chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Entire body especially my joints and limbs hurt excruciatingly. I even had a personal pain pump from my c-section and I was still in severe pain all over. I was very much out of it still and barely even knew I got the shot. As it stands, to this very day I still experience pain in my limbs and joints that just was not to this degree before the shot. Some days are more painful then others but it's persisted since then.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: AFTER PROVIDER FINISHED SEEING PT FOR HER WELL CHILD EXAM APPOINTMENT MD ORDERED MEDICAL ASSISTANT BY GIVING HER A VERBAL ORDER TO GIVE HEPATITIS B VACCINE. PT WAS ADMINISTERED WITH THE SHOT AND MOTHER WAS GIVEN VIS INFORMATION WITH OTHER HANDOUTS IN REGARDS WELL CHILD EXAM FOR HER AGE, 8 MONTHS OF AGE, (THOUGHT PT TODAY 8/3 SHE IS 9 MONTHS). MEDICAL ASSISTANT WAS INPUTTING THE VACCINE INFORMATION INTO PATIENT'S CHART AND NOTICIED THAT THE DATE OF THE VACCINE WAS EXPIRED. PROVIDER WAS NOTIFIED, PER OUR MD OUR DEPARTMENT OF PUBLIC HEALTH WAS NOTIFIED AND TOLD US WHAT TO DO. PATIENT'S MOTHER HAS NOT BEEN NOTIFIED. MD WILL CALL MOTHER'S PT WITH THIS INFORMATION.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swollen, Red, Itchy. Oral Benadryl was given and Topical Benadryl cream was applied.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Swelling and redness of upper arm from shoulder down to elbow with extension onto upper back.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Started to feel dizzy, pale, clammy. Layed down, Blood Pressure taken was 78/56 laying down. HR 67 BP 80/56 sitting up. Had him continue to lay down for 30 minutes or so, color came back started feeling better back to normal within 45 minutes of receiving the vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt receive the ZOSTAVAX shot on Wednesday Aug. 1, 2012 and has the shingles today 8/3/12.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Tender hyperemic area of 2 x 2 on left arm, site of immunization.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: 1. Given DTaP instead of Tdap. 8/2/12. 2. Given Tdap 8/12/12.
Age: 1.39
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Computerised tomogram head normal, Nuclear magnetic resonance imaging brain normal, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Developed high fever 8/1/12. Developed maculopapular, erythematous rash trunk, arms, legs on 8/2/12. Generalized. (-) oral lesions. Possible acute vaccine induced Varicella.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient developed severe herpes zoster (shingles) of the right back, flank and chest in T6 and T7 distribution. Treatment was started on 5/16/12 with generic VALTREX 1 gram tid x 7 days. Reported as vaccine failure.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Computerised tomogram head abnormal, Convulsion, Electroencephalogram normal, Intensive care, Musculoskeletal stiffness
Clinical narrative: Patient with generalized seizure (stiffening of arms & legs). Lasted several minutes than patient asleep. Exam back to baseline later that evening. Concern re not visually tracking. Then on 7/2/2012 generalized prolonged seizures resulting in ICU admission, persistent poor visual tracking.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Neurological examination, Nuclear magnetic resonance imaging brain normal, Ophthalmological examination normal, Visual impairment
Clinical narrative: Patient with generalized seizure (stiffening of arms & legs). Lasted several minutes than patient asleep. Exam back to baseline later that evening. Concern re not visually tracking. Then on 7/2/2012 generalized prolonged seizures resulting in ICU admission, persistent poor visual tracking.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Axillary pain, Erythema, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Patient received PPV-23 8/2/12 (L) deltoid and called Today with c/o (L) arm swelling, redness and pain feeling nauseated. -On exam, Redness, warmth, swelling from axilla to elbow inner aspect (L) arm. Prescribed VICODIN.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Nausea, Swelling
Clinical narrative: Patient received PPV-23 8/2/12 (L) deltoid and called Today with c/o (L) arm swelling, redness and pain feeling nauseated. -On exam, Redness, warmth, swelling from axilla to elbow inner aspect (L) arm. Prescribed VICODIN.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Local reaction, Pain, Swelling, Vaccination complication
Clinical narrative: Patient received PPV-23 8/2/12 (L) deltoid and called Today with c/o (L) arm swelling, redness and pain feeling nauseated. -On exam, Redness, warmth, swelling from axilla to elbow inner aspect (L) arm. Prescribed VICODIN.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Within 30 min post vaccine pt. developed urticaria. No angioedema. No wheeze. See back in clinic given PO BENADRYL with complete resolution of symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on upper right arm x 2 days after vaccine was administered.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site atrophy, Pain, Paraesthesia, Tic
Clinical narrative: TWINRIX #1 - muscular "tics" & mild paresthesia - resolved. TWINRIX #2 pain & paresthesia followed by obvious deltoid atrophy (L) deltoid.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives on arms & legs starting 36 hr after vaccination.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Dizziness
Clinical narrative: Dizziness, chest pain, lightheadedness. Pt complained of dizziness approximately 15 min after vaccine sat & rested for approximately 45 min had dizziness, tightness in chest. BP 140/80 started to feel better approximately 1.5 hrs after vaccine.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Anxiety, Hypersensitivity, Tremor, Urticaria
Clinical narrative: Shaking, anxiety, hives by 1 hr after vaccine given. BENADRYL 50 mg was given IM per MD orders.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Itching on whole body. Pt is known to have had anaphylaxis before w/other meds, allergies reportedly pt. PNCs, sulfas, ibu, iodine red welts on neck & arms, legs.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pustule, Rash generalised, Varicella post vaccine
Clinical narrative: Per medical record-light rash all over body and can feel it. MOB reported baby developed mild chicken pox with varicella vaccination. MOB exposed to HUMIRA from LMP through about 30 to 31 weeks gestation. MOB restarted HUMIRA medication after delivery and breastfed baby while taking HUMIRA. Eight days after vaccination baby developed a single pustule/lesion over injection site. Three days later developed mild case of chicken pox.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Induration, Lethargy, Rash erythematous
Clinical narrative: Hard red raised bump on arm that is bothersome & extreme lethargy.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Adverse events unknown.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Rash pruritic
Clinical narrative: Right upper lateral arm is swollen pink and warm, pruritic rash, no lump at site of injection, no axillary adenopathy.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Right upper lateral arm is swollen pink and warm, pruritic rash, no lump at site of injection, no axillary adenopathy.
Age: 6.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall
Clinical narrative: This spontaneous report as received from a physician refers to a 16 years old female patient with drug allergy to AUGMENTIN IN. The patient was vaccinated IM with the first dose of GARDASIL (dose not reported and lot # 0459AE) on 25-JUN-2012. On 25-JUN-2012 the patient got light-headedness after vaccination and fell on the floor. The patient saw the physician. She did recover on the same date. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: This spontaneous report as received from a 51 years old female patient with asthma, type 2 diabetes and no drug reactions/allergies. The patient's medical history included sleep apnea, prior history of "crack cocaine" abuse seven years ago. The patient was vaccinated with a dose of ZOSTAVAX approximately in 2011, about a year ago. No other co-suspects were reported. Concomitant medications included albuterol, allopurinol, XANAX, NORVASC, vitamin D (unspecified), BENTYL, fluticasone propionate, ADVAIR, LASIX, LANTUS, lisinopril, pravastatin sodium, SEROQUEL, ZANTAC and NASACORT AQ. The patient stated that she had a history of frequent shingles for many years. About a year ago she received ZOSTAVAX, and a the time of reporting she reported that she had an outbreak of shingles every other month and the outbreaks were more severe. The patient also mentioned that VALTREX made her "sick". The patient sought medical attention by an office visit. At the time of reporting, the patient was not recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Serology positive
Clinical narrative: This spontaneous report as received from a physician refers to a couple of patients of unknown age. The patients were vaccinated with VAQTA on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced positive serology post vaccination. It was unknown if the patients sought medical attention. The outcome of the patients was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 60 years old female patient who on 18-JUL-2012 was vaccinated with a dose of ZOSTAVAX (lot# not reported). No other co-suspects were reported. No concomitant medications were reported. In July 2012, the patient experienced hives from her neck to rear end and a raised patch on her arm. The outcome of hives from her neck to rear end and a raised patch on her arm was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with all 3 doses of GARDASIL (lot number unknown) on unknown dates. No other co-suspects were reported. No concomitant medications were reported. After each dose, the patient experienced stomach pain, bloating and stomach cramps. It was unspecified if the patient had sought medical attention. The outcome was reported as unknown. Follow-up information has been received from a healthcare professional concerning a 13-years-old patient with inflammatory bowel disease and no illness at time of vaccination, who on 19-AUG-2011 at 12:00, 02-NOV-2011 at 15:15 and 02-JUL-2012 at 15:15 was vaccinated with the dose 1, 2, and 3 GARDASIL respectively, IM, left arm (dose not reported, lot numbers: dose 1: 670048/0963AA, exp. 09-NOV-2013, dose 2: 668262/0841AA, exp. 08-APR-2013, dose 3: 673256/0629AE). It was reported that after dose 2 of GARDASIL the patient experienced emesis and nausea. On 03-JUL-2012 at 12:00, after dose 3 of GARDASIL, the patient experienced emesis, abdominal pain and nausea. The patient did not seek medical attention. The patient recovered on 05-JUL-2012. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.47
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant concerning an 18 month old patient who on an unspecified date was vaccinated with a first dose of MMR II and a first dose of VARIVAX (Merck) at age 12 months. And both were repeated 6 months later. The patient was now 18 months old. No adverse symptoms noted. Follow-up information has been received from a Certified Medical Assistant concerning a patient with no illness at time of vaccination, no preexisting allergies, birth defects and medical conditions and no adverse events following prior vaccinations. On 26-JUN-2012, the patient was vaccinated with dose 2 M-M-R II, SC (lot # 1023AA), dose 2 VARIVAX (Merck), SC (lot # 671341/1250AA), ACTHIB, PREVNAR and DAPTACEL. No adverse symptoms were noted. No lab test were performed. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare worker indicating that improperly stored GARDASIL (Lot # not reported) might have been administered. No adverse event reported. Follow-up information was received from the healthcare worker indicating that on unknown dates an unspecified number of patients received GARDASIL (dose, route and lot # not reported) which had been improperly stored. No symptoms were reported. Follow up information has been received from a administrative assistant, concerning about one of three male patient (age not reported) who on an unknown date was vaccinated with a dose of GARDASIL (dose, route not reported), (Lot # 669796/0840AA) which had been improperly stored. The vaccine was re-administered to the patient (on an unknown date), dose, route and Lot# not reported. The administrative assistant stated that there had been no adverse events reported at the time. This is one of several reports from the same source. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to her husband of unknown age. The patient was vaccinated with ZOSTAVAX (lot number was unknown, dose and route was not reported) in November 2009. No other co-suspects were reported. No concomitant medications were reported. In March of 2012 the patient experienced a severe case of shingles on his abdomen and all the way around to his spine. "It was huge and very, very painful as you well know", and then patient immediately went to see their primary care doctor for medical attention, and they were told that "the protection is not 100% but rather only about 60%". The reporter mentioned that "It has now been 4 months and he still has pain from the shingles in this area". The report stated that the company should develop a vaccine that actually works for shingles. The patient was not recovered at the time of the report. Follow up information has been received from consumer refers to her husband of unknown age. The reporter provided patient's name and health care address. It was also reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number was unknown, dose and route were not reported) in 25-OCT-2009 between 13:00 and 16:00. The outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Gait disturbance, Oropharyngeal pain, Pain in extremity, Pharyngitis
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. On 01-AUG-2011 a 15 year old female patient was intramuscularly vaccinated with the first dose of GARDASIL (lot # 669308/0636AA) on left arm. Other suspect therapies included VARIVAX (Merck) (lot # 669647/1704Z, the second dose, left arm, subcutaneous) and VAQTA (lot # 670834/0627AA, the first dose, right arm, intramuscular). Concomitant medications included: MENACTRA (lot # U3780AA, the first dose, right arm, intramuscular). One to two days later, the patient complained of pain and difficulty walking in both legs which lasted approximately three days. These symptoms resolved (date not reported) and did not require a doctor's visit. On 12-AUG-2011, the patient was seen by her physician with complaints of a sore throat and she was subsequently diagnosed with acute pharyngitis. The patient denied any concurrent illness or pre-existing medical conditions and she had not been talking any concomitant medications. It was unknown if the patient experienced any adverse events following prior vaccinations. Outcome for the events of pharyngitis was unknown at the time of the report. The event was considered to be non serious. The original reporting source was not provided. The VAERS ID # is 451915. No further information is available.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
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. On 16-MAR-2012 an 11 years old female patient was intramuscularly vaccinated with the first dose of GARDASIL (lot # 672232/1495AA) on left arm. Concomitant medications included BOOSTRIX (lot # AC52B075AA, the first dose, right arm, intramuscular), MENVEO (lot # A10062, the first dose, left arm, intramuscular) and HAVRIX (lot # AHAVB509AA, the second dose, right arm, intramuscular). The patient fainted after 3 min. At the time of reporting, the outcome of the patient was unknown. The patient did not seek medical attention. The event was considered to be non serious. The original reporting source was not provided. The VAERS ID # is 452004. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Pain, 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. On 14-MAR-2012 a 16 years old female patient with no pre-existing illness and a history of depression and attention deficit disorder was intramuscularly vaccinated with the third dose of GARDASIL (lot # 672233/1561AA) on left arm. Concomitant medications included methylphenidate and citalopram. The reporter stated that site of injection painful that day. Next day, 15-MAR-2012, fever and various body aches. On 16-MAR-2012 and 17-MAR-2012 no fever, but body aches. Aching would resolve after acetaminophen or ibuprofen, then return. No rash, no swelling, no nausea. No lab diagnosis was performed. The patient did not seek medical attention. The event was considered to be non serious. The original reporting source was not provided. The VAERS ID # is 452117. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactic reaction, Dyspnoea, Endotracheal intubation, Extubation, Intensive care
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 26 years old female patient with depression/anxiety, allergy to IM TORADOL and IM IMITREX and a history of female pelvic pain, dysmenorrhea, fatigue and ovarian cysts was vaccinated with dose 1 GARDASIL (Lot# not reported) on 08-JUN-2011 with no reported adverse effects and dose 2 GARDASIL (lot # 1395AA) intramuscularly on 29-MAY-2012. Concomitant medications included: clonazepam and PROZAC. On 29-MAY-2012 the patient experienced anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccination of dose 2. Patient was seen in local ER. She was intubated and transferred to ICU on 29-MAY-2012. She was extubated on 30-MAY-2012. The plan was to transfer her from the ICU to the regular medicine ward for observation later if she continued to do well. This was hospital day #2. No other exposures were thought to be responsible for her signs/symptoms. The following information was obtained through follow-up and/or provided by the government. 25-JUN-2012 hospital records were received. Service dates 29-MAY-2012 to 21-JUN-2012. Diagnosis: Allergic reaction. Patient presented to ER on 29-MAY-2012 after developing itching and burning, then swelling of nose and throat, and extreme difficulty breathing. Epinephrine IM was given. The patient was intubated and transferred to hospital for one night and was extubated that night. Follow-up examination: no symptoms, normal physical exam. The patient was discharged home with no medications and was referred to allergy clinic for testing. Like secondary to carrier in IM injections. Later the patient presented for (R) shoulder pain. The patient complained of grinding sensation in shoulder, denies injury or history of pain, however participated in lifeguard tryouts. The patient experienced pain and numbness in fingertips. Tenderness of neck and upper right trapezius, palpable spasm. Bursitis Subacromial Right. Muscle Spasm. MOTRIN, sling. Follow-up: Continued pain, likely labral tear. Continue slip and ROM exercises. The original reporting source was not provided. The VAERS ID # is 456480. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pharyngeal oedema
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 26 years old female patient with depression/anxiety, allergy to IM TORADOL and IM IMITREX and a history of female pelvic pain, dysmenorrhea, fatigue and ovarian cysts was vaccinated with dose 1 GARDASIL (Lot# not reported) on 08-JUN-2011 with no reported adverse effects and dose 2 GARDASIL (lot # 1395AA) intramuscularly on 29-MAY-2012. Concomitant medications included: clonazepam and PROZAC. On 29-MAY-2012 the patient experienced anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccination of dose 2. Patient was seen in local ER. She was intubated and transferred to ICU on 29-MAY-2012. She was extubated on 30-MAY-2012. The plan was to transfer her from the ICU to the regular medicine ward for observation later if she continued to do well. This was hospital day #2. No other exposures were thought to be responsible for her signs/symptoms. The following information was obtained through follow-up and/or provided by the government. 25-JUN-2012 hospital records were received. Service dates 29-MAY-2012 to 21-JUN-2012. Diagnosis: Allergic reaction. Patient presented to ER on 29-MAY-2012 after developing itching and burning, then swelling of nose and throat, and extreme difficulty breathing. Epinephrine IM was given. The patient was intubated and transferred to hospital for one night and was extubated that night. Follow-up examination: no symptoms, normal physical exam. The patient was discharged home with no medications and was referred to allergy clinic for testing. Like secondary to carrier in IM injections. Later the patient presented for (R) shoulder pain. The patient complained of grinding sensation in shoulder, denies injury or history of pain, however participated in lifeguard tryouts. The patient experienced pain and numbness in fingertips. Tenderness of neck and upper right trapezius, palpable spasm. Bursitis Subacromial Right. Muscle Spasm. MOTRIN, sling. Follow-up: Continued pain, likely labral tear. Continue slip and ROM exercises. The original reporting source was not provided. The VAERS ID # is 456480. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactic reaction, Arthropathy, Burning sensation, Bursitis, Cartilage injury
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 26 years old female patient with depression/anxiety, allergy to IM TORADOL and IM IMITREX and a history of female pelvic pain, dysmenorrhea, fatigue and ovarian cysts was vaccinated with dose 1 GARDASIL (Lot# not reported) on 08-JUN-2011 with no reported adverse effects and dose 2 GARDASIL (lot # 1395AA) intramuscularly on 29-MAY-2012. Concomitant medications included: clonazepam and PROZAC. On 29-MAY-2012 the patient experienced anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccination of dose 2. Patient was seen in local ER. She was intubated and transferred to ICU on 29-MAY-2012. She was extubated on 30-MAY-2012. The plan was to transfer her from the ICU to the regular medicine ward for observation later if she continued to do well. This was hospital day #2. No other exposures were thought to be responsible for her signs/symptoms. The following information was obtained through follow-up and/or provided by the government. 25-JUN-2012 hospital records were received. Service dates 29-MAY-2012 to 21-JUN-2012. Diagnosis: Allergic reaction. Patient presented to ER on 29-MAY-2012 after developing itching and burning, then swelling of nose and throat, and extreme difficulty breathing. Epinephrine IM was given. The patient was intubated and transferred to hospital for one night and was extubated that night. Follow-up examination: no symptoms, normal physical exam. The patient was discharged home with no medications and was referred to allergy clinic for testing. Like secondary to carrier in IM injections. Later the patient presented for (R) shoulder pain. The patient complained of grinding sensation in shoulder, denies injury or history of pain, however participated in lifeguard tryouts. The patient experienced pain and numbness in fingertips. Tenderness of neck and upper right trapezius, palpable spasm. Bursitis Subacromial Right. Muscle Spasm. MOTRIN, sling. Follow-up: Continued pain, likely labral tear. Continue slip and ROM exercises. The original reporting source was not provided. The VAERS ID # is 456480. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Endotracheal intubation, Hypersensitivity, Hypoaesthesia, Intensive care
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 26 years old female patient with depression/anxiety, allergy to IM TORADOL and IM IMITREX and a history of female pelvic pain, dysmenorrhea, fatigue and ovarian cysts was vaccinated with dose 1 GARDASIL (Lot# not reported) on 08-JUN-2011 with no reported adverse effects and dose 2 GARDASIL (lot # 1395AA) intramuscularly on 29-MAY-2012. Concomitant medications included: clonazepam and PROZAC. On 29-MAY-2012 the patient experienced anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccination of dose 2. Patient was seen in local ER. She was intubated and transferred to ICU on 29-MAY-2012. She was extubated on 30-MAY-2012. The plan was to transfer her from the ICU to the regular medicine ward for observation later if she continued to do well. This was hospital day #2. No other exposures were thought to be responsible for her signs/symptoms. The following information was obtained through follow-up and/or provided by the government. 25-JUN-2012 hospital records were received. Service dates 29-MAY-2012 to 21-JUN-2012. Diagnosis: Allergic reaction. Patient presented to ER on 29-MAY-2012 after developing itching and burning, then swelling of nose and throat, and extreme difficulty breathing. Epinephrine IM was given. The patient was intubated and transferred to hospital for one night and was extubated that night. Follow-up examination: no symptoms, normal physical exam. The patient was discharged home with no medications and was referred to allergy clinic for testing. Like secondary to carrier in IM injections. Later the patient presented for (R) shoulder pain. The patient complained of grinding sensation in shoulder, denies injury or history of pain, however participated in lifeguard tryouts. The patient experienced pain and numbness in fingertips. Tenderness of neck and upper right trapezius, palpable spasm. Bursitis Subacromial Right. Muscle Spasm. MOTRIN, sling. Follow-up: Continued pain, likely labral tear. Continue slip and ROM exercises. The original reporting source was not provided. The VAERS ID # is 456480. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle spasms, Musculoskeletal pain, Pain in extremity, Pharyngeal oedema, Pruritus
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 26 years old female patient with depression/anxiety, allergy to IM TORADOL and IM IMITREX and a history of female pelvic pain, dysmenorrhea, fatigue and ovarian cysts was vaccinated with dose 1 GARDASIL (Lot# not reported) on 08-JUN-2011 with no reported adverse effects and dose 2 GARDASIL (lot # 1395AA) intramuscularly on 29-MAY-2012. Concomitant medications included: clonazepam and PROZAC. On 29-MAY-2012 the patient experienced anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccination of dose 2. Patient was seen in local ER. She was intubated and transferred to ICU on 29-MAY-2012. She was extubated on 30-MAY-2012. The plan was to transfer her from the ICU to the regular medicine ward for observation later if she continued to do well. This was hospital day #2. No other exposures were thought to be responsible for her signs/symptoms. The following information was obtained through follow-up and/or provided by the government. 25-JUN-2012 hospital records were received. Service dates 29-MAY-2012 to 21-JUN-2012. Diagnosis: Allergic reaction. Patient presented to ER on 29-MAY-2012 after developing itching and burning, then swelling of nose and throat, and extreme difficulty breathing. Epinephrine IM was given. The patient was intubated and transferred to hospital for one night and was extubated that night. Follow-up examination: no symptoms, normal physical exam. The patient was discharged home with no medications and was referred to allergy clinic for testing. Like secondary to carrier in IM injections. Later the patient presented for (R) shoulder pain. The patient complained of grinding sensation in shoulder, denies injury or history of pain, however participated in lifeguard tryouts. The patient experienced pain and numbness in fingertips. Tenderness of neck and upper right trapezius, palpable spasm. Bursitis Subacromial Right. Muscle Spasm. MOTRIN, sling. Follow-up: Continued pain, likely labral tear. Continue slip and ROM exercises. The original reporting source was not provided. The VAERS ID # is 456480. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swelling, Tenderness
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 26 years old female patient with depression/anxiety, allergy to IM TORADOL and IM IMITREX and a history of female pelvic pain, dysmenorrhea, fatigue and ovarian cysts was vaccinated with dose 1 GARDASIL (Lot# not reported) on 08-JUN-2011 with no reported adverse effects and dose 2 GARDASIL (lot # 1395AA) intramuscularly on 29-MAY-2012. Concomitant medications included: clonazepam and PROZAC. On 29-MAY-2012 the patient experienced anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccination of dose 2. Patient was seen in local ER. She was intubated and transferred to ICU on 29-MAY-2012. She was extubated on 30-MAY-2012. The plan was to transfer her from the ICU to the regular medicine ward for observation later if she continued to do well. This was hospital day #2. No other exposures were thought to be responsible for her signs/symptoms. The following information was obtained through follow-up and/or provided by the government. 25-JUN-2012 hospital records were received. Service dates 29-MAY-2012 to 21-JUN-2012. Diagnosis: Allergic reaction. Patient presented to ER on 29-MAY-2012 after developing itching and burning, then swelling of nose and throat, and extreme difficulty breathing. Epinephrine IM was given. The patient was intubated and transferred to hospital for one night and was extubated that night. Follow-up examination: no symptoms, normal physical exam. The patient was discharged home with no medications and was referred to allergy clinic for testing. Like secondary to carrier in IM injections. Later the patient presented for (R) shoulder pain. The patient complained of grinding sensation in shoulder, denies injury or history of pain, however participated in lifeguard tryouts. The patient experienced pain and numbness in fingertips. Tenderness of neck and upper right trapezius, palpable spasm. Bursitis Subacromial Right. Muscle Spasm. MOTRIN, sling. Follow-up: Continued pain, likely labral tear. Continue slip and ROM exercises. The original reporting source was not provided. The VAERS ID # is 456480. Additional information is not expected.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Larger than normal lump at injection site coupled with burning in the area/unusual sourness.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 103.8.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Reaction to preservatives
Clinical narrative: Not sure exactly when it started but the next morning one leg had about 6 inch swollen hard red and hot area other leg about a 1 inch hot swollen area-one vaccine in each leg on tdp one chickenpox I think she is sensitive or allergic to the preservative or base of it never before has had a reaction called advise nrse she said it is normal, but not for my children ever before.
Age: 32.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: The HEP A and HEP B Vaccinations were given after the series completion dates of HEP A: 19OCT2000 AND HEP B: 25MAR1997.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Abdominal pain upper, Asthenia, Back pain, Dizziness, Feeling abnormal
Clinical narrative: Pale, faint, dizzy, vision blacked-out momentarily, nauseated, headache. Later that day, she complained of muscle pain and weakness, especially in arms and legs. 3 days later, still complaining of muscle pain and weakness, including stomach and back in addition to arms and legs. Giving Advil a couple times per day.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Headache, Hypersomnia, Lethargy, Muscular weakness, Myalgia
Clinical narrative: Pale, faint, dizzy, vision blacked-out momentarily, nauseated, headache. Later that day, she complained of muscle pain and weakness, especially in arms and legs. 3 days later, still complaining of muscle pain and weakness, including stomach and back in addition to arms and legs. Giving Advil a couple times per day.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Nausea, Pallor, Syncope, Visual impairment
Clinical narrative: Pale, faint, dizzy, vision blacked-out momentarily, nauseated, headache. Later that day, she complained of muscle pain and weakness, especially in arms and legs. 3 days later, still complaining of muscle pain and weakness, including stomach and back in addition to arms and legs. Giving Advil a couple times per day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat, itching at injection site.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Pertussis
Clinical narrative: Two weeks after vaccination patient developed Barking Cough and Pertussis SxS.
Age: 4.0
Sex: F
Vaccine: DTP, MMR
Symptoms: Hallucination, Incontinence, Pyrexia, Staring, Tremor
Clinical narrative: Fever 102.3, shaking, staring, hallucinating, incontinence.
Age: 30.0
Sex: F
Vaccine: MMR, TD
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Painful swelling of my ankles, joint pain in my toes, elbow and fingers on both hands. Taking ibuprofen.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Headache, Oedema peripheral, Rash erythematous, Skin warm
Clinical narrative: Patient's arm is red, hot, swollen, and she has a headache. Rash is about 3 inches with a darker red center.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Pain, Pruritus
Clinical narrative: Mild persistent painful and itchy area. Dx cellulitis. Antibiotics given.
Age: 76.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema
Clinical narrative: Pt received PNEUMOVAX ON 8/2/12, reports back to pharmacy on 8/4/12 at 11:00am, His arm was red on his upper arm moving towards chest and lower arm. Pt was advised to take BENADRYL and go to the Dr if rash worsens and see PCP on Monday.
Age: 17.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Nausea, Pallor, Vomiting
Clinical narrative: At 12pm immediately after giving the TDP he became pale, I had him lie down, he hen c/o nausea, vomited once, BP 94/52, P70, kept him lying down. He felt better after 10 minutes. BP 100/40, P70. Complete resolution. Allowed to leave at 1220 pm.
Age: 0.02
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with expired ROTATEQ (lot # 668825/0525AA, expiration date 09-JUL-2012) on 19-JUL-2012 (as the first dose). No adverse event reported. It was unspecified whether the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Vomiting
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient was vaccinated with ROTATEQ (lot number and dosage were not known) orally on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient received ROTATEQ and spitted up right after the dose was administered. No adverse event report. The outcome was unknown. It was unspecified if the patient had sought medical attention. 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 pharmacist refers to a patient of unknown age. The patient was vaccinated with VARIVAX (Merck) (lot number 671130/1220AA, expired date 26-JUL-2012) (dose and route were not reported) on 17-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient received an improperly stored VARIVAX (Merck), the vaccine has been stored in the refrigerator since it was received in the pharmacy in February 2012. No adverse symptoms reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 05-JUL-2012 the patient was vaccinated with a dose of ZOSTAVAX that was stored at 21.6F for 25 days (600 hours). It was unknown if the patient sought medical attention. The patient was not experiencing any known symptoms. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 02-JUL-2012 the patient was vaccinated with a dose of ZOSTAVAX that was stored at 21.6F for 25 days (600 hours). It was unknown if the patient sought medical attention. The patient was not experiencing any known symptoms. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 12-JUL-2012 the patient was vaccinated with a dose of ZOSTAVAX that was stored at 21.6F for 25 days (600 hours). It was unknown if the patient sought medical attention. The patient was not experiencing any known symptoms. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient,who subcutaneously vaccinated a dose of ZOSTAVAX (lot # was unknown)0.65 ml on 16-JUL-2012. The patient called" the pharmacy on July 18,2012 to report that starting on the evening of July 16,2012,she developed a rash at the injection site,that is continuing to grow." Pharmacist reports that " the patient reports that the rash is approximately 1-1.25 inches in diameter". "The patient also reports experiencing morning headaches since receiving ZOSTAVAX". The patient had a prior history of morning headache, the patient sought medical attention through calling pharmacy. The outcome of developed a rash at the injection site and morning headache was reported as not recovered/not resolved. The relatedness for developed a rash at the injection site and morning headache was unknown for ZOSTAVAX. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspnoea
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 14 years old female patient on 28-FEB-2012 was vaccinated IM with dose 3 GARDASIL onto left arm (lot # 0690AA, dose not reported). No other co-suspects were reported. No concomitant medications were reported. 5 minutes after HPV vaccine was administered patient felt light headed and stated having difficulty breathing. Patient had sit for 15 minutes. TB test was performed (results was unknown). Outcome was unknown at the time of reporting. The patient had no conditions. No further information is available. The original reporting source was not provided. The VAERS ID # is 450772.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspnoea, Mycobacterium tuberculosis complex test
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 14 years old female patient on 28-FEB-2012 was vaccinated IM with dose 3 GARDASIL onto left arm (lot # 0690AA, dose not reported). No other co-suspects were reported. No concomitant medications were reported. 5 minutes after HPV vaccine was administered patient felt light headed and stated having difficulty breathing. Patient had sit for 15 minutes. TB test was performed (results was unknown). Outcome was unknown at the time of reporting. The patient had no conditions. No further information is available. The original reporting source was not provided. The VAERS ID # is 450772.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, 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 15 years old female patient who on 24-FEB-2012 was vaccinated with the third dose of GARDASIL (lot # 668261/1397AA, intramuscular on right arm, dose not reported). On 24-FEB-2012 the patient experienced fainted and fall down after 5 minutes of vaccination. At the time of reporting, the outcomes were unknown. The original reporting source was unknown. The VAERS ID # 451555-1.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP, IPV, MMR
Symptoms: Erythema, Injection site reaction, Oedema peripheral, Type III immune complex mediated reaction
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 now 11 years old female patient, who on an unspecified date was vaccinated with a dose of M-M-R II (Lot#, dose and route not reported). Secondary suspect therapy included IPOL. On an unknown date the patient experienced adverse event. At the time of reporting, the outcome was unknown. The patient subsequently developed Erythema, Injection site reaction, Oedema peripheral, Type III immune complex mediated reaction while on GARDASIL (MARRS# 1208USA000084). The original reporting source was the nurse. The VAERS ID# 451776-1.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Oedema peripheral, Type III immune complex mediated reaction
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 now 11 years old female patient, who on an unspecified date was vaccinated with a dose of M-M-R II (Lot#, dose and route not reported). Secondary suspect therapy included IPOL. On an unknown date the patient experienced adverse event. At the time of reporting, the outcome was unknown. The patient subsequently developed Erythema, Injection site reaction, Oedema peripheral, Type III immune complex mediated reaction while on GARDASIL (MARRS# 1208USA000084). The original reporting source was the nurse. The VAERS ID# 451776-1.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP, IPV, MMR
Symptoms: Injection site erythema, Oedema peripheral, Type III immune complex mediated reaction
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 now 11 years old female patient, who on an unspecified date was vaccinated with a dose of M-M-R II (Lot#, dose and route not reported). Secondary suspect therapy included IPOL. On an unknown date the patient experienced adverse event. At the time of reporting, the outcome was unknown. The patient subsequently developed Erythema, Injection site reaction, Oedema peripheral, Type III immune complex mediated reaction while on GARDASIL (MARRS# 1208USA000084). The original reporting source was the nurse. The VAERS ID# 451776-1.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Burning sensation, Insomnia, 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.