration of ZOSTAVAX. The pharmacist mentioned that the area of redness was approximately 3 inches in diameter. No treatment information was reported. The outcome of redness (area was approximately 3 inches in diameter) at the injection site and warmth at the injection site following the administration of ZOSTAVAX was reported as not recovered/not resolved. The reporters relatedness of redness (area was approximately 3 inches in diameter) at the injection site and warmth at the injection site to ZOSTAVAX is unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 2 month old (at the time of second vaccination) and currently 18 years old non-pregnant female patient. On 15-NOV-1994 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 10-OCT-1995 and the third dose was administered on 31-AUG-1995. The reported stated that on an unknown date a titer for Hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of Hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site rash, Paraesthesia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with penicillin allergy. On 16-SEP-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot #J002869, expiry date 14-JUN-2013, subcutaneous). On 17-SEP-2013, the patient developed flat rash at the injection site and on the patients abdomen and left side and the patient stated that immediately after vaccination she noticed a tingling in her throat. There was no treatment rendered of the events. The outcome of the reported events were reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 0.84
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to currently a 7 year old non-pregnant female child. On 01-AUG-2006 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 05-SEP-2006 and the third dose was administered on 07-FEB-2007. The reported stated that on an unknown date a titer for Hepatitis B were drawn and the titer resulted negative. The outcome of Hepatitis B titer negative was unknown. No treatment was given for adverse event. This is one of 10 reports from the same source. Additional information has been requested.
Age: 0.9
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a 3 months old (at the time of second vaccination) and currently 5 year old male patient. On 20-MAY-2008 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 31-JUL-2008 and the third dose was administered on 13-MAR-2009. The reported stated that on an unknown date a titer for Hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of Hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
Age: 0.74
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 8 month old (at the time of third vaccination) and currently a 16 year old male patient. On 15-MAR-1997 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 17-APR-1997 and the third dose was administered on 09-DEC-1997. The reported stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. The reporter stated that on unknown date the patient was tested positive for hepatitis B. No treatment was given for adverse event. The outcome of hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: PNC
Symptoms: Chest X-ray abnormal, Drooling, Fear, Febrile convulsion, Tremor
Clinical narrative: She could move, her ayes were big (scared) she was shaking and drooling, was very heavy...(fever seizure) they said at the hospital. Doctor at ER said that it looked like a reaction to the PC vaccine. HIB serial number: UIT627AB  U9281-545-05 PC PREVNAR wyeth: G131939.
Age: 1.25
Sex: F
Vaccine: PNC
Symptoms: Vaccination complication
Clinical narrative: She could move, her ayes were big (scared) she was shaking and drooling, was very heavy...(fever seizure) they said at the hospital. Doctor at ER said that it looked like a reaction to the PC vaccine. HIB serial number: UIT627AB  U9281-545-05 PC PREVNAR wyeth: G131939.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II injection (dose, route and lot# unknown). On an unknown date the patient experienced a negative titer test for rubella (titer test for Measles and Mumps was acceptable). The patient had sought medical attention via office visit. The outcome and action taken were not provided. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray, Cough, Dysphonia, Laryngoscopy
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 68 year old male patient with medical history of atherosclerosis of aorta and colon cancer. Drug reactions/allergies were denied. On 14-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot were not reported). Concomitant therapies included aspirin, reported as 'baby aspirin". In March 2013, the patient experienced throat hoarseness and cough. On an unknown date, the patient sought medical attention. Treatment with omeprazole (manufacturer unknown), prednisone (manufacturer unknown) and unspecified inhalers was given. On an unknown date, lab diagnostics spirometry, chest x-ray and laryngoscopy were performed to the patient, no results given in this report. At the time of the report, the outcome of throat hoarseness and cough was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a unknown number of patients (gender and age unknown). On an unknown date, the patients were vaccinated with M-M-R II injection. It was reported that on unknown date, the patients may have been vaccinated with M-M-R II stored as high as 50F for up to 19 hours. No adverse effect reported. Additional information has been requested. This is one of several reports from the same source.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Eye swelling, Lip swelling, Swelling face
Clinical narrative: Heavy chest, cough, eye swelling, facial and lip swelling at 1930. Worse during night so put ice to face and took BENADRYL at 2130 and again 12A and 0630. Treatment in ER IV Rx Famotidine 20 mg, BENADRYL 25 mg, Dexamethasone 10 mg, Epinephrine SQ 0.3 mg.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Heavy chest, cough, eye swelling, facial and lip swelling at 1930. Worse during night so put ice to face and took BENADRYL at 2130 and again 12A and 0630. Treatment in ER IV Rx Famotidine 20 mg, BENADRYL 25 mg, Dexamethasone 10 mg, Epinephrine SQ 0.3 mg.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Within 12 hrs site appeared red/raised and sore, 1'st day after rec'd site appeared with lg red welt, about 3-4 cm diameter, and red and hardened and sore. Very hot to touch; more to 4 cm size. 3'rd day remained with lg. welt and hard. 4th day just red and softer. Took ADVIL from 2nd day on (06 hrs) (600 mg) applied hydrocortisone and cold compress to site PRN. Also ran low grade fever approximately 100.2 first 2 days.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Within 12 hrs site appeared red/raised and sore, 1'st day after rec'd site appeared with lg red welt, about 3-4 cm diameter, and red and hardened and sore. Very hot to touch; more to 4 cm size. 3'rd day remained with lg. welt and hard. 4th day just red and softer. Took ADVIL from 2nd day on (06 hrs) (600 mg) applied hydrocortisone and cold compress to site PRN. Also ran low grade fever approximately 100.2 first 2 days.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: Menorrhagia, Menstruation irregular, Smear vagina, Vaginitis bacterial
Clinical narrative: This spontaneous report as received from a 29 year old female patient, refers to herself. On an unknown date in September 2011, the patient was vaccinated with the dose of ZOSTAVAX (route of administration, dose and lot number were not provided) for birth control (off label use). Concomitant therapies included metronidazole (manufacturer unknown). In S2011 the patient experienced product: ZOSTAVAX/therapy reason for use: birth control. The patient stated that she had been having irregular periods since January 2013, continuously with no break. The patient had visited her physician and was diagnosed with bacterial vaginosis (BV) due to the heavy bleeding. The patient was treated for the event (unspecified treatment). Lab diagnostics studies were performed and included vagina smear (reported as Papsmear) (results not provided). The outcome of events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling at site no warmth at site several hrs after inject. No itch. No systemic s/s.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to an unspecified number of college students of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unknown dates the patient were vaccinated with the first dose of GARDASIL. Information on dose, route and lot number was not provided. No concomitant medications were reported. The nurse reported that the patients were behind schedule with receiving either their second or third doses of GARDASIL and their remaining doses of an unspecified hepatitis B vaccine (manufacturer unknown) due to being away at college. No adverse symptoms reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site erythema, Injection site warmth, Nausea, Pruritus
Clinical narrative: 9 x 5 cm red warm area on (R) upper arm. Nausea, vomiting, low grade fever, pulse 96. Itching to (R) arm, diarrhea.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: 9 x 5 cm red warm area on (R) upper arm. Nausea, vomiting, low grade fever, pulse 96. Itching to (R) arm, diarrhea.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Induration; heat; pain; pruritis, redness>3 inch diameter; swelling of approx 2 cm height at injection site; headache, itching throughout body; itchy throat, eyes, nose, sneezing, body aches - all within an hour of admin of vaccination.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site warmth, Nasal discomfort, Pain, Pruritus generalised
Clinical narrative: Induration; heat; pain; pruritis, redness>3 inch diameter; swelling of approx 2 cm height at injection site; headache, itching throughout body; itchy throat, eyes, nose, sneezing, body aches - all within an hour of admin of vaccination.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing, Throat irritation
Clinical narrative: Induration; heat; pain; pruritis, redness>3 inch diameter; swelling of approx 2 cm height at injection site; headache, itching throughout body; itchy throat, eyes, nose, sneezing, body aches - all within an hour of admin of vaccination.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Axillary pain, Local swelling, Lymphadenopathy, Pyrexia, Urticaria
Clinical narrative: Swelling & soreness under armpit; fever 102.0*; welts & swelling on upper arm.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia, Urticaria
Clinical narrative: Swelling & soreness under armpit; fever 102.0*; welts & swelling on upper arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: On 10/1/13, she received a flu shot in the Wellness Center at work at 9:45 AM and went back to work. She did not feel well but didn't return to the Wellness Center because she had a subsequent doctor's appointment at 1:30 PM. When she got to the doctor's office she had chills, shivering, body aches, fever 104 F. Her doctor gave her epinephrine and benedryl and sent her home, telling her if she felt worse, go to the hospital.  At home she felt worse and was admitted to the hospital. She called me at the Wellness Center at 9 AM this morning, 10/2/13, to tell me all the above.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye irritation, Influenza like illness, Pain
Clinical narrative: Started having flu like sys. aches, chills burning eyes.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Fatigue, Pain
Clinical narrative: Low grade temperature; body aches, severe at times; tiredness.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye pain, Eye pruritus, Swollen tongue, Throat tightness
Clinical narrative: Tongue started swelling, persistent coughing, throat tightening, eyes started itching/hurting.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Injection site erythema, Injection site pain, Pain
Clinical narrative: CHILLS, ACHING ALL OVER, REDNESS AND PAIN AT SITE OF INJECTION BEGAN DAY AFTER RECEIVING VACCINE.  DIARRHEA STARTED 3 DAYS AFTER, LASTED 1-2 DAYS.  SAW MD 9/25/13, ADVISED PROBABLE REACTION, AND SHOULD FILE VAERS.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: CHILLS, ACHING ALL OVER, REDNESS AND PAIN AT SITE OF INJECTION BEGAN DAY AFTER RECEIVING VACCINE.  DIARRHEA STARTED 3 DAYS AFTER, LASTED 1-2 DAYS.  SAW MD 9/25/13, ADVISED PROBABLE REACTION, AND SHOULD FILE VAERS.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Developed small red spots somewhat itchy rash on wrists, ankles, and back.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Headache, Injection site pain, Mobility decreased
Clinical narrative: Woke up with total body weakness, muscle aches and pain, dizziness, headache and excruciating pain in my left elbow, left forearm and left hand. Unable to hold my head up and get out of bed. I called my doctor and he told me that I may be developing antibodies to the flu vaccine and that I'm experiencing a immune response to the vaccine and that I will get better in time.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Woke up with total body weakness, muscle aches and pain, dizziness, headache and excruciating pain in my left elbow, left forearm and left hand. Unable to hold my head up and get out of bed. I called my doctor and he told me that I may be developing antibodies to the flu vaccine and that I'm experiencing a immune response to the vaccine and that I will get better in time.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via company representative refers to two patients of unknown age. On an unknown date in 2012 (reported as a year ago), the patient was vaccinated with 0.65 ml ZOSTAVAX (lot number, expiry date was unknown), subcutaneous. On an unknown date, the patients presented with unspecified rash that could have been shingles of HSB. The outcome of rash that could have been shingles or HSB was reported as recovered. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 9 months old (at the time of third vaccination) and currently 18 years old non-pregnant female patient. On 26-JAN-1995 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 02-MAR-1995 and the third dose was administered on 28-SEP-1995. The reported stated that on an unknown date a titer for Hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of Hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous stomatitis
Clinical narrative: This spontaneous report as received from a 85 year old female consumer refers to herself with underactive thyroid, arthritis and allergy to penicillin (rash). The patient's medical history included frequent canker sores. On an unknown date in February 2008 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route not reported) for shingles vaccination. Concomitant therapies included meloxicam and TOPROL. The patient suffered from frequent canker sores before she received ZOSTAVAX. After she received ZOSTAVAX her canker sores temporarily went away but the patient developed her first one since the vaccine in September 2013. No lab diagnostics studies performed. Unspecified medical attention was given for treatment. The patient sought medical attention via spoke with unspecified physician. The outcome of the event was reported as not recovered. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Tachycardia
Clinical narrative: Presented to ER for acute onset shortness of breath and tachycardia 5 hrs. Post injection.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Eye discharge, Fatigue, Muscle tightness
Clinical narrative: Nausea, fatigue, muscle pain/tightness, diarrhea, milky ocular discharge, and dizziness. This was the 1st time to take the flu shot.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea
Clinical narrative: Nausea, fatigue, muscle pain/tightness, diarrhea, milky ocular discharge, and dizziness. This was the 1st time to take the flu shot.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site nodule, Injection site warmth
Clinical narrative: Pt. has large hematoma noted to left upper arm (deltoid region) extending up almost to shoulder and down as far as elbow on underside of arm. Pt. reports bruising began after flu vaccine was given and after he experienced a "knot" at injection site and redness. Deltoid is warm to touch. Pt. denies further difficulty and has full rom with arm.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Headache
Clinical narrative: States experienced intense headaches since time of vaccination.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Nausea
Clinical narrative: Trouble breathing through nose and mouth, went to get inhaler got dizzy and felt nauseous.  Used inhaler, nose spray, breathed in paper bag and sat for a while and felt better about 1-2 hours later.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 3-4 inch red, itchy area around injection site.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Chills, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever and chills, hand and finger cramping.
Age: 67.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, pain and warmth to right deltoid area.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Mild low grade fever, no palpable induration or tenderness.  Warmth and redness over upper legs and thighs. Erythematous circular pattern of skin change bilaterally. Mild cellulitic change.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Mild low grade fever, no palpable induration or tenderness. Warmth and redness over upper legs and thighs. Erythematous circular pattern of skin change bilaterally. Mild cellulitic change.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Oedema mouth, Paraesthesia
Clinical narrative: Slight swelling of one side of mouth. Tingle and burning sensation.
Age: 26.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Extreme chills lasting for hours followed by severe sweating; entire event lasted 10 hours.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea, extreme fatigue for about 18 hours.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness, hard area, and heat to the area where immunization was given.  Cellulitis.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: Pain, swelling, redness, hard area, and heat to the area where immunization was given.  Cellulitis.
Age: 1.01
Sex: M
Vaccine: IPV
Symptoms: Mass, Nasal congestion, Neck mass, Rash, Urticaria
Clinical narrative: Stuffy nose, moving rash/hives, large lump on side of neck.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Golf ball size welt at the injection site.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema at injection site greater than 5 cm. The area was about 4 inches in diameter, red, and warm on 10/2/2013.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dysgeusia, Dyspnoea, Headache, Malaise
Clinical narrative: Massive headache, night sweating, body aches, shortness of breath, odd taste in mouth, body weakness. Malaise and fever.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: Massive headache, night sweating, body aches, shortness of breath, odd taste in mouth, body weakness. Malaise and fever.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Hyperhidrosis, Loss of consciousness, Muscle spasms, Muscular weakness
Clinical narrative: My inner thigh had a horrible cramping that hurt so badly I passed out for over 5 hours and was completely soaked in sweat upon awakening in my living room floor. My thigh today 10/02 is still very sore to the touch and feels as if it will start cramping if I exert the muscle too much. If I had not been home alone I would have gone to the emergency room for help but I was afraid to drive myself and did not feel an EMS needed to be called. Muscle weakness in that leg has me limping today.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Lymph gland swollen (size and shape of chicken egg) under left arm. Same arm as received flu shot. Extremely sore. Took Tylenol for pain. As of this filing, still swollen, not as sore.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Neck pain, Nodule
Clinical narrative: Stiff neck developed same day within 12 hours, knot has come up on neck which is extremely sore.  Have tried cold compresses, hot compresses, and Tylenol, and nothing has affected it.  It is now Wednesday evening and it is still just as sore.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: Hot, nauseous, dizzy, then followed by severe chills for more than 1 hour and a temperature around 100.  Took 2 Advil and went to bed.  Heavy sweating all night.  Aching in morning.  Tired later in the day.  OK by 6:00 PM.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Night sweats, Pain
Clinical narrative: Hot, nauseous, dizzy, then followed by severe chills for more than 1 hour and a temperature around 100.  Took 2 Advil and went to bed.  Heavy sweating all night.  Aching in morning.  Tired later in the day.  OK by 6:00 PM.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Soreness on entire right arm and right leg.  Unsure if coincidental or if sciatic nerve bothering. Not interfering with daily activities but noticeable.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Long red streak, swollen also.  Very tiny itchiness.  Used ice but not till the following day.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave intradermal licensed 18-64 yo, influenza vaccine to a 93 yr old.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pustule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient did not have a pertinent medical history and no drug reactions/allergies. On 14-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # J003806; expiry date: 03-JUL-2014). Concomitant therapies included ZYCLARA ("Pharmacy record showed that 2 months ago the patient was on ZYCLARA"). On 15-SEP-2013, the patient experienced at the injection site red raised area "the size of a half dollar piece". Approximately on 15-SEP-2013 (reported as "late last night or today"), the patient developed 1 small pustule at the injection site. The patient sought medical attention (visit to pharmacist) and was treated with TYLENOL, MOTRIN and cold compress. The outcome of the events was reported as not recovered/not resolved. No reporter causality was provided. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: 9/27/13 influenza, pneumonia vaccines given. 9/29 pt c/o pain (L) deltoid, redness, tender x 1 day. Diagnosis of cellulitis. KEFLEX started. 10/2/13 continues to improve.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with drug reaction/allergy to codeine. On 25-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, dose unknown, lot # reported as J000440, expiry date reported as 11-APR-2014. Concomitant therapies included SYNTHROID and DIOVAN. On 26-SEP-2013 the patient experienced swelling, redness, burning and "feels warm to the touch", around the injection site, after receiving ZOSTAVAX. Pharmacist reported there was no rash. There was no treatment given. The patient sought medical attention by calling pharmacy. The outcome of adverse events was unknown. The relatedness between ZOSTAVAX and adverse events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a nurse refers to a 2 patients age and gender unknown. On 20-SEP-2013, the patients were vaccinated with M-M-R II injection (lot# H017027, expiration date on 14-SEP-2014). It was reported that on 20-SEP-2013, the patients were administered a vaccine that went through an unsupported temperature excursion overnight from 19-SEP-2013 to 20-SEP-2013. Additional information has been requested. This is one of several reports from the same source.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMR, VARCEL
Symptoms: Cough, Flushing, Injection site reaction, Injection site swelling, Nasopharyngitis
Clinical narrative: Right arm swelling, flushed. No c/o infection. KINRIX given (R) deltoid.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMR, VARCEL
Symptoms: Upper respiratory tract infection
Clinical narrative: Right arm swelling, flushed. No c/o infection. KINRIX given (R) deltoid.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site nodule, Injection site pain, Pyrexia
Clinical narrative: Pt had chills, fever, redness at site, painful nodule to area that started the next day. Redness lasted 5 days, all other complaints lasted 1 day.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Right arm redness 12 cm. BENADRYL treatment.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Immediate formation of nickel-sized induration and erythemic rash about size of tennis ball at injection site, induration swelled to about size of quarter within 5 mins. Ice applied. Pt observed for about 15 mins. No systemic reaction observed. Pt returned to work.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Pain, tenderness that migrated to bicep from deltoid. Rash started 2 days later.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Local swelling
Clinical narrative: Pt was given flu shot on Saturday 9/21/13 and when she woke up the next day her left arm was swollen and red. She use ice for the inflammation and has since gone down but still red.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt has redness, swelling and elevated skin temperature at injection site of PNEUMOVAX - (R) deltoid - redness goes from lateral anterior upper arm shoulder to elbow.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Injection site reaction, Joint stiffness
Clinical narrative: Painful arm / lump at injection site within 1-2 hrs. Pain moved to elbow and joint stiffened in approximately 72 hrs. By 5 days, elbow joint locked and pain increased. Pt received IM steroid in office and PO steroid Rx -> improvement w/in hours.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Flu shot given 9-25-13. Pt said arm sore, no redness. Put heating pad on it. 9-26-13 not really red, not a lot of pain. Felt better. Put heating pad on again. 9-27-13 came to pharmacy. Said it felt good not hurt. Arm was red, slightly raised. Little warm. Advised to take BENADRYL. Apply cool compress. 9-28-13 arm not as red but redness looked larger. Not hurt. Advised pt to apply cool compress, take BENADRYL and if no better - go to PCP or urgent care. 9/30 pt says arm is fine.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion
Clinical narrative: 15 second generalized seizure slightly more than 48 hours after vaccine given. No fever. No IH seizure. Witnessed by mother who is RN. Eval at UCC normal. Child normal since event. Born preemie at 30 weeks benign NB course.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Heart rate increased, Hypoaesthesia, Paraesthesia, Tachycardia
Clinical narrative: This case was reported by a physician and described the occurrence of paresthesia all over body in a 28-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 26 September 2013 at 15:15 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 26 September 2013, within minutes of vaccination with FLULAVAL (described as "right after" vaccination), the subject experienced paresthesia all over body, blood pressure is up, heart rate up, numbness (described as "numbness from head to toes"), and tachycardia. Per the physician, the subject reported "feeling numb from head to toes, her blood pressure went up, heart rate went up" and the subject had "tachycardia at around 100." Per the physician the injection site "looks ok" and the subject "did not develop fever nor shortness of breath." The subject had "tingling numbness all over her body, including her hands. The physician described symptoms as having paresthesia." Relevant diagnostic tests included on 26 September 2013, heart rate was measured "at around 100." The physician put the subject "on a monitor" however, he did not provide specific details. Treatment included an unknown medication initiated on 26 September 2013 per the physician. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. Per the physician, the subject was "not being hospitalized yet." The physician considered the events were probably related to vaccination with FLULAVAL.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: For approximately 8 hours pt had - fever, chills, aches, headache and fatigue. No treatment was requested.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On an unknown date, the patient died in her shower. The patient was so healthy prior to the vaccination. The post mortem result stated cause of death unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 18-SEP-2013 the patient was vaccinated with expired ZOSTAVAX (lot # 671190/1270AA, expiration date 05-NOV-2012) 0.65 ml, subcutaneous. No concomitant medications were reported. No adverse effects reported. Additional information is not expected.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity, Pyrexia, Skin discolouration
Clinical narrative: Fever and arm was sore, swollen, black and blue, and he felt slightly feverish for an hour; sx resolved.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Rash/hives, itching at injection site on evening after administration. Pt self-medicated with Benadryl.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Redness, pain, swelling at site of injection. Bad headache, nausea.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report refers to a 79 year old female patient. None pertinent medical history or drug reactions/allergies. On 18-SEP-2013, the patient was vaccinated with PNEUMOVAX23, intramuscular in the left arm. Concomitant medication included FLUZONE and unspecified cholesterol medication. It was reported that on 18-SEP-2013, since she received the PNEUMOVAX23, vaccine she has experienced redness, swelling, and muscle pain at the injection site of her left arm. On the same day at the same time she was given a flu shot of FLUZONE, high dose in the right arm. The patient was not treated. Labs diagnostics were not performed. The patient did not seek medical attention. The outcome of redness, muscle pain at the injection site and swelling was reported as not recovered/not resolved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On an unknown date, the patient died 40 hours after her third shot of GARDASIL. The patient had been so healthy prior to the vaccination. The post mortem result stated cause of death unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Between hour of 6:30 A.M. and 8 A.M. she received flu vaccine at her place of employment through "clinic" ran by local health dept. VIS available. Questionnaire filled out by pt and reviewed by RN giving injection. No contraindications noted.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had severe reaction to the vaccine. Injection site is red and swollen. Patient was given antibiotic, anti-inflammatory drug and prescribed hot compress by the doctor.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported fever of 102 degrees after receiving vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) as their booster dose for VARIVAX (Merck). No adverse events were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Epstein-Barr virus test negative, Full blood count normal, Headache, Mononucleosis heterophile test negative, Nausea
Clinical narrative: Headache, nausea, blurred vision lasting about 5 1/2 days - fully recovered on day 6
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Vision blurred
Clinical narrative: Headache, nausea, blurred vision lasting about 5 1/2 days - fully recovered on day 6
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Blood test normal, Convulsion, Gaze palsy, Tic
Clinical narrative: Tic appearing behavior-suspected to be seizure activity r/t immune response to DTaP vaccine. Had similar response for brief period of time after 15 month vaccines including DTaP. Activity was transient. Eye rolling.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Arrhythmia, Death
Clinical narrative: This case was reported in a literature article and described the occurrence of cardiac arrhythmia in a 13-year-old male subject who was vaccinated with DTPa (with small D + P), (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). 14 days after vaccination with DTPa, the subject died from cardiac arrhythmia. An autopsy was performed and showed cardiac arrhythmia. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed Tdap vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal dreams, Fatigue, Hallucination, Vaccine positive rechallenge
Clinical narrative: Pt. says that went to bed at 8PM as was extremely tired - FLUZONE HIGH DOSE given around 1 PM on 10-1-13 - during night had very vivid dreams and woke up in AM was having hallucinations - said same thing happened last year but thought it was due to pneumonia shot she got at same time as HIGH DOSE FLUZONE.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Nausea, Pruritus, Skin discolouration
Clinical narrative: 9/14 started itching and redness, 9/16 went to Dr. - Dx cellulitis. Started Doxycycline and hot packs. Nausea from Doxycycline - DC'd - started LEVAQUIN on 9/23. 9/27 - looks much better. Just a brown spot remains.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Local swelling, Tenderness, X-ray
Clinical narrative: Patient vaccinated 9/21/13. She noted swelling and tenderness above elbow and below elbow in vaccine arm on 9/28/13. She also caught her arm in a sliding door and has had blood drawn in that arm since the vaccine and before the onset of the swelling. Doctor wanted this filled out to be complete.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On unknown date, the patient died in her bath. The patient had been so healthy prior to the vaccination. The post mortem result stated a cause of death unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Dizziness, Nausea, Tremor, Vision blurred
Clinical narrative: Shaky legs, blurred vision (mild), queasy stomach, mild dizziness.