chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient received pneumococcal vaccine in his left arm and 4 hours later experienced swelling, hardness and pain at site. Pain increased through the night and experienced limited mobility due to pain. Swelling increased extending down to elbow so called office Friday - a dose pk to pharmacy. Pain and swelling decreased 2 hours after taking meds. Sx subsided within 2 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt's arm is red, swollen & warm to the touch. Tx: ibu and ice.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis (warm, pain, swollen at the site of injection. Patient received oral antibiotics (cephalexin 500 mg).
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Patient has small bumps all over his body that are very itchy.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Arm redness and swelling that went away. Arm soreness that continues today.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: Serious shoulder and muscle pain for 4 months, till now is not relief.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red circle around area of injection (left deltoid).  Measure about 2 1/2 inches long by 7cm x 6.5cm - area erythematous; tender to the touch & mildly swollen.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Stated feeling achy, my daughter got her at same location and time so we were comparing symptoms.
Age: 67.0
Sex: F
Vaccine: TYP
Symptoms: Lactose intolerance, Muscle spasms
Clinical narrative: Patient took 1st dose at 8 am on 1/18/13. At 1 a.m. she experienced severe cramps. She is lactose intolerant.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Electromyogram, Nerve injury, Neuralgic amyotrophy
Clinical narrative: Pt with Parsonage-Turner Syndrome with long thoracic nerve injury only.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Burning sensation, Dry skin, Erythema, Injection site nodule, Oedema peripheral
Clinical narrative: Swelling of right hand with severe redness like a burn. C/O itching and burning sensation. Knot at injection site grew to approx 1" diameter. Today makes 5 days and knot is approx 1/2" in diameter. Right hand is dry with crusty scabs, itching and unable to tolerate ointment due to stinging.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pain, Pruritus, Scab
Clinical narrative: Swelling of right hand with severe redness like a burn. C/O itching and burning sensation. Knot at injection site grew to approx 1" diameter. Today makes 5 days and knot is approx 1/2" in diameter. Right hand is dry with crusty scabs, itching and unable to tolerate ointment due to stinging.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Vaccine was administered IM instead of SQ.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth at injection site on left upper arm extending out approx. 4 in. in diameter.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site.
Age: 19.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Dizziness, Headache, Malaise
Clinical narrative: Intense headache, at 10pm dizziness, headache, malaise, body aches, 1am temp 102F, chills, nausea, vomit x1 at 5am.
Age: 19.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Neutropenia, Pain, Platelet count decreased, Vomiting
Clinical narrative: Intense headache, at 10pm dizziness, headache, malaise, body aches, 1am temp 102F, chills, nausea, vomit x1 at 5am.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Pyrexia
Clinical narrative: High fever, difficult to breathe, weakness.
Age: 37.0
Sex: M
Vaccine: DTAP
Symptoms: Epistaxis, Headache, Nausea
Clinical narrative: Headache, nose bleed, nausea.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Enema administration, Intussusception, Surgery, Ultrasound scan abnormal
Clinical narrative: Intussusception.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Narcolepsy, Sleep study abnormal, Somnolence
Clinical narrative: Excessive fatigue.  Started falling asleep while driving for short errands, couldn't stay awake while teaching during day, falling asleep at my desk while teaching or when reading stories aloud.  No energy.  Changed anti-depressants, in Feb of 2012 started Ritalin to combat fatigue.  Prescribed by Pyshc NP.  Sleep study ordered.
Age: 1.05
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Decreased appetite, Diarrhoea, Lethargy, Pyrexia, Rash
Clinical narrative: High fever, rash (maybe pox), diarrhea, loss of appetite, hives, lethargy.
Age: 1.05
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: High fever, rash (maybe pox), diarrhea, loss of appetite, hives, lethargy.
Age: 1.24
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: 104-105 degree high fever for 48 hours.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia, Headache, Hyperhidrosis, Skin odour abnormal
Clinical narrative: Metallic taste in the mouth, and my whole body odor smells like metal its been going on now for 8 days, have a headache, my palms are sweating.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hallucination, Pyrexia, Tremor, Vomiting projectile
Clinical narrative: Case number PHEH2013US001846, is an initial spontaneous report received from a consumer on 18 Jan 2013: This report refers to a 66-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: Not reported) intramuscularly on 16 Jan 2013. Thirty minutes after vaccination he experienced uncontrollable shaking and chills followed by high fever and projectile vomiting. He was taken to the emergency room of the physician and was treated for his symptoms. On the next day (17 Jan 2013) he still had high fever and experienced hallucinations not knowing "who she was and where he was". He was again taken to the emergency room of the physician. The outcome, seriousness, and causality of the events were not reported.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Lightheaded and sweaty and passed out.
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Patient received a PNEUMOVAX vaccine administered subcutaneously and has now developed cellulitis, was taken to ER and now on antibiotic txt.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing
Clinical narrative: Face flushing and flat non itchy rash to torso and upper extremities noted. Patient also complained of throbbing sensation of head.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, PNC
Symptoms: Injection site haematoma, Injection site oedema
Clinical narrative: Pt received routine WCC IZ's (L) upper arm edema hematoma secondary to hep B vaccine admin on 1/10/13.
Age: 61.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Rash
Clinical narrative: Patient developed rash over his left shoulder after he received pneumo and tdap vaccine.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Local redness and swelling at the injection site. Pain and body aches.
Age: 16.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Cough, Lymphadenitis, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: FLUMIST rec'd 11/5/12. Mother reports fever, (up to 101 degrees), runny nose, severe sore throat and cough began 11/6/12. 11/8/12 Seen in office with fever of 100.1 and above symptoms. URI diagnosed. Seen again in this office 12/28/12 had been put on OMNICEF elsewhere. Dx cervical adenitis resolving. To complete OMNICEF & if worse to return. Has not returned.
Age: 16.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Streptococcus test negative, Upper respiratory tract infection
Clinical narrative: FLUMIST rec'd 11/5/12. Mother reports fever, (up to 101 degrees), runny nose, severe sore throat and cough began 11/6/12. 11/8/12 Seen in office with fever of 100.1 and above symptoms. URI diagnosed. Seen again in this office 12/28/12 had been put on OMNICEF elsewhere. Dx cervical adenitis resolving. To complete OMNICEF & if worse to return. Has not returned.
Age: 16.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Chills, Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: FLUMIST rec'd 11/5/12. Mother reports fever, (up to 101 degrees), runny nose, severe sore throat and cough began 11/6/12. 11/8/12 Seen in office with fever of 100.1 and above symptoms. URI diagnosed. Seen again in this office 12/28/12 had been put on OMNICEF elsewhere. Dx cervical adenitis resolving. To complete OMNICEF & if worse to return. Has not returned.
Age: 16.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Tonsillar hypertrophy
Clinical narrative: FLUMIST rec'd 11/5/12. Mother reports fever, (up to 101 degrees), runny nose, severe sore throat and cough began 11/6/12. 11/8/12 Seen in office with fever of 100.1 and above symptoms. URI diagnosed. Seen again in this office 12/28/12 had been put on OMNICEF elsewhere. Dx cervical adenitis resolving. To complete OMNICEF & if worse to return. Has not returned.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Head injury, Syncope
Clinical narrative: Patient received flu vaccine. Patient approached register to sign for vaccine received. Patient signed for vaccine, then fainted hitting his head on the floor. We then called 911 for assistance. Paramedic transported patient to hospital. After receiving vaccination and falling patient acknowledged that he had fainted before when receiving a vaccination.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Candidiasis, Rash, Tongue eruption
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old male patient concerning to himself with no known drug reactions or allergies and nothing of importance medical history. On unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously, for shingles prevention (lot number not provided). No other co-suspects were reported. Concomitant medications included losartan potassium, hydrochlorothiazide (manufacturer unknown) and allopurinol. On an unknown date, six to eight months after ZOSTAVAX vaccination, the pharmacist developed a "rash" in his mouth. Both his tongue and roof of mouth were involved and he described it as "being burnt as if he ate something hot". He visited an unspecified primary care physician and was diagnosed with thrush. An unspecified medication was prescribed but did not help. At the time of the report, the pharmacist was still suffering with ulcerative/redness in his mouth. The relatedness for thrush was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a health worker about herself, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dosing information and route were not provided). She was vaccinated at the physician's office where she works. No other co-suspects were reported. No concomitant medications were reported. The patient experienced that the injection site was warm and sore to the touch and the nickel size area was red. No treatment information was reported. The outcome of the events is unknown. The relatedness for the events for PNEUMOVAX23 was not provided. No contact details available. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 years old male patient with no drug reactions/allergies. The patient was vaccinated with a dose of live ZOSTAVAX (lot# 669634/0752AA, exp 20-FEB-2012) subsequently on 03-FEB-2012. No other co-suspects were reported. No concomitant medications were reported. On approximately 10-FEB-2012 the patient experienced shooting pain at the injection site which lasted for 2 or 3 days. This shooting pain outcome of shooting pain at the injection site was reported as not recovered. The relatedness for shooting pain at the injection site was unknown for live ZOSTAVAX. The patient had called the pharmacy for medical attention. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a child patient of unknown age and gender. At an unknown date, the patient was vaccinated with VARIVAX (Merck). Route, dose and frequency were not reported. No other co-suspects were reported. No concomitant medications were reported. Nurse reported that in the past she had a patient who received VARIVAX (Merck) and then developed varicella-like lesions at the injection site. The patient sought medical attention through office visit. No intervention was required to prevent serious criteria. No other details. NO treatment information was reported. The outcome of varicella-like lesions at the injection site was reported as recovered/resolved at an unknown date. The relatedness for varicella-like lesions at the injection site for VARIVAX (Merck) was not provided by the reporter. Additional information has been requested
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age with no pertinent medical history and drug allergies reported, who on unspecified date (mid-1990's), was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse stated that a patient received an unspecified hepatitis B vaccine (recombinant) (manufacturer unknown) and completed series in the mid-1990's but recently was tested on an unspecified date and was not showing any titers. Since the hepatitis B vaccine (recombinant) (manufacturer unknown) reported was unknown, it could possibly have been RECOMBIVAX and therefore AE was reported as a Merck product. The patient sought medical attention. No further information is available. The outcome of anti-hbs antibody negative was unknown. The relatedness for anti-hbs negative was unknown for hepatitis B vaccine (Recombinant) (manufacturer unknown). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Syringe issue, Underdose
Clinical narrative: Patient states that when pharmacist administered vaccine that syringe malfunctioned & needle went inside syringe. Vaccine did not go in arm & he had to administer vaccine again. Patient reports soreness in arm after 12 days. Patient made appointment to see doctor.
Age: 20.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Syringe issue, X-ray limb normal
Clinical narrative: Patient states that when pharmacist administered vaccine that syringe malfunctioned & needle went inside syringe. Vaccine did not go in arm & he had to administer vaccine again. Patient reports soreness in arm after 12 days. Patient made appointment to see doctor.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient received a dose of live ZOSTAVAX on 22-OCT-2012 (lot number H013017 exp 09-OCT-2013) and a second dose on 03-JAN-2013 (lot number H018798 exp 15-JAN-2014). Concomitant medications included: influenza virus vaccine (unspecified) 4 weeks prior to receiving the 2nd dose of live ZOSTAVAX and an unspecified heart medicin. The first dose of live ZOSTAVAX was given on prescription, but the 2nd dose was asked by the patient at pharmacy. On 15-JAN-2013 the patient experienced nose won't stop running, and fever. No treatment was given. The outcome of nose won't stop running and fever was reported as recovering. The relatedness for nose won't stop running and fever was not reported for live ZOSTAVAX. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood pressure fluctuation, Chest pain, Musculoskeletal pain, Pain
Clinical narrative: Fluctuating blood pressure (229/112 - 100/68) - has remained high since December even with added medication. Chest pains, chronic pain between shoulder blades, body / joint pain after flu vaccine and fluctuating blood pressure, PROCARIDA was added but I could not take - very allergic. In Dec., Losartan Potassium 25 mg was added along with Clonidine .1 mg (as needed). Also, Metoprolol was increased to 100 mg twice daily. Blood pressure is still too high.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Dyspnoea, Lethargy
Clinical narrative: Pt reported at 1800 - started with chills et general illness. Felt feverish. Became short of breath - couldn't catch her breath or take deep breath. Took ADVIL and BENADRYL. By 0100 was better and able to sleep. Next day felt lethargic et upset stomach. No appetite. Began feeling "normal" 1/2/13.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: Pt reported at 1800 - started with chills et general illness. Felt feverish. Became short of breath - couldn't catch her breath or take deep breath. Took ADVIL and BENADRYL. By 0100 was better and able to sleep. Next day felt lethargic et upset stomach. No appetite. Began feeling "normal" 1/2/13.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Full body hives appeared. Friday 1/18/13 after receiving flu shot on 1/16/13. Dr appt 1/19 = steroid shot given. Hives disappeared somewhat then came back soon after. Hives still present. 1/21/13 = Dr appt w/ steroid shot & adrenaline shot given. 1/22 = Full body hives still, come & go in diff. spots. No temp.
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: This spontaneous report was received from a Doctor of Pharmacy concerning a male patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). The pharmacist reported that the patient was having difficulty breathing within 10 minutes of receiving the vaccine. The pharmacist stated the patient had an anaphylactic reaction. At the time of the report, the outcome of the events was unknown. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus, Rash erythematous
Clinical narrative: This spontaneous report as received from a physician refers to a 56 years old female patient with arthritis. The patient had no other concurrent conditions and no allergies. On 09-JAN-2013, the patient was vaccinated with dose 1 of 0.65 ml live ZOSTAVAX subcutaneously, in the left posterior triceps. Lot number was reported as H019034, the expiration date was not reported. No other co-suspects were reported. There was no concomitant medication. On 13-JAN-2013, the patient experienced rash around the injection site of where live ZOSTAVAX was administered. The type of rash was reported as erythema and it was 22 mm in diameter. Other symptoms included itching. The patient's body temperature was reported to be normal. The patient was enrolled in the Varicella Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with Merck vaccine strain. A sample was obtained on 14-JAN-2013 (viral culture). No results were available at the time of the report. The patient denied recent exposure to chickenpox or shingles. It was reported that the event was treated with ibuprofen. The outcome of rash around the injection site of where live ZOSTAVAX was administered was reported as recovering; when the patient was seen in 14-JAN-2013, she was getting better. The reporter relatedness for rash around the injection site of where live ZOSTAVAX was administered is unknown for live ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL on an unknown date (dose, lot # were not reported). On an unknown date the patient missed an unspecified dose of the GARDASIL series. It was unknown how many doses the patient received or when they were administered. No adverse effects reported. The outcome was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant refers to a female patient of unknown age who on 18-SEP-2009 was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported). On 17-JUL-2012 and on 26-SEP-2012, the patient was vaccinated, respectively, with the second and third doses of GARDISIL (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. Patient's outcome unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via company representative refers to a female patient of unknown age who on an unspecified date was vaccinated with GARDASIL (Lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The Nurse Practitioner listed in this case heard of a story where a girl who was located somewhere in or near Massachusetts started walking or runny funny after receiving GARDASIL. The Nurse Practitioner may have heard this through a news story or another unspecified source. Patient's outcome is unknown. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient (age and gender not provided). The patient's medical history included smoking. On unknown date, the patient was vaccinated with PNEUMOVAX 23 (route, dose and lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient's arm swelled at the site of injection. No treatment information was reported. The outcome of patient's arm swelled at the sit eof injection was unknown. The relatedness for patient's arm swelled at the site of injection was unknown for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse practitioner (N.P.), concerning a patient of unknown age and gender. In 2010, three years ago, the patient received the first and second doses of GARDASIL (doses, route and frequencies were not reported). It was reported that now, in 2013, the patient would like to receive the third dose of GARDASIL. No adverse symptoms were reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to a 68 years old male patient, who in June 2012 (also reported as December 2012), was vaccinated with a dose of 0.65 ml ZOSTAVAX (route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that in December 2012 the patient was diagnosed with shingles. It was unspecified when the adverse event began. The patient was treated with VALTREX for the adverse event. The physician saw the patient" in the last week or two" and the adverse event had resolved. The patient sought medical attention. The relatedness for the adverse event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule, Injection site warmth, Pruritus generalised
Clinical narrative: This spontaneous report was received from a 88 years old female patient with allergies to sephalasporin. The patient was subcutaneously vaccinated with ZOSTAVAX (lot # 00008496341 MSD) on 14-JAN-2013 to prevent shingles. No other co-suspects were reported. Concomitant medications included: ZYRTEC, "ACIPHEX" and "WELLBUTRIN". On the same day, the patient experienced a hard knot and warmth at the injection site on her right arm. She also stated that she was experiencing itching all over. No treatment information was reported. She was going to the pharmacist. The outcome of AEs were unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Pharmacy student, concerning a 51  year old female patient. On an unspecified date, the patient was supposed to receive a dose of live (Merck) VARIVAX and received a dose of live ZOSTAVAX instead. (Dose and route were not reported) (lot # and expiration date were not reported). It was reported that the patient was not experiencing any known symptoms. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer reporting to her daughter a 17 weeks old female patient with no drug reactions or allergies and no pertinent medical history who on 15-JAN-2013, was vaccinated with a dose 1 ROTATEQ (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The patient's mother stated that the patient was given the first dose of ROTATEQ at 17 weeks of age instead of the indicated 6-12 weeks of age and the patient developed a high fever shortly after receiving ROTATEQ. The patient did not sought medical attention and was treated with TYLENOL. No further AE information was provided. the outcome of the patient high fever was reported as recovering/resolving. The relatedness for high fever was unknown for ROTATEQ. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Eye pain, Headache, Herpes zoster, Pain
Clinical narrative: Initial information has been received a 60 years old male consumer concerning himself with back pain and not drug reactions / allergies. On 11-JAN-2013, the patient was vaccinated with liveZOSTAVAX(Lot # H019042 exp date 17-JAN-2014)(dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On 13-JAN-2013 the patient developed shingles after vaccination with live ZOSTAVAX, and he developed a headache. On 14-JAN-2013 he developed painful vesicles on his right scalp and forehead and also his right eye. His right eye also was sore. The patient was treated with ADVIL and VALTREX. There were not laboratory studies performed. At the time of report, the patient had not recovered. Due to the patient was a physician, it was reported that the patient sought medical attention. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a female consumer in early 50's with allergic to shrimp refers to herself. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number unspecified) subsequently on 08-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. On 08-JAN-2013 the patient experienced injection site redness, with swelling and heat. The patient also reported that the swelling was huge and covered her whole humerus, the whole back of her arm. No treatment information was given for the adverse event. No lab diagnostic studies performed. At the time of the report. the patient was recovering. The relatedness for the adverse events was unknown for ZOSTAVAX. The patient did not seek any medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Renal disorder
Clinical narrative: This spontaneous report was received from a female patient of unknown age refers to herself. The patient was vaccinated with ZOSTAVAX on an unknown date. Lot # and administration route were unspecified. The patient reported having "problems with her kidneys" on an unknown date after receiving ZOSTAVAX. The outcome of event was unknown. It was unspecified if the patient sought medical attention or not. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness, Myalgia, Paraesthesia
Clinical narrative: Muscle pain, limb paresthesias, muscle weakness. Indication Dx: Guillain-Barre Syndrome.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Diarrhoea, Erythema, Pain, Pruritus
Clinical narrative: This spontaneous report refers to a 52 years old female patient, refers to herself, diabetic and allergy to evicatdona and a history of hysterectomy. On 19-OCT-2012, the patient was vaccinated with live ZOSTAVAX right arm (lot # H012578; exp date: 23-SEP-2013) (route, and dose not provided). No other co-suspects were reported. Concomitant medications included JANUVIA, GLUMETZA and glipizide. On 30-OCT-2012 (11 days after vaccination), the patient suffered pain from the injection. The pain stated in her armpit under her right arm. The patient visually saw redness under her arm that was the size of her hand. The patient stated that there were no lumps or swelling. The patient cannot saw any signs of shingles under her arm but it itches a great deal. The patient also mentioned that the pain had developed in her right breast first and from the breast and mammogram tests the pain then occurred in the left breast as well. She has been in pain for 3 months. Treatment was not given. Mammogram and breast exam were performed. The patient sought medical attention, she went to the doctors office. On unknown date, the patient stated that from the metformin she had developed diarrhea. At the time of the report, she was taken GLUMETZA which cleared the diarrhea up for her. The outcome of pain from the injection, pain, itches a great deal and redness was unknown. The outcome of from metformin she developed diarrhea was recovering. At the time of the report, from metformin she developed diarrhea was not related to live ZOSTAVAX. The relatedness from pain from the injection, pain, itches a great deal and redness was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Hypertension, Nausea
Clinical narrative: Patient was given influenza and pneumococcal vaccines. Within 10 minutes after administration, patient became severely anxious, holding chest and stating he could not breathe. Oxygen saturation dropped to 84% and patient was placed on oxygen. Patient was severely hypertensive -225/115- and very wheezy and nauseous, beginning to vomit. Patient given 25 mg IV BENADRYL; BP, anxiety, and breathing improved afterward.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Oxygen saturation decreased, Vomiting, Wheezing
Clinical narrative: Patient was given influenza and pneumococcal vaccines. Within 10 minutes after administration, patient became severely anxious, holding chest and stating he could not breathe. Oxygen saturation dropped to 84% and patient was placed on oxygen. Patient was severely hypertensive -225/115- and very wheezy and nauseous, beginning to vomit. Patient given 25 mg IV BENADRYL; BP, anxiety, and breathing improved afterward.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Flushing, Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Stiff muscles in my neck, tolerable arm pain in the injection arm. Flushed feeling face, unproductive sleep, tension in the muscles on the back and top of my head. Fatigue. It's not life threatening, just uncomfortable, but I absolutely understand the importance of data, so here you go XD. Really it's the sore muscles in my neck and head that are the most curious. I get a flu shot every year and this is the first time I've experienced this. Kind of like the top of my head is throbbing. I take generic Zyrtec (Costco, aller-tec) and a multi-vitamin.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Sleep disorder
Clinical narrative: Stiff muscles in my neck, tolerable arm pain in the injection arm. Flushed feeling face, unproductive sleep, tension in the muscles on the back and top of my head. Fatigue. It's not life threatening, just uncomfortable, but I absolutely understand the importance of data, so here you go XD. Really it's the sore muscles in my neck and head that are the most curious. I get a flu shot every year and this is the first time I've experienced this. Kind of like the top of my head is throbbing. I take generic Zyrtec (Costco, aller-tec) and a multi-vitamin.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Eye pruritus, Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist who was a 50 years old male patient with allergy to sulfa drugs and to unspecified antibiotics. The patient's medical history included chicken pox. The pharmacist had administered ZOSTAVAX for 25-35 times. He stated that last Thursday, 10-JAN-2013, he noticed that one of the vials was wet when he took off his gloves, and he was concerned about the possibility that he could have touched his face or eye with a glove that may have had ZOSTAVAX on it. The pharmacist had not received an injection of ZOSTAVAX. On 11-JAN-2013 he developed pain, a few lesions and itching on the left side of his face and itching of his left eye. He began using TOBRADEX ophthalmic suspension on 12-JAN-2013. The pharmacist saw his physician today, on 14-JAN-2013, and was diagnosed with shingles and prescribed VALTREX. There was no lab diagnostics was performed. The patient sought medical attention by office visit. At the time of report, the patient was not recovered. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist who was a 50 years old male patient with allergy to sulfa drugs and to unspecified antibiotics. The patient's medical history included chicken pox. The pharmacist had administered ZOSTAVAX for 25-35 times. He stated that last Thursday, 10-JAN-2013, he noticed that one of the vials was wet when he took off his gloves, and he was concerned about the possibility that he could have touched his face or eye with a glove that may have had ZOSTAVAX on it. The pharmacist had not received an injection of ZOSTAVAX. On 11-JAN-2013 he developed pain, a few lesions and itching on the left side of his face and itching of his left eye. He began using TOBRADEX ophthalmic suspension on 12-JAN-2013. The pharmacist saw his physician today, on 14-JAN-2013, and was diagnosed with shingles and prescribed VALTREX. There was no lab diagnostics was performed. The patient sought medical attention by office visit. At the time of report, the patient was not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given the incorrect dose for her age.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Localized swelling, redness, warm to the touch.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Ring of redness around injection site ~3/4/" ring.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Very itchy during the night.  Got worse each day (hives appeared).  1/21 seen at doc. office.  Steroid shot.  Referred me to Allergist on 1/22. Taking steroid pack, Zyrtec, Zantec and Benadryl. Docs don't think caused by Vac.  I do.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Pain, Rash erythematous, Rash macular, Swelling
Clinical narrative: Severe pain throughout the night. Morning noticed a rash like redness, blotchy from elbow to shoulder, still very painful and very swollen.  Blotchy turned into bruise like, going from red to dark.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Cardiac stress test normal, Chest pain, Computerised tomogram normal, Dyspnoea
Clinical narrative: Fatigue, chest pain (heart attack like symptoms) lasted until 1st week of Jan. 2013. All tests were negative - no other known cause. Dyspnea, SOB, was told ? pleurisy ? pericarditis, but all tests normal. No temp. I am the patient completing this form. I have had problems, twice, in the past with flu shots - severe vomiting, fever, fatigue. I was given a waiver from my physician to not have it, but our hospital said it was mandatory and even with the waiver, we would be required to wear a mask 8 hours a day until March 1st. I thought I would try and get again. I was assured by occupational health that it was a 'dead virus' and I would not have any problems. The day after receiving it, I was extremely tired, that continued for a few weeks, then I started to notice S.O.B. this occurred gradually. By the night of Nov. 11th I couldn't even lie down to breathe, I had to sleep sitting up. Upon going to work Nov. 12, the pain & SOB became so severe that the other employees rushed me to the ER. I was admitted on the cardio unit and released 2 days later. Pain remained severe off & on for several weeks. All tests were negative including CT, chest, blood, stress, EKG. No real diagnosis was ever made. Until I had that shot I had never missed a sick day from work in almost 5 years.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Fatigue
Clinical narrative: Fatigue, chest pain (heart attack like symptoms) lasted until 1st week of Jan. 2013. All tests were negative - no other known cause. Dyspnea, SOB, was told ? pleurisy ? pericarditis, but all tests normal. No temp. I am the patient completing this form. I have had problems, twice, in the past with flu shots - severe vomiting, fever, fatigue. I was given a waiver from my physician to not have it, but our hospital said it was mandatory and even with the waiver, we would be required to wear a mask 8 hours a day until March 1st. I thought I would try and get again. I was assured by occupational health that it was a 'dead virus' and I would not have any problems. The day after receiving it, I was extremely tired, that continued for a few weeks, then I started to notice S.O.B. this occurred gradually. By the night of Nov. 11th I couldn't even lie down to breathe, I had to sleep sitting up. Upon going to work Nov. 12, the pain & SOB became so severe that the other employees rushed me to the ER. I was admitted on the cardio unit and released 2 days later. Pain remained severe off & on for several weeks. All tests were negative including CT, chest, blood, stress, EKG. No real diagnosis was ever made. Until I had that shot I had never missed a sick day from work in almost 5 years.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Abnormal behaviour, Infantile spasms
Clinical narrative: GM and parents noticed that patient never returned to his smiling self after these shots. They reported that on 12/14/12. Ultimately was admitted to hospital 1/17/13 for sz's and diagnosed with ("Hypsarrhythmia"). Parents relate this back to vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: (L) arm redness.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Pruritus
Clinical narrative: Approximately 15-20 minutes after vaccine administration pt described itching on his left index finger, hand, & shoulder, as well as pain in his lower left back.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Night sweats, Pyrexia
Clinical narrative: 4 hrs. after immunization - symptoms of fatigue slight cough, fever 102-103 F, night sweats, chills, rash (Sunday AM 1/13/13).
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 4 hrs. after immunization - symptoms of fatigue slight cough, fever 102-103 F, night sweats, chills, rash (Sunday AM 1/13/13).
Age: 10.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Pyrexia
Clinical narrative: Fever - 2-3 days post vaccine. Parents gave OTC Ibuprofen.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchitis, Chills, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt 09-Jan-2013) concerns a 54 year old male patient with a medical history of Type II DM (diabetes mellitus), hyperlipidemia and renal calculi. Concomitant medications included fish oil, nicotinic acid, glipizide, cetirizine, acetylsalicylic acid, metformin, ramipril, and gemfibrozil. On 04-Oct-2012, the patient received AFLURIA (batch P59007). On 01-Jan-2013, the patient developed possible pneumonia, bronchitis and influenza like illness with symptoms of sore throat, fever, chills, productive cough, sinus headache, fatigue and body aches. The patient had an office visit to the physician on 08-Jan-2013 and the patient was seen by the physician on 08-Jan-2013. The physician diagnosed bronchitis with possible pneumonia. The patient was treated with doxycycline BID for 10 days. The event outcome was not yet recovered. Reporter's comments: The reporter considered events to be non serious.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Pyrexia, Sinus headache
Clinical narrative: This medically confirmed spontaneous report (initial receipt 09-Jan-2013) concerns a 54 year old male patient with a medical history of Type II DM (diabetes mellitus), hyperlipidemia and renal calculi. Concomitant medications included fish oil, nicotinic acid, glipizide, cetirizine, acetylsalicylic acid, metformin, ramipril, and gemfibrozil. On 04-Oct-2012, the patient received AFLURIA (batch P59007). On 01-Jan-2013, the patient developed possible pneumonia, bronchitis and influenza like illness with symptoms of sore throat, fever, chills, productive cough, sinus headache, fatigue and body aches. The patient had an office visit to the physician on 08-Jan-2013 and the patient was seen by the physician on 08-Jan-2013. The physician diagnosed bronchitis with possible pneumonia. The patient was treated with doxycycline BID for 10 days. The event outcome was not yet recovered. Reporter's comments: The reporter considered events to be non serious.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Thirst
Clinical narrative: After receiving Flu shot, customer passed out and struck head on shelves near front of store. Patient stated he was lightheaded, dizzy and thirsty. Also stated he had not eaten today. EMS arrived w/in 5 minutes and took over care.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Large red, raised area on upper (R) arm. Itchy to touch, warm to touch Given KEFLEX, OTC NSAIDS.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Decreased appetite, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, followed by chills, fever, loss of appetite.  Symptoms lasted for four days.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain and swelling at injection site, 3cm raised red nodule, hot to touch.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Fall, Fatigue, Flushing
Clinical narrative: After administration of flu vaccine, MA left out of the room to check a hemoglobin and mom report that patient became immediately dizzy and fell to the table.  When I went in to see patient, she was pale, flushed, and clammy, and having shallow breathing.  Oxygen quickly placed on patient and color came back slowly, oxygen saturation 100% but patient continued to feel dizzy and tired.  911 called and patient transported to ER for further evaluation.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Hypopnoea, Pallor
Clinical narrative: After administration of flu vaccine, MA left out of the room to check a hemoglobin and mom report that patient became immediately dizzy and fell to the table.  When I went in to see patient, she was pale, flushed, and clammy, and having shallow breathing.  Oxygen quickly placed on patient and color came back slowly, oxygen saturation 100% but patient continued to feel dizzy and tired.  911 called and patient transported to ER for further evaluation.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: 1 cm cutaneous nodule, right deltoid area. Minimally tender without significant erythema or warmth. OTC BENADRYL, cool compress.
Age: 77.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: Flu-like symptoms, rash on arms.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal mass
Clinical narrative: Developed lump in throat followed by difficulty breathing (3pm) went to Dr. (4pm) given DECADRON 6mg.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discharge, Injection site erythema, Injection site reaction, Pain
Clinical narrative: Red swelling at site of vaccine - swelling started disappearing after one week. But area now bruised & small red rash evident oozing this is day 9 - rash itchy & painful.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Vaccination site swelling
Clinical narrative: Red swelling at site of vaccine - swelling started disappearing after one week. But area now bruised & small red rash evident oozing this is day 9 - rash itchy & painful.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: On 11/19/12 the patient was vaccinated at approximately 9:40 am & immediately post vaccination the patient stated she felt nauseous; however, the patient had not had anything to eat for breakfast. At approximately 10:20 am, the patient stated she felt dizzy, so out of an abundance of precaution a decision was made to call 911 so that the patient could receive advanced medical care.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Paraesthesia, Sleep disorder
Clinical narrative: Rapidly beating heart that woke me from sleep. 2-3 hours duration. Slight tingling in fingertips on 1-15-2013 short duration.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Micturition urgency, Vulvovaginal burning sensation
Clinical narrative: Patient states 5 min after vaccine administration she experienced a unpleasant metallic taste in her mouth and a burning sensation in her vagina along with an increased urge to urinate. Symptoms subsided fully by 3:52 pm.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a female consumer refers to herself. The patient had vaccinated with dose 1 PNEUMOVAX23 in October 2009 and then got a second dose in November 2010. The patient did not report any adverse reactions to her shots. Additional information has been requested. The consumer also reported AE regarding her husband (captured in Case # 1301USA010393).
Age: 1.16
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Mother mentions that the patient had rash in the whole body. You can see hives in the entire body.