chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Abasia, Asthenia, Back pain, Dysphagia, Endotracheal intubation
Clinical narrative: 10/8/14 Progressive weakness and parethesias in her hands and feet". Unable to walk to the bathroom 10/9/14. 10/12/14 severe back pain, increased weakness, trouble swallowing. Intubated 10/14/14.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Paraesthesia, Plasmapheresis
Clinical narrative: 10/8/14 Progressive weakness and parethesias in her hands and feet". Unable to walk to the bathroom 10/9/14. 10/12/14 severe back pain, increased weakness, trouble swallowing. Intubated 10/14/14.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Asthenia, Depression, Diarrhoea
Clinical narrative: Beginning symptoms were extreme nausea, fatigue, headache, vomiting, diarrhea, body aches which lasted over a week.  Progressive health problems since including chronic headaches, fatigue and weakness, pityriasis rosea, digestive issues, joint pain, abdominal pain, depression.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspepsia, Fatigue, Headache, Nausea, Pain
Clinical narrative: Beginning symptoms were extreme nausea, fatigue, headache, vomiting, diarrhea, body aches which lasted over a week.  Progressive health problems since including chronic headaches, fatigue and weakness, pityriasis rosea, digestive issues, joint pain, abdominal pain, depression.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pityriasis rosea, Vomiting
Clinical narrative: Beginning symptoms were extreme nausea, fatigue, headache, vomiting, diarrhea, body aches which lasted over a week.  Progressive health problems since including chronic headaches, fatigue and weakness, pityriasis rosea, digestive issues, joint pain, abdominal pain, depression.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Dysphonia, Lip pruritus, Pharyngeal oedema
Clinical narrative: Throat swelling up, difficulty swallowing, cough and hoarseness, itchy lips. At 3 PM of same day I called pharmacy and took one Wal-Dryl gel on her recommendation.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Eye irritation, Tic
Clinical narrative: Parent describes as a TIC, scratching and rubbing at eyes.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Cellulitis, Chills, Diarrhoea, Eye pain
Clinical narrative: Pt tolerated injection and had no immediate adverse response. On 10/1, pt called to report a 2-3 day history of fever ranging from 101.3 to 101.9 and redness/tenderness/swelling around the injection site on her right arm. She also complained of headache with photophobia, nausea, sweats, chills, body aches in her lower back and legs, and pain in her eyes with tearing. She presented to clinic on 10/2 and was admitted to the ED on the same day for fever and right shoulder pain. Her WBC count was 20.1, raising concern for infection and cellulitis. Pt was given 3 doses of IV vancomycin and symptoms improved, but the area of erythema continued to spread. Her final ED diagnosis was cellulitis. Her right upper arm showed no abscess or fluid collection at this time. Pt was transitioned to oral clindamycin 300mg TID for 10 days, and was discharged on 10/5. At the time of discharge, she reported 6/10 continued arm pain, but her WBC count decreased to 5 and she had been afebrile for over 48hr. On 10/7 pt reported continued night sweats, fatigue, and some diarrhea although she planned to return to work the next day. She denied new symptoms and stated that the site of the cellulitis continued to resolve.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Pt tolerated injection and had no immediate adverse response. On 10/1, pt called to report a 2-3 day history of fever ranging from 101.3 to 101.9 and redness/tenderness/swelling around the injection site on her right arm. She also complained of headache with photophobia, nausea, sweats, chills, body aches in her lower back and legs, and pain in her eyes with tearing. She presented to clinic on 10/2 and was admitted to the ED on the same day for fever and right shoulder pain. Her WBC count was 20.1, raising concern for infection and cellulitis. Pt was given 3 doses of IV vancomycin and symptoms improved, but the area of erythema continued to spread. Her final ED diagnosis was cellulitis. Her right upper arm showed no abscess or fluid collection at this time. Pt was transitioned to oral clindamycin 300mg TID for 10 days, and was discharged on 10/5. At the time of discharge, she reported 6/10 continued arm pain, but her WBC count decreased to 5 and she had been afebrile for over 48hr. On 10/7 pt reported continued night sweats, fatigue, and some diarrhea although she planned to return to work the next day. She denied new symptoms and stated that the site of the cellulitis continued to resolve.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Lacrimation increased, Musculoskeletal pain, Nausea, Night sweats
Clinical narrative: Pt tolerated injection and had no immediate adverse response. On 10/1, pt called to report a 2-3 day history of fever ranging from 101.3 to 101.9 and redness/tenderness/swelling around the injection site on her right arm. She also complained of headache with photophobia, nausea, sweats, chills, body aches in her lower back and legs, and pain in her eyes with tearing. She presented to clinic on 10/2 and was admitted to the ED on the same day for fever and right shoulder pain. Her WBC count was 20.1, raising concern for infection and cellulitis. Pt was given 3 doses of IV vancomycin and symptoms improved, but the area of erythema continued to spread. Her final ED diagnosis was cellulitis. Her right upper arm showed no abscess or fluid collection at this time. Pt was transitioned to oral clindamycin 300mg TID for 10 days, and was discharged on 10/5. At the time of discharge, she reported 6/10 continued arm pain, but her WBC count decreased to 5 and she had been afebrile for over 48hr. On 10/7 pt reported continued night sweats, fatigue, and some diarrhea although she planned to return to work the next day. She denied new symptoms and stated that the site of the cellulitis continued to resolve.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Photophobia, Pyrexia, White blood cell count increased
Clinical narrative: Pt tolerated injection and had no immediate adverse response. On 10/1, pt called to report a 2-3 day history of fever ranging from 101.3 to 101.9 and redness/tenderness/swelling around the injection site on her right arm. She also complained of headache with photophobia, nausea, sweats, chills, body aches in her lower back and legs, and pain in her eyes with tearing. She presented to clinic on 10/2 and was admitted to the ED on the same day for fever and right shoulder pain. Her WBC count was 20.1, raising concern for infection and cellulitis. Pt was given 3 doses of IV vancomycin and symptoms improved, but the area of erythema continued to spread. Her final ED diagnosis was cellulitis. Her right upper arm showed no abscess or fluid collection at this time. Pt was transitioned to oral clindamycin 300mg TID for 10 days, and was discharged on 10/5. At the time of discharge, she reported 6/10 continued arm pain, but her WBC count decreased to 5 and she had been afebrile for over 48hr. On 10/7 pt reported continued night sweats, fatigue, and some diarrhea although she planned to return to work the next day. She denied new symptoms and stated that the site of the cellulitis continued to resolve.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: At an unknown time a 67 year old female reported a sore arm after admistration of Fluzone HD at 11:18 am on 23Oct2014. The patient had massage for sore arm and soreness continues. The patient brought in an article. The patient referenced the article stating she feels she recieved the vaccine too high in the arm as described in the article. It is unknown if the patient saw a physician for her sore arm.
Age: 44.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Expired drug administered
Clinical narrative: Found out med was expired.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, Nausea for 4 days.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: CSF protein increased, Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: Severe nausea, lightheadedness, 102.5 degrees Farenheit fever, fatigue.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Hip fracture, Hypotension
Clinical narrative: Woozy, light headed, low blood pressure (80/50), called primary MD, told to take it easy and stay in bed, Fell 12-1pm on 11-8-2014 and broke hip, requiring hospitalization.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain, Rash pruritic
Clinical narrative: Patient developed painful itchy rash on neck, back, and hairline this morning after getting Zostavax and flu shot yesterday.  Patient took Benadryl and then was prescribed prednisone and Zantac by her Dr.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Patient noticed that area near injection site had become red, warm and firm to the touch. Denies any other symptoms.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash generalised
Clinical narrative: Rash over entire body. Prescribed Prednisone at ER.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash generalised, Rash pruritic, Secretion discharge
Clinical narrative: Rash over entire body. Prescribed Prednisone at ER.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness around the injection site, warm feeling, and a little pain.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, slight fever and chills that lasted for 30 minutes. Took Tylenol for aches and fever. Started feeling better on 11/07/2014.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Knot (size of grapefruit), redness, and mild itchig at injection site; got progressively bigger after injection, was reported to pharmacy at 8:45 pm; patient took oral Benadryl and is applying cold compresses.
Age: 35.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Headache, Pruritus, Rash
Clinical narrative: Mild rash and headache. No treatment other than local steroid cream for itching at this time.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Head injury, Pain, Poor quality sleep, Pyrexia
Clinical narrative: According to patient, he started experiencing body aches around 6 pm and took ADVIL around 9 pm because of fever. Didn't sleep too well and woke up at 6 am coughing. Got up at 7 am to go bathroom and fainted hitting his head on floor tile requiring 8 stitches at hospital.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Suture insertion, Syncope
Clinical narrative: According to patient, he started experiencing body aches around 6 pm and took ADVIL around 9 pm because of fever. Didn't sleep too well and woke up at 6 am coughing. Got up at 7 am to go bathroom and fainted hitting his head on floor tile requiring 8 stitches at hospital.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Pt. has swelling and redness at site (per patient phone call). Itching.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: 11/8/14 FLUZONE administered left deltoid. 11/9/14 Left deltoid with raised red welt. 11/10/14 Left deltoid reaction progressed during work day to pruritic erythematic raised 10 cm warm welt. Took BENADRYL PO, some improvement of swelling. 7:20 pm raised 10 cm red patch, warm. TX ice, BENADRYL, follow up PRN.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at injection site. Cont pain after injection, has been improving.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Gave flu-shot while patient was seated. Patient fainted in chair. Lost consciousness for approx 10 seconds. Came back to consciousness and was fine. Had patient wait in lobby for approx 30 mins to make sure of no other reactions.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Gait disturbance, Influenza A virus test, Influenza B virus test, Pain
Clinical narrative: Weakness, instability, rash, pain.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Weakness, instability, rash, pain.
Age: 1.03
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash, Rubella
Clinical narrative: Fever, fussing, rash. x 5 days. Suspected rubella.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TDAP, VARZOS
Symptoms: Asthenia, Vomiting
Clinical narrative: Patient called and complained of vomiting for about 4 hrs. straight and was weak the next day. (Evening after shots).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling around injection site. 5 1/2 in x 2 1/2 in area (5 1/2 in down and 2 1/2 in across).
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Feeling cold, Flushing, Insomnia, Oropharyngeal pain
Clinical narrative: Pt claims to be flushed, cold feeling, sore throats starting +- 5 hours after vaccine administration. Left shoulder joint in particular was painful. #8 pain level. Pt used TYLENOL and a heating paid which helped to resolve the pain. Could not sleep. Did not seek medical help.
Age: 5.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Vaccines errantly administered to child despite previously completed series.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Ear pain, Lymphadenopathy, Musculoskeletal stiffness, Pain
Clinical narrative: On Sun PM pt had joint pain in knees where hurt to walk. Also had throbbing ear pain and today (11/11) has a stiff neck and swollen glands. Saw a provider who ruled out meningitis. Pt reports no localized rxn or any previous problems with vaccines.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder/arm joint continues to hurt (start about an hour after injection).
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspnoea, Influenza like illness, Local reaction, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a roughly 70 year old female patient. Information regarding concurrent conditions and pertinent medical history was not provided. On approximately 21-OCT-2014, the patient was vaccinated with ZOSTAVAX (1 single shot, lot# and route were not provided). Concomitant therapies included "high dose flu shot" which was also administered on the same day as ZOSTAVAX. "About 2 weeks ago", on approximately 23-OCT-2014, "2 days after receiving ZOSTAVAX" the patient presented with a severe localized reaction as well as swelling within her shoulder and neck area which made breathing difficult. The patient also experienced flu-like symptoms. The patient had sought for medical attention. Treatment included prednisone and other unspecified medications (dosages/frequencies/manufacturers unknown) were given for the adverse events. The outcome of the events was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, X-ray
Clinical narrative: Intense pain when raising shoulder and at night during sleep.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt. stopped in today to notify us of a continued sore arm in the spot of vaccine, no redness or other rxn just off and on soreness -> recommended heating pad and massage and follow-up with PCP if necessary.
Age: 12.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large erythematous area to right posterior upper arm. Measures app 6 x 7 inches in diameter, warm to touch, tender but non-fluctuant, no masses present.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Within 24 hours of PNEUMOVAX vaccine pt got red/warm rash, personal physician of pt decided to give antibiotics, rash went away within a few days, pt reports full recovery.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient in his 60's (years of age, exact age were unknown). The patient's medical history, concurrent conditions, drug reactions and allergies were unknown. On an unspecified date, approximately in April 2013 (reported as "approximately 18 months ago"), the patient received ZOSTAVAX, dose, frequency, therapy route, lot # and expiration date were not reported. Concomitant medications were not reported. On an unspecified date, in October 2014 (reported as "last week"), the patient developed unspecified shingles symptoms. The patient sought medical attention and he was treated with acyclovir and prednisone. At the time of the report the patient did not recover from adverse event. The relatedness between vaccination with ZOSTAVAX and the event was not reported. Follow up information had been received on 30-OCT-2014 from register nurse. It was reported that the vaccine ZOSTAVAX was not provided by their practice, and he/she had not seen a patient complaint of adverse reaction with ZOSTAVAX. Additional information is not expected because no more information is available.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Neck pain
Clinical narrative: Pt began having swelling at site within 2 hrs of vaccine. Later at night, began having pain up through neck. Pt used warm compress and TYLENOL. Has helped some she states. 11-4-14 - F/U with pt via phone. She reports pain and swelling went away after two days. No MD visit scheduled.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. Nurse reported that on an unknown date unspecified patients received improperly stored PROQUAD (Merck) (lot number and expiration date were not reported). No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No relevant medical history of the patient was reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, strength and route of administration were not reported) dose 1 and approximately 5 years afterwards, he was vaccinated with the second dose of PNEUMOVAX 23 (lot number, strength and route of administration were not reported). No concomitant medications were reported. It was reported that the patient was vaccinated with 2 doses of PNEUMOVAX 23 before 65 years of age. There were no adverse effects reported. There was no product quality complaint involved. The outcome was unknown. Additional information is not expected because there pharmacist did not want to be contacted about this report.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. Since 05-MAY-2014 the patients were vaccinated with GARDASIL. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and GARDASIL was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range), and also to 49F for 12 hours. No known adverse effects. Lot # and expiration date of GARDASIL was unspecified. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality compliant was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (Licensed practical nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with PEDVAXHIB for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Since August 2014, the patients were administered improperly stored PEDVAXHIB. No adverse effects were reported. Outcome and causality assessment was not reported. Product quality complaint was not reported. No additional information reported. This is one of 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (Licensed practical nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with GARDASIL injection for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Since August 2014, the patients were administered improperly stored GARDASIL. No adverse effects were reported. Outcome and causality assessment was not reported. Product quality complaint was not reported. No additional information reported. This is one of 2 reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site mass, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient was not pregnant. Medical history was not reported. On 24-OCT-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot number was not reported). Secondary and concomitant therapies were not reported. Pharmacist reported that on the same day patient was vaccinated, on 24-OCT-2014, patient experienced inflammation and a blister-like, fluid filled lump at the injection site. Pharmacist reported that he did not assessed the patient, but patient was going to pharmacy on 30-OCT-2014 for assessment. At the time of the report, patient had not recovered from the events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 30-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular. Secondary and concomitant therapies were not reported. Pharmacist reported that an expired dose of PNEUMOVAX 23 was inadvertently administered to a patient on 30-OCT-2014. Dose was supported. No adverse experience reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. None pertinent medical history, drug reactions or allergies were reported. On 18-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K009199, expiration date 27-SEP-2015, 0.65 ml, subcutaneous (dose number and anatomical location were not reported). None concomitant therapies were reported. On 19-OCT-2014, 24 hours after vaccination, the patient experienced intense itching "all over the entire arm". No treatment was given. No rash reported. The outcome of the event was unspecified. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. None pertinent medical history, drug reactions or allergies were reported. On 24-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K009199, expiration date 27-SEP-2015, 0.65 ml, subcutaneous (dose number and anatomical location were not reproted). None concomitant therapies were reported. On 25-OCT-2014, 24 hours after vaccination, the patient's entire body was itching. The patient was seen in an unspecified urgent care center and was prescribed prednisone (manufacturer unknown). No rash reported. The outcome of the event was unspecified. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker on 03-NOV-2014 refers to two patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored VAQTA (strength, dose and lot # were unknown). The vaccine was at 31 F for 8 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. None pertinent medical history, drug reactions or allergies were reported. On 20-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K009199, expiration date 27-SEP-2015, 0.65 ml, subcutaneous (dose number and anatomical location were not reported). None concomitant therapies were reported. On 20-OCT-2014, 20 minutes after vaccination, the patient experienced intense itching at the injection site. No treatment was given. No rash reported. The outcome of the event was unspecified. The relatedness between the event and ZOSTAVAX was not reported. This is one several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a company representative via a letter from a female consumer (age not reported) concerning an adverse reaction with 1 PNEUMOVAX (lot # J-04887). On an unspecified date, the patient was injected with 1 PNEUMOVAX (lot # J-04887) on the right arm. On 04-OCT-2013, the patient experienced "a sustained fever, swelling and red hot to the touch at injection site." No further AE information was provided. Follow up information has been received in a letter from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on an unspecified date was vaccinated with PNEUMOVAX (lot # J-04887) in the right arm. On 04-OCT-2013, the patient sustained "fever, swelling and hot to touch on area where shot was administered." Treatment and outcome of the adverse event were unspecified by the reporter. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from an immunization coordinator referring to a female patient of unknown age who on 10-NOV-2014, was inadvertently vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneously (lot # K004713, expiration date 02-OCT-2015) instead of intended ZOSTAVAX dose. No adverse effects reported. This is one of two reports from the same reporter source (linked report 1411USA004622). Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from an immunization coordinator referring to a male patient of unknown age who on 10-NOV-2014, was inadvertently vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneously (lot # K011311, expiration date 14-FEB-2016) instead of intended ZOSTAVAX dose. No adverse effects reported. This is one of two reports from the same reporter source (linked report 1411USA004810). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On 22-OCT-2014 the patient was vaccinated with expired dose of VARIVAX (Merck), 0.5 ml (lot # H018459, expiration date 09-OCT-2014) subcutaneous. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pruritus, Rash, Rash erythematous
Clinical narrative: Red and white bumps on face neck and chest. Painful joints (knee foot). Itchy scalp and ears.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Diarrhoea, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: Dizziness, back ache, soreness at sight of admin. Redness at sight, diarrhea.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: The patient developed a rash over her body including arms and legs, and pt says she visited her dr. who have her prednisone and PROAIR inhaler. Pt has existing lung condition. Unclear if vaccine made it worse.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 5 year old patient with unknown gender. On 22-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot# and expiration date were unknown, dose 1 vial, subcutaneous) instead of VARIVAX (Merck) due to a human error. No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Dyspnoea, Hypertension, Swollen tongue
Clinical narrative: I administered PREVNAR 13 and within 10-15 minutes she began to feel like she was going to pass out. I had her lie down. She was having trouble breathing and tongue was swelling. EPIPEN given x 2 followed by BENADRYL IM. Called 911. BP was high.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response changed
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 62 year old female patient. The patient had chickenpox as a child and administered vaccine. When she was seventeen, she contracted herpes (fever blister) on her lower lip. Since, she experienced one to three outbreaks each and every year for forty-one years, faithfully. She reported that never a year passed without at least one outbreak. On 16-SEP-2010 (administered when patient was approximately 58 years) the patient and her husband both personally paid for shingles vaccine. The patient reproted that it's been four years now and she have not had a single outbreak of her fever blister. She reported that not one during that time and she have had stress, sunshine, and perhaps a few low grade fevers. Yet she was happy that she have been symptom free ever since. The patient reported that she understood the herpes virus and the chickenpox virus are in the same family which most probably explains why she was no longer bothered by the blisters. Reported that perhaps that the older one gets the less likely it was that a fever blister will reoccur. Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Laboratory test normal, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 93 year old female patient. The patient's current condition included allergy to BACTRIM and sulfa. Approximately on an unknown date in 1994, reported as approximately 20 years ago, the patient was vaccinated with PNEUMOVAX23 (lot number, strength, dose, site of administration and route of administration were not reported). There were no concomitant medications reported. On an unknown date after receiving PNEUMOVAX23 the patient's arm swelled up. The swelling was not only at the injection site. On an unknown date the physician performed unspecified diagnostic tests to rule out infection and the patients arm was found to be negative for infection. The patient sought medical attention by visiting physician's office. There was no product quality complaint (PQC) involved. The outcome of arm swelled up was unknown. The causality of the event was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. Nurse reported that on an unknown date unspecified patients received improperly stored PEDVAXHIB (lot number and expiration date were not reported). No adverse effects were reported. The outcome of event was unknown. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. Medical history current conditions and concomitant medications were not reported. Nurse reported that on an unknown date unspecified patients received improperly GARDASIL (lot number and expiration date were not reported). No adverse effects were reported. The outcome of event was unknown. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practice Nurse refers to an unknown number of patients of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. Nurse reported that on an unknown date unspecified patients received improperly stored (Oka/Merck) VARIVAX (lot number and expiration dates were not reported). No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker on 03-NOV-2014 refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and lot # were unknown). The vaccine was at 31 F for 8 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. Since 05-MAY-2014 the patients were vaccinated with PNEUMOVAX 23. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and PNEUMOVAX 23 was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range), and also to 49F for 12 hours. No known adverse effects. Lot # and expiration date of PNEUMOVAX 23 was unspecified. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via a field representative on 06-NOV-2014 refers to a 12 months old patient of unknown gender. On 13-OCT-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K003420, expiration date: unknown) 1 shot, injection in the left thigh. Other suspect therapies included VAQTA (strength, dose, route and lot# were unknown) started on 13-OCT-2014 (also reported as on the same date). On an unknown date of 2014 the patient developed a varicella-like blister at injection site after receiving VARIVAX (Merck). No lab diagnostics studies performed. The outcome of the event was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report  as received from a physician refers to an unspecified number of patients of unknown demographics. Since 05-MAY-2014 the patients were vaccinated with VAQTA. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and VAQTA was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range), and also to 49F for 12 hours. No known adverse effects. Lot # and expiration date of VAQTA was unspecified. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. The patient is allergic to medication in the mycin family and also has thyroid issues. The patient's medical history included recent unspecified surgery. On 03-OCT-2014 (reported as 3 weeks ago) the patient was vaccinated with PNEUMOVAX 23 (strength, dose and frequency unknown) (Lot # and expiry date not provided) dose 1. Concomitant therapies included SYNTHROID, sulfamethoxazole, BACTRIM and KEFLEX. On 03-OCT-2014 (reported as within 12 hours of receiving the vaccine, the patient experienced swelling, redness and pain to the touch at the injection site after receiving PNEUMOVAX 23. Reporter also stated that this reaction was worse compared to other vaccine injection site reactions she experienced however the reporter could not specify which vaccines. Reporter also stated that Erythromycin (manufacturer unknown) made her throat swollen shut and that she is allergic to medications in the Mycin family. The outcome of pain to touch at injection site, redness at the injection site and swelling at the injection site was reported as recovered/resolved on 8-OCT-2014 (reported as 5 days following AE onset date). Causality of the events with PNEUMOVAX 23 was unspecified by the reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site. Patient taking OTC BENADRYL.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. Since 05-MAY 2014 the patients were vaccinated with RECOMBIVAX. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and RECOMBIVAX was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range), and also to 49F for 12 hours. No known adverse effects. Lot # and expiration date of RECOMBIVAX was unspecified. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Gait disturbance, Visual impairment
Clinical narrative: This spontaneous report as received from an approximately 73 years old male patient concerning himself. Pertinent medical history was susceptible to migraines. Patient had drug reactions/allergies to PENICILLIN and SULFER. On 30-Oct-2014 (also reported as yesterday around noon), the patient was vaccinated with ZOSTAVAX, under skin in left arm, (dose and frequency were not provided). Patient had taken unspecified concomitant medications. On 30-Oct-2014 9also reported as yesterday evening around 6-7 PM), the patient developed dizziness after being vaccinated with ZOSTAVAX. The patient said he sat down for a little and "while looking at the wall it seemed as if it were to be moving back and forth". After being seated for 5 minutes his vision cleared up. He still felt woozy and ate something and later felt fine. On 31-OCT-2014 (also reported as this morning), patient woke up and felt a little "off balance". When he walks he needs to hold on to something so he will not fall. He reported that he was not walking the way he normally walks. The patient was not experiencing any pain or swelling. No fever. No headache. The patient mentioned he get migraines once a week. He was not sure if this was stemming from a migraine that was soon to take place, but he had "never experienced this before". The patient stated that his symptoms are better than they were last night. Action taken with respect to ZOSTAVAX was not applicable. Treatment was not given for adverse events. Lab diagnostics studies performed were reported as none. Patient did not seek medical attention. The outcome of dizziness, off balance, while looking at the wall it seemed as if it were to be moving back and forth. After being seated for 5 minutes his vision cleared up and felt woozy was recovering (also reported as not resolved). Outcome of migraine was no recovered. Causality was not provided. No product quality complaint (PQC) was involved. No additional adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker on 03-NOV-2014 refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (strength, dose and lot # were unknown). The vaccine was at 31 F for 8 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's current condition included liver cirrhosis, BIAXIN allergy, meperidine allergy, morphine allergy, VICODIN allergy, DARVOCET allergy, codeine allergy, opioid allergy, iodine allergy, naloxone allergy, TYLENOL allergy and iodinated contrast media allergy. On 17-MAY-2012, the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, strength, route of administration and the site of administration were not reported) dose 1 and received PNEUMOVAX 23 (lot number, expiration date, strength, route of administration and the site of administration were not reported) second dose on 09-JAN-2013. Concomitant therapies included PROTONIX, ibuprofen, XANAX and levothyroxine sodium (manufacturer unknown). On an unknown date the patient developed redness and swelling at the injection site after receiving the second dose of PNEUMOVAX 23. The patient was treated with ice for the event. There were no lab diagnostic studies performed. It was reported that the patient had sought medical attention for the event. There was no product quality complaint (PQC) involved. The outcome of developed redness and swelling at the injection site was reported as recovered on an unknown date. The causality of the event was not provided. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Swelling
Clinical narrative: She developed shingle after she got a shingle shot. She didn't treat anything. It was a bump on her back.
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report refers to a female patient reporting on herself, of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. The patient reported giving herself an expired GARDASIL vaccine. No adverse event was reported as the patient disconnected before information could be gathered. Additional information is not expected because no reporter details were provided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of approximately 65 years. No relevant medical history of the patient was reported. On 01-OCT-2014, the patient received FLUZONE HIGH DOSE injection (Lot number reported as U5017AA, expiry date: 03-APR-2014) (strength, dose and route of administration were not reported) in her left deltoid. On an unknown date in October 2014, reported as a few days later, the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, strength, dose and route of administration were not reported) in the right arm at a pharmacy. It was also reported that the patient was not sure if she received PNEUMOVAX 23 or PCV13 at the pharmacy. No concomitant medications were reported. The patient asked the reporter if she would be having an injection site reaction to the unspecified PCV 10 days after she received it. On an unknown date in October 2014 the patient experienced adverse symptoms in her right deltoid area, but the patient had not described her adverse symptoms to the reporting pharmacist at the time of the report. The reporter did not know if the patient had notified her health care provider or if she received any treatment for the adverse symptoms. There was no product quality complaint reported. The outcome of adverse symptoms in right deltoid area was unknown. The causality was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt received shot on Sunday 11/2, came down with facial rash on Tuesday 11/4. The rash is red, raised, itchy, and painful.
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Swelling
Clinical narrative: Apparent allergic rxn - severe swelling and redness on arm under vaccination site and down to mid lower arm.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Induration, Local swelling, Pain, Pruritus
Clinical narrative: Got the shot last wk Thurs. By Friday arm had a large swollen area. Itched, it was red. Today a week later swelling is half way down, but area is real hard and still hurts and itches.
Age: 0.18
Sex: M
Vaccine: HEP, HIBV, PNC13, RV5
Symptoms: Blood culture, Culture urine, Full blood count, Irritability, Pyrexia
Clinical narrative: Fever to 102.5 degrees pots vaccines and fussiness.
Age: 0.18
Sex: M
Vaccine: HEP, HIBV, PNC13, RV5
Symptoms: Urine analysis
Clinical narrative: Fever to 102.5 degrees pots vaccines and fussiness.