chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood culture, CSF culture, Cellulitis, Gram stain negative, Incisional drainage
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to a 25 years old female patient. The patient had no medical history and no drug allergies. On 07-DEC-2012 the patient was vaccinated with the second dose of 0.5 ml PNEUMOVAX 23 (lot#672962/0025AE, expired date 18-OCT-2013) for low titers to strep/pneumo. No other co-suspects were reported. Concomitant medications included DULERA, ZETONNA and finished a ZITHROMAX (reported as ZPAK) on 06-DEC-2012. Nurse mentioned a patient was diagnosed with Compartment Syndrome after vaccination. The patient experienced a reaction at the injection site of redness and tenderness the same days as vaccination and then the next day on 08-DEC-2012 the reaction got larger, painful and red streaking. The patient went to an unspecified hospital on 08-DEC-2012 around 11am-12am and then had surgery on 09-DEC-2012 of the affected area. The patient was also treated with unspecified antibiotics. The patient had a test for the specific type of infection and the results were unknown. Nurse did not know what other tests were done at the hospital. The patient previously had PNEUMOVAX 23 in 2005 with no problems. Nurse wanted a lot check for lot number 0025AE, expired date 18-AUG-2013. At the time of report the outcome was unknown. This is one of 6 reports from the same source (other case IDs 1212USA005320, 1212USA005321, 1212USA005322, 1212USA005323, 1212USA005324). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling, Muscle oedema
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to a 25 years old female patient. The patient had no medical history and no drug allergies. On 07-DEC-2012 the patient was vaccinated with the second dose of 0.5 ml PNEUMOVAX 23 (lot#672962/0025AE, expired date 18-OCT-2013) for low titers to strep/pneumo. No other co-suspects were reported. Concomitant medications included DULERA, ZETONNA and finished a ZITHROMAX (reported as ZPAK) on 06-DEC-2012. Nurse mentioned a patient was diagnosed with Compartment Syndrome after vaccination. The patient experienced a reaction at the injection site of redness and tenderness the same days as vaccination and then the next day on 08-DEC-2012 the reaction got larger, painful and red streaking. The patient went to an unspecified hospital on 08-DEC-2012 around 11am-12am and then had surgery on 09-DEC-2012 of the affected area. The patient was also treated with unspecified antibiotics. The patient had a test for the specific type of infection and the results were unknown. Nurse did not know what other tests were done at the hospital. The patient previously had PNEUMOVAX 23 in 2005 with no problems. Nurse wanted a lot check for lot number 0025AE, expired date 18-AUG-2013. At the time of report the outcome was unknown. This is one of 6 reports from the same source (other case IDs 1212USA005320, 1212USA005321, 1212USA005322, 1212USA005323, 1212USA005324). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Nuclear magnetic resonance imaging abnormal, Purulent discharge, Pyrexia, White blood cell count increased
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to a 25 years old female patient. The patient had no medical history and no drug allergies. On 07-DEC-2012 the patient was vaccinated with the second dose of 0.5 ml PNEUMOVAX 23 (lot#672962/0025AE, expired date 18-OCT-2013) for low titers to strep/pneumo. No other co-suspects were reported. Concomitant medications included DULERA, ZETONNA and finished a ZITHROMAX (reported as ZPAK) on 06-DEC-2012. Nurse mentioned a patient was diagnosed with Compartment Syndrome after vaccination. The patient experienced a reaction at the injection site of redness and tenderness the same days as vaccination and then the next day on 08-DEC-2012 the reaction got larger, painful and red streaking. The patient went to an unspecified hospital on 08-DEC-2012 around 11am-12am and then had surgery on 09-DEC-2012 of the affected area. The patient was also treated with unspecified antibiotics. The patient had a test for the specific type of infection and the results were unknown. Nurse did not know what other tests were done at the hospital. The patient previously had PNEUMOVAX 23 in 2005 with no problems. Nurse wanted a lot check for lot number 0025AE, expired date 18-AUG-2013. At the time of report the outcome was unknown. This is one of 6 reports from the same source (other case IDs 1212USA005320, 1212USA005321, 1212USA005322, 1212USA005323, 1212USA005324). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Compartment syndrome, Injection site erythema, Injection site pain, Injection site streaking, Laboratory test
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to a 25 years old female patient. The patient had no medical history and no drug allergies. On 07-DEC-2012 the patient was vaccinated with the second dose of 0.5 ml PNEUMOVAX 23 (lot#672962/0025AE, expired date 18-OCT-2013) for low titers to strep/pneumo. No other co-suspects were reported. Concomitant medications included DULERA, ZETONNA and finished a ZITHROMAX (reported as ZPAK) on 06-DEC-2012. Nurse mentioned a patient was diagnosed with Compartment Syndrome after vaccination. The patient experienced a reaction at the injection site of redness and tenderness the same days as vaccination and then the next day on 08-DEC-2012 the reaction got larger, painful and red streaking. The patient went to an unspecified hospital on 08-DEC-2012 around 11am-12am and then had surgery on 09-DEC-2012 of the affected area. The patient was also treated with unspecified antibiotics. The patient had a test for the specific type of infection and the results were unknown. Nurse did not know what other tests were done at the hospital. The patient previously had PNEUMOVAX 23 in 2005 with no problems. Nurse wanted a lot check for lot number 0025AE, expired date 18-AUG-2013. At the time of report the outcome was unknown. This is one of 6 reports from the same source (other case IDs 1212USA005320, 1212USA005321, 1212USA005322, 1212USA005323, 1212USA005324). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Surgery
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to a 25 years old female patient. The patient had no medical history and no drug allergies. On 07-DEC-2012 the patient was vaccinated with the second dose of 0.5 ml PNEUMOVAX 23 (lot#672962/0025AE, expired date 18-OCT-2013) for low titers to strep/pneumo. No other co-suspects were reported. Concomitant medications included DULERA, ZETONNA and finished a ZITHROMAX (reported as ZPAK) on 06-DEC-2012. Nurse mentioned a patient was diagnosed with Compartment Syndrome after vaccination. The patient experienced a reaction at the injection site of redness and tenderness the same days as vaccination and then the next day on 08-DEC-2012 the reaction got larger, painful and red streaking. The patient went to an unspecified hospital on 08-DEC-2012 around 11am-12am and then had surgery on 09-DEC-2012 of the affected area. The patient was also treated with unspecified antibiotics. The patient had a test for the specific type of infection and the results were unknown. Nurse did not know what other tests were done at the hospital. The patient previously had PNEUMOVAX 23 in 2005 with no problems. Nurse wanted a lot check for lot number 0025AE, expired date 18-AUG-2013. At the time of report the outcome was unknown. This is one of 6 reports from the same source (other case IDs 1212USA005320, 1212USA005321, 1212USA005322, 1212USA005323, 1212USA005324). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Culture wound, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to a 25 years old female patient. The patient had no medical history and no drug allergies. On 07-DEC-2012 the patient was vaccinated with the second dose of 0.5 ml PNEUMOVAX 23 (lot#672962/0025AE, expired date 18-OCT-2013) for low titers to strep/pneumo. No other co-suspects were reported. Concomitant medications included DULERA, ZETONNA and finished a ZITHROMAX (reported as ZPAK) on 06-DEC-2012. Nurse mentioned a patient was diagnosed with Compartment Syndrome after vaccination. The patient experienced a reaction at the injection site of redness and tenderness the same days as vaccination and then the next day on 08-DEC-2012 the reaction got larger, painful and red streaking. The patient went to an unspecified hospital on 08-DEC-2012 around 11am-12am and then had surgery on 09-DEC-2012 of the affected area. The patient was also treated with unspecified antibiotics. The patient had a test for the specific type of infection and the results were unknown. Nurse did not know what other tests were done at the hospital. The patient previously had PNEUMOVAX 23 in 2005 with no problems. Nurse wanted a lot check for lot number 0025AE, expired date 18-AUG-2013. At the time of report the outcome was unknown. This is one of 6 reports from the same source (other case IDs 1212USA005320, 1212USA005321, 1212USA005322, 1212USA005323, 1212USA005324). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Surgery, Ultrasound scan
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to a 25 years old female patient. The patient had no medical history and no drug allergies. On 07-DEC-2012 the patient was vaccinated with the second dose of 0.5 ml PNEUMOVAX 23 (lot#672962/0025AE, expired date 18-OCT-2013) for low titers to strep/pneumo. No other co-suspects were reported. Concomitant medications included DULERA, ZETONNA and finished a ZITHROMAX (reported as ZPAK) on 06-DEC-2012. Nurse mentioned a patient was diagnosed with Compartment Syndrome after vaccination. The patient experienced a reaction at the injection site of redness and tenderness the same days as vaccination and then the next day on 08-DEC-2012 the reaction got larger, painful and red streaking. The patient went to an unspecified hospital on 08-DEC-2012 around 11am-12am and then had surgery on 09-DEC-2012 of the affected area. The patient was also treated with unspecified antibiotics. The patient had a test for the specific type of infection and the results were unknown. Nurse did not know what other tests were done at the hospital. The patient previously had PNEUMOVAX 23 in 2005 with no problems. Nurse wanted a lot check for lot number 0025AE, expired date 18-AUG-2013. At the time of report the outcome was unknown. This is one of 6 reports from the same source (other case IDs 1212USA005320, 1212USA005321, 1212USA005322, 1212USA005323, 1212USA005324). Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, heat, swelling.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Lymph node pain
Clinical narrative: PAINFUL LYMPH NODES IN GROIN, ESPECIALLY ON THE RIGHT SIDE.  INJECTION GIVEN ON RIGHT SIDE, FATIGUE.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Throat tightness, Wheezing
Clinical narrative: Throat closed, severe wheezing, loss of voice.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Death, Malignant neoplasm progression, Neuroendocrine carcinoma of the skin
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an approximately 68 years old female patient with lupus and merkel cell carcinoma. About 3 months ago (reported on 12-DEC-2012)(September 2012) the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number and route were not reported) at an unspecified pharmacy in an unspecified location. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient was given the vaccine even though he had both lupus and merkel cell carcinoma. The nurse reported that after the vaccination, over the following 2 months, the cancer progressed more aggressively (death, medically significant, life threatening and hospitalization). On an unknown date the patient sought medical attention. The patient was admitted to the hospital (date not provided) and died while in the hospital. The patient died about a month ago. (November 2012) and the cause of death was reported as cancer. The patient's doctor at the hospital told the patient's family that he believed that the cancer's progression was caused by ZOSTAVAX. Discrepant information reported in Source Document: patient is referred to as 'female' in the patient section of the report, but referred to as 'he' in Narrative. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On 23-OCT-2012, the patient was vaccinated with a dose of GARDASIL (lot # 0420AE and expiry date was 02-NOV-2014, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of the several reports received from the same reporter (MARRS # 1212USA000913, 1212USA000914, 1212USA003709, 1212USA003711, 1212USA003712, 1212USA003713, 1212USA003714 and 1212USA004285). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On an unspecified date, the patient was vaccinated with GARDASIL (lot number, expiry date, route and dose were not reported) that was exposed to 25 degree  Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter (MARRS#1212USA000913, 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003712, 1212USA003713, 1212USA003714). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site abscess sterile, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Patient developed a lump on left shoulder where vaccine was administered. (+) tender. Suspect sterile abscess, put has "soft" center with ring around it that is firm.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chills, Erythema
Clinical narrative: Chills, redness on neck & chest BP 210/115.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Erythema
Clinical narrative: Has area of redness 8.3 cm x 4.8 cm.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Pain, Rheumatoid arthritis
Clinical narrative: Is it possible the shingles vaccine could trigger an autoimmune problem in the form of rheumatoid arthritis?  My shot was on Oct 1, 2012 and within a week I was in great pain. Following blood work, I have been diagnosed with rheumatoid arthritis. Please check out and get back to me.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain, Rotator cuff syndrome
Clinical narrative: Received vaccine administered high up on shoulder. Shoulder pain with arm movement. Began shortly after. After seeing several doctors and taking medication for pain condition developed and diagnosed as torn shoulder cuff tendon. I think vaccination contributed to this condition.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness at site - increasing in size, warm to touch, itching. Tx: KEFLEX 500mg BID x 10d. Prednisone 20 mg BID x 5d. ZYRTEC 10 mg.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Malaise, Pain
Clinical narrative: Localized redness  / swelling / soreness. General feeling of being sick.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pharyngeal oedema
Clinical narrative: Patient thinks she had a reaction to the flu shot. Had nausea and throat started to swell within about 3 hours from having shot. Was out to dinner when it happened. Pt was fine within a few hours. Pt allergic to thimersal but HD is preservative free without thimersal. Pt thought that was what caused reaction.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haematoma, Muscle tightness, Sensory disturbance
Clinical narrative: Had immediate "funny feeling" down her arm. Two days later she noticed a lg. bruise at the site & muscle tightness up to her neck. She saw her physician she was given FLEXERIL & MOTRIN. If no improvement, possible PT.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus generalised
Clinical narrative: At more than 24 hrs after the injection (11/30 evening) pt. started to itch all over (moderate), then the next morning (12/1) the itching got worse and her lips started to swell. She went to her Dr. on 12/3 & got a steroid shot & prednisone 10mg pack. Pt. never had a reaction to flu vaccine in the past.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt called on call Dr 11/30/12 and 12/1/12 c/o hives she believes from flu shot 11/30/12. Rx BENADRYL & CLARITIN on 12/1/12 3rd call sx worse. Sent to ED. Pt was put on Prednisone. 12-5-12 Sx persisted. Appt. Dx urticaria Rx Prednisone 40 mg daily. Seen by FNP.
Age: 78.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Awoke with numbness in face, tongue, gums & palate, on right side, plus tingling and numbness in fingers & toes, right side. The face & digits are now normal, but tongue, face, gums & palate remain affected.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient present with swelling, erythema, redness at ZOSTAVAX injection site 72 hours after administration, possible cellulitis like reaction, referred to primary care MD, given Rx for antibiotic.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: 11-27-12 - Developed rash 2 days post vaccination also c/o fever at that time - rash worsened covering trunk, arms, legs, back - seen in E.R. 12-6-12 - acute urticaria trunk & arms not hands or feet.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Initial site red and raised - then continued to entire arm swollen, MD told her to take BENADRYL.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: Cough, fever, chills for about 24 hours then pt was fine, started a few hours after administration.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Musculoskeletal pain, Pain in extremity, Polymyalgia rheumatica, Red blood cell sedimentation rate
Clinical narrative: Within 2 days developed severe pains in upper arms and frontal shoulder. Within 1 week was diagnosed with polymyalgia rheumatica (PMR).
Age: 1.27
Sex: M
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Activities of daily living impaired, Aggression, Emotional distress, Poor quality sleep, Pyrexia
Clinical narrative: Patient received vaccines (MMR, VZV, DTaP, Flu) and then had fever x3 days. He has also been "not himself". He's having tantrums all day long and even daycare sent him home due to tantrums. He's difficult to console. He's not sleeping well at night. No regression in language or other milestones.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Head injury, Heart rate decreased, Loss of consciousness, Mental status changes
Clinical narrative: Client had syncopal episode upon leaving vaccine admin area, hit head, regained consciousness. Positive change in mental status, inability to hold up head, answer questions. HR 50, BP 80/40. Paramedics called. No change in status in 10 minutes before they arrived.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Posture abnormal, Presyncope, Syncope
Clinical narrative: Client had syncopal episode upon leaving vaccine admin area, hit head, regained consciousness. Positive change in mental status, inability to hold up head, answer questions. HR 50, BP 80/40. Paramedics called. No change in status in 10 minutes before they arrived.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, CSF cell count
Clinical narrative: This medically confirmed report (initial receipt 30-Nov-2012) concerns a 31-year-old female patient. The patient was enrolled in a randomized controlled clinical trial. The patient had a medical history of frequent infections over the last year. She experienced impetigo a year ago and 2 episodes of methicillin-resistant staphylococcus aureus (MRSA) abscesses. She also had a B12 deficiency. on 24-Oct-2012, the patient received CSL influenza (batch number not specified). On 16-Nov-2012 (3 weeks and 3 days following vaccination) the patient presented to the emergency department (ED) with a severe headache. It was a preliminary case of viral meningitis. Spinal fluid revealed clear, colorless fluid. Total white cells were 33 in the 1st tube count and 39 in the 2nd. Percent lymphocytes were 88% in the 1st tube and 96% in the 2nd. Cerebrospinal fluid (CSF) ependymal cells were seen in both tubes, 6 in the 1st and 2 in the 2nd. CSF glucose was 47, peripheral glucose was 94 and CSF total protein was 89. It was felt that this was consistent with aseptic meningitis as the patient had a total white count in the periphery of 4.5, hemoglobin of 15, hematocrit of 43, platelet count of 209 with 60 segs, 28 lymphs and 7 monos on dip. The patient was admitted and placed on a broad spectrum of antibiotics to treat bacterial meningitis and acyclovir. Immunoglobulin (Ig) levels revealed IgG as 629 and IgM was 52 both only slightly low and IgA as 120 which was normal. The patient had a deficiency which would benefit from immunology consultation. The patient's mean cell volume (MCV) level was elevated at 101-103. A nasopharyngeal swab was negative for influenza A and B. Brain CT on 16-Nov-2012 questioned a mildly bulbous appearance of the anterior communicating artery. A small aneurysm could not be excluded. A final CSF culture was negative for bacterial meningitis. Her intravenous (IV) antibiotics were stopped per the direction of infectious diseases (ID) the day before discharge. The patient was feeling much better and after discussion with ID acyclovir was stopped. On 20-Nov-2012 she was discharged, at this time all viral studies were pending. Discharge medications included ondansetron 4mg orally (po) every 6 hours as needed (prn) for nausea and vomiting, PERCOCET 5/325 one to two po every 4 hours prn for pain, DIFLUCAN 150mg po x 1 prn for vaginal candidiasis, sennosides plus docusate 2 tablets po twice a day (bid) if taking narcotics, TORADOL 10 mg po every 4-6 hours prn for pain, and acetaminophen 325-650mg po every 6 hours for pain. The subject completed her diary card and reported minimal local symptoms and no general symptoms. The subject fully recovered and completed participation in the study.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: CSF culture negative, CSF glucose decreased, CSF lymphocyte count increased, CSF protein increased, CSF test normal
Clinical narrative: This medically confirmed report (initial receipt 30-Nov-2012) concerns a 31-year-old female patient. The patient was enrolled in a randomized controlled clinical trial. The patient had a medical history of frequent infections over the last year. She experienced impetigo a year ago and 2 episodes of methicillin-resistant staphylococcus aureus (MRSA) abscesses. She also had a B12 deficiency. on 24-Oct-2012, the patient received CSL influenza (batch number not specified). On 16-Nov-2012 (3 weeks and 3 days following vaccination) the patient presented to the emergency department (ED) with a severe headache. It was a preliminary case of viral meningitis. Spinal fluid revealed clear, colorless fluid. Total white cells were 33 in the 1st tube count and 39 in the 2nd. Percent lymphocytes were 88% in the 1st tube and 96% in the 2nd. Cerebrospinal fluid (CSF) ependymal cells were seen in both tubes, 6 in the 1st and 2 in the 2nd. CSF glucose was 47, peripheral glucose was 94 and CSF total protein was 89. It was felt that this was consistent with aseptic meningitis as the patient had a total white count in the periphery of 4.5, hemoglobin of 15, hematocrit of 43, platelet count of 209 with 60 segs, 28 lymphs and 7 monos on dip. The patient was admitted and placed on a broad spectrum of antibiotics to treat bacterial meningitis and acyclovir. Immunoglobulin (Ig) levels revealed IgG as 629 and IgM was 52 both only slightly low and IgA as 120 which was normal. The patient had a deficiency which would benefit from immunology consultation. The patient's mean cell volume (MCV) level was elevated at 101-103. A nasopharyngeal swab was negative for influenza A and B. Brain CT on 16-Nov-2012 questioned a mildly bulbous appearance of the anterior communicating artery. A small aneurysm could not be excluded. A final CSF culture was negative for bacterial meningitis. Her intravenous (IV) antibiotics were stopped per the direction of infectious diseases (ID) the day before discharge. The patient was feeling much better and after discussion with ID acyclovir was stopped. On 20-Nov-2012 she was discharged, at this time all viral studies were pending. Discharge medications included ondansetron 4mg orally (po) every 6 hours as needed (prn) for nausea and vomiting, PERCOCET 5/325 one to two po every 4 hours prn for pain, DIFLUCAN 150mg po x 1 prn for vaginal candidiasis, sennosides plus docusate 2 tablets po twice a day (bid) if taking narcotics, TORADOL 10 mg po every 4-6 hours prn for pain, and acetaminophen 325-650mg po every 6 hours for pain. The subject completed her diary card and reported minimal local symptoms and no general symptoms. The subject fully recovered and completed participation in the study.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: CSF white blood cell count increased, Computerised tomogram head, Computerised tomogram head normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: This medically confirmed report (initial receipt 30-Nov-2012) concerns a 31-year-old female patient. The patient was enrolled in a randomized controlled clinical trial. The patient had a medical history of frequent infections over the last year. She experienced impetigo a year ago and 2 episodes of methicillin-resistant staphylococcus aureus (MRSA) abscesses. She also had a B12 deficiency. on 24-Oct-2012, the patient received CSL influenza (batch number not specified). On 16-Nov-2012 (3 weeks and 3 days following vaccination) the patient presented to the emergency department (ED) with a severe headache. It was a preliminary case of viral meningitis. Spinal fluid revealed clear, colorless fluid. Total white cells were 33 in the 1st tube count and 39 in the 2nd. Percent lymphocytes were 88% in the 1st tube and 96% in the 2nd. Cerebrospinal fluid (CSF) ependymal cells were seen in both tubes, 6 in the 1st and 2 in the 2nd. CSF glucose was 47, peripheral glucose was 94 and CSF total protein was 89. It was felt that this was consistent with aseptic meningitis as the patient had a total white count in the periphery of 4.5, hemoglobin of 15, hematocrit of 43, platelet count of 209 with 60 segs, 28 lymphs and 7 monos on dip. The patient was admitted and placed on a broad spectrum of antibiotics to treat bacterial meningitis and acyclovir. Immunoglobulin (Ig) levels revealed IgG as 629 and IgM was 52 both only slightly low and IgA as 120 which was normal. The patient had a deficiency which would benefit from immunology consultation. The patient's mean cell volume (MCV) level was elevated at 101-103. A nasopharyngeal swab was negative for influenza A and B. Brain CT on 16-Nov-2012 questioned a mildly bulbous appearance of the anterior communicating artery. A small aneurysm could not be excluded. A final CSF culture was negative for bacterial meningitis. Her intravenous (IV) antibiotics were stopped per the direction of infectious diseases (ID) the day before discharge. The patient was feeling much better and after discussion with ID acyclovir was stopped. On 20-Nov-2012 she was discharged, at this time all viral studies were pending. Discharge medications included ondansetron 4mg orally (po) every 6 hours as needed (prn) for nausea and vomiting, PERCOCET 5/325 one to two po every 4 hours prn for pain, DIFLUCAN 150mg po x 1 prn for vaginal candidiasis, sennosides plus docusate 2 tablets po twice a day (bid) if taking narcotics, TORADOL 10 mg po every 4-6 hours prn for pain, and acetaminophen 325-650mg po every 6 hours for pain. The subject completed her diary card and reported minimal local symptoms and no general symptoms. The subject fully recovered and completed participation in the study.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Lymphocyte count
Clinical narrative: This medically confirmed report (initial receipt 30-Nov-2012) concerns a 31-year-old female patient. The patient was enrolled in a randomized controlled clinical trial. The patient had a medical history of frequent infections over the last year. She experienced impetigo a year ago and 2 episodes of methicillin-resistant staphylococcus aureus (MRSA) abscesses. She also had a B12 deficiency. on 24-Oct-2012, the patient received CSL influenza (batch number not specified). On 16-Nov-2012 (3 weeks and 3 days following vaccination) the patient presented to the emergency department (ED) with a severe headache. It was a preliminary case of viral meningitis. Spinal fluid revealed clear, colorless fluid. Total white cells were 33 in the 1st tube count and 39 in the 2nd. Percent lymphocytes were 88% in the 1st tube and 96% in the 2nd. Cerebrospinal fluid (CSF) ependymal cells were seen in both tubes, 6 in the 1st and 2 in the 2nd. CSF glucose was 47, peripheral glucose was 94 and CSF total protein was 89. It was felt that this was consistent with aseptic meningitis as the patient had a total white count in the periphery of 4.5, hemoglobin of 15, hematocrit of 43, platelet count of 209 with 60 segs, 28 lymphs and 7 monos on dip. The patient was admitted and placed on a broad spectrum of antibiotics to treat bacterial meningitis and acyclovir. Immunoglobulin (Ig) levels revealed IgG as 629 and IgM was 52 both only slightly low and IgA as 120 which was normal. The patient had a deficiency which would benefit from immunology consultation. The patient's mean cell volume (MCV) level was elevated at 101-103. A nasopharyngeal swab was negative for influenza A and B. Brain CT on 16-Nov-2012 questioned a mildly bulbous appearance of the anterior communicating artery. A small aneurysm could not be excluded. A final CSF culture was negative for bacterial meningitis. Her intravenous (IV) antibiotics were stopped per the direction of infectious diseases (ID) the day before discharge. The patient was feeling much better and after discussion with ID acyclovir was stopped. On 20-Nov-2012 she was discharged, at this time all viral studies were pending. Discharge medications included ondansetron 4mg orally (po) every 6 hours as needed (prn) for nausea and vomiting, PERCOCET 5/325 one to two po every 4 hours prn for pain, DIFLUCAN 150mg po x 1 prn for vaginal candidiasis, sennosides plus docusate 2 tablets po twice a day (bid) if taking narcotics, TORADOL 10 mg po every 4-6 hours prn for pain, and acetaminophen 325-650mg po every 6 hours for pain. The subject completed her diary card and reported minimal local symptoms and no general symptoms. The subject fully recovered and completed participation in the study.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Mean cell volume increased, Meningitis aseptic, Meningitis viral, Monocyte count, Neutrophil count
Clinical narrative: This medically confirmed report (initial receipt 30-Nov-2012) concerns a 31-year-old female patient. The patient was enrolled in a randomized controlled clinical trial. The patient had a medical history of frequent infections over the last year. She experienced impetigo a year ago and 2 episodes of methicillin-resistant staphylococcus aureus (MRSA) abscesses. She also had a B12 deficiency. on 24-Oct-2012, the patient received CSL influenza (batch number not specified). On 16-Nov-2012 (3 weeks and 3 days following vaccination) the patient presented to the emergency department (ED) with a severe headache. It was a preliminary case of viral meningitis. Spinal fluid revealed clear, colorless fluid. Total white cells were 33 in the 1st tube count and 39 in the 2nd. Percent lymphocytes were 88% in the 1st tube and 96% in the 2nd. Cerebrospinal fluid (CSF) ependymal cells were seen in both tubes, 6 in the 1st and 2 in the 2nd. CSF glucose was 47, peripheral glucose was 94 and CSF total protein was 89. It was felt that this was consistent with aseptic meningitis as the patient had a total white count in the periphery of 4.5, hemoglobin of 15, hematocrit of 43, platelet count of 209 with 60 segs, 28 lymphs and 7 monos on dip. The patient was admitted and placed on a broad spectrum of antibiotics to treat bacterial meningitis and acyclovir. Immunoglobulin (Ig) levels revealed IgG as 629 and IgM was 52 both only slightly low and IgA as 120 which was normal. The patient had a deficiency which would benefit from immunology consultation. The patient's mean cell volume (MCV) level was elevated at 101-103. A nasopharyngeal swab was negative for influenza A and B. Brain CT on 16-Nov-2012 questioned a mildly bulbous appearance of the anterior communicating artery. A small aneurysm could not be excluded. A final CSF culture was negative for bacterial meningitis. Her intravenous (IV) antibiotics were stopped per the direction of infectious diseases (ID) the day before discharge. The patient was feeling much better and after discussion with ID acyclovir was stopped. On 20-Nov-2012 she was discharged, at this time all viral studies were pending. Discharge medications included ondansetron 4mg orally (po) every 6 hours as needed (prn) for nausea and vomiting, PERCOCET 5/325 one to two po every 4 hours prn for pain, DIFLUCAN 150mg po x 1 prn for vaginal candidiasis, sennosides plus docusate 2 tablets po twice a day (bid) if taking narcotics, TORADOL 10 mg po every 4-6 hours prn for pain, and acetaminophen 325-650mg po every 6 hours for pain. The subject completed her diary card and reported minimal local symptoms and no general symptoms. The subject fully recovered and completed participation in the study.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Platelet count normal, White blood cell count decreased
Clinical narrative: This medically confirmed report (initial receipt 30-Nov-2012) concerns a 31-year-old female patient. The patient was enrolled in a randomized controlled clinical trial. The patient had a medical history of frequent infections over the last year. She experienced impetigo a year ago and 2 episodes of methicillin-resistant staphylococcus aureus (MRSA) abscesses. She also had a B12 deficiency. on 24-Oct-2012, the patient received CSL influenza (batch number not specified). On 16-Nov-2012 (3 weeks and 3 days following vaccination) the patient presented to the emergency department (ED) with a severe headache. It was a preliminary case of viral meningitis. Spinal fluid revealed clear, colorless fluid. Total white cells were 33 in the 1st tube count and 39 in the 2nd. Percent lymphocytes were 88% in the 1st tube and 96% in the 2nd. Cerebrospinal fluid (CSF) ependymal cells were seen in both tubes, 6 in the 1st and 2 in the 2nd. CSF glucose was 47, peripheral glucose was 94 and CSF total protein was 89. It was felt that this was consistent with aseptic meningitis as the patient had a total white count in the periphery of 4.5, hemoglobin of 15, hematocrit of 43, platelet count of 209 with 60 segs, 28 lymphs and 7 monos on dip. The patient was admitted and placed on a broad spectrum of antibiotics to treat bacterial meningitis and acyclovir. Immunoglobulin (Ig) levels revealed IgG as 629 and IgM was 52 both only slightly low and IgA as 120 which was normal. The patient had a deficiency which would benefit from immunology consultation. The patient's mean cell volume (MCV) level was elevated at 101-103. A nasopharyngeal swab was negative for influenza A and B. Brain CT on 16-Nov-2012 questioned a mildly bulbous appearance of the anterior communicating artery. A small aneurysm could not be excluded. A final CSF culture was negative for bacterial meningitis. Her intravenous (IV) antibiotics were stopped per the direction of infectious diseases (ID) the day before discharge. The patient was feeling much better and after discussion with ID acyclovir was stopped. On 20-Nov-2012 she was discharged, at this time all viral studies were pending. Discharge medications included ondansetron 4mg orally (po) every 6 hours as needed (prn) for nausea and vomiting, PERCOCET 5/325 one to two po every 4 hours prn for pain, DIFLUCAN 150mg po x 1 prn for vaginal candidiasis, sennosides plus docusate 2 tablets po twice a day (bid) if taking narcotics, TORADOL 10 mg po every 4-6 hours prn for pain, and acetaminophen 325-650mg po every 6 hours for pain. The subject completed her diary card and reported minimal local symptoms and no general symptoms. The subject fully recovered and completed participation in the study.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Condition aggravated, Muscular weakness, Osteoarthritis, Pain in extremity
Clinical narrative: Initial information received from a healthcare professional on 21 September 2012. A 50-year-old female patient with no reported illness at the time of vaccination and with infrequent slight twinge in both wrists had received a dose of FLUZONE (batch number unknown) intramuscularly on left deltoid on 18 September 2012. On 19 September 2012 i.e. 01 day after vaccination, the patient experienced left wrist and hand weakness and pain which got worse on 20 September 2012. The patient got slight relief using heating pad. It was reported that on 21 September 2012 the patient was improving and may see the physician for follow-up. Laboratory details were not reported. As of 21 September 2012, the patient had not recovered from the events. Follow-up information was received from a healthcare professional on 05 December 2012. Based upon the new information this case has been upgraded to serious. The lot number for FLUZONE was UH756AA. The patient was seen by an orthopedist and diagnosed with distal ulnar joint degeneration. Symptoms resolved on 28 September 2012. The diagnosis was determined by the orthopedist to not be related to the vaccine. The patient had no illness at the time of vaccination and received no other vaccines within four weeks of FLUZONE. Past medical history included hypothyroid, hypertension (HTN) and diabetes. Concomitant medications included SYNTHROID, metformin, atenolol and lisinopril. The patient received yearly influenza vaccines. Outcome was recovered. Documents held by sender: None.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Paralysis, Tremor
Clinical narrative: Initial report was received from a healthcare professional on 05 December 2012. An 82-year-old male patient had received an injection of FLUZONE High-Dose (lot number, route, site and date of administration not reported) and one day later experienced severe chills and shakes. The patient laid down on the floor, was unable to get up and needed assistance. The office directed the patient to go to the hospital but the patient did not go. The patient was unable to move for two days. The patient "was paralyzed for two days". Outcome was not reported. Documents held by sender: None.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On 31-OCT-2012, the patient was vaccinated with GARDASIL (lot number was reported as 0636AE and expiry date was 09-JAN-2015, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter (MARRS# 1212USA000913, 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003713, 1212USA003714 and 1212USA004285). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On 05-NOV-2012, the patient was vaccinated with GARDASIL (lot number was reported as 0636AE and expiry date was 09-JAN-2015, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of the several reports received from the same reporter (MARRS# 1212USA000913, 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003712, 1212USA003714 and 1212USA004285) Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On 29-OCT-2012, the patient was vaccinated with GARDASIL (lot number was reported as 0636AE and expiry date was 09-JAN-2015, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. It was unspecified if the patient had sought medical attention. This is one of the several reports received from the same reporter (MARRS # 1212USA000913, 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003712, 1212USA003713, 1212USA003714 and 1212USA004285). Additional information has been requested.
Age: 0.45
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Intestinal resection, Intussusception, Irritability, Surgery, Viral infection
Clinical narrative: Began vomiting 11/8/12. Parents took to ER. Dr. diagnosed virus. He continued to be fussy & continued to vomit. Took back to ER 11/12/12 & was X-rayed and sent by ambulance to another hospital & had surgery for intussusception that day. Remained in hospital until 11/20/12. Had 11.8 inches of bowel removed. Patient was in Health Dept. 12/13/12 and got PEDIARIX #3 and PREVNAR #3, but I held the ROTATEQ #3. He is seeing his Pediatrician next week 12/18/12. He will discuss getting ROTATEQ with his Doctor and let me know.
Age: 0.45
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting, X-ray
Clinical narrative: Began vomiting 11/8/12. Parents took to ER. Dr. diagnosed virus. He continued to be fussy & continued to vomit. Took back to ER 11/12/12 & was X-rayed and sent by ambulance to another hospital & had surgery for intussusception that day. Remained in hospital until 11/20/12. Had 11.8 inches of bowel removed. Patient was in Health Dept. 12/13/12 and got PEDIARIX #3 and PREVNAR #3, but I held the ROTATEQ #3. He is seeing his Pediatrician next week 12/18/12. He will discuss getting ROTATEQ with his Doctor and let me know.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Muscle contracture, Muscle tightness, Muscular weakness, Tenderness
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of leg tenderness in a 48-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 5 November 2012 at 10:33 the subject received 1st dose of BOOSTRIX (.5 ml, intramuscular, left arm). On 9 November 2012, 4 days after vaccination with BOOSTRIX, the subject experienced leg tenderness, muscular contracture leg ("contracting muscles in her legs"), weakness of hand and arm, tightness of muscles ("tightness in hands and arms") and activities of daily living impaired. The healthcare professional considered the events were life threatening. The reporter stated that the events were life threatening "because it's affecting the patient's daily life." At the time of reporting the events were unresolved.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Gaze palsy, Tremor
Clinical narrative: Patient was very nervous about needles & after administration of vaccine she had seizure, little shakiness & rolling of eyes. She was ok after few seconds when her mom talk to her & help her to relax.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt was given PNEUMOVAX 12-11-12; on 12/12/12 he was seen for redness, pain & localized swelling at site.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Hypotonic-hyporesponsive episode, Pyrexia
Clinical narrative: Hypotonic hyporesponsive event approx 3 1/2 h after routine 2 month vaccinations. Event happened at home witnessed by mom. Lasted seconds and was self-resolving. To ED with normal exam no recurrent events. Babe has not had DTaP since without fever.
Age: 16.0
Sex: M
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Dyskinesia, Erythema, Mydriasis, Pallor, Posture abnormal
Clinical narrative: Approx 2-3 min after injection, patient became pale, eyes dilated, slumped over, entire body jerked stiffly x1. Became very red in face, open eyes, head went back down on table - became pale again. MD & NP called into office, vital signs monitored.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure decreased, Guillain-Barre syndrome, Hypoaesthesia, Plasmapheresis, Walking aid user
Clinical narrative: Approx. 4 week after receiving ZOSTAVAX, patient developed numbness in feet that progressed up his legs to point he had to walk with walker (previously walked on own fine). Diagnosed in ER with Guillain Barre syndrome, had 5 days of plasmapheresis, admitted due to complications (drop in BP), then to rehab center for 2 1/2-3weeks. On walker expectedly for 4-10 more months.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test, Musculoskeletal pain
Clinical narrative: Approx. 4 week after receiving ZOSTAVAX, patient developed numbness in feet that progressed up his legs to point he had to walk with walker (previously walked on own fine). Diagnosed in ER with Guillain Barre syndrome, had 5 days of plasmapheresis, admitted due to complications (drop in BP), then to rehab center for 2 1/2-3weeks. On walker expectedly for 4-10 more months.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Plasmapheresis, Walking aid user, Wheelchair user
Clinical narrative: Approx. 4 week after receiving ZOSTAVAX, patient developed numbness in feet that progressed up his legs to point he had to walk with walker (previously walked on own fine). Diagnosed in ER with Guillain Barre syndrome, had 5 days of plasmapheresis, admitted due to complications (drop in BP), then to rehab center for 2 1/2-3weeks. On walker expectedly for 4-10 more months.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure.
Age: 0.76
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Vomiting, no other symptoms... after vomiting he was hungry and wanted to eat again also wanted to play, was laughing and seemed fine.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised, warm, reddened area around injection sites.
Age: 1.07
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Musculoskeletal stiffness, Skin warm, Tenderness
Clinical narrative: Stiffness, tender to touch, warm.