chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Balance disorder, Fatigue, Gaze palsy, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a physician refers to a 13 years old male patient with asthma and no drug reactions. On 22-OCT-2012, the patient was vaccinated with a 0.5 mL dose of intramuscular GARDASIL. There were no concomitant medications. On the same date almost fell backward, stiffened up, eyes were opened and rolled up for no more than 20 seconds and then the patient was alert. The patient stated that he felt whitish blurry and tired and felt like he was going to go to sleep and could hear but could not get up. The physician stated that the patient had a history of feeling squeamish with seeing blood. Physician stated after the patient received GARDASIL, that he walked out of the room sit in the waiting room and then walked back to the room to get a PPD test. After the purified protein derivative (PPD-turberculosis skin test) was done the patient experienced the adverse events. No further information was available. No treatment was given. The events were considered to be life threatening by the reporting physician. The outcome of the events was recovered on 22-OCT-2012. The relatedness of the events with GARDASIL was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Somnolence, Vision blurred
Clinical narrative: This spontaneous report as received from a physician refers to a 13 years old male patient with asthma and no drug reactions. On 22-OCT-2012, the patient was vaccinated with a 0.5 mL dose of intramuscular GARDASIL. There were no concomitant medications. On the same date almost fell backward, stiffened up, eyes were opened and rolled up for no more than 20 seconds and then the patient was alert. The patient stated that he felt whitish blurry and tired and felt like he was going to go to sleep and could hear but could not get up. The physician stated that the patient had a history of feeling squeamish with seeing blood. Physician stated after the patient received GARDASIL, that he walked out of the room sit in the waiting room and then walked back to the room to get a PPD test. After the purified protein derivative (PPD-turberculosis skin test) was done the patient experienced the adverse events. No further information was available. No treatment was given. The events were considered to be life threatening by the reporting physician. The outcome of the events was recovered on 22-OCT-2012. The relatedness of the events with GARDASIL was unknown. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a Doctor of microbiology concerning to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. The microbiologist stated that she received an isolette sample from the physician for the patient who received ZOSTAVAX and developed rash. The microbiologist stated this patient was taking immunosuppressives at the same time he received the vaccine and was hospitalized for 5 days. No treatment information was reported. At the time of the report, the patient had not recovered from rash. The relationship between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 years old female patient. 5 years ago approximately on 2007, the patient passed out immediately after administration of her first 0.5 mL dose of intramuscular GARDASIL injection (lot# not provided). The patient recovered in the office without requiring treatment. There were no laboratories performed. Upon internal review the event passed out was considered to be medically significant. The relatedness of the event with GARDASIL was not provided. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a hospital registered nurse, concerning a 65 year old female patient with diabetes, unspecified cardiac issues (for which patient has been hospitalized on 11-OCT-2012), and penicillin allergy. On 11-OCT-2012, the patient was vaccinated with a 0.5 ml PNEUMOVAX23 in the left arm (route and frequency were not reported) (Lot # and expiration date were not reported). On the same date, the patient was vaccinated concomitantly with a dose of unspecified Influenza Virus Vaccine (manufacturer unknown) in the right arm. In October 2012, the patient developed sore of the left arm, cellulitis, swollen and tender where the PNEUMOVAX23 was administered. The nurse stated that she was not sure if the PNEUMOVAX23 was administered below the deltoid site or not. She stated that client was chubby and had odd shaped arms and it was hard to define where the deltoid area was. Nurse stated that the patient also developed reaction of the right arm (MARRS #: 1210USA010519). Nurse stated that she believed the patient's hospitalization may have been prolonged because of the adverse reaction to the PNEUMOVAX23 and flu vaccine (manufacturer unknown). Unspecified antibiotics were given as treatment for the events. On 15-OCT-2012, the patient was released from hospital. At the time of the report, the outcome of the patient was unknown. The relatedness for sore, cellulitis, tender and swollen of the left arm where the PNEUMOVAX23 was administered was unknown for PNEUMOVAX23. This is one of two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Hypoaesthesia, Injection site cellulitis, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a hospital registered nurse, concerning a 65 year old female patient with diabetes, unspecified cardiac issues (for which patient has been hospitalized on 11-OCT-2012), and penicillin allergy. On 11-OCT-2012, the patient was vaccinated with a 0.5 ml PNEUMOVAX23 in the left arm (route and frequency were not reported) (Lot # and expiration date were not reported). On the same date, the patient was vaccinated concomitantly with a dose of unspecified Influenza Virus Vaccine (manufacturer unknown) in the right arm. In October 2012, the patient developed sore of the left arm, cellulitis, swollen and tender where the PNEUMOVAX23 was administered. The nurse stated that she was not sure if the PNEUMOVAX23 was administered below the deltoid site or not. She stated that client was chubby and had odd shaped arms and it was hard to define where the deltoid area was. Nurse stated that the patient also developed reaction of the right arm (MARRS #: 1210USA010519). Nurse stated that she believed the patient's hospitalization may have been prolonged because of the adverse reaction to the PNEUMOVAX23 and flu vaccine (manufacturer unknown). Unspecified antibiotics were given as treatment for the events. On 15-OCT-2012, the patient was released from hospital. At the time of the report, the outcome of the patient was unknown. The relatedness for sore, cellulitis, tender and swollen of the left arm where the PNEUMOVAX23 was administered was unknown for PNEUMOVAX23. This is one of two reports from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Nausea
Clinical narrative: Vaccines administered 1230. Nausea.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Infection
Clinical narrative: Pt had infection under right arm. Doctor prescribed KEFLEX 500mg 1 capsule every 6 hours for 10 days.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Localised infection
Clinical narrative: Pt had infection under right arm. Doctor prescribed KEFLEX 500mg 1 capsule every 6 hours for 10 days.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Eructation, Laboratory test normal, Myalgia, Nausea
Clinical narrative: Reaction 10 days after pt injection. On 9/12/12 pt vaccinated with FLUZONE; 1st pt has stomach cramps and nauseous - lasting about 8-10 hours. Doesn't impact pt. appetite. Pt reports increase in saliva and burping, no passing wind. Pt. believes flu shot to have adversely affected him in past yrs. Pt. reports multiple episodes of stomach cramping and muscle soreness.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Salivary hypersecretion
Clinical narrative: Reaction 10 days after pt injection. On 9/12/12 pt vaccinated with FLUZONE; 1st pt has stomach cramps and nauseous - lasting about 8-10 hours. Doesn't impact pt. appetite. Pt reports increase in saliva and burping, no passing wind. Pt. believes flu shot to have adversely affected him in past yrs. Pt. reports multiple episodes of stomach cramping and muscle soreness.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Pt received vaccine on 10/23/12 and has had fever and stiff neck for two days since HPV vaccine. Pt also dizzy.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling. Prescription of KEFLEX 250mg 1 PO QID x 10 days given 10-25-12.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Rash erythematous
Clinical narrative: Patient developed bruising and red rash at lower half of upper left arm. No reaction near injection site, but reaction an arm of injection.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Chills, Pyrexia, Tremor
Clinical narrative: Shaking, chills, fever, bone joint achiness next morning. All signs and symptoms gone in 24 hours.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 19.0
Sex: F
Vaccine: FLU3, IPV, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site induration
Clinical narrative: Cellulitic induration around 10-15cm circumference around injection site. Rt arm > Lt arm.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Post vaccination autoinoculation, Rash papular, Rash pustular
Clinical narrative: 27 y/o accompanied by provider upstairs to HC with concern regarding pt's "reaction at SPV site" (LUE). Pt received primary SPV (LUE), AVA #1 and Typhoid IM (RUE) on 17NOV11. Today is day #22 s/p receipt of these vaccines. Pt denies any malaise, chest pain or SOB. He is concerned that a new lesion is developing below the central lesion on his LUE. Reports positive take at approximately 7 days post SPV, with no axillary LAD or lymphangitis endorsed. Central Jennerian pustule with small 7mm oval scab, which is almost completely dry now. About 8-10 cms below and medial to central Jennerian pustule, there is another erythemic, raised, papulo-pustular oval area. There are multiple smaller papulo-pustular lesions lateral to and below the central Jennerian pustule. If you step back and visualize the surrounding lesions, you can appreciate a faint erythemic rectangular shape (more visible on bottom right), where tape came in contact with pt's skin to secure dressing.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: Patient experienced pain radiating from injection site to shoulder and neck. She also experienced generalized aches throughout body and had difficulty lifting arm (left) for several days. She took no meds for symptoms which are resolved as of reporting date (10/25/2012).
Age: 46.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site joint pain, Injection site pain, Injection site swelling
Clinical narrative: Nurse NP answers call 05DEC11 re 46 y/o patient with a large local reaction in her left upper arm about 48 hours after receipt of AVA #8 (03DEC11). NP speaks directly with patient, who confirms receipt of AVA #8 in LUE on SAT 03DEC11 around noon (around 48-50 hours ago). Patient denies receiving any other vaccines on the same day, but patient also received Typhoid IM (?) arm on 03DEC11. Patient did not receive any other vaccines w/in 30 day window prior this date. "The person who gave it to me didn't know what he was doing and gave it in in my triceps at the back of my left arm in the fatty tissue." The injection was very painful and it began to swell up that evening. My husband marked the redness last night and now the redness is a couple inches beyond his mark & extends down to just above my left elbow and is increasing in size. I took (1) 800 tab of ibuprofen and a BENADRYL last night for the itching. My left shoulder hurts a bit too. Patient denies prior h/o large local reactions (LLRs) with AVA's #1-7. "AVA's 1-7 were always sore like after a tetanus shot, but NEVER like this." Patient denies systemic malaise, fever, HA or chest pain. Patient denies paresthesias, numbness, weakness in LUE. Patient asked to email NP digital photos for review and further recommendations. PMH: Fibroid tumors uterus & anemia secondary to menorrhagia; partial hysterectomy (ovaries left in place) OCT 2010; no chronic or autoimmune dz. SOCIAL HX: Never smoked; very occasional ETOH; NO ILLICIT DRUG USE. MEDS: ZOLOFT. ALLERGIES: PCN, Sulfa, Latex (contact). FH: M (deceased 1976) Breast CA; MGM DM2; Sister (47 L) Sarcoidosis.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient has red bump, size of softball at injection site. Told her to ice it, take BENADRYL & Ibuprofen.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Pruritus, Pyrexia, Rash, Swelling
Clinical narrative: Pain, fever, redness, swelling, itchy. Tx in ER w/ steroids. Better as of 10/25/12.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: (L) arm red, swollen, tender.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Headache. Swelling, redness at injection site. Mild nausea.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hypogeusia, Hyposmia
Clinical narrative: Client received Flu vaccine on 10/18/12 and developed diminished taste and smell by early evening on 10/19/12. She is still experiencing symptoms as of 10/26/12.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Pt complained to mom "not feeling good", walked to lobby area and fainted.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Food allergy, Urticaria
Clinical narrative: About 24 hours after her vaccines she developed urticaria over her whole body. They resolved after an additional 24 hours.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Raised lymph node supraclavicular area about 5 cm. Had similar rx - 2010. No epitrochlear, axillary or infraclavicular lymph node enlargement (Rt) arm. No erythema or inflammation right deltoid injection.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dyspnoea exertional, Fatigue
Clinical narrative: Weakness, fatigue, dyspnea on exertion, loss of appetite, diarrhea, sinus congestion, headaches.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Sinus congestion
Clinical narrative: Weakness, fatigue, dyspnea on exertion, loss of appetite, diarrhea, sinus congestion, headaches.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Swollen right deltoid. No redness. No fever.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site rash, Pain, Pyrexia, Rash
Clinical narrative: Fever, body aches and rash at injection site on 10/13. Rash travels up to her elbow. Red, hot to the touch on 10/15/12. Pt went to see her PCP and was diagnosed as having rxn to flu vaccine.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Vaccination complication
Clinical narrative: Fever, body aches and rash at injection site on 10/13. Rash travels up to her elbow. Red, hot to the touch on 10/15/12. Pt went to see her PCP and was diagnosed as having rxn to flu vaccine.
Age: 1.42
Sex: M
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Hives/rash.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Became dizzy, lightheaded for about 5 minutes. BP 102/60. States didn't eat lunch and was hungry.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local redness, swelling, pain at injection site.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Nausea, Pyrexia
Clinical narrative: Pt received injection on 10-2-12. That evening arm became red from shoulder to elbow, fever 102 degrees, nausea.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: Headache, neck ache, some nausea. Still c/o of these symptoms on 10-16-12.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral, Pruritus
Clinical narrative: Hands swelling, itching, whelps on hands, behind knees, hips, (L) buttocks, cont. episodes of hives with itching x 1 wk., inj. site, swollen red, tender on 10/18/12.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hands swelling, itching, whelps on hands, behind knees, hips, (L) buttocks, cont. episodes of hives with itching x 1 wk., inj. site, swollen red, tender on 10/18/12.
Age: 25.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Developed large red swollen area and raised and very painful which lasted for 1 and 1/2 week. Area was about 8 inches x 4 inches wide.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hot flush, Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Developed large red, swollen, pruritic area at injection site, immediately. Had mild itching all over and hot flashes. Took BENADRYL and TYLENOL.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Developed large red, swollen, pruritic area at injection site, immediately. Had mild itching all over and hot flashes. Took BENADRYL and TYLENOL.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Patient reports developing a pruritic macular rash on (R) limb 32 hours after vaccine then rash spread to (L) arm the next day. She reported to the nurse who administered the vaccine. It was recommended she seek medical care. Rash only on arms and hands. No other sites. Should dose 3 be given.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Oedema peripheral
Clinical narrative: (R) ant. thigh reddened 1.5 x 3 inches in diameter hard to touch. Itching is present. Edema of upper thigh. This is reported by mother onset Tuesday 10/16/12.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine given in Left deltoid - swelling and redness. Area approx 7 in x 7 in. Hot to the touch. Pt has applied ice packs and taken BENADRYL for swelling.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Nodule
Clinical narrative: 36 hrs post injection developed 10-12 nodules on the outer edge of tongue. Lymph nodes on left neck became sore and swollen at 72 hrs post injection. Headache right side at 96 hrs. Physician prescribed Azithromycin and magic mouth wash.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal faeces, Activities of daily living impaired, Cough, Diarrhoea, Malaise
Clinical narrative: Pt states after she and husband rec. flu vaccination - they fell very ill 4 days later. Horrible diarrhea with horrible smell, coughing, couldn't get out of bed. She just wanted us to know. Had flu vac. before - no problems before - she reported this on 10-17-12 - still sick but better. Got antibiotics.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Musculoskeletal pain
Clinical narrative: (R) arm was numb on top and (R) shoulder hurt still after 7 days after injection.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site induration, Injection site mass
Clinical narrative: Immediately after injection, pt experienced bruising and small, firm lump at the site.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal faeces, Diarrhoea, Malaise
Clinical narrative: Pt stated after 4 day of the flu vacc. pt fell very ill. Had to see MD and get antibiotics - still recovering. (Her and her husband both) - had horrible diarrhea with a very strong smell.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, VARCEL
Symptoms: Excoriation, Fall, Gaze palsy, Hyperhidrosis, Lip injury
Clinical narrative: Student became diaphoretic, his eyes rolled back and fell to the floor while sitting on the chair and sustained laceration wound to his (R) lower lip and abrasion to (R) shoulder. Student also stiffened up for < 5 sec while on the floor and quickly tried to get up. Breathing remained even and nonlabored.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, VARCEL
Symptoms: Musculoskeletal stiffness
Clinical narrative: Student became diaphoretic, his eyes rolled back and fell to the floor while sitting on the chair and sustained laceration wound to his (R) lower lip and abrasion to (R) shoulder. Student also stiffened up for < 5 sec while on the floor and quickly tried to get up. Breathing remained even and nonlabored.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fungal skin infection, Pruritus, Rash
Clinical narrative: 10/22/12 client called and stated "after shot I had 50 cent size red itchy area on my arm & now I have a rash on my back & side could shot cause shingles? Referred to PMD for evaluation. 10/25 called client she saw her doctor & rash is yeast.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: 10/22/12 client called and stated "after shot I had 50 cent size red itchy area on my arm & now I have a rash on my back & side could shot cause shingles? Referred to PMD for evaluation. 10/25 called client she saw her doctor & rash is yeast.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Pruritus
Clinical narrative: Approx. 2 hrs after rec. flu shot, face became bright red, neck itching and c/o H/A. Symptoms resolved within 2 hrs on there own - no meds were taken.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt presented 3 days after shot w/red, itching, warm spot where shot was given. Told pt to take IBU & use hydrocortisone. ZOSTAVAX, ADERS.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Stated she received the flu vaccine and 1 hour later she was having nausea and vomiting, chills. 24 hr after giving the shot she stated she felt better.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Vomiting
Clinical narrative: She started vomiting at about 11 PM after receiving the shot. She also had headache and on 10/25/12 starting having body ache. She received treatment at ER (anti emetic) and injection for pain at urgent care.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccine positive rechallenge, Vertigo
Clinical narrative: I get vertigo when laying down and rolling onto my side. I also get it when sitting up. Also when I raise my head to look up. In most instances it passes within 5-10 seconds. The same thing happened after my flu shot last year.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Fever 103.5 x 6 hrs after FLUMIST.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Cellulitis, Erythema, Induration, Pain
Clinical narrative: Terrible pain - redness, swollen, feverish, that was going down my arm. It reached below my elbow, when I went to the ER room. 10-8-12 Took flu-pneumonia shot at clinic 6:15 PM I only went for flu shot nurse suggested/recommended pneumonia also which I did both in same left arm. Before I went to bed I told my husband my arm was hurting - little red and hard. 10-9-12 4 hr. choir rehearsal at church. My arm was redder, larger area and had moved more redness toward my elbow. In PM took pain pill and put Epsom salts compress on it - then later because of pain soaked in a hot Epsom salts bath. Didn't sleep well - woke up about 1:00AM w/ pain. Decided to go to ER 5:00 AM. 10-8-12 Saw Dr. she said cellulitis got prescription for BACTRIM and NORCO. She drew sharpie lines on my arm top and bottom and said if redness got any more to come back to ER. Also for me to to go pharmacy and report it and also Dr. which I did. Called Health Dept they referred me to: 10-11 called Dr. the local Health officer - (Private Practice) I left message - (no call back). Fri 10-12 - got a call from VAERS and they are sending me paperwork to fill out to report it. 10-19 - Received paperwork from VAERS. 10-21 - Completed paperwork and included copies from clinic where I got the shots and also ER room - mailed back. I am still not up to par - my energy level is so low I have to push myself to do everything. Before shots I was very active.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Poor quality sleep, Pyrexia, Swelling
Clinical narrative: Terrible pain - redness, swollen, feverish, that was going down my arm. It reached below my elbow, when I went to the ER room. 10-8-12 Took flu-pneumonia shot at clinic 6:15 PM I only went for flu shot nurse suggested/recommended pneumonia also which I did both in same left arm. Before I went to bed I told my husband my arm was hurting - little red and hard. 10-9-12 4 hr. choir rehearsal at church. My arm was redder, larger area and had moved more redness toward my elbow. In PM took pain pill and put Epsom salts compress on it - then later because of pain soaked in a hot Epsom salts bath. Didn't sleep well - woke up about 1:00AM w/ pain. Decided to go to ER 5:00 AM. 10-8-12 Saw Dr. she said cellulitis got prescription for BACTRIM and NORCO. She drew sharpie lines on my arm top and bottom and said if redness got any more to come back to ER. Also for me to to go pharmacy and report it and also Dr. which I did. Called Health Dept they referred me to: 10-11 called Dr. the local Health officer - (Private Practice) I left message - (no call back). Fri 10-12 - got a call from VAERS and they are sending me paperwork to fill out to report it. 10-19 - Received paperwork from VAERS. 10-21 - Completed paperwork and included copies from clinic where I got the shots and also ER room - mailed back. I am still not up to par - my energy level is so low I have to push myself to do everything. Before shots I was very active.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Rash erythematous, Rash generalised, Rash macular, Skin plaque, Tooth abscess
Clinical narrative: Patient was given MMR #1, PCV-13 #3, & Hib #4 on 10/19/12. Since then, she developed a rash around her face/legs/arms/abdomen. The rash is erythematous plaques with dried scaly lesions on ankles & face. she also has erythematous macules on her soles of bilateral feet.  She has a large abscess on left upper molar teeth as well  with black discoloration. This was noted 2 days ago. Pt came for evaluation today - 10/26/12.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Tooth discolouration
Clinical narrative: Patient was given MMR #1, PCV-13 #3, & Hib #4 on 10/19/12. Since then, she developed a rash around her face/legs/arms/abdomen. The rash is erythematous plaques with dried scaly lesions on ankles & face. she also has erythematous macules on her soles of bilateral feet.  She has a large abscess on left upper molar teeth as well  with black discoloration. This was noted 2 days ago. Pt came for evaluation today - 10/26/12.
Age: 0.86
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure about 5 hours post vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Erythema, Eyelid oedema, Flushing, Pruritus, Swelling face
Clinical narrative: Patient was given DTaP, Flu vaccine, IPV, MMR & VARIVAX at nurse visit 10/9/12 approximately 9:50AM. Mother took child to medical daycare. She was fine on arrival at medical daycare. Medical daycare called office at 12:12PM child developed flushed face, swollen eyelids, swelling over bridge of nose, red itchy neck. No respiratory symptoms. 1 tsp BENADRYL given via G-tube - symptoms improved within 10 min.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Temp pre vaccine (97.5) within minutes of receiving vaccine injection student became hot feeling, sweaty, and pale - helped her to the floor and put her head towards her lap felt slight nausea. Last ate 6 hours prior to vaccine dose. Gave OJ. BP 96/60 HR 80 RR 20 at 11:50 after resting moved via w/c to cot and felt better. BP 94/60 11:58 at 1215 92/60-72-20 feels fine ate a bagel & went home with her mother. Mother was advised to notify the student's PCP.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash
Clinical narrative: Received injection on 9-11-12, after getting home, she developed rash on chest and upper back and achiness.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Shingles vaccine 9/14. 9/16 red swollen hot area baseball sized around injection site itchy hot & red x 7 days. Took 2.5 - 3 weeks to resolve completely.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Functional gastrointestinal disorder, Muscular weakness, Nausea
Clinical narrative: Severe chills, diarrhea, nausea, body aches, muscle weakness, fainted and loss bowel function.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Syncope
Clinical narrative: Severe chills, diarrhea, nausea, body aches, muscle weakness, fainted and loss bowel function.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received injection on 10-8-12 on 10-9-12 pt woke with area red, warm, and pruritic and painful.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Oedema peripheral, Pyrexia
Clinical narrative: Patient's arm turned red and swollen. Patient got a fever and headache. Stated feeling better the following day.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Joint swelling, Skin warm
Clinical narrative: Pt elbow of same left arm, was swollen, and hot to touch. Pt came in following day still swollen, pink, and warm to touch.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Fall, Gaze palsy, Pallor, Tremor
Clinical narrative: Patient fell back, lost color, eyes rolled back and he was shaky and unresponsive for about 1/2 a minute. He remained dizzy, but conscious for about 10 minutes after.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient fell back, lost color, eyes rolled back and he was shaky and unresponsive for about 1/2 a minute. He remained dizzy, but conscious for about 10 minutes after.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Feeling abnormal, Injection site discolouration, Injection site swelling
Clinical narrative: Felt "funny", ached, arm "big & hot"; elbow joint the size of grapefruit with redness, pain, pressure - injection site dark color, slightly raised. Treated with 10 day antibiotic and OTC ibuprofen. 10/26/12 F/u call; most swelling at elbow gone, pain decreased, redness minor - injection site "maroon" in color & size of 1/2 dollar still.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Oedema peripheral, Pain, Sensation of pressure, Skin warm
Clinical narrative: Felt "funny", ached, arm "big & hot"; elbow joint the size of grapefruit with redness, pain, pressure - injection site dark color, slightly raised. Treated with 10 day antibiotic and OTC ibuprofen. 10/26/12 F/u call; most swelling at elbow gone, pain decreased, redness minor - injection site "maroon" in color & size of 1/2 dollar still.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pt began mild swelling at Pneumonia injection site in the late evening. Fever 101.80 began on Friday and lasted until Sunday evening. Severe body aches with swelling/redness from injection site to elbow. Resolved by Sunday 10/20
Age: 17.0
Sex: M
Vaccine: FLUN3, HEPA, HPV4, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Rash to hands, arms, and shoulders 2 days after administration - will provide BENADRYL before next dose.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Joint range of motion decreased
Clinical narrative: Within 10 days of receiving vaccine, client noted onset of painful shoulder joint - limited ROM - affecting ADL's. Aching pain has continued to be present with some improvement. Client feels pain is slowly resolving. No site redness or tenderness. No treatment sought.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Vaccine administered 10/15/12. Patient has been experiencing pain in arm (Left arm) that is worsening. Painful to lift arm. Pain not relieved w/ APAP or Ibuprofen.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Drug administered at inappropriate site, Pain in extremity, X-ray normal
Clinical narrative: Patient states she went to the doctor because her arm was in a lot of pain. Patient received both the influenza and pneumonia shot in same arm. Patient states doctor told her she was injected in the joint.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Mom states that approximately 13 hrs after receiving her immunizations, patient had 2, short duration seizures. She was seen at a local ER with a diagnosis of febrile seizures. This information was relayed to our office 10/26/12.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia, Erythema, Headache, Injection site warmth
Clinical narrative: Yellow coating on tongue and palate, dizziness, blurred vision, headache, red, warm area at site, metallic taste in mouth.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue discolouration, Vision blurred
Clinical narrative: Yellow coating on tongue and palate, dizziness, blurred vision, headache, red, warm area at site, metallic taste in mouth.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Eye pruritus, Feeling cold, Feeling hot
Clinical narrative: Scratchy, bloodshot eyes. Hot upper body. Cold lower body. Shooting pain left leg. Pain in lower right back. Numbness in hands/feet. Lightheaded/dizziness. Difficulty breathing.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Ocular hyperaemia, Pain in extremity
Clinical narrative: Scratchy, bloodshot eyes. Hot upper body. Cold lower body. Shooting pain left leg. Pain in lower right back. Numbness in hands/feet. Lightheaded/dizziness. Difficulty breathing.
Age: 61.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Blister
Clinical narrative: Blister on back and hip.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pruritus, Skin warm
Clinical narrative: Severe bruising greater than a half dollar size, redness & warmth above bruised area going towards her shoulder. She said that her arm was pretty itchy as well. She didn't go to the doctor, but I recommended cold compress, anti itch crm (BENADRYL or HC) & if not better by Mon. go in to be seen.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Herpes zoster
Clinical narrative: VARIVAX booster given 9/14/12. Pt. diagnosed with shingles 10/26/12.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain, Injection site warmth
Clinical narrative: Patient came into pharmacy on 10/24 and showed a approx 4" round bruise at injection site on (L) arm. It is slightly warm and sore to the touch. She stated it is improving.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complained of soreness in arm. She says she can't move her arm or lift her head.
Age: 1.09
Sex: M
Vaccine: FLU3, HIBV, MMR
Symptoms: Irritability, Pyrexia, Rash generalised
Clinical narrative: Rash all over body and extreme fussiness, fever x 3 days.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Rotavirus vaccine given IM instead of po on 10-12-12 reported to MD immediately after. Checked site given no visible effect. Followed up/status calls in evening & following day. No adverse effects noted. Dr spoke to parents advised to look for reaction.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Generalised erythema, Nausea, Tremor
Clinical narrative: Patient in 10/25/12 to get flu vaccine. At some point through the night woke up with hives and chills. Hives started on trunk, but then redness all over. Also experienced nausea, shakes and chills, dizziness and lightheaded. Came into office and received 0.3mg of epinephrine.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient in 10/25/12 to get flu vaccine. At some point through the night woke up with hives and chills. Hives started on trunk, but then redness all over. Also experienced nausea, shakes and chills, dizziness and lightheaded. Came into office and received 0.3mg of epinephrine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Flu shot. Itching, red, hot, swollen left arm.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No reported symptoms. Off label use of FLULAVAL on a child.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No reported symptoms. Off label use of FLULAVAL on a child.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None reported. Off label use of FLULAVAL for a child.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None reported. Off label use of FLULAVAL for a child.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No reported symptoms. Off label use of FLULAVAL on a child.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Within 8 hrs began to experience pruritus and edema to adjacent skin, by 24 hrs erythema extending distally to medial elbow. No fever/chills. Tx with hydroxyzine for now.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Blood glucose, Pallor, Unresponsive to stimuli
Clinical narrative: Pt became pale in the face and nonresponsive for about 5 min. Color and responsiveness returned after 5-15 min.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthralgia, Back pain, Lymphadenitis, Pain
Clinical narrative: Arthralgia, lymphitis of right under arm, sore back and front, layed in bed most of the day resting, comfort care provided at home.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Back pain, Joint stiffness, Lymphadenopathy
Clinical narrative: Arthralgia, lymphitis of right under arm, sore back and front, layed in bed most of the day resting, comfort care provided at home.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Tenderness
Clinical narrative: Large area of erythema (10cm x 4cm) (elongated) and tenderness day after receiving vaccine - received KEFLEX from PMD on 10/26/12 for 5 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site rash, Rash, Urticaria
Clinical narrative: 10/25/12 Pt. reported / rash at the injection site. 10/26/12 2P examined / Rash / urticaria / cellulitis-like reaction size approx 5 cm dia.
Age: 1.74
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site erythema
Clinical narrative: Large erythematous area 8 cm x 15 cm with central injection sites.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Skin warm, Urticaria
Clinical narrative: Large round raised hive, induration, warm, no itching. BENADRYL 2% topical TID prn.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Pt received PNEUMOVAX and FLUVIRIN in right arm. Over the next couple of days rash spread throughout upper arm. After a couple of days started taking BENADRYL and rash has improved. Still has rash.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid with sore hot area about 50 cent size. Area is red with lump.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Off label use
Clinical narrative: No reported symptoms. Off label use of FLULAVAL on a child.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No reported symptoms. Off label use of FLULAVAL on a child.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Off label use
Clinical narrative: Off label use of FLULAVAL on a child. No symptoms reported.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: FLULAVAL administered to a child when approved for only adults. No symptoms reported.
Age: 15.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: No adverse event, Off label use
Clinical narrative: No reported symptoms. Off label use of FLULAVAL on a child.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Off label use
Clinical narrative: No reported symptoms. Off label use of FLULAVAL on a child.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No reported symptoms. Off label use of FLULAVAL on a child.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site reaction, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Stated on 10-26-12 that the ZOSTAVAX injection made his arm stiff and he could not lift his arm. Blue spot at injection site.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Injection site rash, Nausea, Oedema
Clinical narrative: Pt. received Tdap vaccine on 10/22/12 and next day developed a rash at site of injection, edema, tenderness, and warm. Pt. also c/o chills, nausea and temp 100.1 due to vaccine. Reports she was fine before the vaccine. Pt. was treated with BENADRYL, Loratadine, Prednisone and KEFLEX.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Tenderness
Clinical narrative: Pt. received Tdap vaccine on 10/22/12 and next day developed a rash at site of injection, edema, tenderness, and warm. Pt. also c/o chills, nausea and temp 100.1 due to vaccine. Reports she was fine before the vaccine. Pt. was treated with BENADRYL, Loratadine, Prednisone and KEFLEX.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash at site of injection. Checked it 3 days later & got better. Was not hot or raised. Pt. put ice on & took BENADRYL.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at injection site, decreased range of motion, PCP believes to be bursitis. Still ongoing pain 10/26/12.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Flushing, Injection site warmth, Musculoskeletal pain, Neck pain
Clinical narrative: Heavy bruising, shoulder and neck soreness, injection site warm, flushing and fever.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Heavy bruising, shoulder and neck soreness, injection site warm, flushing and fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythema Lt. upper arm arising 10/26/12 - No signs abscess. Vaccine related.
Age: 71.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Insomnia, Pain, Pain in extremity
Clinical narrative: Tdap shot hurt immediately when pt. received it. Flu vaccination did not hurt. Pt put ice and heat on it. Pt. has tried NSAIDs w/ very slight relief. Pt. is having sleepless nights. Pain running down arm to hands on both sides. Lifting arms hurts. Pain specialist seen 2 weeks after and pt has another apt. to see pain specialist today - 10/11/12.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with 2 doses of GARDASIL (lot# unspecified) on an unknown date and later for the third dose. No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health department registered nurse refers to a 12 years old female patient. The patient was vaccinated with expired GARDASIL (lot # (666595/0096Z), expired on 14-OCT-2012) on 22-OCT-2012. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age (gender not reported). The patient was vaccinated intramuscularly with the first, the second and the third dose of GARDASIL on 26-NOV-2011 on 01-MAR-2012 and on 07-MAY-2012, respectively (doses and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. On an unspecified date in 2009, the patient was vaccinated with dose 1, GARDASIL 0.5 ml, intramuscularly (IM). Lot number was not specified. But again on an unspecified date in 2012, the patient was given her second injection of GARDASIL. Dosage and the lot number were unspecified. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown demographics. The patient was vaccinated with the first and second dose of GARDASIL about a year apart. No other co-suspects were reported. No concomitant medications were reported. Dosing details and the lot number were not specified for both. No adverse effects were reported. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: This spontaneous report as received from a physician refers to a 9 weeks old female patient. On 17-JUL-2012, the patient was vaccinated with dose 1 of ROTATEQ 2 ml orally (lot # 0059AE, exp date not reported). No other co-suspects were reported. No concomitant medications were reported. On approximately 21-JUL-2012, 4-5 days after the 1st dose, the patient experienced bloody diarrhoea. The physician was called due to the event. There was no treatment given for the event. There was no labs/diagnostic studies performed. The outcome of bloody diarrhoea was reported as recovered. The patient had no problem with the second dose, and had not yet received the third. The relationship between the event and ROTATEQ, Oral, was not reported. Additional information has been requested.