chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of 64 year old. The patients medical history and current conditions are not reported. It was reported that the patient received two doses of ZOSTAVAX of 0.5ml (lot # J011338 and expiry date 19-DEC-2014), the first dose on 08-12/2013 and the second dose on 09/25/2014. No adverse effect was reported. The patient did not seek any medical attention. Product quality complaint was not reported. The outcome of the event is unknown.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 02-OCT-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (dose 0.5 ml (milliliter), route subcutaneous (dose, route reported as in prescribing information), strength, product lot #, expiry date not reported) that was  improperly stored. There was no information on concomitant therapy. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to unspecified patients of unknown age and unknown gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route and frequency unknown). Other suspect therapy included unspecified influenza vaccine (defaulted to AFLURIA). The reporter states that she had witnessed some unspecified severe reactions with ZOSTAVAX. The company representative did not know specifically when these reactions occurred, if the unspecified patients consulted healthcare providers, or if any treatment was administered for the severe reactions. The representative stated that the pharmacist told her that the patients had consulted her, but the pharmacist did not clarify any more details about the severe reactions. The company representative states that, one person may have received ZOSTAVAX with an unspecified influenza vaccine (AFLURIA) and one of the events may have occurred in July or August 2014. The pharmacist did not specify how many patients experienced severe reactions after receiving ZOSTAVAX. Reporter stated that no patient died after vaccination. The outcome of the reactions was unknown. The causality of events was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history, drug reactions and allergies were specified. On an unknown date in September 2014 over the past 3 to 4 weeks, the patients were vaccinated with ROTATEQ (lot #, dose, route not reported) for. No concomitant medications were reported. No symptoms reported. There was no product quality complaint. The outcome is unknown. This is one of the three reports received from the same reporter (MARRS # 1410USA004187 and MARRS # 1410USA005092). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history, drug reactions and allergies were specified. On an unknown date in September 2014 over the past 3 to 4 weeks, the patients were vaccinated with RECOMBIVAX HB (lot#, dose, route not reported). No concomitant medications were reported. No symptoms reported. There was no product quality complaint. The outcome is unknown. This is one of the three reports received from the same reporter (MARRS # 1410USA004187 and MARRS1410USA005091). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with improperly stored M-M-R II (lot #, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with improperly stored LIQUID PEDVAXHIB (lot#, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reported stated that on an unknown date the (Oka/Merck)  VARIVAX was improperly stored and was administered to unspecified number of patients were (strength, route not reported0. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction when woke up today 10/5/14: 2x3 inches oval shape, red, hot swollen and tender to touch. Applied ice and got better.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site oedema, Pruritus, Swelling
Clinical narrative: Redness and edema to inijection site. Complaints of itching to skin at 6 pm 10/3/14. Small red raised areas to arm, shoulder, back and chest. Took BENADRYL 25 mg po.
Age: 24.0
Sex: M
Vaccine: IPV, TDAP, TYP
Symptoms: Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: Became nasally congested - spiked temp. 103 degrees - within 7 hrs after vaccines. C/O headache, body aches.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: Redness, swelling to upper right arm and making more red splotches (3) on arm at other spots, warm to touch, tired, lazy feeling, 3rd day starting to slow down.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Redness, swelling to upper right arm and making more red splotches (3) on arm at other spots, warm to touch, tired, lazy feeling, 3rd day starting to slow down.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old patient of unknown gender. On 14-SEP-2014, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (Lot # J014152 exp 07-NOV-2015) (dose and route not reported). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 05-SEP-2014, the patient was vaccinated with an improperly stored dose of  (Oka/Merck) VARIVAX (lot # J014152 exp 07-NOV-2015) (dose and route not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from registered nurse refers to a 66 year old female patient. On 08-OCT-2014 the patient was vaccinated with (Merck) PROQUAD (lot #, dose and route not reported) instead of ZOSTAVAX. Concomitant therapy was not reported. No adverse effects noted by the patient. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Tremor, Vomiting
Clinical narrative: Shaking. Back ache. Vomiting.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Red papular around the injection site more where HIB vaccine was given, 1 day after the vaccines were given.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain, Pain, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with GARDASIL, intramuscular (lot and dose not reported). Concomitant medication was not reported. On an unknown date, the unspecified patients experienced pain and fainting, when receiving GARDASIL injections. It was also reported that the patients complained that the GARDASIL injection "really hurts" and that less than 1% of the reporter patients experienced fainting, after receiving GARDASIL. No treatment was given. No patients were hospitalized. At the time of the report, action taken regarding therapy with GARDASIL and the outcome of the events was not reported. This is one of two reports from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Local swelling, Swelling, Urticaria
Clinical narrative: Patient feeling poorly and had hives/swelling of arms/back. Went to ER was given EPIPEN and fluids. Reaction occurred over 24 hrs after dose. Pt made full recovery.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: (R) thigh red, warm, itchy swelling around site of DTaP. Non-tender, 10 cm diameter, NT, 5 mm (R) inguinal node.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: Patient experienced swelling of the entire upper arm (shoulder to elbow) after receiving the ZOSTAVAX vaccine. She reported that the arm was swollen for approximately 1 week and then remained slightly less swollen for an additional 1 week. Patient did not require medical attention but did see her physician. After follow up after 2 and 1/2 weeks total all symptoms had resolved.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. Since 12-AUG-2014, improperly stored RECOMBIVAX HB was administered to an unknown number of patients (dose, dose number, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. The outcome of the event was unknown. Follow up information has been received from the office manager regarding the patients. The office manager was able to share the lot # K008986 (expiration date: unknown) for RECOMBIVAX HB that experienced a temperature excursion. The office manager had no patients information or dates of vaccination available to share at this time. This is one of several reports from the same reporter. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphonia, Erythema, Pharyngeal oedema, Rash macular, Swelling face
Clinical narrative: Patient was kept for 15 minutes after the vaccine and on the way to work the patient called and said her face is blotchy red, swollen and her throat is swollen and weak voice patient took BENADRYL and advised her to go to ER.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. Since 12-AUG-2014, improperly stored RECOMBIVAX HB was administered to an unknown number of patients (dose, dose number, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. The outcome of the event was unknown. Follow up information has been received from the office manager regarding the patients. The office manager was able to share the lot# K006682 (expiration date: unknown) for RECOMBIVAX HB that experienced a temperature excursion. The office manager had no patients' information or dates of vaccination available to share at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: U
Vaccine: TDAP
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever - 100.5 to 100.6. Nausea. Body aches, chills.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Screaming
Clinical narrative: C/O non stop uncontrollable screaming, loss of appetite.
Age: 17.0
Sex: M
Vaccine: HEP, HPV4, IPV, MMR, TDAP, VARCEL
Symptoms: Dizziness, Nausea
Clinical narrative: Lightheadedness/dizziness/nausea
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Patient phoned on 10-9-14 - complained of redness and swelling at site of injection. Complaints of headache starting on 10-7-14. Phoned PMD was told to take ADVIL and use hydrocortisone cream at site. Patient stated when called on 10-9-14 that she had a reaction to a flu shot in the past at site, but not as much redness or swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Diarrhoea, Erythema, Headache, Local swelling
Clinical narrative: 20 minutes after shingles vaccine given severe diarrhea, body aches, headache, nausea - lasted approx 4 hrs. Arm injected swelled, red, bruising for 1 1/2 weeks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: 20 minutes after shingles vaccine given severe diarrhea, body aches, headache, nausea - lasted approx 4 hrs. Arm injected swelled, red, bruising for 1 1/2 weeks.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash, Rash
Clinical narrative: Rash type around injection site, spread to small area on the lower arm. Will take BENADRYL/ibuprofen to see Dr if not getting better in a day.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Local swelling, Rash
Clinical narrative: Right arm swelling 2 days after (PROQUAD) MMR, Varicella and KINRIX. 3rd day rash spread to up arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Haematoma
Clinical narrative: Pt. formed a hematoma after receiving his DTAP vaccination.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. On 03-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J004332, expiry date: 26-SEP-2014, dose, units, route of administration, anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a Nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients might have received M-M-R II, reconstituted with expired doses of sterile diluent (lot number H006212, expiration 30-JUN-2014). No adverse effects were reported. This is one of three reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients might have received VARIVAX (Merck), reconstituted with expired doses of sterile diluent (lot number H006212, expiration 30-JUN-2014). No adverse effects were reported. This is one of three reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that the patient was administered a dose of ZOSTAVAX (strength, route not reported) approximately on an unknown date in 2012 (also reported as unspecified date two years ago) and a second dose on 08-OCT-2014. No adverse events were reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This spontaneous report was received from a physician refers to a couple of patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, route and lot # were not reported(). The patient's were non-responders to RECOMBIVAX HB. The outcome of were non-responders to RECOMBIVAX HB was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an office manager via field representative refers to a currently 66 year old female patient. On an unknown date (reported as while back on), the patient was vaccinated with ZOSTAVAX (dose, route and lot # were not reported). On an unspecified date in 2014 (also reported as within the last few weeks) the patient developed a severe case of the shingles, particularly on her face and neck. The reporter stated that the patient visited an unspecified emergency room where she received the diagnosis. It was not known if patient was admitted to the hospital. The outcome of developed a severe case of the shingles, particularly on her face and neck was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unkonwn age. Medical history and concurrent conditions were not reported. On an unkonwn date the patient was vaccinated with GARDASIL dose 1 and 2. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that "the patient experienced syncope after receiving the first dose and seemed to be out of it for an hour after, receiving the second dose of GARDASIL". (on an unknown date). The outcome of seem to be out of it and syncope was unknown. The patient sought medical attention, Office visit on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. The patient's medical history and current conditions are not reported. It was reported that the patient received GARDASIL doses off schedule. Patient received her first GARDASIL on 23-SEP-2011 (lot number reported as 1561V and expiry date as 23-MAR-2013). Patient received second GARDASIL dose on 28-FEB-2012, (lot number reported as 0306AA and expiry date as 10-MAY-2013). Also reported that the patient received her 3rd dose of GARDASIL on 30-SEP-2014 (reported as today). No adverse effects reported. It was reported that the patient is not pregnant and there is no product quality complaint involved. The outcome of the event is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a Nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients might have received ZOSTAVAX, reconstituted with expired dose of sterile diluent (lot number reported as H006212 with expiration 20-JUN-2014). No adverse effects were reported. This is one of three reports from the same source. Per memo received on 01-OCT-2014 lot number H006212 is valid for sterile diluent with expiration date of 30-JUN-2014, previously reported as 20-JUN-2014). Additional information has been requested.
Age: 0.82
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Body temperature increased, Febrile convulsion, Full blood count normal, Urine analysis normal
Clinical narrative: Febrile Seizure general, tonic clonic, w/ CPR breaths, lasted approx 1.5 min, w/ post-ictal sluggishness, subsequent rectal temp 102.7 found by EMS.
Age: 0.82
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Body temperature increased, Differential white blood cell count normal, Febrile convulsion, Full blood count normal, Grand mal convulsion
Clinical narrative: Febrile Seizure general, tonic clonic, w/ CPR breaths, lasted approx 1.5 min, w/ post-ictal sluggishness, subsequent rectal temp 102.7 found by EMS.
Age: 0.82
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Postictal state, Resuscitation, Sluggishness, Urine analysis normal
Clinical narrative: Febrile Seizure general, tonic clonic, w/ CPR breaths, lasted approx 1.5 min, w/ post-ictal sluggishness, subsequent rectal temp 102.7 found by EMS.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Vaccine was given very high on the shoulder.  Pain and stiffness began within an hour of administration.  Painful arm and shoulder continues more than three weeks post administration.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Inflammation, Injection site reaction, Rash macular
Clinical narrative: Allergic reaction type redness / swelling / inflammation.  An un-even blotchy red patch about 4 inches across, slightly below injection site. Patient started anti-histamines. No further follow-up at this point.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Allergic reaction type redness / swelling / inflammation.  An un-even blotchy red patch about 4 inches across, slightly below injection site. Patient started anti-histamines. No further follow-up at this point.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Cough, Dizziness, Gait disturbance
Clinical narrative: Fever, chills, severe muscle aches...legs, arms..sweats, upset stomach..difficulty walking...cough, dizzy....
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Fever, chills, severe muscle aches...legs, arms..sweats, upset stomach..difficulty walking...cough, dizzy....
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Flu vax provided by pharmacy to employees at City Hall. A few hours after receiving vax, I noted pain and itching at the vax site. In the evening I could see that the vax site was red and swollen in addition to being painful. No improvement 48 hours later.
Age: 67.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Diarrhoea, Musculoskeletal pain, Pain in extremity, Vomiting
Clinical narrative: Diarrhea, Vomiting lasting all night. 10/09/2014 Pain in shoulders and hands.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Listless, Nausea
Clinical narrative: Chills, shakes, fever 102, nausea, weakness, dizziness  fever broke at midnight.  Next day was listless and achy.  On 10/10/2014 was back to normal.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Chills, shakes, fever 102, nausea, weakness, dizziness  fever broke at midnight.  Next day was listless and achy.  On 10/10/2014 was back to normal.
Age: 44.0
Sex: F
Vaccine: YF, YF
Symptoms: Asthenia, Loss of consciousness, Nausea, Tremor, Urinary incontinence
Clinical narrative: Passed out after feeling very nauseous. Loss of bladder control. Unconscious for about 30 seconds. Weak and shaking for several hours after.
Age: 44.0
Sex: F
Vaccine: YF, YF
Symptoms: Dizziness, Nausea
Clinical narrative: Passed out after feeling very nauseous. Loss of bladder control. Unconscious for about 30 seconds. Weak and shaking for several hours after.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pyrexia
Clinical narrative: I developed very high fever by the late evening of the same day.  It lasted all night and on the next day, going up to 102.4 F. No other flu symptoms, like cough or sneezing. Very strong headache that does not go away with taking aspirin.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Pt had severe swelling at inj site.  Treated by Dr WITH ANTIINFLAMATORY and STEROIDS.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pyrexia, Rash
Clinical narrative: Pt contacted pharmacy. Complained about redness and swelling on injection arm, fever. Overnight, rash appeared across chest, stretching to both shoulders.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pruritus, Urticaria
Clinical narrative: Patient said reaction began day after vaccine administered - large hives back of legs, itching, trouble sleeping due to itch.  She took Benadryl PO and topical last night, but did not help.  Reaction getting worse.  No difficulty breathing.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chest discomfort, Cough, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: Sore throat- heavy chest - ears ringing and itching- glands itching, tongue tingling. Burning cough.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Tinnitus
Clinical narrative: Sore throat- heavy chest - ears ringing and itching- glands itching, tongue tingling. Burning cough.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Injection site haematoma, Platelet count decreased
Clinical narrative: Hematoma at the site, ITP with platelets of 1000 noted on 10/11/14.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye pruritus, Peripheral coldness, Tremor
Clinical narrative: Itchy eyes, chills, cold hands and feet, uncontrolled shaking, vomiting, coughing.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Itchy eyes, chills, cold hands and feet, uncontrolled shaking, vomiting, coughing.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling hot, Sensation of foreign body
Clinical narrative: THE PATIENT NOTED A LUMP IN HER THROAT, AND SUBSEQUENTLY THE ONSET OF CHILLS. LATER IN THE EVENING, SHE FELT HOT. HER SYMPTOMS HAD ABATED BY THE FOLLOWING DAY.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Malaise, Pyrexia
Clinical narrative: THE PATIENT EXPERIENCE SIGNIFICANT LOCAL PAIN AT THE INJECTION SITE. LATER IN THE EVENING, SHE COMPLAINED OF CHILLS, FEVER, AND GENERAL MALAISE. THE SYMPTOMS ABATED BY THE NEXT DAY.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Patient noticed warmth in bicep later that evening on left arm. Patient received injection in left deltoid, approx 3 inchs away from where reaction is noticed.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose increased, Erythema, Injection site pruritus, Injection site swelling, Local swelling
Clinical narrative: Arm started hurting Friday night 10/3/14. By Saturday 10/4/14 patient ached all day, arm swelled up and changed colors around injection site.  Patient also began running a fever of 101.  Blood sugars were also higher than normal by approximately 50 points beginning on Saturday.  Sunday 10/5/14 and Monday 10/6/14 fever continued, high blood sugars continued, arm got redder, but swelling began to go down.  By Wednesday 10/8/14 patient still had a bump on her arm but the pain is almost gone and the fever has come down below 100. By Thursday 10/9/14 patient's blood sugars have returned to normal, fever is gone, swelling is gone but there is slight discoloration around the injection site and it itches.  By Saturday 10/11/14 patient has returned to normal with a little discoloratioon around the injection site still.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm started hurting Friday night 10/3/14. By Saturday 10/4/14 patient ached all day, arm swelled up and changed colors around injection site.  Patient also began running a fever of 101.  Blood sugars were also higher than normal by approximately 50 points beginning on Saturday.  Sunday 10/5/14 and Monday 10/6/14 fever continued, high blood sugars continued, arm got redder, but swelling began to go down.  By Wednesday 10/8/14 patient still had a bump on her arm but the pain is almost gone and the fever has come down below 100. By Thursday 10/9/14 patient's blood sugars have returned to normal, fever is gone, swelling is gone but there is slight discoloration around the injection site and it itches.  By Saturday 10/11/14 patient has returned to normal with a little discoloratioon around the injection site still.
Age: 64.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Abdominal pain upper, Chest pain, Dizziness, Feeling abnormal, Headache
Clinical narrative: Had chest pain, dry heaves, shaking, stomach ache and head ache and dizziness. I waited it out. Felt rotten the rest of the day.
Age: 64.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Retching, Tremor
Clinical narrative: Had chest pain, dry heaves, shaking, stomach ache and head ache and dizziness. I waited it out. Felt rotten the rest of the day.
Age: 64.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Influenza
Clinical narrative: Had chest pain, dry heaves, shaking, stomach ache and head ache and dizziness. I waited it out. Felt rotten the rest of the day.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: On Tuesday, October 7th I had an immunization clinic.  I had a 39 year old female that I immunized with the Pneumovax vaccine in the left arm and the Fluarix Quad in the right arm.  The Pneumovax vaccine was indicated because she had asthma and had never received the pneumococcal vaccine before.  She stated that her doctor recommended that she receive the vaccine.  Patient describes that she developed a reaction in her left arm where she received the Pneumovax vaccine on the morning of Tuesday October 7, 2014.  She began feeling "bad" that afternoon and started running fever.  She states that it became very red and warm to the touch and became swollen to the size of a grapefruit at the injection site.  On October 10, 2014, she decided to see a physician.  At that time the physician prescribed her an antibiotic and ibuprofen.  I spoke with her on the evening of October 10th and she stated that she felt "much better."
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperaesthesia, Induration, Pain, Rash
Clinical narrative: Redness, golfball size swelling, hot to touch; on 10/10/2014 swelling, hot to touch, redness moved down arm; 10/11/2014 rash on neck and chest; redness down more of arm; swelling, hardness, hot to touch; pain, sensitive to touch.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Redness, golfball size swelling, hot to touch; on 10/10/2014 swelling, hot to touch, redness moved down arm; 10/11/2014 rash on neck and chest; redness down more of arm; swelling, hardness, hot to touch; pain, sensitive to touch.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swollen at injection and surrounding site. Pain in the arm where he received the vaccine. Advised patient to take Benadryl in case he is allergic to vaccine and Alleve for pain and swelling.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash on Left side of face around eye and Left ear.
Age: 67.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Hives like red bumps on face, no treatment as of this date.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Pain
Clinical narrative: Vaccine administered high up on left deltoid. The nurse administering the vaccine met resistance and forcefully injected vaccine. For last two weeks, I have now had pain upon waking and severe pain with movement in my arm greater than 90 degrees. My provider diagnosed shoulder bursitis from the vaccine being administered incorrectly into the bursa. I have had no relief from pain since the administration and will be starting physical therapy this week.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Vaccine administered high up on left deltoid. The nurse administering the vaccine met resistance and forcefully injected vaccine. For last two weeks, I have now had pain upon waking and severe pain with movement in my arm greater than 90 degrees. My provider diagnosed shoulder bursitis from the vaccine being administered incorrectly into the bursa. I have had no relief from pain since the administration and will be starting physical therapy this week.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient has pain in her arm.  It was sore the days following the vaccine and never improved for two weeks so the patient went to the Dr and the Dr gave a steroid.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt began having pain in arm and body, self treated with acetaminophen.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pain, Pruritus, Swelling
Clinical narrative: Swollen, Hot, Sore, Itchy.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Antibody test, VIIth nerve paralysis
Clinical narrative: Bell's Palsy.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Eyelid oedema, Headache
Clinical narrative: Beginning at 1:00 pm (approximately 2 hours after I received the flu shot), I began feeling symptoms of weakness, dizziness, and mild muscle ache. By 3:30 pm, I felt overcome with paleness (changing for a brief period to green, facial coloration, I was told by others), added weakness, added dizziness, headache, mild swelling around the eyes, muscle ache, fever, nausea, and mildly loose bowels. For treatment, I relaxed at home and drank fluids. By 11:00 am the following day (10/10/14), a headache and mildly cloudy thinking remained. These symptoms reduced steadily through the day. My adverse reaction may likely be due in part to never before having a flu shot.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Pallor, Pyrexia, Skin discolouration
Clinical narrative: Beginning at 1:00 pm (approximately 2 hours after I received the flu shot), I began feeling symptoms of weakness, dizziness, and mild muscle ache. By 3:30 pm, I felt overcome with paleness (changing for a brief period to green, facial coloration, I was told by others), added weakness, added dizziness, headache, mild swelling around the eyes, muscle ache, fever, nausea, and mildly loose bowels. For treatment, I relaxed at home and drank fluids. By 11:00 am the following day (10/10/14), a headache and mildly cloudy thinking remained. These symptoms reduced steadily through the day. My adverse reaction may likely be due in part to never before having a flu shot.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Thinking abnormal
Clinical narrative: Beginning at 1:00 pm (approximately 2 hours after I received the flu shot), I began feeling symptoms of weakness, dizziness, and mild muscle ache. By 3:30 pm, I felt overcome with paleness (changing for a brief period to green, facial coloration, I was told by others), added weakness, added dizziness, headache, mild swelling around the eyes, muscle ache, fever, nausea, and mildly loose bowels. For treatment, I relaxed at home and drank fluids. By 11:00 am the following day (10/10/14), a headache and mildly cloudy thinking remained. These symptoms reduced steadily through the day. My adverse reaction may likely be due in part to never before having a flu shot.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Flushing, Headache, Lethargy
Clinical narrative: Severe chills - fever (100.5) - vomiting - lethargy - mild facial swelling - facial flushing - headache - feeling of restricted breathing.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Swelling face, Vomiting
Clinical narrative: Severe chills - fever (100.5) - vomiting - lethargy - mild facial swelling - facial flushing - headache - feeling of restricted breathing.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Local swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Fever 102.4, severe right upper arm pain (location of vaccine injection), right axillary lymph node swelling, right arm swelling. Came to urgent care.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Hypoaesthesia, Neck pain, Pain
Clinical narrative: Vomiting; weakness; pain; numbness in hands; aching neck; chills.  On 10/11/2014 rash on front of chest in AM.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vomiting
Clinical narrative: Vomiting; weakness; pain; numbness in hands; aching neck; chills.  On 10/11/2014 rash on front of chest in AM.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Paraesthesia, Swollen tongue
Clinical narrative: Pain in site of injection (right shoulder) and some tingling in fingers with some tongue swelling. We offered the patient that we can call 911/paramedics or give her the EPI shot. Patient did not want to go to the ER or get the EPI shot. We gave the patient a one time oral dose of benadryl 50mg and observed the patient for one hour. Her condition did not worsen and she was able to communicate clearly and was breathing normal. Her mom came by to pick her up after the one hour. Then we gave her the liquid Benadryl to take home and advised her to take onther dose of 25mg in 4 hours. I followed up with the patient and she told me that her mom took her to the ER to fully get her check her out.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site rash, Rash, Swollen tongue
Clinical narrative: Pain in site of injection (right shoulder) and some tingling in fingers with some tongue swelling. We offered the patient that we can call 911/paramedics or give her the EPI shot. Patient did not want to go to the ER or get the EPI shot. We gave the patient a one time oral dose of benadryl 50mg and observed the patient for one hour. Her condition did not worsen and she was able to communicate clearly and was breathing normal. Her mom came by to pick her up after the one hour. Then we gave her the liquid Benadryl to take home and advised her to take onther dose of 25mg in 4 hours. I followed up with the patient and she told me that her mom took her to the ER to fully get her check her out.
Age: 8.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Breast enlargement, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician refers to a 8 year old female patient. The patient's pertinent medical history was not provided. On an unspecified date in December 2013, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported). No concomitant medications were provided. On an unknown date, the patient experienced lymph nodes enlarged in left neck area (post cervical region), sub ancipital (also reported as sub acc) area, left axillary area and mammillary gland enlargement left side (left sub a occipital region). The patient required doctor visit. The outcome of lymph nodes enlarged was reported as recovered/resolved in approximately 2014 (reported as within 1-3 months0. The outcome of mammillary gland enlargement was reported as recovered/resolved in approximately 2014 (reported as within 6-8 months).  The relatedness between the events and the vaccination with M-M-R II was unknown. Additional information is not expected as all information has been obtained.
Age: 8.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician refers to a 8 year old female patient. The patient's pertinent medical history was not provided. On an unspecified date in December 2013, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported). No concomitant medications were provided. On an unknown date, the patient experienced lymph nodes enlarged in left neck area (post cervical region), sub ancipital (also reported as sub acc) area, left axillary area and mammillary gland enlargement left side (left sub a occipital region). The patient required doctor visit. The outcome of lymph nodes enlarged was reported as recovered/resolved in approximately 2014 (reported as within 1-3 months0. The outcome of mammillary gland enlargement was reported as recovered/resolved in approximately 2014 (reported as within 6-8 months).  The relatedness between the events and the vaccination with M-M-R II was unknown. Additional information is not expected as all information has been obtained.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient complained the injection was painful and after removing the syringe there appeared to some swelling. We applied cold pack and she went home - no dizziness, hives or itching.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash macular
Clinical narrative: One spot on his face, then mom noticed others. Splotchy, macular erythematous rash on face includes sides of neck and (L) ear. Gave 1 dose of BENADRYL.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Headache, Influenza like illness, Muscle spasms
Clinical narrative: 10-8-14 approximately noon -> dizzy/HA/nausea. 10-8-14 approximately 9 pm -> cramp, diarrhea, cold, dizzy, shaking, hives, flu-like symptoms.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Nausea, Tremor, Urticaria
Clinical narrative: 10-8-14 approximately noon -> dizzy/HA/nausea. 10-8-14 approximately 9 pm -> cramp, diarrhea, cold, dizzy, shaking, hives, flu-like symptoms.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Patient was given FLu vaccine, less than 5 to 10 min. later she was lightheaded and dizzy. She fell to floor passed out less than 1 minute. I checked her pulse and we called 911. Patient felt better after some time and refused transport to hospital.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dizziness postural, Dysarthria, Tinnitus
Clinical narrative: Pt lives about 10 min from store. About 15-20 minutes after coming home, he began to feel dizzy. About an hour later, he seemed to have slightly slurred speech. He recently started taking two capsules of Gingko Biloba for ringing in his ears just the day before he got his vaccine. His wife called today to say his symptoms were improving, but had questions about the cause. Pt did have HD Flu shot last year as well. Called approximately 5 hours after being informed today of adverse reaction and wife said his speech has improved even more. Verified there were no symptoms of FAST (stroke) other than what was stated. Pt is feeling better enough to go to a ball game and does not plan to go to MD. Still has some dizziness upon standing and stairs.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood glucose normal, Electrocardiogram normal, Loss of consciousness, Pallor
Clinical narrative: Pt. received AFLURIA.  Minutes later she passed out in aisle of our store. She was very pale. Came back to rx and we gave her candy and H2O. She hadn't eaten since noon. Vaccine given at 8:10 pm. Passed out at 8:13 pm. Her BP and BS were normal. She was weak but better shortly after events.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient came in 9 days after vaccine. Said a few days after administration she had swelling, redness and itching. Symptoms resolved after another 2-3 days.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Bronchospasm, Dizziness, Flushing
Clinical narrative: Bronchospasm, dizziness, flushing (required 2 albuterol and oral steroids). Placed on 5 days oral steroids afterwards.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 08-OCT-2013 the patient was vaccinated with the first dose of PNEUMOVAX23 (0.5 ml, intramuscularly, lot # not reported) and subsequently inadvertently received another (second) dose of PNEUMOVAX23 (0.5 ml, intramuscularly, lot # not reported) on 08-OCT-2014 (also reported as a year later). No symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 30 years old female, non-pregnant patient. Her concurrent conditions included migraines (since unknown date) and allergy to penicillin. On an unspecified dates in 2010, for school purposes, the patient received series of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as "unspecified Hepatitis B series"), (exact dates, doses, dose numbers, route and sites of administrations, lot# and expiration dates not reported). Concomitant therapies included NEURONTIN, LAMICTAL, ZYRTEC, ZANTAC, AMERGE, acetaminophen, NORCO and COMPAZINE. On an unknown date, after hepatitis b vaccine (recombinant) (manufacturer unknown) was administered, the patient had titers drawn and the results were negative. The reporting nurse also stated that the patient's mother believed that the patient received unspecified Hepatitis B series as a child (dates unspecified), but there was no documentation of the first series being administered. The patient did not seek medical attention and received no treatment. The outcome of the adverse event was unknown. Relatedness between use of hepatitis b vaccine (recombinant) (manufacturer unknown) and the negative result of titers was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 3 patients of unknown age and gender. On an unknown date those patients were inadvertently vaccinated with an improperly stored ZOSTAVAX (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects reported. Additional information is not expected because the reporter refused to be contacted.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's medical history, concurrent conditions, allergies or previous drug reactions were not reported. On an unknown date in 2009, the patient received the first dose of GARDASIL, dose, lot#, exp. date, route of administration and anatomical location were not reported. The patient received the second dose of GARDASIL on 29-SEP-2014 (dose, lot#, exp. date, route of administration and anatomical location were not reported. No adverse events were reported. Additional information is not expected, no patient's or physician's contact information is available.