chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # K019560 with expiration date 02-JUN-2016, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 4 month old male patient. The patient's pertinent medical history was not reported. On 10-JUN-2015, the patient was vaccinated with PEDVAXHIB lot # K009955 (expiration date not provided), 0.5 ml, intramuscular and PENTACEL (dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 03-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 30-MAY-2015, the patient was vaccinated with improperly stored dose of VAQTA (Lot no. K001792 Expiration date: 22-OCT-2015) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were inadvertently vaccinated with GARDASIL (dose, route and lot# were not reported) (confirmed not GARDASIL 9) that had been improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 08-SEP-2014, the patient was vaccinated with an improperly stored dose of VAQTA (Lot No. K001792 Expiration date: 22-OCT-2015) (dose, route, anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015, concerning a patient of unknown age and gender. On 21-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 02-JUL-2015 the patient was inadvertently administered with improperly stored M-M-R II vaccine, rHA therapy type, lot # K007107, expire date 16-MAY-2016 (dose, route therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received form the same source. Additional information was been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 06-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (Lot No. J006850 Expiration date: 31-MAR-2016 this lot was not improperly stored). Then, on 16-SEP-2014, the patient received the second dose of an improperly stored GARDASIL (Lot No. J010668 Expiration date: 29-APR-2016) (doses, routes and anatomical locations of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 1 year old male patient. The concurrent condition, medical history and concomitant medication was not reported. On 17-JUL-2015, the patient was inadvertently vaccinated with PROQUAD (Merck) and VARIVAX (Merck) (dose, route and dose details unavailable) (inappropriate schedule of vaccine administration). No adverse event was reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received via communication agency from online articles covered by several local outlets and TV channels refers to a 2 year old male patient, who participated in program providing regular childhood vaccines for uninsured kids. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, between July 2014 and June 2015 (also reported as between October 2014 and June 2015), the patient was vaccinated with "a high dose" (also reported as an "excessive dose", "double dose") of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). Although it was stated that GARDASIL administration to someone of tender years could present a problem with regard to neurological development (also reported as "the child might be at risk of neurological damage", "might suffer neurological effects from receiving the excessive dose"), the effect of faulty vaccination was not yet known at the time of the report and no such condition was reported. The child had been subjected to further medical monitoring. 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 received from a Licensed Vocational Nurse referring to an unspecified number of patients. On 02-JUL-2015, the nurse called but she did not report any adverse event at that time, however she called the next day to report that in approximately July 2015, the patients were vaccinated with (Oka/Merck) VARIVAX that were improperly stored (lot number and expiration date unknown) dose and route of vaccination were unknown. No symptoms reported. No other details. This is one of two reports from the same reporter (1507USA003019). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant referring to a patient of unknown age and gender. On 02-JUL-2015, the patient was vaccinated with a dose of GARDASIL, lot # K006960, (expiration date, dose and site of administrations were not reported) that was exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all the follow ups requested to complete the case were received.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 19-SEP-2014, the patient was vaccinated with improperly stored dose of VAQTA (Lot No. K001792 Expiration date: 22-OCT-2015) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. 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: Information has been received from a healthcare worker (medical assistant) referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent condition were not provided. On unknown dates the patients received improperly stored doses of RECOMBIVAX HB (strength, lot#, expiration date, therapy type, dose and route were unspecified). No adverse effect was reported. This is one of the several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 24-APR-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion of 72 hours. This is one of several reports from the same reporter (MARRS 1507USA000441). Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy was not reported. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # J009721 expiration date 07-AUG-2015, lot # K002047,. expiration date 10-FEB-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II, albumin status rHA, batch # J006136, lot # 0116AE, expiration date 06-JUL-2015 (dose, and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent condition were not provided. On unknown dates the patients received improperly stored doses of VAQTA (strength, lot#, expiration date, dose and route were unspecified). No concomitant therapy was provided. No adverse effect was reported. This is one of the several reports that received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: After receiving the second GARDASIL shot the pt started having a hard time breathing. She tried taking BENADRYL but it continued to worsen. She had two doses of epi 1:1000 and prednisone. It improved.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Blood creatine phosphokinase increased, Laboratory test, Lumbar puncture, Muscular weakness, Pain in extremity
Clinical narrative: WEAKNESS AND PAIN IN ARMS & HANDS.  COULD NOT PINCH FINGERS AND THUMBS TOGETHER. WAITED THROUGH WEEKEND AND WENT TO DOCTOR ON MONDAY.  HE HAD ME MEET A NEUROLOGIST AT ER ON TUESDAY MORNING. AFTER RUNNING SEVERAL TESTS ALONG WITH A LUMBAR PUNCTURE, IT WAS DETERMINED THAT MY CPK LEVEL WAS AROUND 1400. I WAS ADMITTED TO HOSPITAL ON 10/09/12 AND STAYED 4 DAYS.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Injection site pain, Malaise, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-Dec-2014) concerns a 44 year old female patient. The patient's medical history included asthma. The patient did not have any current illness at the time of vaccination. On 23-Sep-2014, the patient received intramuscular AFLURIA, (batch number: T58006) in the left arm. On 23-Sep-2014, the patient experienced injection site pain, followed by fever, chills, body aches, malaise and vomiting. On 24-Sep-2014 at 05:00 AM, the patient developed headache. All symptoms resolved by mid-morning. The outcome was reported as resolved. Reporter's comments: The health authority assessed the events as non-serious. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse vents reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out-of-specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically developed process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-Dec-2014) concerns a 44 year old female patient. The patient's medical history included asthma. The patient did not have any current illness at the time of vaccination. On 23-Sep-2014, the patient received intramuscular AFLURIA, (batch number: T58006) in the left arm. On 23-Sep-2014, the patient experienced injection site pain, followed by fever, chills, body aches, malaise and vomiting. On 24-Sep-2014 at 05:00 AM, the patient developed headache. All symptoms resolved by mid-morning. The outcome was reported as resolved. Reporter's comments: The health authority assessed the events as non-serious. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse vents reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out-of-specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically developed process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient received Prevnar 13 vaccine on 6/9/15; on 6/14/15 rash developed at the vaccine site. The area was warm to the touch and itchy. 9 hrs later the rash spread down her arm. On 6/15/15 patient was seen in the office for the reaction. Patient was given an rx for Clindamycin. In addition she given Rx for Benadryl tablets and cream and hydrocortisone cream. Patient developed rash at vaccination site and was treated for possible cellulitis and allergic reaction.  Though injection-site reactions are very common with vaccines, they often occur soon after the vaccination but have been reported several days later.  Cellulitis may be more likely as this is a late manifestation.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pruritus, Rash, Vaccination site rash, Vaccination site warmth
Clinical narrative: Patient received Prevnar 13 vaccine on 6/9/15; on 6/14/15 rash developed at the vaccine site. The area was warm to the touch and itchy. 9 hrs later the rash spread down her arm. On 6/15/15 patient was seen in the office for the reaction. Patient was given an rx for Clindamycin. In addition she given Rx for Benadryl tablets and cream and hydrocortisone cream. Patient developed rash at vaccination site and was treated for possible cellulitis and allergic reaction.  Though injection-site reactions are very common with vaccines, they often occur soon after the vaccination but have been reported several days later.  Cellulitis may be more likely as this is a late manifestation.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's medical history included rosacea. Her concurrent conditions and drug reactions/ allergies were not reported. On 28-MAY-2015 the patient was vaccinated with ZOSTAVAX (lot # L000448, expiry date: 08-MAR-2016), .65 ml, subcutaneous in the left arm. No concomitant medications were reported. On an unspecified date in 2015, the patient developed a hematoma at the injection site post administration with ZOSTAVAX, which resulted in skin discoloration the size of a quarter where the hematoma was located. Reporting pharmacist confirmed that this was not a varicella like rash. Patient sought medical attention and visited the pharmacist for recommendations. No treatment was provided or recommended for the events. Reporting pharmacist stated that the skin discoloration was not recovered (reported as unresolved). Outcome of the event, injection site haematoma was unknown. Reporting pharmacist did not assessed the causality of the events with respect to ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site haematoma
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's medical history included rosacea. Her concurrent conditions and drug reactions/ allergies were not reported. On 28-MAY-2015 the patient was vaccinated with ZOSTAVAX (lot # L000448, expiry date: 08-MAR-2016), .65 ml, subcutaneous in the left arm. No concomitant medications were reported. On an unspecified date in 2015, the patient developed a hematoma at the injection site post administration with ZOSTAVAX, which resulted in skin discoloration the size of a quarter where the hematoma was located. Reporting pharmacist confirmed that this was not a varicella like rash. Patient sought medical attention and visited the pharmacist for recommendations. No treatment was provided or recommended for the events. Reporting pharmacist stated that the skin discoloration was not recovered (reported as unresolved). Outcome of the event, injection site haematoma was unknown. Reporting pharmacist did not assessed the causality of the events with respect to ZOSTAVAX. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Biopsy, Herpes zoster disseminated
Clinical narrative: Acute disseminated varicella infection. Occipital headache and neck stiffness 5 days post vaccine; erythematous pruritic rash throughout body. Low grade fever.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Chest X-ray normal, Full blood count abnormal, Headache, Liver function test abnormal, Musculoskeletal stiffness
Clinical narrative: Acute disseminated varicella infection. Occipital headache and neck stiffness 5 days post vaccine; erythematous pruritic rash throughout body. Low grade fever.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Pyrexia, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Acute disseminated varicella infection. Occipital headache and neck stiffness 5 days post vaccine; erythematous pruritic rash throughout body. Low grade fever.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Acute disseminated varicella infection. Occipital headache and neck stiffness 5 days post vaccine; erythematous pruritic rash throughout body. Low grade fever.
Age: 38.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Culture negative, Deafness unilateral, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Acute onset of right sided deafness.
Age: 33.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Pyrexia
Clinical narrative: Severe headache and fever.  Patient had continuous headache and intermittent fever for approximately 6 weeks after.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Started with muscle aches and joint pain, headache, and fatigue. On 07/26/2015 developed sore throat, swollen glands in neck, fever of 101.2F, chills, Still had headache, muscle and joint pain.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Started with muscle aches and joint pain, headache, and fatigue. On 07/26/2015 developed sore throat, swollen glands in neck, fever of 101.2F, chills, Still had headache, muscle and joint pain.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Extreme sensitivity and massive swelling of upper right thigh. Red blotches around injection sight.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Dizziness, Feeling cold, Haemoglobin decreased, Intra-uterine contraceptive device insertion
Clinical narrative: Pt brought back HPV cax from her pharmacy, HPV #1. Pt was waiting at the lobby after IUD insertion and HPV #1. FD initiated code blue. Pt fainted on her seat, her husband was next to her. 11:15 am Code blue called. RN and provider arrived at the lobby. Called pt's name but pt is not answering, eyes were closed. pt's husband reported, pt not responsive. VS: Bp 106/76, pulse 64, O2 sat 98 % on room air, BG 98, Hgb FS 11.5. Provider instructed to call 911 for EMS. 11:18am 911 called. Pt was escorted to floor by staffs. called pt's name and she was not answering and her eyes were reminded closed. 11:20am Vital Signs: BP 124/72, pulse 63, O2 sat 99% on room air. Dr. verbal order: IV fluids 5% Dextrose 0.45% Nacl 500ml. IV line was insterted by Dr. and IV fluids given, wide open. (needle gauge: 22, site: right antecubital vein). 11:25am Vital Signs: BP 120/80, pulse 68, O2 sat 100% on room air. Pt opened her eyes and she was responding to her name, where and when. 11:36am Called EMS again, they reported, it is on the way. Pt reported, she is A&O x3 and feeling cold and dizzy. 2 blankets given. 11:37 am 2nd bag of IV fluids given (0.9% Nacl). 11:40 am EMS arrived. Vital signs: pulse 68, O2 sat 100%. 11:50 am EMS and patient left the clinic. informed pt's husband that RN will call tomorrow for f/u and call back for any questions. He verbalized understanding.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Pt brought back HPV cax from her pharmacy, HPV #1. Pt was waiting at the lobby after IUD insertion and HPV #1. FD initiated code blue. Pt fainted on her seat, her husband was next to her. 11:15 am Code blue called. RN and provider arrived at the lobby. Called pt's name but pt is not answering, eyes were closed. pt's husband reported, pt not responsive. VS: Bp 106/76, pulse 64, O2 sat 98 % on room air, BG 98, Hgb FS 11.5. Provider instructed to call 911 for EMS. 11:18am 911 called. Pt was escorted to floor by staffs. called pt's name and she was not answering and her eyes were reminded closed. 11:20am Vital Signs: BP 124/72, pulse 63, O2 sat 99% on room air. Dr. verbal order: IV fluids 5% Dextrose 0.45% Nacl 500ml. IV line was insterted by Dr. and IV fluids given, wide open. (needle gauge: 22, site: right antecubital vein). 11:25am Vital Signs: BP 120/80, pulse 68, O2 sat 100% on room air. Pt opened her eyes and she was responding to her name, where and when. 11:36am Called EMS again, they reported, it is on the way. Pt reported, she is A&O x3 and feeling cold and dizzy. 2 blankets given. 11:37 am 2nd bag of IV fluids given (0.9% Nacl). 11:40 am EMS arrived. Vital signs: pulse 68, O2 sat 100%. 11:50 am EMS and patient left the clinic. informed pt's husband that RN will call tomorrow for f/u and call back for any questions. He verbalized understanding.
Age: 56.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Back pain, Chronic inflammatory demyelinating polyradiculoneuropathy, Fall, Muscular weakness, Neuralgia
Clinical narrative: Legs gave out and kept falling, severe back pain and leg pain. Pain pills that didn't help until LYRICA was given in hospital for nerve pain-2013.
Age: 56.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity
Clinical narrative: Legs gave out and kept falling, severe back pain and leg pain. Pain pills that didn't help until LYRICA was given in hospital for nerve pain-2013.
Age: 56.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Back pain, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram abnormal, Electromyogram abnormal, Fall
Clinical narrative: Legs gave out and kept falling, severe back pain and leg pain. Pain pills that didn't help until LYRICA was given in hospital for nerve pain-2013.
Age: 56.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Immunoglobulin therapy, Lumbar puncture abnormal, Muscular weakness, Nerve injury, Nuclear magnetic resonance imaging normal
Clinical narrative: Legs gave out and kept falling, severe back pain and leg pain. Pain pills that didn't help until LYRICA was given in hospital for nerve pain-2013.
Age: 56.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity, Wheelchair user
Clinical narrative: Legs gave out and kept falling, severe back pain and leg pain. Pain pills that didn't help until LYRICA was given in hospital for nerve pain-2013.
Age: 33.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dizziness, Drooling, Eye movement disorder, Hyperhidrosis, Loss of consciousness
Clinical narrative: PAIN IN ARM, SWEATING, FEELING LIGHT HEADED WITHIN SECONDS OF RECIEVING ANTHRAX VACCINE.  PATIENT PASSED OUT, EYES ROLLED INTO BACK OF HEAD AND STARTED DROOLING WITHIN 3 MINS OF VACCINES.  PATIENT CAME TOO ABOUT 1 MINUTE LATER. PATIENT THEN BEGAN GETTING SICK. 911 WAS CALLED WHEN PATIENT COLLASPED AND AN AMBULANCE TRANSPORTED HER TO HOSPITAL FOR EVALUATION.  AMBULANCE ARRIVED 5 MINS AFTER CALL WAS PLACED.
Age: 33.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Malaise, Pain in extremity, Syncope
Clinical narrative: PAIN IN ARM, SWEATING, FEELING LIGHT HEADED WITHIN SECONDS OF RECIEVING ANTHRAX VACCINE.  PATIENT PASSED OUT, EYES ROLLED INTO BACK OF HEAD AND STARTED DROOLING WITHIN 3 MINS OF VACCINES.  PATIENT CAME TOO ABOUT 1 MINUTE LATER. PATIENT THEN BEGAN GETTING SICK. 911 WAS CALLED WHEN PATIENT COLLASPED AND AN AMBULANCE TRANSPORTED HER TO HOSPITAL FOR EVALUATION.  AMBULANCE ARRIVED 5 MINS AFTER CALL WAS PLACED.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling at the injection site about the size of a half-dollar. Pt stated that she had taken Zyrtec and put Benadryl cream on the site. On 7/25/15 size of affected area was bigger about 3 inches x 3 inches, pt was instructed to take Benadryl and continue cream. Spoke to pt on 7/28/15 pt states that the area has not really changed but it is not bothering here. Instructed pt to have her primary care physician look at the reaction site.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Blood test, Chills, Confusional state, Cough
Clinical narrative: Fever, chills, coughing, muscle spasms, loss of appetite, dizziness, confusion, headache, disorientation, extreme body aches, thick stringy phlegm, extreme fatigue, extreme weakness.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Disorientation, Dizziness, Fatigue, Headache
Clinical narrative: Fever, chills, coughing, muscle spasms, loss of appetite, dizziness, confusion, headache, disorientation, extreme body aches, thick stringy phlegm, extreme fatigue, extreme weakness.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Muscle spasms, Pain, Productive cough, Pyrexia
Clinical narrative: Fever, chills, coughing, muscle spasms, loss of appetite, dizziness, confusion, headache, disorientation, extreme body aches, thick stringy phlegm, extreme fatigue, extreme weakness.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Per office visit with Dr. 7/27/15 following the allergic reaction: Patient had Prevnar vaccine administration over L upper arm and has had swelling/itching/erythema/warmth over this arm, no mouth/throat/eyes/breathing issues or swelling.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Head injury, Syncope
Clinical narrative: reportedly: 5 min after vaccine patient had syncope that led to head injury
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever and myalgias; nausea and vomiting.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injected limb mobility decreased, Pain, Pyrexia
Clinical narrative: High fever of over 104, severe difficulty breathing, pain all over body, unable to move arm where vaccine was put in for 3 days.
Age: 9.0
Sex: F
Vaccine: HIBV
Symptoms: Abdominal pain, Blood glucose normal, Blood urea increased, Blood urine present, Full blood count normal
Clinical narrative: Per Family, developed a very high fever and abdominal pain, went to ER.  Was told that this was a known complication of Hepatitis A vaccination.  However, our inventory audit revealed that she had been given a Haemophilus vaccination by mistake.  I found out about the ER visit when I called Mom to tell her about the med error.
Age: 9.0
Sex: F
Vaccine: HIBV
Symptoms: Lipase normal, Metabolic function test normal, Protein urine present, Pyrexia, Wrong drug administered
Clinical narrative: Per Family, developed a very high fever and abdominal pain, went to ER.  Was told that this was a known complication of Hepatitis A vaccination.  However, our inventory audit revealed that she had been given a Haemophilus vaccination by mistake.  I found out about the ER visit when I called Mom to tell her about the med error.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Blood culture, Culture urine, Electrocardiogram, Electroencephalogram, Headache
Clinical narrative: Patient complained of Headache, there was no vomiting. Had a loss of conciousness for about 3 hours. Pt is stable now in the hospital.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Loss of consciousness
Clinical narrative: Patient complained of Headache, there was no vomiting. Had a loss of conciousness for about 3 hours. Pt is stable now in the hospital.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Blood test, Chills, Computerised tomogram head, Electrocardiogram, Electroencephalogram
Clinical narrative: Patient complained of Headache, there was no vomiting. Had a loss of conciousness for about 3 hours. Pt is stable now in the hospital.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Headache, Pyrexia, Syncope
Clinical narrative: Patient complained of Headache, there was no vomiting. Had a loss of conciousness for about 3 hours. Pt is stable now in the hospital.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Dizziness postural, Loss of consciousness, Nausea, Unresponsive to stimuli
Clinical narrative: Patient complained of Headache, there was no vomiting. Had a loss of conciousness for about 3 hours. Pt is stable now in the hospital.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Syncope & sweating. Client laid down with feet up and fan on her for about 20-30 minutes with this nurse and her mom.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Patient developed hives across chest and arms & reported to nursing at 14:00 PM. Nursing contacted MD. Benadryl 25mg orally was ordered and administered @ 14:09 PM.  No further symptoms reported or noted. Symptoms resolved in approximately 3 hours.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Panic attack, Vaccine positive rechallenge
Clinical narrative: Within a week of the shot and extending for a month patient developed panic attacks.  Occurred with all three doses of Gardasil vaccine.
Age: 1.13
Sex: M
Vaccine: PNC13
Symptoms: Cough, Hypersensitivity, Insomnia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Between his first and second birthday my son developed allergies. He was and still is often congested. He suffers from constant runny nose, sneezing, coughing, and has trouble sleeping at night due to his coughing.
Age: 1.13
Sex: M
Vaccine: PNC13
Symptoms: Sneezing
Clinical narrative: Between his first and second birthday my son developed allergies. He was and still is often congested. He suffers from constant runny nose, sneezing, coughing, and has trouble sleeping at night due to his coughing.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Head injury, Headache, Loss of consciousness
Clinical narrative: Patient passed out about 2 minutes after receiving shot and hit head on floor.  He woke up a few seconds later and was helped back to bench and stayed there until he felt better.  Patient did not want anyone to drive him home.  He stayed at pharamcy for about 30 minutes until leaving.  We had given him water and icebag when he was on bench.  He said he had passed out before after getting a shot.  I called him when he got home and he said he felt a little weak and had headache.  I told him not to take nap for at least 4 hours, and to call doctor tomorrow if he still felt bad.  I am going to call tomorrow to check on him.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site hypersensitivity, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Patient had 104 degree fever F, swelling on injection site, rash, sensitive to touch.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria pruritus
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 3 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age. The nurse noted, that she heard from other health care professionals, that on multiple unspecified dates the patients were vaccinated with GARDASIL (batch #; lot #, dose and route of administration were not reported) on an administration schedule outside of the labeled administration schedule. There was no adverse event reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age. The nurse noted, that she heard from other health care professionals, that on multiple unspecified dates the patients were vaccinated with GARDASIL 9 (batch #; lot #, dose and route of administration were not reported) on an administration schedule outside of the labeled administration schedule. There was no adverse event reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Injection site pruritus, Injection site swelling
Clinical narrative: Red raised itchy area at injection site. On 2/16 ER provider diagnoses cellulitis and gave a course of CEFTIN. Patient seen again in ER on 2/22 for unrelated condition and reaction had almost completely resolved. Cefuroxime 250 mg bid.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner (N.P.) refers to an unknown number of patients of unknown age and gender. Medical history and drug allergies were not reported. On 23-JUL-2015, the patients were inadvertently vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L000453, expiration date 06-JAN-2017, dose and frequency were not reported). Concomitant medication was not provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Pain, Swelling, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with GARDASIL (dose, route of administration and lot number were not reported). There were no concomitant therapies reported. On an unknown dates the patients experienced localized redness, swelling and pain after receiving GARDASIL. The physician reported that the patients also felt lightheaded and had fainted in the office. According to the physician, these adverse events seemed to happen to the most of the patients who had been vaccinated with GARDASIL. Outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 19-JUN-2015, the patient was inadvertently administered with improperly stored MMR II vaccine, lot # K002816, expire date: 25-FEB-2016 (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history or concurrent condition was not provided. On 17-JUN-2015, the patient received a dose of improperly stored MMR II 0.5 ml, (lot # J014876, expiration date 21-NOV-2015, therapy type rHA (recombinant human albumin)) subcutaneously. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history or concurrent condition was not provided. On 16-JUN-2015, the patient received a dose of improperly stored M-M-R II 0.5 ml, (lot # J014876, expiration date 21-NOV-2015, therapy type rHA subcutaneously. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from an office manager via a company representative referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 24-JUN-2014, 04-NOV-2014 and 02-JAN-2015, the patient was vaccinated with the first, second and third dose of GARDASIL (strength, dose, route, lot# and expiration date unknown) separately. The 3rd dose was too early. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. On 20-JUL-2015 the patient was vaccinated with an expired dose of MMR II (lot # reported as J000534, expiration date 12-JUL-2015, dose and route of administration not specified). Lot # reported as J000534 has been verified to be not valid for MMR II. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On an unknown dates (reported as "over the past year"), unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency, lot#, expiration date, route of administration and indication were not reported). No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a consumer and refers to her 68 years old husband with high blood pressure. Concomitant therapies included blood pressure medicine. There were no known drug allergies. On 30-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot #, dose and frequency not specified) subcutaneously. On 17-JUL-2015 the patient began to experience pain and on 19-JUL-2015 developed shingles rash. The reporter stated that the rash was on the chest wall under the arms, across the back and ended at the spine. The shingles was treated with an unspecified antiviral, prednisone and unspecified pain medication. The rash stopped spreading as of 23-JUL-2015. The patient sought medical attention by calling the doctor's office. There were no laboratory tests performed. The outcome of the event was reported as not recovered/not resolved, also reported as the patient was doing slightly better. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 30.0
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 30-year-old patient of unknown gender. No information about patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unknown dates (reported as "on unspecified dates in the past"), the patient was vaccinated with an unspecified number of doses of M-M-R II (strength, dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient had low titers for M-M-R. The outcome of low titers for M-M-R was unknown. The relatedness between M-M-R II and the event was not reported. 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 licensed practical nurse refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since 07-MAY-2015, the patients were vaccinated with doses of VARIVAX, lot number K016129, expiration date 23-SEP-2016 and lot number L002870, expiration date 27-JAN-2017, (dose, route of administration and injection site were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since 07-MAY-2015, the patients were vaccinated with doses of PROQUAD (Merck), lot number reported as K025764, expiration date 08-JUN-2016, (dose, route of administration and injection site were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.