chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Laboratory test, Neoplasm malignant
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with allergy to quinolones. Three years ago approximately in June 2010 the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot number were not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown) and alprazolam. On an unknown date, the patient was diagnosed with an unspecified cancer. The patient was treated with chemotherapy from October 2012 through January 2013. Laboratory test were performed, unspecified by the reporter. The outcome of unspecified cancer was reported as recovered on an unspecified date. Unspecified cancer was considered as life threatening event by the reporter. Upon internal review unspecified cancer was considered as an other important medical event. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On an unspecified date around 01-JUN-2013 (also reported as "last week" by the reporter by the time of the call), the patient was vaccinated subcutaneously with an expired dose of PROQUAD (lot # 666078/0192Z), 0.5 ml. The nurse did not have any patient or physician demographics available at the time of the call. No adverse effect reported. The outcome of a patient is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 12-JUN-2013 the patient was subcutaneously vaccinated expired dose of ZOSTAVAX (lot # 0423AE,exp 02-APR-2013). No adverse effect reported. 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 registered nurse refers to a patient of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (lot #, expiry, dose, route not reported) outside of the administration schedule in the prescribing information. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck), subcutaneously and also PROQUAD (Merck) (route not reported) on the same day. No adverse effects have occurred. 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 registered nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL (dose, route and lot # not reported) on 04-FEB-2009 and 27-APR-2009 and would like to receive the third dose on 05-JUN-2013. No adverse symptoms reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 55 year old female patient. No medical history was reported. On 08-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry, dose, route not reported). Concomitant therapies included ESTRING and vitamin d (unspecified). On an unknown date in June 2013, the patient had swelling and redness at the injection site. Pharmacist stated he was currently filling a prescription from the patient's unspecified healthcare provider for a MEDROL dose pack. Patient sought medical attention- saw her unspecified primary care provider. The outcome of she had swelling and redness at the injection site was reported as not recovered. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. No medical history was reported. On 03-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry, dose, route not reported). No concomitant medications were reported. On an unknown date June 2013, the patient experienced a red, raised and itchy rash about the size of a quarter around the injection site where the ZOSTAVAX was administered. Patient sought medical attention-contacted pharmacist. Varicella Zoster Virus Identification Program (VZVIP) packet faxed. The outcome of red, raised and itchy rash about the size of a quarter around the injection site was reported as not 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 CMA (certified medical assistant) regards an unknown number of patients (no demographic details were provided). The medical history of the patients was unknown. The reporter stated that an unknown number of patients may have received VAQTA, RECOMBIVAX HB, VARICELLA (Merck), LIQUID PEDVAXHIB and GARDASIL that was improperly stored. This report concerns GARDASIL. No details were provided regarding the administration dates, dosing regimen or lot number. No adverse event was reported. This report is linked to the cases with MARRS ID 1305USA003372, 1305USA007106, 1306USA007107 and 1306USA007108 which concern VAQTA, RECOMBIVAX HB, VARIVAX (Merck) and LIQUID PEDVAXHIB respectively. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a CMA (certified medical assistant) regards an unknown number of patients (no demographic details were provided). The medical history of the patients was unknown. The reporter stated that an unknown number of patients may have received VAQTA, RECOMBIVAX HB, VARIVAX (Merck), LIQUID PEDVAXHIB and GARDASIL that was improperly stored. This report concerns VAQTA. No details were provided regarding the administration dates, dosing regimen or lot number. No adverse event was reported. This report is linked to the cases with MARRS ID 1305USA007106, 1306USA007107, 1306USA007108 and 1306USA007109 which concern RECOMBIVAX HB, VARIVAX (Merck), LIQUID PEDVAXHIB and GARDASIL, respectively. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site macule, Injection site pain, Local reaction
Clinical narrative: Local reaction to KINRIX 5cm x 3cm macule, (L) thigh erythematous, no fluctuance, and TTP noted day after adminisration. Seen by MD in office on 5/30/13. Reassurance, TYLENOL PRN.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pruritus, Myalgia, Pruritus
Clinical narrative: 3 hrs after vaccine: starting itching at injection site. Next AM redness spread and itching continued. 2nd day redness spread farther and muscle soreness - muscle soreness is very uncomfortable.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Myalgia
Clinical narrative: 3 hrs after vaccine: starting itching at injection site. Next AM redness spread and itching continued. 2nd day redness spread farther and muscle soreness - muscle soreness is very uncomfortable.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Hot flush, Injection site pain, Injection site warmth
Clinical narrative: 10AM - Thurs, Feb 7th, rec'd injection; that night had hot flashes; Sat and Sun - had low grade fever, headache, warm and sore area at injection site. Monday AM - had chicken pox-like bumps on face, arms, scalp - red, felt like mild sunburn. Bumps scabbed over after approx 5 days. Thurs, Feb 28th (see back).
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash vesicular, Scab, Skin warm
Clinical narrative: 10AM - Thurs, Feb 7th, rec'd injection; that night had hot flashes; Sat and Sun - had low grade fever, headache, warm and sore area at injection site. Monday AM - had chicken pox-like bumps on face, arms, scalp - red, felt like mild sunburn. Bumps scabbed over after approx 5 days. Thurs, Feb 28th (see back).
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hot flush, Rash erythematous, Rash vesicular, Seborrhoea, Weight increased
Clinical narrative: 10AM - Thurs, Feb 7th, rec'd injection; that night had hot flashes; Sat and Sun - had low grade fever, headache, warm and sore area at injection site. Monday AM - had chicken pox-like bumps on face, arms, scalp - red, felt like mild sunburn. Bumps scabbed over after approx 5 days. Thurs, Feb 28th (see back).
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Vasovagal syncope in shower morning of 6/6 - no prior such sx. HPV vaccine given at 13:30 6/5 #1.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: 5 days after immunizations developed papular erythematous rash, itchy, on arms, trunk, and 6/1 - worst on inner thighs.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pollakiuria, Ultrasound bladder, Ultrasound kidney, Urine analysis, Weight decreased
Clinical narrative: Excessive urination no treatment 8-16 oz every hour. Have lost 42 lbs. Bladder check, kidney ultrasound. I was fine before this.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash papular, Rash pruritic
Clinical narrative: Received vaccine 6/11/13 before discharge from hospital. Several hours later (while still in hospital) developed rash on (L) hand and on chin. Later that night at home after discharge rash on chin and hand became bumpy, red, and itchy. Redness on arms, back, buttocks, belly with itching. To take BENADRYL PO, contact precautions.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pruritus, Injection site rash, Injection site urticaria, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old male patient who on 07-JUN-2013, was vaccinated with a dose of ZOSTAVAX, subcutaneously, (lot # J000435, expiration date 10-APR-2014). The pharmacist reported that on 08-JUN-2013, the patient developed hive and rash type wheal at the site of ZOSTAVAX injection. The patient complained of itchiness and scratched the site. The redness spread down to the elbow and patient went to an urgent care facility and got treated with an antibiotic. The outcome of itchiness and scratched the site, hive and rash type wheal at the site of ZOSTAVAX injection and redness spread down to the elbow was reported as recovering/resolving. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Skin infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old male patient who on 07-JUN-2013, was vaccinated with a dose of ZOSTAVAX, subcutaneously, (lot # J000435, expiration date 10-APR-2014). The pharmacist reported that on 08-JUN-2013, the patient developed hive and rash type wheal at the site of ZOSTAVAX injection. The patient complained of itchiness and scratched the site. The redness spread down to the elbow and patient went to an urgent care facility and got treated with an antibiotic. The outcome of itchiness and scratched the site, hive and rash type wheal at the site of ZOSTAVAX injection and redness spread down to the elbow was reported as recovering/resolving. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a other health professional refers to a 18 month old male patient who on 11-JAN-2013, was vaccinated with the first dose of VAQTA (dose and lot number not reported) and on 12-JUL-2013, was vaccinated with the second dose of VAQTA (dose and lot number not reported). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Irregularly shaped area on (L) UE (tricep area) warm to touch, red and slightly tender. Apply cool packs - take OTC antihistamine and pain reliever.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye movement disorder, Trismus, VIIth nerve paralysis
Clinical narrative: 3 weeks and 1 day after ZOSTAVAX, pt noticed jaw was dropped down (and unable to open mouth far), can't spit, can't close left eye. Pt was diagnosed with Bell's Palsy on that day (6/8/13).
Age: 1.06
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Rash
Clinical narrative: This spontaneous report as received from a registered nurse (R.N) refers to a 12 month old patient. On 14-MAY-2013 the patient was vaccinated with (Merck) VARIVAX (lit # H018782, expiry date 15-OCT-2014) (1350 U, 0.5 ml, subcutaneous in the right thigh, strength not specified) and MMR II (lot # not reported) (in the left thigh, strength and total daily dose not reported). It was reported that the patient developed swelling in the groin lymph nodes bilaterally which lasted for 5 days. On 22-MAY-2013, the patient developed red swelling on the right thigh, and a little rash on arms by elbow but nowhere else. The patient was afebrile. The patient was examined by a physician on 23-MAY-2013. And no treatment was prescribed. The outcome of red swelling on the right thigh and a little rash on arms was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose normal, Dizziness, Headache, Nodule
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning to a 15 year old male patient with a history of infected toe and with no drug reactions/allergies. On 30-JAN-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H009746 and expiration date 11-JAN-2015), intramuscular in the right arm. NO other co-suspect therapy was reported. Concomitant therapies included ZOLOFT and CETIRIZINE HYDROCHLORIDE. The Licensed Practical Nurse reported that on 30-JAN-2013, the patient was administered his first dose of GARDASIL and experienced a knot in right arm, dizziness and headache when he reached his car in the parking lot of physician's office that same day after being administered GARDASIL. Patient immediately returned to the physician's office and treatment at physician's office was a blood sugar by finger stick and vital signs. The result of the patient's blood sugar obtained by finger stick was 76. Vital signs were assessed as blood pressure 117/70, pulse 80, respiratory rate 16 and temperature 97.2. Nurse stated that vital signs were within normal limits for this patient. Patient recovered on 30-JAN-2013. It was reported that the patient did not seek medical attention. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Pain in extremity, Skin warm
Clinical narrative: 3 days after injection - arm sore, warm and red. No previous reaction. 5" area - circular erythema in right deltoid.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to two or three patients of unknown age. On an unknown date the patients was vaccinated with a dose of ZOSTAVAX, administered by the pharmacist On an unknown date the patients developed "wheel reaction" at the injection site after receiving the dose of ZOSTAVAX. This "wheel reaction" was defined as redness and swelling. No rash was involved. The pharmacist stated that he believed that the "wheel reaction" for these patients may have been attributed to the manner in which he was administering ZOSTAVAX (administration method not specified). These patients recovered from the "wheel reaction" after an unspecified amount of time. It was unspecified if the patient sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: No treatment, LD warm to touch and swollen.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Severe headache, dizziness, nausea onset 2 hours after shot baby aspirin administered at home around 6:00 pm.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: RA red and itchy, a day after the shot 06/14/13.
Age: 0.18
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 10 weeks old patient of unknown gender. Healthcare worker reported that a patient who was 3 month age, received the first dose of M-M-R II (dose, route and lot number were not reported) on 18-MAR-1999, and another dose in January 2004 (dose, route and lot number were not reported). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 5 years old patient of unknown gender. The pharmacist reported that the patient's mother, reported the incident to him. The pharmacist reported that on 04-JUN-2013 a physician administered ZOSTAVAX 0.5 ml (lot number and route were not reported) instead of the intended VARIVAX to the patient. Concomitant medications were not reported. The pharmacist reported that "this was probably intended to be the patient's first dose of VARIVAX". No adverse effect reported. The outcome of the patient at the moment of the report was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to numerous unspecified patients. It was reported that in 2013, numerous unspecified patients received (Merck) VARIVAX that might have been exposed to temperatures outside the range of the recommended storage temperatures. No lot# was reported. This occurred over a period of 2 months. No adverse effect reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with hypothyroidism and no drug reactions or allergies. On 08-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J000443, expiration date 11-APR-2013) 0.65 ml, subcutaneous in the left arm for prevention of shingles. Concomitant therapies included SYNTHROID. Approximately in June 2013 the patient developed a lump under her skin (described as a "round ball"), redness and warmth on her left arm at the injection site after receiving ZOSTAVAX. Patient sought medical attention by coming back to pharmacy, treatment was not given and laboratory tests were not performed. 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. It was reported that on July 2009 the patient received the first dose of GARDASIL (route, dosage and lot number unknown) for prophylaxis. On September 2009 the patient received the 2nd dose (route, dosage and lot number unknown) for prophylaxis. On 04-JUN-2013 (reported as today) the patient was going to receive the 3rd dose (route, dosage and lot number unknown) for prophylaxis. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a set of twins patients of unknown age and gender. On 23-AUG-2007, the patients were vaccinated with the first dose of RECOMBIVAX HB (dose, strength and route: Not reported). On 12-AUG-2008, the patients were vaccinated with the second dose of RECOMBIVAX HB (dose, strength and route: Not reported). On 12-SEP-2008 (4 weeks after the second dose), the patients were vaccinated with the third dose of RECOMBIVAX HB (dose, strength and route: Not reported). There was not concomitant medication reported. No adverse effects were reported. Patients outcome was unknown. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Had 3 x 4-5" red, warm area around injection area. Also itched. Treatment: DEPO-MEDROL injection and KEFLEX for 10 days.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test abnormal, Dyspnoea, Erythema, Inflammation, Injection site reaction
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a 42 year old female patient with multiple allergies and several drug reactions (unspecified medications). The patient's medical history included pneumonia several times (unknown dates). The Nurse Practitioner reported that on 2002 the patient was vaccinated with PNEUMOVAX 23 (lot # and expiration date unspecified) (dose, route and anatomical location unspecified) for low titer levels. Approximately in 2002 the patient experienced trouble breathing and tightened throat. The Nurse Practitioner also reported that the patient received PNEUMOVAX 23 (lot # and expiration date, dose, route and anatomical location unspecified) in the year 2002 and experienced swelling of the arm and a large welt on her arm. The patient received PNEUMOVAX 23 (lot # and expiration date, dose, route and anatomical location unspecified) in April 2013 and experienced swelling of the arm, soreness, hot to touch, and difficulty lifting. The patient received PNEUMOVAX23 (lot # and expiration date, dose, route and anatomical location unspecified) on 11-JUN-2013 and experienced an inflamed arm, swollen arm and redness on her arm. The Nurse Practitioner reported that all injection site reactions were treated with the patient putting a cold compress on her arm. Patient sought medical attention by visiting doctor. At the time of the report, the outcome of redness on arm, difficulty lifting, hot to touch, soreness, large welt on arm, swelling of the arm, tightened throat, trouble breathing, inflamed arm, swollen arm was unknown. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Oedema peripheral, Pain, Skin warm, Throat tightness
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a 42 year old female patient with multiple allergies and several drug reactions (unspecified medications). The patient's medical history included pneumonia several times (unknown dates). The Nurse Practitioner reported that on 2002 the patient was vaccinated with PNEUMOVAX 23 (lot # and expiration date unspecified) (dose, route and anatomical location unspecified) for low titer levels. Approximately in 2002 the patient experienced trouble breathing and tightened throat. The Nurse Practitioner also reported that the patient received PNEUMOVAX 23 (lot # and expiration date, dose, route and anatomical location unspecified) in the year 2002 and experienced swelling of the arm and a large welt on her arm. The patient received PNEUMOVAX 23 (lot # and expiration date, dose, route and anatomical location unspecified) in April 2013 and experienced swelling of the arm, soreness, hot to touch, and difficulty lifting. The patient received PNEUMOVAX23 (lot # and expiration date, dose, route and anatomical location unspecified) on 11-JUN-2013 and experienced an inflamed arm, swollen arm and redness on her arm. The Nurse Practitioner reported that all injection site reactions were treated with the patient putting a cold compress on her arm. Patient sought medical attention by visiting doctor. At the time of the report, the outcome of redness on arm, difficulty lifting, hot to touch, soreness, large welt on arm, swelling of the arm, tightened throat, trouble breathing, inflamed arm, swollen arm was unknown. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a 42 year old female patient with multiple allergies and several drug reactions (unspecified medications). The patient's medical history included pneumonia several times (unknown dates). The Nurse Practitioner reported that on 2002 the patient was vaccinated with PNEUMOVAX 23 (lot # and expiration date unspecified) (dose, route and anatomical location unspecified) for low titer levels. Approximately in 2002 the patient experienced trouble breathing and tightened throat. The Nurse Practitioner also reported that the patient received PNEUMOVAX 23 (lot # and expiration date, dose, route and anatomical location unspecified) in the year 2002 and experienced swelling of the arm and a large welt on her arm. The patient received PNEUMOVAX 23 (lot # and expiration date, dose, route and anatomical location unspecified) in April 2013 and experienced swelling of the arm, soreness, hot to touch, and difficulty lifting. The patient received PNEUMOVAX23 (lot # and expiration date, dose, route and anatomical location unspecified) on 11-JUN-2013 and experienced an inflamed arm, swollen arm and redness on her arm. The Nurse Practitioner reported that all injection site reactions were treated with the patient putting a cold compress on her arm. Patient sought medical attention by visiting doctor. At the time of the report, the outcome of redness on arm, difficulty lifting, hot to touch, soreness, large welt on arm, swelling of the arm, tightened throat, trouble breathing, inflamed arm, swollen arm was unknown. Additional information has been requested.
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Dyspnoea, Electrocardiogram abnormal, Injection site pruritus, Myalgia, Supraventricular extrasystoles
Clinical narrative: This study case was received from the investigator in a trial on 05 June 2013. A female subject (birth date not reported) with a history of migraine headaches since 26 July 2012 had received the ACAM2000 (lot number and route not reported) in the left arm on 22 August 2012. The subject also received the following vaccinations on 22 August 2012: anthrax vaccine (other manufacturer; lot number, route and site not reported), and typhoid vaccine (unknown manufacturer; lot number, route and site not reported). On 27 August 2013, 5 days post vaccination, the subject experienced moderate shortness of breath lasting 2-3 minutes in absence of other cardiac symptoms, with onset during walking and resolution upon sitting. There was no recurrence and it was not ongoing. The subject answered "No" to all the additional myopericarditis questions. The subject also reported mild itching on the smallpox vaccine site (left arm) and mild muscle pain under the left arm. Both symptoms began 26 August 2012 and were ongoing. Rapid and lab troponin from 30 August 2012 was <0.10 ng/mL (normal). The ECG from 30 August 2012 was normal with occasional ectopic atrial premature complexes. The subject was referred for care, but not seen. The subject was taking IMITREX every night for migraine headaches and another unknown prescription as needed. The subject had no other medical history or concomitant medications. The subject's outcome was reported as recovered on 27 August 2012. According to the investigator, the event of shortness of breath was considered possibly related to vaccination. Documents held by sender: Medical Records.
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 05 June 2013. A female subject (birth date not reported) with a history of migraine headaches since 26 July 2012 had received the ACAM2000 (lot number and route not reported) in the left arm on 22 August 2012. The subject also received the following vaccinations on 22 August 2012: anthrax vaccine (other manufacturer; lot number, route and site not reported), and typhoid vaccine (unknown manufacturer; lot number, route and site not reported). On 27 August 2013, 5 days post vaccination, the subject experienced moderate shortness of breath lasting 2-3 minutes in absence of other cardiac symptoms, with onset during walking and resolution upon sitting. There was no recurrence and it was not ongoing. The subject answered "No" to all the additional myopericarditis questions. The subject also reported mild itching on the smallpox vaccine site (left arm) and mild muscle pain under the left arm. Both symptoms began 26 August 2012 and were ongoing. Rapid and lab troponin from 30 August 2012 was <0.10 ng/mL (normal). The ECG from 30 August 2012 was normal with occasional ectopic atrial premature complexes. The subject was referred for care, but not seen. The subject was taking IMITREX every night for migraine headaches and another unknown prescription as needed. The subject had no other medical history or concomitant medications. The subject's outcome was reported as recovered on 27 August 2012. According to the investigator, the event of shortness of breath was considered possibly related to vaccination. Documents held by sender: Medical Records.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Generalised erythema, Pain in extremity, Pruritus generalised, Rash
Clinical narrative: After taking the zoster shot 11-20-12 3 weeks I broke out in a heat like rash from head to toe, skin felt like it was on fire blisters on back and groin area still not gone. My body and skin has not been the same since I received the shingle shot. I have gone through pure hell. My skin was on fire, red, hot, burning from head to toe. I just wanted to rip my skin from my body. I was covered with welts from head to toe all over my body. Many have never gone away. My eyes and hands were so swollen could hardly open my eyes. For months have been in pure agony. No matter what type of medication the doctors gave me nothing helped. Once the redness went away my whole body was like sand paper. Then I started to peel like a snake from head to toe. Now seen months later my arms are still like sandpaper. My nails are not the same. I still have bumps all over my back and my head. I have gone to a dermatologist for treatment. Nothing is helping. He said they may not go away and may remain weak. I do not recommend any one to get the shingle shot unless they have shingles.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: After taking the zoster shot 11-20-12 3 weeks I broke out in a heat like rash from head to toe, skin felt like it was on fire blisters on back and groin area still not gone. My body and skin has not been the same since I received the shingle shot. I have gone through pure hell. My skin was on fire, red, hot, burning from head to toe. I just wanted to rip my skin from my body. I was covered with welts from head to toe all over my body. Many have never gone away. My eyes and hands were so swollen could hardly open my eyes. For months have been in pure agony. No matter what type of medication the doctors gave me nothing helped. Once the redness went away my whole body was like sand paper. Then I started to peel like a snake from head to toe. Now seen months later my arms are still like sandpaper. My nails are not the same. I still have bumps all over my back and my head. I have gone to a dermatologist for treatment. Nothing is helping. He said they may not go away and may remain weak. I do not recommend any one to get the shingle shot unless they have shingles.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blister, Erythema, Eye swelling, Heat rash
Clinical narrative: After taking the zoster shot 11-20-12 3 weeks I broke out in a heat like rash from head to toe, skin felt like it was on fire blisters on back and groin area still not gone. My body and skin has not been the same since I received the shingle shot. I have gone through pure hell. My skin was on fire, red, hot, burning from head to toe. I just wanted to rip my skin from my body. I was covered with welts from head to toe all over my body. Many have never gone away. My eyes and hands were so swollen could hardly open my eyes. For months have been in pure agony. No matter what type of medication the doctors gave me nothing helped. Once the redness went away my whole body was like sand paper. Then I started to peel like a snake from head to toe. Now seen months later my arms are still like sandpaper. My nails are not the same. I still have bumps all over my back and my head. I have gone to a dermatologist for treatment. Nothing is helping. He said they may not go away and may remain weak. I do not recommend any one to get the shingle shot unless they have shingles.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Nail disorder, Oedema peripheral, Rash, Rash generalised, Sensation of foreign body
Clinical narrative: After taking the zoster shot 11-20-12 3 weeks I broke out in a heat like rash from head to toe, skin felt like it was on fire blisters on back and groin area still not gone. My body and skin has not been the same since I received the shingle shot. I have gone through pure hell. My skin was on fire, red, hot, burning from head to toe. I just wanted to rip my skin from my body. I was covered with welts from head to toe all over my body. Many have never gone away. My eyes and hands were so swollen could hardly open my eyes. For months have been in pure agony. No matter what type of medication the doctors gave me nothing helped. Once the redness went away my whole body was like sand paper. Then I started to peel like a snake from head to toe. Now seen months later my arms are still like sandpaper. My nails are not the same. I still have bumps all over my back and my head. I have gone to a dermatologist for treatment. Nothing is helping. He said they may not go away and may remain weak. I do not recommend any one to get the shingle shot unless they have shingles.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Skin burning sensation, Skin exfoliation, Skin warm, Urticaria
Clinical narrative: After taking the zoster shot 11-20-12 3 weeks I broke out in a heat like rash from head to toe, skin felt like it was on fire blisters on back and groin area still not gone. My body and skin has not been the same since I received the shingle shot. I have gone through pure hell. My skin was on fire, red, hot, burning from head to toe. I just wanted to rip my skin from my body. I was covered with welts from head to toe all over my body. Many have never gone away. My eyes and hands were so swollen could hardly open my eyes. For months have been in pure agony. No matter what type of medication the doctors gave me nothing helped. Once the redness went away my whole body was like sand paper. Then I started to peel like a snake from head to toe. Now seen months later my arms are still like sandpaper. My nails are not the same. I still have bumps all over my back and my head. I have gone to a dermatologist for treatment. Nothing is helping. He said they may not go away and may remain weak. I do not recommend any one to get the shingle shot unless they have shingles.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Aphasia, Cardiac telemetry, Computerised tomogram head, Computerised tomogram head normal, Computerised tomogram normal
Clinical narrative: Pt. was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt. developed hot tingling sensation in L face involving cheek down to chin as well as LUE/LLE weakness; no other neuro sxs reported. EKG performed and pt. send to ED for stroke evaluation. Pt. was seen in ED and stroke alert called. Not determined a TIA candidate per neurology. Pt. was admitted and found to have L facial droop, L facial numbness, and L hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt. stated feeling good but still having trouble with words. On ER call 5/31/13, pt. reported worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (no aphasic speech) but otherwise normal and CT/MRI was negative. Pt. was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt. reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Differential white blood cell count normal, Dysphemia, Electrocardiogram, Electroencephalogram normal, Full blood count normal
Clinical narrative: Pt. was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt. developed hot tingling sensation in L face involving cheek down to chin as well as LUE/LLE weakness; no other neuro sxs reported. EKG performed and pt. send to ED for stroke evaluation. Pt. was seen in ED and stroke alert called. Not determined a TIA candidate per neurology. Pt. was admitted and found to have L facial droop, L facial numbness, and L hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt. stated feeling good but still having trouble with words. On ER call 5/31/13, pt. reported worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (no aphasic speech) but otherwise normal and CT/MRI was negative. Pt. was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt. reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Glycosylated haemoglobin decreased, Hemiparesis, Hypoaesthesia, Laboratory test normal, Muscular weakness
Clinical narrative: Pt. was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt. developed hot tingling sensation in L face involving cheek down to chin as well as LUE/LLE weakness; no other neuro sxs reported. EKG performed and pt. send to ED for stroke evaluation. Pt. was seen in ED and stroke alert called. Not determined a TIA candidate per neurology. Pt. was admitted and found to have L facial droop, L facial numbness, and L hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt. stated feeling good but still having trouble with words. On ER call 5/31/13, pt. reported worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (no aphasic speech) but otherwise normal and CT/MRI was negative. Pt. was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt. reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Pt. was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt. developed hot tingling sensation in L face involving cheek down to chin as well as LUE/LLE weakness; no other neuro sxs reported. EKG performed and pt. send to ED for stroke evaluation. Pt. was seen in ED and stroke alert called. Not determined a TIA candidate per neurology. Pt. was admitted and found to have L facial droop, L facial numbness, and L hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt. stated feeling good but still having trouble with words. On ER call 5/31/13, pt. reported worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (no aphasic speech) but otherwise normal and CT/MRI was negative. Pt. was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt. reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Speech disorder, Transient ischaemic attack, Troponin I normal, VIIth nerve paralysis
Clinical narrative: Pt. was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt. developed hot tingling sensation in L face involving cheek down to chin as well as LUE/LLE weakness; no other neuro sxs reported. EKG performed and pt. send to ED for stroke evaluation. Pt. was seen in ED and stroke alert called. Not determined a TIA candidate per neurology. Pt. was admitted and found to have L facial droop, L facial numbness, and L hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt. stated feeling good but still having trouble with words. On ER call 5/31/13, pt. reported worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (no aphasic speech) but otherwise normal and CT/MRI was negative. Pt. was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt. reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Aphasia, Cardiac telemetry normal, Computerised tomogram head, Computerised tomogram head normal, Computerised tomogram normal
Clinical narrative: Pt. was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt. developed hot tingling sensation in L face involving cheek down to chin as well as LUE/LLE weakness; no other neuro sxs reported. EKG performed and pt. send to ED for stroke evaluation. Pt. was seen in ED and stroke alert called. Not determined a TIA candidate per neurology. Pt. was admitted and found to have L facial droop, L facial numbness, and L hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt. stated feeling good but still having trouble with words. On ER call 5/31/13, pt. reported worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (no aphasic speech) but otherwise normal and CT/MRI was negative. Pt. was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt. reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Differential white blood cell count normal, Dysphemia, Electrocardiogram, Electroencephalogram normal, Feeling hot
Clinical narrative: Pt. was given Tdap vaccination in left arm, IM at a routine history and physical exam. After immunization, pt. developed hot tingling sensation in L face involving cheek down to chin as well as LUE/LLE weakness; no other neuro sxs reported. EKG performed and pt. send to ED for stroke evaluation. Pt. was seen in ED and stroke alert called. Not determined a TIA candidate per neurology. Pt. was admitted and found to have L facial droop, L facial numbness, and L hemiparesis. The left hemiparesis and expressive aphasia improved prior to discharge, and he was diagnosed with a TIA. It was determined the event was possibly due to Tdap vaccination due to timing, which was reported to the state health vaccine department. Follow-up care coordination call on 5/30/13 pt. stated feeling good but still having trouble with words. On ER call 5/31/13, pt. reported worsening of symptoms experienced in the hospital (expressive aphasia, left arm numbness) then developed nausea and further speech difficulties. CT/MRI performed and lorazepam administered and patient felt better. Neurology exam showed stuttering (no aphasic speech) but otherwise normal and CT/MRI was negative. Pt. was observed on telemetry and EEG negative for epileptiform activity. After discharge, on follow-up care coordination call 6/3/13, pt. reported still having trouble speaking. At follow-up office visit 6/4/13, abnormal CT reported and a follow-up CT scan was recommended in 6 months.