chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Pain to right shoulder since the day I received the flu shot. Hurts to pull my arm across my body, hurts to remove my top "shirts" or put on.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: About 3 minutes after receiving flu shot, pt passed out in chair, moved pt to floor, pt regained consciousness, moved to a sitting position after a few mins, moved into chair and passed out again - 911 arrived seconds later and took pt to E.R.
Sex: F
Vaccine: FLUX
Symptoms: Abasia, Acute disseminated encephalomyelitis, Bedridden, Malaise
Clinical narrative: Initial report was retrieved on 30 October 2014 during a routine media monitoring by a company representative. A female patient (date of birth not reported) had received on an unspecified date in November 2013 a INFLUENZA VACCINE (manufacturer, lot number, route and site of administration not reported) and four days later on an unspecified date in 2013, experienced Acute Disseminated Encephalomyelitis. According to the mother of the patient, she took her daughter for her routine flu shot and four day later fell ill. The daughter is bedridden and can no longer walk. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Patient's mom stated he had swelling of right arm - we didn't see patient in our office.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Asthma, Condition aggravated
Clinical narrative: Pt had asthma attack after receiving vaccine - was treated w/ albuterol neb soln.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Patient received flu vaccine and shingles vaccine on 10/6/14. Patient reporting chills, fever, aching and nausea from 10/13/14 - 10/15/14.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Induration, Local swelling
Clinical narrative: Redness, swelling, area slightly indurated about 3x2" in diameter. Positive bruise on upper part dime size at left arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Pt stated that she noticed about a 4 x 3" swelling below the point of immunization that occurred several hours after receiving the shot and lasted about 4 days and went away after ice application and OTC ibuprofen.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Erythema, Feeling hot, Hyperhidrosis
Clinical narrative: 14 hrs after injection, skin burning over entire body from scalp to toes then turning very red. Dizziness, sweats and nausea followed for a short period. Intense burn turned to itching burn followed by chills. Took 2 BENADRYL which eased symptoms within an hour. Felt very hot, but temperature was 97.5.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pruritus, Skin burning sensation
Clinical narrative: 14 hrs after injection, skin burning over entire body from scalp to toes then turning very red. Dizziness, sweats and nausea followed for a short period. Intense burn turned to itching burn followed by chills. Took 2 BENADRYL which eased symptoms within an hour. Felt very hot, but temperature was 97.5.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea, Fall, Headache, Heart rate increased
Clinical narrative: Terrible spasms, fast heart rate, troubled breathing. Fell on floor - pain in skull down back and couldn't move myself. Husband couldn't get me up as would stiffen. Finally got me in bed sick.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Mobility decreased, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Terrible spasms, fast heart rate, troubled breathing. Fell on floor - pain in skull down back and couldn't move myself. Husband couldn't get me up as would stiffen. Finally got me in bed sick.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Throat tightness
Clinical narrative: Initial report received from a consumer (the patient) on 27 October 2014. The reporter also reported another adverse event on the same day which is captured under the case 2014SA148532 (cluster). A 52-year-old female patient, with no reported medical history and no known allergies, had received a dose of FLUZONE (lot number U2744AA, route and site of administration not reported) on 15 October 2008. She did not receive any previous dose of this vaccine. On the same day of the vaccination, she went home from work, fell asleep; had throat tightness and palpitations. The patient was able to drink water and sat for about an hour and it resolved. There was no relevant diagnostic tests done. The patient outcome was recovered. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cough, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever 102 then down to 100 lasted for  5 days.  She also experienced weakness, slight headache, sor ethroat, coughing.  Rash occured last and it lasted for 3 days.  Pt is fully recovered after 1 week.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Fever 102 then down to 100 lasted for  5 days.  She also experienced weakness, slight headache, sor ethroat, coughing.  Rash occured last and it lasted for 3 days.  Pt is fully recovered after 1 week.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Blood test, Diarrhoea, Endoscopy, Haematochezia
Clinical narrative: Stomach pain, bloody stool, diarrhea up to 7 times a day, arm pain lasting for weeks.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Stool analysis, Urine analysis
Clinical narrative: Stomach pain, bloody stool, diarrhea up to 7 times a day, arm pain lasting for weeks.
Age: 15.0
Sex: M
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Vertigo for 3 days, seen in my office, rx meclizine.
Age: 33.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Asthenia, Cough, Dizziness, Dysphonia
Clinical narrative: Coughing, wheezy, dizzy, weak, shortness of breath, hoarse (no voice), body aches, arm sore where vaccinated.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pain, Vaccination site pain, Wheezing
Clinical narrative: Coughing, wheezy, dizzy, weak, shortness of breath, hoarse (no voice), body aches, arm sore where vaccinated.
Age: 85.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia, Pain in extremity, Tendonitis
Clinical narrative: Pt received a flu vaccine (R) arm on 10/28/2014 - I received a phone call from pt on 10/29/14 - she states she began to have pain/numbness and achy feeling in (R) arm about 12 hours after receiving vaccine. Pain has increased - I instructed her to call her PCP for evaluation.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Local swelling, Pain in extremity, Petechiae, Rash
Clinical narrative: Rash, pruritic, red, petechiae; began on feet and spread up legs after injection. Swelling in (R) hand. Severe pain in feet and legs and bruising.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Rash, pruritic, red, petechiae; began on feet and spread up legs after injection. Swelling in (R) hand. Severe pain in feet and legs and bruising.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHEH2014US021232, is an initial spontaneous report from a consumer received on 20 Oct 2014. This report refers to a female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported) on an unknown date (years ago). On an unknown date after vaccination, she experienced Guillain-Barre syndrome. It was reported that the patient cannot get the vaccine now. The outcome of the event was unknown. Seriousness and causality was not reported. Seriousness assessment of the event Guillain-Barre syndrome was based on NVD key events.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Pt states a few hours after flu shot she was at home and got hives then had trouble breathing and went to hospital, was admitted to hospital for unknown # of days. Patients phone # is not working re follow up questions.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient says shot was given; was sore at time given since then has gotten progressive worse. Seen MD has been given antibiotic, been to ER and PCP has ordered MRI.
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Heart rate increased, Muscular weakness, Nervousness, Syncope
Clinical narrative: 1 hour after vaccination felt rapid heartbeat, faint, muscle weakness. Called doctor but did not get a call back. Feels better after 2 days but still has muscular weakness and nervousness.
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Abasia, Crying, Injection site pain, Pyrexia
Clinical narrative: Mother called on-call provider on 10/5/14 - pt had fever, not walking, crying about leg pain. Went to ED.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: 9/23/14 Received flu and pneumonia shots. 9/24/14 Pneumonia injection site swollen and red, 99.6 fever. 9/25/14 Redness and swelling spread from injection site to 5" below elbow. 9/25/14 Prescribed doxycycline for infection (Bacterial).
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: 9/23/14 Received flu and pneumonia shots. 9/24/14 Pneumonia injection site swollen and red, 99.6 fever. 9/25/14 Redness and swelling spread from injection site to 5" below elbow. 9/25/14 Prescribed doxycycline for infection (Bacterial).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Started with the area of vaccine administration becoming hot and swollen. Then developed a fever and after 2 days, she presented to the Hospital and was admitted 10/25-10/20/2014 for cellulitis treatment.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient presented to the pharmacy on 11/5 at 1PM with red, inflamed site of injection (left upper arm). She said it was warm to touch. It hurt going in and remained painful that night. She said it was 100% better today than before. 3 x 5 in red area was visible. Pt said she took aspirin and Telnol.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient started to experience dizziness. Has remained since 11/3/14. Onset was two days after receiving the influenza vaccination.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Feeling cold, Pain, Pyrexia
Clinical narrative: Patient states on 10/17/14 he felt cold, freezing, and achy. Had a fever of 101.7. No appetite. Same symptoms on 10/18/2014. Went to emergency room on 10/19/14. Was admitted and given IV fluids and antibiotics. He states he was not given a diagnosis. Was discharged on 10/21/14.
Age: 31.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Sensation of heaviness, Tenderness
Clinical narrative: Increased tenderness and pain to uppper arm/shoulder. Arm feels heavy at times. Limited mobility of arm due to pain.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Eye swelling, Lacrimation increased
Clinical narrative: Patient complained to physician about myalgia, shortness of breath, watery/swollen eyes, chest tightness, dizziness, nausea.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea
Clinical narrative: Patient complained to physician about myalgia, shortness of breath, watery/swollen eyes, chest tightness, dizziness, nausea.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood culture negative, Body temperature increased, Injection site cellulitis, White blood cell count increased
Clinical narrative: Cellulitis at, around, above, and below injection site with 103 degree temperature. Required hospitalization with IV Vancomycin as well as IV Zosyn with po 10-day course doxycycline and cefdinir upon hospital discharge.  The pharmacy says the manufacturer was Merck but I cannot find neither the seasonal flu vaccine nor the pneumococcal vaccine listed under Merck.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthritis infective
Clinical narrative: Cellulitis at, around, above, and below injection site with 103 degree temperature. Required hospitalization with IV Vancomycin as well as IV Zosyn with po 10-day course doxycycline and cefdinir upon hospital discharge.  The pharmacy says the manufacturer was Merck but I cannot find neither the seasonal flu vaccine nor the pneumococcal vaccine listed under Merck.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood culture negative, Body temperature increased, Injection site cellulitis, White blood cell count increased
Clinical narrative: Patients wife said patient had to be admitted for treatment of infection in the shoulder. States he started having symptoms a day or two after injection.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthritis infective
Clinical narrative: Patients wife said patient had to be admitted for treatment of infection in the shoulder. States he started having symptoms a day or two after injection.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash
Clinical narrative: Itching all over after receiving the Flu Vaccine.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness unilateral, Nuclear magnetic resonance imaging, Sudden hearing loss
Clinical narrative: Sudden hearing loss in right ear.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dysphagia, Injection site pain, Injection site swelling, Local swelling, Tenderness
Clinical narrative: Burning, stinging and swelling of right arm where injections given.  Complain of swelling and difficulty in swallowing in right side of neck. Complain of tender to touch right arm. Administered EPI 1:1000 X one dose and Diphenhydramine 50 mg.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Hyperhidrosis, Nausea, Pyrexia, Tremor
Clinical narrative: 5:15 PM Nausea, 5:45 PM Shaking, 6:00 PM Diarrhea, 6:45 PM Extreme Shaking, 7:15 PM Vomiting, 7:45 PM Retired to Bed With Heating Pad on Chest to Control Shaking, 12:30 AM Fever Broke with soaked Bed Clothes, 9:00 AM, 11/04/2014, Near Normal.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 5:15 PM Nausea, 5:45 PM Shaking, 6:00 PM Diarrhea, 6:45 PM Extreme Shaking, 7:15 PM Vomiting, 7:45 PM Retired to Bed With Heating Pad on Chest to Control Shaking, 12:30 AM Fever Broke with soaked Bed Clothes, 9:00 AM, 11/04/2014, Near Normal.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Headache, Pruritus, Pyrexia
Clinical narrative: PT states she had a fever, itching, headache, general weakness.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Weight bearing difficulty
Clinical narrative: Following my flu shot I could not lift my right arm over my head. I struggled to get dressed, lift a cup of coffee, and carry anything heavy. I have been unable to reach things from a shelf.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Condition aggravated, Hyperinsulinism, Hypoglycaemia, Pyrexia, Stress
Clinical narrative: Fever, recurrent preprandial hypoglycemia.
Age: 49.0
Sex: M
Vaccine: HEPAB
Symptoms: Ear discomfort, Rhinorrhoea, Tinnitus
Clinical narrative: Pt complaining of ringing in left and right ears. Worse in left. Both sound plugged, runny nose. Had same symptoms 1 month prior when received 1st Twinrix. Stopped 1 week before 2nd Twinrix. Pt did not report this to RN. Pt had MD appt on Fri 10/31/2014, cancelled appt even though symptoms remain. TC 11/05/2014 as followup. Ringing in ears continue, left worse than right. Recommended going to MD for followup.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus, Rash erythematous, Swelling
Clinical narrative: Raised red bump increasing in size over time and developed red bumps/vesicles. Site is itchy and the size of a baseball in circumference as described by the patient. Advised to see a doctor.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Feeling abnormal, Hot flush, Mobility decreased, Muscle tightness
Clinical narrative: Within 30 min of receiving vaccination my muscles all became very tight and tense in my neck, lower back and upper back. By night I was itching all over. In the morning I could barely move to get out of bed. I felt as though I had been beat with a bat. Hot flashes began later that day the itching continued and the muscle pain lasted 4-5 days. I missed work on the 20th which was 5 days after the vaccination due to symptoms.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pruritus generalised
Clinical narrative: Within 30 min of receiving vaccination my muscles all became very tight and tense in my neck, lower back and upper back. By night I was itching all over. In the morning I could barely move to get out of bed. I felt as though I had been beat with a bat. Hot flashes began later that day the itching continued and the muscle pain lasted 4-5 days. I missed work on the 20th which was 5 days after the vaccination due to symptoms.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Chromaturia, Cough, Decreased appetite
Clinical narrative: Rash, itching, swelling, vomiting, fever, dark urine, yellow coloring to skin and eyes. Stomach pain, loss of appetite, loss of energy, frequent urination, dizziness, cough. Treatment: Diphenhydramine 25mg. 1-2 tabs every 6-8 hrs and methylprednisolone 4mg dose Pak, steroid injection
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Pollakiuria, Pruritus, Pyrexia, Rash
Clinical narrative: Rash, itching, swelling, vomiting, fever, dark urine, yellow coloring to skin and eyes. Stomach pain, loss of appetite, loss of energy, frequent urination, dizziness, cough. Treatment: Diphenhydramine 25mg. 1-2 tabs every 6-8 hrs and methylprednisolone 4mg dose Pak, steroid injection
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Scleral discolouration, Swelling, Vomiting, Yellow skin
Clinical narrative: Rash, itching, swelling, vomiting, fever, dark urine, yellow coloring to skin and eyes. Stomach pain, loss of appetite, loss of energy, frequent urination, dizziness, cough. Treatment: Diphenhydramine 25mg. 1-2 tabs every 6-8 hrs and methylprednisolone 4mg dose Pak, steroid injection
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Ear pain, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Throat felt swollen and was feeling tingling sensation in the mouth. Also complained of ear pain.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Areflexia, Faecal incontinence, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Pain in neck and left shoulder initially responsive to ibuprofen/heat/cold. Progressed to increased pain, profound weakness in left arm, numbness tingling in both arms, numn tight belt around upper abdomen, loss of ability to feel urge to stool, lower extremity weakness, loss of reflexes. hospital stay, 5 day IVIG infusion for atypical Guillain Barre. Home now with continued weakness and neuropathies.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Injection site pain, Muscular weakness, Neck pain, Neuropathy peripheral
Clinical narrative: Pain in neck and left shoulder initially responsive to ibuprofen/heat/cold. Progressed to increased pain, profound weakness in left arm, numbness tingling in both arms, numn tight belt around upper abdomen, loss of ability to feel urge to stool, lower extremity weakness, loss of reflexes. hospital stay, 5 day IVIG infusion for atypical Guillain Barre. Home now with continued weakness and neuropathies.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Pain in neck and left shoulder initially responsive to ibuprofen/heat/cold. Progressed to increased pain, profound weakness in left arm, numbness tingling in both arms, numn tight belt around upper abdomen, loss of ability to feel urge to stool, lower extremity weakness, loss of reflexes. hospital stay, 5 day IVIG infusion for atypical Guillain Barre. Home now with continued weakness and neuropathies.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient states she has a rash and hives on palms and fingers. Patient refered to Urgent Care doctor as she does not have a primary care doctor.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: CSF cell count, Encephalopathy, Headache, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Patient reports fever and headache on 10/27/14.  Brought to the emergency room on 10/29/14 and admitted with encephalopathy.  Resolved after 3 days, CSF 15wbc, MRI negative.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 3 hours after injection it was noted to be swollen and tender below injection site. On 11/5/14 there was an area of redness with swelling noted upon waking (06:00 AM) that was approximately 3 inches in diameter. By 4:15 PM on 11/5/14 the area of swelling and redness was measured at 4 inches from proximal to distal edges on left upper arm. This area is hot to touch and begins at about an inch below the injection site. On 11/4/14 the patient took ibuprofen that seemed to help decrease the tenderness.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia
Clinical narrative: Left shoulder was sore on 10-13-14. The shoulder was more achy the next day. No redness or warmth. On 10-15-14 she began having problems moving her shoulder. On 10-18, 19, 20 and 21 she felt fine. On 10-21-14 the left shoulder woke her from her sleep and she problems moving her shoulder/arm. She is currently under treatment with her personal Physician and will be having an MRI of the shoulder.
Age: 29.0
Sex: F
Vaccine: DTP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Arthus reaction.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: Itching, escalated to pain and heat, redness, hardness and blisters at and around injection site.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Itching, escalated to pain and heat, redness, hardness and blisters at and around injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pustule, Injection site reaction, Neuralgia, Paraesthesia
Clinical narrative: Two pustule filled sacs appeared the next day at the site of injection with tingling/nerve pain also at the site of injection. Patient called doctor and explained to him symptoms and was not prescribed any antivirals or pain medications as it was mild in nature. Patient states it resolved on its own approximately 2 to 3 weeks after appearing.
Age: 85.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen red skin at injection site.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Patient came to pharmacy and stated after flu shot her arm started to hurt. Redness and swelling is also present. She is using ice and TYLENOL.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Throat irritation
Clinical narrative: Patient received FLUZONE HD. About an hour later, she felt burning in her throat. Went to local ER and was treated for allergic reaction including fluids and prednisone.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: Irritation at injection site, Right Thigh, Swelling at injection site.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Pt started out with myalgias, headache, and fever of 102.  Fever continued to climb despite ibuprofen around the clock.  On day 2, pt with 104 fever.
Age: 1.51
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion, Influenza A virus test negative, Influenza virus test negative, Streptococcus test negative
Clinical narrative: Febrile Seizure.
Age: 29.0
Sex: F
Vaccine: PER
Symptoms: Fatigue, Insomnia, Lacrimation increased, Myalgia, Oropharyngeal pain
Clinical narrative: All muscles in body began to ache nose and eyes became watery throat became very sore and it hurt to talk. Extremely tired but unable to sleep.
Age: 29.0
Sex: F
Vaccine: PER
Symptoms: Pain
Clinical narrative: All muscles in body began to ache nose and eyes became watery throat became very sore and it hurt to talk. Extremely tired but unable to sleep.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Hypoaesthesia, Impaired work ability, Loss of employment
Clinical narrative: It start that night, I had numbness on my fingers, sharp shocking pain on shoulder, neck and elbow. It was so painful I could barely move my arm I missed work for two days, it seemed to go away but on Sunday November the 5th the pain came back I wasn't able to work for three straight days. I  went back to pharmacy and they didn't offer a solution but to go to a physician the lady didn't even believe for one minute the flu shot would cause that kind of pain even though I had never had any pain in arm what so ever in my life, she was very defensive about it even though I was in a lot of pain. I went to see a doctor and he continued saying there is no way the shot could cause that kind of pain at this point I had missed a lot of days at work because everything from dressing to driving was a challenge he did give me two medications, meloxicam & methylpred after one day the pain went away but came back two days after using all the medication, I missed more days at work as this time I felt like someone had hit me with a 2*4 on my arm neck and shoulder. I was in the process of seeking further medical attention but due to the fact I was a new hire, no insurance and only three paychecks with a lot of missed time I wasnt able to come up with an immediate solution. They said I had missed to many days and FIRED ME, I took the flu shot because it was required by the job, I had never had a flu shot before I took it because of the requirement, otherwise I had no intentions of getting one.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: It start that night, I had numbness on my fingers, sharp shocking pain on shoulder, neck and elbow. It was so painful I could barely move my arm I missed work for two days, it seemed to go away but on Sunday November the 5th the pain came back I wasn't able to work for three straight days. I  went back to pharmacy and they didn't offer a solution but to go to a physician the lady didn't even believe for one minute the flu shot would cause that kind of pain even though I had never had any pain in arm what so ever in my life, she was very defensive about it even though I was in a lot of pain. I went to see a doctor and he continued saying there is no way the shot could cause that kind of pain at this point I had missed a lot of days at work because everything from dressing to driving was a challenge he did give me two medications, meloxicam & methylpred after one day the pain went away but came back two days after using all the medication, I missed more days at work as this time I felt like someone had hit me with a 2*4 on my arm neck and shoulder. I was in the process of seeking further medical attention but due to the fact I was a new hire, no insurance and only three paychecks with a lot of missed time I wasnt able to come up with an immediate solution. They said I had missed to many days and FIRED ME, I took the flu shot because it was required by the job, I had never had a flu shot before I took it because of the requirement, otherwise I had no intentions of getting one.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Formication, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Severe swelling, redness, & bruising at injection site. Rash on both arms, legs, feet, back, stomach, & neck. Lots of itching, skin was crawling. Swelling with some blistering. The reaction continued to progress until 10/08/2014 when Benadryl was taken & a Kenalog shot was administered. Benadryl was taken through 10/10/2014 to control reaction.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised, Swelling
Clinical narrative: Severe swelling, redness, & bruising at injection site. Rash on both arms, legs, feet, back, stomach, & neck. Lots of itching, skin was crawling. Swelling with some blistering. The reaction continued to progress until 10/08/2014 when Benadryl was taken & a Kenalog shot was administered. Benadryl was taken through 10/10/2014 to control reaction.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray
Clinical narrative: Shot itself was virtually painless, but I did think the doctor injected it very high up my left arm, near my shoulder. The next morning the area was sore and got progressively work, limiting movements of my left arm.
Age: 29.0
Sex: F
Vaccine: FLUN4
Symptoms: Activities of daily living impaired, Asthenia, Burning sensation, Decreased appetite, Dizziness
Clinical narrative: Constant Headache/migraine since the day after the vaccine without going away.  At present day of reporting pain has not ceased and has increased causing loss of sleep.  Increased in pain to the point of tears and unable to ease the pain.  Feeling like my head would explode.  Unbearable headache pain.  Soreness around and under eyes.  Soreness in nose with a burning sensation.   Rash/hives along jawline/cheek on left side of face.  Itchiness.  Dizziness when laying down and getting up.  Dizziness when bending over.  Blurred vision with 'stars' when I get up from laying or bending over position.  Vision becomes so clouded I have to brace myself so I do not fall until it comes back.  Lasts about 30 seconds or so.  Irritable.  Nausea.  Sluggishness.  Have not felt myself.  Felt off since getting the vaccine.  Sore/stiff neck.   Decreased appetite.  Shortness of breath.  Lack of energy.  Weakness. Heart races at random times.  All of these reactions have impaired my daily life.  They have all been consistent since the day after receiving the vaccine.  Treatment: Dr. prescribed Amitriptyline to help reduce the headaches/migraines.
Age: 29.0
Sex: F
Vaccine: FLUN4
Symptoms: Dyspnoea, Facial pain, Feeling abnormal, Insomnia, Irritability
Clinical narrative: Constant Headache/migraine since the day after the vaccine without going away.  At present day of reporting pain has not ceased and has increased causing loss of sleep.  Increased in pain to the point of tears and unable to ease the pain.  Feeling like my head would explode.  Unbearable headache pain.  Soreness around and under eyes.  Soreness in nose with a burning sensation.   Rash/hives along jawline/cheek on left side of face.  Itchiness.  Dizziness when laying down and getting up.  Dizziness when bending over.  Blurred vision with 'stars' when I get up from laying or bending over position.  Vision becomes so clouded I have to brace myself so I do not fall until it comes back.  Lasts about 30 seconds or so.  Irritable.  Nausea.  Sluggishness.  Have not felt myself.  Felt off since getting the vaccine.  Sore/stiff neck.   Decreased appetite.  Shortness of breath.  Lack of energy.  Weakness. Heart races at random times.  All of these reactions have impaired my daily life.  They have all been consistent since the day after receiving the vaccine.  Treatment: Dr. prescribed Amitriptyline to help reduce the headaches/migraines.
Age: 29.0
Sex: F
Vaccine: FLUN4
Symptoms: Migraine, Musculoskeletal stiffness, Nausea, Neck pain, Palpitations
Clinical narrative: Constant Headache/migraine since the day after the vaccine without going away.  At present day of reporting pain has not ceased and has increased causing loss of sleep.  Increased in pain to the point of tears and unable to ease the pain.  Feeling like my head would explode.  Unbearable headache pain.  Soreness around and under eyes.  Soreness in nose with a burning sensation.   Rash/hives along jawline/cheek on left side of face.  Itchiness.  Dizziness when laying down and getting up.  Dizziness when bending over.  Blurred vision with 'stars' when I get up from laying or bending over position.  Vision becomes so clouded I have to brace myself so I do not fall until it comes back.  Lasts about 30 seconds or so.  Irritable.  Nausea.  Sluggishness.  Have not felt myself.  Felt off since getting the vaccine.  Sore/stiff neck.   Decreased appetite.  Shortness of breath.  Lack of energy.  Weakness. Heart races at random times.  All of these reactions have impaired my daily life.  They have all been consistent since the day after receiving the vaccine.  Treatment: Dr. prescribed Amitriptyline to help reduce the headaches/migraines.
Age: 29.0
Sex: F
Vaccine: FLUN4
Symptoms: Photopsia, Pruritus, Rash, Rhinalgia, Sluggishness
Clinical narrative: Constant Headache/migraine since the day after the vaccine without going away.  At present day of reporting pain has not ceased and has increased causing loss of sleep.  Increased in pain to the point of tears and unable to ease the pain.  Feeling like my head would explode.  Unbearable headache pain.  Soreness around and under eyes.  Soreness in nose with a burning sensation.   Rash/hives along jawline/cheek on left side of face.  Itchiness.  Dizziness when laying down and getting up.  Dizziness when bending over.  Blurred vision with 'stars' when I get up from laying or bending over position.  Vision becomes so clouded I have to brace myself so I do not fall until it comes back.  Lasts about 30 seconds or so.  Irritable.  Nausea.  Sluggishness.  Have not felt myself.  Felt off since getting the vaccine.  Sore/stiff neck.   Decreased appetite.  Shortness of breath.  Lack of energy.  Weakness. Heart races at random times.  All of these reactions have impaired my daily life.  They have all been consistent since the day after receiving the vaccine.  Treatment: Dr. prescribed Amitriptyline to help reduce the headaches/migraines.
Age: 29.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria, Vision blurred
Clinical narrative: Constant Headache/migraine since the day after the vaccine without going away.  At present day of reporting pain has not ceased and has increased causing loss of sleep.  Increased in pain to the point of tears and unable to ease the pain.  Feeling like my head would explode.  Unbearable headache pain.  Soreness around and under eyes.  Soreness in nose with a burning sensation.   Rash/hives along jawline/cheek on left side of face.  Itchiness.  Dizziness when laying down and getting up.  Dizziness when bending over.  Blurred vision with 'stars' when I get up from laying or bending over position.  Vision becomes so clouded I have to brace myself so I do not fall until it comes back.  Lasts about 30 seconds or so.  Irritable.  Nausea.  Sluggishness.  Have not felt myself.  Felt off since getting the vaccine.  Sore/stiff neck.   Decreased appetite.  Shortness of breath.  Lack of energy.  Weakness. Heart races at random times.  All of these reactions have impaired my daily life.  They have all been consistent since the day after receiving the vaccine.  Treatment: Dr. prescribed Amitriptyline to help reduce the headaches/migraines.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure abnormal, Fatigue, Pain, Palpitations, Pyrexia
Clinical narrative: Patient's husband called and reported that his wife has been fatigued, had body aches, a fever, and a "racing heartbeat" a few days after receiving her flu vaccine. After further questioning, the fever is between 102-103 (F) and the heart rate is around 85 bpm with a blood pressure of 138-87 (not a typical BP for the patient).
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Dyspnoea, Rhinorrhoea, Tinnitus
Clinical narrative: Runny nose, cough, shortness of breath, wheezing, coughing, chills, tinnitus.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Runny nose, cough, shortness of breath, wheezing, coughing, chills, tinnitus.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient called pharmacy on 11/1/2014 saying she could not raise her arm above her head and had to take Tylenol for the pain.  On 11/5/2014 she said it was getting better.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging, Optic neuritis, Optic neuropathy, Visual acuity reduced
Clinical narrative: Decreased vision OD > OS related to optic neuropathy - likely optic neuritis.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Decreased vision OD > OS related to optic neuropathy - likely optic neuritis.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Pain, Vomiting
Clinical narrative: Aching, headache then vomiting at about 8:00 PM.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in left hand and arm which has not gone away. Dizziness lasted for 3 weeks.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Joint range of motion decreased, Pain in extremity
Clinical narrative: What I thought was typical arm soreness continues to this date, 11/6/2014. Pain is high on the arm causing limited range of motion and discomfort even while sleeping.  It is slowly improving, but persists.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Lymphadenopathy, Musculoskeletal pain, Neck pain
Clinical narrative: Shot given in left arm. A few hours later, pain in the right shoulder and neck, then severe pain in right armpit. (NOT the arm in which shot was given.) 24 hours later, shoulder, neck, and arm pain remain, as well as pain and slightly swollen lymph nodes in armpit and neck. Right side only.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Herpes zoster, Pain, Pyrexia, Rash
Clinical narrative: Shingles rash returned.  Fever, aches, headache.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Mobility decreased, Myalgia
Clinical narrative: A few days later the muscle in my arm started to ache.  I can't raise my arm to take my shirt off or do anything that I had to lift my arm for.  It only hurts in the muscle of my arm.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pain at the injection site, can't lift arm afterward, and still in pain.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site, pain is on and off, and notice more when weather get colder.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea
Clinical narrative: Diarrhea, weakness.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site for 2 days after the shot, the pain went away.  Per patient, she got pain back on the day she came to pharmacy on 11/4/2014.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Nausea starts 20 minutes after administration and does not stop yet.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Caregiver of pt called to say pt had low-grade fever, chills, nausea and dizziness about 8 hrs after receiving flu vaccine. Pt took ibuprofen which resolved some symptoms.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: The patient noticed a red patch on 10/28/14. Little warm, but no itching or pain. Resolved next day.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt received vaccine 10/28 and complained of "severe pain" later in the day. The pharmacist on duty recommended APAP for pain. Rph checked in on patient next day and was told issue resolved. Now on 11/5/14 pt's husband contacted us saying pain persists.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: Patient experienced a sore arm and tingling in his fingers and cramping in muscle. Symptoms began after receiving the vaccine and for 3-4 weeks.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Abasia, Dystonia, Injection site reaction, Pyrexia
Clinical narrative: Pt developed high fever, refusal to walk and lower extremity dystonia which lasted a few hours, 2 days following admin of injectible flu vaccine.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Fatigue, Vomiting
Clinical narrative: Pt developed chills, temp 101 degrees and vomiting x 2 hours and the pt felt tired but symptoms resolved per wife.
Age: 66.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Varicella virus vaccine given insetad of zoster vaccine.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain and swelling in right upper arm where shot given within hour. Swelling resolved in 2-3 days but pain in upper arm persists, especially when raising arm.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR
Symptoms: Body temperature fluctuation, Body temperature increased, Injection site pain, Irritability, Vomiting
Clinical narrative: Temp of 102 degrees (Temporal artery scan), started 5 hrs after (about 8 pm 10/27/14) the immunizations were administered and fluctuated for 24 hrs. Last temp 100.2 degrees (TA) at 7:30 pm 10/28/14. Vomited x 4 in 24 hrs from 10/28/14, 1:45 am to 10/28/14 5:30 am. No history of diarrhea. Fussy/cranky for 24-36 hrs, starting 5 hrs after imm.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site red, swollen, sore and hot. Approx. 16 hrs after injection I had a bad headache and nausea, diarrhea and vomiting. Symptoms resolved within 24 hrs or so from onset on 11/2/14 approximately 10 AM.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Nausea, Vomiting
Clinical narrative: Injection site red, swollen, sore and hot. Approx. 16 hrs after injection I had a bad headache and nausea, diarrhea and vomiting. Symptoms resolved within 24 hrs or so from onset on 11/2/14 approximately 10 AM.
Age: 58.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Ear discomfort, Ear pain, Pain in jaw, Vomiting projectile
Clinical narrative: Described as projective vomiting, pain in jaw, and dull ache in lower ear lobes, felt like her ear lobes had rocks hanging from them.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling around injection site/shoulder (L) deltoid. Pt physician treated wtih KEFLEX, uncertain if infection actually present.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Vision blurred
Clinical narrative: Bruise and pain at injection site 1 week post vaccination. Patient also reports blurry vision in right eye.
Age: 34.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Chest X-ray, Computerised tomogram, Computerised tomogram abdomen, Dehydration, Hallucination
Clinical narrative: Extreme dehydration, high fever causing hallucination. Very high blood pressure and heart rate. Pain in left arm - "Tdap" - no swelling or redness.
Age: 34.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Heart rate increased, Hypertension, Laboratory test, Pain in extremity, Pyrexia
Clinical narrative: Extreme dehydration, high fever causing hallucination. Very high blood pressure and heart rate. Pain in left arm - "Tdap" - no swelling or redness.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Received flu shot 8 am - pain started about noon time at 3 pm took ibuprofen - rested. On 10-17-14 trouble lifting arm. On 11/5/14 examined by employee health services nurse practitioner to use ALEVE, or ibuprofen use heat. Recheck in emp health services on.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Vomiting
Clinical narrative: Syncopal episode 3 min. after administration. Lasted 15 sec. ? Twitching. No sz, no post ictal. Full recovery in 10 min. Emesis x 1. Neg previous history.
Age: 28.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Dizziness, Fatigue, Influenza like illness
Clinical narrative: This spontaneous report as received from a nurse refers to a 28 year old female patient with celiac disease. On 29-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K009106, expiry date: 25-FEB-2016, route of administration, anatomical location and dose unknown) and PREVNAR 13 (dose, route of administration and anatomical location was unknown). Concomitant therapies included MAXALT, meclizine, SYNTHROID, PLAQUENIL and cholecalciferol (reported as Vitamin D3). Approximately on 30-OCT-2014 (reported as 24 hours later) the patient experienced flu-like symptoms such as lightheadedness and fatigue. No treatment was given for the events. No lab tests were performed. The patient had called the reporter and visited the reporter and sought medical attention. The outcome of flu-like symptoms, fatigue and lightheadness was reported as recovering/resolving. The causality was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. Initially reported as PNEUMOVAX23, (sealed vials) (lot # K007824, expiration: 05-NOV-2015) and GARDASIL vial wet SD 120 Y (lot # K005083; expiration 04-NOV-2016) were improperly exposed to 31 Fahrenheit (F) for 48  hours on an unspecified date, and to several other unspecified temperature excursions on unspecified dates. An unspecified number of patients received at least one of these vaccines on unspecified dates. Further it was reported that PNEUMOVAX23, (sealed vials) (lot # K007824, expiration: 05-NOV-2015) were exposed to 31 F for 600 hours and GARDASIL (lot # K005083; expiration: 04-NOV-2016) were exposed to 31F for 15 days (360 hours). However later it was confirmed that GARDASIL was not administered to anyone. On 29-SEP-2014, the patients were vaccinated with improperly exposed PNEUMOVAX23 intramuscularly (lot # K007824, expiration: 05-NOV-2015).  Later it was confirmed with the reporter that PNEUMOVAX23 were improperly exposed to 33F for 96  hours from 04-SEP-2014 to 08-SEP-2014, and to 34F for 48 hours from 09-SEP-2014 to 11-SEP-2014, and to 34F for 72 hours from 12-SEP-2014 to 15-SEP-2014, and to 33F for 168 hours from 15-SEP-2014 to 22-SEP-2014, and to 31F for 240 hours from 26-SEP-2014 to 06-OCT-2014. No adverse effects reports. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 17 year old female patient. Patient's medical history was not reported. Patient had no previous allergic reactions to drug. Approximately in October 2014 (2-3 weeks ago) the patient was vaccinated with first dose of GARDASIL (strength, lot number and expiry date unknown) 0.5 ml, one dose intramuscular. No concomitant therapies were reported. Approximately in October 2014 after vaccination, the patient began to experience hair loss and was diagnosed with alopecia. Patient called to physician for medical attention to the events. No treatment was given to the patient. No laboratory test was conducted. Action taken with GARDASIL was unknown. The outcome of the patient began to experience hair loss and was diagnosed with alopecia was reported as not recovered/not resolved. The investigator did not provide the causality of patient began to experience hair loss and was diagnosed with alopecia to GARDASIL. No further information was provided. Additional information has been requested.