chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: No adverse event. Child reported having period on Dec. 15, 2013. Admits to sexually active but using protection. Pregnancy test completed and came back positive for pregnancy on 01/06/2013.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Pain at the injection site when immunization given. About 2 days later noticed problem lifting arm when putting in shirt. Still with pain when raising arm. Pain is positional. Tx: PT, NAPROSYN limit to 100 WT, ROM, heat. Recheck 1 week.
Age: 23.0
Sex: M
Vaccine: FLU3, RAB, TDAP
Symptoms: Dizziness, Headache
Clinical narrative: 10 minutes after imms given patient complained of dizziness & severe headache - laid down - dizziness resolved after 30 minutes - headache remained. Pt. went home to rest - headache resolved that evening - felt better 1-16-13 AM.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site reaction, Local reaction, Pruritus, Skin lesion
Clinical narrative: 45 minutes after flu vaccine pt had onset of several erythematous raised lesions on face & left arm - slightly itchy - no SOB. No local reaction at injection site.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Dizziness, Flushing, Nausea
Clinical narrative: Upon tending to her daughter, mom reported dizziness, weakness, need to vomit. I helped mom to floor to lie down. She was flushed but spoke with me until EMT arrived.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cold sweat, Dizziness, Malaise, Muscle spasms, Nausea
Clinical narrative: Upon tending to her daughter, mom reported dizziness, weakness, need to vomit. I helped mom to floor to lie down. She was flushed but spoke with me until EMT arrived.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pallor, Paraesthesia
Clinical narrative: Upon tending to her daughter, mom reported dizziness, weakness, need to vomit. I helped mom to floor to lie down. She was flushed but spoke with me until EMT arrived.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blindness transient, Crying, Dizziness, Nausea, Pallor
Clinical narrative: Within minutes after flu shots patient reported dizziness, nausea, tingling in legs, loss of sight in one eye. Patient vomited was crying/pale. 911/EMT's were called. Eye sight had returned by time EMT arrived.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Paraesthesia, Vomiting
Clinical narrative: Within minutes after flu shots patient reported dizziness, nausea, tingling in legs, loss of sight in one eye. Patient vomited was crying/pale. 911/EMT's were called. Eye sight had returned by time EMT arrived.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Blindness unilateral, Crying, Dizziness, Fear
Clinical narrative: Within minutes after flu shots patient reported dizziness, nausea, tingling in legs, loss of sight in one eye. Patient vomited was crying/pale. 911/EMT's were called. Eye sight had returned by time EMT arrived.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Malaise, Muscle spasms, Muscular weakness, Nausea, Pallor
Clinical narrative: Within minutes after flu shots patient reported dizziness, nausea, tingling in legs, loss of sight in one eye. Patient vomited was crying/pale. 911/EMT's were called. Eye sight had returned by time EMT arrived.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Within minutes after flu shots patient reported dizziness, nausea, tingling in legs, loss of sight in one eye. Patient vomited was crying/pale. 911/EMT's were called. Eye sight had returned by time EMT arrived.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blindness unilateral, Dizziness, Nausea, Pallor, Paraesthesia
Clinical narrative: Within minutes after flu shots patient reported dizziness, nausea, tingling in legs, loss of sight in one eye. Patient vomited was crying/pale. 911/EMT's were called. Eye sight had returned by time EMT arrived.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 63 years old female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot# was unknown) during the second week of June, 12. No concomitant medications were reported. On unknown date two to three weeks after vaccination in 2012 the patient experienced zoster on her thoracic/back area. The patient was seen by the physician. Antivirals was given for the treatment. The outcome of zoster on her thoracic/back area was unknown. The relatedness for zoster on her thoracic/back area was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. The patient was vaccinated with the second dose of GARDASIL (lot #, dose and route were unknown) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On unknown date the patient had pain that went down the injection arm and leg of the same side for 1 month. Nurse stated the patient was in the office for the third dose of GARDASIL today, 10-JAN-2013 and the patient mentioned prior to getting the third dose of GARDASIL she had pain after receiving the second dose of GARDASIL. The patient has not been given the third dose of GARDASIL. It was unknown if the patient had sought medical attention. The action taken was not provided. The outcome of pain that went down the injection arm and the leg of the same side was reported as recovered on an unknown date. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer reporting about her friend who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on an unknown date, her friend experienced the shingles after receiving the vaccine. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The relatedness for patient experienced shingles was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a pediatric patient of unknown age who on 11-JAN-2013, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported) rather than intended VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC13, VARCEL, DTAP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Convulsion, Cough, Dysphonia, Hypotonia, Malaise
Clinical narrative: See ER visit. Mother called today 1/16/13 to report this as adverse event. See progress note from this health department Re; phone calls. This is a 2-year-old male was behind on his immunizations and was seen at clinic yesterday and had immunizations to "include catch-up immunizations" done at that time. He has had a fever since this morning and dad states that his legs were swollen. Tonight he was staring blankly ahead and had the small generalized tonic-clonic activity. No vomiting. No other complaints. He is better at this point in time. He is brought in now for evaluation and treatment.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC13, VARCEL, DTAP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Mobility decreased, Speech disorder, Tremor
Clinical narrative: See ER visit. Mother called today 1/16/13 to report this as adverse event. See progress note from this health department Re; phone calls. This is a 2-year-old male was behind on his immunizations and was seen at clinic yesterday and had immunizations to "include catch-up immunizations" done at that time. He has had a fever since this morning and dad states that his legs were swollen. Tonight he was staring blankly ahead and had the small generalized tonic-clonic activity. No vomiting. No other complaints. He is better at this point in time. He is brought in now for evaluation and treatment.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC13, VARCEL, DTAP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Injection site swelling, Pyrexia, Staring, Tonic clonic movements
Clinical narrative: See ER visit. Mother called today 1/16/13 to report this as adverse event. See progress note from this health department Re; phone calls. This is a 2-year-old male was behind on his immunizations and was seen at clinic yesterday and had immunizations to "include catch-up immunizations" done at that time. He has had a fever since this morning and dad states that his legs were swollen. Tonight he was staring blankly ahead and had the small generalized tonic-clonic activity. No vomiting. No other complaints. He is better at this point in time. He is brought in now for evaluation and treatment.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Rapid, heavy heart beat - different from normal.  Woke up at 3:00 a.m. and it was still abnormal.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia, Pain
Clinical narrative: General muscle soreness, body aches, headache.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a female patient with no pertinent medical history. The patient was vaccinated with a dose of live (Merck) VARIVAX at age 12 months and a second dose as an adult. No other co-suspects were reported. No concomitant medications were reported. The physician reported that a recent varicella titer was negative. Medical assistant then came to the phone to provide the patient's name. The patient was seen in the office for medical attention. At the time of the report, the patient had not recovered from negative varicella titer. The patient experienced negative hepatitis B titer while on therapy with RECOMBIVAX HB (MARRS # 1301USA002522). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthropathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with one dose of 0.65 ml live ZOSTAVAX (Subcutaneous, lot number unknown) on 30-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The patient is scheduled to receive an unspecified corticosteroid shot (manufacturer unknown) on an unspecified date for a knee issue. The pharmacist noted that she doesn't know if the corticosteroid shot was scheduled before or after live ZOSTAVAX vaccination, but she doesn't suspect it is due to the ZOSTAVAX vaccination. The outcome of knee issue is unknown. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Feeling cold, Headache, Injection site reaction, Muscle spasms
Clinical narrative: Haedache, body aches and fatigue, at 1:00 PM cramping in bicep below shoulder where I received the shot, 6:00 pm feeling cold, nausea.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain
Clinical narrative: Haedache, body aches and fatigue, at 1:00 PM cramping in bicep below shoulder where I received the shot, 6:00 pm feeling cold, nausea.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Peripheral coldness
Clinical narrative: Headache, 7:00 PM felt cold to the touch, 8:00 PM Nausea, 6:00 AM on 1/17/2013 more nauseous than previous day.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Feeling cold, Headache, Injection site pain, Nausea
Clinical narrative: Shaky and cold, 12:00 midnight stomach upset and nausea, 01/17/2013 6:30 AM headache and ongoing nausea and shakiness. Arm is very sore and a bit swollen but does not appear red. Bicep sore below injection site (shoulder).
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Nervousness, Oedema peripheral, Pain in extremity
Clinical narrative: Shaky and cold, 12:00 midnight stomach upset and nausea, 01/17/2013 6:30 AM headache and ongoing nausea and shakiness. Arm is very sore and a bit swollen but does not appear red. Bicep sore below injection site (shoulder).
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Dizziness, Headache, Pain
Clinical narrative: Dizziness, fever, chills, body aches, headache, cough.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Dizziness, fever, chills, body aches, headache, cough.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site pain
Clinical narrative: As described by patient in DPH report: "On 12/2/12 I went to Pharmacy for a shingles injection (Zostavax), on 12/4/12 my right (injection site) had turned red and in pain. I went to my doctor that day and the doctor said I had an infection. He gave me an antibiotic (cephalexin) told me to take it for a week, if not healed to come back on 12/11/12. Today is 12/10/12 and I plan to go back to him tomorrow.  The infection has gotten better, but not gone."  PHYSICIAN UNABLE TO PROVIDE ME WITH ADDITIONAL INFORMATION.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site, no swelling no redness, applying cortisone.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient around 80 years old. The patient was vaccinated with a 0.65 ml dose of live ZOSTAVAX in approximately January 2012 (about a year ago). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles. The patient had office visit for medical attention. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with the first dose of RECOMBIVAX HB on 15-JUN-2012 and inquired about receiving a second dose on 03-JAN-2013. No adverse symptoms reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 30 years old female patient. The patient was vaccinated with (Merck) PROQUAD on 04-JAN-2012. The nurse reported that the 30 year old women had no history of previous vaccination with either MMR II or (Merck) VARIVAX at the time of the call. It was unclear at the time of the call why the (Merck) PROQUAD was administered on 04-JAN-2013. No product confusion discovered, only medication error. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient received the first dose of GARDASIL (lot number, expiry date, route and dose were not reported) on an unknown date in March 2007. The second dose of GARDASIL (lot number, expiry date, route and dose were not reported) on an unknown date in May 2007 and was in the office on 02-JAN-2013 (reported as today) for receiving the third dose of GARDASIL (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. No adverse event reported. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Herpes zoster, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 years old female patient without drug reactions or allergies. The patient's medical history included herpes simplex, genital herpes and shingles. On 07-JAN-2013, the patient was vaccinated subcutaneously in the left arm with a dose of 0.65 ml live ZOSTAVAX (lot number H018088, expiration date: unspecified). No other co-suspects were reported. No concomitant medications were reported. Past drug therapy included: VALTREX. The pharmacist reported that on 08-JAN-2013, the patient developed tenderness and swelling of her left arm at the injection site and around to the back on her arm and up into her left underarm area, after received live ZOSTAVAX. The patient also developed shingle like lesions on her left arm. It was reported that the patient's arm was getting worse each day. The pharmacist stated that the patient had shingles on the same side she had a few years ago, on her left trunk. Pharmacist stated that there was also lymph node involvement, there was a lump in patient's left underarm. The patient had tenderness and swelling, at the injection site of left arm that was silver dollar in size. Tenderness and swelling also extended from left elbow to the top of left arm. The patient seems to have blotches, not pustules on her left arm. The patient did not feel like she had a temperature. The patient sought medical attention by phone call to pharmacy. The patient would follow-up with her health provider. No treatment information was reported. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 years old female patient without drug reactions or allergies. The patient's medical history included herpes simplex, genital herpes and shingles. On 07-JAN-2013, the patient was vaccinated subcutaneously in the left arm with a dose of 0.65 ml live ZOSTAVAX (lot number H018088, expiration date: unspecified). No other co-suspects were reported. No concomitant medications were reported. Past drug therapy included: VALTREX. The pharmacist reported that on 08-JAN-2013, the patient developed tenderness and swelling of her left arm at the injection site and around to the back on her arm and up into her left underarm area, after received live ZOSTAVAX. The patient also developed shingle like lesions on her left arm. It was reported that the patient's arm was getting worse each day. The pharmacist stated that the patient had shingles on the same side she had a few years ago, on her left trunk. Pharmacist stated that there was also lymph node involvement, there was a lump in patient's left underarm. The patient had tenderness and swelling, at the injection site of left arm that was silver dollar in size. Tenderness and swelling also extended from left elbow to the top of left arm. The patient seems to have blotches, not pustules on her left arm. The patient did not feel like she had a temperature. The patient sought medical attention by phone call to pharmacy. The patient would follow-up with her health provider. No treatment information was reported. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events was unknown for live ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Pt complaining of shoulder pain since receiving FLUZONE vaccine. Sought help/seen Dr 11/6/12.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test, Infection, No therapeutic response, Pneumonia
Clinical narrative: This spontaneous report was received from a registered nurse (who is the mother) refers to a 1 year 4 month old female patient. The patient had pertinent medical history of multiple ear infection and pneumonia. The patient has AMOXIL allergy. On 22-MAR-2007, the patient was vaccinated with a dose 1 of PNEUMOVAX 23 (manufacturer unknown) (also reported as PNEUMOVAX 7 and PNEUMOVAX 13 (lot number, expiration date and route not reported). The patient was vaccinated with PNEUMOVAX 23 (also reported as PNEUMOVAX 7) on 22-MAR-2007, 31-MAY-2007, 31-JUL-2007, 25-JAN-2008. She was also vaccinated with PNEUMOVAX 23 (manufacturer unknown) (also reported as PNEUMOVAX 13) (lot number, expiration date and route not reported) on 09/02/2010. No concomitant medications were reported. The patient did not develop immunity to either one of the vaccines. On an unknown date in May-2008, the reporter stated that the patient kept getting unspecified infections and was diagnosed with pneumonia where she was hospitalized from 10-NOV-2012 to 11-NOV-2012. It was unknown whether the product involved was PNEUMOVAX 23 or PREVNAR (other manufacturer) as the reporter referred to the vaccine as PNEUMOVAX 7 and PNEUMOVAX 13. Pneumococcal titers were performed and the result was unknown. There was no treatment rendered for the events. Outcome of the reported events were unknown. The patient sought medical attention. 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. The patient was vaccinated with the first and the second dose of GARDASIL (dose, route and lot# not reported) on 08-DEC-2011 and on 13-MAR-2012 respectively. It was reported the patient would like to receive her third dose of GARDASIL on 14-JAN-2013. No adverse symptoms. Additional information has been requested.
Age: 1.71
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough
Clinical narrative: Mom & dad requested flu vaccine for baby - Brought baby to office for vaccine 1/10/13. 103 degrees Temp sudden onset with dry cough. Spoke to mom 1/17/13. Mild cough remains. Fever gone. The symptoms began on the 14th.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Low grade fever for 24 hours, no adverse effects.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Pyrexia
Clinical narrative: Parents report fever of 102.9 F starting the morning after (1/5/13) MMR administration. Fever of 100-101 lasted for 4 days. Treated with supportive measures. Pt did report dry cough as well.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red circle about 2 inches in diameter around the injection site, hot to the touch and itchy.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Balance disorder, Bladder dysfunction, CSF protein increased, Functional gastrointestinal disorder
Clinical narrative: 19 days post vacc numbness both legs up to hips. Loss of ability to walk. Diagnosed Guillain Barre syndrome. Having trouble bowel & bladder - due to numbness. Continues to have numbness in both legs to hip. Received IVIG -> able to walk now but having balance issue especially left leg.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Nerve conduction studies abnormal, Nerve injury
Clinical narrative: 19 days post vacc numbness both legs up to hips. Loss of ability to walk. Diagnosed Guillain Barre syndrome. Having trouble bowel & bladder - due to numbness. Continues to have numbness in both legs to hip. Received IVIG -> able to walk now but having balance issue especially left leg.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Muscular weakness, Musculoskeletal stiffness, X-ray
Clinical narrative: Patient started around 12/25/12 with leg weakness & stiffness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Pt had vomiting, fever, chills. All symptoms resolved by 5 pm on 1/8/13.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Warm, redness, swollen, itchy, near injection site, size of 2 quarters.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Patient called our pharmacy on 1/9/13 to let us know that she developed cellulitis at the flu shot injection site.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus, Skin warm
Clinical narrative: 3 1/2 x 4" swollen, warm to touch red area rt arm itches now - woke up during middle of night due to pain in area.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Generalised erythema, Lip swelling, Pruritus generalised
Clinical narrative: Lips swelled, body turned red & was itchy everywhere about 30 min. after administration patient on her own took CLARITIN & felt better in an hour. Symptoms resolved after 3 hours & was back to normal.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. The patient was vaccinated (intramuscular) with dose 2, .5 ml GARDASIL (lot # H016238, expiry date 11-APR-2015) on 10-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The registered nurse stated that her patient received her first dose of GARDASIL one year ago on an unspecified date. The registered nurse stated that the patient received the second dose yesterday, 10-JAN-2013. No adverse experiences reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: This spontaneous report was received from a physician via a sales representative concerning a 16 years old male patient with sinus infection, who on 08-JAN-2013 was vaccinated with dose 1 of GARDASIL (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 was being treated for sinus infection simultaneously to receive the first dose of the vaccine and the patient developed fainting spells and dizziness on 09-JAN-2013, 24 hours after receiving the vaccine. The patient sought medical attentions. No treatment information was reported. The outcome of fainting spells and dizziness was unknown. The relatedness for fainting spells and dizziness was unknown for GARDASIL. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: Information was received for a case for live (Merck) VARIVAX (MARRS # 1301USA005117) from medical records concerning an approximately nine year old female. Vaccination records indicated the female was vaccinated with PNEUMOVAX23 on 15-FEB-2004 (lot number 647039/0604N; expiration date 17-APR-2005) (site of vaccination illegible) and 26-JUN-2012 in the left arm (lot number 672962/0025AE; expiration date 18-OCT-2013). Medical record date 15-DEC-2012 indicated that the female had a history of low PNEUMOVAX23 titers in 2005 "with adequate response to PNEUMOVAX." She again had low titers in 2012 with subsequent PNEUMOVAX23 titers. The outcome was not specified. All available medical records will be provided upon request. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pts rxn started Tuesday night 1-15-13. Has swelling Rt arm from below injection sight to elbow. Painful. Taking BENADRYL & ibuprofen.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: 6 x 6 area of redness, warm to touch no tenderness, itchy. Patient states symptoms began 1 day after vaccine. Pt was referred to urgent care.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: 6 x 6 area of redness, warm to touch no tenderness, itchy. Patient states symptoms began 1 day after vaccine. Pt was referred to urgent care.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Pt has been dx with transverse myelitis.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary pain, Body temperature increased, Pain in extremity
Clinical narrative: 01-17-13 1230p Client's mother telephoned to report: Client c/o arm pain as soon as he got home from getting flu shot yesterday. She is out of town and rec'd a phone call from a school nurse advising client has a temp of 101F and c/o severe arm pain going into axilla referred client's mother to their pediatrician. Mother awaiting dr return call.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician refers to a multiple patients (age and gender unknown). The patients were vaccinated with GARDASIL (route, lot number and dose were not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patients experienced post-vaccination syncope occurring within 15 minutes of vaccination. The occurrence had minimized by taking appropriate precautions with patients. The outcome of syncope was unknown. The relatedness for syncope was unknown for GARDASIL. She also reported that a local pediatric cardiologist was receiving many consultations due to syncope and raising levels of concern about this AE in community. Additional information has been requested. This is one of several reports from the same source.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Confusional state, Feeling abnormal, Headache, Pallor, Seizure like phenomena
Clinical narrative: Pt received first HPV (Gardasil) vaccine, MCV4 (Menactra) booster and Influenza injectable vaccine.  Injections administered per office protocol and well tolerated.  Within 3 minutes pt became pale, declared that he had a frontal headache and felt off, and then proceeded to lay down on exam table.  He displayed brief seizure-like behaviors.  He then opened his eyes, was momentarily confused, and then gradually returned to his normal baseline with good color and resolved HA.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: The patient stated that her arm became red and swollen. Then she reported 1/17/13 that on her opposite hand, her knuckle became bright red and her hand was swelling.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash macular, Urticaria
Clinical narrative: RED BLOTCHY SKIN ON FACE AND HIVES ON FACE, NECK, BACK, CHEST, ARMS. CHECKED BREATHING AND THAT SHE COULD SWALLOW THEN TOOK HOME AND GAVE BENADRYL.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Chills, Cough, Diarrhoea
Clinical narrative: Watery eyes, ear ache, chills, loose stool, upset stomach, cough, weakness.  Symptoms were gone by 7:30 AM the next morning.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pain, Lacrimation increased
Clinical narrative: Watery eyes, ear ache, chills, loose stool, upset stomach, cough, weakness.  Symptoms were gone by 7:30 AM the next morning.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Bradycardia, Diarrhoea, Electrocardiogram, Flushing, Hyperhidrosis
Clinical narrative: Initial flushing, profuse sweating, nausea and dry heaves, a little diarrhea. Slowed HR to 52 (normal above 70) - EKG done while at work-employee health gave me a Benadryl, sent to ER. Given Epi-pen Rx - diagnosed as allergic reaction to flu vaccine - am no longer allowed to take it - also had reaction to pneumonia vaccine given in Dr.'s office in Sept. (that was reddenned, swollen arm only - thought it was just local reaction) - I have COPD-tracheal brochial malacia - high risk - want to get it in the future - my question - do I go to an ER just in case I have a reaction? I am an RN. Please advise. Also - what about shingles vaccine - recommend I try to get that? If you can't answer this - what kind of a doctor would I go to to ask? Thanks.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Retching, Vaccination complication
Clinical narrative: Initial flushing, profuse sweating, nausea and dry heaves, a little diarrhea. Slowed HR to 52 (normal above 70) - EKG done while at work-employee health gave me a Benadryl, sent to ER. Given Epi-pen Rx - diagnosed as allergic reaction to flu vaccine - am no longer allowed to take it - also had reaction to pneumonia vaccine given in Dr.'s office in Sept. (that was reddenned, swollen arm only - thought it was just local reaction) - I have COPD-tracheal brochial malacia - high risk - want to get it in the future - my question - do I go to an ER just in case I have a reaction? I am an RN. Please advise. Also - what about shingles vaccine - recommend I try to get that? If you can't answer this - what kind of a doctor would I go to to ask? Thanks.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Vaccination site discolouration, Vaccination site inflammation
Clinical narrative: Vaccination discoloration - site. Vaccination inflammation - site. Muscle aches. Fever. Has had shingles 5/2012 on right side.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Diarrhoea, Dysstasia, Pyrexia
Clinical narrative: Continuous severe vomiting every half hour from 7:30 PM until 3 am. Chills, fever, unable to sit or stand due to weakness and doing so provoked more vomit. Diarrhea. Was home alone with no help. Did not know this would happen otherwise I would not have gotten this vaccine. I wanted to call 911 but I have no health insurance and was scared of getting another big bill.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Continuous severe vomiting every half hour from 7:30 PM until 3 am. Chills, fever, unable to sit or stand due to weakness and doing so provoked more vomit. Diarrhea. Was home alone with no help. Did not know this would happen otherwise I would not have gotten this vaccine. I wanted to call 911 but I have no health insurance and was scared of getting another big bill.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain, soreness, redness around injection site.  Headache and chills.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Feeling abnormal, Immediate post-injection reaction, Injection site reaction, Oedema peripheral
Clinical narrative: Pain, soreness, redness around injection site.  Headache and chills.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Tremor, Wound
Clinical narrative: Pain, soreness, redness around injection site.  Headache and chills.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: The patient had a syncopal event immediately following administration of the HPV vaccine. She recovered quickly and was fully alert and oriented. Normal BP and pulse.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Oedema peripheral, Rash, Rash erythematous, Skin warm
Clinical narrative: Red rash bilateral arms & shoulders. Hot to touch. Pt. reports edema in (L) arm on 1/15/13 & resolving 1/16/13. Pt. referred to her PCP - being seen today.
Age: 21.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling 50cm including both inj sites, soreness, warm, pink/redness in left upper arm/deltoid area.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood test normal, Computerised tomogram head normal, Dizziness, Electrocardiogram normal, Malaise
Clinical narrative: About 12:02pm, C/O dizziness, "feel sick", shaky. Layed down 8-10 min. Felt better, sat up, took sip of pop, and within a minute felt dizzy & sick again. B/P, Pulse Ox, Pulse, Temp all taken and WNL. Around 12:20-25, became increasing non verbal, eyes closed, although responding with head nods and moved hands and feet when asked. Called Paramedics to transport to ER, arriving @ 12:30, Transported Pt. At 12:40pm.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Tremor
Clinical narrative: About 12:02pm, C/O dizziness, "feel sick", shaky. Layed down 8-10 min. Felt better, sat up, took sip of pop, and within a minute felt dizzy & sick again. B/P, Pulse Ox, Pulse, Temp all taken and WNL. Around 12:20-25, became increasing non verbal, eyes closed, although responding with head nods and moved hands and feet when asked. Called Paramedics to transport to ER, arriving @ 12:30, Transported Pt. At 12:40pm.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash began one day after injection and consisted of painful itchy large red bumps in 2 clusters (abdomen and hip). Bumps are still there 6 days later (today). Patient called physician and was told to keep an eye on rash and report any further problems. She is keeping the area clean and dry and applying triple antibiotic.
Age: 37.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Arthralgia, Blood test, Body temperature increased, Electromyogram, Headache
Clinical narrative: Pins and needles in hands and feet, severe thigh knee pain, thigh arm muscles twitching, inability to sleep, stinging sensation around body, headache, low temp, weakness is feet and hands, malaise, issues may or may not be resolving 5 days later.
Age: 37.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Insomnia, Malaise, Muscle twitching, Muscular weakness, Pain
Clinical narrative: Pins and needles in hands and feet, severe thigh knee pain, thigh arm muscles twitching, inability to sleep, stinging sensation around body, headache, low temp, weakness is feet and hands, malaise, issues may or may not be resolving 5 days later.
Age: 37.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pins and needles in hands and feet, severe thigh knee pain, thigh arm muscles twitching, inability to sleep, stinging sensation around body, headache, low temp, weakness is feet and hands, malaise, issues may or may not be resolving 5 days later.
Age: 37.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Antinuclear antibody positive, Arthralgia, Electroencephalogram normal, Electromyogram normal, Headache
Clinical narrative: Pins and needles in hands and feet, severe thigh knee pain, thigh arm muscles twitching, inability to sleep, stinging sensation around body, headache, low temp, weakness is feet and hands, malaise, issues may or may not be resolving 5 days later.
Age: 37.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Muscle twitching, Nerve conduction studies normal, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Pins and needles in hands and feet, severe thigh knee pain, thigh arm muscles twitching, inability to sleep, stinging sensation around body, headache, low temp, weakness is feet and hands, malaise, issues may or may not be resolving 5 days later.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 4 x 4 cm firm swollen area at immunization site. This being upper left leg. Also a 2 x 2 cm area of erythema in the center of the area.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash, itch, and swelling at sight of injection. Spoke with client on again on 01/17/13, she stated no improvement, her symptoms were actually worsening. Advised to go back to the doctor for re-evaluation.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Feeling abnormal, Feeling hot, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: I gave patient the Gardasil vaccination at approximately 4:30, about 10 minutes later, while performing a finger stick on patient, he began to become pale in his face and began to sweat, at that time his Dad ask him if he felt okay, patient replied, "No, I feel weird" I then stopped the procedure I was performing and asked patient to lay down on the exam table and I asked Dad to please elevate patient feet. I asked patient how he was feeling once we got him to lay down with is feet elevated and he stated" I am starting to feel a little better". I then asked Dad to please continue to elevate his feet while I got Dr so that he could check on patient as well and so that he was aware of the near syncope episode. Patient did not have a full on syncope episode but he was very close to having one had we not caught him in enough time to stop what we were doing to lie him down and elevate his legs. We then gave him water and placed a small fan in the room because he was hot and also gave him a cold compress for his forehead. After about 15-20 he began to feel well enough to sit up slowly and then within a few minute he was able to stand and walk. He and Dad then stated that he felt well enough to leave the office. I instructed Dad that if this were to happen again at home that he needed to contact us immediately and seek medical attention.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Patient complaining of heart racing and increased heart rate at rest.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 1-15-13 VARIVAX, right arm, polio normal. MMR II DTP left arm redness, swelling, no pain.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Dysphonia, Injection site erythema, Injection site pain, Oropharyngeal pain
Clinical narrative: 30 minutes after vaccination felt throat sore and voice hoarseness, sneezing a lot. Yesterday stayed the same in bed. Today just hoarse not sore, runny nose yesterday. Soreness and redness at site of injection wouldn't be able to lay on it.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: 30 minutes after vaccination felt throat sore and voice hoarseness, sneezing a lot. Yesterday stayed the same in bed. Today just hoarse not sore, runny nose yesterday. Soreness and redness at site of injection wouldn't be able to lay on it.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Gait disturbance, Myalgia, Oropharyngeal pain
Clinical narrative: Early November experienced fever, chills, muscle aches, pain which lasted a few days. Yesterday barely walking, sore throat, fever, chills/shivering, diarrhea, only gave her TYLENOL yesterday and NYQUIL last night.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Early November experienced fever, chills, muscle aches, pain which lasted a few days. Yesterday barely walking, sore throat, fever, chills/shivering, diarrhea, only gave her TYLENOL yesterday and NYQUIL last night.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Large area of erythema at site of injection (L) deltoid.
Age: 1.28
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pallor, Papule, Pyrexia, Rash erythematous, Skin plaque
Clinical narrative: Fever 1/11 to 1/13/13 with rash over trunk; Rash is large erythematous plaques and papules that blanch. Consistent with MMR reaction rash & fever.
Age: 1.28
Sex: F
Vaccine: DTAP, MMR
Symptoms: Vaccination complication
Clinical narrative: Fever 1/11 to 1/13/13 with rash over trunk; Rash is large erythematous plaques and papules that blanch. Consistent with MMR reaction rash & fever.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, PNC
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Hep A was inadvertently given at age 6 mos.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 21 year old male patient with no pertinent medical history or drug/reaction allergies. The patient was vaccinated with lot # (H013831, expiration date 06-MAR-2015) dose 1, 0.5 ml GARDASIL (lot number H013831, expiration date not provided) on 07-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that on 08-JAN-2012, the patient developed lower lip swelling. No laboratory tests were performed. He was given unspecified antihistamines and on 08-JAN-2013, the swelling resolved. The relatedness for lower lip swelling was unknown for GARDASIL. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician and licensed practical nurse refers to a 8 years old male patient (student) with strabismus (since 2009), no illness at the time of vaccination and no known drug allergies (NKDA) and Hep B positive mother. On 12-JUL-2012 at 16:00 PM, the patient was revaccinated with the fourth dose of RECOMBIVAX HB 5 mcg, (reported as 'pediatric dose", given intramuscularly in left arm)(lot# 671326/1522A, exp, date not reported) due to decreased (low) titers. No concomitant medications were reported. The patient did not visit the emergency room or doctor. At the time of report, the patient's outcome was unknown. Vaccine information statement (VIS) was given. The relatedness for the patient's event was not reported for RECOMBIVAX HB. It was also reported that the patient was given GARDASIL in error on 12-JUL-2012(MARRS # 1207USA005280). Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Dehydration, Pyrexia, Vomiting
Clinical narrative: Case number PHEH2013US001121 is an initial spontaneous report received from a consumer on 11 Jan 2013: This report refers to a 46-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with Flu vaccination (manufacture and batch number: unknown) on an unspecified date in 1999. After vaccination on an unspecified date, she experienced vomiting, fever and dehydration. The outcome, seriousness and causality of the events were not reported.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Electroencephalogram, Grand mal convulsion, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a female consumer concerning her 5 year old son with no pertinent medical history and drug reactions/allergies who on an unknown day in August 2008 was vaccinated with a dose of MMR II (route, lot number and expiration date were not provided), included (Merck) VARIVAX (route, lot number and expiration date were not provided), diphtheria toxoid, pertussis acellular vaccine (unspecified) (manufacturer unknown) (route, lot number and expiration date were not provided), and poliovirus vaccine inactivated (unspecified) (manufacturer unknown) (route, lot number and expiration date were not provided). No concomitant medications were reported. The consumer reported that her son experienced grandmal seizures after being given the vaccines. On an unknown date, a MRI and an EEG were performed (result not provided). The patient sought medical attention, therefore, he did not received any treatment for the event. On an unknown date, the patient had recovered from the event. The relatedness for grandmal seizures was unknown for all the vaccines given in August 2008. This is one of several reports received from the same source (other case number 1301USA007397). Upon internal review, the event of grandmal seizures was considered to be another important medical event. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: HEP, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash macular
Clinical narrative: Approximately 20 minutes after receiving vaccines, pt developed few red macular blotches on forehead and cheeks. No other symptoms noted.  Pt rxd Benadryl to take every 6 hr if rash present. Rxd Tylenol every 4 hr for pain/fever if occurs. Advised mother to RTC if symptoms worsen. ER precautions provided.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Chills, Eye pruritus, Fatigue, Headache
Clinical narrative: My reaction started with itchy eyes.  Then I started experiencing back pain, chills and headache.  On 01/16/2013 I continued to experience chills, fever, headache, fatigue and developed wide spread hives.  On 01/17/2013 I was no longer experiencing chills and fever but the hives and headache continue.  I have extreme sensitivity to touch on my head and abdomen.