chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 25 years old female patient with penicillin allergy and seasonal allergy was vaccinated IM into left arm with the second dose of GARDASIL (lot # 672193/1524AA, expired date 23-AUG-2014) on 10-APR-2012. No other suspect therapies were reported. Concomitant medications included BOOSTRIX (lot #AC52B080AA) which vaccinated IM into right arm on 10-APR-2012. On 12-APR-2012 the patient experienced weakness in right arm and hand, hand stiff and swollen, unable to lift a glass of milk. Tingling and burning in elbow and shoulder. The patient had fever on and off. The patient's arm was constantly throbbing. Pain waked her up at night. The patient was seen by primary care physician on 16-APR-2012. This report was considered not serious, required ER visit. The original reporting source was not provided. The VAERS ID # is 453792. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Activities of daily living impaired, Burning sensation, Muscular weakness, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 25 years old female patient with penicillin allergy and seasonal allergy was vaccinated IM into left arm with the second dose of GARDASIL (lot # 672193/1524AA, expired date 23-AUG-2014) on 10-APR-2012. No other suspect therapies were reported. Concomitant medications included BOOSTRIX (lot #AC52B080AA) which vaccinated IM into right arm on 10-APR-2012. On 12-APR-2012 the patient experienced weakness in right arm and hand, hand stiff and swollen, unable to lift a glass of milk. Tingling and burning in elbow and shoulder. The patient had fever on and off. The patient's arm was constantly throbbing. Pain waked her up at night. The patient was seen by primary care physician on 16-APR-2012. This report was considered not serious, required ER visit. The original reporting source was not provided. The VAERS ID # is 453792. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 25 years old female patient with penicillin allergy and seasonal allergy was vaccinated IM into left arm with the second dose of GARDASIL (lot # 672193/1524AA, expired date 23-AUG-2014) on 10-APR-2012. No other suspect therapies were reported. Concomitant medications included BOOSTRIX (lot #AC52B080AA) which vaccinated IM into right arm on 10-APR-2012. On 12-APR-2012 the patient experienced weakness in right arm and hand, hand stiff and swollen, unable to lift a glass of milk. Tingling and burning in elbow and shoulder. The patient had fever on and off. The patient's arm was constantly throbbing. Pain waked her up at night. The patient was seen by primary care physician on 16-APR-2012. This report was considered not serious, required ER visit. The original reporting source was not provided. The VAERS ID # is 453792. No further information is available.
Age: 20.0
Sex: F
Vaccine: HEP, HPV4, VARCEL, HEPAB, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 20 years of female patient with no known allergy, no known drug allergy and no previous illness. The patient was vaccinated IM with dose 2 GARDASIL (lot # 670048/0963AA) on 10-APR-2012. Other suspect therapies included VARIVAX (Merck) (lot # 669920/0342AA, SQ dose 1) on 10-APR-2012. Concomitant medications included: TWINRIX (lot # AHBVC039AA, dose 2, IM). On 10-APR-2012 the patient experienced swelling and 1/2 dollar sized blistering at varicella administration site surrounding area of erythema and heat. CDC contacted. Tx=cold compress, analgesia and BENADRYL. Patient instructed to go to ER if area worsens. At the time of the report, the outcome was unknown. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Laboratory test normal, Nausea, Pain, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 19 year old female patient with none medical history and none prex-illness vaccinated with the third dose of GARDASIL (lot number: 672233/1561AA), IM into the left arm on 29-MAR-2012. On the same day, the patient was vaccinated with the second dose of HAVRIX (lot number: AHAVB524AA) IM into the right arm. There was no other medication. On 01-APR-2012, the patient experienced nausea, vomiting and body aches (pain). Lab done-NI. At the time of reporting, the outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID #: 453814-1.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 19 year old female patient with none medical history and none prex-illness vaccinated with the third dose of GARDASIL (lot number: 672233/1561AA), IM into the left arm on 29-MAR-2012. On the same day, the patient was vaccinated with the second dose of HAVRIX (lot number: AHAVB524AA) IM into the right arm. There was no other medication. On 01-APR-2012, the patient experienced nausea, vomiting and body aches (pain). Lab done-NI. At the time of reporting, the outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID #: 453814-1.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 10 years old male patient with no previous illness on 12-APR-2012 was vaccinated IM with the dose 1 GARDASIL (dose not reported, lot # 1291AA) onto right arm, dose 1 BOOSTRIX (dose not reported, lot # AC52B072AE) onto left arm and dose 1 MENACTRA (dose not reported, lot # U4001AA) onto left arm. There were no other concomitant medicines. On 13-APR-2012 the patient experienced (L) arm swollen, hot-to-touch, hard-to-touch, very red, temp 97.5, 2 days after onset of therapy. All AEs were assessed as non serious. The patient had no conditions. MD prescribed then stopped BACTRIM. Outcome was unknown at the time of reporting. No further information is available. The original reporting source was not provide. The VAERS ID # is 454362.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test normal, Insomnia, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under Freedom of Information Act. An 11 years old female patient with no history and no prex illness who on 03-MAR-2012, was vaccinated with the third dose of GARDASIL (Lot#, dose and route not reported). No concomitant therapy reported. On 10-MAR-2012 the patient experienced unable to sleep and nausea, nausea was now 24hrs a day. No vomiting. All blood test normal so far. At the time of reporting, the outcomes were unknown. The original reporting source was not provided. No further information is available. The VAERS ID# 454544-1.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Injection site pruritus, Swelling face
Clinical narrative: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 11 years old female patient with no pertinent medical history and no known drug allergies or previous illness was vaccinated IM into right arm with lot # (670050/1229AA) dose 3 GARDASIL on 30-MAY-2012. No other co-suspects were reported. There was no concomitant medication. There was no illness at time of vaccination. On 30-MAY-2012 the patient developed injection site itching and pain with facial swelling the evening after receiving the GARDASIL. No wheezing, shortness of breath or tongue swelling. No history of food, drug or environmental allergies. Mother administered TYLENOL and BENADRYL and the patient was seen in the office on 31-MAY-2-12. The original reporting source was not provide. The VAERS ID # is 456548-1. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 years old female patient with no medical history and no prex illness who on 01-JUN-2012 was vaccinated with the second dose of GARDASIL (lot # 670049/1261AA), intramuscular on left deltoid, dose not reported. Concomitant medications included: the second dose of HAVRIX (Lot # AHAVB541CA, intramuscular  on right deltoid). On 01-JUN-2012 the patient experienced syncope. The patient was to wait in the room for print out. When she came out to waiting room, she preceeded to faint. The patient rested and was given water and crackers. At the time of reporting, the outcome was unknown. The original reporting source was unknown. The VAERS ID# 456616-1.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash, Pruritus, Rash erythematous
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old female patient with no medical history and no previous illness. The patient was vaccinated IM with dose 1 GARDASIL (lot # 666597/0768Z) on left arm on 25-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 25-APR-2012 the patient broke out after receiving vaccine at school. She did not return to the health center that afternoon but came in the next morning. The patient presented with raised, red rash to (left) upper arm, (left) upper chest, and (left)ankle and pruritus, at the time of the report, the outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash, Pruritus, Rash, Rash erythematous
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old female patient with no medical history and no previous illness. The patient was vaccinated IM with dose 1 GARDASIL (lot # 666597/0768Z) on left arm on 25-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 25-APR-2012 the patient broke out after receiving vaccine at school. She did not return to the health center that afternoon but came in the next morning. The patient presented with raised, red rash to (left) upper arm, (left) upper chest, and (left)ankle and pruritus, at the time of the report, the outcome was unknown. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the Food and Drug Administration (FDA) (agency number 456969-1) under the Freedom of Information Act. A 23 years old female patient with none previous illness was vaccinated with a second dose of GARDASIL (lot # reported as 672653/1860AA) via unknown route at her left arm on 29-MAY-2012. No other co-suspects were reported. Concomitant medications included ORTHO TRI-CYCLEN. On 30-MAY-2012 the patient experienced generalized hives. The patient didn't perform any laboratory tests. The patient was given prednisone taper, ZYRTEC and BENADRYL for 14 days for the adverse event. The outcome of generalized hives was unknown. Additional information is not expected. The original reporting source was not provided.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 years old male patient with no pertinent medical history and no drug reaction or allergies. The patient was vaccinated subcutaneously in his left arm with a dose of ZOSTAVAX (Lot# 671074/1199AA, expired date 25-OCT-2012, dose not reported) on 12-JUL-2012. No other co-suspects were reported. Concomitant medications included glimepiride, metformin and lisinopril. On 18-JUL-2012 (also reported as 5 days later after onset of therapy) the patient experienced pain in his left arm. The pharmacist clarified the patient's pain was not around the injection site and the arm was painful, not sore. The patient contacted pharmacist for medical attention. No lab diagnostics studies were performed. No treatment was given. At the time of this report the patient was recovering. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 years old male patient with no pertinent medical history and no drug reaction or allergies. The patient was vaccinated subcutaneously in his left arm with a dose of ZOSTAVAX (Lot# 671074/1199AA, expired date 25-OCT-2012, dose not reported) on 12-JUL-2012. No other co-suspects were reported. Concomitant medications included glimepiride, metformin and lisinopril. On 18-JUL-2012 (also reported as 5 days later after onset of therapy) the patient experienced pain in his left arm. The pharmacist clarified the patient's pain was not around the injection site and the arm was painful, not sore. The patient contacted pharmacist for medical attention. No lab diagnostics studies were performed. No treatment was given. At the time of this report the patient was recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shooting discomfort in never ends of right side of face and teeth and gums.  Went to doctor's office on 8/3/2012 and was told I had Shingles.  My Shingles Shot adminstered two days previously. Zostavax (NDC: 00006-4963-31) caused my Shingles.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, soreness, itching, warm to touch at site of injection -- 4" x 2".
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Laboratory test, Pruritus, Rash vesicular
Clinical narrative: Bright red and itching at injection site of an area abouth 3in x 3in. Back and Legs with lesions resembling chicken pox blisters and itching.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Pyrexia, Vomiting
Clinical narrative: Had fever as high as 102, then had presumed seizure lasting 3 minutes.  Had some vomiting.  Taken to Urgent Care, given ibuprofen, oral fluids.  I saw her the  next day with low grade fever, tolerating fluids well.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Pt got shot on 8/1/2012, redness, swelling and warmth sensation developed that same evening. Pt saw her doctor the next day and was given acyclovir. Pt did not take it though. Day 3, pt's symptoms progressed, so pt went to ER, received SEPTRA DS. Day 4, symptoms progressed, went back to ER, got KEFLEX added to SEPTRA DS and was told to start acyclovir. Patient has been on Prednisone therapy since 2005. The current dose of prednisone is 3 mg po qd started 6 months ago.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: 8/02 Pt woke in a.m. with 3" - dia red rash and pain at injection site. 8/03 Rash expanded to 4" diameter with pain/itch. MD dx cellulitis & Rx KEFLEX 500 mg. 8/04 Rash expanded about 8" dia; ER MD ordered to continue BENADRYL, KEFLEX & ice. 8/05 Rash size stable, color fading, pain & itch persist, swelling visible.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: 8/02 Pt woke in a.m. with 3" - dia red rash and pain at injection site. 8/03 Rash expanded to 4" diameter with pain/itch. MD dx cellulitis & Rx KEFLEX 500 mg. 8/04 Rash expanded about 8" dia; ER MD ordered to continue BENADRYL, KEFLEX & ice. 8/05 Rash size stable, color fading, pain & itch persist, swelling visible.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Flushing, profuse sweating, nausea, light-headed (not severe) subsided after approx. One hour (<24 hr- still feces "washed out") (Began approx. 30 minutes post injection).
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash erythematous, Rash pruritic
Clinical narrative: Pt developed "red" rash - from (RT) eye down face - across chin & up left side - (itchy-burning) tried antihistamines (BENADRYL) approximately 3 days later started MEDROL Dose pak - improving.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Tongue disorder, Urticaria
Clinical narrative: This spontaneous report as received from an other health professional refers to an 89 years old female patient. The patient was vaccinated SC. with ZOSTAVAX (lot # 671901/0421AE), 0.65 ml) on 24-JUL-2012. No other co-suspects were reported. Concomitant medications included amoxicillin, carbidopa (+) levodopa, dicyclomine hydrochloride, lorazepam, phenytoin sodium and VOLTAREN transdermal gel. On 24-JUL-2012 the patient experienced swelling and hives in the throat and her tongue felt full which happened 3 hours after onset of therapy. There was no wheezing or facial swelling or respiratory distress. The patient went to Urgent Care and Family Center for an unspecified duration. The patient was treated with IM corticosteroids (unspecified) and phenyltoloxamine. The outcome of swelling and hives in the throat, tongue feel full and hives in throat was unknown. The relatedness for swelling and hives in the throat, tongue fell full and hives in throat was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with first 2 doses of GARDASIL on the appropriate schedule in 2010 (reported as "2 years ago") and received a third dose on 18-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer refers to a 65 years old female patient with AUGMENTIN allergic. The patient's medical history included patient tested positive antibody for chickenpox prior to the vaccination. The patient was vaccinated with a dose of ZOSTAVAX (Lot#, dose and route not reported) on 20-JUL-2012. Concomitant medications included: "blood pressure and anginal medications", AMBIEN and vitamins (unspecified). On 21-JUL-2012 the patient developed a lump at the injection site and experienced itchy rash on her ankle, belly and neck after receiving a dose of therapy. BENADRYL pills and cortisone cream were given. The patient sought medical attention by talking to the pharmacist. At the time of reporting, the outcomes were not recovered. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a 90 years old female patient with breast cancer, gallbladder disease and allergy to red Iron Oxide. The patient was vaccinated with dose 1 ZOSTAVAX (lot# was unknown)in approximately June 2012 (reported as about a month ago), A week after received ZOSTAVAX. There was no concomitant therapy, the patient experienced chickenpox, It went away than a week later it came back. The patient sought medical attention, doctor give her a cream which help with the extension of the chickenpox, The outcome of chickenpox was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with dose 1, dose 2 and dose 3 GARDASIL (lot # 673256/0629AE, exp date: 16-DEC-2014, reported by a healthcare worker) on 30-JAN-2012, 24-MAY-2012 and 20-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old female patient with nickel allergic and chrome allergic and medical history nickel chrome dermatitis. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (Lot# 0366AE, Exp date: 23-MAR-2013) on 24-JUL-2012. On 25-JUL-2012 the patient experienced itchy, rash about 2 1/2 inches long and 1 inch wide at the injection site of left arm. No treatment information was given. The patient sought medical attention by calling to the pharmacy. At the time of reporting, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported) on 08-AUG-2011. On 27-JUL-2012 the patient received the second dose. No adverse event reported. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (0.65 ml, SUB-Q, lot # 670755/0622AA) on 31-JUL-2012 and it expired on 26-JUL-2012. No adverse effects reported. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 21 years old female patient. The patient was vaccinated with first dose of GARDASIL on 10-NOV-2009, and second dose on 05-JAN-2012 (both lot# and route were unspecified). The reporter stated that the patient has not received the third dose of GARDASIL. No adverse effect was reported. The outcome of patient was unspecified. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from an lab technician refers to a female patient of unknown age. The patient was vaccinated with all 3 doses RECOMBIVAX HB (lot#, dose and route were unspecified). It was reported the patients did not seroconvert. In May-2009, the patient did not have protective titers when it was measured 5 years later. There was no treatment given for the event. The outcome of patient was unspecified. Additional information is not expected.
Age: 0.76
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a parent consumers refers to their 9 months old daughter with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated IM with RECOMBIVAX HB (lot# was unspecified) on 16-JUL-2012. No other co-suspects were reported. Concomitant medications included generic ZANTAC (manufacturer unknown). No lab diagnostic studies performed. On 19-JUL-2012 the patient experienced fever 100.9 degrees, 4 days after onset of therapy. No treatment information was reported. The outcome of fever 100.9 degrees was reported as recovered/resolved on 20-JUL-2012. The patient did not seek medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a female patient of unknown age. The nurse reported that patient started CERVARIX (manufacturer unspecified) when she was over 26 years of age and will receive a dose of GARDASIL to complete the HPV series on 24-JUL-2012. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a immunization worker. The reporter stated that a facility vaccinated clients with improperly stored VARIVAX (Merck) (Lot# 1878AA Exp 20-NOV-2013, Lot# 0359AE Exp 15-FEB-2014) within the last 3 months (route unspecified). Unknown how many clients were vaccinated with the improperly stored VARIVAX (Merck). No adverse events reported at this time. It was unspecified if patients sought medical attention. The outcome of patients was unspecified. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site rash, Injection site swelling, Pyrexia, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old female patient with pcn and no previous illness. The patient was vaccinated IM with dose 1 GARDASIL on the right arm on 23-APR-2012. Concomitant therapy included MENACTRA (IM, on the right arm) and FLUZONE (IM, on the right arm) on 23-APR-2012 and BOOSTRIX (IM, dose 1, on the left arm). On 24-APR-2012 the patient experienced fever, syncope at 1215, fever stayed until 0300 on 25-MAR-2012. Rash and raised area 1 cm by 3 cm long at injection site. No treatment information was reported. The outcome of the events were unknown. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient with morphine, codeine and PERCOCET allergy. The patient was vaccinated with ZOSTAVAX (lot #672676/0069AE, expire date 03-APR-2013) subcutaneous on 20-JUL-2012. There were no co-suspects or concomitant medications. On 20-JUL-2012, 45 minutes after the injection, the patient developed itch and swelling at the site of injection. No treatment was given. No Laboratory diagnostics studies performed. The outcome of itch and swelling at the site of injection was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a nurse practitioner student refers to herself of unknown age. The nurse was received dose of an unspecified RECOMBIVAX HB on the following date: on 27-FEB-2004 (lot # LNG5379A4, exp date 13-MAY-2004), 02-APR-2004 (lot # ENGI507A4, exp date 14-FEB-2005), and 11-OCT-2004 (lot # EWGI589A4, exp date 15-SEP-2005). She was tested "last week" for hepatitis B titers because she was going to be starting her clinical rotation, and she was negative for immunity to hepatitis B. She stated that she has not experienced any other adverse effects. She did not want to provide her physician's information, but she stated that she can be contacted for additional information. The outcome of negative for immunity to hepatitis b was unknown. Additional information has been requested.
Age: 0.98
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner refers to an 11 months old patient. The patient was vaccinated with initial doses of both VARIVAX (Merck) and M-M-R II on 05-JUL-2009 at another (unspecified) provider's office. Nurse Practitioner reports that the child received the second dose of each vaccine on 20-July-2012. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse who reported that unknown number of patients was vaccinated with GARDASIL doses outside of recommended dosing schedule. Follow-up information has been received from the registered nurse who reported that sometimes she had patient came in and state they did not receive the third dose and she had called to doublecheck if she could go ahead and give the third dose to the patient and did not think to keep track of their names. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from an office worker refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, dosage, route and injection site were not known) on 07-JUL-2011. No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient was given the second dose of GARDASIL (lot number, dosage, route and injection site were not known) late and the second dose was given on 22-MAY-2012. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood glucose normal, Hypotension, Seizure like phenomena
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 years old male patient was vaccinated with lot # (672193/1524AA) dose 2 GARDASIL into right arm on 27-JAN-2012. No other co-suspects were reported. No concomitant medications were reported. The patient showed signs of seizure tonic clonic for less than 3 seconds, paleness, hypotension and dizziness. The symptoms persisted for about 20 minutes. The patient had no recollection of seizing event. There were no conditions. No lab data was performed. Upon internal review, the event of signs of seizure tonic clonic was determined to be an other important medical event. The original reporting source was not provided. The VAERS ID # is 448284. No further information is available.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Grand mal convulsion, Hypotension, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 years old male patient was vaccinated with lot # (672193/1524AA) dose 2 GARDASIL into right arm on 27-JAN-2012. No other co-suspects were reported. No concomitant medications were reported. The patient showed signs of seizure tonic clonic for less than 3 seconds, paleness, hypotension and dizziness. The symptoms persisted for about 20 minutes. The patient had no recollection of seizing event. There were no conditions. No lab data was performed. Upon internal review, the event of signs of seizure tonic clonic was determined to be an other important medical event. The original reporting source was not provided. The VAERS ID # is 448284. No further information is available.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Communication disorder, Confusional state, Dizziness, Electrolyte imbalance, Erythema
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 17 years old male patient with a healthy history and no previous illness, here for well visit. The patient was vaccinated IM with dose 1 GARDASIL (lot # 669795/1317AA) on the right arm on 17-FEB-2012. Other suspect therapies included VAQTA (lot # 671235/0984AA, dose 1, on left arm) on 17-FEB-2012. Concomitant medications included" MENACTRA (lot # U3848AA, dose 1, on the left arm). On 17-FEB-2012 the patient experienced redness of lower arms, itching sensation in throat then seemed very confused, unable to complete sentence. The patient felt dizzy and was taken to ER via 911. The patient was given IVF's/sketotolac and BENADRYL and recovered. The patient was sent home. CBC, electrolytes was done in ER with the result of NL. No further information is available. The original reporting source was not provided.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Full blood count normal, Throat irritation
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 17 years old male patient with a healthy history and no previous illness, here for well visit. The patient was vaccinated IM with dose 1 GARDASIL (lot # 669795/1317AA) on the right arm on 17-FEB-2012. Other suspect therapies included VAQTA (lot # 671235/0984AA, dose 1, on left arm) on 17-FEB-2012. Concomitant medications included" MENACTRA (lot # U3848AA, dose 1, on the left arm). On 17-FEB-2012 the patient experienced redness of lower arms, itching sensation in throat then seemed very confused, unable to complete sentence. The patient felt dizzy and was taken to ER via 911. The patient was given IVF's/sketotolac and BENADRYL and recovered. The patient was sent home. CBC, electrolytes was done in ER with the result of NL. No further information is available. The original reporting source was not provided.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Blood electrolytes normal, Confusional state, Dizziness, Erythema, Full blood count normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 17 years old male patient with a healthy history and no previous illness, here for well visit. The patient was vaccinated IM with dose 1 GARDASIL (lot # 669795/1317AA) on the right arm on 17-FEB-2012. Other suspect therapies included VAQTA (lot # 671235/0984AA, dose 1, on left arm) on 17-FEB-2012. Concomitant medications included" MENACTRA (lot # U3848AA, dose 1, on the left arm). On 17-FEB-2012 the patient experienced redness of lower arms, itching sensation in throat then seemed very confused, unable to complete sentence. The patient felt dizzy and was taken to ER via 911. The patient was given IVF's/sketotolac and BENADRYL and recovered. The patient was sent home. CBC, electrolytes was done in ER with the result of NL. No further information is available. The original reporting source was not provided.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Speech disorder, Throat irritation
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 17 years old male patient with a healthy history and no previous illness, here for well visit. The patient was vaccinated IM with dose 1 GARDASIL (lot # 669795/1317AA) on the right arm on 17-FEB-2012. Other suspect therapies included VAQTA (lot # 671235/0984AA, dose 1, on left arm) on 17-FEB-2012. Concomitant medications included" MENACTRA (lot # U3848AA, dose 1, on the left arm). On 17-FEB-2012 the patient experienced redness of lower arms, itching sensation in throat then seemed very confused, unable to complete sentence. The patient felt dizzy and was taken to ER via 911. The patient was given IVF's/sketotolac and BENADRYL and recovered. The patient was sent home. CBC, electrolytes was done in ER with the result of NL. No further information is available. The original reporting source was not provided.
Age: 22.0
Sex: M
Vaccine: HPV4, TYP, HPV4, TYP
Symptoms: Rash papular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old male patient with CECLOR, unknown reaction when he was a child, PCN, rash. The patient was vaccinated IM with dose 1 GARDASIL (lot # 1668AA) on left arm on 08-MAR-2012. No other co-suspects were reported. Concomitant medications included TYPHIM VI (lot # G0181, dose 1, IM, on left arm). On 09-MAR-2012 the patient experienced erythematous 1.5 cm well circumscribed papules-trunk, posteriorly/anteriorly. Non-pruritic, non-painful. The patient was given steroid cream (1%) and diphenhydramine. At the time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 22.0
Sex: M
Vaccine: HPV4, TYP, HPV4, TYP
Symptoms: Rash, Rash papular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old male patient with CECLOR, unknown reaction when he was a child, PCN, rash. The patient was vaccinated IM with dose 1 GARDASIL (lot # 1668AA) on left arm on 08-MAR-2012. No other co-suspects were reported. Concomitant medications included TYPHIM VI (lot # G0181, dose 1, IM, on left arm). On 09-MAR-2012 the patient experienced erythematous 1.5 cm well circumscribed papules-trunk, posteriorly/anteriorly. Non-pruritic, non-painful. The patient was given steroid cream (1%) and diphenhydramine. At the time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old female with allergy to cats and egg whites treated with lot # (670049/1261AA) dose 2 GARDASIL on 29-FEB-2012. There was no concomitant therapy. Within fifteen minutes, the patient experienced rash on chest and localized rash around injection site. The patient sent home with prescription (antihistamine).  No laboratory test was performed. At time of the report, the patient's outcome was unknown. The listing indicated that the events were non-serious. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Antinuclear antibody negative, Arthralgia, Back pain, Borrelia test negative, C-reactive protein normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with reflux was vaccinated IM into left arm with lot # (1560AA) dose 3 GARDASIL on 24-FEB-2012. Concomitant medications included dose 1 MENVEO (lot # A10060) vaccinated IM into right arm, dose 2 HAVRIX (lot # AHAVB549BA) vaccinated IM into right arm and omeprazole. On 29-FEB-2012 the patient experienced fever, back pain, neck pain and was treated with NAPROSYN. On 12-MAR-2012 the patient experienced back pain, joint pain, swollen lymph nodes-neck, fatigue. Labs were ordered on 12-MAR-2012. EBV (Epstein-Barr virus) twice, CMV titre (Cytomegalovirus), ANA (Antinuclear antibody), CRP (C-reactive protein), ESR (Red blood cell sedimentation rate), Lyme titre, CMP (Comprehensive Metabolic Panel), all were normal. On 16-MAR-2012 a phone call from parent: patient complained of arm pain and numbness - rheumatologist referral made. The status of the patient was unknown. All adverse events onset date were also reported as 25-FEB-2012. The report was considered to be no condition and non serious. The original reporting source was not provided. The VAERS ID is 452066. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Cytomegalovirus test negative, Epstein-Barr virus antibody negative, Epstein-Barr virus test negative, Fatigue, Hypoaesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with reflux was vaccinated IM into left arm with lot # (1560AA) dose 3 GARDASIL on 24-FEB-2012. Concomitant medications included dose 1 MENVEO (lot # A10060) vaccinated IM into right arm, dose 2 HAVRIX (lot # AHAVB549BA) vaccinated IM into right arm and omeprazole. On 29-FEB-2012 the patient experienced fever, back pain, neck pain and was treated with NAPROSYN. On 12-MAR-2012 the patient experienced back pain, joint pain, swollen lymph nodes-neck, fatigue. Labs were ordered on 12-MAR-2012. EBV (Epstein-Barr virus) twice, CMV titre (Cytomegalovirus), ANA (Antinuclear antibody), CRP (C-reactive protein), ESR (Red blood cell sedimentation rate), Lyme titre, CMP (Comprehensive Metabolic Panel), all were normal. On 16-MAR-2012 a phone call from parent: patient complained of arm pain and numbness - rheumatologist referral made. The status of the patient was unknown. All adverse events onset date were also reported as 25-FEB-2012. The report was considered to be no condition and non serious. The original reporting source was not provided. The VAERS ID is 452066. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Lymphadenopathy, Metabolic function test normal, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with reflux was vaccinated IM into left arm with lot # (1560AA) dose 3 GARDASIL on 24-FEB-2012. Concomitant medications included dose 1 MENVEO (lot # A10060) vaccinated IM into right arm, dose 2 HAVRIX (lot # AHAVB549BA) vaccinated IM into right arm and omeprazole. On 29-FEB-2012 the patient experienced fever, back pain, neck pain and was treated with NAPROSYN. On 12-MAR-2012 the patient experienced back pain, joint pain, swollen lymph nodes-neck, fatigue. Labs were ordered on 12-MAR-2012. EBV (Epstein-Barr virus) twice, CMV titre (Cytomegalovirus), ANA (Antinuclear antibody), CRP (C-reactive protein), ESR (Red blood cell sedimentation rate), Lyme titre, CMP (Comprehensive Metabolic Panel), all were normal. On 16-MAR-2012 a phone call from parent: patient complained of arm pain and numbness - rheumatologist referral made. The status of the patient was unknown. All adverse events onset date were also reported as 25-FEB-2012. The report was considered to be no condition and non serious. The original reporting source was not provided. The VAERS ID is 452066. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with reflux was vaccinated IM into left arm with lot # (1560AA) dose 3 GARDASIL on 24-FEB-2012. Concomitant medications included dose 1 MENVEO (lot # A10060) vaccinated IM into right arm, dose 2 HAVRIX (lot # AHAVB549BA) vaccinated IM into right arm and omeprazole. On 29-FEB-2012 the patient experienced fever, back pain, neck pain and was treated with NAPROSYN. On 12-MAR-2012 the patient experienced back pain, joint pain, swollen lymph nodes-neck, fatigue. Labs were ordered on 12-MAR-2012. EBV (Epstein-Barr virus) twice, CMV titre (Cytomegalovirus), ANA (Antinuclear antibody), CRP (C-reactive protein), ESR (Red blood cell sedimentation rate), Lyme titre, CMP (Comprehensive Metabolic Panel), all were normal. On 16-MAR-2012 a phone call from parent: patient complained of arm pain and numbness - rheumatologist referral made. The status of the patient was unknown. All adverse events onset date were also reported as 25-FEB-2012. The report was considered to be no condition and non serious. The original reporting source was not provided. The VAERS ID is 452066. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Antinuclear antibody negative, Arthralgia, Back pain, C-reactive protein normal, Cytomegalovirus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with reflux was vaccinated IM into left arm with lot # (1560AA) dose 3 GARDASIL on 24-FEB-2012. Concomitant medications included dose 1 MENVEO (lot # A10060) vaccinated IM into right arm, dose 2 HAVRIX (lot # AHAVB549BA) vaccinated IM into right arm and omeprazole. On 29-FEB-2012 the patient experienced fever, back pain, neck pain and was treated with NAPROSYN. On 12-MAR-2012 the patient experienced back pain, joint pain, swollen lymph nodes-neck, fatigue. Labs were ordered on 12-MAR-2012. EBV (Epstein-Barr virus) twice, CMV titre (Cytomegalovirus), ANA (Antinuclear antibody), CRP (C-reactive protein), ESR (Red blood cell sedimentation rate), Lyme titre, CMP (Comprehensive Metabolic Panel), all were normal. On 16-MAR-2012 a phone call from parent: patient complained of arm pain and numbness - rheumatologist referral made. The status of the patient was unknown. All adverse events onset date were also reported as 25-FEB-2012. The report was considered to be no condition and non serious. The original reporting source was not provided. The VAERS ID is 452066. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Fatigue, Hypoaesthesia, Lymphadenopathy, Metabolic function test normal, Neck pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with reflux was vaccinated IM into left arm with lot # (1560AA) dose 3 GARDASIL on 24-FEB-2012. Concomitant medications included dose 1 MENVEO (lot # A10060) vaccinated IM into right arm, dose 2 HAVRIX (lot # AHAVB549BA) vaccinated IM into right arm and omeprazole. On 29-FEB-2012 the patient experienced fever, back pain, neck pain and was treated with NAPROSYN. On 12-MAR-2012 the patient experienced back pain, joint pain, swollen lymph nodes-neck, fatigue. Labs were ordered on 12-MAR-2012. EBV (Epstein-Barr virus) twice, CMV titre (Cytomegalovirus), ANA (Antinuclear antibody), CRP (C-reactive protein), ESR (Red blood cell sedimentation rate), Lyme titre, CMP (Comprehensive Metabolic Panel), all were normal. On 16-MAR-2012 a phone call from parent: patient complained of arm pain and numbness - rheumatologist referral made. The status of the patient was unknown. All adverse events onset date were also reported as 25-FEB-2012. The report was considered to be no condition and non serious. The original reporting source was not provided. The VAERS ID is 452066. Additional information is not expected.