chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a multiple unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU), lot # M035691 with expiration date: 07-NOV-2017, for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT) lot # reported as N015632 with expiration date: 18-FEB-2019. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.; Sender's Comments: US-009507513-1707USA001501:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 26-JUN-2017, the patient was vaccinated with PROQUAD lot # L044057 which expired on 02-MAY-2017 (therapy type, dose and route of administration were not reported). Vaccine was reconstituted with sterile diluent. No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was reported. On 20-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not provided). On 23-JUN-2016, the patient received the second dose GARDASIL 9. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Emotional distress, Herpes zoster, Injection site vesicles, Pain
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  No information was received regarding the patient's medical history, concurrent conditions or concomitant medications.  On or about 17-JAN-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles.  It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 19-JAN-2013, the patient broke out in blistering lesions on her arm surrounding the injection site.  On or about 22-JAN-2013, the patient was treated by a physician for the onset of a vesicular rash accompanied by symptoms of weakened immunity, which was diagnosed as severe herpes zoster or shingles.  The patient was prescribed gabapentin, valacyclovir hydrochloride (VALTREX), oxycodone hydrochloride (OXYCONTIN), and lidocaine (LIDODERM) to help manage her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  No information was received regarding the patient's medical history, concurrent conditions or concomitant medications.  On or about 17-JAN-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles.  It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 19-JAN-2013, the patient broke out in blistering lesions on her arm surrounding the injection site.  On or about 22-JAN-2013, the patient was treated by a physician for the onset of a vesicular rash accompanied by symptoms of weakened immunity, which was diagnosed as severe herpes zoster or shingles.  The patient was prescribed gabapentin, valacyclovir hydrochloride (VALTREX), oxycodone hydrochloride (OXYCONTIN), and lidocaine (LIDODERM) to help manage her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information was received on 28-JUN-2017 from a physician via a company representative regarding a 60 year old female. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in MAY 2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, site of administration and lot number not reported). The physician saw the patient last Friday (23-JUN-2017) and she still had pain at the injection site. No further information was available. The outcome of the event was not recovered at the time of this report.  The causal relationship between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received on 28-JUN-2017 from a registered nurse refers to a patient of unknown age and gender. Medical history, concomitant medications, and allergies were not reported. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. On 22-JUN-2017 the patient was vaccinated with PROQUAD (Lot number and expiration date not reported) for prophylaxis after it underwent a temperature excursion (no further details). Labororatory data is unknown. As of 28-JUN-2017, it is unknown if the patient will continue PROQUAD and the outcome of the vaccine that underwent an excursion and was administered is unknown.  Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV9, RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant supervisor who reported that an unknown number of patients (unknown age and gender) received GARDASIL 9 (lot #N002720, expiration date 12-MAY-2019); ROTATEQ (lot #M041765, expiration date 02-MAY-2018); and PEDVAXHIB (lot #B000327, expiration date 25-OCT-2019) on unknown dates in June 2017 (dosages and routes of administration not provided). Past medical history, concomitant medications, past drug history and laboratory data are all unknown. These vaccines had experienced a temperature excursion outside of the recommended storage range of 59°F-77°F. As of 27-JUN-2017, the outcome of administration of the vaccines stored outside the recommended storage range is unknown. Dates of excursion: Unknown. Total time in range 31°F/-1°C or colder: None. Total time in range 32°F to 35°F (0°C to 1°C): 34 F, 5 minutes. Total time in range 47°F to 77°F (9°C to 25°C): 48 F, 16 minutes. Total time at 78°F (26°C) or warmer: None. Data logger involved: Yes. Previous temperature excursion: No. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: This prospective literature marketed report has been received from the author of a literature article. Objective of this report was to assess availability and use of measles-mumps-rubella (MMR) vaccination documentation for people vaccinated elsewhere. 1500 records were selected from 14 places from March 2013 through July 2015 to determine whether vaccination records were available at the health assessment and integrated into the Advisory Committee on Immunization Practices schedule. Number of doses, dosing interval, and contraindications were assessed. Twelve of 14 (85.7%) places provided data on 1118 (7 4.5%) people. Records for 972 (86.9%) people were available, most from the Centers for Disease Control and Prevention's Electronic Disease Notification system (66.9%). Most people (829; 85.3%) were assessed appropriately for M-M-R II vaccination; 37 (3.8%) should have received the vaccine but did not; 106 (10.9%) did not need the vaccine but were vaccinated. Author reported that 106 patients of unknown gender and age who did not require vaccination, were vaccinated with M-M-R II (inappropriate schedule of drug administration).  This is one of the two reports received from the same reported. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007838:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (Lot # L004742, expiry date : 18-AUG-2016, Lot # M009377, expiry date : 17-JUN-2017, NDC# 0006-4047-41 expiry date : 31-MAR-2018) (Strength, dose and route of administration were not reported) for prophylaxis (incorrect product storage). Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) as prophylaxis. There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved. On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was temperature excursions of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported. This is 1 of 6 reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007802:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # L048849, Expiry date : 04-FEB-2018, NDC# 0006-4995-00, expiry date 31-MAR-2018) (Strength, dose and route of administration were not reported) for prophylaxis (incorrect product storage). Other suspect therapies included sterile diluent(MERCK STERILE DILUENT) as prophylaxis. There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved. On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was temperature excursions of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported. This is 1 of 6 reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007802:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a multiple unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with VARIVAX (lot # M033907 with expiration date: 20-JUL-2017, lot # M033214 with expiration date: 13-JUL-2018), for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT) lot # reported as N015632 with expiration date: 18-FEB-2019. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA000187:
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Productive cough, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report was received from a currently 73-year-old male patient reporting on himself. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (reported as "pneumonia shot") and experienced an adverse reaction to the vaccine of itchy rash that covered his entire body. The outcome of itchy rash that covered his entire body was not reported. The patient subsequently experienced persistent cough with phlegm and shortness of breath while on therapy with mometasone furoate (+) formoterol fumarate(DULERA) (captured in MARRS #1706USA011777).; Sender's Comments:  US-009507513-1706USA011777:
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient was standing at the checkout window when he fainted. Patient was in supine position and feet elevated for 10 mins and a cold compress. Was monitored in office for 45 mins.
Age: 10.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pain at injection site x 2 months and palpable lump.
Age: 10.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Pain at injection site x 2 months and palpable lump.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Bacterial infection, Cellulitis, Chills, Erythema, Fatigue
Clinical narrative: Started out with chills, fatigue, severe headache, muscle/joint pain, arm soreness, nausea, red/hard/hot/swelling from elbow to armpit. Seen by Dr. 7/12, told she has cellulitis and bacterial infection. Prescribed BACTRIM and advised to rest. Told to take Ibuprofen for inflammation and headache. Pt is feeling better, but is still experiencing pain in her arm.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Headache, Induration, Inflammation, Laboratory test normal, Myalgia
Clinical narrative: Started out with chills, fatigue, severe headache, muscle/joint pain, arm soreness, nausea, red/hard/hot/swelling from elbow to armpit. Seen by Dr. 7/12, told she has cellulitis and bacterial infection. Prescribed BACTRIM and advised to rest. Told to take Ibuprofen for inflammation and headache. Pt is feeling better, but is still experiencing pain in her arm.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Started out with chills, fatigue, severe headache, muscle/joint pain, arm soreness, nausea, red/hard/hot/swelling from elbow to armpit. Seen by Dr. 7/12, told she has cellulitis and bacterial infection. Prescribed BACTRIM and advised to rest. Told to take Ibuprofen for inflammation and headache. Pt is feeling better, but is still experiencing pain in her arm.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Started out with chills, fatigue, severe headache, muscle/joint pain, arm soreness, nausea, red/hard/hot/swelling from elbow to armpit. Seen by Dr. 7/12, told she has cellulitis and bacterial infection. Prescribed BACTRIM and advised to rest. Told to take Ibuprofen for inflammation and headache. Pt is feeling better, but is still experiencing pain in her arm.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Peripheral swelling
Clinical narrative: Started out with chills, fatigue, severe headache, muscle/joint pain, arm soreness, nausea, red/hard/hot/swelling from elbow to armpit. Seen by Dr. 7/12, told she has cellulitis and bacterial infection. Prescribed BACTRIM and advised to rest. Told to take Ibuprofen for inflammation and headache. Pt is feeling better, but is still experiencing pain in her arm.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Bacterial infection, Cellulitis, Chills, Erythema, Fatigue
Clinical narrative: Pt had red, swollen arm below the injection site and under left armpit that was extremely painful the day after the shot was administered. Pt went to nurse practitioner, was give BACTRIM for cellulitis. Today the area below the injection site was still very red. The swelling and redness at the area under the left armpit had dissipated.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Headache, Induration, Inflammation, Laboratory test normal, Myalgia
Clinical narrative: Pt had red, swollen arm below the injection site and under left armpit that was extremely painful the day after the shot was administered. Pt went to nurse practitioner, was give BACTRIM for cellulitis. Today the area below the injection site was still very red. The swelling and redness at the area under the left armpit had dissipated.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt had red, swollen arm below the injection site and under left armpit that was extremely painful the day after the shot was administered. Pt went to nurse practitioner, was give BACTRIM for cellulitis. Today the area below the injection site was still very red. The swelling and redness at the area under the left armpit had dissipated.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had red, swollen arm below the injection site and under left armpit that was extremely painful the day after the shot was administered. Pt went to nurse practitioner, was give BACTRIM for cellulitis. Today the area below the injection site was still very red. The swelling and redness at the area under the left armpit had dissipated.
Age: 54.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Peripheral swelling
Clinical narrative: Pt had red, swollen arm below the injection site and under left armpit that was extremely painful the day after the shot was administered. Pt went to nurse practitioner, was give BACTRIM for cellulitis. Today the area below the injection site was still very red. The swelling and redness at the area under the left armpit had dissipated.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning to an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition or concomitant medications were not reported. On 13-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL 9 lot # M014929 and expiration date 27-MAY-2017 (dose and route of administration were not provided) for prophylaxis. No symptoms were reported. There was no product quality complaint involved.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling the size of a fist under injection site on right deltoid, warm to touch and painful with movement reported by patient and daughter. Clinic nurse advised daughter to take patient to Urgent Care on 7/11/17. Urgent care prescribed cephalexin 500mg 3 times a day x 10days. Urgent Care advised patient to see primary care MD on 7/12/17. Patient went to Primary Care MD on 7/12/17 for further evaluation. MD found patient was afebrile, swelling subsided, some erythema further down the arm possible due to gravity, cellulitis but could not rule out allergic reaction. Addition prescription for cephalexin to continue 7 days after first 10 days. Acetaminophen recommended for discomfort.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Redness and swelling the size of a fist under injection site on right deltoid, warm to touch and painful with movement reported by patient and daughter. Clinic nurse advised daughter to take patient to Urgent Care on 7/11/17. Urgent care prescribed cephalexin 500mg 3 times a day x 10days. Urgent Care advised patient to see primary care MD on 7/12/17. Patient went to Primary Care MD on 7/12/17 for further evaluation. MD found patient was afebrile, swelling subsided, some erythema further down the arm possible due to gravity, cellulitis but could not rule out allergic reaction. Addition prescription for cephalexin to continue 7 days after first 10 days. Acetaminophen recommended for discomfort.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient called the office at 4:16pm stating he was having extreme pain and swelling in his arm that he received the vaccination in.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Erythema, Eyelid oedema, Face oedema
Clinical narrative: On 07/07/17 BEXSERO #2 administered rt. deltoid at 11:00 am; on 07/12/17 between 7 am and 8 am, resident's face was noted to have erythema and edema especially of eye area bilaterally. He was examined by Dr. Doctor's impression was that symptoms appeared to be in relationship to BEXSERO.  He was prescribed CLARITIN and Prednisone.
Age: 1.5
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching at injection site, measured at 40 mm X 50 mm. Advised to apply ice,  calamine cream to site, and oral BENADRYL for itching. Report to PCP if it worsens.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Eye swelling, Lip swelling, Rash
Clinical narrative: Client began having lip and right eye swelling, as well as broke out in a rash to his face, right hip and right lower back the evening of his immunization. Had a dose of BENADRYL at home before bedtime.  Came in to clinic to speak with this nurse 07/13/17 and showed rash and swelling. Recommended physician visit.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Joint range of motion measurement, Myalgia, Nausea
Clinical narrative: Headache, muscle pain, muscle soreness, nausea. Treatment: HYDROCODONE/ACETAMINOPHEN 5-325 mg 1 tablet Oral Q8H PRN for pain, NAPROXEN 500 mg Oral BID for pain and inflammation, ONDANSETRON HCL 4 mg Oral Q8H PRN  for nausea.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Confusional state, Eye movement disorder, Feeling cold, Loss of consciousness
Clinical narrative: 20 seconds after receiving shot, she started to convulse with seizure like symptoms- shaking, twitching, mouth open with tongue moving rapidly, eyes rolling back- she then passed out. When she came to consciousness, patient did not know what happened. She had confusion, tingling/ cold all over body, and weakness. She rested for about 15 minutes, and then felt ok enough to leave doctor's office.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle twitching, Paraesthesia, Seizure, Seizure like phenomena, Tongue movement disturbance
Clinical narrative: 20 seconds after receiving shot, she started to convulse with seizure like symptoms- shaking, twitching, mouth open with tongue moving rapidly, eyes rolling back- she then passed out. When she came to consciousness, patient did not know what happened. She had confusion, tingling/ cold all over body, and weakness. She rested for about 15 minutes, and then felt ok enough to leave doctor's office.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: 20 seconds after receiving shot, she started to convulse with seizure like symptoms- shaking, twitching, mouth open with tongue moving rapidly, eyes rolling back- she then passed out. When she came to consciousness, patient did not know what happened. She had confusion, tingling/ cold all over body, and weakness. She rested for about 15 minutes, and then felt ok enough to leave doctor's office.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site reaction, Muscle swelling
Clinical narrative: Muscle swelling, shoulder to elbow of arm of injection site, began within a few hours of immunization.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: CSF glucose decreased, CSF lymphocyte count abnormal, CSF monocyte count increased, CSF neutrophil count increased, CSF protein increased
Clinical narrative: ADMITTED 6/6/2017 WITH MENINGITIS. PATIENT DISCHARGED HOME ON 6/8/2017 IN GOOD HEALTH AFTER  48 HOURS OF  VANCOMYCIN AND ROCEPHIN. AFTER 5 DAYS ALL CULTURES WERE NEGATIVE. PRESUMPTIVE VIRAL MENINGITIS.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: CSF red blood cell count positive, CSF white blood cell count increased, Culture negative, Eosinophil percentage, Haematocrit decreased
Clinical narrative: ADMITTED 6/6/2017 WITH MENINGITIS. PATIENT DISCHARGED HOME ON 6/8/2017 IN GOOD HEALTH AFTER  48 HOURS OF  VANCOMYCIN AND ROCEPHIN. AFTER 5 DAYS ALL CULTURES WERE NEGATIVE. PRESUMPTIVE VIRAL MENINGITIS.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Haemoglobin normal, Lymphocyte percentage, Meningitis viral, Monocyte percentage increased, Neutrophil percentage decreased
Clinical narrative: ADMITTED 6/6/2017 WITH MENINGITIS. PATIENT DISCHARGED HOME ON 6/8/2017 IN GOOD HEALTH AFTER  48 HOURS OF  VANCOMYCIN AND ROCEPHIN. AFTER 5 DAYS ALL CULTURES WERE NEGATIVE. PRESUMPTIVE VIRAL MENINGITIS.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Platelet count increased, White blood cell count normal
Clinical narrative: ADMITTED 6/6/2017 WITH MENINGITIS. PATIENT DISCHARGED HOME ON 6/8/2017 IN GOOD HEALTH AFTER  48 HOURS OF  VANCOMYCIN AND ROCEPHIN. AFTER 5 DAYS ALL CULTURES WERE NEGATIVE. PRESUMPTIVE VIRAL MENINGITIS.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site mass, Pyrexia, Rash
Clinical narrative: Mother states Pt developed a rash, fever (104), and a lump in his legs following vaccination.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Irritability, Opisthotonus, Pyrexia, Rash, Screaming
Clinical narrative: 06JUL2017 - Vaccination at 8:30am. 08JUL2017 - Spiked mild fever at 11:30am (100.9 degrees). Fever continued on/off through 11JUL2017. 08JUL2017-09JUL2017 - Given TYLENOL for fever. Took an hour for fever to subside and broke through again an hour after that. 10JUL2017 - Began giving MOTRIN for fever. Fever subsided within 20 minutes. 11JUL2017 - Rash on  neck/chest. Rash continued to spread to back, ears, and below waist. Still spreading today 13JUL2017. The bumps are raised, turn white when pressure applied. 11JUL2017 - Woke up at 10pm screaming and arching back. Was consolable only for 5-10 minutes at a time. Continued until 11:30pm. 12JUL2017 - Morning screaming and arching back. Extreme fussiness all day. 13JUL2017 - Rash has spread to face.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: PATIENT PRESENT WITH LARGE RED AREA THAT WAS PAINFUL AND WARM TO THE TOUCH. SHE WAS ASSESSING IF IT HAD SPREAD OVERNIGHT AND IT DID. I ADVISED HER TO PRESENT TO THE DOCTOR FOR ASSESSMENT AND I AM AWAITING PATIENT'S CONTACT.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Diet refusal, Fatigue, Hypersomnia, Opisthotonus
Clinical narrative: Inconsolable high pitched scream along with arching back for hours after vaccination all while refusing to breastfeed. Called doctor they said it was "normal" and to give TYLENOL, we did not give TYLENOL knowing it isn't healthy. Finally passed out do to exhaustion and slept longer than usual.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Screaming
Clinical narrative: Inconsolable high pitched scream along with arching back for hours after vaccination all while refusing to breastfeed. Called doctor they said it was "normal" and to give TYLENOL, we did not give TYLENOL knowing it isn't healthy. Finally passed out do to exhaustion and slept longer than usual.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Apnoea, Chest X-ray normal, Cyanosis, Dyspnoea, Echocardiogram normal
Clinical narrative: Baby turned blue localized from navel to knees 4 hours following vaccinations. Massaged baby color returned. While on phone with Doctors office baby turned blue localized from the nipples to toes (20 mins later). Baby screaming, spewing saliva, and mildly gasping. Baby was in father's arms cradled. Massaged. Color turned ghost white. Was awake during both episodes. 3 Days following episode full body.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Electroencephalogram normal, Pallor, Salivary hypersecretion, Screaming, Sleep study normal
Clinical narrative: Baby turned blue localized from navel to knees 4 hours following vaccinations. Massaged baby color returned. While on phone with Doctors office baby turned blue localized from the nipples to toes (20 mins later). Baby screaming, spewing saliva, and mildly gasping. Baby was in father's arms cradled. Massaged. Color turned ghost white. Was awake during both episodes. 3 Days following episode full body.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound chest, Ultrasound scan normal
Clinical narrative: Baby turned blue localized from navel to knees 4 hours following vaccinations. Massaged baby color returned. While on phone with Doctors office baby turned blue localized from the nipples to toes (20 mins later). Baby screaming, spewing saliva, and mildly gasping. Baby was in father's arms cradled. Massaged. Color turned ghost white. Was awake during both episodes. 3 Days following episode full body.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthenia, Cellulitis, Dizziness, Erythema, Headache
Clinical narrative: Pain and swelling on both arms. Red welts/hives on both arms. Dizziness and weakness. Fever for 48 hours at 102+. Headache. Nausea. Vomiting (ER doctor gave three doses of anti-nausea medicine to get me to stop throwing up).
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Hypersensitivity, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pain and swelling on both arms. Red welts/hives on both arms. Dizziness and weakness. Fever for 48 hours at 102+. Headache. Nausea. Vomiting (ER doctor gave three doses of anti-nausea medicine to get me to stop throwing up).
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Urticaria, Vomiting
Clinical narrative: Pain and swelling on both arms. Red welts/hives on both arms. Dizziness and weakness. Fever for 48 hours at 102+. Headache. Nausea. Vomiting (ER doctor gave three doses of anti-nausea medicine to get me to stop throwing up).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Insomnia, Mobility decreased, Skin warm, Swelling
Clinical narrative: Left shoulder cellulitis, warm to touch, extremely swollen, difficulty moving arm, couldn't sleep on it. Was given antibiotic.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given vaccine by LPN during office visit yesterday with primary care provider. Patient reports she had pain when vaccine was administered, and pain continued. Patient then reports she noticed swelling to her left arm approx. 6pm yesterday evening. Today, was at pre-op for surgery, and was told to come back to PCP office for evaluation for redness, swelling, tenderness and warmth to left upper arm. Patient arrived to our "walk in" side of the clinic for evaluation. Seen by PA. Contacted local "shot line" and given this information. Patient was given AUGMENTIN course and return precautions. Patient states she had to reschedule her surgery. She was ambulatory without any respiratory distress.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: Patient was given vaccine by LPN during office visit yesterday with primary care provider. Patient reports she had pain when vaccine was administered, and pain continued. Patient then reports she noticed swelling to her left arm approx. 6pm yesterday evening. Today, was at pre-op for surgery, and was told to come back to PCP office for evaluation for redness, swelling, tenderness and warmth to left upper arm. Patient arrived to our "walk in" side of the clinic for evaluation. Seen by PA. Contacted local "shot line" and given this information. Patient was given AUGMENTIN course and return precautions. Patient states she had to reschedule her surgery. She was ambulatory without any respiratory distress.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Crying, Diarrhoea, Vulvovaginal rash
Clinical narrative: Shortly after receiving the vaccine, my daughter developed a serious rash on and around her vagina and up to her anus area. She developed severe diarrhea and nonstop crying. Currently, she is still experiencing these symptoms. I made a follow up appointment for 7/13/2017 at 3:45 with her pediatrician.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Headache, Mobility decreased, Pain in extremity
Clinical narrative: Pronounced arm pain within two hours then inability to raise arm above shoulder after 3 hours, then weak feeling, fever at 103 and severe fatigue and sleepiness and headache.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Somnolence
Clinical narrative: Pronounced arm pain within two hours then inability to raise arm above shoulder after 3 hours, then weak feeling, fever at 103 and severe fatigue and sleepiness and headache.
Age: 4.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Mother brought child to doctor's office on 7/12/17, reporting child's right upper arm swollen, warm to touch and feels hard. Mother states she used ice to site the previous evening. Patient seen by Dr. on 7/12/17, was prescribed ZITHROMAX 100 mg/5 mL oral suspension 5 cc to start then 2 1/2 cc daily.  Mother called 7/13/17 stating the swelling was going down the patient's arm, advised to go to the ER.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Headache, Induration, Pruritus
Clinical narrative: Redness, induration, itching, increased warmth, headache.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Impaired work ability, Oropharyngeal pain, Pain, Streptococcus test negative
Clinical narrative: He started to have sore the day after the vaccine, two days later had body aches and chills. No sure of fever. Severe pain in  throat, did not go to work. Rapid strep test was negative. Asked to take advil for pain, warm water gargle.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Pain in extremity, Syncope
Clinical narrative: Felt arm pain. Walked up the stairs, felt dizzy and fainted the evening after receiving vaccines. Woke up moments later and went to sleep. No treatment indicated. Acting as usual the following day - arm pain persists but no dizziness or other symptoms noted.
Age: 17.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Arthralgia, Headache, Nausea, Pyrexia, Vaccination complication
Clinical narrative: Father called on 7/12/17. Chief complaint: reaction to MMR, low grade fever, headache, today nausea and vomiting but may be related to workout, also had meningococcal vaccine the same day. Associated symptoms: did develop joint pain in her wrists for the past two days. Duration/Onset: shot was given 6/24/17. Pertinent history: Raynaud's and positive ANA. Aggravated by: vaccine. Alleviated by: nothing. Denied symptoms: no rash, seizures, SOB. Telephone encounter sent to Dr. and her reply: Pt appears to have had mild reaction to MMR, these symptoms are already known possible reactions from MMR. If father would like reported, we can do so. I would recommend she get second dose, but if father concerned, recommend he discuss with her rheumatologist.
Age: 17.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Vomiting
Clinical narrative: Father called on 7/12/17. Chief complaint: reaction to MMR, low grade fever, headache, today nausea and vomiting but may be related to workout, also had meningococcal vaccine the same day. Associated symptoms: did develop joint pain in her wrists for the past two days. Duration/Onset: shot was given 6/24/17. Pertinent history: Raynaud's and positive ANA. Aggravated by: vaccine. Alleviated by: nothing. Denied symptoms: no rash, seizures, SOB. Telephone encounter sent to Dr. and her reply: Pt appears to have had mild reaction to MMR, these symptoms are already known possible reactions from MMR. If father would like reported, we can do so. I would recommend she get second dose, but if father concerned, recommend he discuss with her rheumatologist.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Pain in extremity, Paraesthesia
Clinical narrative: Patient reports immediately she developed diffuse aches in the left arm and hand. In the week to follow she developed joint pain along hands/knees/arms bilaterally. Now having bilateral hand numbness tingling.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Crying, Irritability, Pain, Pruritus, Rash
Clinical narrative: (PLEASE NOTE PATIENT RECEIVED MMR 1ST DOSE, VARICELLA 1ST DOSE AND PCV 13 4TH DOSE ALL ON 7/10/17). Mom states patient had a few small pink pimple-typed bumps at her face about 20-30 minutes after the vaccines, and 6 hours later patient woke up from a nap with large red itchy blotches and welt-type rash over her face and neck. Mom called our clinic and was advised to start oral BENADRYL, which she did and the rash went away. The rash has not returned. Mom states the patient has been fussy at night and is screaming and crying as if in pain for past 2 nights. Did take her to the emergency room last night and instructed to use NSAIDS for pain.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash macular, Screaming, Urticaria
Clinical narrative: (PLEASE NOTE PATIENT RECEIVED MMR 1ST DOSE, VARICELLA 1ST DOSE AND PCV 13 4TH DOSE ALL ON 7/10/17). Mom states patient had a few small pink pimple-typed bumps at her face about 20-30 minutes after the vaccines, and 6 hours later patient woke up from a nap with large red itchy blotches and welt-type rash over her face and neck. Mom called our clinic and was advised to start oral BENADRYL, which she did and the rash went away. The rash has not returned. Mom states the patient has been fussy at night and is screaming and crying as if in pain for past 2 nights. Did take her to the emergency room last night and instructed to use NSAIDS for pain.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On 28-JUN-2017, the patient was inadvertently vaccinated with an expired dose of VARVAX, lot # L017144, expiration date 13-MAY-2017 (dose, route of administration, and frequency were not reported) for prophylaxis. On an unspecified date, the patient was vaccinated with an improperly stored dose of VARVAX (dose, route of administration, frequency, and lot #  were not reported) [it was not further specified if the expired dose of VARIVAX, was also the improperly stored dose of VARVAX]. No adverse effects were reported. No additional information was provided. Additional information was requested.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chest discomfort, Dyspnoea, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 17 year old male patient. He has no medical history, past drug history, and no concomitant medications. On 25-MAY-2017 the patient was vaccinated with GARDASIL 9 injection (route and lot # unknown) in his arm one time, dose unknown for immunization. Other suspect therapies included TRUMENBA received at the same time in unspecified separate arm. After receiving the vaccines he experienced "massive swelling in his arm". The chief complaint was reported as "soreness in both arms". The patient complained of shortness of breath and chest tightness after the immunization. The patient was taken to emergency room due to shortness of breath and chest tightness. However patient was not treated due to long wait. The family called doctor and patient was instructed to take MOTRIN for pain in his arms. His breathing was fine at the time but he was still having shortness of breath. He no longer receives GARDASIL 9. On unknown date the symptoms of "massive swelling in his arms", soreness in both arms, shortness of breath, chest tightness, and pain in his arms have been resolved and patient is better now. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 27-JUN-2017 from a certified medical assistant regarding a 20 year old female patient who received one VARIVAX (lot# M046924, expiration 28-NOV-2018) at a 0.5ml dose subcutaneously in her right arm with sterile diluent (lot# N007760, expiration 31-MAY-2018) and one M-M-R II (lot# reported as M045395, expiration 14-NOV-2018) (see MARRS# 1707USA001861) at a 0.5ml dose subcutaneously in her left arm with sterile diluent (lot# N007760, expiration 31-MAY-2018) on 22-JUN-2017 due to a titer drawn on an unknown date showing lack of immunity to mumps and varicella. The patient's medical history included that she was a health care worker with recent titer results showing lack of immunity to mumps and varicella. The medical assistant stated that the patient has no relevant laboratory data or concomitant medications. The medical assistant reported that on 27-JUN-2017, after an interview where the patient stated that she had not received VARIVAX or M-M-R II, the patient was administered VARIVAX at a 0.5ml subcutaneous dose in her left arm and M-M-R II at a 0.5ml subcutaneous dose in her right arm. Upon a chart review later on in the day, medical assistant discovered that the patient had received these vaccines on 22-JUN-2017 as well. The medical assistant reported that the patient has not experienced an adverse reaction and therefore no treatments have been provided. The medical assistant stated that the patient received the same lot# and expiration dates of the vaccine and diluents on both administration dates. As of 27-JUN-2017, it was unknown if the patient will continue on VARIVAX and M-M-R II and the outcome of receiving doses of both of these agents in a five day interval is unknown. The is one of two cases concerning the same patient. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001861:
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 27-JUN-2017 from a certified medical assistant regarding a 20 year old female patient who received one M-M-R II (lot# reported as M045395, expiration 14-NOV-2018) at a 0.5ml dose subcutaneously in her left arm with sterile diluent (lot# N007760, expiration 31-MAY-2018) on 22-JUN-2017 due to a titer drawn on an unknown date showing lack of immunity to mumps and varicella. The patient's medical history included that she was a health care worker with recent titer results showing lack of immunity to mumps and varicella. The medical assistant stated that the patient has no relevant laboratory data or concomitant medications. The medical assistant reported that on 27-JUN-2017, after an interview where the patient stated that she had not received M-M-R II, the patient was administered M-M-R II at a 0.5ml subcutaneous dose in her right arm. Upon a chart review later on in the day, medical assistant discovered that the patient had received this vaccine on 22-JUN-2017 as well. The medical assistant reported that the patient has not experienced an adverse reaction and therefore no treatments have been provided. The medical assistant stated that the patient received the same lot# and expiration dates of the vaccine and diluent on both administration dates. As of 27-JUN-2017, it was unknown if the patient will continue on M-M-R II and the outcome of receiving doses in a five day interval is unknown.  The is one of two cases concerning the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1707USA001754:
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site mass, Injection site pain, Muscular weakness, Paraesthesia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 05-JUL-2017. This case involves a 61-year-old female patient who was vaccinated with a first dose of ADACEL (batch number: U5626AA, expiry date: 05-APR-2019, dose, route of administration were not reported) in left deltoid, on 19-JUN-2017. Any other vaccinations within four weeks of vaccinations was reported as none. Patient had Laceration on stomach at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications included DEXTROPROPOXYPHENE/PARACETAMOL (Darvocet). On 21-JUN-2017 (since the am), two days following the vaccination, the patient has been having numbness tingling in her left arm, pain at the injection site with a lump noted at the site. She is also having weakness in the arm and difficulty using it due to pain. It was reported that the patient required emergency room/doctor visit. No lab test was performed. The patient was advice to treat it along with rest. The patient had not recovered from the events. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: After gave patient 3 shots, patient fainted have patient lying knee up on table, ice pack on forehead, cracker, juice, B/P taken. Also seen by Dr. It happened when Dr. was in the room. Patient to stay 30 min B/P taken again before patient leave office.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient began having a rash within one hour of vaccine. Patient has received antibiotics and steroids.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Rash erythematous, Rash morbilliform, Rash vesicular, Skin discolouration
Clinical narrative: Patient began having a rash within one hour of vaccine. Patient has received antibiotics and steroids.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient began having a rash within one hour of vaccine. Patient has received antibiotics and steroids.