chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid factor positive, Splinter haemorrhages, Vasculitis necrotising
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09645. The following is verbatim from the article: "A healthy 50-year-old male received the influenza vaccine in October 1997. Two days later he developed fatigue, chills and low-grade fevers. Over the next 4 weeks he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his fingernails, but the rest of his exam was unremarkable. Workup at that time demonstrated an erythrocyte sedimentation rate of 56 mm/h, positive rheumatoid factor and positive cytoplasmic ANCA at a titer of 1:80 with a positive proteinase 3 ELISA. Blood cultures were negative. A transthoracic echocardiogram did not reveal any valvular vegetation. Two weeks later, he was noted to have microscopic hematuria and an increase in his serum creatinine from 0.9 to 1.3 mg/dl. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. CT chest was unremarkable. He was treated with oral prednisone and oral cyclophosphamide; after achievement of remission of his vasculitis he was switched to azathioprine for maintenance of remission. His renal function was stable with a serum creatinine of 1.3 mg/dl at the time of his last follow-up in October 2012." Outcome was not reported. Documents held by sender: None.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Antineutrophil cytoplasmic antibody positive, Arthralgia, Biopsy kidney abnormal, Blood creatinine increased, Blood culture negative
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09645. The following is verbatim from the article: "A healthy 50-year-old male received the influenza vaccine in October 1997. Two days later he developed fatigue, chills and low-grade fevers. Over the next 4 weeks he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his fingernails, but the rest of his exam was unremarkable. Workup at that time demonstrated an erythrocyte sedimentation rate of 56 mm/h, positive rheumatoid factor and positive cytoplasmic ANCA at a titer of 1:80 with a positive proteinase 3 ELISA. Blood cultures were negative. A transthoracic echocardiogram did not reveal any valvular vegetation. Two weeks later, he was noted to have microscopic hematuria and an increase in his serum creatinine from 0.9 to 1.3 mg/dl. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. CT chest was unremarkable. He was treated with oral prednisone and oral cyclophosphamide; after achievement of remission of his vasculitis he was switched to azathioprine for maintenance of remission. His renal function was stable with a serum creatinine of 1.3 mg/dl at the time of his last follow-up in October 2012." Outcome was not reported. Documents held by sender: None.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Glomerulonephritis, Haematuria, Myalgia, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09645. The following is verbatim from the article: "A healthy 50-year-old male received the influenza vaccine in October 1997. Two days later he developed fatigue, chills and low-grade fevers. Over the next 4 weeks he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his fingernails, but the rest of his exam was unremarkable. Workup at that time demonstrated an erythrocyte sedimentation rate of 56 mm/h, positive rheumatoid factor and positive cytoplasmic ANCA at a titer of 1:80 with a positive proteinase 3 ELISA. Blood cultures were negative. A transthoracic echocardiogram did not reveal any valvular vegetation. Two weeks later, he was noted to have microscopic hematuria and an increase in his serum creatinine from 0.9 to 1.3 mg/dl. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. CT chest was unremarkable. He was treated with oral prednisone and oral cyclophosphamide; after achievement of remission of his vasculitis he was switched to azathioprine for maintenance of remission. His renal function was stable with a serum creatinine of 1.3 mg/dl at the time of his last follow-up in October 2012." Outcome was not reported. Documents held by sender: None.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Renal function test normal, Rheumatoid factor positive, Splinter haemorrhages, Vasculitis necrotising
Clinical narrative: Initial report was retrieved from the scientific literature on 17 September 2013. This case is linked to case number 2013-09645. The following is verbatim from the article: "A healthy 50-year-old male received the influenza vaccine in October 1997. Two days later he developed fatigue, chills and low-grade fevers. Over the next 4 weeks he experienced worsening joint pains and muscle aches. His physical exam was notable for splinter hemorrhages in his fingernails, but the rest of his exam was unremarkable. Workup at that time demonstrated an erythrocyte sedimentation rate of 56 mm/h, positive rheumatoid factor and positive cytoplasmic ANCA at a titer of 1:80 with a positive proteinase 3 ELISA. Blood cultures were negative. A transthoracic echocardiogram did not reveal any valvular vegetation. Two weeks later, he was noted to have microscopic hematuria and an increase in his serum creatinine from 0.9 to 1.3 mg/dl. Renal biopsy revealed necrotizing vasculitis and focal necrotizing pauci-immune glomerulonephritis. CT chest was unremarkable. He was treated with oral prednisone and oral cyclophosphamide; after achievement of remission of his vasculitis he was switched to azathioprine for maintenance of remission. His renal function was stable with a serum creatinine of 1.3 mg/dl at the time of his last follow-up in October 2012." Outcome was not reported. Documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling around injection site, blisters around injection site and warm at injection site.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Swelling around injection site, blisters around injection site and warm at injection site.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dizziness, Fatigue, Feeling hot
Clinical narrative: Started to get body aches. Woke up next morning couldn't move. Felt like I had the  flu. Didn't get out of bed until 3Pm. Those symptoms went away. Still stayed sick with cold like symptoms and cough. Racing heart and light headed ness started on 9/16/2013. went to dr on 9/18 said no flu. On 9/21/2013 racing heart, insomnia and extreme heat radiating from body from waist up but no fever. On 9/23/2013 racing heart, extreme fatigue now and burning skin with no fever. Took Tylenol cold once and acetaminophen and ibuprophen throughout.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Insomnia, Movement disorder, Nasopharyngitis, Pain
Clinical narrative: Started to get body aches. Woke up next morning couldn't move. Felt like I had the  flu. Didn't get out of bed until 3Pm. Those symptoms went away. Still stayed sick with cold like symptoms and cough. Racing heart and light headed ness started on 9/16/2013. went to dr on 9/18 said no flu. On 9/21/2013 racing heart, insomnia and extreme heat radiating from body from waist up but no fever. On 9/23/2013 racing heart, extreme fatigue now and burning skin with no fever. Took Tylenol cold once and acetaminophen and ibuprophen throughout.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Skin burning sensation
Clinical narrative: Started to get body aches. Woke up next morning couldn't move. Felt like I had the  flu. Didn't get out of bed until 3Pm. Those symptoms went away. Still stayed sick with cold like symptoms and cough. Racing heart and light headed ness started on 9/16/2013. went to dr on 9/18 said no flu. On 9/21/2013 racing heart, insomnia and extreme heat radiating from body from waist up but no fever. On 9/23/2013 racing heart, extreme fatigue now and burning skin with no fever. Took Tylenol cold once and acetaminophen and ibuprophen throughout.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Swelling face
Clinical narrative: Vaccine was administered around 9:30 pm on Monday, September 9th. At around noon on Tuesday, September 10th, patient woke up with swelling of the lips and cheeks. Patient went to the ED. No treatments were administered. Swelling came down and patients lips and cheeks returned to normal prior to waking up the next day.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral
Clinical narrative: Employee complained of lip numbness a couple hours after getting the flu vaccine. This lasted for 5 days. Employees own PCP was notified on Friday afternoon.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site pain, Mobility decreased
Clinical narrative: Shoulder pain ensued upon vaccine administration as normal; however as time went by the pain became more intense and has led to a more than modest decreased mobility of the shoulder.  Of note - the vaccine was administer very high in the shoulder muscle.
Age: 0.16
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 9/6/13. Mother brought pt. back to clinic. R thigh-tender, warm to touch with redness almost up to the kole.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, Herpes zoster, Renal failure
Clinical narrative: This spontaneous report as received from a 85 year old female patient regarding herself. The patient's pertinent medical history was none and the current conditions included allergic to iodine (which caused rash) and allergic to PERCOCET (which caused nausea). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) vial. Concomitant medications were none. Approximately on 06-SEP-2013 (reported as 2 weeks ago), the patient experienced shingles after receiving ZOSTAVAX. The patient was treated with Valacyclovir. Approximately on 16-SEP-2013 (reported as 4 days ago) the event shingles was recovered. The patient also stated that after taking Valacyclovir she developed renal failure and hallucinations, approximately on an unknown date in September 2013. Patient sought medical attention and had visited a Physician. Laboratory tests was none. The outcome of renal failure and hallucinations was unknown. Upon internal review, the event renal failure was considered as medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL, HEP, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Pt. feeling dizzy after receiving 4 vaccines.  Cool compress applied and a sucker was given.  Pt. recovered 15 minutes later and left.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Malaise, Nasal congestion, Rhinorrhoea
Clinical narrative: Stuffy, runny nose, headache, significant fatigue and malaise - lasted 72 hours onset about 48 hrs after vaccination - no treatment.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: After receiving flu vaccine about 5 hours started having swelling, warmth, itching, pain at site.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Myalgia, Pyrexia, Swelling
Clinical narrative: Swelling, fever, red streaks, muscle pain limited range of motion.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Periorbital oedema, Pyrexia
Clinical narrative: After vaccination for 2 days myalgia, fever. Facial edema.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Received flu shot 9/19/13 5 pm. Low grade fever overnight. Indurated hot rash 1 1/2 cm below injection site - tender about 3 in diameter developed 9/20/13 about 4-5 pm. Hives developed on stomach 9/20/13 10 pm. BENADRYL 50 mg PO x 1; hydrocortisone ointment applied 9/20/13 10-10:30 pm.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Received flu shot 9/19/13 5 pm. Low grade fever overnight. Indurated hot rash 1 1/2 cm below injection site - tender about 3 in diameter developed 9/20/13 about 4-5 pm. Hives developed on stomach 9/20/13 10 pm. BENADRYL 50 mg PO x 1; hydrocortisone ointment applied 9/20/13 10-10:30 pm.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 31 year old female patient with allergy to cantaloupe, pear, tree nuts, penicillin, cucumber, oxycodone, shellfish, lactose and latex. On 19-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot# reported as J004061, expiry: 25-JUN-2014), intramuscularly in the left deltoid. On 19-SEP-2013, the patient developed a 4 inch in diameter red indurated injection site reaction. The patient also had chills. Patient sought medical attention. The patient was already hospitalized at the Medical Center for a vaginal hysterectomy and the PNEUMOVAX23 was given before discharge. The discharge was delayed due to this reaction and pain management post surgery. This was her first vaccination with PNEUMOVAX23. She has been treated with ice packs to the site and BENADRYL. The outcome of red indurated injection site reaction and chills was reported as not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female who on 15-SEP-2011 was vaccinated with a dose of GARDASIL and VARIVAX (Merck), also a Pregnancy Registry product, while pregnant (lot# and route was not reported). The patient sought medical attention via contacting the registered nurse. Additional information received from the registered nurse on 18-OCT-2012. On an unknown date the patient gave birth to a healthy baby without any problems encountered. The nurse did not have any other information about facts surrounding the delivery or infant demographics; only that her community sources stated that the birth was a healthy outcome and the patient moved from the area. No further information is available. Additional information is not expected.
Age: 29.0
Sex: M
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: Nausea after 1st pill.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Headache
Clinical narrative: Abdominal cramping and mild headache after 1 dose.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Localized reaction with redness/swelling (R) thigh.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a 11 year old male patient. On 11-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J003727, expiration date 07-NOV-2015) (reported as 07-JAN-2015) in the right arm (dose and route of administration were not reported). On the same day (11-JUL-2013) the patient was vaccinated with MENACTRA in the right arm (dose, route and lot number not reported), and TDAP in the left arm. On 11-JUL-2013 the patient developed swelling at the injection site after receiving GARDASIL. On 12-JUL-2013 (reported as the next day), the patient developed blisters around the injection site that lasted "around 3-4 days". The patients was not treated for the events. The patient's mother called the physician office on 18-SEP-2013 to schedule the second dose of GARDASIL. The patient recovered from blisters around the injection site in July 2013 (lasted "around 3-4 days"). The patient recovered from swelling at the injection site on an unknown date in 2013. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pallor, Vomiting
Clinical narrative: Pallor, nausea, vomiting, faintness symptoms resolved in 10 min, pt was layed flat with cool compresses on forehead and neck.
Age: 39.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Biopsy muscle abnormal, Biopsy skin abnormal, Dermatomyositis
Clinical narrative: Initial report was received via a search of the scientific literature on 10 September 2013. According to the author, a 39-year-old female patient had received an injection of H1N1 (manufacturer, lot number, route, site and date of administration not reported), and one week later, she developed DM (dermatomyositis) which was skin/muscle biopsy confirmed (date of testing not reported). She received prednisone as corrective treatment and recovered (date of recovery not reported). The reporter for this case is the same as for case number F2000-01658. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus, Rash generalised
Clinical narrative: Initial report received from a health care professional on 17 September 2013. A female patient (date of birth not reported) had received FLUZONE INTRADERMAL (lot number, site and date of administration not reported) and an unspecified amount of time later, "broke out in a rash all over her body and the doctor had to give her a shot of BENADRYL." The patient's arm swelled up "about the size half of a dollar bill and is extremely red and itches." No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 0.62
Sex: F
Vaccine: HIBV, PPV, TDAP
Symptoms: Hypersomnia, Incorrect dose administered
Clinical narrative: 2nd dose given on 7/3. 3rd series of Tdap/HIB/PCV combo was administered on 9/17/13. Nurse administered extra dose on 9/23 by mistake instead of giving Hep B which was due. Doctor realized error when patient still in the office and apologized for mistake. Baby slept for 14 hours straight that day.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye swelling
Clinical narrative: Under eye swelling; mild erythema remains this morning. Right eye worse than left. No new skin or hair products.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient has a two inch diameter area of redness that is itchy but not painful. This area is on the left deltoid where the vaccination was given.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Flushing, Musculoskeletal pain
Clinical narrative: 1-2 minutes after shot felt pain in shoulder, into (R) chest then felt flushed, short of breath. No previous reaction to multiple flu shots. No egg allergy.
Age: 43.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site discharge, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received from a healthcare professional on 18 September 2013. A 43-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, lot number C443 (corresponding Sanofi Pasteur Inc. lot number U4667AA) and an intramuscular injection in the left deltoid of FLUZONE, lot number UH896AB, on 05 September 2013. An immediate bump developed on the left deltoid and the area became hot to touch. On 12 September 2013, the bump popped and had yellow/greenish drainage. Several days later the bump became hard. The patient was seen by her primary care physician and clindamycin was prescribed. The patient was seen in the office on 18 September 2013 and symptoms have improved but have not yet resolved. The patient had no illness at the time of vaccination and allergies to ZITHROMAX, BACTRIM and doxycycline. Outcome was not recovered. Documents held by sender: None.
Sex: U
Vaccine: FLUX
Symptoms: Renal impairment, Rhabdomyolysis
Clinical narrative: Initial report was received via a search of the scientific literature on 10 September 2013 which involved a cluster of two patients. According to the author, in two patients (patient identifiers not reported), rhabdomyolysis with acute, transient renal dysfunction occurred after influenza administration to patients concurrently treated with HMGCOA reductase inhibitors (statins) with/without a fibrate. Speculatively, the concomitant use of myotoxic drugs increased the risk for muscle breakdown in these patients. The influenza vaccine manufacturer, lot number, route, site and date of administration was not reported. Outcome was not reported. The reporter for this case is the same as for case number F2000-01658. Documents held by sender: None.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: 5 red bumps on left/back.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLUN4
Symptoms: Laboratory test, Local reaction
Clinical narrative: Childs mom call after hours triage on 9/12 to report event was sent to ED and then was hospitalized with large local immunization reaction. D/C home later on 9/13/13.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction: red, painful to touch, hot to touch, 6 mm diameter swelling 48 hours post injection. Started approx. 6 hours post injection. NP suggested the use of BENADRYL and ice. No treatment at time of visit.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pruritus, Rash generalised, Rash papular
Clinical narrative: One day after HAVRIX and ADACEL administered child developed a flesh colored papular rash on neck and face, spread intermittently to trunk and legs. Taking CLARITIN due to pruritis, MENVEO also administered.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Developed (L) arm swelling and redness on 9/20 - 9/20. Vaccine was given on 9/19. Pt ordered Triamcinolone tropical cream 2 times a day.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Pain in extremity, Poor quality sleep
Clinical narrative: 24-26 hrs post vaccine administration, started with sore arm, headache, restless sleep.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Rash generalised
Clinical narrative: Vaccine 9/21/13 developed rash on neck 9/22/13. Progressed throughout body 9/24/13.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Dizziness, Feeling of body temperature change, General physical health deterioration, Heart rate increased
Clinical narrative: Five minutes after receiving flu shot, patient felt dizzy and had elevated heart rate and blood pressure. Her symptoms continued and she was very cold, then very warm. It called an ambulance. While waiting, her condition seemed to deteriorate - she had a wave of nausea and was shaking. She complained her throat hurt and felt tight, so I administered an EPIPEN. At that point about 25 minutes had passed. Several minutes later, paramedics arrived and took her to ER. Patient received BENADRYL and steroids at ER.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Oropharyngeal pain, Throat tightness, Tremor
Clinical narrative: Five minutes after receiving flu shot, patient felt dizzy and had elevated heart rate and blood pressure. Her symptoms continued and she was very cold, then very warm. It called an ambulance. While waiting, her condition seemed to deteriorate - she had a wave of nausea and was shaking. She complained her throat hurt and felt tight, so I administered an EPIPEN. At that point about 25 minutes had passed. Several minutes later, paramedics arrived and took her to ER. Patient received BENADRYL and steroids at ER.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Flushing, Heart rate increased
Clinical narrative: Five minutes after receiving flu shot, patient felt dizzy and had elevated heart rate and blood pressure. Her symptoms continued and she was very cold, then very warm. It called an ambulance. While waiting, her condition seemed to deteriorate - she had a wave of nausea and was shaking. She complained her throat hurt and felt tight, so I administered an EPIPEN. At that point about 25 minutes had passed. Several minutes later, paramedics arrived and took her to ER. Patient received BENADRYL and steroids at ER.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hyporesponsive to stimuli, Nausea, Oropharyngeal pain, Throat tightness, Tremor
Clinical narrative: Five minutes after receiving flu shot, patient felt dizzy and had elevated heart rate and blood pressure. Her symptoms continued and she was very cold, then very warm. It called an ambulance. While waiting, her condition seemed to deteriorate - she had a wave of nausea and was shaking. She complained her throat hurt and felt tight, so I administered an EPIPEN. At that point about 25 minutes had passed. Several minutes later, paramedics arrived and took her to ER. Patient received BENADRYL and steroids at ER.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Patient reports she still has a mark on her arm where she received the vaccine a year ago. There is a small bump where injection was given and the skin around it is white/lightened. She didn't notice any injection site problems immediately after vaccine.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Pt said she ran fever and had nausea and vomiting and then developed a rash on right arm.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient received her flu shot on 9-18-13 about 1pM, then came in 4:36pm 9-19-13 stating she had a rash with itching at injection site. I recommended she apply warm compresses throughout the evening after work, take BENADRYL, and apply triple antibiotic ointment. I also suggested she have Dr. (for whom she works) exam her arm after leaving here on 9-19-13. I called her at 11:30am at work on 9-20-13 to see how -- about the same. She said the BENADRYL and compresses did give her some relief on 9-19-13.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Blepharospasm
Clinical narrative: Eye twitching when tired or concentrating daily since injection.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Local reaction erythema, progressed and radiated from injection site, warm to touch. Pt. followed at urgent care. Keflex 500g, D20 x 10 days - Cellulitis
Age: 4.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Fall, Loss of consciousness, Musculoskeletal stiffness, Somnolence
Clinical narrative: Pt received MMR, Varivax and Quad flu - sitting on exam table and talking and "passed out" - fell face first off table to floor then stiffened - questionable seizure. Was drowsy and "out of it" for quite some time. - 911 called and sent to ED.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh swelling and red. 9/20/13 at 11:45 plan of treatment Augmentin 400 mg-57 mg/5ml take 1tsp twice daily; Prednisolone 15 mg/5ml take 1 1/2 tsp daily.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Received vaccine 9-06-13 in PM. On 09-08-13 evening developed a rash with itching on both legs. Itching and rash still present 9-10-13. Client's mother states rash also in clients two brothers.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Administration related reaction, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Symptoms: severe shoulder pain and limited range of motion and shoulder injury related to vaccine administration (SIRVA).
Age: 5.0
Sex: M
Vaccine: FLUN4, IPV, MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Physician order in EHR for DTap, nurse administered Tdap. Pt tolerated vaccination without incident - mother made aware of incorrect vaccination having been administered. Advised to monitor for side effects.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with rheumatoid arthritis, high blood pressure and high cholesterol. On 23-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot # H017448, Exp date 20-DEC-2013), 0.65 ml, subcutaneous in the arm. On an unspecified date after ZOSTAVAX was administered to a patient on 23-MAY-2013, the patient developed a dark mark and tenderness at the injection site. The dark mark was still present on the patient's arm and that area felt tender upon palpation. There was not treatment given for the adverse event. No lab diagnostics studies were performed. At the time of reporting, the outcome of the events was reported as recovering. It was reported that the patient had came back to see the pharmacist. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old patient. On 18-SEP-2013 the patient was vaccinated with the second dose of PNEUMOVAX23 (lot# J005011, Exp date 04-DEC-2014), injection, 0.5 ml, intramuscular (anatomical location was not reported). The reporter stated that a patient received her first dose of PNEUMOVAX23 "two years ago" (in 2011) and received the second dose on 18-SEP-2013. No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to an 18 year old female patient with depression, bi-polar and tomatoes allergy. The patient's medical history included 2 previous pregnancies. On 09-SEP-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H021346, expiry date: 01-OCT-2015) (route, dose and location unspecified). Other suspect therapy included the second dose of VARIVAX (Merck) (lot# J002616, expiry date: 01-MAR-2015) (route, dose and location unspecified) vaccinated on 09-SEP-2013. The first dose of VARIVAX (Merck) was administered on 22-SEP-2009. Concomitant therapies included influenza virus vaccine (unspecified) (manufacturer Sanofi Pasteur), DEPAKOTE and valacyclovir. The patient was found to be pregnant with LMP (Last Menstrual Period) of 20-AUG-2013 and EDD (estimated due date) of 27-MAY-2014 while given the first dose of GARDASIL and the second dose of VARIVAX (Merck). The pregnancy test was performed in office. Trimester(s) of exposure were the first. The patient contacted the office and no treatment was given. At the time of the report, the pregnancy outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of ROTATEQ (lot #, expiration date, dose, route unspecified) stored as high as 53F and as low as 26F for unknown periods of time. No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 5 year old patient. The patient was administered first dose of VARIVAX (Merck) 0.5 milliliter, subcutaneous (lot number and expiry date were not reported) and M-M-R II (lot number, expiry date, route and dose were not reported) prior to the 12 month birthday on 06-FEB-2007. The second dose of both VARIVAX (Merck) (lot number, expiry date, route and dose were not reported) and M-M-R II (lot number, expiry date, route and dose were not provided) was administered on 13-JUL-2011. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of PNEUMOVAX23 (lot #, expiration date, dose, route unspecified) stored as high as 53F and as low as 26F for unknown periods of time. No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of COMVAX (lot #, expiration, dose, route unspecified), stored as high as 53F and as low as 26F for unknown periods of time. No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Blister, Herpes virus infection, Pain in extremity, Skin lesion
Clinical narrative: This spontaneous report as received from a 61 year old female patient refers to herself with thyroid disorder and hypersensitivity. Medical history included cataract surgery, hysterectomy, carpel tunnel both hands and methylprednisolone allergy and break out on itch and scratch if medication not taken. In approximately April 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route was not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown) and ATARAX. The patient had been experienced two outbreaks of herpes. She advised the first outbreak was about a month after the vaccine in May 2013 and the second was in June but not sure on exact date. She described it as having lesions, swelling, pimple like blisters. She stated that the pimples were now scabbing. The patient sought unspecified medical attention. The doctor prescribed acyclovir for future break outs. She advised that she started to get a pain on the upper right thigh area prior to the outbreak. The outcome of events was unknown. On 09-MAY-2013 before herpes eruption, the patient performed an unspecified lab diagnostics study. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a 61 year old female patient refers to herself with thyroid disorder and hypersensitivity. Medical history included cataract surgery, hysterectomy, carpel tunnel both hands and methylprednisolone allergy and break out on itch and scratch if medication not taken. In approximately April 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route was not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown) and ATARAX. The patient had been experienced two outbreaks of herpes. She advised the first outbreak was about a month after the vaccine in May 2013 and the second was in June but not sure on exact date. She described it as having lesions, swelling, pimple like blisters. She stated that the pimples were now scabbing. The patient sought unspecified medical attention. The doctor prescribed acyclovir for future break outs. She advised that she started to get a pain on the upper right thigh area prior to the outbreak. The outcome of events was unknown. On 09-MAY-2013 before herpes eruption, the patient performed an unspecified lab diagnostics study. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, HPV2, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Vaccine 2 days ago on Monday. Approximately 4 x 4 cm area with hardening, warmth, erythematous at Lt thigh.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse via company representative, refers to a two female patients of unknown age. On an unknown date the patients were vaccinated with the dose of ZOSTAVAX (dose, route of administration and lot number were not reported). On an unknown date, the patients developed shingles after vaccination. The patients sought medical attention via office visit. The outcome of shingles was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Muscle twitching
Clinical narrative: This spontaneous report as received from a registered nurse refers to currently 14 years old male patient with none pertinent medical history and none drug reactions/allergies. On 30-AUG-2012 the patient was vaccinated with his first and the only dose of GARDASIL intramuscular injection, (dose and site of administration were not reported) (lot # H010915; exp. date: 13-FEB-2015). On the same day as the GARDASIL (30-AUG-2012) the patient was also administered 2 concomitant vaccines: a dose of Hepatitis A virus vaccine and a dose of FLUMIST. On an unknown date the patient experienced facial twitching occurred off and on for a month. The patient sought medical attention via seeing at the office (30-AUG-2013), one year after the dose of GARDASIL was administered. The patient recovered from facial twitching on an unspecified date. There was no treatment given and no lab tests were performed. The relatedness between the therapy with GARDASIL and facial twitching was not reported. This is one of several reports from the same reporter (MARRS # 1309USA000780). The additional information has been requested.
Sex: U
Vaccine: HPV4, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a immunization official. An unknown number of patients were vaccinated with doses of GARDASIL (lot#, expiration date, dose, frequency, route indication not reported) or M-M-R II (lot#, expiration date, dose, frequency, route, indication not reported), that was stored out of range not supported. No adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a unspecified employee via company representative refers to a 12 year old male patient. The patient had received the first dose of VARIVAX (Merck) as a younger child (dates unspecified). On 23-AUG-2013, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot number, expiry date, route and dose were not reported). Approximately on 06-SEP-2013 (reported as 2 weeks after vaccination), the patient broke out in a shingles rash on his neck. Patient sought medical attention and had been to an unspecified health care professional (HCP). The HCP diagnosed the patient with Shingles on 07-SEP-2013. The rash was being covered by a Band-Aid and no other treatment was given. The outcome of broke out in a shingles rash on his neck was reported as not recovered/not resolved. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: This spontaneous report as received from a physician as part of a marketing research program conducted by Research Group refers to a 75 year old female patient with diabetes and hypertension. In approximately September 2003 (reported as 10 years ago) the patient was vaccinated intramuscularly (IM) with a 0.5 ml once dose of PNEUMOVAX23 (lot # was not reported). Concomitant therapies included bisoprolol and metformin. On 28-AUG-2013 the patient had pneumonia. On 28-AUG-2013 chest X-ray was performed and result was pneumonia. The outcome of the event was reported as recovered on 05-SEP-2013. The reporter considered the event to be not related to PNEUMOVAX23. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with diabetes. Drug reactions/allergy to BACTRIM. Pharmacist reported that on 04-SEP-2013 patient developed itchy, red, raised uncomfortable rash on the back of the arm at the injection site after a 0.65 dose of ZOSTAVAX (lot # J003806, expiry date: 03-JUL-2014) subcutaneous at the back of the arm vaccinated on 03-SEP-2013. The rash was hot to the touch and about 4-5 inches in diameter. Concomitant therapies included  furosemide, hydrochlorothiazide, irbesartan, meloxicam, NOVOLOG, PRILOSEC, PRISTIQ, VALTURNA, WELCHOL, and ZETIA. The patient has sought medical attention via pharmacist visit. No lab diagnostics studies were performed. BENADRYL and cortisone cream were given for treatment. At the time of report, the outcome of the events was not recovered,  Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a 74 year old consumer regarding himself. The patient had no drug reactions/allergies. The patient's current condition included a rash on his skin that felt like insect bites and itched miraculously. Approximately on an unknown date in 2012 (reproted as about a year ago), the patient was vaccinated with a dose of one time vaccination ZOSTAVAX (lot number, expiry date, route and ose were not reported) injection. Concomitant therapies included pravastatin sodium and fenofibrate. The rash was existed on his skin that felt like insect bites and itched miraculously went away on an unspecified date, within a week or so after having received ZOSTAVAX. Approximately on 27-AUG-2013 (reported as 2 weeks ago), the patient experienced a similar rash that returned. No medical attention was sought. Lab Diagnostics Studies were not Performed. The patient treated the more recent rash with apple cider vinegar and tumeric. Approximately on 08-SEP-2013 (reported as a couple days ago), the event rash was recovered/resolved. The outcome of a rash on his skin that felt like insect bites and itched miraculously went away within a week or so after having received ZOSTAVAX was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Swelling
Clinical narrative: 9/23/13 PM - Pt noticed itching. 9/24/13 PM - Area itching-removed band aid noticed area red and swollen. Took Benadryl 50mg P.O. at bedtime. 9/25/13 Observed. Reddened, feverish, raised area on R upper arm-60 mm x 50 mm (Applied cool compress. Advised to continue cool compress-PRN-may apply cortisone cream to R upper arm.
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Activities of daily living impaired, Back pain, Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: See attached.
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: See attached.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Erythema, Induration, Pain in extremity
Clinical narrative: About 6" long. About 8" around arm. Bright red, hard, painful bruising in the center. BENADRYL decreased on 9/23.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site injury, Tendon injury
Clinical narrative: Pt reported on 9/25/13 that they experienced a nicked tendon from flu vaccine. Went to Dr. and they said that it will heal in time and to use ice and anti-inflammatory.
Age: 40.0
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to approximately 40 years old female patient with no known drug reactions/allergies. The patient's history of previous pregnancies and live births was not known. On 07-NOV-2012, the patient was vaccinated with a dose of VARIVAX (Merck) lot number G009083, expiry date was 06-SEP-2013, route and dose were not reported), tetanus toxoid, Hepatitis A virus vaccine unspecified, M-M-R II and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (Lot number, expiry date route and dose were unspecified). No concomitant medications were reported. Subsequently, the patient became pregnant with an last menstrual period (LMP) of 19-OCT-2012 and estimated date of conception (EDD) 25-JUL-2013. It was reported that the patient's date of conception was either on 02-NOV-2012 or 03-NOV-2012. The patient sought medical attention. The patient was treated and the treatment details were unspecified. No adverse effects reported at the time of the report. The outcome of pregnancy was unknown (outcome pending). Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a patient's mother regarding her approximately 15 month old daughter with asthma. On 13-FEB-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# reported as 017011 Expiry 24-SEP-2014). Concomitant therapies included albuterol. On an unknown date in 2013, the patient developed shingles after receiving VARIVAX. It was unspecified if the patient sought medical attention. The outcome of shingles was reported as not recovered. Additional information has been requested.