chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Immunoglobulin therapy, Injection site reaction, Polymerase chain reaction, Rash vesicular, Scab
Clinical narrative: Information has been received from a published literature article. Vaccination with attenuated varicella zoster virus (VZV) could lead to infectious complications in immunodeficient patients. It was reported two immunocompromised patients who developed initial or reactivated vaccine strain varicella, leading to unique vesicular rashes involving the vaccinated limbs, without becoming wide-spread or remaining limited to a single dermatome. Case 2-A 17 month old female with Hurler Syndrome, on day +6 after receiving an unrelated 7/8 Human Leukocyte Antigen matched cord blood transplant, developed a vesicular rash on her right thigh, which was the site for VARIVAX vaccination 4 months prior to transplant. A lesion was unroofed and the fluid revealed VZV by PCR. Subsequent analysis revealed the virus to be vaccine strain varicella. She was started on treatment with intravenous acyclovir and intravenous immunoglobulin and her lesions crusted over within 2 weeks. These two cases highlighted unusual presentations of vaccine strain varicella in immunocompromised patients. Vaccine strain varicella could cause a vesicular rash in a non-classical distribution. It was also notable that vaccine strain can trigger hemophagocytic lymphohistiocytosis in immune deficient patients. This is one of two reports received from the same literature. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Information has been received from a published literature article. Vaccination with attenuated varicella zoster virus (VZV) could lead to infectious complications in immunodeficient patients. It was reported two immunocompromised patients who developed initial or reactivated vaccine strain varicella, leading to unique vesicular rashes involving the vaccinated limbs, without becoming wide-spread or remaining limited to a single dermatome. Case 2-A 17 month old female with Hurler Syndrome, on day +6 after receiving an unrelated 7/8 Human Leukocyte Antigen matched cord blood transplant, developed a vesicular rash on her right thigh, which was the site for VARIVAX vaccination 4 months prior to transplant. A lesion was unroofed and the fluid revealed VZV by PCR. Subsequent analysis revealed the virus to be vaccine strain varicella. She was started on treatment with intravenous acyclovir and intravenous immunoglobulin and her lesions crusted over within 2 weeks. These two cases highlighted unusual presentations of vaccine strain varicella in immunocompromised patients. Vaccine strain varicella could cause a vesicular rash in a non-classical distribution. It was also notable that vaccine strain can trigger hemophagocytic lymphohistiocytosis in immune deficient patients. This is one of two reports received from the same literature. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 18-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular, lot # was unknown) and the second dose of GARDASIL (0.5 ml, intramuscular, lot # was unknown) given on 19-OCT-2012. The Registered Nurse reported the third dose of GARDASIL (0.5 ml, intramuscular, lot # was unknown) was given early on 28-DEC-2012. No adverse effect reported. The outcome of event was unknown. Additional information is not expected.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 weeks and 6 days old patient of unknown gender. No information regarding th epatient's medical history was provided. On 11-FEB-2013 the patient received the frist dose of ROTATEQ at the age of 15 weeks and 6 days. No concomitant medication was reported. No adverse effect was reported. No outcome was reported. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Infection, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On an unknown date the patient received PNEUMOVAX23 and FLUZONE, concomitantly in the same arm, 1 inch apart. Within 48 hours, the patient experienced redness and warmth at the injection-site and soreness under axillary region; the person did not report any fever or chills. No information was available on the duration or outcome of these AEs. The person was treated with KEFLEX for suspected infection. The outcome of event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 29-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (route, dose and lot # were unknown). The nurse reported the patient developed a headache and a fever one week (05-FEB-2013) after receiving a first dose of GARDASIL. The outcome of fever and headache was reported as not recovered/not resolved. The patient sought unspecified medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Headache, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 29-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (route, dose and lot # were unknown). The nurse reported the patient developed a headache and a fever one week (05-FEB-2013) after receiving a first dose of GARDASIL. The outcome of fever and headache was reported as not recovered/not resolved. The patient sought unspecified medical attention. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient with hearing loss. The patient had no drug reactions or allergies. On 29-JAN-2013, the patient was vaccinated with the first dose of GARDASIL (lot # 0459AE; expiration date: 13-DEC-2014) (dose and route not reported). After her first vaccination, the patient developed a headache, low grade fever, nausea and back pain. The patient sought medical attention, called office. The patient was treated with TYLENOL. The outcome of the patient events was reported as not recovered/not resolved. Additional information has been requested
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Headache, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient with hearing loss. The patient had no drug reactions or allergies. On 29-JAN-2013, the patient was vaccinated with the first dose of GARDASIL (lot # 0459AE; expiration date: 13-DEC-2014) (dose and route not reported). After her first vaccination, the patient developed a headache, low grade fever, nausea and back pain. The patient sought medical attention, called office. The patient was treated with TYLENOL. The outcome of the patient events was reported as not recovered/not resolved. Additional information has been requested
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives on upper & lower extremities x 4 days. Tx oral prednisone & CLARITIN.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Lymphadenopathy, Skin lesion
Clinical narrative: Patient presents to office with painful, cellulitic appearing lesion (L) arm. Afebrile, no N/V, no SOB. Postiive lymphadenopathy.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: 2-15-13 Nurse reported that client presented to health dept on 2-14-13 and complained about pain in right arm that reportedly is caused by a flu and pneumonia shot she got in 10-18-12. Pt. left her phone number so supervisor can call her. I called pt. on 2-15-13 11:10am and spoke to her husband about the incident. When questioning pt. about the start of adverse signs/symptoms. She could not recall the time or day her symptoms started. She could not recall the day she visited the primary doctor, but only reports she was having much pain in right arm which had her to make a clinic visit. She reports getting a steroid injection in rt. arm. Pt. reports she may have possible nerve damage or muscle damage.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Lip swelling, Oropharyngeal pain
Clinical narrative: Mother brought patient back c/o sore throat, cough, and swollen lower lip. None of these symptoms were present prior to immunizations. I brought patient back and done an O2 check it was O2 97% and HR 102. Patient tells me he is breathing fine. I was instructed to administer BENADRYL 7.5mL pre Dr.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Myalgia, Pain
Clinical narrative: Rec. vaccine Thurs 2/7/13, became painful Wed. 2/12/13, 2/13/13 really sore to touch, can perform activities muscle very sore. No temp, no redness, no swelling. "Very delayed typical rxn." Warm compress suggested. Planned to call dr if not improvement..
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Myalgia
Clinical narrative: Weakness & extreme fatigue for 3 days muscles aches, chills but did not check temperature. She stayed 2 1/2 days in bed.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Blister, Burning sensation, Erythema
Clinical narrative: This consumer report (initial receipt: 23-Jan-2013) concerns a 68-year-old male patient, who had a medical history of high cholesterol. Concomitant medication included lovastatin. On 10-Sep-2012 the patient received a flu shot (manufacturer and batch number not specified) and ZOSTAVAX (batch number not specified). On 21-Sep-2012 the patient was bright red from the chest down, almost purple, had blisters the size of golf balls on his legs and groin and was on fire from the waist down. He was hospitalised for 4 nights. The outcome was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: This medically confirmed spontaneous report (initial receipt 06-Feb-2013) concerns a female patient. On an unknown date, the patient received AFLURIA (batch P50908A). After receiving AFLURIA, the patient developed severe pain in the arm and limited range of motion. The patient recovered 2 months after the vaccination.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 56 year old patient with unknown gender. No information regarding the patient's medical history was provided. on 25-JAN-2013 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml intramuscular, after its expiration date. Lot number was reported as 0631AA (expiry date: 21-JAN-2013). No concomitant medication was reported. No adverse effect was reported. No outcome was reported. Additional information has been requested.
Sex: M
Vaccine: DTP
Symptoms: Paralysis
Clinical narrative: Initial case was received from a healthcare professional on 06 February 2013. A 36-year-old male patient, whose past medical history was not reported, received an injection of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE, MFR UNK, (lot number, route, site, side and dose in series not reported) on an unknown, unspecified date as a small child. On an unspecified date, "shortly" after vaccination, the patient was paralyzed from the waist down, which lasted for six months (mos). The reporter did not have any other information about the vaccination and would not be able to obtain information since the patient was not vaccinated at the reporter's facility. The reporter was unable to obtain information about what facility or from which provider the patient had received the vaccination. The reporter did not want further contact for this vaccination. The patient's outcome was reported as recovered on an unspecified date. Documents held by sender: None.
Age: 53.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Received chicken pox vaccine: Developed full-blown case of chicken pox from vaccine. Started with 2 days low-grade fever. Developed 300+ pox. Case is still ongoing with 3rd wave of 100 additional pox on 1/18/2013.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling at injection site, warm to touch, sore, painful to touch.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Pharyngeal oedema, Pruritus, Swelling
Clinical narrative: Patient developed local redness, swelling, and itching within 30 minutes of injection. About 2 hours later, pt developed throat swelling and shortness of breath.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia oral, Type IV hypersensitivity reaction, Vaccination complication
Clinical narrative: Tingling at the tip of the tongue and swelling of both lips. Diagnosis: Delayed hypersentivity reaaction to the Flu vaccine.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin normal, Blood test normal, Eczema, Rash
Clinical narrative: Rashes developed over large areas of arms, legs, back, chest, and buttocks.  Went back to see Dr., who administered the Shingles Shot, and she said it was eczema.  Sent me to Dermatology for review. Worked with them for 10 months doing blood tests, using ointments, testing for scabies, had a biopsy of 2 sores, and all to no avail.  Am now seeing a holistic doctor, who is treating me with hydrogen peroxide body cleanings.  Still after 3 of these treatments there is no change.
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Headache, Incorrect dose administered, Injection site pain
Clinical narrative: This spontaneous report as received from a consumers mother refers to a female patient of unknown age with asthma. The patient has no drug allergies. Approximately on an unknown date in  2011(reported as about two year ago), the patient  had received three shot series of GARDASIL (product circular number was reported as 9883616). On 07-FEB-2013 the patient was given an additional dose of GARDASIL in error by an unspecified physician at an unspecified clinic. Since receiving the additional dose of vaccine(07-FEB-2013), the patient had developed a headache, soreness around the injection site and lack of appetite. The patient has been using MOTRIN to alleviate the symptoms but has not sought medical attention. The outcome of lack of appetite, soreness around the injection site and headache was reported as recovering/resolving. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Patient developed flu vaccine reaction. Was given BENADRYL 25 mg IM injection and began to improve within 5 minutes. Was also given prednisone 30 mg PO. Provider noted: Chest is CTA without noted rales/wheezing. There is no noted shortness of breath.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Wheezing
Clinical narrative: Within 5 minutes of administration of below listed 4 vaccines & ibuprofen exhibited symptoms of allergic reaction, began wheezing, required supplemental O2; albuterol & epinephrine administration & was transferred to ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Hypersensitivity, Wheezing
Clinical narrative: Within 5 minutes of administration of below listed 4 vaccines & ibuprofen exhibited symptoms of allergic reaction, began wheezing, required supplemental O2; albuterol & epinephrine administration & was transferred to ER.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Pt fainted after receiving vaccines - came to within 20 seconds - was sweaty & denied dizziness. Left office fine.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Back pain, Blood test, Cardiac monitoring, Gastrostomy tube insertion
Clinical narrative: Toes numb, feet and ankles, fingers, hands numb, tongue, teeth, gums numb, back hurts then goes numb, abdomen numb was seen by family MD 12/27/2012, neurologist 01/10/2013 ER 01/12/2012 ER 01/13/2013 and hospitalized till 01/26/2013 then transferred to rehab in hospital till released 02/14/2013 currently out pt rehab diagnosed with Guillain Barre Syndrome unable to work and has a PEG for nutrition.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Impaired work ability, Lumbar puncture, Nerve conduction studies
Clinical narrative: Toes numb, feet and ankles, fingers, hands numb, tongue, teeth, gums numb, back hurts then goes numb, abdomen numb was seen by family MD 12/27/2012, neurologist 01/10/2013 ER 01/12/2012 ER 01/13/2013 and hospitalized till 01/26/2013 then transferred to rehab in hospital till released 02/14/2013 currently out pt rehab diagnosed with Guillain Barre Syndrome unable to work and has a PEG for nutrition.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Ultrasound scan, Urine analysis, X-ray
Clinical narrative: Toes numb, feet and ankles, fingers, hands numb, tongue, teeth, gums numb, back hurts then goes numb, abdomen numb was seen by family MD 12/27/2012, neurologist 01/10/2013 ER 01/12/2012 ER 01/13/2013 and hospitalized till 01/26/2013 then transferred to rehab in hospital till released 02/14/2013 currently out pt rehab diagnosed with Guillain Barre Syndrome unable to work and has a PEG for nutrition.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site.
Age: 1.05
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Saw mother & toddler today.  Mother stated that child had a rash & fever of 104 degrees on 1/23/13, after vaccines were given on 1/22/13.  Mother took child to ED for treatment.
Age: 19.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Mother called: states daughter complaining of left arm swollen and painful. Asked to stop at Health Dept so we could view and assess arm. Client did not comply.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Vomiting
Clinical narrative: Complaints of vomiting and headache.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Severe mucousy diarrhea.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Asthenia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within hours swelling, red, hot @ IM injection site Deltoid m. origin, lasting 1 wk, Tx Amox caps & Bacitracin topical ointmt. Severe loss of muscle strength 2wks post injection. Deep pain unable to raise arm, open car door, lift canned goods currently.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased
Clinical narrative: Within hours swelling, red, hot @ IM injection site Deltoid m. origin, lasting 1 wk, Tx Amox caps & Bacitracin topical ointmt. Severe loss of muscle strength 2wks post injection. Deep pain unable to raise arm, open car door, lift canned goods currently.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: Had a febrile seizure, seen at ER.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Pain during movements, putting on belt, jacket, sleeping and pain increases with use.  Trying to use it and work thru the pain.  Still having pain and don't know what to do.  Needle high in arm, never had such a problem.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Nausea, Pyrexia, Vomiting
Clinical narrative: Per Nursing note 10/8/12: This 77 y/o male presents with: report that he received a flu shot on Friday AM and began experiencing elevated temps Friday night. He states that his stomach has been a little queasy but no vomiting. He has been taking TYLENOL for temps. Per physician's note 10/8/13: Assessment: Febrile reaction to influenza vaccine. Plan: Reaussurance.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Rash generalised
Clinical narrative: Rash in the hands, legs, chest, groin, axilla, stomach. Ate pizza afterwards.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Abnormal sensation in eye, Blood 25-hydroxycholecalciferol decreased, Blood potassium decreased, Body temperature increased
Clinical narrative: Within 5 min pain at inj. site radiating down (L) arm to fingers & overall feeling of warmth, progress to HA, dizziness, nausea, vomiting, chills, 100.4 temp, fasciculations, malaise, myalgias, photosensitivity, pressure (L) temporal area & behind (L) eye & jaw claudication over 3 days cont. with interm. fasciculations, nausea with occas. emesis, arm soreness & weakness, fatigue, HA & now increase eye pressures, night diaphoresis, nausea & tachycardia with occas. abd pain (gastric). Dx'd with cervical nerve root irritation from vaccine by neuro. F/U with neuro 2/21/13.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: C-reactive protein increased, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: Within 5 min pain at inj. site radiating down (L) arm to fingers & overall feeling of warmth, progress to HA, dizziness, nausea, vomiting, chills, 100.4 temp, fasciculations, malaise, myalgias, photosensitivity, pressure (L) temporal area & behind (L) eye & jaw claudication over 3 days cont. with interm. fasciculations, nausea with occas. emesis, arm soreness & weakness, fatigue, HA & now increase eye pressures, night diaphoresis, nausea & tachycardia with occas. abd pain (gastric). Dx'd with cervical nerve root irritation from vaccine by neuro. F/U with neuro 2/21/13.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Injection site pain, Intermittent claudication, Malaise, Muscle contractions involuntary
Clinical narrative: Within 5 min pain at inj. site radiating down (L) arm to fingers & overall feeling of warmth, progress to HA, dizziness, nausea, vomiting, chills, 100.4 temp, fasciculations, malaise, myalgias, photosensitivity, pressure (L) temporal area & behind (L) eye & jaw claudication over 3 days cont. with interm. fasciculations, nausea with occas. emesis, arm soreness & weakness, fatigue, HA & now increase eye pressures, night diaphoresis, nausea & tachycardia with occas. abd pain (gastric). Dx'd with cervical nerve root irritation from vaccine by neuro. F/U with neuro 2/21/13.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Myalgia, Nausea, Nerve root lesion, Night sweats
Clinical narrative: Within 5 min pain at inj. site radiating down (L) arm to fingers & overall feeling of warmth, progress to HA, dizziness, nausea, vomiting, chills, 100.4 temp, fasciculations, malaise, myalgias, photosensitivity, pressure (L) temporal area & behind (L) eye & jaw claudication over 3 days cont. with interm. fasciculations, nausea with occas. emesis, arm soreness & weakness, fatigue, HA & now increase eye pressures, night diaphoresis, nausea & tachycardia with occas. abd pain (gastric). Dx'd with cervical nerve root irritation from vaccine by neuro. F/U with neuro 2/21/13.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Photosensitivity reaction, Tachycardia, Vitamin B12 decreased, Vomiting
Clinical narrative: Within 5 min pain at inj. site radiating down (L) arm to fingers & overall feeling of warmth, progress to HA, dizziness, nausea, vomiting, chills, 100.4 temp, fasciculations, malaise, myalgias, photosensitivity, pressure (L) temporal area & behind (L) eye & jaw claudication over 3 days cont. with interm. fasciculations, nausea with occas. emesis, arm soreness & weakness, fatigue, HA & now increase eye pressures, night diaphoresis, nausea & tachycardia with occas. abd pain (gastric). Dx'd with cervical nerve root irritation from vaccine by neuro. F/U with neuro 2/21/13.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Dizziness, Headache, Injection site pain, Muscle twitching
Clinical narrative: Within 5 min pain at inj. site radiating down (L) arm to fingers & overall feeling of warmth, progress to HA, dizziness, nausea, vomiting, chills, 100.4 temp, fasciculations, malaise, myalgias, photosensitivity, pressure (L) temporal area & behind (L) eye & jaw claudication over 3 days cont. with interm. fasciculations, nausea with occas. emesis, arm soreness & weakness, fatigue, HA & now increase eye pressures, night diaphoresis, nausea & tachycardia with occas. abd pain (gastric). Dx'd with cervical nerve root irritation from vaccine by neuro. F/U with neuro 2/21/13.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Pain in extremity, Photosensitivity reaction, Temporomandibular joint syndrome, Vomiting
Clinical narrative: Within 5 min pain at inj. site radiating down (L) arm to fingers & overall feeling of warmth, progress to HA, dizziness, nausea, vomiting, chills, 100.4 temp, fasciculations, malaise, myalgias, photosensitivity, pressure (L) temporal area & behind (L) eye & jaw claudication over 3 days cont. with interm. fasciculations, nausea with occas. emesis, arm soreness & weakness, fatigue, HA & now increase eye pressures, night diaphoresis, nausea & tachycardia with occas. abd pain (gastric). Dx'd with cervical nerve root irritation from vaccine by neuro. F/U with neuro 2/21/13.
Age: 1.02
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Body temperature increased, Cyanosis, Dyspnoea, Febrile convulsion, Somnolence
Clinical narrative: Child was sleepy after immunization & took nap. Upon arising child seemed less alert per mother. During diaper change, child became unresponsive, lips turned blue, & developed hand tremor. Mother noted she was not breathing & called EMS. Episode lasted 1-3 minutes. Upon arrival of EMS child was breathing & started to regain consciousness. Temp 101.9 ax EMS contacted primary care physician; child was not seen by physician or taken to ER. Dx - likely febrile seizure. Child recovered without further incident.
Age: 1.02
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Child was sleepy after immunization & took nap. Upon arising child seemed less alert per mother. During diaper change, child became unresponsive, lips turned blue, & developed hand tremor. Mother noted she was not breathing & called EMS. Episode lasted 1-3 minutes. Upon arrival of EMS child was breathing & started to regain consciousness. Temp 101.9 ax EMS contacted primary care physician; child was not seen by physician or taken to ER. Dx - likely febrile seizure. Child recovered without further incident.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: MMR, VZV & TB skin test (PPD) given at 1230 pm - Mom noticed rash "all over legs" around 1 pm - returned to clinic. Advised to give BENADRYL as needed by MD.
Age: 1.76
Sex: M
Vaccine: DTAP, FLU3, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Patient had febrile seizure post vaccines. Mom/Parent forgot to give dose of ADVIL before child went to bed.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase increased, Blood culture negative, Borrelia test negative, C-reactive protein increased, Chest X-ray normal
Clinical narrative: Pt. developed fever, malaise, whole body urticaria-like rash assoc. with generalized edema (increased in hands & feet) with 24 hour of vaccine. To ER 2-8-13 hospital. Worsening parasthesias of bilat LE, bilat UE with increased pain in (L) arm -> To ER 2-13-13. Pt. with loss of (L) hand function -> neuro eval.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Culture throat positive, Culture urine negative, Generalised oedema, Malaise, Musculoskeletal disorder
Clinical narrative: Pt. developed fever, malaise, whole body urticaria-like rash assoc. with generalized edema (increased in hands & feet) with 24 hour of vaccine. To ER 2-8-13 hospital. Worsening parasthesias of bilat LE, bilat UE with increased pain in (L) arm -> To ER 2-13-13. Pt. with loss of (L) hand function -> neuro eval.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Rash generalised, Streptococcus test positive
Clinical narrative: Pt. developed fever, malaise, whole body urticaria-like rash assoc. with generalized edema (increased in hands & feet) with 24 hour of vaccine. To ER 2-8-13 hospital. Worsening parasthesias of bilat LE, bilat UE with increased pain in (L) arm -> To ER 2-13-13. Pt. with loss of (L) hand function -> neuro eval.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt. developed fever, malaise, whole body urticaria-like rash assoc. with generalized edema (increased in hands & feet) with 24 hour of vaccine. To ER 2-8-13 hospital. Worsening parasthesias of bilat LE, bilat UE with increased pain in (L) arm -> To ER 2-13-13. Pt. with loss of (L) hand function -> neuro eval.
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Patient and husband came into pharmacy to ask about reaction she was experiencing. She had a very large welt at injection site and it was red, painful and itchy. Husband is MD and gave her prednisone and hydrocortisone cream which is helping.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 2 red raised spots developed at PREVNAR 13 injection site started 2/19/13 in the morning.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a female consumer who reported that she received GARDASIL (dosing dates and lot number not reported). The patient reported that she has "medical problems due to the vacation [sic]." Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to a couple of patients of unknown age. On an unknown date the couple of patients were vaccinated with ZOSTAVAX (lot number not provided). The couple of patients that had a local adverse reaction at the injection site post vaccination with ZOSTAVAX. The site reaction was firm, red, painful, no rash. The reporter did not have the patient's data at the reporting time. The patients had sought unspecified medical attention. The outcome of adverse events was not provided. The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) (Lot #, dose and route not reported) instead of ZOSTAVAX. It was staff error only. No adverse effects reported. It was not known if the patient sought medical attention. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Joint swelling, Radioallergosorbent test negative, Rash, Urticaria
Clinical narrative: A report has been received from a consumer and follow-up from the responsible physician, concerning a 3 year old male patient (height: 36.0 inches; weight: 32.0 pounds). The patient was allergic to peanuts. There was no information on his concomitant medication. On 28-Sep-2012, the patient received nasal FLUMIST. The patient's father reported that the next day (on 29-Sep-2012), the patient had head to toe hives/rash and really bad cough. Patient was taken to pediatrician's office the following Monday, on 01-Oct-2012, and he got dose of steroids and ZANTAC. Approximately a week later (during Oct-2012), the patient's hives, coughing and vomiting got much worse, and he was brought to the emergency room and he got an EPIPEN shot and additional steroids and antihistamines. It was also reported that the patient had been previously tested for allergies in the past and reported had was a little bit allergic to peanuts. The allergy testing was repeated on 14-Oct-2012. RAST (radioallergosorbent test) was performed with the following results: negative for environmental (36 test) and food (26 items), so it did not show any new allergies. The father stated that his son was not exposed to peanuts during the past few weeks of reporting. On 21-Oct-2012 the patient started to experiencing swelling of joints. The patient recovered from the event of swelling of joints during Oct-2012 and from the event of head to toe hives/rash during Nov-2012. The outcome of the other events was unknown. The company physician assessed the event of head to to hives to be serious, due to other important medical event criteria. The remaining events were assessed as non-serious. Summary of the follow up information received by AstraZeneca/MedImmune on 14-Nov-2012 from a physician: case became medically confirmed, new event of swelling of joints was added, and event term was updated to head to toe hives/rash. Patient and reporter page was updated, indication was provided, outcome changed to recovered for the event of hives, lab result was clarified.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A report has been received from a consumer and follow-up from the responsible physician, concerning a 3 year old male patient (height: 36.0 inches; weight: 32.0 pounds). The patient was allergic to peanuts. There was no information on his concomitant medication. On 28-Sep-2012, the patient received nasal FLUMIST. The patient's father reported that the next day (on 29-Sep-2012), the patient had head to toe hives/rash and really bad cough. Patient was taken to pediatrician's office the following Monday, on 01-Oct-2012, and he got dose of steroids and ZANTAC. Approximately a week later (during Oct-2012), the patient's hives, coughing and vomiting got much worse, and he was brought to the emergency room and he got an EPIPEN shot and additional steroids and antihistamines. It was also reported that the patient had been previously tested for allergies in the past and reported had was a little bit allergic to peanuts. The allergy testing was repeated on 14-Oct-2012. RAST (radioallergosorbent test) was performed with the following results: negative for environmental (36 test) and food (26 items), so it did not show any new allergies. The father stated that his son was not exposed to peanuts during the past few weeks of reporting. On 21-Oct-2012 the patient started to experiencing swelling of joints. The patient recovered from the event of swelling of joints during Oct-2012 and from the event of head to toe hives/rash during Nov-2012. The outcome of the other events was unknown. The company physician assessed the event of head to to hives to be serious, due to other important medical event criteria. The remaining events were assessed as non-serious. Summary of the follow up information received by AstraZeneca/MedImmune on 14-Nov-2012 from a physician: case became medically confirmed, new event of swelling of joints was added, and event term was updated to head to toe hives/rash. Patient and reporter page was updated, indication was provided, outcome changed to recovered for the event of hives, lab result was clarified.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Formication, Hallucination, Pyrexia, Wheezing
Clinical narrative: A report has been received from a health professional concerning a 3 year old male patient. No relevant history of patient was reported. The patient's concomitant disease included upper respiratory infection and asthma. The patient's concomitant drugs included salbutamol for wheezing. The patient received nasal FLUMIST which started on 22-Oct-2012 for unknown indication. The patient had high fever of over 102, wheezing, creepy crawlies and was hallucinating which were started on 22-October-2012. He was evaluated in doctor office next day with symptoms still occurring. The action taken with the FLUMIST was not applicable. The outcome of creepy crawlies was unknown and all other reported event was ongoing. The events of hallucinations, fever of over 102, wheezing and creepy crawlies was considered to be non-serious by the reporter. Summary of follow up information received by AstraZeneca/MedImmune on 14-Nov-2012 from health professional: Concomitant drug of albuterol added along with its indication. Corrected report 27-Nov-2012: Changed the action taken of suspect vaccine to not applicable. Changed the event outcome of creepy crawlies to unknown. Updated the reporter and disease page.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 26 year old, female patient. Concomitant medications and medical history were not reported. The patient received FLUMIST on 07-Sep-2012 and later found out she was pregnant. The patient reported that she had no symptoms after FLUMIST administration. The date of the patient's last menstruation was unknown. At the time of the reporting the outcome of pregnancy was unknown. The report was considered to be non-serious by the reporting Health Professional.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Excessive eye blinking, Throat irritation
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Male subject, who had been receiving Nasal FLUMIST. The patient's medical history included chronic bronchitis and tube placed in his ears. FLUMIST started on 19-Oct-2012. The patient experienced blinking eyes constantly and making a throat clearing noise which started on 19-Oct-2012. At the time of reporting, the event of blinking eyes constantly and making a throat clearing noise was ongoing. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 03-Dec-2012 from a Health Professional: Outcome of events blinking eyes constantly and making a throat clearing noise changed from Unknown to Not recovered. Corrected report 10-Dec-2012: Disease type for tube placed in his ears changed from concomitant to relevant history.
Age: 31.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 05 February 2013. A 31-year-old male subject received an injection of ACAM2000 (lot number not reported), Anthrax (D1, lot not reported, other MFR), and Influenza, live vaccine (intranasal, lot not reported, other manufacturer) on 15 November 2012. The subject had no significant medical history. On 03 December 2012, the subject was diagnosed with Non-specific myocarditis. Diagnostic testing on 29 November 2012 revealed abnormal Troponin I (highest value 00.13); and on 03 December 2012 diagnostic testing included: normal ECG and Echocardiogram. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Cough, Lymphadenitis, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns a 16 year old, Female consumer, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced chills, cough, fever, sore throat, swollen tonsillitis and congestion which started on 06-Nov-2012. The outcome of the event of chills, cough, fever, sore throat, swollen tonsillitis and congestion is unknown. The report was considered to be non-serious.
Age: 16.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Streptococcus test negative, Upper respiratory tract infection
Clinical narrative: A consumer report has been received. The report concerns a 16 year old, Female consumer, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced chills, cough, fever, sore throat, swollen tonsillitis and congestion which started on 06-Nov-2012. The outcome of the event of chills, cough, fever, sore throat, swollen tonsillitis and congestion is unknown. The report was considered to be non-serious.
Age: 16.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Chills, Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: A consumer report has been received. The report concerns a 16 year old, Female consumer, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced chills, cough, fever, sore throat, swollen tonsillitis and congestion which started on 06-Nov-2012. The outcome of the event of chills, cough, fever, sore throat, swollen tonsillitis and congestion is unknown. The report was considered to be non-serious.
Age: 16.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Tonsillar hypertrophy
Clinical narrative: A consumer report has been received. The report concerns a 16 year old, Female consumer, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced chills, cough, fever, sore throat, swollen tonsillitis and congestion which started on 06-Nov-2012. The outcome of the event of chills, cough, fever, sore throat, swollen tonsillitis and congestion is unknown. The report was considered to be non-serious.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Back pain, Hypoaesthesia, Laboratory test normal, Pain in extremity
Clinical narrative: Fever every day!!!! Now going on four months. Wakes with 101.6 and night around 102.9. Daily pain in stomach, legs, back, hair follicles, numbness in hands.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain of skin, Platelet count increased, Pyrexia
Clinical narrative: Fever every day!!!! Now going on four months. Wakes with 101.6 and night around 102.9. Daily pain in stomach, legs, back, hair follicles, numbness in hands.
Age: 26.0
Sex: M
Vaccine: TD
Symptoms: Catheterisation cardiac, Chest crushing, Chest pain, Myocardial infarction, Troponin increased
Clinical narrative: Burning, crushing feeling in chest. 911 was called. I was rushed to the E.R.  It was ruled a Heart Attack. I was given a Heart Cath procedure. Hospitalized for 3 days.
Age: 74.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Dizziness, Dyspnoea
Clinical narrative: Had difficulty breathing, weakness and dizziness.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed swelling and fever at injection site, large knot golf ball size present at injection site, tender to touch.  By 02/04/13, know was the size of palm of hand.  Treated with Keflex and symptoms resolved.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Cough, Electromyogram, Lumbar puncture, Malaise
Clinical narrative: Became ill with cold like symptoms within 2-3 days - body aches, cough, fever, was hospitalized Oct 14th - Oct 18 continued with muscle weakness, pain & CIDP to present day.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Became ill with cold like symptoms within 2-3 days - body aches, cough, fever, was hospitalized Oct 14th - Oct 18 continued with muscle weakness, pain & CIDP to present day.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Blood culture, Chest X-ray normal, Culture urine negative, Full blood count normal, Influenza virus test negative
Clinical narrative: Fever started on 2-18-2013 102 axillary. Went to ER CBC, urine & urine culture. Flu & RSV test, chest x-ray completed. All normal. 2-19-2013: Pt c/o 101 temperature and a petechial rash that started that morning of 2/19/2013. Rash started with a small tiny red dot beside the left eye & left side of mouth.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Lumbar puncture, Petechiae, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever started on 2-18-2013 102 axillary. Went to ER CBC, urine & urine culture. Flu & RSV test, chest x-ray completed. All normal. 2-19-2013: Pt c/o 101 temperature and a petechial rash that started that morning of 2/19/2013. Rash started with a small tiny red dot beside the left eye & left side of mouth.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Respiratory syncytial virus test negative, Urine analysis normal
Clinical narrative: Fever started on 2-18-2013 102 axillary. Went to ER CBC, urine & urine culture. Flu & RSV test, chest x-ray completed. All normal. 2-19-2013: Pt c/o 101 temperature and a petechial rash that started that morning of 2/19/2013. Rash started with a small tiny red dot beside the left eye & left side of mouth.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Blood test, Chills, Dyspepsia
Clinical narrative: This spontaneous report as received from a 57 years old female consumer with allergy to Sulfa and cortisone, no pain medications or anti-inflammatories. The patient's concurrent condition included heart flutters and asthma, medical history "last July" (July, 2012), she had a rash on her ribs on one side of her body and her dermatologist told her that it was shingles, but her PCP, said it wasn't shingles. On 15-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number not provided). Concomitant therapies included XANAX. She still had a purple area of 3X3 inches around the injection site. Since the injection she has been sick. She had had a fever on and off and got the chills a lot. She had horrible stomach and back pain and digestive problems. She felt like she had seizure (had tremors in her pain). Her face got really red and flushed. She had nerve pain throughout her body. Blood work was performed and results were unknown. KEFLEX (manufacture unspecified) for one week was put as treatment for adverse event. The outcome of adverse events was reported as not recovered. The patient saw the HCP for seeking medical attention. Her PCP thought that she was just having an allergic reaction to the vaccine. Upon internal review, convulsion was considered to be medically significant event. This is one of several reports received from the same source. Additional information is not expected.