chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication, X-ray normal
Clinical narrative: Initial information received from another manufacturer (service request number 1-5587971112) on 02 October 2012. The information was originally provided to the other manufacturer from a health care professional." A patient, whose age, gender, medical history and concomitant medications were not reported, received a dose of intramuscular (IM) FLUZONE injection (lot number, route and site of vaccination not reported) on an unspecified date. On an unspecified date, the patient had "a severe reaction to FLUZONE". Corrective medications and laboratory investigations were not reported. The patient's outcome was not reported. Follow-up information was received from a healthcare professional on 02 January 2013. Based upon the new information provided, this case has been upgraded to serious due to hospitalization and was life threatening illness with prolonged hospitalization. A five-year-old male patient received dose three, right arm intramuscular injection of FLUZONE, sanofi pasteur Inc., lot number U4483AA on 10 October 2012 at 2:58. The patient had an upper respiratory infection (URI) one to two weeks before adverse event started. Nineteen days post vaccination on 29 October 2012 (also reported as "on about 29 October 2012") the patient complained of leg pain, left leg initially. The patient was seen in the emergency room (E.R.) on 04 November 2012 with leg pain and limping. X-rays were normal, and the child was given MOTRIN and discharged home. The child was seen in the office on 05 November 2012 for complaint of child unable to walk at school. X-rays and throat culture were obtained. On 09 November 2012, the patient was seen at another E.R. for inability to move muscles without pain and was discharged to home. On 12 November 2012, 33 days post vaccination, the child was seen in the office for incontinence (unspecified) related to pain with sitting and urinating. The adverse event was previously reported as "a severe reaction to FLUZONE" with MedDRA coding adverse event NOS. On an unspecified date the child was hospitalized and was still in the hospital at time of the report. Other laboratory tests performed on unspecified dates were: elevated erythrocyte sedimentation rate (sed rate), spinal tap revealed huge amount of protein, and magnetic resonance imaging (MRI) with coronal lighting up. Concomitant medications were reported as none. The child has one brother. The patient had two previous doses of influenza vaccine H1N1 on unspecified dates in 2009 and 2011. At the time of report, the patient's outcome was reported as unknown as he was still in the hospital. List of documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood glucose increased, Diabetes mellitus, Malaise, Polydipsia, Thirst
Clinical narrative: Malaise, increased thirst, polydipsia, blurred vision requiring new vision prescription. Elevated blood sugars above 300 mg/dL.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Vision blurred
Clinical narrative: Malaise, increased thirst, polydipsia, blurred vision requiring new vision prescription. Elevated blood sugars above 300 mg/dL.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Laboratory test, Unevaluable event, Urine analysis
Clinical narrative: Initial information has been received from a 30 years old female consumer concerning herself, with an unspecified pertinent medical history of drug reactions / allergies. On 15-NOV-2012, the patient was vaccinated with the first dose of GARDASIL (lot number H015863 exp date February 2015) (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 15-NOV-2012, the patient experienced heart palpitations, fast heart rate, her system was out of whack and felt it was an onset of diabetes. The patient stated she thought she was having a heart attack. The consumer indicated she was administered the first dose of the series only and believe she might have a possible been double dosed accidentally. The patient stated she was hospitalized overnight. No treatment was given for the events. It was reported that a blood work was done last week (results were not provided). At the time of report, the patient had not recovered. GARDASIL therapy was discontinued. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Diabetes mellitus, Feeling abnormal, Heart rate increased, Palpitations
Clinical narrative: Initial information has been received from a 30 years old female consumer concerning herself, with an unspecified pertinent medical history of drug reactions / allergies. On 15-NOV-2012, the patient was vaccinated with the first dose of GARDASIL (lot number H015863 exp date February 2015) (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 15-NOV-2012, the patient experienced heart palpitations, fast heart rate, her system was out of whack and felt it was an onset of diabetes. The patient stated she thought she was having a heart attack. The consumer indicated she was administered the first dose of the series only and believe she might have a possible been double dosed accidentally. The patient stated she was hospitalized overnight. No treatment was given for the events. It was reported that a blood work was done last week (results were not provided). At the time of report, the patient had not recovered. GARDASIL therapy was discontinued. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Asthenia, Injection site pain, Middle insomnia, Pain in extremity
Clinical narrative: Patient received PNEUMOVAX shot around 4 pm on 01/07/13, patient stated around 10 pm began to feel pain, and around 1 am on 01/08/13 she began to experience severe pain in her left arm. Patient had taken ADVIL in the AM of 01/08/13 with no relief -> instructed pt to see MD on 01/08/13.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient received PNEUMOVAX shot around 4 pm on 01/07/13, patient stated around 10 pm began to feel pain, and around 1 am on 01/08/13 she began to experience severe pain in her left arm. Patient had taken ADVIL in the AM of 01/08/13 with no relief -> instructed pt to see MD on 01/08/13.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Tremor
Clinical narrative: Aching joints, shaking (possibly chills).
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a female patient of unknown age who on an unknown date was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient experienced redness in the arm at the injection site and also had headache that occurred on a daily basis. No laboratory tests were performed. The patient sought medical attention; however, she did not receive any treatment for the event. The outcome of redness in the arm at the injection site and headache was unknown. The relatedness for redness in the arm at the injection site and headache was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
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 the first dose of GARDASIL (dose, route, lot number not reported) and received her second doe of GARDASIL (dose, route, lot number not reported) 4 and 1/2 months after receiving her first dose of GARDASIL (date unspecified), then received her third dose of GARDASIL (dose, route, lot number not reported) less than 6 weeks after receiving her second dose of GARDASIL (date unspecified). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via a sales representative concerning a female patient of unknown age who on an unknown date was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient experienced swelling at the injection site in her arm within an hour after administration. The patient did not seek medical attention; and did not receive any treatment for the event. The outcome of swelling at the injection site in her arm within an hour after administration was unknown. The relatedness for swelling at the injection site in her arm within an hour after administration was unknown for ZOSTAVAX. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria - hives, on legs, trunk, face. Unknown if vaccine reaction, vaccinated 1/7/13 mother noticed hives on legs, trunk, face on 1/8/13.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Dizziness, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a non-healthcare professional on 6 December 2012. A 12-year-old male patient, had received a dose of FLUZONE (batch number UH745AC, number in series and route of administration were not reported) on the right deltoid, a dose of MENACTRA (batch number U4414AA, number in series and route of administration were not reported) on the right deltoid and a dose of ADACEL (batch number C4251AA, number in series and route of administration were not reported) on the left deltoid, all on 03 December 2012. The patient had no known allergies. The patient had no illness at the time of vaccination. On 04 December 2012, after vaccination, the patient developed red, warm to touch area, size of half dollar at injection site of right arm. On 04 December 2012, the patient took BENADRYL. On 06 December 2012, the patient's symptoms were worse. ON an unspecified date, the patient had developed slightly swollen, red, warm to touch rash on right arm size of 3 cm and the patient also experienced lightheaded ness and right arm felt weak and heavy. Laboratory details were not reported. At the time of this report, the patient had not recovered from the events. Documents Held by Sender: None.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Muscular weakness, Sensation of heaviness
Clinical narrative: Initial report received from a non-healthcare professional on 6 December 2012. A 12-year-old male patient, had received a dose of FLUZONE (batch number UH745AC, number in series and route of administration were not reported) on the right deltoid, a dose of MENACTRA (batch number U4414AA, number in series and route of administration were not reported) on the right deltoid and a dose of ADACEL (batch number C4251AA, number in series and route of administration were not reported) on the left deltoid, all on 03 December 2012. The patient had no known allergies. The patient had no illness at the time of vaccination. On 04 December 2012, after vaccination, the patient developed red, warm to touch area, size of half dollar at injection site of right arm. On 04 December 2012, the patient took BENADRYL. On 06 December 2012, the patient's symptoms were worse. ON an unspecified date, the patient had developed slightly swollen, red, warm to touch rash on right arm size of 3 cm and the patient also experienced lightheaded ness and right arm felt weak and heavy. Laboratory details were not reported. At the time of this report, the patient had not recovered from the events. Documents Held by Sender: None.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender who on 26-OCT-2012 was vaccinated with dose 1 of live, oral ROTATEQ (route, lot number and expiration date were not provided) and on 20-DEC-2012 was vaccinated with a second dose of live, oral, ROTATEQ that had expired on 13-DEC-2012 (Lot number reported as 0229AA) (route was not provided). No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site irritation, Injection site pruritus
Clinical narrative: This spontaneous report was received regarding a 65 year old male patient. On 29-DEC-2012, the patient was vaccinated with one dose of ZOSTAVAX, (lot number, expiration date and route was not reported) on the left arm. The patient had no drug reactions or allergies. Concomitant medications included blood pressure medicine. On 30-DEC-2012, the patient had discomfort in her arm on the injection site mostly itching and irritation. There was no treatment rendered for the events. The outcome of the events were unknown at the time of this report.The patient did not seek medical attention. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenopia, Head discomfort, Headache, Pain in extremity
Clinical narrative: This spontaneous report was received from an approximately 66 year old female patient with no pertinent medical history and no drug reactions/allergies. Approximately on 31-DEC-2012 (2 days ago), the patient was vaccinated with 0.65 milliliter (ml) (reported as normal) ZOSTAVAX (lot number and expiry date unspecified) subcutaneously in the arm (reported as normal). Concomitant medications included carvedilol and simvastatin. Approximately on 01-JAN-2013 (last night), the patient experienced an unusual type of headache that included heaviness at the top of her head and across her eyes. Her arm hurt within a couple of hours of receiving the ZOSTAVAX and continued to hurt Monday through previous day (yesterday). She was treated with ibuprofen. She did not seek any medical attention. No laboratory diagnostic tests were performed. At the time of the report, her arm hurt was feeling much better. The outcome of an unusual type of headache that includes heaviness at the top of her head and across her eyes was unknown. The relatedness for both the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Foreign body sensation in eyes, Rash
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a female patient of unknown age with allergy to sulfa and allergy to quinolones. On 29-DEC-2012 the patient was vaccinated with a dose of, .65 milliliters (ml) ZOSTAVAX (lot# H013944, expiration date 25-OCT-2013) subcutaneously in the left posterior arm. Concomitant medications included estrogen and occasional unspecified antibiotics. The patient reported that she experienced pain in her eye on an unknown date in December 2012 (reported as very soon after receiving ZOSTAVAX). The pain in her eye resolved on an unknown date. The patient developed a rash on her face that extends "from around her nose and to her eye sockets." The pharmacist had observed the rash, and she reported that the rash was "not oozing". It did not appear to be vesicular, and the patient's nurse practitioner examined the patient and said that she "had never seen anything like it". No treatment was recommended for the patient. The patient called on 04-JAN-2013. She stated on 31-DEC-2012 she began to "feel like something was in the right eye." On 02-JAN-2013 she developed "a rash on the entire right side of her face". The patient started valacyclovir on 04-JAN-2013 (reported as today). The patient had not recovered. No lab diagnostic studies were performed. The patient sought medical attention for the events by consulting the pharmacist and the nurse practitioner. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Foreign body sensation in eyes, Rash
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a female patient of unknown age with allergy to sulfa and allergy to quinolones. On 29-DEC-2012 the patient was vaccinated with a dose of, .65 milliliters (ml) ZOSTAVAX (lot# H013944, expiration date 25-OCT-2013) subcutaneously in the left posterior arm. Concomitant medications included estrogen and occasional unspecified antibiotics. The patient reported that she experienced pain in her eye on an unknown date in December 2012 (reported as very soon after receiving ZOSTAVAX). The pain in her eye resolved on an unknown date. The patient developed a rash on her face that extends "from around her nose and to her eye sockets." The pharmacist had observed the rash, and she reported that the rash was "not oozing". It did not appear to be vesicular, and the patient's nurse practitioner examined the patient and said that she "had never seen anything like it". No treatment was recommended for the patient. The patient called on 04-JAN-2013. She stated on 31-DEC-2012 she began to "feel like something was in the right eye." On 02-JAN-2013 she developed "a rash on the entire right side of her face". The patient started valacyclovir on 04-JAN-2013 (reported as today). The patient had not recovered. No lab diagnostic studies were performed. The patient sought medical attention for the events by consulting the pharmacist and the nurse practitioner. Additional information has been requested.
Sex: M
Vaccine: PNC
Symptoms: Renal failure chronic, Renal transplant, Urethral valves
Clinical narrative: This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age and ethnicity received PREVNAR (Lot Number: F45119; Expiration Date: Feb2014) via an unspecified route of administration on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced posterior urethral valve issues, which lead to end stage renal disease. Therapeutic measures were taken as a result of the event and included a kidney transplant. The outcome of the event, posterior urethral valve issues, which lead to end stage renal disease, was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a female pharmacist of unknown age reporting on herself. The pharmacist was vaccinated with, 0.65 ml ZOSTAVAX, SC in November or December 2012 (lot # and site of administration not reported). No other co-suspects were reported. No concomitant medications were reported. Subsequently, in November or December 2012, the pharmacist experienced red raised area at the injection site that lasted about a week. No treatment was given. The pharmacist did not seek medical attention. It was also reported that the therapy was not reintroduced. The outcome of red raised area at the injection site was reported as recovered/resolved. The relatedness for red raised area at the injection site was not reported for ZOSTAVAX. This is one of several reports from the same source. Additional information is not expected.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Convulsion, Electroencephalogram
Clinical narrative: Patient has seizure onset on 8th day (after 4 month vaccine). He is diagnosed with seizure disorder based on EEG. There is positive family history of seizure. Not sure if any relation.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, HEP, HEPA, MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) upper deltoid erythematous arm with swelling and tenderness assessed cellulitis (R) deltoid. KEFLEX 250mg p.o. q 6 hr x 10 day / 3 day after shot.
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Arm soreness, achy pain, weakness in arm} after 1 month.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Breath holding, Pallor
Clinical narrative: Right after patient received her shots she did not cry, held her breath became pale. Did not respond to stimulation, had pulse, was breathing. Kept eyes shut for 1/2 hr looked like was sleeping. After long period of time became alert & recovered.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abasia, Computerised tomogram head abnormal, Nuclear magnetic resonance imaging, Pain in extremity, Transient ischaemic attack
Clinical narrative: Hx. "stroke" with influenza vaccine (5 days after) years ago. Researched online & found no documented correlation. Gave influenza vaccine and c/o left arm pain & inability to ambulate which resolved in 12hrs. Diagnosed with TIA.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, Joint stiffness, Mobility decreased
Clinical narrative: Influenza inoculation with FLUZONE HD 2012-2013 syr - pf- on December 5, 2012 starting December 6, 2012 and continuing through current date of January 2, 2013 constant severe ache/pain/stiffness in all joints - shoulders, knees, lower back-almost to the point of being paralyzed. Could not bend over or haunch down. Could hardly walk. Felt like someone had hit be with a hammer.
Age: 0.5
Sex: U
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant refers to a 6 months old patient who on 07-JAN-2013 was vaccinated intramuscularly with a dose of GARDASIL (dose and Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The Medical assistant reported that the patient was to have received the third dose of PENTACEL (dose of PENTACEL had not been administered at the time of the call). No product confusion discovered, just medication error. No adverse event reported. Patient's outcome was unknown. Action taken was not applicable. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local swelling, Pruritus
Clinical narrative: About 1/2 hr. after shot, turned red felt warm, put ice on it, red spot got bigger about the size of a baseball, got hard, swelled up, red spot is still the size of quarter. It also itched.
Age: 69.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at deltoid, hot & red. Cold compress and hot compress later. Swelling & persistent pain again following day. Elbow painful to touch as reported by patient.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: The patient came in 12/14/12 complaining of some soreness and itching at the injection site. The site had a red whelp about 1 to 1 1/2 inches wide. No other complaints but that it itched. She will watch the site to see if it gets any worse.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Headache, left sided neck/shoulder pain, heaviness left arm, swelling at injection site, lump, redness, arm pain.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Neck pain, Sensation of heaviness
Clinical narrative: Headache, left sided neck/shoulder pain, heaviness left arm, swelling at injection site, lump, redness, arm pain.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Insomnia, Nausea
Clinical narrative: Fast heart beat, nausea, insomnia.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: Approximately 20 minutes after flu vaccine administration, client reported mouth tingling and itching on face, scalp and torso.  No hives/rash observed.  Personal Epi Pen used and client went to nearest ER via personal vehicle (she was not driving).  Client contacted later in evening and advised she was given IV steroids and Benadryl and was referred to allergist "to be tested to see what I'm allergic to in flu shot."
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Malaise, Mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: 5 days of extreme malaise/fatigue. 2+ months of severe deltoid and shoulder pain with significantly limited mobility; primary mobility restrictions were with external rotation; felt similar to a rotator cuff tear.  Currently, pain is abating and mobility improving.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Pyrexia
Clinical narrative: Client had a fever starting at 4pm on 1/5 approximately 48 hours after vaccination. Fever was controlled with Tylenol, was highest at 104 degrees on 1/6. Fever on 1/9 at 99.7 degrees.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling of body temperature change, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Hot and cold feel like had a fever, achy, and L upper arm swollen and very sore.
Age: 4.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: Patient became pale and vomited. Complained of dizziness. Taken to an exam room and laid flat. Vital signs were 97.8, HR=120, respirations = 20. The patient felt better after 10 minutes. Was observed for 30 minutes until fully recovered.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Dizziness, Electrocardiogram, Erythema, Hyperhidrosis
Clinical narrative: Immediately c/o being dizzy, light headed, red face, sweating, nausea, c/o back pain-muscle tightness. Lasted less than 5 minutes.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Muscle tightness, Nausea
Clinical narrative: Immediately c/o being dizzy, light headed, red face, sweating, nausea, c/o back pain-muscle tightness. Lasted less than 5 minutes.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: Shortness of breath, fast heart rate, chest pain, aches. BP 174/107 pulse 79 oxygen saturation 96% temp 98.8. BP on discharge 105/75 pulse 73.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fibrin D dimer normal, Heart rate increased, Laboratory test normal, Pain, Troponin normal
Clinical narrative: Shortness of breath, fast heart rate, chest pain, aches. BP 174/107 pulse 79 oxygen saturation 96% temp 98.8. BP on discharge 105/75 pulse 73.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count decreased
Clinical narrative: Shortness of breath, fast heart rate, chest pain, aches. BP 174/107 pulse 79 oxygen saturation 96% temp 98.8. BP on discharge 105/75 pulse 73.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid warm to touch, swollen, redden area, rash, small nodule at injection site.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Patient had flu shot around 9 am this morning. Throat/tongue swelling around 3pm. Never had reaction to flu shots previously, but never had HD version.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Rheumatoid arthritis
Clinical narrative: Extreme shoulder pain.  Went to an infectious disease specialist. Thought it was Lymes disease.  Turned out to be Rheumatoid Arthritis.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Severe leg and knee aches. Lasted 24 hrs. Treated with ibuprofen, rest and Ultram.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Insomnia, Irritability, Pyrexia
Clinical narrative: Fever, up to 102.8 F. Irritability. Inability to sleep.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Lip swelling, Nausea, Oedema mouth
Clinical narrative: Around 6pm there was chills, feeling of fever. Around 8 pm: swelling of the lips, area above lip below nose, swelling under the tongue followed by slight nausea and chest tightness.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Around 6pm there was chills, feeling of fever. Around 8 pm: swelling of the lips, area above lip below nose, swelling under the tongue followed by slight nausea and chest tightness.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Activated partial thromboplastin time prolonged, Anion gap increased, Blood fibrinogen decreased, Coagulopathy, Fibrin D dimer increased
Clinical narrative: Fever; Fussiness; Poor sleep; Elevated INR / coagulopathy, bleeding from PIV sites.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Haemorrhage, International normalised ratio increased, Irritability, Poor quality sleep, Prothrombin time prolonged
Clinical narrative: Fever; Fussiness; Poor sleep; Elevated INR / coagulopathy, bleeding from PIV sites.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Pyrexia, Transaminases increased
Clinical narrative: Fever; Fussiness; Poor sleep; Elevated INR / coagulopathy, bleeding from PIV sites.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Feeling cold, Muscle spasms, Pyrexia
Clinical narrative: Diarrhea followed by shivering, muscle spasms, felt very cold, fever.  Could not get warm.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Feeling cold, Tremor
Clinical narrative: Diarrhea, followed by terrible cold sensation and shaking all over. Unable to warm up. Almost asked wife to take me to Emergency Room.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tic
Clinical narrative: Explosive tics.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: 2 hours after shot, severe pain in right shoulder present.  Pain persistent and still present, now almost 4 months later.
Age: 10.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Pallor
Clinical narrative: Child with redness to vaccine site. Blanching to chest.
Age: 1.51
Sex: M
Vaccine: DTPIHI
Symptoms: Autism spectrum disorder, Irritability, Sleep disorder, Speech disorder developmental
Clinical narrative: Extreme irritability speech ability regression, sleep pattern disruption.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Feeling hot, Headache, Musculoskeletal stiffness
Clinical narrative: Received shingles vac in Lf arm, woke up hot, achy, with headache. Felt weak, achy, very stiff neck for 2 days. Broke out in fluid filled itchy pustules Mon. AM. Itchy all over, but only a few spots, One large on on RT forearm. Felt much better Tues, less itchy. All symptoms gone Wed. except a few itchy pustules which are crusty now. Had chicken pox as a child.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus generalised, Rash pruritic, Rash pustular, Scab
Clinical narrative: Received shingles vac in Lf arm, woke up hot, achy, with headache. Felt weak, achy, very stiff neck for 2 days. Broke out in fluid filled itchy pustules Mon. AM. Itchy all over, but only a few spots, One large on on RT forearm. Felt much better Tues, less itchy. All symptoms gone Wed. except a few itchy pustules which are crusty now. Had chicken pox as a child.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site mass, Injection site pain, Musculoskeletal pain
Clinical narrative: Lump at injection site and pain that radiated to shoulder.
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Seizure with fever, 30 seconds, witnessed in a public location, brought by ambulence to the ED.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Biopsy skin abnormal, Extranodal marginal zone B-cell lymphoma (MALT type), Injection site erythema, Injection site nodule, Positron emission tomogram abnormal
Clinical narrative: The site of injection became a bump and turned red. I didn't think much about it. Months went by and the place never changed. I visited a dermatologist to have the spot removed. He suggested having a biopsy. I did and it came back a little strange. I was sent to an oncologist. He quickly ordered a PET scan and then scheduled surgery to have the "tumor" removed.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tumour excision
Clinical narrative: The site of injection became a bump and turned red. I didn't think much about it. Months went by and the place never changed. I visited a dermatologist to have the spot removed. He suggested having a biopsy. I did and it came back a little strange. I was sent to an oncologist. He quickly ordered a PET scan and then scheduled surgery to have the "tumor" removed.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Biopsy skin abnormal, Extranodal marginal zone B-cell lymphoma (MALT type), Injection site erythema, Injection site mass, Positron emission tomogram abnormal
Clinical narrative: The site of injection became a bump and turned red. I didn't think much about it. Months went by and the place never changed. I visited a dermatologist to have the spot removed. He suggested having a biopsy. I did and it came back a little strange. I was sent to an oncologist. He quickly ordered a PET scan and then scheduled surgery to have the "tumor" removed.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: B-cell lymphoma, Biopsy, Biopsy lymph gland abnormal, Flow cytometry, Injection site erythema
Clinical narrative: The site of injection became a bump and turned red. I didn't think much about it. Months went by and the place never changed. I visited a dermatologist to have the spot removed. He suggested having a biopsy. I did and it came back a little strange. I was sent to an oncologist. He quickly ordered a PET scan and then scheduled surgery to have the "tumor" removed.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site swelling, Lesion excision, Positron emission tomogram
Clinical narrative: The site of injection became a bump and turned red. I didn't think much about it. Months went by and the place never changed. I visited a dermatologist to have the spot removed. He suggested having a biopsy. I did and it came back a little strange. I was sent to an oncologist. He quickly ordered a PET scan and then scheduled surgery to have the "tumor" removed.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Balance disorder, Diarrhoea, Dizziness, Fall
Clinical narrative: Vomiting, diarrhea, dizziness, loss of balance, stomach pain, tiredness.  Seemed to bruise easily, quickly developed bruises after bumping into furniture or falling from dizziness.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Increased tendency to bruise, Vomiting
Clinical narrative: Vomiting, diarrhea, dizziness, loss of balance, stomach pain, tiredness.  Seemed to bruise easily, quickly developed bruises after bumping into furniture or falling from dizziness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Pt returned to pharmacy complaining of her throat closing and difficulty swallowing.  Administered 1 Epipen.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Hypotension, Syncope
Clinical narrative: Patient fainted, was brought to emergency room due to severe hypotension but has since been released and is fully recovered per patient's mother.
Age: 43.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose, Cold sweat, Disorientation, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: Localized swelling & redness. Pt states mild dizziness, lightheaded and chills.
Age: 43.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Musculoskeletal pain, Peripheral coldness, Presyncope, Tremor
Clinical narrative: Localized swelling & redness. Pt states mild dizziness, lightheaded and chills.
Age: 43.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Erythema, Local swelling
Clinical narrative: Localized swelling & redness. Pt states mild dizziness, lightheaded and chills.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age with no medical history and drugs allergies reported who on 01-AUG-2007, was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported). On 26-MAR-2012, was vaccinated with dose 2 GARDASIL (lot #, dose and route not provided). On 03-JAN-2013, was vaccinated with dose 3 GARDASIL (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that there was no adverse symptoms reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a male patient of unknown age with no medical history and drug allergies reported, who on 03-JAN-2013, was vaccinated with GARDASIL (exp date: June/July 2011) (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The Health Care Professional did not report that the patient experienced any Adverse experience. No further AE information provided. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N), concerning a patient of unknown age and gender. On 03-JAN-2013, the patient was vaccinated with a dose of GARDASIL (dose and route were not reported) (Lot #: 663559/1178Y; Expiration date: 11-NOV-2011), that had expired. There were no adverse effects. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from an office administrator, concerning a some patients of unknown age and gender. On an unspecified date, the patients were vaccinated with a dose of (Merck) PROQUAD (dose and route were not reported) (Lot # and expiration date unknown), that had been exposed to 15F for 13 days. The specific number of patients was unknown. There was no adverse event. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Decreased appetite
Clinical narrative: Information has been received from a pharmacist referred to a 85 years old female patient with hypertension and asthma. On 24-OCT-2012, the patient was vaccinated with PNEUMOVAX 23 (lot # 1947AA, exp date 20-OCT-2013) 0.5 ml once, intramuscular left deltoid. Other suspect therapies included Influenza Virus Vaccine (unspecified) on 24-OCT-2012. No concomitant medications were reported. It was reported that within "the next two or three days" on approximately 25-OCT-2012, the patient began to experience a loss of appetite. The reporter did not think the patient has been reported this adverse experience to her healthcare provider. According to the reporter, the patient reports that her appetite was still poor on 02-JAN-2013. No treatment was given. The patient did not sought medical attention. The outcome of loss of appetite was reported as not recovered. The relatedness for loss of appetite was unknown for PNEUMOVAX 23 and Influenza Virus Vaccine (unknown). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Diabetes mellitus
Clinical narrative: Information was received from a consumer about her daughter who in 1997 was vaccinated with a dose of VARIVAX (Merck) (lot not reported). It was reported that the patient was diagnosed with diabetes two days after receiving the VARIVAX (Merck). The mother asked about reimbursement of medical expenses as a result of reaction to vaccines. The patient was reported as not recovered from the event. No additional information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Patient stated that her arm swelled to size of egg 2 hours after administration and continued to swell in the next couple hours. Vaccine was administered evening of 1/8/13 and patient called concerning adverse event at 11 AM on 1/9/13.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Redness at injection site & swelling. Itching in some parts of body mainly injection site. Tenderness at injection site. Ice, BENADRYL cream.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Pt reported to ER w/"cellulitis" from PNEUMOVAX vaccine.
Age: 1.02
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Pt developed local erythema, swelling, induration at injection site within one minute of VARIVAX injection - given po BENADRYL with decrease in local swelling & induration - few local urticarial rash present also.
Age: 1.02
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Local swelling, Urticaria
Clinical narrative: Pt developed local erythema, swelling, induration at injection site within one minute of VARIVAX injection - given po BENADRYL with decrease in local swelling & induration - few local urticarial rash present also.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5
Symptoms: Erythema, Immediate post-injection reaction, Pallor
Clinical narrative: Blanching non-raised red patches - 12 > 1 cm developed immediately after administration of vaccines on Lt shoulder. First time receiving flu vaccine, received other vaccines previously. BENADRYL 7.5 mg liquid administered and observed in office 30 minutes.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Patient called complaining of pain in her arm since her injection 2 wks ago. The pain has been getting worse and is affecting her sleep and hurts when she gets dressed. She said she was going to call her doctor about it. No redness or inflammation present.
Age: 1.39
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Breath holding, Crying
Clinical narrative: Child seemed to hold breath after 2nd vaccine - was picked up, then started crying - no prior rxn to any shots.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Pt. left exam room, checked out at front desk. Became pale & light headed in hallway after leaving clinic. No LOC.
Age: 0.1
Sex: U
Vaccine: HEP, HPV4
Symptoms: Medication error, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse, concerning a 1 month infant of unknown gender. On an unspecified date, the patient was vaccinated intramuscularly with a dose of GARDASIL (dose was not reported) (Lot # and expiration date were not reported). It was reported that the patient was to have received the first dose of RECOMBIVAX HB, but instead was administered GARDASIL. No product confusion was discovered, just a medication error. It was reported that the patient did receive the first dose of RECOMBIVAX HB on 03-JAN-2013 (dose and route were not reported) (Lot # and expiration date were not reported). There were no adverse effects. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial information has been received from registered nurse concerning a patient with an unspecified age, gender, pertinent medical history or drug reactions / allergies. On 12-JAN-2012, the patient was vaccinated with the first dose of GARDASIL (dose, route were not reported). On 31-MAY-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route were not reported). On 09-AUG-2012, the patient was vaccinated with the third dose of GARDASIL (dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Condition aggravated
Clinical narrative: This spontaneous report as received from a 64 years old male patient with herpes simplex and no drug reactions/allergies. The patient was vaccinated with a dose of ZOSTAVAX on 24-DEC-2012. Concomitant medications included: LIPITOR. On approximately 24-DEC-2012 (within 24-48 hours), the patient experienced worsening of his herpes simplex symptoms after receiving ZOSTAVAX. He stated that he had never had shingles, and his healthcare professional (HCP) did not think there was a correlation with the worsening rash and vaccination. The patient went to HCP for medical attention. He was treated with VALTREX and cream. Blood test was performed. The outcome of worsening of his herpes simplex symptoms was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site reaction, Migraine, Paraesthesia
Clinical narrative: Information has been received from a physician, concerning a 17 years old female patient. On an unspecified date, the patient was vaccinated with a dose of GARDASIL (dose and route were not reported) (lot # and expiration date were not reported). On an unknown date four days after vaccination the patient experienced migraine headache. In addition, at the site of injection, her arm was tingling and pain was radiating distally. At the time of the report, the patient's outcome of migraine headache, pain was radiating distally and tingling arm at the site of injection was unknown. The relatedness for migraine headache, pain was radiating distally and tingling arm at the site of injection was unknown for GARDASIL. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Emotional distress, Immediate post-injection reaction, Irritability, Opisthotonus
Clinical narrative: This case was reported by a physician and by the same physician via a sales representative, and described the occurrence of high-pitched crying in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included haemophilus influenzae type b vaccine (non-gsk) ;Merck;unknown;unknown given on 28 August 2012; live attenuated human rotavirus vaccine ;GlaxoSmithKline;unknown;unknown given on 28 August 2012; pneumococcal vaccines (non-gsk) ;PFIZER;unknown;unknown given on 28 August 2012. The subject was solely breast-fed. On 28 August 2012 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, right thigh). On 28 August 2012, immediately after vaccination with PEDIARIX, the subject experienced fussiness and on 28 August 2012, 30 minutes after vaccination with PEDIARIX, the subject experienced high-pitched crying and screaming and was inconsolable, arching back and vomiting. The subject was treated at home with TYLENOL after the fussiness began. The high-pitched crying, screaming, inconsolable, arching back and vomiting lasted for 5.5 hours into the afternoon and evening of 28 August 2012. The fussiness continued until the next morning of 29 August 2012. The office also filed a VAERS form. The vaccination course with PEDIARIX was discontinued. The physician considered the events were probably related to vaccination with PEDIARIX due to the pertussis component and will no longer be giving the subject PEDIARIX.