chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Tinnitus, Vision blurred
Clinical narrative: Increased heart rate, dizziness, low-grade fever, near fainting spell, flush cheeks, muscle pain (arm, shoulder and back), and loss of ability to focus (went home from work).  Significantly elevated tinnitus symptoms as well.
Sex: U
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Initial report was received on 20 February 2013 from a health care professional via company representative. An unidentified number of fragile or thin elderly patients (names and dates of birth not reported) had received FLUZONE HIGH-DOSE (lot number, route site and date of administration not reported) and an unspecified amount of time later "got sick", even some were hospitalized. No further information was available at the time of the report. Outcomes were not reported. Documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26 year old female patient. On 20-FEB-2012 the patient was inadvertently administered ZOSTAVAX (lot number H016230 expiration date 30-NOV-2013) 0.5ml subcutaneous, instead of VARIVAX. No adverse effect was reported. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 74 year old female patient with drug allergy to amoxicillin, clindamycin, sulfa drugs, and gentamicin. On 21-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # H020844, expiration date 10-FEB-2014 subcutaneously. Concomitant medications included blood pressure and migraine medicine. Within a couple of minutes after vaccination, the patient developed tingling in the same arm in which ZOSTAVAX was injected all the way down to her fingers, the injection site was painful and tender to the touch, and she also had a one centimeter raised red wheal that was one-by-one-and-a-half inches big. This reaction was still there the next day but was gone by 24-FEB-2013. The reaction occurred at the pharmacy. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain
Clinical narrative: This spontaneous report as received from a nurse practitioner reporting on herself via company representative, refers to a female of unknown age. In February 2013 a few days ago the patient was vaccinated with a dose of ZOSTAVAX, 1 injection (lot # and route not reported). The morning after vaccination (in February 2013), the patient experienced pain across her body down to her legs. No treatment was given for the patient's events. The outcome of pain across her body down to her legs and in her joints was reported as recovered/resolved (date unspecified). The patient did not seek medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a consumer who is the patient mother refers to a female patient of unknown age. The patient mother explained that her daughter received her first dose of GARDASIL (lot # not reported) in August of 2011, she stated that her daughter second dose of GARDASIL was given in October of 2011. The patient has not received the third dose at this time, and the family was debating on completing the series. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: TYP
Symptoms: Disorientation, Mania, Mental disorder, Paranoia
Clinical narrative: This case was forwarded by Crucell no.: CVAE-041-2012. An initial report was received from a nurse on 01.Nov.2012 and concerns a 39-year-old female patient, who on 23.Oct.2012, received an oral administration of VIVOTIF (batch no.: not available). The patient's medical history was not provided. Concomitant medications included VOMEX, metoprolol, SEROQUEL, potassium, LAMICTAL and KEPPRA. On an unspecified date, after taking all four VIVOTIF capsules as prescribed, the patient experienced maniac, craziness, disorientation and paranoia. She contacted her primary doctor and an appointment was booked for the following week. She did not have the packing, hence could not provide the lot number. At the time of reporting, the event was ongoing. The events were considered serious (medically important).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin exfoliation, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient who did not have pertinent medical history, drug reactions or allergies. On 05-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot # H019998; exp 20-FEB-2014), subcutaneous for shingles prevention (dose not provided). No concomitant medication was reported. On 06-FEB-2013, the patient developed "redness, heat and swelling the size of a grapefruit from her shoulder down to her elbow, 1 to 2 days after administration of ZOSTAVAX. The patient's unspecified physician treated the reaction with ZYRTEC. It was reported that the patient's arm was "getting better" but that it was now "peeling and flaky". Laboratories were not performed. At the time of the report, the outcome of redness, heat and swelling was reported as recovering/resolving. The outcome of peeling and flaky is unknown. The events of redness, heat and swelling, peeling and flaky was unknown related to ZOSTAVAX. Additional information has been requested.
Age: 1.16
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Rubella, Viral rash
Clinical narrative: Viral exanthema NOS on 2013-02-18, clinician comment: Likely Rubella symptoms following MMR.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Drug administration error, Injection site reaction, Musculoskeletal stiffness, Periarthritis
Clinical narrative: Localized stiffness at injection site never went completely away.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pt called clinic on 2/28/13 reporting painful swollen R arm. I got 3 shots on 2/26/2013. Advised warm/cold compresses and Tylenol/and or Advil.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt experienced pain & swelling & erythema below injection site.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Full blood count normal, Headache, Influenza virus test negative
Clinical narrative: Fever, chills, myalgias, headache, fatigue, neck pain, and right arm pain.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, myalgias, headache, fatigue, neck pain, and right arm pain.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Feeling hot
Clinical narrative: I began to have fatigue/ was very sleepy the evening I got the Tdap vaccine. By at least 2/10/13 I had an elevated temperature (I didn't take my temperature right away), and a fever through 2/14/13 (at highest, 102.1). At my doctor's direction I took Tylenol to reduce the fever.  I had severe chills and times when I was very hot/sweaty.  I had a rash from my chest down from about 2/12/13 until 2/18/13, which my dermatologist stated was very likely from the vaccine.  For several days I had very achy joints (it was hard to walk at one point) and neck pain and headaches.  I did not have any cold/respiratory symptoms or stomach symptoms.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hyperhidrosis, Neck pain, Pyrexia, Rash
Clinical narrative: I began to have fatigue/ was very sleepy the evening I got the Tdap vaccine. By at least 2/10/13 I had an elevated temperature (I didn't take my temperature right away), and a fever through 2/14/13 (at highest, 102.1). At my doctor's direction I took Tylenol to reduce the fever.  I had severe chills and times when I was very hot/sweaty.  I had a rash from my chest down from about 2/12/13 until 2/18/13, which my dermatologist stated was very likely from the vaccine.  For several days I had very achy joints (it was hard to walk at one point) and neck pain and headaches.  I did not have any cold/respiratory symptoms or stomach symptoms.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Somnolence
Clinical narrative: I began to have fatigue/ was very sleepy the evening I got the Tdap vaccine. By at least 2/10/13 I had an elevated temperature (I didn't take my temperature right away), and a fever through 2/14/13 (at highest, 102.1). At my doctor's direction I took Tylenol to reduce the fever.  I had severe chills and times when I was very hot/sweaty.  I had a rash from my chest down from about 2/12/13 until 2/18/13, which my dermatologist stated was very likely from the vaccine.  For several days I had very achy joints (it was hard to walk at one point) and neck pain and headaches.  I did not have any cold/respiratory symptoms or stomach symptoms.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, OPV, PPV, RVX
Symptoms: Crying, Dyspnoea, Pyrexia, Respiratory rate increased, Screaming
Clinical narrative: Non-stop high screaming and crying, Breathing at very fast pace, nervous type body tic about every 3-4 seconds, gasping for air, 101 fever (on infant tylenol). Called ER spoke to nurse and then Dr., told to stay home watch him and call or come in if symptoms got worse or if he turned blue or gray.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, OPV, PPV, RVX
Symptoms: Tic
Clinical narrative: Non-stop high screaming and crying, Breathing at very fast pace, nervous type body tic about every 3-4 seconds, gasping for air, 101 fever (on infant tylenol). Called ER spoke to nurse and then Dr., told to stay home watch him and call or come in if symptoms got worse or if he turned blue or gray.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Headache, Hyperhidrosis, Insomnia, Lymphadenopathy
Clinical narrative: Throat closing, sweating, insomnia, headache, wheezing. 12/13/12 swollen lymph nodes. 2/12/13 Eczema.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness, Wheezing
Clinical narrative: Throat closing, sweating, insomnia, headache, wheezing. 12/13/12 swollen lymph nodes. 2/12/13 Eczema.
Age: 12.0
Sex: F
Vaccine: IPV, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hypotonia, Incontinence, Nausea, Pallor
Clinical narrative: Became pale, light headed, closed eyes and became limp. Aroused immediately, by calling name and tapping cheek. While this was being done, she urinated onto chair and floor. Once aroused, became aware of surroundings. Became nauseated and threw up twice. Father was present through entire incident. B/P was 112/60. She was kept with the nurse for another 20 minutes, took sips of water, ate a sucker. She did mention that she had not eaten since the day before. She left the office ambulating independently, talking to father. I contacted dad at 5:05 pm. States she took a nap after eating and appeared to be fine.
Age: 12.0
Sex: F
Vaccine: IPV, MNQ, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Became pale, light headed, closed eyes and became limp. Aroused immediately, by calling name and tapping cheek. While this was being done, she urinated onto chair and floor. Once aroused, became aware of surroundings. Became nauseated and threw up twice. Father was present through entire incident. B/P was 112/60. She was kept with the nurse for another 20 minutes, took sips of water, ate a sucker. She did mention that she had not eaten since the day before. She left the office ambulating independently, talking to father. I contacted dad at 5:05 pm. States she took a nap after eating and appeared to be fine.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: High fever followed by a rash.
Age: 1.03
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Abasia, Blood test abnormal, C-reactive protein, Cyanosis, Dysstasia
Clinical narrative: My daughter came home from daycare and went to sleep at 6:30 p.m. on February 13, 2013.  She woke early a.m. on February 14, 2013 with a low fever (99.8).  She came home from daycare that day (Feb. 14) and again went to sleep really early (7:00 p.m.).  She woke early a.m. on February 15, 2013, with a fever of 102.5.  By 2:30 p.m. on February 15, 2013, her fever was 103.3.  By 3:30 p.m., she had a rash.  By 9:30 p.m., her hands and feet were swollen & blue and she was unable to stand, walk or use her hands and her rash was worse.  ED trip & bloodwork revealed elevated SED Rate of 34.  Was seen in ED on Friday, February 15, 2013; seen again in ED at Saturday, February 16, 2013; admitted via direct admit to Medical Center on Sunday, February 17, 2013 & released on February 18, 2013.  Seen by pediatrician on Feb. 19 & Feb. 21 & Feb. 25.  On February 25, 2013 she was sent for direct admit at another hospital for IVIG infusion and additional treatment of Kawasaki disease.
Age: 1.03
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Immunoglobulin therapy, Kawasaki's disease, Laboratory test abnormal
Clinical narrative: My daughter came home from daycare and went to sleep at 6:30 p.m. on February 13, 2013.  She woke early a.m. on February 14, 2013 with a low fever (99.8).  She came home from daycare that day (Feb. 14) and again went to sleep really early (7:00 p.m.).  She woke early a.m. on February 15, 2013, with a fever of 102.5.  By 2:30 p.m. on February 15, 2013, her fever was 103.3.  By 3:30 p.m., she had a rash.  By 9:30 p.m., her hands and feet were swollen & blue and she was unable to stand, walk or use her hands and her rash was worse.  ED trip & bloodwork revealed elevated SED Rate of 34.  Was seen in ED on Friday, February 15, 2013; seen again in ED at Saturday, February 16, 2013; admitted via direct admit to Medical Center on Sunday, February 17, 2013 & released on February 18, 2013.  Seen by pediatrician on Feb. 19 & Feb. 21 & Feb. 25.  On February 25, 2013 she was sent for direct admit at another hospital for IVIG infusion and additional treatment of Kawasaki disease.
Age: 1.03
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Oedema peripheral, Oedema peripheral, Platelet count increased, Pyrexia, Rash
Clinical narrative: My daughter came home from daycare and went to sleep at 6:30 p.m. on February 13, 2013.  She woke early a.m. on February 14, 2013 with a low fever (99.8).  She came home from daycare that day (Feb. 14) and again went to sleep really early (7:00 p.m.).  She woke early a.m. on February 15, 2013, with a fever of 102.5.  By 2:30 p.m. on February 15, 2013, her fever was 103.3.  By 3:30 p.m., she had a rash.  By 9:30 p.m., her hands and feet were swollen & blue and she was unable to stand, walk or use her hands and her rash was worse.  ED trip & bloodwork revealed elevated SED Rate of 34.  Was seen in ED on Friday, February 15, 2013; seen again in ED at Saturday, February 16, 2013; admitted via direct admit to Medical Center on Sunday, February 17, 2013 & released on February 18, 2013.  Seen by pediatrician on Feb. 19 & Feb. 21 & Feb. 25.  On February 25, 2013 she was sent for direct admit at another hospital for IVIG infusion and additional treatment of Kawasaki disease.
Age: 1.03
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Red blood cell sedimentation rate increased, Somnolence
Clinical narrative: My daughter came home from daycare and went to sleep at 6:30 p.m. on February 13, 2013.  She woke early a.m. on February 14, 2013 with a low fever (99.8).  She came home from daycare that day (Feb. 14) and again went to sleep really early (7:00 p.m.).  She woke early a.m. on February 15, 2013, with a fever of 102.5.  By 2:30 p.m. on February 15, 2013, her fever was 103.3.  By 3:30 p.m., she had a rash.  By 9:30 p.m., her hands and feet were swollen & blue and she was unable to stand, walk or use her hands and her rash was worse.  ED trip & bloodwork revealed elevated SED Rate of 34.  Was seen in ED on Friday, February 15, 2013; seen again in ED at Saturday, February 16, 2013; admitted via direct admit to Medical Center on Sunday, February 17, 2013 & released on February 18, 2013.  Seen by pediatrician on Feb. 19 & Feb. 21 & Feb. 25.  On February 25, 2013 she was sent for direct admit at another hospital for IVIG infusion and additional treatment of Kawasaki disease.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Induration, erythema, excessive heat, itching, and pain 6/10 at upper 1/3 of arm around injection site.
Sex: F
Vaccine: FLUX
Symptoms: Dyspepsia, Gastrointestinal disorder, Infrequent bowel movements, Muscle spasms, Pneumonia
Clinical narrative: This case was reported by a consumer and described the occurrence of intestinal problems in a female patient who received ADVAIR unspecified inhaler device for an unknown drug indication. A physician or other health care professional has not verified this report. Co-suspect included unknown (Concurrent medications). On an unknown date, the patient started Fluticasone propionate+salmeterol xinafoate (inhaled), unknown dosing. At an unknown time after starting Fluticasone propionate+salmeterol xinafoate, the patient experienced intestinal problems, digestion problem, urinary infection, cramp and decreased bowel movements. At the time of reporting, the outcome of the events was unknown. The report was received via monitoring of online GSK. The patient said she has a lot of problems with digestion and bowels and feels there is a huge problem there. She had a "scope" performed and no obstruction was found but she was still having severe cramps and weeks without a bowel movement. The patient said her physician discusses all her conditions with her. The physician said the medications that she takes causes urinary infections which she has quite frequently. She said a urologist said the medications were causing the infections. Follow-up information was received via the consumer (the patient) via GSK on 30 December 2012. The patient reported that she "had a very bad episode of exaspiration (exasperation: unspecified event) which placed me into the hospital for eight days." No further detail was provided. Follow-up information was received via the consumer (the patient) via GSK on 21 February 2013. The patient reported "my husband and I both got the flu shot in November and I got the pneumonia shot three years ago. Well, I went into the hospital two weeks ago with pneumonia for eight days and came home and was home for three days and he came down with the flu. He is not allowed around me at all. If I get the flu I am going to get it ten times worse so, we are really trying to avoid it as much as possible this year has been really bad because of this crazy weather pattern". For the husband's case please see case A1014087A.
Sex: F
Vaccine: FLUX
Symptoms: Urinary tract infection
Clinical narrative: This case was reported by a consumer and described the occurrence of intestinal problems in a female patient who received ADVAIR unspecified inhaler device for an unknown drug indication. A physician or other health care professional has not verified this report. Co-suspect included unknown (Concurrent medications). On an unknown date, the patient started Fluticasone propionate+salmeterol xinafoate (inhaled), unknown dosing. At an unknown time after starting Fluticasone propionate+salmeterol xinafoate, the patient experienced intestinal problems, digestion problem, urinary infection, cramp and decreased bowel movements. At the time of reporting, the outcome of the events was unknown. The report was received via monitoring of online GSK. The patient said she has a lot of problems with digestion and bowels and feels there is a huge problem there. She had a "scope" performed and no obstruction was found but she was still having severe cramps and weeks without a bowel movement. The patient said her physician discusses all her conditions with her. The physician said the medications that she takes causes urinary infections which she has quite frequently. She said a urologist said the medications were causing the infections. Follow-up information was received via the consumer (the patient) via GSK on 30 December 2012. The patient reported that she "had a very bad episode of exaspiration (exasperation: unspecified event) which placed me into the hospital for eight days." No further detail was provided. Follow-up information was received via the consumer (the patient) via GSK on 21 February 2013. The patient reported "my husband and I both got the flu shot in November and I got the pneumonia shot three years ago. Well, I went into the hospital two weeks ago with pneumonia for eight days and came home and was home for three days and he came down with the flu. He is not allowed around me at all. If I get the flu I am going to get it ten times worse so, we are really trying to avoid it as much as possible this year has been really bad because of this crazy weather pattern". For the husband's case please see case A1014087A.
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis B, Hepatitis B antigen positive, Incorrect dose administered, Vaccination failure
Clinical narrative: This case was reported by a pharmacist (subject) and described the occurrence of hepatitis b in an adult female subject who was vaccinated with TWINRIX (GlaxoSmithKline), Hepatitis a + b vaccine. Concurrent medical conditions included needle stick in 2012 (approximately 6 months ago). The pharmacist stated that "it was unknown if the source was positive for Hepatitis B Surgace Antigen." Historic vaccination included hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given on an unspecified date "20 years ago". On an unspecified date the subject received 1st dose of TWINRIX (unknown details), on an unspecified date the subject received 2nd dose of Hepatitis a + b vaccine (unknown details), and on 17 August 2012 the subject received 3rd dose of Hepatitis a + b vaccine (unknown details, left arm) and experienced extra dose administered. The subject received 4 doses of the hepatitis b antigen. In February 2013, at an unspecified time after vaccination with Hepatitis a + b vaccine (2nd dose) and TWINRIX (1st dose), 6 months after vaccination with Hepatitis a + b vaccine (3rd dose), the subject experienced hepatitis b and vaccination failure. The pharmacist stated that monthly blood work had been conducted since a needle stick approximately 6 months ago (approximately August 2012). The pharmacist has been "told that she was positive for Hep B antigen. She was "not sure if she has Hep B from the needle stick or if she has a positive result from the vaccine she completed in August." The pharmacist also stated that she was sure the first dose was TWINRIX but was unsure if the remaining doses were TWINRIX. Relevant test results included a positive result for Hepatitis b antigen in February 2013. GlaxoSmithKline considered this case serious. At the time of reporting the outcome of the events were unspecified.
Age: 1.31
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Vaccines given, within 1 minute after administration RA site became inflamed, swollen. Within 2 minutes swelling and redness diminished. No f/u treatment.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Skin warm, Swelling, Urticaria, Vaccination complication
Clinical narrative: Vaccination complication. Rt arm as a large 5 cm x 4 cm welt, warm to touch, but not indurated. Slightly elevated and consistent with histamine reaction.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Platelet count decreased
Clinical narrative: Platelet count went down.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen at right thigh.
Age: 16.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Syncope
Clinical narrative: Patient fainted in her chair a few minutes after receiving the yellow fever vaccine. Reported feeling dizzy afterwards.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: Fatigue, headache, myalgia, generalized weakness, chills, felt hot. Symptoms began 02/23/13, had swelling to injection site. Seen in ER on 02/25/13 d/c any meds, take TYLENOL, & MOTRIN for pain. Occ Health saw her on 02/26/13 still weak & headache. Seen in Occ Health 03/01/13 symptoms resolved.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Fatigue, headache, myalgia, generalized weakness, chills, felt hot. Symptoms began 02/23/13, had swelling to injection site. Seen in ER on 02/25/13 d/c any meds, take TYLENOL, & MOTRIN for pain. Occ Health saw her on 02/26/13 still weak & headache. Seen in Occ Health 03/01/13 symptoms resolved.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Hives around site and inner upper arm no respiratory symptoms.
Age: 30.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient wanted TWINRIX shot and at 1 mth timeline & needed it before he left country and would not be back in time so gave him shot. Realized too early. Let him know to come back & he said he would.
Age: 39.0
Sex: M
Vaccine: ANTH, MNQ, TDAP, TYP
Symptoms: Cellulitis, Chills, Erythema, Oedema peripheral, Pain
Clinical narrative: Fever 101.8, chills, body aches. Swelling, redness, pain, and itching spread throughout entire upper arm. PA diagnosed condition as cellulitis and prescribed antibiotics.
Age: 39.0
Sex: M
Vaccine: ANTH, MNQ, TDAP, TYP
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Fever 101.8, chills, body aches. Swelling, redness, pain, and itching spread throughout entire upper arm. PA diagnosed condition as cellulitis and prescribed antibiotics.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative concerning to a female patient, who was not in pregnant, had none pertinent medical history and none drug reactions/allergies on her "early 20's", who on an unknown date received her second dose of GARDASIL (dose and Lot not reported), intramuscular. None concomitant medications were reported. On an unknown date reported as eight days later she broke out in hives up and down her arm. The patient informed her healthcare professional that she also had an injection site reaction after the first dose of GARDASIL (dose, route and lot# not reported) and she did not report before having the second injection administered. At the time of the report the patient was recovering from broke out in to hives up and down her arm. The patient sought medical attention via telephone call to physician's office. No treatment information, lab diagnostics, drug reaction or allergies were reported. The causality between broke out in hives up and down her arm and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Dyspnoea, Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender unknown who on 29-NOV-2012 was vaccinated with a 0.5 ml dose of MMR II subcutaneously (anatomical location was not provided) lot number H012140. On 29-DEC-2012, the patient experienced a severe dyspnea and headache. On the same date, the patient visited at clinic. Later the patient visited other clinic 3-4 days after the visit on 29-DEC-2012 and the patient was prescribed unspecified steroids and Z-PAK. The outcome of severe dyspnea and headache was unknown. The relatedness for severe dyspnea and headache was unknown for MMR II. Additional information has been requested. This is one of several reports received from the same source.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 year old male patient. The patient was vaccinated with GARDASIL (lot # not reported) 0.5 mL on 17-JUL-2012 (dose 1), 16-NOV-2012 (dose 2) and 18-JAN-2013 (dose 3), intramuscularly. No adverse events were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative concerning a 62 year old female patient. On 30-JAN-2013, the patient was vaccinated with ZOSTAVAX (lot # H013017, exp: not reported), 0.65 ml/ one shot, subcutaneous. Pharmacist informed that a patient after receiving the ZOSTAVAX developed increased swelling in the back of their left arm, pain and very large swelling, on 30-JAN-2013. The outcome of increased swelling in the back of her left arm, very large swelling and pain was unknown. The relationship between medication and events was unknown. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, refers to an unknown number of patients that may have been vaccinated, on unknown dates, with a dose of VAQTA (lot number and expiration date not reported) after incorrect temperature exposure. The medical assistant stated that VAQTA was exposed to 28.4 F for 10 minutes. Temperature conditions unsupported. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Feeling hot, Headache, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age who on 30-JAN-2013 was vaccinated with a 0.5 ml dose of M-M-R II subcutaneously (anatomical location was not provided) lot number reported as H0125569. On 02-FEB2013, the patient experienced a headache, her body was warm all over and she had not appetite. The patient visited to physician and was diagnosed with lymphadenopathy. The patient was treated with unspecified steroids. The outcome of lymphadenopathy was unknown. The relatedness for lymphadenopathy was unknown for M-M-R II. Additional information is not expected. This is one of several reports received from the same source.
Sex: M
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: An initial report was received from a nurse on 25.Jan.2012 and concerns a male patient of unspecified age who, on an unspecified date, received the fourth oral administration of VIVOTIF (batch no: not reported). The patient's medical history and concomitant medications were not reported. On an unspecified date, 1 day following the fourth VIVOTIF administration, the patient began to experience waves of nausea and had vomited once. No further information was provided. At the time of reporting, the patient had not yet recovered. The events were considered non-serious.
Age: 57.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Discomfort, Fibromyalgia, Laboratory test, Myalgia
Clinical narrative: This case was forwarded by Crucell, No: CVAE-005-2012. An initial report was received from a nurse on 13.Feb.2012 and concerns a 57-year-old male patient who, on 14.Jan.2012, received his fourth administration of VIVOTIF (batch no: 3002119). It was noted that the patient received a Hep A vaccination on the day of his first VIVOTIF dose. The patient's medical history and concomitant medications were not reported. On 20.Jan.2012, 6 days following VIVOTIF administration, he experienced muscle soreness, especially his arms. Laboratory investigations have been undertaken and the results are awaited. No further information was available. At the time of reporting, the patient had not yet recovered and he was still feeling some discomfort. The event was considered non-serious. Follow-up information received from the nurse on 03.Apr.2012: Upon internal review, the case was upgraded to serious (other medically important condition) due to the duration of the events. The patient had a concurrent medical history of diabetes, treated with metformin, hypertension, treated with metoprolol, gastro-oesophageal reflux and depression, treated with PROZAC. The patient's symptoms were defined as fibromyalgia. He received treatment with prednisone, with no subsequent improvement of his condition. At the time of this report, the patient had not yet recovered.
Age: 0.46
Sex: F
Vaccine: BCG, DTAPIPVHIB, PNC13, RV5
Symptoms: Culture wound negative, Incisional drainage, Injection site reaction, Injection site swelling, Purulent discharge
Clinical narrative: Left arm developed swelling and had pus drainage on 2/23 and 2/24, No fever. She was happy and normal at office visit on 2/25/12 she was placed on antibiotic and had I & D done at site. She returned on 2/27/13. No drainage or fever noted.
Sex: M
Vaccine: TYP
Symptoms: Dry mouth
Clinical narrative: This case was forwarded to Crucell, No: CVAE-026-2012. An initial report was received from a healthcare professional on 26.Jun.2012 and concerns a male patient of unspecified age who, on 20.Apr.2012, received an administration of VIVOTIF (batch no: not reported). The patient's medical history and concomitant medications were not reported. On an unspecified date, at an unspecified time following the HAV-Pur administration, the patient experienced a severely dry mouth. No further information was available. At the time of reporting the patient had not yet recovered. The events were considered non-serious. Follow-up received on 17-Sep-2012: The patient's age was between 30-40 years. The event was short term which the patient recovered from on an unspecified date. The patient stated that he and his primary care doctor concluded that the reaction was not related to VIVOTIF but something else which he does not remember.
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: This case was forwarded by Crucell, No: CVAE-027-2012 An initial report was received from a healthcare professional on 28.Jun.2012 and concerns a 48-year-old male patient who, on 25.Jun.2012, received the first administration of oral VIVOTIF (batch no: 3000132). The patient's medical history and concomitant medications were not reported. On 25.Jun.2012, at an unspecified time following the VIVOTIF administration, the patient experienced fever. The patient did not continue taking the VIVOTIF. The fever was still persisting four days later. No further information was available. At the time of reporting the patient was recovering. The event was considered non-serious.
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Incorrect storage of drug
Clinical narrative: An initial report was received from a doctor's office on 10.Dec.2012 and concerns a 35-year-old female patient who, on 29.Nov.2012, received the first administration of VIVOTIF (batch no: 3000261). The second administration was taken on 01.Dec.2012. Both the first and second administrations of VIVOTIF had not been refrigerated. The patient returned to the doctor's office and was given an new pack of VIVOTIF and she took the first dose from this pack on 03.Dec.2012. The patient's medical history and concomitant medications were not reported. On 04.Dec.2012, the day following her first administration of VIVOTIF from the new pack, ie the third dose, the patient experienced stomach cramps. No further information was available. At the time of reporting, the patient had not yet recovered. The event was reported as non-serious.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: An initial report was received from a nurse on 12.Dec.2012 and concerns an 18-year-old female who, on 08.Dec.2012, received the first administration of VIVOTIF (batch no: 3000261). The patient's medical history and concomitant medications were not reported. On 08.Dec.2012, the evening following the first administration of VIVOTIF, the patient experienced severe abdominal cramps. The patient took the second dose of VIVOTIF on 10.Dec.2012 and the cramps continued. No further information was reported. At the time of reporting, the outcome of the event was unknown. The event was considered to be non-serious.
Age: 34.0
Sex: M
Vaccine: TYP
Symptoms: Muscle spasms
Clinical narrative: This case was forwarded by Crucell, No: CVAE-047-02012 An initial report was received from a nurse on 13.Dec.2012 and concerns a 34-year-old male who, on 11.Dec.2012, had received the first administration of VIVOTIF (batch no: 3000128). The patient's medical history and concomitant medications were not reported. On 11.Dec.2012, in the evening following the first administration of VIVOTIF, the patient experienced leg cramps. No further information was reported. At the time of reporting, the event was ongoing. The event was considered to be non-serious.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Muscle spasms
Clinical narrative: This case was forwarded by Crucell, no: CVAE-044-2012. An initial report was received from a nurse on 28.Nov.2012 and concerns a 17-year-old female patient, who on 28.Nov.2012 received the first oral dose of VIVOTIF (batch no,: 3000220). Medical history was not reported. Concomitant medication included an unspecified birth control mediation. On 28.Nov.2012, at an early time, the patient took the vaccination on an empty stomach. 5 hours later, the patient are pasta and experienced severe cramping. At the time of reporting, the patient had not yet recovered. The event was considered non-serious.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: This is an initial case report reported by a healthcare professional on 30.Aug.2012 and forwarded by Crucell, no: CVAE-033-2012. A spontaneous report was received and concerns a 25-year-old male patient who, on 25.Aug.2012 received the first dose of VIVOTIF (batch no: 3000132). The patient's medical history was not provided. Concomitant medication included prednisone. On 25.Aug.2012, following administration of the first dose of vaccination, the patient experienced hives. The patient did not take any more of the vaccine. The outcome of the event was not reported. The event was considered non-serious.
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Immune system disorder, Inappropriate schedule of drug administration, Oropharyngeal pain, Pyrexia
Clinical narrative: This case was received from a healthcare professional on 30.Jan.2011 and forwarded by Crucell: This spontaneous report concerns a patient of unspecified age and sex who received VIVOTIF (batch number not reported). The patient took the 4 doses of VIVOTIF on consecutive days, with the last one taken on 29- or 30.Jan.2012. The patient subsequently developed sore throat and stomach cramps. At the time of this report, she  had not yet recovered. The case was considered non-serious. Follow-up information was received from the pharmacist on 14.Feb.2012: The patient was a 20-year-old male with no medical conditions and no known drug allergies. The patient failed to read the product leaflet and took VIVOTIF daily for four days consecutively from 26- to 29.Jan.2012 as typhoid prevention for travel in March 2012. On 30.Jan.2012, the patient complained of sore throat, stomach cramps, fever and "felt immune system weakened". The symptoms resolved on 08.Feb.2012.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Nausea, Pain
Clinical narrative: Case received from a health professional  and forwarded by Crucell ref. no. CVAE-003-2012. A spontaneous report was received on 11.Jan.2012 and concerns a 63-year-old female patient who received VIVOTIF (batch number 3002144). The patient's medical history and concomitant medications were not reported. On an unreported date, the patient took the first dose of VIVOTIF with a full glass of water, two hours after eating. Approximately one hour later, the patient "became achy" and experienced nausea and upset stomach. The patient decided not to take any more doses. The outcome was not reported. The case was considered non-serious.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Rash, Urticaria
Clinical narrative: Case received from a healthcare professional and forwarded by Crucell Vaccines, Inc.: A spontaneous report was received on 10.Jan.2012 and concerns a 32-year-old male patient who received VIVOTIF (batch number 3002144). The patient's medical history and concomitant medications were not provided. On 05.Jan.2012, the patient was vaccinated with Tdap, TWINRIX and flu vaccines. On 07.Jan.2012, the patient took the first dose of VIVOTIF. No adverse reaction was observed. On 09.Jan.2012, the patient took the second dose of VIVOTIF. Several hours later, he developed rash and hives on the arms and legs. The patient took BENADRYL and went to sleep. When he woke up the next day, on 10.Jan.2012, the rash and hives had cleared up. The case was considered non-serious.
Sex: U
Vaccine: TYP
Symptoms: Rectal discharge
Clinical narrative: This case was forwarded by Crucell An initial report was received from a nurse on 01.Mar.2012 and concerns a patient of unspecified age and gender who, on 26.Feb.2012, received the fourth capsule of VIVOTIF (batch no: not reported). The patient's medical history and any concomitant medications were not reported. On an unspecified date, about 48 hours following the last oral typhoid administration, the patient experienced "orange leaking from the anus". No further information was available. At the time of reporting the patient had recovered. The event was considered non-serious.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Report received on 24.May.2012 from a nurse and forwarded, ref. no. CVAE-021-2012. This case concerns a 21-year-old female patient who received VIVOTIF (batch number 3000009). The patient's medical history and concomitant medications were not reported. On 22.May.2012, the patient took the first oral dose of VIVOTIF. On the same day, she experienced diarrhea. The event regressed on the interval day. On 24.May.2012, the patient took the second dose of VIVOIF, with further onset of diarrhea. The patient discontinued VIVOTIF. At the time of the report, the patient's event was resolving. The event was considered non-serious.
Age: 40.0
Sex: M
Vaccine: TYP
Symptoms: Rash, Urticaria
Clinical narrative: An initial report was received from a nurse on 06-Sep.2012 and concerns a 40-year-old male patient, who on 28.Aug.2012, received the first oral dose of VIVOTIF (batch no.: 3000132). The patient's medical history was not reported. Vaccinations given on the on 16.Aug.2012 included, other manufacturers, Yellow fever vaccine (batch no.: not reported), Polio vaccine (batch no.: not reported), TWINRIX (batch no.: not reported), and MMR (batch no.: not reported). On 28.Aug.2012, following administration of the first dose of vaccination, the patient broke out in rash - hives. The patient also experienced the same event after the second dose. The vaccination was discontinued. The patient was treated with BENADRYL. On an unspecified date, the patient recovered from the event. The event was considered non-serious.
Sex: M
Vaccine: TYP
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: An initial report was received from a nurse on 17.Aug.2012 and concerns a male patient in his 50's, who on 13.Sep.2012 received the first dose of VIVOTIF orally (batch no.: 3000132). The patient's medical history and concomitant medications were not reported. On 13.Sep.2012, following administration of the vaccination, the patient experienced chills, nausea and fever. At the time of reporting, the patient had not yet recovered from the event. The events were considered non-serious.
Age: 65.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: An initial report was received from a nurse on 16.Oct.2012 and concerns a 65-year-old male patient, who on 12.Oct.2012, received an oral administration of VIVOTIF (batch no.: 3000201). The patient's medical history and concomitant medications were not provided. On an unspecified date, following administration of the second dose of the vaccination, the patient experienced mild diarrhea. On an unspecified date, the event resolved by itself. The patient will continue with dose. The events were considered non-serious.
Age: 54.0
Sex: F
Vaccine: TYP
Symptoms: Burn oesophageal, Oesophageal discomfort
Clinical narrative: This case was forwarded by Crucell, no.: CVAE-043-2012. An initial report was received from a pharmacist on 26.Nov.2012 and concerns a 54-year-old female patient, who on an unspecified date received VIVOTIF (batch no.: not available). Medical history and concomitant medications were not reported. On an unspecified date, following administration of the vaccination, the patient experienced burning and uncomfortable sensation in the esophageal area. No further detail was provided. The outcome of the event was not known. The event was considered non-serious.
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Report received on 20.Apr.2012 from a physician and forwarded by Crucell, ref. no. CVAE-015-2012. This case concerns a female patient in her thirties who received the first dose of VIVOTIF (batch number not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. An unspecified amount of time after VIVOTIF intake, the patient developed rash on the abdomen. The outcome was not reported. The event was considered non-serious.
Sex: M
Vaccine: TYP
Symptoms: Rash erythematous
Clinical narrative: Report received on 03.Apr.2012 from a healthcare professional and forwarded by Crucell Vaccines. This case concerns a male patient of unspecified age who received the first dose of VIVOTIF (batch number not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. Some time after vaccination, the patient developed a 2x2 red, non-vesicular rash on his leg. The outcome was not reported. The event was considered non-serious. During internal review on 11.Oct.2012 it was noted that the Crucell reference number was CVAE-017-2012.
Sex: F
Vaccine: TYP
Symptoms: Salmonella test positive
Clinical narrative: Report received on 10.May.2012 from an Infectious Disease Clinic and forwarded by Crucell, ref. no. CV-026-2012. This case concerns a female patient who received VIVOTIF (batch number not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. The patient took VIVOTIF 2 to 4 months before the time of this report. She then traveled. It was reported that she was not sick. On an unspecified date, the patient was tested positive for salmonella typhi O type 6 antibodies. No further details were provided. The case was considered non-serious.
Age: 18.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Report received on 04.Jun.2012 from a nurse and forwarded by Crucell, ref. no. CVAE 022-2012. This case concerns an 18-year-old male patient who received the first dose of VIVOTIF (batch number 3000128) per oral on 02.Jun.2012. The patient's medical history and concomitant medications were not reported. On 02.Jun.2012 ie the same day as the first intake of VIVOTIF, the patient started feeling nausea and stomach ache. The reporter also specified that the patient participated in heavy physical activity. The patient took the second dose of VIVOTIF on 04.Jun.2012 and was still experiencing nausea and stomach ache. The outcome was reported as resolving. The event was considered non-serious.
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: An initial report was received from a nurse on 01.Mar.2012 and concerns a female patient of unspecified age who, on an unspecified date, received oral typhoid (batch no: not reported). The patient's medical history and any concomitant medications were not reported. On an unspecified date, at an unspecified time following the oral typhoid administration, the patient experienced hives on her arms. No further information was available. At the time of reporting the outcome was unknown. The event was considered non-serious.