chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Shot given 9-11-13. Patient presents back at pharmacy 9-13-13 with red swollen left upper arm. Patient complaint of heat, swollen, rashy appear at injection site, also dazed "drugged feeling".
Age: 77.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Shot given 9-11-13. Patient presents back at pharmacy 9-13-13 with red swollen left upper arm. Patient complaint of heat, swollen, rashy appear at injection site, also dazed "drugged feeling".
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Increased bronchial secretion, Injection site erythema, Injection site induration, Lethargy
Clinical narrative: Softball size site reaction red and hard - resolving post 5 days of vaccination; pt reported malaise lethargic for 13 hrs-24 hrs following vaccine with headache and bronchial secretions.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Softball size site reaction red and hard - resolving post 5 days of vaccination; pt reported malaise lethargic for 13 hrs-24 hrs following vaccine with headache and bronchial secretions.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: (R) leg swollen, red, itchy after shots 2 days ago. On exam noted macular rash swelling at (R) injection site warm to touch. No systemic reaction. No fever no systemic pain. Denied SOB. Abscess, cellulitis. Triamcinolone 0.1% cream apply to effected area, BACTROBAN oint apply to effected abscess. ZYRTEC 1mg/1ml 5 ml PO QD.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: (R) leg swollen, red, itchy after shots 2 days ago. On exam noted macular rash swelling at (R) injection site warm to touch. No systemic reaction. No fever no systemic pain. Denied SOB. Abscess, cellulitis. Triamcinolone 0.1% cream apply to effected area, BACTROBAN oint apply to effected abscess. ZYRTEC 1mg/1ml 5 ml PO QD.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: Began 9 pm night of shots -> chills, soreness at site of arm; Did not record temperature, weak, achy, flu-like symptoms, fatigue, nauseous-> lasted 2 days off work.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain
Clinical narrative: Began 9 pm night of shots -> chills, soreness at site of arm; Did not record temperature, weak, achy, flu-like symptoms, fatigue, nauseous-> lasted 2 days off work.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Neck pain, Paraesthesia
Clinical narrative: Chills, pain up her neck, tingling in her face.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Nausea, Palpitations, Throat tightness
Clinical narrative: Heart racing, fatigue, nauseous, constriction in throat, cough.
Age: 9.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Chills, Lethargy, Pyrexia, Tremor
Clinical narrative: Approx. 12 hrs after immunization - fever 104, shaking chills, lethargy lasted about 12 hrs then improved.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Light headed, woozy, headachy, nauseous.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Pruritus, Skin discolouration
Clinical narrative: Patient called 2 days after vaccines and said arm really sore and red, came in day 4 and arm red, warm to touch, swollen, itchy and sore with whitish patch, suggested to see dr. Dr prescribed antibiotic and steroid.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Patient called 2 days after vaccines and said arm really sore and red, came in day 4 and arm red, warm to touch, swollen, itchy and sore with whitish patch, suggested to see dr. Dr prescribed antibiotic and steroid.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Balance disorder, Fall, Gaze palsy, Head injury, Tremor
Clinical narrative: After given TDaP, IPV and HAV boosters while sitting on the exam table, patient got off the table, walked over to his Dad and was redressing himself; about this time he began to list to his left, fell against the base cabinet and then fell to the floor, striking his head on both surfaces; Dad then lifted him onto his lap, noted he was shaking a bit and that his eyes were rolled back; he gradually returned back to his nl self in about 5 minutes. I saw him shortly after his Dad picked him up, he was awake, moving a bit but quiet. Several minutes later he appeared to be acting normal and exam of HEENT, heart, lungs, and neuro (incl. cerebellar function) was normal. Intend to report incident to VAERS and try to determine what type of reaction he might have had, which of the vaccine components might have been responsible for it and how to proceed with future immunizations.
Sex: U
Vaccine: HBHEPB, HPV4, MMR, PPV, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) refers to an unspecified number of patients of unknown ages and gender. On an unknown dates the patients might have received improperly stored COMVAX, GARDASIL, M-M-R II, PNEUMOVAX 23 and ROTATEQ. CMA reported that vaccines were exposed to 50F for unspecified time and that prior to that, vaccines were exposed to 35F for unspecified time. No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Muscle spasms
Clinical narrative: Started oral typhoid 9-30-12. Shortly after, taking med's she experienced stomach ache, diarrhea and severe leg cramping. No vomiting, This occurred after each pill but would subside that day, before the next pill due.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Myalgia, Pyrexia
Clinical narrative: 102 degrees fever for 3 hrs, severe muscle aches, diarrhea.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender who was less than 50 years old. Pertinent medical history and drug reactions/allergies were not reported. On 05-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (dose and route were not reported). Concomitant therapy was not reported. The patient would additionally receive the ZOSTAVAX on 05-SEP-2013 at the pharmacy. No adverse effects reported.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Local swelling, Pain in extremity, Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 62 year old female patient. No medical history was reported. Drug reactions/allergies was denied. On 13-AUG-2013, the patient was vaccinated with ZOSTAVAX lot # J001692 exp date: 08-MAY-2014, 0.65 ml, once. Patient was unsure whether ZOSTAVAX was administered subcutaneously or intramuscularly. Concomitant therapies included ARMOUR THYROID tablets (unspecified dose/frequency and manufacturer). On 13-AUG-2013, after being administered ZOSTAVAX the patient experienced local red and itchy reaction, aching and swelling in extremities, six inch long area on her arm, swollen hands, legs and feet and aching in the legs, arms and hands. Was treated with a diuretic (unspecified name, dosage/frequency and manufacturer) for five days.  On an unknown date, lab tests "Blood test" was performed, no results information was reported. At the time of the report, the outcome of the events was reported as not recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 05-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot number and dose were not reported), subcutaneous into the outer aspect of the elbow. Concomitant medications were not reported. Registered nurse reported that on 05-SEP-2013, the site of administration was red and swollen and had been treating it with ice. The outcome of site of administration was red and swollen was reported as not recovered/not resolved. No lab diagnostic studies were performed. Patient visited the physician. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Pt said hurt at injection site and it hurt her joint. We think she meant bone. She went to MD and MD said could not do anything. We called pt today 9/13/13 and she's feeling better now.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Pt had a dime-sized knot at the injection site. It was red. Pt reported no pain associated with this. No itching either.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pain in jaw
Clinical narrative: 1 Day of jaw pain and trouble opening mouth.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Influenza like illness, Injection site reaction, Loss of consciousness, Muscle tightness
Clinical narrative: Severe site reaction. Fever greater than or equal to 104 degrees F. Neck tightness. Passing out/black out. Body aches. Possible cellulitis. Flu-like symptoms. ER visit.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, X-ray
Clinical narrative: Severe site reaction. Fever greater than or equal to 104 degrees F. Neck tightness. Passing out/black out. Body aches. Possible cellulitis. Flu-like symptoms. ER visit.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Local swelling
Clinical narrative: Left arm redness, swelling Benadryl 25mg.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Local swelling
Clinical narrative: Localized swelliing, warmth, redness-significant.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 9/13/13 1035 pt presented to clinic with induration, redness, warmth to Lt. upper outer arm. Was advised by FNP to apply ice packs through out the day.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Posture abnormal, Tremor
Clinical narrative: 11:15 AM patient received 3 vaccines (TDAP, MCV, HPV). After receiving MCV vaccine I noticed his head was down. When I turned around pt. was leaning forward. I caught pt. and had pt. lay down. Soon after he started shaking. I carried him to the trauma room.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache, nausea, vomiting.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Flat rash covering face, neck, and upper body. No itching.  Rash is beginning to resolve 9/14/2013.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Diarrhoea, Hyperhidrosis, Pyrexia
Clinical narrative: Diarrhea, sweats and chills.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Condition aggravated, Feeling abnormal, Muscle strain
Clinical narrative: Very weird, after aprox. 2 1/2 hours of receiving the shot my aggravated leg became much worse, to the point I could not walk on it. I simply drove home and was relaxing after the shot.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Heart rate increased, Nausea, Vomiting
Clinical narrative: Chills, rapid heart beat, BP-112/62, general weakness, nausea, vomiting.
Age: 12.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain upper, Burning sensation, Cyanosis, Immediate post-injection reaction, Malaise
Clinical narrative: Verbatim report from CMA: immediately starting c/o burning when it went in and then his lips started turning blue he lost all color in his face then started saying he didn't feel well. I asked him what was bothering him and he said his stomach was hurting like stomach pain and then he said he began to feel nauseous and felt like he was going to vomit. I asked him to lay down and asked mom to stay with him then I went and got another medical assistant to help me and she told me to go get him some juice so I did. After the patient starting drinking the juice he started feeling better mom had said also that he had nothing in his system yet today. I asked him to keep lying down and when I felt like his color came back and that he was feeling okay I let him leave. Mom said she was going to take him to get something to eat and come right back. I then spoke to the registered nurse and asked what she thought and she said she feels that he had a possible reaction to the vaccine. Then when Dr. came out of the room I told her what happened and asked if she wanted the patient to come back today or wait a couple days to come in and get the other two vaccines and she said wait and come back another day so mom was then informed when she walked back in the office to wait a couple days and then bring patient back in to get MCV4 and hep A. I kept patient laying down and in the room for 15 minutes after the incident happened.  Note: I (Dr.) called the mother later in the afternoon.  She reported that he was fully recovered after he ate.
Age: 12.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Nausea, Pallor
Clinical narrative: Verbatim report from CMA: immediately starting c/o burning when it went in and then his lips started turning blue he lost all color in his face then started saying he didn't feel well. I asked him what was bothering him and he said his stomach was hurting like stomach pain and then he said he began to feel nauseous and felt like he was going to vomit. I asked him to lay down and asked mom to stay with him then I went and got another medical assistant to help me and she told me to go get him some juice so I did. After the patient starting drinking the juice he started feeling better mom had said also that he had nothing in his system yet today. I asked him to keep lying down and when I felt like his color came back and that he was feeling okay I let him leave. Mom said she was going to take him to get something to eat and come right back. I then spoke to the registered nurse and asked what she thought and she said she feels that he had a possible reaction to the vaccine. Then when Dr. came out of the room I told her what happened and asked if she wanted the patient to come back today or wait a couple days to come in and get the other two vaccines and she said wait and come back another day so mom was then informed when she walked back in the office to wait a couple days and then bring patient back in to get MCV4 and hep A. I kept patient laying down and in the room for 15 minutes after the incident happened.  Note: I (Dr.) called the mother later in the afternoon.  She reported that he was fully recovered after he ate.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local swelling, Oedema, Pain
Clinical narrative: Initially pain and swelling.  The next day markedly swollen in dependent area and hot and red with pain and some itching.  Since then better, but still at 6 days out it is still indurated, edematous and very itchy.  Not painful and hot and red anymore.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Initially pain and swelling.  The next day markedly swollen in dependent area and hot and red with pain and some itching.  Since then better, but still at 6 days out it is still indurated, edematous and very itchy.  Not painful and hot and red anymore.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Eye swelling, Gait disturbance, Induration, Injection site pain, Injection site swelling
Clinical narrative: Symptoms included left thigh swelling, point tenderness, reduced weight bearing tolerance leading to a limp. By Thursday night at 8:00 PM left eye swelling, hard edema and extreme tenderness to passive range of motion were present. 25mg tablet of Benadryl given along with 7.5 ml of children's ibuprofen. Repeated dosage the following morning at 6:30 A.M leading to significant symptom improvement by early afternoon.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema, Tenderness, Weight bearing difficulty
Clinical narrative: Symptoms included left thigh swelling, point tenderness, reduced weight bearing tolerance leading to a limp. By Thursday night at 8:00 PM left eye swelling, hard edema and extreme tenderness to passive range of motion were present. 25mg tablet of Benadryl given along with 7.5 ml of children's ibuprofen. Repeated dosage the following morning at 6:30 A.M leading to significant symptom improvement by early afternoon.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Pyrexia
Clinical narrative: Patient's husband described the adverse event as "fever, and fatigue".
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Pyrexia
Clinical narrative: Patient described adverse event as "fever and fatigue".
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Cough, Dysphonia, Eye pain, Eye pruritus
Clinical narrative: Hoarseness, sore red & itchy eyes, cough for short time, ache, chills, lasted til after 10 PM, took two Tylenol and BED.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Pain
Clinical narrative: Hoarseness, sore red & itchy eyes, cough for short time, ache, chills, lasted til after 10 PM, took two Tylenol and BED.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Increased upper airway secretion, Pain
Clinical narrative: Hoarseness, sore red & itchy eyes, cough for short time, ache, chills, lasted til after 10 PM, took two Tylenol and BED.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Constipation, Rectal tenesmus
Clinical narrative: Constipation and straining.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation, Injection site mass
Clinical narrative: Golf-ball sized lump at injection site, redness and irritation.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Varicella
Clinical narrative: SMALL RASH AND ITCH ON FEET, LEGS AND ON LEFT SIDE OF BODY.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Staphylococcal infection
Clinical narrative: Pt came over with red/swollen inner upper left arm 9/14/13. (She received her Pneumovax on 9/12/13 on left deltoid and Fluzone HD on right deltoid.) I noticed a small white spot among the swollen area and informed her to go to urgent care.  Pt came back 1:50pm informing us that urgent care diagnosed her with staph infection possible due to not throughly clean the injection site.  Pt was given abx for it.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Rash
Clinical narrative: Erythema, pain, swelling at injection site.  Rash also appeared under breast and in groin region and patient complained of fever.  Advised patient to ice areas and to treat pain/ fever with acetaminophen.  Advised patient if condition worsen to call back or seek care of physician.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Defaecation urgency, Dyspnoea, Feeling hot, Palpitations
Clinical narrative: About four minutes after the shot was given I started getting really hot. Then my chest got really tight. My heart was racing and I was having trouble breathing. I also felt like I was going to have a bowel movement. I was shakey. It went away by itself after about 3 minutes.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: About four minutes after the shot was given I started getting really hot. Then my chest got really tight. My heart was racing and I was having trouble breathing. I also felt like I was going to have a bowel movement. I was shakey. It went away by itself after about 3 minutes.
Age: 0.21
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Contacted parent of pt, but has not had call back.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin ulcer, Staphylococcal infection, Varicella post vaccine
Clinical narrative: Got chicken pox from her second dose.  HUGE sores and infection.  Caused staph. Hospital prescribed Keflex. Problem is that she has to have a DTAP shot again (one on 8/9 also) but shes sick now and school says "its the law". May be forced to keep her out, but the school says they will call cops.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Pain
Clinical narrative: Vomiting 4 times, diarrhea, headache, body aches, joint pain, chills.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Vomiting 4 times, diarrhea, headache, body aches, joint pain, chills.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Nausea, severe headache, lightheaded.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Ache / pain in shoulder area of left arm (where vaccine was administered), especially with any movement. Also painful if pt sleeps on either arm. Pain is alleviated with 325 mg of aspirin in the morning, but pain returns by evening.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: 9/10 Received vaccines early afternoon, next day arm was red and warm to the touch, raised and red 2 areas, also feeling. 9/12 Patient came in recommended cetirizine at night and acetaminophen for the pain and aches.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Vaccine administered 9/11/13. Patient's wife states patient started experiencing hives on 9/13/13. Took BENADRYL, hives stopped. Has had flu shots before w/ no reaction.
Age: 70.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt.'s arm that received FLUZONE HD (L deltoid) was red and sore from shoulder to elbow. Occurred the day after the vaccine.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, heat, pain to site.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, pain, tenderness, swelling, warmth at injection site of ZOSTAVAX in left arm occurred 24-48 hours after injection.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Injection site erythema, Pain, Pyrexia
Clinical narrative: "Within hours," fever, aches and pains, and cough. Ring of redness around the arm starting from the injections sites. Treated by TYLENOL, fluids, and bed rest over 4 days.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Bed rest, Cough, Erythema, Injection site erythema, Pain
Clinical narrative: "Within hours", fever, aches, and pains and cough. Significantly increased need to urinate. Ring of redness around the arm starting from injection sites. Treated by Tylenol, fluids, and bed rest, over 4 days.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pollakiuria, Pyrexia
Clinical narrative: "Within hours", fever, aches, and pains and cough. Significantly increased need to urinate. Ring of redness around the arm starting from injection sites. Treated by Tylenol, fluids, and bed rest, over 4 days.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Immediate post-injection reaction, Induration, Skin discolouration, Swelling
Clinical narrative: Ecchymosis and induration, bluish color and hard raised area appeared immediately after immunization. Hardened raised area-already going down.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Insomnia
Clinical narrative: Severe headache evening after vaccine. Sleepless night B/C of headache. Thursday noon trouble breathing went to ER.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever appx 102, went to ER. Treated with antipyretic, TYLENOL and Ibuprofen.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Localised infection, Skin warm, Swelling
Clinical narrative: Red, swollen, line going down, very warm. MD said maybe some type of infection. Pt was given clindamycin.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a 78 year old female patient with hypercholesterolemia and no drug allergies. On 10-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot No. J001698, exp. 08-MAY-2014), 0.65 ml, subcutaneous in the left arm. Concomitant therapies included CRESTOR. On 11-JUL-2013, the patient developed a fever and redness, pain, swelling and warmth of her left arm at the injection site. The patient was treated with ADVIL and ice pack on left arm at injection site. No labs diagnostic tests were performed. The patient was seen at the reporter's office on 03-SEP-2013, at that time no redness or swelling was noted at the injection site, but the patient continued to have pain in her left arm at the injection site. The outcome of fever was not reported. Relationship between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Body temperature increased, Gait disturbance, Muscular weakness
Clinical narrative: Feeling of weakness, back and leg pain started Friday evening and continued through Sunday morning. On Saturday the muscle pain intensified and my right leg was weak to the point of buckling. Temperature rose through the day from 96.8 (my normal is usually around 97) to 100.13 by evening and remained over 100 until around 5am on Sunday - leg and back pain continued during that time. By 10am on Sunday temperature returned to 96.5 and pain and walking difficulties had subsided. I was in good health-had just completed 4 mile hike prior to the vaccination and, until Saturday, have been walking a minimum of 10,000 steps a day. Take no medications other than multi-vitamin and an occasional NSAID.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Feeling of weakness, back and leg pain started Friday evening and continued through Sunday morning. On Saturday the muscle pain intensified and my right leg was weak to the point of buckling. Temperature rose through the day from 96.8 (my normal is usually around 97) to 100.13 by evening and remained over 100 until around 5am on Sunday - leg and back pain continued during that time. By 10am on Sunday temperature returned to 96.5 and pain and walking difficulties had subsided. I was in good health-had just completed 4 mile hike prior to the vaccination and, until Saturday, have been walking a minimum of 10,000 steps a day. Take no medications other than multi-vitamin and an occasional NSAID.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives all over chest, back, arms.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Rotator cuff syndrome
Clinical narrative: Hurt like hell, when she injected in my shoulder.  She said to make sure I move my arm the rest of that day to help relief the pain.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain
Clinical narrative: Hurt like hell, when she injected in my shoulder.  She said to make sure I move my arm the rest of that day to help relief the pain.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Vision blurred
Clinical narrative: Pt stated blurred vision and sweating.
Age: 1.83
Sex: M
Vaccine: FLU3
Symptoms: Aphasia, Decreased eye contact, Immediate post-injection reaction, Pyrexia, Sensory disturbance
Clinical narrative: High fever, immediate loss of words, loss of weight, development of sensory issues and immediate loss of eye contact.
Age: 1.83
Sex: M
Vaccine: FLU3
Symptoms: Toxic encephalopathy, Weight decreased
Clinical narrative: High fever, immediate loss of words, loss of weight, development of sensory issues and immediate loss of eye contact.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Injection site reaction, Pain, Pain in extremity, Pruritus
Clinical narrative: Fever 101 degrees, coughing, aching. 6x4 inch welt at injection site. Very sore and itchy arm.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever 101 degrees, coughing, aching. 6x4 inch welt at injection site. Very sore and itchy arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: Large whelp at least 3 inches in diameter raised and had heat.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Patient received the flu-HD and Pneumo shot in her left arm on 09/06/2013. On 9/13/2013 she stopped at the pharmacy that she developed the cellulitis in her left arm and was treated by her MD with KEFLEX 500 mg TID. She is feeling fine.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Asthenia, Fatigue, Headache, Injection site pain
Clinical narrative: Patient reported pain, warmth, and swelling down the entire length of left arm. She also experienced generalized weakness, headache and feeling "exhausted". Missed work 2 days because of how she felt. Is better now.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Patient reported pain, warmth, and swelling down the entire length of left arm. She also experienced generalized weakness, headache and feeling "exhausted". Missed work 2 days because of how she felt. Is better now.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Red, itchy swollen arm.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist (P.Ph) refers to a patient of unknown age and gender. On 06-SEP-2013 the patient was administered an expired dose of ZOSTAVAX (lot# 0563AE, expiration date: 21-MAR-2013) (formulation, dose, and frequency unspecified) subcutaneously. No adverse effect was reported. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 month old patient. On 10-SEP-2013, the patient was inadvertently administered VAQTA (lot # H012669, expiry date 17-APR-2015), 0.5 milliliter (ml), intramuscular instead of RECOMBIVAX HB. No adverse events reported. Patient sought no medical attention for the same. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 65 year old female patient. On 03-SEP-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reproted as J003796 and 28-JUN-2014 respectively), subcutaneously. No concomitant therapy was reported. Approximately on an unknown date in September 2013, the patient experienced as rash around the ZOSTAVAX injection site which was the size of a quarter and did not appear real red. The rash, around the ZOSTAVAX injection site was tender and warm to the touch. The patient sought medical attention (saw the pharmacist on 07-SEP-2013). No treatment was provided. It was unspecified if any lab tests were performed. Outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 59 year old female patient. On 27-AUG-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J003796 and 28-JUN-2014 respectively), subcutaneously. Concomitant therapies included pantoprazole, pramipexole, sumatriptan, gabapentin, carbidopa, levodopa and folic acid. Approximately on an unknown date in 2013, the patient experienced a rash around the ZOSTAVAX injection site which was described by the husband of the patient as red and the size of a nickel. The patient sought medical attention (saw physician in office). The patient was treated with BENADRYL and cephalexin. It was unspecified if any lab tests were performed. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient who was vaccinated with the first and the second dose of CERVARIX on 09-AUG-2011 and 19-JUL-2012 respectively received the third dose of GARDASIL (Lot number and expiry date was not reported), 0.5 milliliter (ml), intramuscular in the left arm on 10-SEP-2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning unspecified number of patients of unknown demographics. On an unknown date, patients were vaccinated with doses of GARDASIL (lot number, expiry date, dose and route unspecified) outside of the schedule recommended. The reporter did not know exactly how many patients she had observed to receive GARDASIL outside of the schedule recommended in the product information (PI). She stated that many times, teenagers do not report to the practice to receive their scheduled second and third doses of GARDASIL. She stated that, to her knowledge, none of them experience any adverse effects. She stated that this is a typical behavior of teenagers. No concomitant therapy was reported. Additional information has been requested.
Sex: M
Vaccine: FLU3, HEPA, FLU3, HEPA
Symptoms: Syncope
Clinical narrative: Initial report was received from a healthcare professional on 05 September 2013. A male patient had received an injection of FLUZONE (lot number UH898AA) and hepatitis A (other manufacturer) on an unspecified date (route, site and side of administration not reported). Shortly after receiving the vaccines, the patient leaned back and slid out of his chair (fainted) to the floor. The patient awoke approximately  1 minute later and seemed normal and talking. Vital signs were stable and the patient had no breathing difficulties. Upon follow-up later that day at home, the patient was fine. Outcome was recovered. This case is linked to cases 2013-09450, 2013-09508, 2013-09507, and 2013-09509. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Body temperature increased, Rash erythematous, Rash generalised
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 16 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 19-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H021608, expiry date 13-AUG-2015, 0.5 ml, intramuscularly). Concomitant therapies included MENACTRA (lot number unspecified) on 19-AUG-2013. On 25-AUG-2013, the patient developed a headache, fever, and non-itchy red spots on her face and body. Her highest temperature was 101F. Her physician assistant thought she could possibly have Fifth Disease. No lab tests were performed. Her symptoms lasted approximately 1 week. The outcome of events was reported as recovered/resolved approximately on 01-SEP-2013. The patient had sought medical attention by office visit. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Pyrexia, Rash erythematous
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 16 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 19-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H021608, expiry date 13-AUG-2015, 0.5 ml, intramuscularly). Concomitant therapies included MENACTRA (lot number unspecified) on 19-AUG-2013. On 25-AUG-2013, the patient developed a headache, fever, and non-itchy red spots on her face and body. Her highest temperature was 101F. Her physician assistant thought she could possibly have Fifth Disease. No lab tests were performed. Her symptoms lasted approximately 1 week. The outcome of events was reported as recovered/resolved approximately on 01-SEP-2013. The patient had sought medical attention by office visit. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Head injury, Loss of consciousness
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old male patient with none drug reactions or allergies and no pertinent medical history. On 04-SEP-2013 the patient was vaccinated with the first dose of GARDASIL (lot number# J006850, exp.date not specified), injection (route not provided). Within 15 minutes of receiving GARDASIL the patient passed out in the office. He was observed in the office for a while, fully recovered and was sent home. On 05-SEP-2013 the patient's father reported that patient passed out again at home and fell and hit his head and he was on his way to emergency room (ER). It was reported that no treatment was given for the adverse events. The outcome of patient passed out and felt and hit his head was reported as not recovered/not resolved. The outcome of syncope episode within 15 minutes of receiving GARDASIL was reported as recovered/resolved on 04-SEP-2013. This is one of two reports received from the same reporter (MARRS #1309USA003869). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old male patient with none drug reactions or allergies and no pertinent medical history. On 04-SEP-2013 the patient was vaccinated with the first dose of GARDASIL (lot number# J006850, exp.date not specified), injection (route not provided). Within 15 minutes of receiving GARDASIL the patient passed out in the office. He was observed in the office for a while, fully recovered and was sent home. On 05-SEP-2013 the patient's father reported that patient passed out again at home and fell and hit his head and he was on his way to emergency room (ER). It was reported that no treatment was given for the adverse events. The outcome of patient passed out and felt and hit his head was reported as not recovered/not resolved. The outcome of syncope episode within 15 minutes of receiving GARDASIL was reported as recovered/resolved on 04-SEP-2013. This is one of two reports received from the same reporter (MARRS #1309USA003869). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity, Rash pruritic
Clinical narrative: Initial report was received from a healthcare professional on 02 September 2013. A 50-year-old female had received a dose three injection of FLUZONE, lot number UH888AA (route and site not reported) on 22 August 2013. Nine days later on 31 August 2013, the patient returned with a patchy, painful, fluid filled vesicular rash all over her body. It was on the extremities, trunk and "all over". The rash was getting worse. The patient had no illness at the time of vaccination. Outcome was not recovered. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Rash generalised, Rash vesicular
Clinical narrative: Initial report was received from a healthcare professional on 02 September 2013. A 50-year-old female had received a dose three injection of FLUZONE, lot number UH888AA (route and site not reported) on 22 August 2013. Nine days later on 31 August 2013, the patient returned with a patchy, painful, fluid filled vesicular rash all over her body. It was on the extremities, trunk and "all over". The rash was getting worse. The patient had no illness at the time of vaccination. Outcome was not recovered. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injected limb mobility decreased, Insomnia, Local swelling, Muscular weakness
Clinical narrative: 10/06/2012 had flu shot at pharmacy. I'm not sure of exact time but it was early afternoon. Roughly 2-3 hours after flu shot was administered on 10/6/2012 I began to suffer shoulder pain in the upper deltoid muscle. 10/07/2012 woke up with low grade fever, body aches and frozen shoulder. Could not move my left arm. Arm was pinned down to my left side. 10/8/2012 woke up, fever and body aches gone. Arm still "pinned down to left side". From night of 10/6/2012 - been unable to sleep on left side. From physical therapy my range of motion has increased considerably but I continue to have symptoms such as: extreme hypersensitivity in my upper shoulder, arm pain and swelling, tingling, weakness, "shooting pain" going down my arm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Paraesthesia, Periarthritis
Clinical narrative: 10/06/2012 had flu shot at pharmacy. I'm not sure of exact time but it was early afternoon. Roughly 2-3 hours after flu shot was administered on 10/6/2012 I began to suffer shoulder pain in the upper deltoid muscle. 10/07/2012 woke up with low grade fever, body aches and frozen shoulder. Could not move my left arm. Arm was pinned down to my left side. 10/8/2012 woke up, fever and body aches gone. Arm still "pinned down to left side". From night of 10/6/2012 - been unable to sleep on left side. From physical therapy my range of motion has increased considerably but I continue to have symptoms such as: extreme hypersensitivity in my upper shoulder, arm pain and swelling, tingling, weakness, "shooting pain" going down my arm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 10/06/2012 had flu shot at pharmacy. I'm not sure of exact time but it was early afternoon. Roughly 2-3 hours after flu shot was administered on 10/6/2012 I began to suffer shoulder pain in the upper deltoid muscle. 10/07/2012 woke up with low grade fever, body aches and frozen shoulder. Could not move my left arm. Arm was pinned down to my left side. 10/8/2012 woke up, fever and body aches gone. Arm still "pinned down to left side". From night of 10/6/2012 - been unable to sleep on left side. From physical therapy my range of motion has increased considerably but I continue to have symptoms such as: extreme hypersensitivity in my upper shoulder, arm pain and swelling, tingling, weakness, "shooting pain" going down my arm.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a child of unknown age. On 18-JUN-2013 the patient was vaccinated with GARDASIL (route, dose, Lot # and expiration date were not provided). The patient was vaccinated with improperly stored vaccine. The patient experienced no adverse effects. It was reported that revaccination will be scheduled. This case is linked by same reporter to case # 1309USA006535 of a child who received improperly store COMVAX vaccine and case # 1309USA006536 of a child who received improperly stored ROTATEQ vaccine. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Cough, Heart rate increased, Oropharyngeal pain
Clinical narrative: Initial report was received from a healthcare professional on 05 September 2013. A female patient had received an injection of FLUZONE (lot number UH898AA) on an unspecified date (route, site and side of administration not reported). Approximately 5 hours after the patient received the vaccination, the husband called and asked the triage nurse to call the patient at home. The patient reported itchy throat, tightness in chest, rapid heartbeat, "cold chills," dry cough, and sore throat. The patient was told to go directly to the emergency department. The symptoms became worse so the patient called 911. The patient was admitted overnight to the hospital. The diagnosis was that it was unclear of the cause of symptoms but a possible reaction to the influenza vaccine. The patient previously received an influenza vaccine on January 2013 with no reactions. Outcome was not reported. This case is linked to cases 2013-09448, 2013-09508, 2013-09507, and 2013-09509. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Initial report was received from a healthcare professional on 05 September 2013. A female patient had received an injection of FLUZONE (lot number UH898AA) on an unspecified date (route, site and side of administration not reported). Approximately 5 hours after the patient received the vaccination, the husband called and asked the triage nurse to call the patient at home. The patient reported itchy throat, tightness in chest, rapid heartbeat, "cold chills," dry cough, and sore throat. The patient was told to go directly to the emergency department. The symptoms became worse so the patient called 911. The patient was admitted overnight to the hospital. The diagnosis was that it was unclear of the cause of symptoms but a possible reaction to the influenza vaccine. The patient previously received an influenza vaccine on January 2013 with no reactions. Outcome was not reported. This case is linked to cases 2013-09448, 2013-09508, 2013-09507, and 2013-09509. Documents held by sender: None.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Angiogram abnormal, Colour vision tests normal, Fundoscopy abnormal, Intraocular pressure test normal, Ophthalmological examination abnormal
Clinical narrative: Case retrieved from the literature on 04 September 2013. A 53-year-old male patient presented with a complaint of "seeing a purple haze in his right eye (00) for 3 days." Ocular history was significant for remote ptetygium excision OD. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. He was currently taking buprenorphine and naloxone. He had received an influenza vaccine (manufacturer unknown, batch number, route and site of administration not reported) 10 days before noting visual symptoms. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late taining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma, which improved over. A diagnosis of MEWDS was made and the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.