chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site haematoma, Swelling, Urticaria
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age with no drug reactions or allergies. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # H009826, expiration date 11-FEB-2014) IM on 16-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced bruise at the injection site as well as reddish, swollen welts approximately 2 inches below the injection site. The patient was treated with TYLENOL. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age. The patient was vaccinated with an expired 0.65 ml dose of ZOSTAVAX (lot # 671021/0747AA, expiration date 18-AUG-2012) SQ on 18-OCT-2012. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a physician, concerning 4,214 Enhanced Perinatal Hepatitis B Case Management Projects (EPHBP)-managed infants born to HBsAg-positive women who completed 3 or more Hepatitis B vaccine (Recombinant) (manufacturer unknown) doses, 63.7% had reported post vaccination serologic testing (PVST) results, 13.3% had reported PVST results but infant age was unknown, and 23.0% had no reported PVST results. Of 2,683 infants with PVST results by age 24 months, 3.2% (87 infants) remained susceptible. PVST is critical for guiding medical management of infants born to HBsAg-positive women, identifying infants with HBV infection and in need of further care, and monitoring progress toward the elimination of perinatal HBV transmission. Of infants with reported PVST results and date, HBV serology status was categorized as "protected" (anti-HBs-positive, HBsAg-negative), "HBV-infected" (anti-HBs-negative, HBsAg-positive; anti-HBs-positive, HBsAg-positive; or anti-HBs unreported. HBsAg-positive), "susceptible (anti-HBs-negative, HBsAg-negative), or "indeterminate") (all other result combinations). A protective anti-HBs result was defined as >10 mlU/mL. Records of susceptible infants were reviewed for revaccination and repeat PVST. This is one of several reports from the same literature source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 62 years old female patient. Patient's current conditions included penicillin allergy, iodine allergy and sulfonamides allergy. On 17-SEP-2012, the patient was vaccinated subcutaneously on her left arm with a single dose of ZOSTAVAX (lot # 672675/0068AE, expiry 03-APR-2013). Concomitant medications included LUMIGAN, FLONASE, pravastatin sodium, timolol, valproic acid, bupropion hydrochloride and hydrochlorothiazide, ramipril. On 19-SEP-2012, the patient developed erythema and swelling at injection site. The patient was evaluated by the physician on 19-SEP-2012 and was found to have a 9 centimeter (cm) by 3 cm area of redness and swelling at the injection site on the left upper arm. There was no rash or blisters. The patient sought medical attention (office visit). The patient received treatment with a "Z pack", BENADRYL and cool compresses. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Hepatitis B surface antigen positive
Clinical narrative: Information has been received from a literature article, concerning of 4,214 project-managed infants born to HBsAG-positive women, who completed 3 or more hepatitis B vaccine (recombinant) (manufacturer unknown) doses, 63.7% had reported post vaccination serologic testing (PVST) results, 13.3% had reported PVST results but infant age was unknown, and 23.0% had no reported PVST results. Of 2,683 infants with PVST results by age 24 months, 1.0% (28 infants) were infected and had Anti-HBs Antibody Negative. PVST is critical for guiding medical management of infants born to HBsAg-positive women, identifying infants with HBV infection and in need of further care, and monitoring progress toward the elimination of perinatal HBV transmission. Of infants with reported PVST results and date, HBV serology status was categorized as "protected" (anti-HBs-positive, HBs-Ag-negative), "HBV-infected" (anti-HBs-negative, HBsAg-positive; anti-HBs-positive, HBsAg-positive; or anti-HBs unreported, HBsAg-positive), "susceptible" (anti-HBs-negative, HBsAg-negative), or "indeterminate" (all other result combinations). A protective anti-HBs result was defined as >10mIU/mL. Records of susceptible infants were reviewed for revaccination and repeat PVST. This is one of several reports from the same literature source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot # 671454/1125AA, expiration date 12-OCT-2012) on 16-OCT-2012. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot # 671454/1125AA, expiration date 12-OCT-2012) on 18-OCT-2012. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 70 years old male patient with allergy contrast dye. On 17-OCT-2012, the patient was vaccinated subcutaneously with dose of ZOSTAVAX (lot number H013014 in process of validation, expiration date: 03-OCT-2013). No other co-suspects were reported. Concomitant medication included: FLUVIRIN. The pharmacist reported that the patient developed a rash in the same spot on the back of thighs on 17-OCT-2012. Labs diagnostics studies were not performed. The patient sought unspecified medical attention. The patient was treated with anti itch cream. At the time of the report, the patient had not recovered from adverse event. The relatedness for the adverse event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arterial occlusive disease, Dyspnoea
Clinical narrative: This spontaneous report as received from an 80 years old male consumer with penicillin allergy, diabetes and heart problems reporting on himself. The consumer was vaccinated with a dose of ZOSTAVAX (Lot # not reported) SQ on 01-SEP-2012. No other co-suspects were reported. Concomitant medications included metformin, COUMADIN, omeprazole, doxazosin mesylate, "liberide", PLAVIX, valsartan, atenolol and "atervista". The consumer reported that on 03-SEP-2012, he experienced a symptom like a blocked artery. He stated that he was having trouble getting his breath, and had no symptoms before the vaccine. He also stated his physicians were unable to treat. The patient did not receive treatment for the adverse events. There were no Lab diagnosis or studies performed. The outcome of blocked artery and trouble getting his breath was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 18-OCT-2012 the patient received an expired dose of ZOSTAVAX (lot # not reported). No symptoms 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: Nasopharyngitis
Clinical narrative: This spontaneous report as received from a consumer refers to her male husband of unknown age. She and her husband (the patient) were vaccinated with ZOSTAVAX (dose, route and lot number not provided) on 28-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. After the vaccination her husband caught a cold. It was unspecified if the patient had sought medical attention. The outcome of caught a cold was unknown. She refused to answer any other question except for when they gotten the ZOSTAVAX shot. She had experienced no adverse events from receiving the ZOSTAVAX shot. She refused to provide information about the patient and the physician. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Induration, Injection site rash, Limb discomfort
Clinical narrative: This spontaneous report as received from a 73 years old female patient with asthma and allergic to pain medicine that begins with letter k refers to herself. The patient was vaccinated with ZOSTAVAX (lot number, dose and route were not reported) in the arm on 29-SEP-2012. No other co-suspects were reported. Concomitant medications included budesonide, SYMBICORT, PROAIR, hydrochloride, amlodipine, vitamins, omega-3 marine triglycerides, potassium, magnesium, MUCINEX and raspberry ketone. On 07-OCT-2012 the patient began to experience symptoms that included redness, swelling, rash and a hard, warm, swollen lump. The rash started as a four-inch rectangle area near the injection site and "now has moved to include more of her arm". Her whole arm felt funny and hurts and her fingers were numb. There was no treatment information given for adverse events and no laboratory diagnosed study performed. The adverse events were improved on therapy. The patient was not recovered at the time of report. The patient had sought unspecified medical attention, and she saw her pulmonologist on Monday but had not seen her primary physician yet for this experience. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pain in extremity, Rash, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a 73 years old female patient with asthma and allergic to pain medicine that begins with letter k refers to herself. The patient was vaccinated with ZOSTAVAX (lot number, dose and route were not reported) in the arm on 29-SEP-2012. No other co-suspects were reported. Concomitant medications included budesonide, SYMBICORT, PROAIR, hydrochloride, amlodipine, vitamins, omega-3 marine triglycerides, potassium, magnesium, MUCINEX and raspberry ketone. On 07-OCT-2012 the patient began to experience symptoms that included redness, swelling, rash and a hard, warm, swollen lump. The rash started as a four-inch rectangle area near the injection site and "now has moved to include more of her arm". Her whole arm felt funny and hurts and her fingers were numb. There was no treatment information given for adverse events and no laboratory diagnosed study performed. The adverse events were improved on therapy. The patient was not recovered at the time of report. The patient had sought unspecified medical attention, and she saw her pulmonologist on Monday but had not seen her primary physician yet for this experience. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 years old female patient with no pertinent medical history and no allergies. The patient was vaccinated with 0.5 ml PNEUMOVAX23 (lot # 1947AA, exp 20-OCT-2013, Intramuscular, left arm) on 01-OCT-2012 for Vaccination. There was no concomitant medications. On 01-OCT-2012 the patient developed welts and swelling of the left arm at the injection site in the evening. The patient sought medical attention. Treatment was Ibuprofen. The patient was recovered as reported. This is one of the two reports from the same source using the same PNEUMOVAX23 LOT. The other report was captured in marrs #1210US007540. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced red rash of the size of palm at the injection site. No treatment information was reported. No medical attention was sought by the patient. The outcome of red rash of the size of palm at the injection site is unknown. The relatedness for red rash of the size of palm at the injection site is unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age (gender unspecified). On 22-AUG-2012, the patient was vaccinated with dose 1 of RECOMBIVAX HB (Lot # and route was not reported). On 17-SEP-2012, the patient was vaccinated with dose 2 of RECOMBIVAX HB (Lot # and route was not reported). No adverse symptoms were reported. No concomitant medications were reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes simplex, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to an over 50 years old female patient (who was also the doctor's office manager). The patient was vaccinated with ZOSTAVAX (lot # unspecified) subcutaneously on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient had a herpes simplex like reaction on her upper lip, and 2 zoster blisters on her waist. She was prescribed an unspecified antiviral. The outcome of the events was reported as recovered. The patient had sought medical attention. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a licensed Vocational nurse refers to a 75 years old patient with codeine allergy. The patient was vaccinated with ZOSTAVAX (dose, route and frequency unknown) (lot number reported as #0071AE and expiry date reported as 03-APR-2013) (expiry date also reported as 03-APR-2020) on 12-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in September 2012 the patient experienced redness and soreness and the injection area became swollen about the size of an egg. The patient took BENADRYL as treatment. Medical attention has been sought by office visit. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lymphadenopathy, Pyrexia, Rash generalised
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 66 years old female patient with allergy to erythromycin, macrolides and morphine and without pertinent medical history. The patient was inadvertently received her second dose of 0.5 ml PNEUMOVAX 23 (lot number not provided) intramuscularly on 05-SEP-2012 after receiving first dose in January 2012. No other co-suspects were reported. There were no concomitant medications. Patient did not experience any adverse effects after the first dose in January but after the second dose, she experienced swelling around the injection site which went away in a couple of days but on approximately 26-SEP-2012 about 3 weeks after second injection in September 2012, patient came down with rash all over her body and swelling of lymph nodes and high fever. Patient went to see internist and dermatologist (name of physicians unspecified) but they could not find anything wrong with the patient. Patient received some kind of treatment (unspecified) and all the symptoms were resolved at the reporting time. No laboratory diagnostics studies were performed. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a female patient over 80 years old. Information regarding the patient's medical history was not provided. In the year 2007 (exact date not reported) the patient was vaccinated, subcutaneously, with ZOSTAVAX. Further information regarding dosing regimen was not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date (reported: "while on ZOSTAVAX") the patient experienced shingles. The patient had sought medical attention, no treatment information was reported. The outcome of shingles was reported as not recovered. A reporter causality for shingles was not provided for ZOSTAVAX. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 years old male patient. The patient was vaccinated with ZOSTAVAX in October 2011 ("a year ago") (route, dose, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. At an unspecified date in approximately 2011, the patient developed shingles in the ophthalmic dermatome and was prescribed an unspecified ophthalmic ointment as a treatment. The pharmacist stated that the patient did not develop any post-herpetic neuralgia. The pharmacist was uncertain if the patient has recovered fully. The patient sought unspecified unspecified medical attention. The relatedness for shingles in the ophthalmic dermatome is unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Surgery
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 61 years old female patient. The patient was vaccinated "under the skin" with ZOSTAVAX (lot number not specified) on 22-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-OCT-2012 the patient had surgery. No further information regarding surgery was reported. Two days later, on 10-OCT-2012, the glands behind her right ear swelled. The next day the glands went back down to normal. No treatment information was reported. The patient sought medical attention. She told her doctor that she had had the vaccine and the primary reason for calling was to determine "if the antibiotics destroyed the vaccine". The reporter did not provide a causality assessment. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with a dose of VAQTA (lot number not specified). Route was unknown). The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were MMR II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. This is one of multiple reports from the same source (other case IDs 1210USA005704, 1210USA009229 and 1210USA009231). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 ZOSTAVAX on 29-JUL-2011. Route of administration was unknown. No other co-suspects were reported. No concomitant medications were reported. On 26-SEP-2012 the patient received the second dose of ZOSTAVAX. The patient was not experiencing any known symptoms. Additional information is expected.
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was vaccinated with a dose of LIQUID PEDVAXHIB (reported lot number UH156AA) on 05-OCT-2012. Route was not reported. The product had expired on 23-SEP-2012. No adverse symptoms were reported. Additional information has been requested.
Age: 0.02
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with a dose of RECOMBIVAX HB (lot number not specified). Route was unknown. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were M-M-R II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. This is one of multiple reports from the same source (other case IDs 1210USA005704, 1210USA009229 and 1210USA009230). Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient were vaccinated with a dose of MMR II (lot number not specified). Route was unknown. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were MMR II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. This is one of multiple reports from the same source (other case IDs 1210USA005704, 1210USA009230 and 1210USA009231). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker. The reporter informed that an unknown number of patients (no details provided) had been vaccinated with improperly stored VAQTA (lot number, dose, dose number and route not reported). The vaccines were exposed to 30 degrees Fahrenheit for 15 hours. No adverse effect reported. This case is linked to case reports 1210USA001182 and 1210USA010300 (same reporter; same medication error reported for other vaccines). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B surface antibody positive, Hepatitis B surface antigen positive
Clinical narrative: Information has been received from a literature article, concerning of 4,214 Enhanced Perinatal Hepatitis B Case Management Projects (EPHBP)-managed infants born to HBsAG-positive women, who completed 3 or more Hepatitis B Vaccine (Recombinant) (manufacturer unknown) doses, 63.7% had reported post vaccination serologic testing (PVST) results, 13.3% had reported PVST results bur infant age was unknown, and 23.0% had no reported PVST results. Of 2,683 infants with PVST results by age 24 months, 0.1% (4 infants) were infected. PVST is critical for guiding medical management of infants born to HBsAg-positive women, identifying infants with HBV infection and in need of further care, and monitoring progress toward the elimination of perinatal HBV transmission. Of infants with reported PVST results and date, HBV serology status was categorized as "protected" (anti-HBs-positive, HBsAg-negative), "HBV-infected" (anti-HBs-negative, HBsAg-positive; anti-HBs-positive, HBsAg-positive; or anti-HBs unreported, HBsAg-positive), "susceptible" (anti-HBs-negative, HBsAg-negative), or "indeterminate" (all other result combinations). A protective anti-HBs result was defined as >10mlU/mL. Records of susceptible infants were reviewed for revaccination and repeat PVST. This is one of several reports from the same literature source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR II (non-gsk); Merck; subcutaneous; left arm given on 27 April 2012; VARIVAX (non-gsk); Merck; subcutaneous; right arm given on 27 April 2012. There were no concurrent medications. On 27 April 2012 the subject received 5th dose of KINRIX (.5 unknown, unknown, right thigh) and experienced vaccine administered at inappropriate site (right thigh). On 28 April 2012, less than one day after vaccination with KINRIX, the subject experienced swelling injection site, hotness at injection site and injection site redness. The subject was administered KINRIX and by the next morning she had swelling of eight centimeters, redness and heat at the injection site. The subject was seen in the office and prescribed KEFLEX for 10 days. The reporter stated the KINRIX vial was used, but they do use latex band aids. At the time of reporting the swelling injection site, hotness at injection site and injection site redness were resolved. This is one of two reports regarding KINRIX; please see A0978949A.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR II (non-gsk); Merck; subcutaneous; left arm given on 27 April 2012; VARIVAX (non-gsk); Merck; subcutaneous; right arm given on 27 April 2012. There were no concurrent medications. On 27 April 2012 the subject received 5th dose of KINRIX (.5 unknown, unknown, right thigh) and experienced vaccine administered at inappropriate site (right thigh). On 28 April 2012, less than one day after vaccination with KINRIX, the subject experienced swelling injection site, hotness at injection site and injection site redness. The subject was administered KINRIX and by the next morning she had swelling of eight centimeters, redness and heat at the injection site. The subject was seen in the office and prescribed KEFLEX for 10 days. The reporter stated the KINRIX vial was used, but they do use latex band aids. At the time of reporting the swelling injection site, hotness at injection site and injection site redness were resolved. This is one of two reports regarding KINRIX; please see A0978949A.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Rash vesicular
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site vesicles in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). Concurrent medications included PROAIR HPA. On 5 June 2012 at 15:30 the subject received 1st dose of KINRIX (.5 ml, unknown, left deltoid) as the 5th dose in the DTaP series and 4th dose in the IPV series. On 5 June 2012 the subject received 2nd dose of Varicella virus vaccine (Non-GSK) (unknown). On 5 June 2012 at 15:30, immediately after vaccination with KINRIX and Varicella virus vaccine (Non-GSK), the subject experienced injection site "pinpoint skin color" vesicles, injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified. Follow up information was received on 31 July 2012 via healthcare professional who reported the events of injection site vesicles, injection site redness and swelling injection site resolved on 11 June 2012.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site vesicles in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). Concurrent medications included PROAIR HPA. On 5 June 2012 at 15:30 the subject received 1st dose of KINRIX (.5 ml, unknown, left deltoid) as the 5th dose in the DTaP series and 4th dose in the IPV series. On 5 June 2012 the subject received 2nd dose of Varicella virus vaccine (Non-GSK) (unknown). On 5 June 2012 at 15:30, immediately after vaccination with KINRIX and Varicella virus vaccine (Non-GSK), the subject experienced injection site "pinpoint skin color" vesicles, injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified. Follow up information was received on 31 July 2012 via healthcare professional who reported the events of injection site vesicles, injection site redness and swelling injection site resolved on 11 June 2012.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site vesicles in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). Concurrent medications included PROAIR HPA. On 5 June 2012 at 15:30 the subject received 1st dose of KINRIX (.5 ml, unknown, left deltoid) as the 5th dose in the DTaP series and 4th dose in the IPV series. On 5 June 2012 the subject received 2nd dose of Varicella virus vaccine (Non-GSK) (unknown). On 5 June 2012 at 15:30, immediately after vaccination with KINRIX and Varicella virus vaccine (Non-GSK), the subject experienced injection site "pinpoint skin color" vesicles, injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified. Follow up information was received on 31 July 2012 via healthcare professional who reported the events of injection site vesicles, injection site redness and swelling injection site resolved on 11 June 2012.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 years old female patient with allergy to TEGRETOL and no pertinent medical history. On 16-OCT-2012, the patient was vaccinated subcutaneously with ZOSTAVAX (dose not reported) (lot # 0467AE exp: 04-APR-2013). Concomitant medications included alprazolam, vitamin D (unspecified), hydrocodone, benazepril hydrochloride, spironolactone, hydrochlorothiazide, oxcarbazepine and fluoxetine. The pharmacist stated that on 18-OCT-2012, a patient developed redness and swelling at the injection site after receiving ZOSTAVAX. The patient sought medical attention. The patient did not received treatment for adverse events. No laboratory tests were performed. At the time of the report, the outcome of adverse events was reported as not recovered/not resolved. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 years old female patient with allergy to TEGRETOL and no pertinent medical history. On 16-OCT-2012, the patient was vaccinated subcutaneously with ZOSTAVAX (dose not reported) (lot # 0467AE exp: 04-APR-2013). Concomitant medications included alprazolam, vitamin D (unspecified), hydrocodone, benazepril hydrochloride, spironolactone, hydrochlorothiazide, oxcarbazepine and fluoxetine. The pharmacist stated that on 18-OCT-2012, a patient developed redness and swelling at the injection site after receiving ZOSTAVAX. The patient sought medical attention. The patient did not received treatment for adverse events. No laboratory tests were performed. At the time of the report, the outcome of adverse events was reported as not recovered/not resolved. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Barium enema, Condition aggravated, Dehydration, Diarrhoea, Enema administration
Clinical narrative: On October 5th, patient developed diarrhea with multiple green/mucousy stools. On October 7th, his mother noted a rash on patient's buttocks, and went to a pediatric urgert care, who advised them to proceed to ED for further evaluation. At ED, the patient was evaluated and diagnosed with a perianal abscess and sent home with instructions to perform Sitz baths and follow-up with his PMD (us) in two days. The next day (October 8th), patient returned to ok ED with complaint of draining abscess, increasing irritability, decreased PO intake, vomiting and blood in stool. Patient was admitted with preliminary diagnoses of dehydration and perianal abscess. After being admitted, it was noted that patient had currant jelly stools, at which point a STAT abdominal sonogram was ordered. The sonogram revealed that the patient had intussusception, that was not able to be resolved with barium enema. Patient was then sent for surgery. Since the patient's hospitalization he continues to have feeding difficulties.
Age: 0.21
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Gastrooesophageal reflux disease, Haematochezia, Hypophagia, Intussusception, Surgery
Clinical narrative: On October 5th, patient developed diarrhea with multiple green/mucousy stools. On October 7th, his mother noted a rash on patient's buttocks, and went to a pediatric urgert care, who advised them to proceed to ED for further evaluation. At ED, the patient was evaluated and diagnosed with a perianal abscess and sent home with instructions to perform Sitz baths and follow-up with his PMD (us) in two days. The next day (October 8th), patient returned to ok ED with complaint of draining abscess, increasing irritability, decreased PO intake, vomiting and blood in stool. Patient was admitted with preliminary diagnoses of dehydration and perianal abscess. After being admitted, it was noted that patient had currant jelly stools, at which point a STAT abdominal sonogram was ordered. The sonogram revealed that the patient had intussusception, that was not able to be resolved with barium enema. Patient was then sent for surgery. Since the patient's hospitalization he continues to have feeding difficulties.
Age: 0.21
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: On October 5th, patient developed diarrhea with multiple green/mucousy stools. On October 7th, his mother noted a rash on patient's buttocks, and went to a pediatric urgert care, who advised them to proceed to ED for further evaluation. At ED, the patient was evaluated and diagnosed with a perianal abscess and sent home with instructions to perform Sitz baths and follow-up with his PMD (us) in two days. The next day (October 8th), patient returned to ok ED with complaint of draining abscess, increasing irritability, decreased PO intake, vomiting and blood in stool. Patient was admitted with preliminary diagnoses of dehydration and perianal abscess. After being admitted, it was noted that patient had currant jelly stools, at which point a STAT abdominal sonogram was ordered. The sonogram revealed that the patient had intussusception, that was not able to be resolved with barium enema. Patient was then sent for surgery. Since the patient's hospitalization he continues to have feeding difficulties.
Age: 0.21
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Anal abscess, Barium enema, Dehydration, Diarrhoea, Faeces discoloured
Clinical narrative: On October 5th, patient developed diarrhea with multiple green/mucousy stools. On October 7th, his mother noted a rash on patient's buttocks, and went to a pediatric urgert care, who advised them to proceed to ED for further evaluation. At ED, the patient was evaluated and diagnosed with a perianal abscess and sent home with instructions to perform Sitz baths and follow-up with his PMD (us) in two days. The next day (October 8th), patient returned to ok ED with complaint of draining abscess, increasing irritability, decreased PO intake, vomiting and blood in stool. Patient was admitted with preliminary diagnoses of dehydration and perianal abscess. After being admitted, it was noted that patient had currant jelly stools, at which point a STAT abdominal sonogram was ordered. The sonogram revealed that the patient had intussusception, that was not able to be resolved with barium enema. Patient was then sent for surgery. Since the patient's hospitalization he continues to have feeding difficulties.
Age: 0.21
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Feeding disorder of infancy or early childhood, Haematochezia, Hypophagia, Intussusception, Irritability
Clinical narrative: On October 5th, patient developed diarrhea with multiple green/mucousy stools. On October 7th, his mother noted a rash on patient's buttocks, and went to a pediatric urgert care, who advised them to proceed to ED for further evaluation. At ED, the patient was evaluated and diagnosed with a perianal abscess and sent home with instructions to perform Sitz baths and follow-up with his PMD (us) in two days. The next day (October 8th), patient returned to ok ED with complaint of draining abscess, increasing irritability, decreased PO intake, vomiting and blood in stool. Patient was admitted with preliminary diagnoses of dehydration and perianal abscess. After being admitted, it was noted that patient had currant jelly stools, at which point a STAT abdominal sonogram was ordered. The sonogram revealed that the patient had intussusception, that was not able to be resolved with barium enema. Patient was then sent for surgery. Since the patient's hospitalization he continues to have feeding difficulties.
Age: 0.21
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Mucous stools, Rash, Secretion discharge, Surgery, Ultrasound abdomen abnormal
Clinical narrative: On October 5th, patient developed diarrhea with multiple green/mucousy stools. On October 7th, his mother noted a rash on patient's buttocks, and went to a pediatric urgert care, who advised them to proceed to ED for further evaluation. At ED, the patient was evaluated and diagnosed with a perianal abscess and sent home with instructions to perform Sitz baths and follow-up with his PMD (us) in two days. The next day (October 8th), patient returned to ok ED with complaint of draining abscess, increasing irritability, decreased PO intake, vomiting and blood in stool. Patient was admitted with preliminary diagnoses of dehydration and perianal abscess. After being admitted, it was noted that patient had currant jelly stools, at which point a STAT abdominal sonogram was ordered. The sonogram revealed that the patient had intussusception, that was not able to be resolved with barium enema. Patient was then sent for surgery. Since the patient's hospitalization he continues to have feeding difficulties.
Age: 0.21
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Vomiting
Clinical narrative: On October 5th, patient developed diarrhea with multiple green/mucousy stools. On October 7th, his mother noted a rash on patient's buttocks, and went to a pediatric urgert care, who advised them to proceed to ED for further evaluation. At ED, the patient was evaluated and diagnosed with a perianal abscess and sent home with instructions to perform Sitz baths and follow-up with his PMD (us) in two days. The next day (October 8th), patient returned to ok ED with complaint of draining abscess, increasing irritability, decreased PO intake, vomiting and blood in stool. Patient was admitted with preliminary diagnoses of dehydration and perianal abscess. After being admitted, it was noted that patient had currant jelly stools, at which point a STAT abdominal sonogram was ordered. The sonogram revealed that the patient had intussusception, that was not able to be resolved with barium enema. Patient was then sent for surgery. Since the patient's hospitalization he continues to have feeding difficulties.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Activities of daily living impaired, Dizziness, Gait disturbance, Posture abnormal, Vision blurred
Clinical narrative: Student presented with blurry vision and appeared disoriented at 12:00 PM to school office. Parent was called and student was picked up and taken to the emergency room.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Disorientation, Vision blurred
Clinical narrative: Student presented with blurry vision and appeared disoriented at 12:00 PM to school office. Parent was called and student was picked up and taken to the emergency room.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Tendon pain
Clinical narrative: The shot was given in my left arm while I was working at the hospital.  A week later my tendon in my left arm has begun to ache.  The pain has come and gone for the past month and is slightly relieved with Advil.  It aches at night.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Development of huge, hot red welts with smaller red areas surrounding some, but not all, of the welts.  Use of antihistamines and Aveeno.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Rash erythematous, Swelling
Clinical narrative: The shot was given in my left arm. About an hour after, my arm was in lots of pain, more then I ever experienced with a shot. I got a large red rash that extended to my elbow, also swollen. Very painful. Went to the doctor the next day. Said I had a severe reaction. I took Benadryl which seemed to help. Started improving by third day.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Respiratory tract congestion, Restlessness
Clinical narrative: 102.3 degree fever, restless, congested. Children's Ibuprofen 5ml.
Sex: F
Vaccine: HPV4
Symptoms: Eye pain, Pain in extremity, Sensory loss
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated intramuscularly with the second dose of 0.5 ml GARDASIL (schedule reported as 0, 2 months, 6 months, intramuscular injection, lot # was unknown) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient called and reported pain in left arm and was told to take ADVIL, then called back a week later and said that she had a loss of sensation in her left arm and pain behind her left eyeball. Initially the patient was told to take ADVIL, then she was told to go to an optometrist and have an magnetic resonance imaging (MRI) done. At the time of this report, the outcome of the events was unknown. The reporter considered one or more of these events to be significant disability. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash, Rash vesicular, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 70 years old female patient with no pertinent medical history. The patient was vaccinated with ZOSTAVAX in the left arm on approximately 08-OCT-2012 "about a week and a half ago". Lot# was unspecified. Other suspect therapy included influenza virus vaccine (manufacturer unknown) in right arm on 08-OCT-2012, the same day that she received ZOSTAVAX. On approximately 11-OCT-2012, "about 3 days after receiving ZOSTAVAX", the patient developed a vesicular, urticarial rash on her right shoulder and right side of her neck. Unspecified topical cream was given as treatment. The outcome of patient was reported as not recovered/not resolved. The patient sought medical attention via office visit. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain, Pyrexia, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot number not provided) on 04-OCT-2012. Other suspect therapies included FLUZONE which was also vaccinated on 04-OCT-2012. No concomitant medications were reported. On 04-OCT-2012 the patient developed "a low grade fever, body aches and bilateral thumb swelling where the patient's thumbs are warm to touch". The patient sought medical attention via office visit. The outcome of bilateral thumb swelling, a low grade fever, body aches and bilateral thumb swelling where the patient's thumbs are warm to touch was reported as not recovered/not resolved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Half dollar size knot at injection site - baseball red spot around injection site. Advised to take BENADRYL as directed and apply cold compress.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Half dollar size knot at injection site - baseball red spot around injection site. Advised to take BENADRYL as directed and apply cold compress.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Chills, Cough, Headache, Pyrexia
Clinical narrative: HIGH FEVER; CHILLS; SEVERE HEADACHE; PRESSURE IN EYES; COUGH. 2 ASPIRIN TWO TIMES OVER 8 HOURS.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Pain of skin, Pyrexia
Clinical narrative: Fever of 101 and severe soreness/stiffness.  Skin sore to the touch and muscles sore with any movement.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Hives on her chest and a temperature of 100.5.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site haematoma, Malaise, Pain
Clinical narrative: CLIENT RECEIVED BRUISING BELOW THE INJECTION SITE ON THE ARM. BRUISING WAS RED, GREEN, YELLOW, AND DARK BROWN.  CLIENT ALSO REPORTED FEELING ILL THE DAY AFTER INJECTION. THIS IS THE 4TH CLIENT TO REPORT ILLNESS, BRUISING, AND PAIN AFTER RECEIVING THIS SHOT.
Age: 30.0
Sex: M
Vaccine: HEP, IPV, MNQ
Symptoms: Pyrexia, Rash erythematous, Rash macular, Rash pruritic, Reaction to previous exposure to any vaccine
Clinical narrative: Client reported red, blotchy, mildly itchy rash on his upper and lower extremities. Then on 09/02/2012 he reported that he developed a fever on 102.9 which persisted for 4 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness size of quarter and swelling size of apple. No red streaks, no fever.