chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Injection site pain, injection site swelling and erythema, fever, body aches, tiredness, sore shoulder, rash at injection site.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain, Pyrexia, White blood cell count normal
Clinical narrative: Injection site pain, injection site swelling and erythema, fever, body aches, tiredness, sore shoulder, rash at injection site.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram, Diplopia, Eye swelling, Eyelid function disorder
Clinical narrative: Eye started to swell.  Saw eye Dr. and she said it was a stye.  The eye continued to swell and was completely closed in 4-5 days.  Saw eye Dr. again and was immediately sent to the ER. Was hospitalized for 8 days with multiple scans of the eye, head and body. Diagnosis was damage to the 3rd cranial nerve.  No treatment. It may get better in time. Eye can not be opened and pupil is not straight.  There is double vision when examined. Also weakness and nausea since flu shot. Oddly, I also had eye shingles after a flu shot 2 years ago.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Hordeolum, IIIrd nerve injury, Laboratory test, Nausea, Nuclear magnetic resonance imaging brain
Clinical narrative: Eye started to swell.  Saw eye Dr. and she said it was a stye.  The eye continued to swell and was completely closed in 4-5 days.  Saw eye Dr. again and was immediately sent to the ER. Was hospitalized for 8 days with multiple scans of the eye, head and body. Diagnosis was damage to the 3rd cranial nerve.  No treatment. It may get better in time. Eye can not be opened and pupil is not straight.  There is double vision when examined. Also weakness and nausea since flu shot. Oddly, I also had eye shingles after a flu shot 2 years ago.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Pupillary disorder, Whole body scan
Clinical narrative: Eye started to swell.  Saw eye Dr. and she said it was a stye.  The eye continued to swell and was completely closed in 4-5 days.  Saw eye Dr. again and was immediately sent to the ER. Was hospitalized for 8 days with multiple scans of the eye, head and body. Diagnosis was damage to the 3rd cranial nerve.  No treatment. It may get better in time. Eye can not be opened and pupil is not straight.  There is double vision when examined. Also weakness and nausea since flu shot. Oddly, I also had eye shingles after a flu shot 2 years ago.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, soreness and swelling at injection site. Fever, chills, fatigue. On call doctor prescribed triamcinolone for injection site and rest and ibuprofen for other symptoms.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Redness, soreness and swelling at injection site. Fever, chills, fatigue. On call doctor prescribed triamcinolone for injection site and rest and ibuprofen for other symptoms.
Age: 27.0
Sex: M
Vaccine: FLUC3
Symptoms: Lip swelling, Pruritus
Clinical narrative: Swollen lips and itching.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Itching.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Blister, Rash erythematous, Rash generalised
Clinical narrative: Red bumps and blisters spread on skin throughout the body.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient reported to ER at hospital with rash, patient is unaware if related to vaccine or not.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Cough, Increased bronchial secretion, Sensation of foreign body, X-ray
Clinical narrative: Started coughing with each breath and felt a lump in throat and foaming in bronchial. Went to Urgent Care. Heart rate at 145 and BP @ 185/98. Not sure of oxygen saturation but was put on oxygen before receiving a shot of Benadryl and prednisone. Was transported to ER by ambulance and given a Benadryl drip in transport. Was in ER for five hours and had an xray of soft tissue in throat. BP was still elevated @ 165/89 when released from hospital with prescription for 5 day course of prednisone and Pepcid.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Tenderness, Urticaria
Clinical narrative: Tender, welted area surrounding 1x3 inch red rash. First noted evening of day following injection, persisting into evening two days following injection, no treatment required.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site pain, Mobility decreased
Clinical narrative: ~5:00AM 10/17/2014, awakened by L arm pain, aching all joints, worse with movement (only minimal pain at injection site); flu like symptoms, all over body joint aching, extreme fatigue. Continuing through 10/17, 10/18 (severe aching, limiting movement), better but ongoing 10/19.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: ~5:00AM 10/17/2014, awakened by L arm pain, aching all joints, worse with movement (only minimal pain at injection site); flu like symptoms, all over body joint aching, extreme fatigue. Continuing through 10/17, 10/18 (severe aching, limiting movement), better but ongoing 10/19.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Vomiting projectile
Clinical narrative: Projectile vomiting (water based). Tired, weak, mental "fuzziness", dizzy.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: THE PATIENT STATED THAT HER ARM WAS VERY SORE AND WARM TO THE TOUCH AND DIFFICULT TO RAISE HER ARM.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Decorticate posture, Muscle rigidity, Tonic convulsion
Clinical narrative: Tonic seizure activity of approximately 45 secs duration followed almost immediately by a second episode that included decorticate rigidity. Administered 0.3mg epinephrine by EpiPen. Transported by EMS in stable condition to local emergency room.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Barium swallow, Fatigue, Hypophagia, Irritability
Clinical narrative: Became fussy on 10/13/14, 10/14/14 tired and more sleepy decreased oral intake 10/15/14 developed emesis, came to ED, 10/16/14 diagnosis with transverse colon intussusception and was reduced.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Large intestinal obstruction reduction, Oesophagram, Somnolence, Ultrasound abdomen, Urinary system X-ray
Clinical narrative: Became fussy on 10/13/14, 10/14/14 tired and more sleepy decreased oral intake 10/15/14 developed emesis, came to ED, 10/16/14 diagnosis with transverse colon intussusception and was reduced.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting, X-ray, X-ray gastrointestinal tract
Clinical narrative: Became fussy on 10/13/14, 10/14/14 tired and more sleepy decreased oral intake 10/15/14 developed emesis, came to ED, 10/16/14 diagnosis with transverse colon intussusception and was reduced.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal, Pain
Clinical narrative: Substernal reproducible chest pressure described as aching soreness, associated with dyspnea. Self treated with Advil.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Activities of daily living impaired, Bronchospasm, Dyspnoea, Pyrexia, Rhinorrhoea
Clinical narrative: Received Flumist on 10/15.  Began with low grade fever and runny nose on 10/16 so bad had to be kept home from school. Progressed to shortness of breath with wheezing and fevers reaching 103 with treatment of Tylenol and Motrin, saline spray on 10/17, same on 10/18, worse on 10/19 sought tx at urgent care, diagnosed with bronchospasm and viral infection requiring neb tx and Flonase and orders to be kept at home on bed rest for few days.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Viral infection, Wheezing
Clinical narrative: Received Flumist on 10/15.  Began with low grade fever and runny nose on 10/16 so bad had to be kept home from school. Progressed to shortness of breath with wheezing and fevers reaching 103 with treatment of Tylenol and Motrin, saline spray on 10/17, same on 10/18, worse on 10/19 sought tx at urgent care, diagnosed with bronchospasm and viral infection requiring neb tx and Flonase and orders to be kept at home on bed rest for few days.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Pain
Clinical narrative: About 4 hours after the HIGH DOSE shot, she began to experience a persistent cough, aches, shooting pain, and extreme chills. This lasted with slowly lessening severity, for about 4 days. She has had the flu shot before, but this is the first time that she got the HIGH-DOSE.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Patient experienced mild flu-like symptoms on the evening of the day on which he received a flu shot. He had received flu shots in the past, but believes that this was the first time he had received High Dose.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Received both PNEUMOVAX and FLUZONE HD same day. Had redness and swelling in arm that received both vaccines (upper arm to elbow). Also complained of chills and fever the day after receiving vaccines. Gave BENADRYL on 10/16/2014.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dyspnoea, Hyperhidrosis
Clinical narrative: Sweating, clammy. SOB. Laid pt on floor. Administered 1 EPIPEN injection. Called 911; 2nd EPIPEN approximately 10 minutes later. EMT arrived. Pt recovered full consciousness.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Puffy around area of injection, very squishy. Muscle is pink, red in color. Not itchy, slightly warmer than other deltoid (R) arm. Headache at 20-3 am - took 2 TYLENOL. First year getting HIGH DOSE flu vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Myalgia, Swelling
Clinical narrative: Large swelling and muscle tenderness - limited use of arm. Injected in same arm due to other arm involvement with breast surgery.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: Swelling, redness on arm of injection. Soreness - severe - limited use of arm (left arm only).
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash papular
Clinical narrative: Broke out large red and swollen rash. Took BENADRYL but symptoms got worse. Went to ER and was given antibiotics and prednisone. Swelling better 10/13/14.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness
Clinical narrative: Pt experienced dizziness, chest tightness. Vitals checked, BP/HR/BG all normal. Pt agreed to 12.5mg oral diphenhydramine x1.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Nasopharyngitis, Peripheral coldness, Pyrexia, Throat irritation
Clinical narrative: Patient got flu vaccine 10/17/14 at around 12:45 P.M. He reported having fever, chills, and cold hands and feet around 6 P.M. Then when he woke up Sat AM still had fever and had to take ADVIL. Fever cleared up but still has scratchy throat and cold like symp.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swollen at the site of injection. Pt took acetaminophen. Redness, swelling improved in 1-2 days then swelling again.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient received ZOSTAVAX in right upper arm 9/11/14. Developed rash localized to upper right chest which was a little raised and itchy. Rash resolved in 1-2 weeks.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Body temperature increased, Feeling abnormal, Pain, Vomiting
Clinical narrative: Received FLUVIRIN, ADACEL, PNEUMOVAX. Went home. About 6PM started to vomit. Felt bad and sore. Went to work Thur. Felt worse. Went back to work Fri. Went home sick with 101 temp. Went to MD office temp 104. MD put her on antibiotics monitored and sent home. She was sick all weekend.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Inflammation, Local swelling
Clinical narrative: 10/17/14, PM, customer has swelling and inflammation in his left interior arm (side closest to chest). 10/18/14 PM customer informs me of issue. He declined over the counter analgesics. He was given hydrocortisone 12 cream.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had swelling and redness in area of immunization shot. Pt had gone to walk in clinic to have treatment normal side effect of shot. Pt took diphenhydramine and swelling and redness cleared up.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Pt reported having a constant medium severity headache starting 4 to 5 hours after receiving vacc. Headache constant. Started taking acetaminophen 650 mg every 4 hrs which helped, Headache is ongoing at present.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Redness, "bump" swelling and itching the size of the bandaid at injection site. Stated 10/19/14 verbally. Vaccinated 10/17/14 two days prior. Not getting worse and will allow to heal on its own.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Received PNEUMOVAX in right arm on 10/16. Friday 10/17 arm sore but not red or warm. Saturday AM 10/18 sore, red, warm on inside of arm. Went to urgent care. Provider prescribed azithromycin.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Joint range of motion decreased, Pyrexia
Clinical narrative: Patient had transient fever. Then pain in armpit that decreased ROM.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Large rash around injection site with high fever.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Arm became swollen at injection site the night following vaccine. Pain and stiffness shoulder progressively got worse. Visited urgent care. 9-26-14 advised to take ibuprofen or TYLENOL. Pain and stiffness.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Condition aggravated, Dyspnoea, Pain
Clinical narrative: Reported me on 9/22 6PM. Patient had flu like rxn, aching, chilling, severe weakness. Patient is a COPD patient that is on oxygen - had some increased shortness of breath. Refer patient to physician or ER room. Follow up with patient 9/23 and 9/25, still with SOB. Recommend see Dr. again. 9/23 - Recommend pt see Dr. 9/25 follow up done yet.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red warm area which continued to enlarge in size decreased go down to at 1" above elbow.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse concerning to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 08-JUL-2008 the patient was vaccinated with first dose of GARDASIL (lot number, dose and route unspecified). Concomitant medications were not reported. The reporter stated that the patient was in the office on an unspecified date in 2014 to receive second dose of GARDASIL. No adverse symptoms were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 09-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot number and dose unspecified), subcutaneously. On 03-OCT-2014 the patient was vaccinated with another dose of PROQUAD (Merck) (lot number and dose unspecified), subcutaneously. Concomitant medications were not reported. No known adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5, HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (medical assistant) refers to a patient of unknown age and demographics. Current conditions and medical history was not reported. On 16-SEP-2014, the patient was vaccinated with ROTATEQ, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 16-SEP-2014, it was reported that the patient received ROTATEQ that was exposed to temperature outside of the proper storage range. No adverse effect reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (medical assistant) refers to a patient of unknown age and demographics. Current conditions and medical history was not reported. On 16-SEP-2014, the patient was vaccinated with ROTATEQ, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 16-SEP-2014, it was reported that the patient received ROTATEQ that was exposed to temperature outside of the proper storage range. No adverse effect reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 30-SEP-2014 the patient was vaccinated with ROTATEQ, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 30-SEP-2014, it was reported that the patient was exposed to temperature outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperature outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 07-OCT-2014 the patient was vaccinated with ROTATEQ, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 07-OCT-2014, it was reported that the patient was exposed to temperature outside of the proper storage range. No adverse reported. The outcome of were exposed to temperature outside of the proper storage range and no adverse effect is unknown. There was no product quality complaint (PQC) involved. 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 was received from a other health professional refers to an unspecified number of patients of unknown demographics. On an unknown date the patient was vaccinated with PEDVAXHIB, (lot #, expiry, dose, dose # and route unspecified). No concomitant medications were reported. On an unknown date, it was reported that patients received doses that were exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of patients received doses that were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 25-SEP-2014 the patient was vaccinated with GARDASIL lot # H021861, expiry: 09-OCT-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 25-SEP-2014, the patient received doses that were exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of patient received doses that were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: This spontaneous report as received from another health professional (Registered Nurse) refers to an approximately 19 year old female patient. Patient was not pregnant. Current conditions and medical history were reported as none. On 13-OCT-2014, the patient was vaccinated with VARIVAX (Merck) injection, lot number-K003412, expiry date-06-MAR-2016, 0.5 milliliter, subcutaneously. On 14-OCT-2014, the patient experienced, flat, light pink discoloration measuring 45 millimeter (mm) x 60mm in her left upper arm. In the center of the light pink discoloration was a darker pink discoloration measuring 15mm x 25mm. It was also reported that on 14-OCT-2014, patient had 2 out of 10 pain in the left arm. No treatment was given. No lab diagnostics studies performed. The outcome of 20 out of 10 pain in the left upper arm and discoloration was reported as recovering on 15-OCT-2014. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Chills, Erythema, Headache, Induration, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 70 year old male patient. On 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # J005068; expiration date: 18-JAN-2015), 0.5 ml, intramuscular, right arm. Other suspect therapies included FLUZONE in the left arm. On 25-SEP-2014, the patient stated he was not feeling well described as lightheaded, night sweats, low grade fever and a swollen right arm. On 27-SEP-2014, the patient sought medical attention at the physician's assistant office. On an unspecified date, the patient was prescribed with KEFLEX. The outcome of swollen right arm, low grade fever, not feeling well described as lightheaded and night sweats was reported as recovered/resolved on unspecified date in 2014. This is one of several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Pain, Pyrexia, Skin lesion, Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 70 year old male patient. On 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # J005068; expiration date: 18-JAN-2015), 0.5 ml, intramuscular, right arm. Other suspect therapies included FLUZONE in the left arm. On 25-SEP-2014, the patient stated he was not feeling well described as lightheaded, night sweats, low grade fever and a swollen right arm. On 27-SEP-2014, the patient sought medical attention at the physician's assistant office. On an unspecified date, the patient was prescribed with KEFLEX. The outcome of swollen right arm, low grade fever, not feeling well described as lightheaded and night sweats was reported as recovered/resolved on unspecified date in 2014. This is one of several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Dizziness, Local swelling, Malaise, Night sweats, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 70 year old male patient. On 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # J005068; expiration date: 18-JAN-2015), 0.5 ml, intramuscular, right arm. Other suspect therapies included FLUZONE in the left arm. On 25-SEP-2014, the patient stated he was not feeling well described as lightheaded, night sweats, low grade fever and a swollen right arm. On 27-SEP-2014, the patient sought medical attention at the physician's assistant office. On an unspecified date, the patient was prescribed with KEFLEX. The outcome of swollen right arm, low grade fever, not feeling well described as lightheaded and night sweats was reported as recovered/resolved on unspecified date in 2014. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 65 year old female patient with an allergy to CEFTIN who on 29-SEP-2014 was vaccinated with a dose of ZOSTAVAX (dose and site not reported) for the prevention of shingles. On 01-OCT-2014, the patient sought for attention at the pharmacy since she was presenting mild redness, swelling, warmth and itching at the injection site. Pharmacist stated that no rash was present. Patient was treated with BENADRYL (dose and frequency unknown) and cold compresses. No lab diagnostic studies were performed. There was not intervention to prevent serious criteria. No life threatening, hospitalization or disability reported. At the time of the report the patient had not recovered from mild redness, swelling, warmth and itching. Relationship between mild redness, swelling, warmth, itching and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 65 year old female patient with an allergy to CEFTIN who on 29-SEP-2014 was vaccinated with a dose of ZOSTAVAX (dose and site not reported) for the prevention of shingles. On 01-OCT-2014, the patient sought for attention at the pharmacy since she was presenting mild redness, swelling, warmth and itching at the injection site. Pharmacist stated that no rash was present. Patient was treated with BENADRYL (dose and frequency unknown) and cold compresses. No lab diagnostic studies were performed. There was not intervention to prevent serious criteria. No life threatening, hospitalization or disability reported. At the time of the report the patient had not recovered from mild redness, swelling, warmth and itching. Relationship between mild redness, swelling, warmth, itching and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Oedema peripheral, Pain, Swelling
Clinical narrative: Pain in Rt armpit. Swelling in area from back to across chest to Rt nipple, and down to bottom of rib cage.
Age: 54.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Axillary pain, Nipple swelling, Swelling
Clinical narrative: Pain in Rt armpit. Swelling in area from back to across chest to Rt nipple, and down to bottom of rib cage.
Age: 68.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Patient developed a rash 10/1/14. The rash began on the arm the ZOSTAVAX was administered. Urgent care physician diagnosed patient with shingles on 10/2/14.
Age: 68.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed a rash 10/1/14. The rash began on the arm the ZOSTAVAX was administered. Urgent care physician diagnosed patient with shingles on 10/2/14.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Chest pain, Dyspnoea, Muscle spasms, Productive cough
Clinical narrative: I had a very hard time breathing that woke me up. I thought I might be having an extreme Asthma attack. I only have a Asthma attack perhaps every other year. I couldn't call out for my daughter for help & barely made it to my inhalers. I've never been so scared & close to calling 911 for help before. I had back spasms from being so tense. It took a good 5 hours before I could breathe without my back & chest hurting. 2 days later I'm now coughing up some real nasty stuff I have no idea where it came from.  I'm healthy for the most part & I'll never get another flu shot.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Tension
Clinical narrative: I had a very hard time breathing that woke me up. I thought I might be having an extreme Asthma attack. I only have a Asthma attack perhaps every other year. I couldn't call out for my daughter for help & barely made it to my inhalers. I've never been so scared & close to calling 911 for help before. I had back spasms from being so tense. It took a good 5 hours before I could breathe without my back & chest hurting. 2 days later I'm now coughing up some real nasty stuff I have no idea where it came from.  I'm healthy for the most part & I'll never get another flu shot.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Swelling, redness, rash surrounding administration site.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Arthralgia, Chills, Ear pain, Fatigue, Feeling cold
Clinical narrative: Violent teeth chattering and body shaking for so long my left ear ached and kidneys hurt.  I was freezing but I couldn't move from couch for an hour, then went to bed with clothes on and fell asleep. Woke up 2 hours later and took my evening meds. Still cold but not shaking.  Extremely tired and all of my joints hurt (I have rheumatoid arthritis). None of my symptoms were on the sheet I was given. I almost called a friend to take me to the hospital. I have never had this happen. I have never had any side effects from flu or pneumonia vaccinations. Did I have a seizure? I'm going to call my doctor and report it to the pharmacy.  I don't know if this side effect affected my body and I need to check it out next week. I'm not going to check a box in the next section.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Renal pain, Tremor
Clinical narrative: Violent teeth chattering and body shaking for so long my left ear ached and kidneys hurt.  I was freezing but I couldn't move from couch for an hour, then went to bed with clothes on and fell asleep. Woke up 2 hours later and took my evening meds. Still cold but not shaking.  Extremely tired and all of my joints hurt (I have rheumatoid arthritis). None of my symptoms were on the sheet I was given. I almost called a friend to take me to the hospital. I have never had this happen. I have never had any side effects from flu or pneumonia vaccinations. Did I have a seizure? I'm going to call my doctor and report it to the pharmacy.  I don't know if this side effect affected my body and I need to check it out next week. I'm not going to check a box in the next section.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Chills, Fatigue, Tremor
Clinical narrative: Violent teeth chattering and body shaking for so long my left ear ached and kidneys hurt.  I was freezing but I couldn't move from couch for an hour, then went to bed with clothes on and fell asleep. Woke up 2 hours later and took my evening meds. Still cold but not shaking.  Extremely tired and all of my joints hurt (I have rheumatoid arthritis). None of my symptoms were on the sheet I was given. I almost called a friend to take me to the hospital. I have never had this happen. I have never had any side effects from flu or pneumonia vaccinations. Did I have a seizure? I'm going to call my doctor and report it to the pharmacy.  I don't know if this side effect affected my body and I need to check it out next week. I'm not going to check a box in the next section.
Age: 20.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Clinical history and exam consistent with acute urticaria, likely secondary to FluMist exposure. Absence of historical red flags or exam findings concerning for anaphylaxis or imminent threat to pulmonary capabilities. Will treat as outpatient with oral Benadryl and recommend avoidance of FluMist in the future. Warning signs/symptoms prompting reevaluation reviewed and pt vocalized understanding. Will f/u with PCM on PRN basis. Medication(s):   -UCC/MOD DIPHENHYDRAMINE 25MG CAP (12/BTL - TAKE 1 TO 2 CAPSULE BY MOUTH THREE TIMES A DAY AS NEEDED FOR ALLERGY SYMPTOMS #12 RF0
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash papular
Clinical narrative: Severe itching and systemic raised rash.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Agitation, Disturbance in attention, Irritability
Clinical narrative: Irritability, lack of focus, in ability to focus, agitation.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PAIN AND HOT WITH LARGE REDDENED AREA AT INJECTION SITE LASTING 1 WEEK / NO TREATMENT GIVEN.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Condition aggravated, Headache
Clinical narrative: Pt received Flu Mist vaccine 1 week ago and since that time has c/o HA's 5-6 times per day x 7 days. * pt should cont daily Nasonex.  Will switch pt to Zyrtec 10 mg nightly to monitor for any improvement in sx's. * will send pt to allergy clinic for further evaluation and mngt in sx control. * mom can give Tylenol alternated w/motrin prn for HA relief.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Hard, bright red warm are approximately 3 1/2 inches diameter, itching.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Site iswarm, swollen, red;  reaction area is below site, appears to be a flacid fluid filled area approximately 3 X 4 inches.  Some itching.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site reaction, Joint range of motion decreased, Local swelling, Musculoskeletal pain
Clinical narrative: Red rash from injection site all the way down to elbow. Swelling of entire upper arm. Cellulitis diagnosis. Put on 10 days of cephalexin 500mg qid. 2 days later swelling of the shoulder and extreme pain. Put on prednisone 20mg. 2 weeks later pain still in shoulder limiting range of motion.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Red rash from injection site all the way down to elbow. Swelling of entire upper arm. Cellulitis diagnosis. Put on 10 days of cephalexin 500mg qid. 2 days later swelling of the shoulder and extreme pain. Put on prednisone 20mg. 2 weeks later pain still in shoulder limiting range of motion.
Age: 42.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood pressure increased, Dizziness, Flushing, Hyperhidrosis, Malaise
Clinical narrative: Flushed, warm, malaise, sweating, nausea, dizzy, light headed, elevated blood pressure.
Age: 42.0
Sex: F
Vaccine: FLUC3
Symptoms: Nausea, Skin warm
Clinical narrative: Flushed, warm, malaise, sweating, nausea, dizzy, light headed, elevated blood pressure.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Acoustic stimulation tests abnormal, Hearing impaired
Clinical narrative: Mom stated that patient woke up 3 days after Flumist was given and stated that she could not hear. Mom looked up online and found that the Flumist can cause hearing loss. She then waited it out but no patient showed no improvement. Mom then contacted our office to have patient seen for follow up and a full work up was done on patient. No drainage, no swelling and no associated symptoms were found during check up. A hearing test was performed on patient and she failed the right ear. Mom has scheduled a test with audiology and has been referred to hospital. At this time we are unable to predict if this will be a permanent disability.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Nausea, achy, fever.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Shoulder pain surrounding site of injection 5 days after injection.
Age: 75.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Urticaria
Clinical narrative: Wife reported that he broke out in whelps the same day as he recieved the vaccines.  She gave him Benadryl and later used hydrocortisone cream 1%.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Hypersensitivity, Pain in extremity
Clinical narrative: Redness over whole back of arm; grapefruit size; spreading and painful; Pt went to urgent care on 10/19/14, where she was diagnosed with cellulitus and an allergic reaction; she was given prescriptions for Bactrim ds 800-160 mg twice daily for 10 days and prednisone 20 mg 3 tabs once daily for 3 days; she was also told to take diphenhydramine 25 mg every 6 hours.  On 10/20/14, she said she was much better.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Generalized Itchiness along arms and chest presenting approximately 30 minutes after injection.
Age: 18.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Headache, Influenza virus test negative, Myalgia, Pyrexia
Clinical narrative: Feverish, chills, HA-- taking Advil. TMAX (10/20/14 @ 9:30AM): 102.2F, chills myalgias.
Age: 18.0
Sex: M
Vaccine: FLUX
Symptoms: Streptococcus test negative
Clinical narrative: Feverish, chills, HA-- taking Advil. TMAX (10/20/14 @ 9:30AM): 102.2F, chills myalgias.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Rash erythematous
Clinical narrative: Red rash, knot. Hydrocortisone ointment applies.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant swelling, redness, pain at site of injection; Swelling became progressively worse to involve entire upper arm from shoulder to elbow.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Injection site haemorrhage, Injection site inflammation
Clinical narrative: Immediately on recieving injection the localized area around the injection site became inflammed and swollen with more than usual bleeding following the injection. Patient was monitored and recieved a cold compress and returned to work after approximately 15 minutes. Patient returned complaining of still feeling off approximately 2 hours later, patient stated she was feeling dizzy and lightheaded as well as feeling tingly in the injection arm. Patient was given Benadryl and reccommended to take ibuprofen for pain which she did. The following day 10/14/2014 patient developed a rash on her upper body and head and went to the emergency room for treatment.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain, Paraesthesia, Rash
Clinical narrative: Immediately on recieving injection the localized area around the injection site became inflammed and swollen with more than usual bleeding following the injection. Patient was monitored and recieved a cold compress and returned to work after approximately 15 minutes. Patient returned complaining of still feeling off approximately 2 hours later, patient stated she was feeling dizzy and lightheaded as well as feeling tingly in the injection arm. Patient was given Benadryl and reccommended to take ibuprofen for pain which she did. The following day 10/14/2014 patient developed a rash on her upper body and head and went to the emergency room for treatment.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Rash macular
Clinical narrative: Left thigh (where injection was given) had a six inch red blotchy rash that is still present today on 10/20/14.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itching at the injection site of the Zostavax injection.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever 101.3, muscle aches, chills, severe headache.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient came into the pharmacy on Friday, 10/17/2014 at 11:00am to show the pharmacist on duty her left arm where she had received the Zostavax vaccine subcutaneously a week prior (10/10/2014 at 1:00pm). She said that on Monday, 10/13/14 or Tuesday, 10/14/14 she noticed that the site looked a little red and wasn't sure if she was having a reaction to the vaccine or if it could be caused from having the shingles previously. The pharmacist on duty on 10/17/14 looked at the injection site and noticed it there was a red spot about the size of a quarter with what possibly looked like a small blister underneath. There weren't any signs of swelling, puss, warmth, and the patient said she felt perfectly fine expect the site itched a litte. The pharmacy manager that administered the vaccine called the patient the night of 10/17/2014 and she said that the site wasn't spreading and that she thought the redness was starting to go down. She said she did not feel that she needed to seek medical attention and that she just wanted to continue to monitor it. The pharmacy manager called back on Sunday, 10/19/14 to follow up with the patient and she said that the redness was starting to go away and that it was not itching as much. On Monday, 10/20/2014 the patient said that the redness was almost completely gone and the site really didn't itch anymore and that she thought it was pretty much resolved. The pharmacy manager called the patients Doctor's office and spoke to R.N. to let them know about the possible adverse reaction and they said that they would make note of it and to instruct the patient to be seen if the redness doesn't go away, comes back, or gets worse.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient came into the pharmacy on Friday, 10/17/2014 at 11:00am to show the pharmacist on duty her left arm where she had received the Zostavax vaccine subcutaneously a week prior (10/10/2014 at 1:00pm). She said that on Monday, 10/13/14 or Tuesday, 10/14/14 she noticed that the site looked a little red and wasn't sure if she was having a reaction to the vaccine or if it could be caused from having the shingles previously. The pharmacist on duty on 10/17/14 looked at the injection site and noticed it there was a red spot about the size of a quarter with what possibly looked like a small blister underneath. There weren't any signs of swelling, puss, warmth, and the patient said she felt perfectly fine expect the site itched a litte. The pharmacy manager that administered the vaccine called the patient the night of 10/17/2014 and she said that the site wasn't spreading and that she thought the redness was starting to go down. She said she did not feel that she needed to seek medical attention and that she just wanted to continue to monitor it. The pharmacy manager called back on Sunday, 10/19/14 to follow up with the patient and she said that the redness was starting to go away and that it was not itching as much. On Monday, 10/20/2014 the patient said that the redness was almost completely gone and the site really didn't itch anymore and that she thought it was pretty much resolved. The pharmacy manager called the patients Doctor's office and spoke to R.N. to let them know about the possible adverse reaction and they said that they would make note of it and to instruct the patient to be seen if the redness doesn't go away, comes back, or gets worse.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Cellulitis, Chest discomfort, Erythema, Local swelling
Clinical narrative: The night of the shots on 10/7/14 (flu and pneumonia shot in same arm)I had minor swelling and pain. I figured it was normal after two injections in the same arm. On 10/8/14 my arm was very red and swollen and sore and hot. The swelling was getting larger on 10/9 & 10/10 and very hot and sore/itchy. I contacted my primary cares office and they told me it was probably normal and to see them over the weekend at urgent care if needed. On the evening of 10/10 my chest felt tight and I was very achy and my arm was very hot and red and swollen. I was brought to the hospital around 10-11 pm for what I thought was a reaction. I was told I had a bacterial infection called cellulitis and was put on Doxycycline. I was released from the hospital around 5:30 am on 10/11 and was told to go back if the infection spread past the line they drew on me. I have not gone back but am watching it carefully, the infection is still there but not getting any larger at this time.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: The night of the shots on 10/7/14 (flu and pneumonia shot in same arm)I had minor swelling and pain. I figured it was normal after two injections in the same arm. On 10/8/14 my arm was very red and swollen and sore and hot. The swelling was getting larger on 10/9 & 10/10 and very hot and sore/itchy. I contacted my primary cares office and they told me it was probably normal and to see them over the weekend at urgent care if needed. On the evening of 10/10 my chest felt tight and I was very achy and my arm was very hot and red and swollen. I was brought to the hospital around 10-11 pm for what I thought was a reaction. I was told I had a bacterial infection called cellulitis and was put on Doxycycline. I was released from the hospital around 5:30 am on 10/11 and was told to go back if the infection spread past the line they drew on me. I have not gone back but am watching it carefully, the infection is still there but not getting any larger at this time.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: The night of the shots on 10/7/14 (flu and pneumonia shot in same arm)I had minor swelling and pain. I figured it was normal after two injections in the same arm. On 10/8/14 my arm was very red and swollen and sore and hot. The swelling was getting larger on 10/9 & 10/10 and very hot and sore/itchy. I contacted my primary cares office and they told me it was probably normal and to see them over the weekend at urgent care if needed. On the evening of 10/10 my chest felt tight and I was very achy and my arm was very hot and red and swollen. I was brought to the hospital around 10-11 pm for what I thought was a reaction. I was told I had a bacterial infection called cellulitis and was put on Doxycycline. I was released from the hospital around 5:30 am on 10/11 and was told to go back if the infection spread past the line they drew on me. I have not gone back but am watching it carefully, the infection is still there but not getting any larger at this time.