chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Infection, Injection site reaction
Clinical narrative: Pt called on 9/27/12 and said son an infection in arm was administered. Pediatrician gave antibiotic. (Potential injection site reaction).
Age: 89.0
Sex: U
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Feeling cold, Nausea, Nervousness
Clinical narrative: Appx 6 hours after vaccination, patient felt nausea, had shivers & cold chills, felt shaky, unsteady. Feelings persisted until next morning.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: 9/6/12 Pt was seen for allergic reaction to 2nd varicella shot at our clinic. It was red, swollen at injection site. 6 x 7 cm lump site, felt warm no fever. Treatment was children's BENADRYL & ice pack to put on arm when needed.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Pt. felt fine but later went to ER, notified by family member 9/27/12 about ER visit.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Body temperature increased, Tremor
Clinical narrative: 5 second "tremor" over entire body occurred 1 day after FLUMIST. 100.5 temperature.
Age: 59.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Shock, Syncope, Vomiting
Clinical narrative: Syncope, shock, emesis.
Age: 74.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Itching - rash on left side of body - left arm, lower back, stomach, left leg - thigh & behind left knee. Patient reported event on 9/26/12 & rash still prominent in all areas stated above. So far patient has been treating with Calamine lotion.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, MNQ
Symptoms: Dizziness, Visual impairment
Clinical narrative: Dizziness, seeing black spots < 5 minutes.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, DTAP, PPV, VARZOS
Symptoms: Activities of daily living impaired, Erythema, Malaise, Nodule, Oedema peripheral
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 67 years old female patient with no medical history or drug allergies reported. The nurse called to report that a patient received PNEUMOVAX 23 0.5 mL (lot#H013581, exp: 03-MAR-2014) on 29-AUG-2012 and experienced a fever with temperature of 101F and developed nodes under right arm near the injection site area. No laboratory tests were performed. It was reported that the patient did not receive treatment for the adverse events. The patient contacted physician's office. No treatment was given. The outcome of the events was reported as not recovered. The relatedness of the events PNEUMOVAX 23 was unknown. This was the second of 2 AE's being reported by this nurse for the same PNEUMOVAX 23 lot#H013581, exp date: 03-MAR-2014. This is one of several report from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, DTAP, PPV, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 67 years old female patient with no medical history or drug allergies reported. The nurse called to report that a patient received PNEUMOVAX 23 0.5 mL (lot#H013581, exp: 03-MAR-2014) on 29-AUG-2012 and experienced a fever with temperature of 101F and developed nodes under right arm near the injection site area. No laboratory tests were performed. It was reported that the patient did not receive treatment for the adverse events. The patient contacted physician's office. No treatment was given. The outcome of the events was reported as not recovered. The relatedness of the events PNEUMOVAX 23 was unknown. This was the second of 2 AE's being reported by this nurse for the same PNEUMOVAX 23 lot#H013581, exp date: 03-MAR-2014. This is one of several report from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, DTAP, PPV, VARZOS
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 67 years old female patient with no medical history or drug allergies reported. The nurse called to report that a patient received PNEUMOVAX 23 0.5 mL (lot#H013581, exp: 03-MAR-2014) on 29-AUG-2012 and experienced a fever with temperature of 101F and developed nodes under right arm near the injection site area. No laboratory tests were performed. It was reported that the patient did not receive treatment for the adverse events. The patient contacted physician's office. No treatment was given. The outcome of the events was reported as not recovered. The relatedness of the events PNEUMOVAX 23 was unknown. This was the second of 2 AE's being reported by this nurse for the same PNEUMOVAX 23 lot#H013581, exp date: 03-MAR-2014. This is one of several report from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Chlamydial infection, Delivery, Live birth, Maternal exposure during pregnancy, Meconium in amniotic fluid
Clinical narrative: This spontaneous report as received from a physician refers to a male patient who was born from a 18 year old mother, who on 19-JUL-2011 was vaccinated intramuscularly on left deltoid with the first 0.5 ml dose of GARDASIL and on 03-OCT-2011 was vaccinated intramuscularly on left deltoid with the second dose of GARDASIL. The patient's mother concomitant therapies included prenatal vitamins and TYLENOL. The physician reported that during labor on 23-JUL-2012, the patient's mother experienced a placental abruption of 10%, and it was needed the use of forceps assisted vaginal delivery (FAVD) (MARRS 1112USA00914). On the same date, the patient experienced light meconium. The patient's apgar score was 9/9. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pregnancy test positive, Premature separation of placenta, Treponema test negative, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous report as received from a physician refers to a male patient who was born from a 18 year old mother, who on 19-JUL-2011 was vaccinated intramuscularly on left deltoid with the first 0.5 ml dose of GARDASIL and on 03-OCT-2011 was vaccinated intramuscularly on left deltoid with the second dose of GARDASIL. The patient's mother concomitant therapies included prenatal vitamins and TYLENOL. The physician reported that during labor on 23-JUL-2012, the patient's mother experienced a placental abruption of 10%, and it was needed the use of forceps assisted vaginal delivery (FAVD) (MARRS 1112USA00914). On the same date, the patient experienced light meconium. The patient's apgar score was 9/9. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Foetal exposure during pregnancy, Forceps delivery, Meconium stain, Premature separation of placenta
Clinical narrative: This spontaneous report as received from a physician refers to a male patient who was born from a 18 year old mother, who on 19-JUL-2011 was vaccinated intramuscularly on left deltoid with the first 0.5 ml dose of GARDASIL and on 03-OCT-2011 was vaccinated intramuscularly on left deltoid with the second dose of GARDASIL. The patient's mother concomitant therapies included prenatal vitamins and TYLENOL. The physician reported that during labor on 23-JUL-2012, the patient's mother experienced a placental abruption of 10%, and it was needed the use of forceps assisted vaginal delivery (FAVD) (MARRS 1112USA00914). On the same date, the patient experienced light meconium. The patient's apgar score was 9/9. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Disturbance in attention, Fatigue, Headache, Immune system disorder, Infectious mononucleosis
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date finished a 2 year series of GARDASIL and was now complaining of fatigue, headaches, can't concentrate and had mono. She had blood work done that diagnosed MONO (infectious Mononucleosis). The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Follow-up information was received from a nurse concerning a 27 year old female (139 pounds; 46 inches) who in approximately September 2010 was vaccinated with GARDASIL. The patient had no adverse events following prior vaccinations, had no illnesses at the time of the vaccination and had no pre-existing allergies, birth defects or medical conditions. In November 2010, she experienced fatigue and was diagnosed with "several sicknesses- mono, flu". She had a very weak immune system and was unable to fight off illness. The nurse stated she was very healthy before. The nurse indicated it was unknown whether the pt had recovered. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza, Mononucleosis heterophile test positive
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date finished a 2 year series of GARDASIL and was now complaining of fatigue, headaches, can't concentrate and had mono. She had blood work done that diagnosed MONO (infectious Mononucleosis). The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Follow-up information was received from a nurse concerning a 27 year old female (139 pounds; 46 inches) who in approximately September 2010 was vaccinated with GARDASIL. The patient had no adverse events following prior vaccinations, had no illnesses at the time of the vaccination and had no pre-existing allergies, birth defects or medical conditions. In November 2010, she experienced fatigue and was diagnosed with "several sicknesses- mono, flu". She had a very weak immune system and was unable to fight off illness. The nurse stated she was very healthy before. The nurse indicated it was unknown whether the pt had recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients who an unspecified dates were vaccinated with improperly stored doses of GARDASIL (doses, routes and lot numbers not provided). It was reported that the vaccines were exposed to 26.8 F over the days in August 2012. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a currently 6 month old patient who on 27-DEC-2011 was vaccinated with the first dose of ROTATEQ (dose, route and lot # not provided). On 13-JAN-2012, 2 weeks after the first dose, the patient received the second dose of ROTATEQ (dose, route and lot # not provided) and on 24-FEB-2012, the patient received the third dose of ROTATEQ (dose, route and lot # not provided). No adverse effect had been observed. Follow up information has been received from the physician. The male patient was vaccinated with the fourth dose of ROTATEQ (lot# reported as 1672AA) orally on 24-MAY-2012. The patient tolerated well. The lot number of the third dose of ROTATEQ was reported as 1539AA. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender, who on 23-AUG-2012 was inadvertently administered with a dose of GARDASIL 0.5 ml IM (lot # 666121/0597Z) that had expired on 19-AUG-2012. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients who approximately in August 2012, were vaccinated with improperly stored doses of PEDVAXHIB (doses, routes and lot numbers not provided). It was reported that the vaccines were exposed to 26.8 F over the 4 days in August 2012. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a mother concerning her daughter who, she reported, received three doses (dates not provided) of GARDASIL. Vaccine that had been improperly stores (not further specified). No details of the temperatures that the product was exposed to were provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender who on unspecified dates 2 years ago "in 2010" was vaccinated with the first and second dose of GARDASIL (dose, route and lot numbers not reported). On 11-SEP-2012, the patient was in the office to receive the third dose of GARDASIL (dose, route and lot # not reported). No adverse effects were reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age who on beginning of February 2010, was vaccinated IM with the first dose of GARDASIL (route, dose and lot # not reported). On 11-SEP-2012, the patient was vaccinated IM with the third dose of GARDASIL (lot # not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a Doctor in osteopathy concerning an unknown number of patients of unknown age and sex. On unspecified dates, the patients were vaccinated with "the second or third" dose of GARDASIL (dose and route were not reported) (lot # and expiration date were not reported). The physician reported that on unknown dates the patient experienced "more adverse events after receiving second or third dose of GARDASIL". It was unknown if the patients sought medical attention. At the time of the report, the patient's outcomes were unknown. The relatedness of GARDASIL and the event was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a female consumer refers to herself. The patient was vaccinated with GARDASIL (dose, route and lot# not reported). It was reported that the patient experienced the arm where she received the GARDASIL shot hurted. It was unknown if the patient sought medical attention. The outcome of event was unknown. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Information was received from a field employee who reported on a 19 year-old female. Two weeks ago, the patient was placed on therapy with GARDASIL, .5 ml/series of 3 shots, intramuscular. Two weeks ago, the patient experienced a drop in blood pressure and fainted after the first shot of GARDASIL. The patient recovered in 20 minutes. It was reported to the field employee that this has happened several times in this office with GARDASIL. Therapy with GARDASIL was discontinued and the adverse event improved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 04-AUG-2011, the patient was vaccinated with first dose of GARDASIL. No concomitant medications were reported. On 14-JUL-2012, the patient received the second dose of GARDASIL. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a nurse concerning a female patient. It was reported that on 12-OCT-2010, the patient was administered the first dose of GARDASIL, 0.5 ml, intramuscular. On 11-SEP-2012, the second dose of GARDASIL (lot# 673256/0629AE exp. December 2014) was administered. No adverse effects were reported. No further information is expected.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a physician via a company representative concerning a 39 year old male who on 12-SEP-2012 was vaccinated with a dose of PNEUMOVAX 23 (lot#HOL3581, exp date not provided). On 14-SEP-2012 the patient experienced swelling of the arm, itching, and chills from receiving PNEUMOVAX 23. The patient was seen by the physician and treated with BENADRYL. At the time of report, it was unknown if the patient had recovered. A lot check has been requested by the reporting physician. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated
Clinical narrative: Information was received via telephone call from a pharmacist regarding a 76 year old female who 5 years ago was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and experienced an exacerbation of an unspecified health condition. The pharmacist stated that the exacerbation of the patient's health condition had nothing to do with pneumococcal vaccine, polyvalent (23-valent). Permission to follow up with the patient's physician was denied. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age, who on 21-AUG-2012 was vaccinated with a dose of ZOSTAVAX 0.65 ml subcutaneously (lot # 0565AE, Exp: 23-MAR-2012 - in verification process). No other co-suspects were reported. No concomitant medications were reported. The pharmacist mentioned that a patient received ZOSTAVAX and on 22-AUG-2012 experienced injection site that was red, warm and a little swollen that was about 2 inches in diameter. No treatment was given for the events. The outcome of the events was reported as not recovered. No laboratory diagnostic studies were performed. The patient sought medical attention via visit to pharmacist. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a Pharmacist concerning a male who on 16-SEP-2012 was inadvertently administered an expired dose of PNEUMOVAX 23 (lot #0595AA, exp date 30AUG12). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information was received via telephone call from a pharmacist regarding a patient who on 10-SEP-2012, was inadvertently vaccinated with a dose of PNEUMOVAX 23 that had expired (Lot #669579/0595AA, Expiration: 30-AUG-2012). No adverse effects were reported. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a health care professional (medical assistant via a field representative). The medical assistant reported on 20-SEP-2012, a patient was administered an expired dose of PNEUMOVAX 23 (lot number 667134/0738Z, expiration date 24-NOV-2011) (site and route not provided). No adverse effects reported. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender who on 27-JUN-2012, was vaccinated with the first dose of PNEUMOVAX23 (route and lot# not reported). On 14-SEP-2012, the patient received another dose of PNEUMOVAX23 (route not reported, lot# 1418AA, exp: 25-MAY-2013) inadvertently. No adverse effects were reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer refers to a 77 years old female patient with cancer and chemotherapy. On 16-AUG-2012, the patient was vaccinated with ZOSTAVAX 1 time. Concomitant therapy included blood pressure meds (3 total) and vitamin D (unspecified). On 18-AUG-2012, the patient experienced nausea, numbness in the toes, tingling, headache and joint pain. The outcome of all events was unknown. The relatedness for nausea, numbness in the toes, tingling, headache and joint pain was unknown for ZOSTAVAX. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to an about 80 years old male patient. The patient was vaccinated SC with single 0.65 ml dose of ZOSTAVAX in approximately 2009 ("2 to 3 years ago"). No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient had a skin rash. The outcome of skin rash was reported as recovered (date unspecified). Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning her mother (patient) of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (19400, units unspecified) (lot number, dose unspecified). No concomitant medications were reported. On an unknown date, after the vaccination, the patient experienced injection site redness and swelling about an inch in diameter. The patient did not seek medical attention. The events injection site redness and swelling were resolved in about a week (date unspecified). The relatedness for injection site redness and swelling was unknown for ZOSTAVAX. This case is related to 1209USA005140 (same reporter link and patient/partner link). Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a 20 years old female patient, who was administered 3 dose of RECOMBIVAX HB (doses, routes and lot numbers not reported) on unspecified dates as an infant, and was now found to have negative antibody titers. No treatment was given for AE. The patient's present status was reported as other: negative antibody titers (not recovered, at the time of the report). The relatedness for the event was unknown for RECOMBIVAX HB. Laboratory diagnostic studies were performed: antibody titers. The patient sought medical attention via office visit. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from a Registered nurse refers to a 1 year old female patient with no drug reactions or allergies and no pertinent medical history. On 30-AUG-2012, the patient was vaccinated subcutaneously with first dose, 0.5 milliliter (ml) VARIVAX (Merck) single dose vaccination (Lot number was not provided). No concomitant medications were reported. On 11-SEP-2012 the patient returned to the practice with six varicella-like spots or lesions. The patient sought medical attention, office visit. No treatment was given. The nurse reported that the lesions had scabbed over by 12-SEP-2012. The outcome of the event was reported as recovering/resolving. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash macular
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient was vaccinated with ZOSTAVAX, (lot number 0073AE) on 12-SEP-2012. No concomitant medications were reported. The patient reported that after receiving ZOSTAVAX vaccine on 12-SEP-2012, a red rash appeared. On 13-SEP-2012 (reported as next day), the rash generated a red blotchy area that was itchy. The patient sought medical attention. BENADRYL and Z-pack antibiotics were given as a treatment. The outcome of the events were unknown at the time of this report. Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 47 year old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml subcutaneous injection, (lot number not reported). No concomitant medications were reported. Subsequently the patient received ZOSTAVAX and broke out with shingles within 2 months. No treatment information was reported. The outcome of the event was unknown. This case is linked to 1209USA008748(same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a doctor of pharmacy concerning a patient of unknown age and sex. The patient's pertinent medical history and drug reactions or allergies were not reported. On 31-AUG-2012, the patient was vaccinated intramuscularly with an expired dose of PNEUMOVAX23 (dose was not reported) (lot #: 669579/0595AA; expiration date; 30-AUG-2012). There were no adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a R.N. who stated that improperly stored MMR II (lot numbers not reported) might have been administered to a child. It was reported MMR II was exposed to 64 F for 18 hours. No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported) that was stored at -74 degrees Fahrenheit for 70 hours. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist (local reference ID # US12-036670) concerning a female healthcare professional with a history of chickenpox 3 times in her childhood and a history of shingles in her adulthood ("a time when she had outbreak every 3-4 months"). On an unknown date, the reporter broke out in a case of shingles within 48 hours of administering ZOSTAVAX. She sought a medical attention immediately and received VALTREX. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to 3 patients. The age range of all 3 patients involved was from 55 to 65 years old. This involved one male patient and 2 female patients. All patients were vaccinated subcutaneously in the deltoid area of the upper arm with a 0.65 ml dose of ZOSTAVAX (lot number reported as H109779, expiration date unspecified). No other co-suspects were reported. No concomitant medications were reported. On approximately 03-AUG-2012, approximately a week ago, all 3 patients experienced similar localized reactions that included redness and swelling. One of the patients (unspecified which one) also had a headache and another patient (unspecified which one) had a lump at the injection site. It was reported that all 3 doses of ZOSTAVAX came from the same lot number. All 3 patients did not seek medical attention. No treatment was given for the events. No lab diagnostics studies were performed. The causality between the events and a ZOSTAVAX was unknown. At the time of the reports patients' outcomes were unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to unknown number of patients. The patient was vaccinated with 2 doses of M-M-R II (lot number, route, dose and injection site were not reported) on an unknown date for recommended immunization schedule. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients were vaccinated with 2 doses of M-M-R II as children had no titers at the time of report. The outcome was unknown at the time of report. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a physician refers to a 68 years old female patient. The patient was vaccinated with a vial dose of PNEUMOVAX 23 (lot# reported as HOL3581) injected on 11-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-SEP-2012 the patient experienced swollen right arm and a "3/4 edema". The patient had sought medical attention by saw physician. BENADRYL was given for treatment. The physician requested a lot check. The outcome was unknown. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC, VARCEL
Symptoms: Blister, Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a consumer concerning his/her son, a 12 month old male patient with penicillin allergy and bronchiolitis and a history of ear infection who on 12-MAY-2012 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included albuterol. It was reported that on 15-MAY-2012 the patient developed a virus with blisters all over his body and he got a fever after he had the VARIVAX (Merck). The patient sought unspecified medical attention. The patient was given BENADRYL and Calamine Lotion. Lab tests were not performed. AE did not improve. Outcome was reported as not recovered. Follow up information has been received from the patient's mother concerning her a 12 months old male son with latex allergy and none illness at time of vaccination. On 12-MAY-2012, the patient was vaccinated with dose 2 of VARIVAX (Merck) subcutaneously in right thigh (lot # 671163/1208AA) (dose not reported). Other suspect therapies included M-M-R II given subcutaneously in left thigh, second dose (lot number 1001AA) on 12-MAY-2012. Concomitant medications included PENTACEL (IM, left thigh) and PREVNAR (IM, right thigh). On an unknown date the patient was seen in ER for rash. No treatment information was reported. The outcome of developed virus with blisters all over his body and got a fever after he had VARIVAX (Merck) was reported as not recovered/not resolved. The outcome of rash was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician. The physician reported that 40 - 50 patients with renal disease at their dialysis facility have had Hepatitis B antibody titers with negative (non-immune) results, over an unspecified time period. The patients were vaccinated with RECOMBIVAX HB (Lot# unspecified) on an unknown date. No other co-suspects were reported. No treatment information was reported. The outcome of hepatitis B antibody titers with negative (non-immune) results is unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This pharmacist reports that a 79 year old female consumer started taking PNEUMOVAX 23 (lot #669579/0595AA), dose, frequency and route unknown on 16SEP2012, for an unknown indication. The consumer's relevant medical history, concomitant medications, and past drug history are unknown. On 16SEP2012, the consumer was administered a PNEUMOVAX 23 that had expired on 30AUG2012. It is unknown if there is any relevant laboratory data. As of 16SEP2012, the outcome of receiving the expired vaccine is unknown, and it is unknown if the consumer continues to take PNEUMOVAX 23. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a nurse practitioner regarding a 2 year old male with asthma, frequent episodes of otitis media, allergy to SUPRAX, and history of pneumonia, respiratory syncytial virus infection, and colic who received PNEUMOVAX 23 (lot# 0491AE; expiration date 01-SEP-13) intramuscularly on 14-SEP-2012, for recurrent asthma. Concomitant medication included ALVESCO, montelukast sodium (MSD), XOPENEX, AXID, and FLOVENT. On 15-SEP-2012, the patient developed cellulitis at the injection site in his left thigh. Treatment included clindamycin and SEPTRA. No further information provided. Additional information is not expected.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse, who is also the patient's mother, regarding a 27 year old HIV-positive male with asthma and history of pneumonia, who was administered PNEUMOVAX 23 on 17-SEP-2012. Concomitant medication included rescue inhaler and steroids on occasion. On 18-SEP-2012, the patient experienced "soreness, tenderness, pain and swelling at the injection site, as well as it being warm to the touch. In addition, he experienced fever, chills, and fatigue." The patient was treated with TYLENOL. The present patient status was that he was recovering. No further information is available. Additional information is not expected.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse, who is also the patient's mother, regarding a 27 year old HIV-positive male with asthma and history of pneumonia, who was administered PNEUMOVAX 23 on 17-SEP-2012. Concomitant medication included rescue inhaler and steroids on occasion. On 18-SEP-2012, the patient experienced "soreness, tenderness, pain and swelling at the injection site, as well as it being warm to the touch. In addition, he experienced fever, chills, and fatigue." The patient was treated with TYLENOL. The present patient status was that he was recovering. No further information is available. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Benign intracranial hypertension, Eyelid disorder, Fatigue, Headache, Intracranial pressure increased
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 18 September 2012. An 18-year-old female patient had received a dose one injection of MENACTRA, lot number U4254AA, on 09 August 2012 (route and site of administration not reported). The next morning on 10 August 2012, the patient experienced lethargy, severe headache at temple area and a stiff neck. The patient also had swelling of the right and left optic nerve. The patient returned to her pediatrician, had numerous tests done and was now being seen by two specialists. The patient had many tests, an MRI and ultrasound. All tests were negative except for "pressure on optic nerve". It has been six weeks since the vaccination and the patient still has constant headache, fatigue, optic nerve pressure and cognitively feels "like she can't articulate, can't get the words out". The patient continues to follow-up with specialists. The patient had no illness at the time of vaccination and no known allergies. The patient's outcome was not recovered. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Lumbar puncture, Musculoskeletal stiffness, Neurological examination, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 18 September 2012. An 18-year-old female patient had received a dose one injection of MENACTRA, lot number U4254AA, on 09 August 2012 (route and site of administration not reported). The next morning on 10 August 2012, the patient experienced lethargy, severe headache at temple area and a stiff neck. The patient also had swelling of the right and left optic nerve. The patient returned to her pediatrician, had numerous tests done and was now being seen by two specialists. The patient had many tests, an MRI and ultrasound. All tests were negative except for "pressure on optic nerve". It has been six weeks since the vaccination and the patient still has constant headache, fatigue, optic nerve pressure and cognitively feels "like she can't articulate, can't get the words out". The patient continues to follow-up with specialists. The patient had no illness at the time of vaccination and no known allergies. The patient's outcome was not recovered. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Papilloedema, Venogram
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 18 September 2012. An 18-year-old female patient had received a dose one injection of MENACTRA, lot number U4254AA, on 09 August 2012 (route and site of administration not reported). The next morning on 10 August 2012, the patient experienced lethargy, severe headache at temple area and a stiff neck. The patient also had swelling of the right and left optic nerve. The patient returned to her pediatrician, had numerous tests done and was now being seen by two specialists. The patient had many tests, an MRI and ultrasound. All tests were negative except for "pressure on optic nerve". It has been six weeks since the vaccination and the patient still has constant headache, fatigue, optic nerve pressure and cognitively feels "like she can't articulate, can't get the words out". The patient continues to follow-up with specialists. The patient had no illness at the time of vaccination and no known allergies. The patient's outcome was not recovered. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cognitive disorder, Fatigue, Headache, Laboratory test abnormal, Lethargy
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 18 September 2012. An 18-year-old female patient had received a dose one injection of MENACTRA, lot number U4254AA, on 09 August 2012 (route and site of administration not reported). The next morning on 10 August 2012, the patient experienced lethargy, severe headache at temple area and a stiff neck. The patient also had swelling of the right and left optic nerve. The patient returned to her pediatrician, had numerous tests done and was now being seen by two specialists. The patient had many tests, an MRI and ultrasound. All tests were negative except for "pressure on optic nerve". It has been six weeks since the vaccination and the patient still has constant headache, fatigue, optic nerve pressure and cognitively feels "like she can't articulate, can't get the words out". The patient continues to follow-up with specialists. The patient had no illness at the time of vaccination and no known allergies. The patient's outcome was not recovered. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, Papilloedema, Sensation of pressure, Speech disorder
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 18 September 2012. An 18-year-old female patient had received a dose one injection of MENACTRA, lot number U4254AA, on 09 August 2012 (route and site of administration not reported). The next morning on 10 August 2012, the patient experienced lethargy, severe headache at temple area and a stiff neck. The patient also had swelling of the right and left optic nerve. The patient returned to her pediatrician, had numerous tests done and was now being seen by two specialists. The patient had many tests, an MRI and ultrasound. All tests were negative except for "pressure on optic nerve". It has been six weeks since the vaccination and the patient still has constant headache, fatigue, optic nerve pressure and cognitively feels "like she can't articulate, can't get the words out". The patient continues to follow-up with specialists. The patient had no illness at the time of vaccination and no known allergies. The patient's outcome was not recovered. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Ultrasound scan normal
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 18 September 2012. An 18-year-old female patient had received a dose one injection of MENACTRA, lot number U4254AA, on 09 August 2012 (route and site of administration not reported). The next morning on 10 August 2012, the patient experienced lethargy, severe headache at temple area and a stiff neck. The patient also had swelling of the right and left optic nerve. The patient returned to her pediatrician, had numerous tests done and was now being seen by two specialists. The patient had many tests, an MRI and ultrasound. All tests were negative except for "pressure on optic nerve". It has been six weeks since the vaccination and the patient still has constant headache, fatigue, optic nerve pressure and cognitively feels "like she can't articulate, can't get the words out". The patient continues to follow-up with specialists. The patient had no illness at the time of vaccination and no known allergies. The patient's outcome was not recovered. Documents held by sender: None.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt. arm red, hot to touch, edema from deltoid to elbow on posterior and lateral side of arm. Pain at "7". Given antibiotic and ibuprofen by PCP.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: Rt. arm red, hot to touch, edema from deltoid to elbow on posterior and lateral side of arm. Pain at "7". Given antibiotic and ibuprofen by PCP.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Unevaluable event
Clinical narrative: Initial report was received from a healthcare professional on 17 September 2012, with follow-up information received on 20 September 2012. The reporter for this case is the same as serious case number 2012-08814 and non-serious case number 2012-08815. A 48-year-old female patient received dose one (single dose, prefilled syringe) of a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd., sanofi pasteur Inc lot number U4384AA, (corresponding sanofi pasteur Ltd. lot number C4203) on 17 September 2012. On 17 September 2012, five minutes after vaccination, the patient had numbness to left side of face and she was sent to the emergency room (ER). On follow-up, the reporter stated the patient also had a swollen tongue "felt thick", (outcome was not reported). (The reporter clarified information received on 17 September 2012, reporting one patient had a swollen tongue, one patient had a swollen cheek and one patient was hospitalized, stating that was all the same patient.) The reporter denied that the patient had a swollen cheek. On the 19 September 2012, two day post vaccination, the patient had pain radiating from her left shoulder to clavicle. At time of follow-up information, the patient remained hospitalized. Laboratory or diagnostic testing and treatments were not reported. The patient's past medical history and concomitant medications were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Musculoskeletal pain, Swollen tongue, Tongue disorder
Clinical narrative: Initial report was received from a healthcare professional on 17 September 2012, with follow-up information received on 20 September 2012. The reporter for this case is the same as serious case number 2012-08814 and non-serious case number 2012-08815. A 48-year-old female patient received dose one (single dose, prefilled syringe) of a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd., sanofi pasteur Inc lot number U4384AA, (corresponding sanofi pasteur Ltd. lot number C4203) on 17 September 2012. On 17 September 2012, five minutes after vaccination, the patient had numbness to left side of face and she was sent to the emergency room (ER). On follow-up, the reporter stated the patient also had a swollen tongue "felt thick", (outcome was not reported). (The reporter clarified information received on 17 September 2012, reporting one patient had a swollen tongue, one patient had a swollen cheek and one patient was hospitalized, stating that was all the same patient.) The reporter denied that the patient had a swollen cheek. On the 19 September 2012, two day post vaccination, the patient had pain radiating from her left shoulder to clavicle. At time of follow-up information, the patient remained hospitalized. Laboratory or diagnostic testing and treatments were not reported. The patient's past medical history and concomitant medications were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a registered nurse regarding to a 72 years old female patient with gout, hypothyroidism, hyperlipidemia, hypertension and tetracycline allergy. On 06-SEP-2012, the patient was vaccinated with 0.65 ml dose of ZOSTAVAX, subcutaneous, (Lot number H009779, expiration date 27-MAR-2013). No other co-suspects were reported. Concomitant medications included anagrelide hydrochloride, ECOTRIN, labeled hcl, levothyroxine sodium, omeprazole, hydrochlorothiazide, ULORIC, VERAMYST and LEXAPRO. On 08-SEP-2012, the patient developed a fever of 101.2 degrees F and a vesicular rash at the injection site. The patient had an office visit on 11-SEP-2012 and there was no more fever. The rash was red and itchy and the size of a silver dollar. The patient did not receive treatment for the adverse events. There was no laboratory test performed. At the time of the report the patient had not recovered from vesicular rash at the injection site, redness and rash pruritic. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a registered nurse regarding to a 72 years old female patient with gout, hypothyroidism, hyperlipidemia, hypertension and tetracycline allergy. On 06-SEP-2012, the patient was vaccinated with 0.65 ml dose of ZOSTAVAX, subcutaneous, (Lot number H009779, expiration date 27-MAR-2013). No other co-suspects were reported. Concomitant medications included anagrelide hydrochloride, ECOTRIN, labeled hcl, levothyroxine sodium, omeprazole, hydrochlorothiazide, ULORIC, VERAMYST and LEXAPRO. On 08-SEP-2012, the patient developed a fever of 101.2 degrees F and a vesicular rash at the injection site. The patient had an office visit on 11-SEP-2012 and there was no more fever. The rash was red and itchy and the size of a silver dollar. The patient did not receive treatment for the adverse events. There was no laboratory test performed. At the time of the report the patient had not recovered from vesicular rash at the injection site, redness and rash pruritic. Additional information has been requested.