chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a nurse practitioner via field representative refers to a female patient of unknown date. No pertinent history was reported. On 04-DEC-2013 (also reported as 05-DEC-2013) the patient was vaccinated with MMR II 1 single shot for the prevention of MMR II. Concomitant medications was reported as none. On an unknown date, the patient experienced lymph node enlargement in the sub occipital region on the left side of her neck and on the left auxillary, mammary gland enlargement on the left side and the lymph nodes in the post cervical region was enlarged. Patient sought medical attention. No treatment was given. The outcome of events was reported as recovered on an unknown date. Causality assessment was not provided by the reporter. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. In 2014 (reported as a few months ago) the patient was vaccinated with ZOSTAVAX (lot#, dose and route unspecified). On an unspecified date in 2014 the patient experienced a mild case of shingles and the shingles went away in two days. Additional information is not expected as there was no constent to contact the physician.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Local swelling, Musculoskeletal stiffness
Clinical narrative: Stiffness in arm. Fatigue. Swelling in bicep area.
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Local swelling, Urticaria
Clinical narrative: Patient experienced hives and swelling of hands.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to 78 years old female patient. Patient had no medical history and other previous drug allergic reactions. On 22-SEP-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, (dose number, frequency strength, lot number and expiry date unknown) subcutaneous. No concomitant therapies were reported. On an unknown date in 2014 the patient experienced unspecified condition. Patient received an electronic prescription written from her physician. Physician prescribed unspecified steroidal treatment for unspecified condition. Action taken with ZOSTAVAX was not applicable. The outcome of unspecified condition was unknown. The causality of unspecified condition was unknown to ZOSTAVAX was unknown. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, those patients were vaccinated with a dose of RECOMBIVAX (lot # H015537, expiration date: 09-JUL-2015, units, route of administration, anatomical location were not reported) that were improperly stored. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 26-SEP-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (strength, route not reported). The reporter mentioned that temperature excursion involved was found to be an unsupported excursion with in-house stability data. No adverse symptoms reported. The outcome of administered improperly stored PNEUMOVAX and no adverse symptoms reported is unknown. No product quality complaint was involved. This case is linked to the case 1410USA001798 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 27-SEP-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (strength, route not reported). The reporter mentioned that temperature excursion involved was found to be unsupported excursion with in-house stability data. No adverse symptoms reported. The outcome of administered improperly stored PNEUMOVAX and no adverse symptoms reported is unknown. No product quality complaint was involved. This case is linked to the case 1409USA015044 via same reporter link. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Swelling face, Urticaria, Vomiting
Clinical narrative: Pt diaphoretic, vomiting, hives and swelling to face.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender with an unspecified allergy to neomycin (manufacturer unknown). On 30-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, indication and lot # were not reported) despite an unspecified allergy to neomycin (manufacturer unknown). Concomitant medication was not reported. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a consumer read on the news website. A doctor talked about his teenage daughter became severely ill after her first dose of GARDASIL (vaccination date, strength, dose, route and lot # not reported). The outcome of the adverse event was unknown. This is one of the several reports received from the same reporter. 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 nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (does, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored VARIVAX (Merck) (lot # J014152, expiry date: 07-NOV-2015 (also reported as 17-NOV-2015)) was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician's nurse (also reported as physician's assistant) via a Company Representative referring to a 20 year old female patient. On 29-SEP-2014 the patient was vaccinated with the first dose of GARDASIL (Lot# was reported as K00163) (dose, frequency and route unspecified). On 02-OCT-2014, the patient called her physician reporting that she had bumps on the side of the face and all under her chin. The physician prescribed a metronidazole (manufacturer unknown) 500 mg tablet 4 tablet but the bumps were already present on the patient before she took the first tablet. (The tablet was additional medicine that was ordered along with the GARDASIL). The patient explained the bumps are not itchy, there was no swelling and she did not experience shortness of breath. The patient reported there were no other symptoms except the bumps. The patient had sought medical attention via calling physician's office. The outcome of "bumps on the side of the face and all under her chin" was reported as not recovered/not resolved. The reporter would like a call back on how to continue therapy and whether or not to continue on with the following scheduled shots of GARDASIL. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: This spontaneous report was received from a 84 year old female patient referring to herself. The patient's current conditions included codeine allergy and penicillin allergy. The patient's medical history included shingles. On unspecified date in October 2012 (reported as about two year ago) the patient was vaccinated with ZOSTAVAX (dose, frequency, route and Lot# unspecified). On unspecified date in October 2014 the patient experienced red rashes on waistline, jaw pain, and pain all over body after taking ZOSTAVAX. She also stated that she had a case of shingles prior to vaccination as well and stated that this was a case of shingles as well. The patient was given ointments for rash, and medication for pain. The patient had blood work, result was not reported. The patient also had her teeth treated. The patient had sought medical attention. The outcome of shingles was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Pyrexia, Skin exfoliation
Clinical narrative: This spontaneous report as received from healthcare worker refers to a 4 year old female patient. Patient's concurrent conditions were not reported. Other relevant medical history included vaccination in 2011 with PROQUAD (manufacturer unknown) and (Oka/Merck) VARIVAX with no incidents. On 08-SEP-2014 the patient was vaccinated with (Oka-Merck) PROQUAD (dose and route unspecified) (lot number: K007800 with expiry date 29-NOV-2015) in the leg for prevention. Concomitant medications were not reported. Within 24 hours (also reported as 08-SEP-2014) of injection with (Oka-Merck) PROQUAD, the patient developed red area at the injection side on leg. The patient's mother reported that the area continued to get larger. On 10-SEP-2014 (reported as 2 days after injection), the patient experienced fever of 101 (units not provided). The patient sought medical attention by visiting physician on 29-SEP-2014. The injection site red area measured 2x3 centimeters on the leg. It was scaly and blistered. The patient was treated with topical corticosteroid (also reported as no treatment was given for the adverse events). The outcome of the event fever was recovered/resolved on an unknown date. The outcome of the other events was reported as not recovered/not resolved. The causality of th events with (Oka-Merck) PROQUAD was not reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 79 year old female patient with COPD (Chronic obstructive pulmonary disease), emphysema, hypertension and hyperlipidaemia (unspecified). The patient had a history of nausea from BIAXIN (reported as BIAXCI) and erythromycin. On 26-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (in the arm, lot # J014401, expiry date: 26-NOV-2014, dose, units, route of administration were not reported). Concomitant therapies included SPIRIVA, ZOCOR and hydrochlorothiazide. In September 2014 (exact date unspecified), the patient experienced a swollen arm from the deltoid to the elbow. There was no treatment given for the adverse event. None lab diagnostics studies were performed. The patient sought medical attention via visiting the physician. The outcome of event was reported as recovering. The relatedness between event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 79 year old female patient with COPD (Chronic obstructive pulmonary disease), emphysema, hypertension and hyperlipidaemia (unspecified). The patient had a history of nausea from BIAXIN (reported as BIAXCI) and erythromycin. On 26-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (in the arm, lot # J014401, expiry date: 26-NOV-2014, dose, units, route of administration were not reported). Concomitant therapies included SPIRIVA, ZOCOR and hydrochlorothiazide. In September 2014 (exact date unspecified), the patient experienced a swollen arm from the deltoid to the elbow. There was no treatment given for the adverse event. None lab diagnostics studies were performed. The patient sought medical attention via visiting the physician. The outcome of event was reported as recovering. The relatedness between event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored ZOSTAVAX administered to patients and no adverse effects were noted. Follow up information was received from the registered nurse. The registered nurse stated that she did not have patient identifiers or dates of vaccine administration available at that time. On an unknown date unspecified number of patients were vaccinated with ZOSTAVAX (lot#J014811, expiration validated as 21-FEB-2015). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, those patients were vaccinated with a dose RECOMBIVAX (lot# H017018, expiration date: 11-JUL-2015, dose, units, route of administration, anatomical location were not reported) that were improperly stored. No adverse effect was reported. This is one of several reports received from the same reporter. 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 nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (dose, route and lot number were not provided). On an unkonwn date, the nurse reported that since unspecified date, improperly stored VARIVAX (Merck) (lot # J014228, expiry date: 08-NOV-2015) was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient called the pharmacy 2 days after receiving her shot complaining of pain and swelling at the site of injection.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 01-JUL-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 03-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On 30-SEP-2014 the patient received 2 doses of PNEUMOVAX 23 (lot # and dose not reported, intramuscular) for preparation for an elective splenectomy. Concomitant therapy was not reported. The patient received the 2 doses during unspecified timed during 8-hour shift. The patient has not experienced any adverse effects. At the time of the report the pharmacist does not have access to the patient's medical records, so he could not provide the patient's identifying information. He also could not provide the lot number and expiration date of the 2 separate doses of PNEUMOVAX 23 which were administered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, vial (lot# and expiration date not provided) (dose not reported). The reporter stated that a patient experienced a red rash while using ZOSTAVAX. The physician did not administer the ZOSTAVAX, but a pharmacist that the physician wished not to name. The patient was not seen by the time of this reporting. The outcome of "red rash while using ZOSTAVAX" was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, because the reporter did not wish to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 10-JUL-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On unknown date in October 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, lot # and route of administration were not reported). The patient also received another dose of ZOSTAVAX (dose, lot # and route of administration were not reported) on unknown date in September 2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 02-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously; lot# and expiration date unknown. It was reported that the patient received a dose of ZOSTAVAX, exposed to -10.8C for 23 hours (date of the temperature excursion unknown). No adverse effects were reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Hyperhidrosis, Hypersomnia
Clinical narrative: Arm was extremely sore after injection. By night was having chills and sweats. Fever. Every joint ached and had zero energy for 2 weeks. Slept 12 hrs a night and took naps.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm was extremely sore after injection. By night was having chills and sweats. Fever. Every joint ached and had zero energy for 2 weeks. Slept 12 hrs a night and took naps.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Merck) VARIVAX which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 18 year old female patient (student). On 04-JUL-2014 at 8:31 am, the patient might have been immunized with a dose of (Merck) VARIVAX lot number J009165, expiration date 24-JUL-2015, in the right arm (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 12-JUN-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Chills
Clinical narrative: Severe chills around 7 hours after shot for 8 hours. Unbalance for around 12 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 26-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX with an unspecified lot and expiration date 30-APR-2014. The pharmacist stated that the dose of ZOSTAVAX was reconstituted with an unspecified diluent that was expired since on an unknown date in January (date and year not provided). No adverse effects reported. Additional information is not expected as the pharmacist did not wish to be contacted.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Pain of skin
Clinical narrative: Flu shot about 11:30 am. About 2:30 pm started coughing followed by headache, sore throat. By 4:30 "severe" chills with shaking, "skin hurt". Subsided about 8 pm. Woke up this AM "fine" T. 98.5 P 83 BP 106/66 O2 97%.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Flu shot about 11:30 am. About 2:30 pm started coughing followed by headache, sore throat. By 4:30 "severe" chills with shaking, "skin hurt". Subsided about 8 pm. Woke up this AM "fine" T. 98.5 P 83 BP 106/66 O2 97%.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site rash, Rash
Clinical narrative: Within 5-10 min of vaccine, large red (pencil-eraser sized) bumps developed from left wrist to shoulder. Initially were flat, but became raised but did not itch. Vaccine site was red, hot, raised. Took diphenhydramine 25 mg po and ibuprofen 400 mg po. Throughout day, ran temp (100 degrees F) and experienced chills x 4-5 hours. Later in the evening rash changed to fine red rash from left shoulder to elbow and did itch. Resembled beat rash. Repeated diphenhydramine and ibuprofen. Rash improved on 10/4/14 -> BENADRYL gel applied and ibup 400 mg x 2. 10/5/14 pm about resolved.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Within 5-10 min of vaccine, large red (pencil-eraser sized) bumps developed from left wrist to shoulder. Initially were flat, but became raised but did not itch. Vaccine site was red, hot, raised. Took diphenhydramine 25 mg po and ibuprofen 400 mg po. Throughout day, ran temp (100 degrees F) and experienced chills x 4-5 hours. Later in the evening rash changed to fine red rash from left shoulder to elbow and did itch. Resembled beat rash. Repeated diphenhydramine and ibuprofen. Rash improved on 10/4/14 -> BENADRYL gel applied and ibup 400 mg x 2. 10/5/14 pm about resolved.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Pyrexia, Rash, Urinary tract infection, Vomiting
Clinical narrative: Child came into clinic one day after given immunizations with symptoms of vomiting, fever, rash. Patient was advised to go to ER. In ER patient was diagnosed with UTI.
Age: 60.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Blood glucose increased, Cellulitis, Condition aggravated, Diabetes mellitus, Impaired work ability
Clinical narrative: Developed infection. Cellulitis. (Also Diabetic). Increased blood glucose. Missed 1 week work w/blood glucose probs (395 mg/DL). Given cephalexin 500 3x/day x 1 wk.
Age: 60.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Infection
Clinical narrative: Developed infection. Cellulitis. (Also Diabetic). Increased blood glucose. Missed 1 week work w/blood glucose probs (395 mg/DL). Given cephalexin 500 3x/day x 1 wk.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Swelling
Clinical narrative: Pain under left arm close to put of arm. Between arm pit and mammary gland. Vaccine give in left arm. It also feels a little swollen. Did not feel this way the morning of start last night around 10 pm.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood pressure increased, Body temperature increased, Chills, Pain
Clinical narrative: 6 hours later, pt experienced severe chills, knees aches and body ached. Blood pressure elevated 177/101 pulse 105, temp elevated 100.6 at 10 pm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Injection site pain, Malaise, Musculoskeletal pain, Neck pain
Clinical narrative: This spontaneous report as received from a 68 year old female patient with depression and EFUDEX allergy reporting on herself. On 26-SEP-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot # and expiration date were not provided). Concomitant therapies included diazepam, LIPITOR, aspirin, PROTONIX and VIIBRYD. On 26-SEP-2014, the patient experienced pain around the injection site, red bumps, pain in the neck and shoulder area, as well as series of coughing and overall feeling sick after being administered ZOSTAVAX. The patient received ALEVE as treatment. On an unknown date, unspecified blood work was performed (results were not provided). The patient sought unspecified medical attention. At the time of the report, the patient did not recover from pain around the injection site, red bumps, pain in the neck and shoulder area, as well as a series of coughing and overall feeling sick. Additional information is not expected. There was no authorization to contact physician.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a 68 year old female patient with depression and EFUDEX allergy reporting on herself. On 26-SEP-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot # and expiration date were not provided). Concomitant therapies included diazepam, LIPITOR, aspirin, PROTONIX and VIIBRYD. On 26-SEP-2014, the patient experienced pain around the injection site, red bumps, pain in the neck and shoulder area, as well as series of coughing and overall feeling sick after being administered ZOSTAVAX. The patient received ALEVE as treatment. On an unknown date, unspecified blood work was performed (results were not provided). The patient sought unspecified medical attention. At the time of the report, the patient did not recover from pain around the injection site, red bumps, pain in the neck and shoulder area, as well as a series of coughing and overall feeling sick. Additional information is not expected. There was no authorization to contact physician.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (lot#, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up has been received from a physician and a licensed practical nurse (LPN) regarding a 4 year old male patient (child). On 07-JUL-2014 at 4:47 pm, the patient might have been immunized with a dose of PROQUAD lot number J015596, expiration date 05-JUN-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with improperly stored GARDASIL (lot#, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Rash macular
Clinical narrative: Rash, left arm at injection site and macular  rash over trunk and right arm
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: Pt received FLUMIST 10-4-14 4-5 hours after receiving FLUMIST pt vomited 2x.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient developed hives on various parts of her body a few days later. She went to the doctor and was given a steroid injection.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Edema, redness, warmth.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Chills, Musculoskeletal pain, Neck pain
Clinical narrative: Lost voice x 2 days. Chills (intermittent and minor). Shoulder and neck pain. Pt says she felt fine after 2 days.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Heart rate irregular, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site - red, hot, swollen, ache, fever and chills - 9-3-14. Tachycardia and irregular heart rate - 9-5-14 and continues through 9-25-14.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pyrexia, Tachycardia
Clinical narrative: Injection site - red, hot, swollen, ache, fever and chills - 9-3-14. Tachycardia and irregular heart rate - 9-5-14 and continues through 9-25-14.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt rec'd influenza vaccine on 9/29/14 and developed a rash to her face and trunk 9/29/14 in the evening. Pt tx'd with MEDROL dose pak and VISTARIL. Pt to f/u in 48 hours.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Pt. received injection of 4 month shots - within 15-20 minutes pt had red whelps on both legs. Rash persisted approx. 20 minutes then diminished.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Arm extremely red and sore from elbow to shoulder. Pt received 2 immunizations in same arm. Adverse rxn started 1 day after injection.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Pt reported fever and chills starting the evening after receiving immunization. Lasted entire evening but resolved following day.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Swelling
Clinical narrative: Swelling occurred after taking flu vaccine in (L) arm. No redness and it's not tender to touch. Swelling under (L) arm and into the (L) side of chest into clavicle area.
Age: 54.0
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site hypersensitivity
Clinical narrative: Local allergic reaction at site of injection immediate onset. Treated with 50mg of BENADRYL.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site pain, Injection site reaction, Myalgia, Pyrexia
Clinical narrative: Day after vaccines given: Fever, chills, muscle aches (9-30). (10-1) Red, painful rash around injection site; patient went to MD and received clincamycin prescription for possible cellulitis.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous
Clinical narrative: Day after vaccines given: Fever, chills, muscle aches (9-30). (10-1) Red, painful rash around injection site; patient went to MD and received clincamycin prescription for possible cellulitis.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cyanosis, Dizziness, Dyspnoea, Erythema, Loss of consciousness
Clinical narrative: Pt. got dizzy and very red in face after a minute of getting vaccine. She said she had trouble breathing. After a few minutes, pt passed out, lips turned blue, and when she came to a minute later she vomited and EMS arrived. She was responsive from then on. (All happened in course of 10 minutes).
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Pt. got dizzy and very red in face after a minute of getting vaccine. She said she had trouble breathing. After a few minutes, pt passed out, lips turned blue, and when she came to a minute later she vomited and EMS arrived. She was responsive from then on. (All happened in course of 10 minutes).
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Day following vaccination the injection site and surrounding area were very swollen, red and hot to the touch.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Dyspnoea, Fatigue, Malaise
Clinical narrative: Fever/shaking chills (severe)/nausea/palpitations. Fatigue/malaise/dyspnea (moderate), disequilibrium.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Palpitations, Pyrexia, Tremor
Clinical narrative: Fever/shaking chills (severe)/nausea/palpitations. Fatigue/malaise/dyspnea (moderate), disequilibrium.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness, Urinary incontinence
Clinical narrative: Patient was NPO for fasting labs, with blood drawn around 11 AM. Following phlebotomy, he received 2 vaccines and felt faint. As the final two vaccines were given he passed out briefly with urinary incontinence. He quickly revived. Blood sugar and BP were normal.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Middle insomnia, Mobility decreased, Pain
Clinical narrative: Having real stabbing pain, mostly when I sleep and wake up for almost for couple of hours it stay like that, that time I won't be able to lift my hand or cannot lift anything.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dizziness, Erythema, Local swelling, Mobility decreased
Clinical narrative: Arm red from shoulder to elbow. Wrap around arm. Swollen up. So painful could not move arm for five days. Dizziness and weakness still today. I took BENADRYL and hot pack on arm. I took pain med.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Arm red from shoulder to elbow. Wrap around arm. Swollen up. So painful could not move arm for five days. Dizziness and weakness still today. I took BENADRYL and hot pack on arm. I took pain med.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Influenza like illness, Paraesthesia, Pyrexia
Clinical narrative: Large induration, redness, tenderness, tingling, low grade fever, flu-like symptoms for x 2 days. Took 1 TYLENOL before shot.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Large induration, redness, tenderness, tingling, low grade fever, flu-like symptoms for x 2 days. Took 1 TYLENOL before shot.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient called on 9/25/14 to report dizziness after receiving flu vaccine that had continued off and on for almost 24 hours.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives - entire body - for 5 days until doctor visit. Given a shot then for 2 1/2 days after doctor visit. On 9/27 I was given shot - SOLU-MEDROL 125 mg.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, MNQ, TDAP
Symptoms: Anxiety, Crying, Dyspnoea, Hypoaesthesia, Muscular weakness
Clinical narrative: Client began c/o abnl sym. 10 min post vaccination: numbness and decreased strength in hands moving to legs, nausea, throat fullness, trouble breathing, anxiety - crying. Gave epinephrine and BENADRYL based on above. Vital signs normal prior to administration.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, MNQ, TDAP
Symptoms: Nausea, Throat tightness
Clinical narrative: Client began c/o abnl sym. 10 min post vaccination: numbness and decreased strength in hands moving to legs, nausea, throat fullness, trouble breathing, anxiety - crying. Gave epinephrine and BENADRYL based on above. Vital signs normal prior to administration.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eye swelling, Wheezing
Clinical narrative: Pt received FLUZONE HD in pharmacy on 9/9/14. 3 1/2-4 hours later, pt started to feel wheezy, tight in chest and eyes started to swell. Pt took BENADRYL but reaction progressed so she went to ER where she received IV BENADRYL. We are unsure if the vaccine triggered some type of reaction 4 hours later, pt has never reacted to previous flu vaccine, but this was first HD dose.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Dyspnoea, Headache, Pain
Clinical narrative: Pt received vaccine 9/31/14 at 4:20 pm. Reported having chills/cold sweats, heart racing, difficulty breathing, severe headache beginning on 9/30/14 at about 10:30 pm. Pt also reports aches and pains. Pt take ASA on 10/1/14 in the am. Pts only current symptom is a headache on 10/1/14 at 8:35 pm.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: Pt received vaccine 9/31/14 at 4:20 pm. Reported having chills/cold sweats, heart racing, difficulty breathing, severe headache beginning on 9/30/14 at about 10:30 pm. Pt also reports aches and pains. Pt take ASA on 10/1/14 in the am. Pts only current symptom is a headache on 10/1/14 at 8:35 pm.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Condition aggravated, Injected limb mobility decreased, Insomnia, Limb discomfort
Clinical narrative: After a few hrs (lft) arm began aching more than normal. Then it hurt so much that I couldn't lift it or move it. Or find a comfortable way to hold it. I had a very long sleepless nite with more pain (in the arm) than I've ever experienced (I live with chronic joint pain) it was off the charts. Today 3:45 pm 10/1/2014 I'm back to normal aches in arm (left).
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: After a few hrs (lft) arm began aching more than normal. Then it hurt so much that I couldn't lift it or move it. Or find a comfortable way to hold it. I had a very long sleepless nite with more pain (in the arm) than I've ever experienced (I live with chronic joint pain) it was off the charts. Today 3:45 pm 10/1/2014 I'm back to normal aches in arm (left).
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Fatigue, Pain in extremity
Clinical narrative: 10/7/14 family member reported c/o less hurting; stomach hurting; and tiredness, encouraged to see doctor.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelling, redness, pain, itching.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Presyncope, Seizure like phenomena
Clinical narrative: During new employee health screening pt. was given TB skin test and influenza vaccine. Blood drawn; during blood draw pt experienced vasovagal response including seizure like movements. 911 called, pt declined ER visit, returned to work.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Contractured left arm with severe pain and complete loss of use for 24 hours, then 4 days before pain was completely gone and use of arm returned fully.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Chills, Erythema, Neck pain
Clinical narrative: Patient in office for complete physical exam including pelvic exam and following had blood draw and influenza vaccination. After leaving office husband who is a physician and who was driving reports her face was red and she became chilled. Later she felt weak and had neck pain. He called office 10/1 reporting she was feeling better today but he felt she had allergic or adverse reaction. I theorized possible vasovagal response to all events.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Headache, Injection site pain, Injection site swelling, Muscle spasms, Nausea
Clinical narrative: Fever 101 for 24 hrs, headache, sore throat, nausea, pain at injection site with swelling moderate spasms of arm vaccine given in.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Fever 101 for 24 hrs, headache, sore throat, nausea, pain at injection site with swelling moderate spasms of arm vaccine given in.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Fatigue, Headache, Injection site reaction, Rash pruritic
Clinical narrative: (L) deltoid area itchy rash-raised first night had chills day 2 and 3 very tired and slight HA.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: 10-6-14 Pt called and reported pain in shoulder and neck. Started 6 hrs after receiving Tday on 9/23/14. Unable to use arm R/T pain. Denise any redness, swelling, fever. Encourage dto contact primary care doctor.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Redness and tenderness at site of vaccination. Vaccine given 10/1/14 symptoms started on evening of 10/02/14.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching began shortly after receiving flu vaccine on 10/1/14. Went to MD - took BENADRYL, received IM SOLU-MEDROL - later took dose pack steroids.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: 9/27 Chills and fever. Red/swollen injection site . Chills so bad my teeth were chattering. Fever 102 degrees - 104 degrees night after shot. Weak, shaky 9/28. Recovered by 9/29.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: 9/27 Chills and fever. Red/swollen injection site . Chills so bad my teeth were chattering. Fever 102 degrees - 104 degrees night after shot. Weak, shaky 9/28. Recovered by 9/29.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient called pharmacy 1 week after receiving vaccine - said had Rash and Hives - was advised to call physician on that day for treatment.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased, Muscular weakness, Tinnitus
Clinical narrative: 15 min after vaccine administered I experienced ringing in my ears, dizziness, fast heart rate and leg weakness.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Diplopia, Dizziness, Fatigue, Hypoaesthesia
Clinical narrative: Fatigue, dizziness, feet, hand numbness, double vision, weakness, pain in legs, arms, face numbness. Transverse myelitis.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Fatigue, dizziness, feet, hand numbness, double vision, weakness, pain in legs, arms, face numbness. Transverse myelitis.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Febrile convulsion, Irritability, Pain, Pyrexia, Tremor
Clinical narrative: Child received 15 month shots about 11:00AM, Pt became fussy and seemed in pain when mom changed Diaper. Around 10PM patient developed fever and was shaking. Temp 102.9. Mother call triage Nurse was advised to take child nearest ER, OK per mom. Seen at ER was advised Ibuprofen: Monitor temp, warm compresses to upper legs. Dx: Febrile seizure.
Age: 0.37
Sex: F
Vaccine: RV5
Symptoms: Soft tissue disorder
Clinical narrative: This spontaneous report was received from dietician and refers to a 4 month old female patient with no pertinent medical history, concurrent conditions or drug/reactions allergies. On 15-JUL-2014 the patient was vaccinated with ROTATEQ dose 1, intramuscular in the patient's right tight (lot number reported as A41FD390A). It was unspecified which thigh the ROTATEQ was injected into. 23-SEP-2014 while the patient was at the physician's office to receive the 2nd dose of ROTATEQ, (the physician noted that the "joint tissue on the left hip area was loose (onset date was unknown), (The 2nd dose of ROTATEQ was received via the oral route by the patient on 23-SEP-2014.) The patient has not recovered. Additional information has been requested.