chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 3 patients of unknown age and gender. On an unknown date the patients were vaccinated an improperly stored dose of VAQTA (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 3 patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, 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. Medical histories and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (administration routes, lot numbers and expiration dates were not provided). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On 24-FEB-2015, the patient was inadvertently administered with a dose of PROQUAD (Merck), subcutaneous (dose, strength and lot number were not reported) and with a dose of VARIVAX (Merck) (dose, strength, route and lot number were not reported). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Underdose, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old female patient who received ENGERIX B adult (batch number UNKNOWN, expiry date unknown). Co-suspect products included ENGERIX B adult. Previously administered products TWINRIX (dose 1). On an unknown date, the patient received the 2nd dose of ENGERIX B adult and the 3rd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult and ENGERIX B adult, the patient experienced wrong vaccine administered and underdose. On an unknown date, the outcome of the wrong vaccine administered and underdose were unknown. Additional information: a patient was started on TWINRIX series (received 1 dose) but completed her HepB portion with ENGERIX-B for the last 2 doses.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Asthma, Condition aggravated, Pruritus, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 11-year-old male patient who received DTaP vaccine. Concurrent medical conditions included asthma. On an unknown date, the patient receivd DTaP vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced fever, pruritus and asthma. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the fever, pruritus and asthma were unknown and the outcome of the rash was unknown. It was unknown if the reporter considered the fever, pruritus, asthma and rash to be related to DTaP vaccine. Additional information: the caller reported that her grandson received a DTaP vaccine when he was 4 years old. She did not know the manufacturer of the vaccine. She reports that he developed a rash after receiving the vaccine. He also had a very high fever and was itching after receiving the vaccine. She reports that now he suffers from asthma and feels that this may be related to the vaccine. Her grandson is now 11 years old.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 23-OCT-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). On unspecified dates the patients were vaccinated with unspecified number of doses of PNEUMOVAX 23 (Lot # and dose not reported), intramuscular, which had been improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse manager refers to unspecified number of patients of unknown age and gender. On an unknown dates, since October 2014, the patients were vaccinated with a dose of VAQTA (doses, routes, lot numbers and expiration date were not provided) which were exposed to multiple excursions. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 27-OCT-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse manager refers to unspecified number of patients of unknown age and gender. On an unknown dates, since October 2014, the patients were vaccinated with a doses of RECOMBIVAX HB (doses, routes, lot numbers and expiration date were not provided) which were exposed to multiple excursions. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, 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. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported that, on unknown dates, an unspecified number of improperly stored VARIVAX (Merck) INJ doses had been administered to patients (lot numbers and routes not provided). No adverse effects were reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth at injection site.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a "ton" of unspecified patients of unknown demographics. On unspecified dates, those patients received the doses of an unspecified Hepatitis B vaccine (manufacturer unknown) (strength, dose, route of administration, lot# and expiry date unspecified) (RECOMBIVAX could not be ruled out) out of schedule. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same reporter (linked to MARRS# 1501USA006830 and MARRS# 1501USA001237). Additional information is not requested as the reporter does not wish to receive any further follow-up letters.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a stored improperly dose of VARIVAX (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. Additional information is not expected because reporter refused additional contact.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: 3-4 inch "knot" on left arm at site of injection. Area is reddened, warm to touch, per patient and patient's wife. Patient states he noticed area "about 2 days after I got the shot". Patient reports area has improved "some" since 2/21/15, however states area is "still red and swollen, about 3-4 inches". Instructed patient to use warm or cold compress on area for about 10-15 minutes at a time and take TYLENOL, if permitted by doctor, for inflammation. Advised to follow-up with MD if no improvement.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 02-MAR-2015, the patient was vaccinated with RECOMBIVAX HB 2.5 microgram/0.5 ml (dose, route of administration, anatomical location and lot number was unspecified by reporter) which was expired on 07-FEB-2015. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No additional information was provided. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA
Symptoms: Drug administration error, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report was received from a nurse refers to a 12 month old patient. Concurrent conditions, medical history and allergies were not reported. On 09-FEB-2015, the patient was vaccinated with a dose of VAQTA 25/0.5 (units not provided), (dose, frequency, route and anatomical location were not reported), (lot # reported as K015827, expiration date: 11-MAR-2016). Other suspect and concomitant therapies were not reported. The reporter stated that the patient received three needle sticks instead of one because the VAQTA unit plunger rod "shot out of the syringe" while she was attempting to administer the vaccine. The nurse placed the needle in the patient and she drew back the plunger rod with her thumb to check for blood return before the administering VAQTA injection. At that time, the plunger rod shot out of the syringe barrel. The nurse replaced the needle a second and a third time and the same event with the plunger happened again. Nurse did not want to stick the patient a fourth time so after the third try she placed the plunger rod that shot out back into the syringe and complete the injection. It was also reported that the patient did not miss a dose and also only receive one dose. Product quality complaint (PQC) was filled. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Nuclear magnetic resonance imaging, Pain, Vertebral column mass
Clinical narrative: This spontaneous report as received from a consumer referring to himself as a 69 year old male patient with hypertension and not known drug reactions or allergies. Approximately in 2010, about four or five years ago, the patient was vaccinated with ZOSTAVAX, 1 injection (dose, route of administration and lot number not provided). Concomitant medication included unspecified blood pressure medication. On 12-MAY-2014, the patient experienced herpes zoster located at the T-10 vertebra causing a bulge and herpes zoster rash on his right buttocks. The patient reported that the pain was so bad that he was like a slithering snake, unable to cough, sneeze or clear his throat he also felt like being jabbered with an electric probe. On an unspecified date, the patient sought for medical attention and had a magnetic resonance imaging (MRI) and an X-ray done (results for both of them were not provided); he was also treated with ibuprofen, acupuncture, massages and oxycodone. Regarding the bulge on the T-10 vertebra, the patient recovered on an unknown date; and regarding the event of herpes zoster the patient reported he was feeling a 90 percent better at the time of reporting. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: This spontaneous report as received from a consumer referring to himself as a 69 year old male patient with hypertension and not known drug reactions or allergies. Approximately in 2010, about four or five years ago, the patient was vaccinated with ZOSTAVAX, 1 injection (dose, route of administration and lot number not provided). Concomitant medication included unspecified blood pressure medication. On 12-MAY-2014, the patient experienced herpes zoster located at the T-10 vertebra causing a bulge and herpes zoster rash on his right buttocks. The patient reported that the pain was so bad that he was like a slithering snake, unable to cough, sneeze or clear his throat he also felt like being jabbered with an electric probe. On an unspecified date, the patient sought for medical attention and had a magnetic resonance imaging (MRI) and an X-ray done (results for both of them were not provided); he was also treated with ibuprofen, acupuncture, massages and oxycodone. Regarding the bulge on the T-10 vertebra, the patient recovered on an unknown date; and regarding the event of herpes zoster the patient reported he was feeling a 90 percent better at the time of reporting. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased
Clinical narrative: (R) shoulder pain started immediately after vaccine given, has continued intermittently x 18 days. Decreased passive ROM. Am starting physical therapy x2-4 wks. No swelling, erythema or fevers.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: (R) shoulder pain started immediately after vaccine given, has continued intermittently x 18 days. Decreased passive ROM. Am starting physical therapy x2-4 wks. No swelling, erythema or fevers.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a 28 year old female patient reporting on herself without medical history, drug reactions and allergies. On 23-FEB-2015 the patient was vaccinated accidentally with GARDASIL while she was 34 weeks and 5 days pregnant (dose, route of administration and lot # were not reported). The reporter stated that the incident did not happen at her primary care. Concomitant medications included unspecified medications. Patient's last menstrual period (LMP) was 25-JUN-2014 and estimated date of delivery (EDD) of 01-APR-2015. Initial exposure to GARDASIL was at 34 weeks and 5 day(s). The pregnancy outcome was outcome pending. Patient did not receive any treatment and there were no laboratory diagnostics studies performed. There were no symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, 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. In April 2014, the patients were vaccinated with doses of GARDASIL (Lot # J011272 exp date 21-APR-2015) (doses not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. The patient pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX. Concomitant therapy information was not provided. On an unknown date, the patient experienced rash vesicular described as in appearance a varicella like rash over his entire body. The patient sought medical attention by an office visit. At the time of the report, the outcome of rash vesicular was unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Persistent left arm soreness, muscle ache. Symptom present from date of administration and continues to date. Apply Lidocaine patch for symptom control.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 08-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a non-medical healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. On an unknown date the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (dose, route of administration, anatomical location and lot number was unspecified by reporter). Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age an gender. On 08-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported). which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to patient of unknown age and gender. On 20-FEB-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot # K000329, exp. date: 06-MAR-2015) (strength and route not reported). The ZOSTAVAX was exposed to 12 Celsius degree for 14 hours. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 13-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 14-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Peripheral swelling
Clinical narrative: Swelling, redness spread over the whole tricep and armpit over 6-7 days. MD was not visited. Swelling and redness subsided after the 7th day.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 15-OCT-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was prescribed ZOSTAVAX (dose, route and lot# not provided). However on 27-FEB-2015 the patient was inadvertently given VARIVAX (Merck) (dose, route and lot# not provided) instead of prescribed vaccine. No adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist regarding to a 60 year old female patient. Patient's current condition included high blood pressure. On 23-FEB-2015, the patient was vaccinated with ZOSTAVAX (lot # K011002, Expiry: 07-NOV-2015) (dose and route was unknown). Concomitant medication included unspecified flu vaccine on 20-JAN-2015. On 25-FEB-2015 (also reported as today) the patient experienced a raised, red, 2 inch by 2 inch, rash around the injection site. No treatment was received. Patient sought medical attention, called to the pharmacy. No product quality complaint was involved. The outcome of the events was reported as not recovered. The reporter causality was not provided. No further information was provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Mom states appx 45 mins after receiving 1st dose of GARDASIL pt developed fever of 105.7; chills, body aches, heart rate to 130's and dizzy. No respiratory distress. Temp decreased w/medication. Temp this am was 99.8.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to five patients of unknown age and gender. On unspecified dates five doses of improperly stored VARIVAX (Merck) (0.5 ml 1 dose, subcutaneously: lot# was not reported) were inadvertently administered to unspecified patients. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Dysstasia, Nausea, Respiratory rate increased
Clinical narrative: Dizziness, nauseous, vision blurred to black then breathing rapidly, unable to stand, difficulty breathing, ringing in ears. EPIPEN administered, helped recover - EMTs examined and deemed patient OK.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Dizziness, nauseous, vision blurred to black then breathing rapidly, unable to stand, difficulty breathing, ringing in ears. EPIPEN administered, helped recover - EMTs examined and deemed patient OK.
Age: 0.19
Sex: M
Vaccine: HIBV, IPV
Symptoms: Apnoea test, Asphyxia, Cyanosis, Electrocardiogram, Laboratory test
Clinical narrative: Asphyxiation, turned blue and white.
Age: 0.19
Sex: M
Vaccine: HIBV, IPV
Symptoms: Pallor
Clinical narrative: Asphyxiation, turned blue and white.
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Pain, Swelling, Syncope
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of muscle swelling in a 11-year-old male patient who received FLUARIX (batch number ZE4G7, expiry date 19th June 2015). On 6th January 2015 17:30, the patient received FLUARIX. On 7th January 2015 17:00, less than a day after receiving FLUARIX, the patient experienced muscle swelling. On an unknown date, the outcome of the muscle swelling was unknown. It was unknown if the reporter considered the muscle swelling to be related to FLUARIX.
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscle swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of muscle swelling in a 11-year-old male patient who received FLUARIX (batch number ZE4G7, expiry date 19th June 2015). On 6th January 2015 17:30, the patient received FLUARIX. On 7th January 2015 17:00, less than a day after receiving FLUARIX, the patient experienced muscle swelling. On an unknown date, the outcome of the muscle swelling was unknown. It was unknown if the reporter considered the muscle swelling to be related to FLUARIX.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Blood glucose normal, Headache, Loss of consciousness, Pallor
Clinical narrative: Approximately 10 minutes after patient received her vaccines she complained of a headache.  She was picked up by her dad at which point she laid her head down and closed her eyes.  She appeared very pale.  I called her name and she didn't respond.  I called her name a second time and patted her on her back.  She looked up, very drowsy like, and said her stomach hurt. She then vomited a very small amount of liquid.  She was moved into an exam room and placed lying down with her legs elevated.  We continued to talk to her as she became more alert.  She was able to answer several questions appropriately. The doctor came in and evaluated her. A blood glucose was performed and was within normal limits.  The pt drank water well and progressed to a sitting position within 10 minutes.  She continued to stabilize on her own. She was discharged from the office with a minor headache but was talking and walking normally.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Approximately 10 minutes after patient received her vaccines she complained of a headache.  She was picked up by her dad at which point she laid her head down and closed her eyes.  She appeared very pale.  I called her name and she didn't respond.  I called her name a second time and patted her on her back.  She looked up, very drowsy like, and said her stomach hurt. She then vomited a very small amount of liquid.  She was moved into an exam room and placed lying down with her legs elevated.  We continued to talk to her as she became more alert.  She was able to answer several questions appropriately. The doctor came in and evaluated her. A blood glucose was performed and was within normal limits.  The pt drank water well and progressed to a sitting position within 10 minutes.  She continued to stabilize on her own. She was discharged from the office with a minor headache but was talking and walking normally.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Blood glucose normal, Headache, Pallor, Somnolence
Clinical narrative: Approximately 10 minutes after patient received her vaccines she complained of a headache.  She was picked up by her dad at which point she laid her head down and closed her eyes.  She appeared very pale.  I called her name and she didn't respond.  I called her name a second time and patted her on her back.  She looked up, very drowsy like, and said her stomach hurt. She then vomited a very small amount of liquid.  She was moved into an exam room and placed lying down with her legs elevated.  We continued to talk to her as she became more alert.  She was able to answer several questions appropriately. The doctor came in and evaluated her. A blood glucose was performed and was within normal limits.  The pt drank water well and progressed to a sitting position within 10 minutes.  She continued to stabilize on her own. She was discharged from the office with a minor headache but was talking and walking normally.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Approximately 10 minutes after patient received her vaccines she complained of a headache.  She was picked up by her dad at which point she laid her head down and closed her eyes.  She appeared very pale.  I called her name and she didn't respond.  I called her name a second time and patted her on her back.  She looked up, very drowsy like, and said her stomach hurt. She then vomited a very small amount of liquid.  She was moved into an exam room and placed lying down with her legs elevated.  We continued to talk to her as she became more alert.  She was able to answer several questions appropriately. The doctor came in and evaluated her. A blood glucose was performed and was within normal limits.  The pt drank water well and progressed to a sitting position within 10 minutes.  She continued to stabilize on her own. She was discharged from the office with a minor headache but was talking and walking normally.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Sore arm, limited range of motion from day after injection and continuing at date of report on 02/27/2015.
Age: 1.37
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood test, Cough, Eye swelling, Ocular hyperaemia, Pyrexia
Clinical narrative: High fever, red eyes, swollen eyes, runny nose, cough, rash covering entire face, ears, arms, chest, and back. Some on legs.
Age: 1.37
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Rhinorrhoea
Clinical narrative: High fever, red eyes, swollen eyes, runny nose, cough, rash covering entire face, ears, arms, chest, and back. Some on legs.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood pressure abnormal, Confusional state, Dizziness, Dyskinesia, Electrocardiogram normal
Clinical narrative: The patient became lightheaded and dizzy soon after the injection was administered. The patient was instructed to lay back on the exam table and a cold towel was placed on her head. The patient then had jerking movements. She was also confused. A code blue was called; three physicians and other nursing staff responded. An ammonia capsule was wafted to the patient's nares. She was still confused an pale for about one more minute, but then she became alert and oriented to name and location. Her blood pressure was checked every five minutes - 52/40 and 80/50. The patient was taken to the ER where she was monitored for about two hours. The patient did vomit; Zofran ODT was administered. Oral fluids were provided. EKG revealed normal sinus rhythm. Blood pressure returned to baseline. The patient was stable during her ED stay; she was discharged with instructions to warn her nurse when receiving future shots.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pallor, Vomiting
Clinical narrative: The patient became lightheaded and dizzy soon after the injection was administered. The patient was instructed to lay back on the exam table and a cold towel was placed on her head. The patient then had jerking movements. She was also confused. A code blue was called; three physicians and other nursing staff responded. An ammonia capsule was wafted to the patient's nares. She was still confused an pale for about one more minute, but then she became alert and oriented to name and location. Her blood pressure was checked every five minutes - 52/40 and 80/50. The patient was taken to the ER where she was monitored for about two hours. The patient did vomit; Zofran ODT was administered. Oral fluids were provided. EKG revealed normal sinus rhythm. Blood pressure returned to baseline. The patient was stable during her ED stay; she was discharged with instructions to warn her nurse when receiving future shots.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: The patient became lightheaded and dizzy soon after the injection was administered. The patient was instructed to lay back on the exam table and a cold towel was placed on her head. The patient then had jerking movements. She was also confused. A code blue was called; three physicians and other nursing staff responded. An ammonia capsule was wafted to the patient's nares. She was still confused an pale for about one more minute, but then she became alert and oriented to name and location. Her blood pressure was checked every five minutes - 52/40 and 80/50. The patient was taken to the ER where she was monitored for about two hours. The patient did vomit; Zofran ODT was administered. Oral fluids were provided. EKG revealed normal sinus rhythm. Blood pressure returned to baseline. The patient was stable during her ED stay; she was discharged with instructions to warn her nurse when receiving future shots.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Adverse event
Clinical narrative: The patient became lightheaded and dizzy soon after the injection was administered. The patient was instructed to lay back on the exam table and a cold towel was placed on her head. The patient then had jerking movements. She was also confused. A code blue was called; three physicians and other nursing staff responded. An ammonia capsule was wafted to the patient's nares. She was still confused an pale for about one more minute, but then she became alert and oriented to name and location. Her blood pressure was checked every five minutes - 52/40 and 80/50. The patient was taken to the ER where she was monitored for about two hours. The patient did vomit; Zofran ODT was administered. Oral fluids were provided. EKG revealed normal sinus rhythm. Blood pressure returned to baseline. The patient was stable during her ED stay; she was discharged with instructions to warn her nurse when receiving future shots.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Choking, Cough, Vomiting projectile
Clinical narrative: Choking cough. Intermittent - mostly at night, but also during the day.  Worst bouts of coughing in the middle of the night resulted in projectile vomiting on two occasions.  Periods between cough were several hours long.  During the entire period, she had no other symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema multiforme, Feeding disorder, Immediate post-injection reaction
Clinical narrative: Information has been received from a nurse practitioner via field representative referring to her son, a 1 year old (reported as 12 months and 1 week) patient. Sometime between 27-NOV-2014 and 25-DEC-2014 the patient was vaccinated with a dose of M-M-R II (one time, route, lot# and dose were unknown). Other suspect therapies included a dose of varicella virus vaccine (manufacturer unknown) (route, lot# and dose were unknown) and a dose of hepatitis A vaccine (manufacturer unknown) (route, lot# and dose were unknown) both of which were vaccinated simultaneously. Concomitant therapies included Hib conj vaccine (unspecified carrier) and PREVNAR 13 vaccinated on the same day. The patient also received amoxicillin along with these vaccines. The patient developed erythema multiforme all over his body immediately following administration of these products. The patient also could not eat. 4 days from the date of vaccination, the doctor prescribed an unknown dosage of unspecified steroids for the patient. There were no lab diagnostics studies performed. After one week of being on this treatment, the patient was fully recovered. The reporter considered that the patient was significant disability as he could not eat. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Immediate post-injection reaction, Injection site pain, Insomnia, Tendonitis
Clinical narrative: Tdap injection administered in Lt arm--was immediately painful.  Pain (#9) became severe, in Lt Deltoid area, even keeping me up at night. Pain has been continuous since then--started to lessen a bit, after 2-3 wks, and then gradually increased. Was advised to report to Occupational Health; saw Dr yesterday, and dx with Bicep Tendonitis. Was given Mederol Dosepak, and Rx for Physical Therapy (for Ultrasound tx.)  I am to see Dr again in two weeks, for follow-up.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Redness at injection site, low-grade fever.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Exposure during pregnancy, Lip swelling, Nausea, Swelling face
Clinical narrative: Nausea, vomiting, diarrhea, tongue swelling, nose swelling, lips swelling.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Swollen tongue, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, tongue swelling, nose swelling, lips swelling.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: Patient felt lightheaded, turned pale and passed out.  Patient then began having seizure activity which lasted about 5 seconds.  Patients arms stiffened and shook to the left.  Patient also had staring episode where both eyes were focused to the left side.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure, Staring, Tremor
Clinical narrative: Patient felt lightheaded, turned pale and passed out.  Patient then began having seizure activity which lasted about 5 seconds.  Patients arms stiffened and shook to the left.  Patient also had staring episode where both eyes were focused to the left side.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash, Rash erythematous
Clinical narrative: Right upper arm swollen, red, and hot to touch, red raised rash on torso and legs.  The rash was itching and bothered her.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash pruritic
Clinical narrative: Right upper arm swollen, red, and hot to touch, red raised rash on torso and legs.  The rash was itching and bothered her.
Age: 3.0
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Electroencephalogram abnormal, Hiccups, Nuclear magnetic resonance imaging abnormal, Tic
Clinical narrative: Vocal Tic. Every few seconds- half hiccup (quick intake of breath).  Nurse heard over phone and was upset.
Age: 10.0
Sex: M
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Edema, erythema, warmth of left deltoid.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Patient had a 4 day hospital admission for right upper arm cellulitis following administration of vaccines. Symptoms started about 6 hrs after vaccine administration.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Febrile convulsion, Rash
Clinical narrative: On 2/25/15, mother reports febrile seizure, rash, seen in the ER and observed overnight.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Faecal incontinence, Urinary incontinence, Vaccination complication
Clinical narrative: Initial information received for this unsolicited case from a consumer on 23 February 2015. The reporter also reported another event for this patient which is captured in case number 2015SA023949. A female patient who is approximately 50 years old was vaccinated intramuscularly with Flu vaccine, manufacturer, batch and site of administration were not reported. It is unknown if the patient had other vaccinations within 4 weeks. It is unknown if the patient was ill at the time of vaccination. On an unreported date, the patient experienced a "bad reaction" to the flu vaccine and had a 105 degree temperature with complete loss of bowel and bladder. She was hospitalized for a week. The reporter was not sure of the time frame or vaccine. The reporter considered the event life-threatening and the patient required an ER doctor visit. The patient's concomitant medications and medical history are unknown. It is unknown if the patient was ill at the time of vaccination. The patient also experienced a "severe reaction" on an unreported date to a pertussis vaccine in the distant past requiring hospitalization when she was a child. The patient outcome is recovered on an unknown date. Documents held by sender: None.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Left Thigh has small non painful, not red bump at injection site. No fever, no other concerns.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Pyrexia, Rash, Rash erythematous
Clinical narrative: Bumpy red rash started on face and spread to back and abdomen, also fever. Rash lasted for 3-5 days. Fever treated with ibuprofen and resolved after 2 days. Nasal viral culture for measles sent to lab and results for negative for measles.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Death, Full blood count, Pneumonia, White blood cell count
Clinical narrative: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" (eight of which were identified) received from the same reporter. The other patients are captured in cases 2014SA157362, 2015SA023267, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924 and 2015SA023928. A 73 year-old elderly male patient had received on 26 September 2014 an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U5024CA with expiration date of 12 May 2015) and an unspecified amount of time later was diagnosed with pneumonia and died 21 days after vaccination on 17 October 2014. The patient had a chest x-ray, WBC and CBC results were not reported. Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Death, Full blood count, Pneumonia
Clinical narrative: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patients identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924 and 2015SA023928. An 83 year-old male patient had received on 26 September 2014 an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U5024CA with expiration date of 12 May 2015) and "shortly after vaccination" was diagnosed with pneumonia; the patient died on 17 December 2014, approximately 3 months after vaccination. The patient had a chest x-ray on which pneumonia was noted; CBC was obtained, but results were not reported. Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Pneumonia
Clinical narrative: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patients identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023893, 2015SA023267, 2015SA023910, 2015SA023917, 2015SA023924 and 2015SA023928. A 62 year-old male patient (also reported as 63 year-old) had received on 05 October 2014 an intramuscular left arm injection of FLUZONE (lot number UI197AC with expiration date of 30 June 2015) and 2 days post-vaccination on 07 October 2014 was diagnosed with influenza and pneumonia. Diagnostic testing was positive for the flu. Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was recovered. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Pneumonia
Clinical narrative: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" (eight of which were identified) received from the same reporter. The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023267, 2015SA023893, 2015SA023902, 2015SA023917, 2015SA023924 and 2015SA023928. A 63 year-old male patient had received on 14 October 2014 a left arm injection of FLUZONE (lot number UI197AC with expiration date of 30 June 2015) and 14 days later on 28 October 2014 was diagnosed with pneumonia and flu. Laboratory and diagnostic testing were unknown. Illness at the time of vaccination was reported as "non-healthy". Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was recovered. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pneumonia
Clinical narrative: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" (eight of which were identified) received from the same reporter. The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023267, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023924 and 2015SA023928. A 50 year-old female patient had received on 09 October 2014 an intramuscular left arm injection of FLUZONE (lot number UI197AC with expiration date of 30 June 2015) and 39 days later on 17 November 2014 was diagnosed with pneumonia and flu. Laboratory and diagnostic testing were unknown. Illness at the time of vaccination was reported as "non-healthy". Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was recovered. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pneumonia
Clinical narrative: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patient identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023267, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023928. An 85 year-old female patient, had received on 26 September 2014 in the morning, an intramuscular left arm injection of FLUZONE HIGH DOSE, lot number 45024CA with expiration date of 12 May 2015 and 3 days later on 29 September 2014 the patient experienced pneumonia and Flu. Illness at the time of vaccination was reported as none, healthy. Concomitant medications and pre-existing conditions were reported as "NA". Laboratory tests were reported as unknown. No further information was provided. Outcome was recovered, date not reported. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Rash, Urticaria
Clinical narrative: Pt has pictures of hive like rash that appeared Sunday morning 3/1/15 on her left arm, near site of injection and right leg.  States rash spread over her entire leg and most of arm.  Rash was gone by Sunday night.  Rash reappeared the next morning, Monday, on leg and lasted for several hours and this morning, 3/3/15, as well.