chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Epistaxis, Face injury, Fall, Loss of consciousness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old female patient with asthma, mono and seasonal allergies. The patient had not drug reaction allergies. On 05-JUN-2013, the patient was vaccinated with a second dose of GARDASIL (lot number H020002, expiration date 08-AUG-2015) intramuscular in the left arm (dose was not reported). Concomitant medication was not reported. On 05-JUN-2013, a few minutes after the vaccination the patient was observed unconscious for "about a minute" which caused patient to fall from examining table, hit her nose and experience a nose bleed. Treatment was to "get nose to stop bleeding", placed patient in trendelenburg and assessed blood pressure. Blood pressure was 110/70 lying down and 98/60. Nurse confirmed these blood pressure measurements were within normal limits for this patient. The father of the patient, who did not accompany the patient to the physician's office, was contacted. Treatment also included that the father of the patient drove the patient to the hospital. The physician's office confirmed with hospital that the patient arrived at the emergency room. The outcome of the patient was observed unconscious for "about a minute" which caused patient to fall from examining table hit her nose and experience a nose bleed was unknown. Upon internal review the event of unconscious for "about a minute" was considered medically significant. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Epistaxis, Fall, Head injury, Headache, Presyncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old female patient with asthma, mono and seasonal allergies. The patient had not drug reaction allergies. On 05-JUN-2013, the patient was vaccinated with a second dose of GARDASIL (lot number H020002, expiration date 08-AUG-2015) intramuscular in the left arm (dose was not reported). Concomitant medication was not reported. On 05-JUN-2013, a few minutes after the vaccination the patient was observed unconscious for "about a minute" which caused patient to fall from examining table, hit her nose and experience a nose bleed. Treatment was to "get nose to stop bleeding", placed patient in trendelenburg and assessed blood pressure. Blood pressure was 110/70 lying down and 98/60. Nurse confirmed these blood pressure measurements were within normal limits for this patient. The father of the patient, who did not accompany the patient to the physician's office, was contacted. Treatment also included that the father of the patient drove the patient to the hospital. The physician's office confirmed with hospital that the patient arrived at the emergency room. The outcome of the patient was observed unconscious for "about a minute" which caused patient to fall from examining table hit her nose and experience a nose bleed was unknown. Upon internal review the event of unconscious for "about a minute" was considered medically significant. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: PREVNAR 13 given in top of (R) thigh erythema, induration surrounding injection site 6/7/13.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Blood sodium decreased, C-reactive protein increased, Haemoglobin urine present, Headache, Injection site erythema
Clinical narrative: 1 day after vaccine had redness around site, this progressively worsened and enlarged and 3 days after vaccine he had fever, headache, pain.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: 1 day after vaccine had redness around site, this progressively worsened and enlarged and 3 days after vaccine he had fever, headache, pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: KINRIX was administered on RA on 06/05/13. Next day patient developed swelling and tenderness on that area, no fever. Patient came back to clinic 2 days later with moderate swelling and tenderness on right arm, but improving from day before as per mother. Treated with warm compress locally.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Computerised tomogram head normal, Head injury, Headache, Neurological examination normal, Syncope
Clinical narrative: 20 minutes after vaccinations patient fainted, hit his head, after lying down for 20 minutes, while sitting fainted again - when recover complaint of headache where he hit the floor (right occipital). Physical exam normal - Neurological exam normal. Decided to send him to E.R in ambulance for CT scan and further eval.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from an approximately 64 year old female patient regarding herself. Current condition of the patient included high blood pressure and allergic to aspirin. On 12-OCT-2012, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number, and expiry date unspecified), subcutaneously. Concomitant therapies included losartan potassium (100 milligrams), venlafaxine hydrochloride (extended release, 150 milligrams), atorvastatin (40 milligrams) and nortriptyline hydrochloride (20 milligrams). On 03-NOV-2012, the patient suffered from pain, redness and stiffness in the right arm at the injection site. The pain eventually became intolerable. On an unknown date, she was hospitalized after receiving ZOSTAVAX and she was diagnosed with bursitis of the arm (duration of hospitalization was unspecified). The patient lost all her mobility of the right arm, could not work and lost her job (disability). The patient sought medical attention (saw the doctor). An unspecified treatment was given. No laboratory diagnostic tests were performed for the events. The patient was recovering from the event. The relatedness for the event was unknown for ZOSTAVAX. This adverse event was sent to legal department. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from an approximately 64 year old female patient regarding herself. Current condition of the patient included high blood pressure and allergic to aspirin. On 12-OCT-2012, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number, and expiry date unspecified), subcutaneously. Concomitant therapies included losartan potassium (100 milligrams), venlafaxine hydrochloride (extended release, 150 milligrams), atorvastatin (40 milligrams) and nortriptyline hydrochloride (20 milligrams). On 03-NOV-2012, the patient suffered from pain, redness and stiffness in the right arm at the injection site. The pain eventually became intolerable. On an unknown date, she was hospitalized after receiving ZOSTAVAX and she was diagnosed with bursitis of the arm (duration of hospitalization was unspecified). The patient lost all her mobility of the right arm, could not work and lost her job (disability). The patient sought medical attention (saw the doctor). An unspecified treatment was given. No laboratory diagnostic tests were performed for the events. The patient was recovering from the event. The relatedness for the event was unknown for ZOSTAVAX. This adverse event was sent to legal department. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: Patient had leg weakness and difficulty walking for 12 hours after receiving vaccines.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Drug allergies or reactions were not reported. On 15-MAR-2013 the patient was vaccinated with VARIVAX (merck) first dose (dose, lot number and expiration date were not reported). On 22-MAR-2013, the patient was inadvertently administered a second dose of VARIVAX (merck) administered by "intramuscular" injection (lot number 1912AA) (dose and expiration date were not reported). No adverse effect reported. The outcome of events was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: Pain in leg at site of injection.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash generalised
Clinical narrative: Robust take ? Pulse 92, Resp 20, BP 160/72, Temp 97.4, PSO2 96% Rash anterior/posterior head to toe. Alert and oriented-transported to ER.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Not stated.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Pt got a rash on bottom of feet and stomach. No reaction around injection site. 6.25mg BENADRYL liquid given po.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had swelling and redness at injection site. Patient treated with doxycycline, prednisone, and BENADRYL. Swelling and redness gone per MD ofc. on 6/6/13.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old male patient who was allergic to penicillin. Patient's pertinent medical history was none. On 29-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H021710, expiry date 07-MAR-2014) 1 vial, subcutaneously. Concomitant medications included fluid pills and arthritis medications. Approximately on an unknown date in 2013, the patient developed redness, swelling at the injection site after getting ZOSTAVAX. The patient sought medical attention for the same (patient was seen by a pharmacist). The patient was treated with ibuprofen and TYLENOL. The outcome of developed redness and swelling at the injection site was reported as recovering/resolving. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Chills, Depressed level of consciousness, Posture abnormal
Clinical narrative: Sudden drop in blood pressure. Shivering. Body stretched. Semi-conscious state/was passing out --> Paramedics were called immediately.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a several patients of unknown ages who on an unknown date, were vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). The pharmacist reported that several patients had experienced unspecified reactions after received ZOSTAVAX administration on an unspecified dates. At the time of the report, the patient's outcome was unknown. The relatedness for unspecified reactions and ZOSTAVAX was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 22 year old female patient with no allergies. In approximately June 2012 (about 1 year ago) the patient was vaccinated with an unspecified dose of GARDASIL (0.5 ml once, lot number and expiration date not reported) intramuscular. Concomitant therapies included VELIVET. In approximately June 2012 the patient experienced pain at injection site for one day. No treatment was given for the event. The patient did not seek for medical attention. The outcome of the event was reported as recovered in approximately June 2012. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to herself, a female patient of unknown age with 19 weeks of gestation. On 08-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported), and found out she was pregnant "a few weeks later. No concomitant medications were not reported. She has not continued the regimen. Consumer said she did not experience any side effects. The patient became pregnant with estimated Last Menstrual Period (LMP) of 21-JAN-2013 and Estimated Date of Delivery (EDD) of 28-OCT-2013. Initial exposure to GARDASIL was at approximately 2 week. The outcome of the patient at the moment of the report was unknown. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 5 year old patient (gender unknown). On 04-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose and route not reported) instead of a dose of VARIVAX (Merck). The CMA did not specify if this dose was the first for second dose in the patient's vaccination series. No adverse symptoms reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of 17 years old who on 15-MAR-2013 was vaccinated with GARDASIL injection, first dose intramuscular (lot # H015863, exp date: 15-MAR-2013) (indication and application site unspecified). The reporter stated that the GARDASIL vaccine was exposed to unknown temperature for 48 hours (also reported few days) due to the vaccine left in a car unrefrigerated. No adverse effect reported. On 17-MAY-2013 the patient received the second dose of GARDASIL which was stored properly. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from an unknown age, female consumer reporting on herself with no pertinent medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (route and dose not reported, in the left arm). No other suspect therapies or concomitant medications were reported. On an unknown date the patient experienced pain in the left arm where shot was given, it was low in the muscle, pain on upper back and shoulder area, next day from shot until now. No treatment information was reported. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a male patient of unknown age. On 25-OCT-2011 the patient was vaccinated with the first dose of VAQTA (route, dose and lot number unknown). On 17-APR-2012 the patient received the second dose of VAQTA (route, dose and lot number unknown). No adverse event was reported. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 63 year old female patient with penicillin allergy who on 04-JUN-2013, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). The pharmacist reported that on 05-JUN-2013, the patient came into the pharmacy complaining of significant pain, redness and swelling (almost down to the elbow) on the arm where she received the vaccination. No treatment was given for the experience. At the time of the report, the patient outcome was unknown. The relatedness for significant pain, redness and swelling (almost down to the elbow) and ZOSTAVAX was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 63 year old female patient with penicillin allergy who on 04-JUN-2013, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). The pharmacist reported that on 05-JUN-2013, the patient came into the pharmacy complaining of significant pain, redness and swelling (almost down to the elbow) on the arm where she received the vaccination. No treatment was given for the experience. At the time of the report, the patient outcome was unknown. The relatedness for significant pain, redness and swelling (almost down to the elbow) and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients with unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot number and expiration date unknown), (dose number, route, dose and anatomical location unspecified) for prophylaxis and VAQTA (lot number and expiration date unknown), (dose number, route, dose and anatomical location unspecified). Concomitant medications were not reported. It was reported that on an unknown date unspecified patients may have received improperly stored and VAQTA and GARDASIL, which were exposed to 31F for 15 hours. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 2 female patients of 80 and 81 years of age. Medical history and drug reactions were unspecified. On an unknown date in 2008, the patients were vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and route were not reported), 0.65 milliliter (ml). Concomitant medication were unspecified. It was unspecified whether these patients received ZOSTAVAX from the same lot number. One of these patients developed shingles five years after receiving ZOSTAVAX on an unspecified date in 2012, and the other patient developed shingles five years after receiving ZOSTAVAX on an unspecified date in 2013 (reported as a month or so ago), but it was unspecified whether the 80-year-old or the 81-year-old developed the more recent shingles case a month or so ago. Laboratory studies were unspecified. The patient who developed shingles a month or so ago sought medical attention. The patient went to an unspecified emergency room for treating the shingles (treatment unspecified). Neither patient was hospitalized for the shingles. The patient with the more recent case of shingles had not followed up with the physician since notifying the physician of seeking treatment in the unspecified emergency room. Neither patient died, neither patient adverse reaction involved cancer or overdose, and neither patient had intervention to prevent serious criteria. The outcome of shingles for both the patient was unknown. The recovery status of both patients was unspecified. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in jaw
Clinical narrative: This spontaneous report as received from a health care worker refers to a 23 year old female patient. The patient's medical history was unknown. On 12-MAR-2013 the patient received her first dose of GARDASIL lot # H014645, administered intramuscularly in the left or right arm at a dose of 0.5 ml, for prophylaxis. Concomitantly, the patient was using an unspecified oral contraceptive. On 12-MAR-2013, after receiving GARDASIL, the patient experienced right sided jaw pain. She called the physician's office the next day and was instructed to go to an emergency room. It was unknown if the patient went to an emergency room or if she received any treatment for the adverse event. The right sided jaw pain resolved on an unknown date. The reporter did not provide a causality assessment for the jaw pain and GARDASIL. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac infection, Death
Clinical narrative: This spontaneous report as received from a pharmacist (or pharmacy technician - it was not confirmed) via company representative refers to a female patient of unknown age and unknown medical history. The husband reporting on his wife to the pharmacist, on an unknown date the patient was vaccinated with ZOSTAVAX, (0.65 ml in one shot; subcutaneously) (lot number, exp. date not reported). On an unknown date reported as shortly after receiving ZOSTAVAX the patient had developed an infection in her heart and died from the infection in her heart shortly after having development of infection on an unknown date. It was reported that the patient may had been immunodeficient because her husband stated that she was not the healthiest prior to receiving ZOSTAVAX and that she might also have developed a rash after receiving ZOSTAVAX but neither the presence of immunodeficiency or the development a rash had been confirmed. The outcome of the heart infection was fatal. The cause of death was heart infection. The patient's husband was adamant that ZOSTAVAX caused the infection in the patient's heart. No legal issues was suspected at this time. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative concerning a female patient two patients were also reported of unknown age who on an unknown date started therapy with [therapy unspecified] (THERAPY UNSPECIFIED) (dose, duration and indication were not reported). The registered nurse stated that on an unknown date the patient had 0 titres. It was reported that was unsure what products or vaccines the patients had received prior to the low titres count. Action taken with suspect therapy was unknown. The outcome of patient had 0 titres was unknown. Follow-up received. This report concerns a 21-year-old female patient. She was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown). Patient had no antibodies to Hepatitis B. This patient was being revaccinated with the Hepatitis B vaccine (Recombinant) (manufacturer unknown). No patient names were provided. This is one of the several reports from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 14-MAY-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, subcutaneous, anatomical location were not provided). On 17-MAY-2013, the patient experienced a 4 inch circle of redness on her arm (unspecified site). The patient received BENADRYL for treatment. The outcome of 4 inch circle of redness on her arm (unspecified site) is unknown. No reporter causality provided. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a other health professional refers to a 23 year old male patient. Patient received both M-M-R vaccinations (M-M-R II) (injection, strength, lot#, dose/frequency, route and duration were unspecified) as a child. Nurse called regarding equivocal titers for Rubella drawn on an unspecified date in the patient. The outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative concerning a female patient two patients were also reported of unknown age who on an unknown date started therapy with [therapy unspecified] (THERAPY UNSPECIFIED) (dose, duration and indication were not reported). The registered nurse stated that on an unknown date the patient had 0 titres. It was reported that was unsure what products or vaccines the patients had received prior to the low titres count. Action taken with suspect therapy was unknown. The outcome of patient had 0 titres was unknown. Follow-up received. This report concerns a high school girl approximately 16-17 years of age. She received a puncture wound in school. She was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown). Patient had no antibodies to Hepatitis B. This patient was being revaccinated with the Hepatitis B Vaccine (Recombinant) (manufacturer unknown). No patient names were provided. The outcome of puncture wound was unknown. This is one of the several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Autism
Clinical narrative: This spontaneous report has been received from a consumer, a mother of a male patient who was health of new born and was later diagnosed with autism via a survey of Merck vaccine website. On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (manufacture unknown) and Hepatitis A Vaccine (manufacturer unknown). Reported consumer stated that she know that "the only thing he received that was dangerous to him from his third day of life until he was two half was the nasty chemical filled vaccines". The reporter stated also that "Your hurting child destroying people's lives" and "I never would have used a single shot especially Hep B and Hep A. I can't thru blood my baby wasn't out having sex or using injectable drugs on his third day of life. Or at any time since." The action taken, outcome and relatedness was not reported. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative concerning a female patient. Two patients were also reported of unknown age who on an unknown date started therapy with [therapy unspecified] (dose, duration and indications were not provided). The registered nurse stated that on an unknown date the patient had 0 titres. It was reported that was unsure what products or vaccines the patients had received prior to the low titres count. Action taken with suspect therapy was unknown. The outcome of patient had 0 titres was unknown. Follow-up received. This report concerns a female patient of unknown age. She was vaccinated with a dose of Hepatitis B vaccine (manufacturer unknown). Patient had no antibodies to Hepatitis B. This patient was being revaccinated with the Hepatitis B vaccine (manufacturer unknown). No patient names were provided. This is one of the several reports from the same source. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old male patient with no drug allergies. On 28-MAY-2013 the patient was vaccinated with ZOSTAVAX 0.65 ml, (lot # J000433, Exp. 04-OCT-2014), subcutaneously in the "inside of the arm" (not the deltoid region) and had a sore arm. No treatment was given. The patient's wife called to the pharmacist. The outcome of sore arm was unknown. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Eye burns, Eye pain, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a 79 year old male pharmacist refers to himself. He stated that on 23-MAY-2013 while drawing ZOSTAVAX up in a syringe to administer a consumer, he felt something wet went into his eye, vaccine's lot # was not reported. Pharmacist's historical drugs and vaccines includes ZOSTAVAX (received on an unknown date). On 23-MAY-2013, reported as several hours later, his affected eye began to sting and burn and at the time of reporting was really red. He believed it was some of ZOSTAVAX that splashed in his eye and he was very worried that he might got 'shingles in his eye'. Pharmacist did not specify whether he performed an eye wash on his eye. No treatment was given for the events. The patient did not seek medical attention. There was no intervention to prevent serious criteria. The outcome of adverse events was unknown. The relatedness between ZOSTAVAX and adverse events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 28-DEC-2012 the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot# not reported). On 26-MAR-2013 the patient was vaccinated with the second dose of RECOMBIVAX HB. On 30-MAY-2013 the patient was vaccinated with the third dose of RECOMBIVAX HB. No adverse event reported. Additional information is not expected.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Tenderness
Clinical narrative: This spontaneous report as received form a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that a dose of ZOSTAVAX (dose and lot number were not reported) for vaccination, was administered intramuscularly rather than subcutaneously to the patient on 15-MAY-2013. No concomitant medications were reported. No adverse event reported. Follow-up information was received from the Pharmacist. Patients demographics were updated. Illness at the time of vaccination was none. On 15-MAY-2013, patient was vaccinated with a dose of ZOSTAVAX (Lot # J000445, expiry date was 11-APR-2014) intramuscularly instead of subcutaneous route. Patient had slight tenderness on 17-MAY-2013 that went away on an unknown date in 2013. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Feeling hot, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report was received from a 62 year old female patient. The patient has egg allergies, penicillin allergy and sulfa allergy. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown), (lot number, expiry date and route was not reported). Other suspect therapies included influenza virus vaccine (manufacturer unknown). Concomitant medications were none. On an unknown date, the patient after the administration with an unspecified flu vaccine and unspecified pneumonia vaccine she developed similar adverse reactions. The patient stated that she developed fatigue as well as swelling of the arm that received the injection accompanied by bright redness, achiness and heat in the arm. The patient explained that the reactions lasted for a period of about 2 weeks following both vaccinations. The patient received these vaccines at different times and did not receive multiple vaccines during administration. The patient stated that her reaction to the flu vaccine was less severe than the reaction caused by the pneumonia vaccine. The patient received the pneumonia vaccine approximately 10 months ago and received flu vaccine (reported as the flu season before last). There was no treatment rendered for the events. There was no laboratory diagnostic tests performed. On an unknown date (reported as after a couple of weeks), the patient recovered from the reported events. The patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Local reaction to Adacel R deltoid: slight erythema/ sts; min to no tenderness.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed urticarial rash, starting on the face and spreading to the trunk and arms by the time of appointment.  No associated respiratory or GI symptoms.  No other new exposures.  Treated with steroids and Benadryl.
Age: 1.01
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Lump at injection site that lasted for one month.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Redness, itching and about a golfball sized, hard area. Condition still exists as of this date, 6/8/13, but to a lesser degree.
Age: 1.28
Sex: F
Vaccine: MENHIB
Symptoms: Asthenia, Decreased appetite, Injection site erythema, Pyrexia
Clinical narrative: Large red area around injection site, loss of appetite, loss of energy, 100+ fever.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Head injury, Loss of consciousness, Vomiting
Clinical narrative: Pt was here of WCE / PE and 2nd GARDASIL shot (no incident w/first shot. After receiving shot pt passed out walking into waiting room, hit head hard (+) concussion.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Tremor
Clinical narrative: Pain, redness at injection site that worsened 3 days post injection. Pt. also experienced tremors in hands. Surveillance, ice.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dyspnoea, Injection site cellulitis, Oedema peripheral, Skin warm
Clinical narrative: Increased BP, arm swollen and warm to the touch, difficulty breathing.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients, who on an unknown dates were vaccinated with a dose of PEDVAXHIB (lot# and doses were not reported). On an unknown date PEDVAXHIB was exposed to minus 0.5C greater than 170 hours due to multiple temperature excursions occurring over the course of one year. The vaccine was found to be unsupported by in-house stability data. No adverse symptoms reported. This is one of several reports received from the same source. 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.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients, who on an unknown dates were vaccinated with a dose of GARDASIL (lot# and doses were not reported). On an unknown date GARDASIL was exposed to minus. 0.5C greater than 170 hours due to multiple temperature excursions occurring over the course of one year. The vaccine was found to be unsupported by in-house stability data. No adverse symptoms reported. This is one of several reports received from the same source. 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: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Hives on face, giving her Benadryl.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Pt experienced a large, circular area of swelling, approximately 9cm in diameter.  This area was very tender to touch and very warm to touch.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Large hive formed around & below injection site (about 4 inches in diameter).  Hive is still there 48 hrs later, but not as bright red. Gave Benadryl orally and applied cortisone cream to hive.  Itches A LOT.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient came into pharmacy 6-8-13 with redness and soreness around injection site of ZOSTAVAX. Pt stated had taken 2 BENADRYL.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Adverse site reaction - red, swollen, hot. Reported per pt request.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis injection site - Rx doxycycline 100mg BID x 10 days.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Pt rec. ZOSTAVAX shot 6-3-13. Several (2-3) days later called pharmacy and was complaining of a swollen area on the vaccinated arm, in the elbow area with a slightly bumpy feel to it.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large reddened area from injection site to lower part of elbow. Slightly raised and warm to touch pt says it is not uncomfortable.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness (size of a one-dollar coin). Itchiness. Slight swelling.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that on an unspecified date in January 2013 the patient was possibly vaccinated with a low dose of ZOSTAVAX (dose, route and lot # unknown). The patient stated "her arm was wet" around the injection site after ZOSTAVAX was administered and there was a possibility that "some of the ZOSTAVAX leaked out of the syringe". No adverse effect reported. No PQC identified. Additional information has been assistant.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix
Clinical narrative: This spontaneous report as received from a physician assistant and a nurse refers to a 22 year old female patient. On an unknown date the patient was vaccinated with series of doses of GARDASIL (dose, route and lot # unknown). Physician assistant reported the patient experienced a positive HPV test with a PAP test, two years after completing the GARDASIL vaccination series. Nurse resumed the call, stated patient was in office to receive results of PAP test. The outcome of the event was unknown. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Ataxia, Blood creatinine, Blood electrolytes, Blood potassium increased, Blood urea
Clinical narrative: None stated.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram normal, Gait disturbance, Hyperkalaemia, Monocyte count, Rash maculo-papular
Clinical narrative: None stated.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Reflexes abnormal, Swollen tongue
Clinical narrative: None stated.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 80.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Realized within 3-4 days from booster Tdap I was reacting. Entire area of injection site and surrounding area to elbow involved by 1 wk's time. Worst reaction on May 22, my B.D. Excessive swelling, erythema, heat and itching present.
Age: 80.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Realized within 3-4 days from booster Tdap I was reacting. Entire area of injection site and surrounding area to elbow involved by 1 wk's time. Worst reaction on May 22, my B.D. Excessive swelling, erythema, heat and itching present.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Central nervous system lesion, Convulsion, Cough, Headache, Joint swelling
Clinical narrative: First day bad headache. Next sore scratchy throat, cough, high fever. About week later swollen hands, swollen feet and joints. White lesion on spine and brain. Loss of pigmentation on hands and face. He was given lots of steroids, IV's, etc. Nerve damage was another reaction and seizures. Temp: 101-104 degrees.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve injury, Oedema peripheral, Oropharyngeal pain, Pyrexia, Skin hypopigmentation
Clinical narrative: First day bad headache. Next sore scratchy throat, cough, high fever. About week later swollen hands, swollen feet and joints. White lesion on spine and brain. Loss of pigmentation on hands and face. He was given lots of steroids, IV's, etc. Nerve damage was another reaction and seizures. Temp: 101-104 degrees.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: First day bad headache. Next sore scratchy throat, cough, high fever. About week later swollen hands, swollen feet and joints. White lesion on spine and brain. Loss of pigmentation on hands and face. He was given lots of steroids, IV's, etc. Nerve damage was another reaction and seizures. Temp: 101-104 degrees.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Hypersomnia, Pyrexia
Clinical narrative: Excessive crying at time of injections, 4:30 PM; excessive sleeping for the rest of the day and through the night (woke only to nurse), 5:00 PM through 10:00 AM on 05/08/2013; high fever (102.3), 12:00 PM on 05/08/2013.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Epistaxis, Face injury, Fall, Loss of consciousness
Clinical narrative: Patient was given HPV #2. She had a vasovagal reaction and fell off the examining table and hit her head. C/o of headache epistaxis. B/P 110/70 examined by dr. Dad took her to the ER for eval.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Epistaxis, Fall, Head injury, Headache, Presyncope
Clinical narrative: Patient was given HPV #2. She had a vasovagal reaction and fell off the examining table and hit her head. C/o of headache epistaxis. B/P 110/70 examined by dr. Dad took her to the ER for eval.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Chills, Hypersensitivity, Pruritus, Rash erythematous, Skin discolouration
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: MNQ, TYP, YF
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: 4-5 cm itchy hive rash appearing 6/5, seen in clinic 6/7/13. Had travel vaccinations 6/4/13 planned travel 6/9/13 for 7 weeks. Rash only to left deltoid where all 3 vaccines given. Afebrile, temp 97.5 F. Treatment - BENADRYL and local hydrocortisone.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Body temperature increased, Decreased appetite, Dehydration, Irritability, Vomiting
Clinical narrative: Pt. went home after the office visit and 4-5 hours post vaccination presented with vomiting temp of 100.9; irritability, poor appetite, all of these resulting in hospitalization due to dehydration.
Age: 0.52
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, vomiting within 6 hours of injection/ingestion. Received Acetaminophen for fever.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Pallor, Rash, Rash pruritic
Clinical narrative: 14 years old boy felt nauseous, appeared pale. Complained of itchy rash on hands right after MENVEO vaccination. Also complained of feeling dizzy. Did not lose consciousness. No drooling. No wheezing. EPIPEN 1x injection was placed on his left thigh.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Hypersensitivity, Local reaction
Clinical narrative: Patient received Tdap 6/3 and had severe local allergic reaction on (L) arm with probable cellulitis requiring admission.
Age: 57.0
Sex: M
Vaccine: HEPAB, TD, TYP, YF
Symptoms: Dizziness, Vertigo
Clinical narrative: TWINRIX given per accelerated dosing due to departure date. At appt. for 3rd dose he stated he had been experiencing dizziness and wondered if vaccine could cause that. On 5/21/13 he called in and said he felt certain the vaccine had caused his "vertigo". Stated dizziness started about 1 week after 1st dose, that it comes and goes. Denies any previous episodes of dizziness. Has seen PCP and stated that she doesn't feel like the vaccine would have caused it.
Age: 16.0
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old patient who on 05-JUN-2013, was vaccinated subcutaneously with the first dose of MMR II (dose and lot number not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients, who on an unknown dates were vaccinated with PNEUMOVAX 23 (lot# and doses were not reported). ON an unknown date PNEUMOVAX 23 was exposed to minus 0.5C greater than 170 hours due to multiple temperature excursions occurring over the course of one year. The vaccine was found to be unsupported by in-house stability data. No adverse symptoms reported. This is one of several reports received from the same source. 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: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 18 year old female patient. On 03-JUL-2013 the patient was vaccinated by a nurse with expired GARDASIL (lot # 667930/1561Z, expiry date 23-MAR-2013) (strength and total daily dose not reported). No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to an elderly ("over 80 years") male patient. No medical history provided. On an unknown date the patient was vaccinated with ZOSTAVAX (vial; dosing, indication unknown. No concomitant medications were reported. On an unknown date the patient experienced shingles. The outcome of shingles was reported as not recovered. Medical attention was sought by the patient's wife by going to the pharmacy. Additional information is not expected.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Immunisation
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative concerning a female patient "two patients were also reported" of unknown age who on an unknown date started therapy with (therapy unspecified) (dose, duration and indication were not provided). The registered nurse stated that on an unknown date the patient had "0 titres". It was reported that was unsure what products or vaccines the patients had received prior to the low titres count. Action taken with suspect therapy was unknown. The outcome of patient had 0 titres was unknown. Follow-up received. This report concerns a male patient. He was vaccinated with a dose of Hep B (manufacturer unknown). Patient had no antibodies to hepatitis B. This patient was being revaccinated with the Hep B vaccine (manufacturer unknown). No patient names were provided. This is one of the several reports from the same source. Additional information has been requested.