chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 years old female patient with no drug reactions/allergies and no pertinent medical history, who on 11-DEC-2012, was vaccinated with the third dose of GARDASIL 0.5 ml intramuscularly in her right arm (lot # 672721/0101AE, Exp: 10-OCT-2012). No other co-suspects were reported. No concomitant , medications were reported. The next day, on 12-DEC-2012, the patient started to have severe pain in her right arm, which she described as muscle pain. There was no sign of swelling or redness at the injection site. The patient called the physician's office. They recommended acetaminophen (dosage and manufacturer unspecified) and she reported no pain relief. It was also reported that no treatment was given for the AE. The patient reported no pain relief since that day. The patient reported previous doses of GARDASIL 0.5ml intramuscularly (lot numbers not reported): the first on 13-JUN-2012, and the second on 09-JUL-2012, which she did not experienced any adverse reaction. No diagnostic laboratory studies were performed. The patient sought medical attention via office visit. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Culture throat negative, Myalgia, Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Developed high fever (Tmax 102-axillary), sore throat, vomiting, muscle aches/myalgias 4 hours after immunes.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Vomiting
Clinical narrative: Developed high fever (Tmax 102-axillary), sore throat, vomiting, muscle aches/myalgias 4 hours after immunes.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Antinuclear antibody negative, Blood creatine phosphokinase normal, Blood creatinine normal, Burning sensation, C-reactive protein normal
Clinical narrative: Numbness and pain - bil upper extremities, Lt > Rt. Burning sensation all over body. Easy fatigability. Tingling of face. Neck pain. Left eye watering.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Computerised tomogram normal, Fatigue, Hypoaesthesia, Lacrimation increased, Myoglobin blood
Clinical narrative: Numbness and pain - bil upper extremities, Lt > Rt. Burning sensation all over body. Easy fatigability. Tingling of face. Neck pain. Left eye watering.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Neck pain, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia
Clinical narrative: Numbness and pain - bil upper extremities, Lt > Rt. Burning sensation all over body. Easy fatigability. Tingling of face. Neck pain. Left eye watering.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Numbness and pain - bil upper extremities, Lt > Rt. Burning sensation all over body. Easy fatigability. Tingling of face. Neck pain. Left eye watering.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (L) deltoid redness pain, swollen, itchy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report as received from a Doctor of pharmacist concerning a 62 years old female patient who was vaccinated with ZOSTAVAX (lot # H018497, Exp date 10-JAN-2014) (dose and route not provided) on 15-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that on 16-DEC-2012 the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as red and itchy about 2 inched in diameter at the injection site. There was no treatment given for the event. There were no labs performed. The outcome of red and itchy about 2 inched in diameter at the injection site was reported as not recovered/not resolved. The relatedness for red and itchy about 2 inched in diameter at the injection site and red and itchy about 2 inched in diameter at the injection site she was unknown for ZOSTAVAX. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Chest discomfort, Dizziness, Fall, Immediate post-injection reaction, Pallor
Clinical narrative: Approximately 5 seconds after administering HPV vaccine in left deltoid to 20 year-old female, client veered sideways from a sitting position.  Nurse (myself) supported client back to an upright sitting position.  Client was pale and stated she felt "dizzy."  Client was instructed to place down head between legs. Nurse applied cold, wet towel to the back of client's neck.  Upon client's stating that syncope had resolved, nurse (myself) provided apple juice.  Client stated that she had eaten breakfast.  Client further stated that upon inspiration she "feels some pressure in my lower lungs," and client's color had not returned to her face.  Client displayed no signs of having difficulty breathing or speaking.  Client was helped to rest on exam table.  Nurse (myself) sought assistance from NP, who assessed client.  Client denied further symptoms of syncope and pressure in her lower lungs.  Nurse (myself) brought father into room from waiting room for parental support and explained the occurrence.  Father sat beside client for remainder of stay.  Upon confirmation that client denied further syncopal symptoms or pressure in lower lungs, nurse (myself) directed client to finish the apple juice.  Client was administered flu vaccine.  No further symptoms were reported.  Client remained under nursing supervision for 15 minutes lying prone and for 15 minutes on exam table in an upright sitting position.  Upon completion of waiting period, client denied syncope and pressure in lower lungs.  Color returned to her face.  Client stated that she "felt fine."  Client was released.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Student reported to school nurse with hives on face and above left eye.  Mother arrived at school and gave student 25mg of Benadryl.  Mother reported that symptoms were already resolving by 2:50 PM, on their way to see the MD.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Acute Pain in upper arm, shoulder; limited range of motion and weakness in left shoulder for 72 hours following administration.  No swelling or pain at injection site.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dyskinesia, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal, Oedema peripheral
Clinical narrative: Started with partial numbness and involuntary movement of fingers and then progressed to whole right side. Developed facial tics, loss of equilibrium, loses train of thought. Went to emergency room on Dec 14, 2012 and Dec 29, 2012.  Went to a neurologist on Dec 31, 2012. Had an MRI on Jan 3, 2013 and showed brain changes of normal aging. Has gotten worse from first day of symptoms. Also has swelling of right arm. ER prescribed prednisone, Valium and Baclofen which did not help.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Thinking abnormal, Tic
Clinical narrative: Started with partial numbness and involuntary movement of fingers and then progressed to whole right side. Developed facial tics, loss of equilibrium, loses train of thought. Went to emergency room on Dec 14, 2012 and Dec 29, 2012.  Went to a neurologist on Dec 31, 2012. Had an MRI on Jan 3, 2013 and showed brain changes of normal aging. Has gotten worse from first day of symptoms. Also has swelling of right arm. ER prescribed prednisone, Valium and Baclofen which did not help.
Age: 59.0
Sex: F
Vaccine: DTAP, HEPAB, TYP
Symptoms: Alopecia, Thyroid function test normal
Clinical narrative: On August 27th I went to a travel clinic prior to trip abroad.  Had Twinrix vaccine, Typhoid Vaccine, and Tdap vaccine. My hair began falling out. I first noted this in the shower - as I pulled fingers through hair - large amounts would come out. I am 59 years old and have NEVER had hair come out  like this.  The hair came out diffusely - there were not particular bald spots perse. I stopped frequent hair washing and was afraid to even brush hair. I am a physician and after a few weeks of this - had my thyroid functions tested - normal. I did not have any life "changes" associated with hairloss - stress, hormone changes, dietary changes, illnesses etc.  I began looking on web and found association with Hepatitis B vaccine. (could not find association with Typhoid or Tdap) I then had a second Twinrix shot November 5, 2012.  It has only been in the past 2-3 weeks that I have noticed the hair loss has lessened. Given the time line and lack of any other events the only factor I can attribute the hair loss to is the vaccine. I am reluctant to get my third shot - due in 2 months.
Age: 18.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Listless, Muscle fatigue, Oropharyngeal pain, Pain
Clinical narrative: Achy, fatigue, sore throat, listless, muscle fatigue, congestion.
Age: 18.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: Achy, fatigue, sore throat, listless, muscle fatigue, congestion.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Lip dry, Ocular hyperaemia, Pyrexia, Rash
Clinical narrative: Patient states she had a fever within 3 days, her eyes were red and swollen, she got bumps around her face and her lips were dry.  She also states she saw and eye doctor as well as a dermatologist.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Mobility decreased
Clinical narrative: Could not lift arm, been to doctor 3 times since, now they say it is bursitis of shoulder, never lifted or injured or had any problem with shoulder till this shot, on prednisone now.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Aggression, Condition aggravated, Screaming
Clinical narrative: Mom stated child became aggressive and began screaming violent things(blood, and killing). Mom was able to take child to Local ER with assistance of police where they sat for 2 hrs. before "calming down". No meds. administered and no tx. given at the ER, mom stated never even saw a Phsyician because the ER was so busy?
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Notices dime sized, hard lump at injection site.  Now bump is at 10cm.  Patient complains of pain at injection site and it feels hot.  88 MDG physician diagnosed as cellulitis.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Musculoskeletal pain, Neck pain
Clinical narrative: Developed pain in front, right of neck - thought it might be in trachea.  Later, pain spread to right shoulder and to right upper back and to right chest. Pain remained overnight and throughout the next day.  Took, one Advil.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swollen, pain RD where Tdap was administered.  Resolved 2 days later (12/22/2012).
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Injected limb mobility decreased, Injection site induration, Musculoskeletal stiffness, Neck pain
Clinical narrative: Sore/pain/stiffness..loss of mobility.  Pain and unable to move arm still occuring on Jan 7, 2013.  Limited movement still.  Have been to doctor 3 times.  Given anti-inflammatory, prednisone and finally cortisone shot in shoulder rotator cuff area.  Pain has spread from upper arm to shoulder, upper back and neck.  Tingling down arm to fingers and hand. Hardness around injection site.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Sore/pain/stiffness..loss of mobility.  Pain and unable to move arm still occuring on Jan 7, 2013.  Limited movement still.  Have been to doctor 3 times.  Given anti-inflammatory, prednisone and finally cortisone shot in shoulder rotator cuff area.  Pain has spread from upper arm to shoulder, upper back and neck.  Tingling down arm to fingers and hand. Hardness around injection site.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Headache
Clinical narrative: Father called on 1/4/2013 and stated daughter developed severe headache and stomach ache after receiving vaccines. Treated with Tylenol. Lasted until 1/6/2013. Stated it was worst headache ever. No stiff neck.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm injection site: warm to the touch; elevated - raised area 7 cm x 5 cm with 105 cm (Length) x 2 cm (width) slightly red center. MD evaluation: Left arm erythematous & indurated. Treatment: NSAIDS; Motrin as needed & ice to area. Monitor for signs of infection.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Influenza
Clinical narrative: Flu syndrome & dermatologic (vesicles at lower lip).
Age: 0.36
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Rotarix vaccine administered intramuscularly.  No adverse symptoms at this time.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray, Heart rate increased
Clinical narrative: Fast heart rate for 5 days. Went to ER, chest Xray, IV Fluid, and anxiety meds given. DID NOT have anxiety.
Age: 2.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Pt given MMRV and chicken pox stand alone vaccine at the same time.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Diarrhea began the evening of the 21st of Dec and lasted through the 30th of Dec 2012. Also she got a fever of 104 beginning 12/24/2012 at 4:00 PM that lasted through 12/25/2012 around 5:00 PM. No other symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Nausea
Clinical narrative: I got chills and severe tremors that lasted for hours, was fatigued, nauseated, and had a stomach ache. I put multiple blankets on me, turned on extra sources of heat, took 3/4 mg. of Xanax and finally felt somewhat better around midnight. I was extremely fatigued the next day, and my knees hurt this morning, but I feel better now.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: I got chills and severe tremors that lasted for hours, was fatigued, nauseated, and had a stomach ache. I put multiple blankets on me, turned on extra sources of heat, took 3/4 mg. of Xanax and finally felt somewhat better around midnight. I was extremely fatigued the next day, and my knees hurt this morning, but I feel better now.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Muscular weakness, Myelitis transverse
Clinical narrative: I woke up with severe lower extremity weakness. Having difficulty walking.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Inappropriate schedule of drug administration, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a physician assistant who refers to a 20 year old no pregnant female patient with none pertinent medical history and none drug reactions/allergies. The patient was vaccinated with 2 first doses of GARDASIL (doses, route and lot numbers not provided by the reporter) on an unknown date in 2010 (reported as 3 years ago). On 02-JAN-2013 was in the doctor office to get her third dose of GARDASIL (dose, route and lot number not provided by the reporter). None concomitant medications were reported. On an unknown date (reported as recently the patient underwent Pap smear test (resulted in a positive HPV). At the time of the report patient's state was reported as not recovered. The patient sought medical attention via doctor visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with dose 1, 0.5 ml GARDASIL (lot number unknown) in July 2012. Route of administration and site was not reported. In November 2012 the patient was vaccinated with dose 2, 0.5 ml GARDASIL (lot number unknown). Route of administration and site was not reported. No adverse effect was reported. The original reporting source was provided by a nurse practitioner. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pyrexia
Clinical narrative: Flu shot (HD) caused fever 1-2 nights. Bruising on arm. Patient is on PLAVIX. Bruise about 5 inches x 8 inches on left arm. Pt. advised to use cold pack sporadically to minimize spread of bruise.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: (L) upper thigh with erythematous, warm tender lesion, 5 cm x 4 cm in length. Puncture wound noted. No streaking noted. Ibuprofen, cold compress, BENADRYL as needed.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Wound
Clinical narrative: (L) upper thigh with erythematous, warm tender lesion, 5 cm x 4 cm in length. Puncture wound noted. No streaking noted. Ibuprofen, cold compress, BENADRYL as needed.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: After administering FLUZONE High Dose and PNEUMOVAX in right arm, she later called to report swollen, hot, sore arm that lingered at least 4 days. Some diarrhea too.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 24 hrs following vaccination. Erythema swelling at site. No systemic signs.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Immediate post-injection reaction, Loss of consciousness, Vomiting
Clinical narrative: Pt started getting dizzy immediately after the shot. He lost consciousness and had a seizure. After seizure, he regained consciousness & started vomiting. We called 911 and EMT personnel took him to ER.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Arm soreness for over 2 weeks by injection site.
Age: 1.56
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, warmth & induration to injection site in (L) thigh. Treated with Cephalexin to cover for cellulitis.
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, erythema, swelling of 7 cm at injection site.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Sz approx 2 min after flu vac. was given.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt states that she can't move her left arm since got the flu shot and it has gotten worse since. Has pain in the left arm since she has gotten the shot.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Musculoskeletal pain
Clinical narrative: Pt. states he is still experiencing excruciating pain after receiving flu shot on 12/13/12. Pt. states pharmacist administered shot in his shoulder blade rather than deltoid & required medical attention due to pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Ocular hyperaemia, Sensation of foreign body
Clinical narrative: Patient called and reported that within 2 1/2 hours of receiving FLUZONE HD, she experienced red eyes, chills, and a "lump" in her throat.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 years old female patient with multiple sclerosis, hypercholesterolemia, drug allergy to AUGMENTIN, CLEOCIN, ULTRAM, ibuprofen and sulfa. The patient was vaccinated with ZOSTAVAX (lot#reported asH013940, exp 25-OCT-2013) 0.65ml subcutaneously in left deltoid on 19-DEC-2012. No other co-suspects were reported. Concomitant medications included morphine, oxycodone, tizanidine hydrochloride, lovastatin and gabapentin. On 19-DEC-2012 evening, the patient experienced full-body rash. This experience was accompanied by itching, which seems to be alleviated by BENADRYL. The patient had sought medical attention by consulted pharmacist. The action taken was not reported. The outcome was reported as not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 60 year old male patient. On 02-JAN-2013, the patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX, (lot number was reported as 671660/1254AA, expiry date 01-NOV-2012, route- subcutaneous). No concomitant medications were reported. The nurse stated that she noticed the expiration date when she documented the vaccination in patients chart. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with dose 1, 1 ml RECOMBIVAX (intramuscular, lot number was not reported) on 20-JUN-2012 and was vaccinated with dose 2, 1 ml RECOMBIVAX HB (intramuscular, lot number was not reported) on 13-AUG-2012. No adverse effect was reported. Additional information is not expected (reporter does not went to be contacted).
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a registered nurse who refers to a 44 year old female patient. The nurse reported that patient was vaccinated with a dose of M-M-R II (dose, route and lot# not reported) on an unknown date (reported as on an unspecified date in the past). On 02-NOV-2012 the patient was vaccinated with another dose of M-M-R II (dose, route and lot# not reported). It was reported that the patient underwent serologic testing for titers in 2010, on 15-OCT-2012 and 21-DEC-2012, and all tests gave negative results for titers for mumps. The patient did not seek medical attention. At the time of the report patient outcome was not recovered. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Insomnia
Clinical narrative: This spontaneous report was received from a physician refers to a 79 year old female patient. The patient has drug allergy with PRADAXA, LEVAQUIN, sulfa and tetracycline. The patient had no pertinent medical history. On 18-DEC-2012, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23, (lot number was reported as H014196, expiration date 19-MAR-2014, route intramuscularly). Concomitant medications included hydrochlorothiazide, DYAZIDE, SYNTHROID, TOPROL, Vitamin D3, XARELTO and fish oil. On an unknown date, the patient could not sleep because of redness and pain at injection site after receiving a dose of PNEUMOVAX23. The patient was given an antibiotic as a treatment. On an unknown date, the patient recovered from the reported events. The patient sought medical attention (patient called the office). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a male consumer of unknown age refers to himself. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # not reported). On an unspecified date after this, he developed a "rash at the site of ZOSTAVAX injection." It was unspecified whether the patient sought for medical attention. The patient had not recovered. The relatedness for "rash at the site of ZOSTAVAX injection" was unknown for ZOSTAVAX. Legal issue was involved. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse referred to a patient of unknown age. The patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX (lot # unspecified, EXP date 25-OCT-2012, subcutaneous) on 02-JAN-2013. No adverse effects reported. No treatment information was reported. The outcome was unknown. This was one of several reports that received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse referred to a patient of unknown age. The patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX (lot # 669746/0356AA, EXP date 09-JUN-2012, subcutaneous) on 02-JAN-2013. No adverse effects reported. No treatment information was reported. The outcome was unknown. This is one of several reports that received from the same source. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 71 year old female patient with no drug reactions/allergies. On 28-DEC-2012, the patient was vaccinated with 0.5 milliliter (ml) PNEUMOVAX 23 (lot number and expiry date reported as 1947AA and 20-OCT-2013 respectively) intramuscularly. Concomitant medication included unspecified medications and FLUVIRIN received in the opposite arm on the same day (28-DEC-2012). Approximately on 29-DEC-2012 (reported as 1 or 2 days after vaccination), the patient experienced a rash 1 or 2 inches below the injection site. There was no fever and the rash was not itchy. The patient sought medical attention for the event by visiting the pharmacy. The pharmacist told the patient to take BENADRYL. No lab diagnostic tests were performed. There were no symptoms in the arm that received FLUVIRIN. The outcome of a rash 1 or 2 inches below the injection site was unknown. The relatedness for rash 1 or 2 inches below the injection site was unknown for PNEUMOVAX 23. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain in extremity, Paraesthesia, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 70 years old female patient. The patient had a medical history of 2 stents and a drug allergy to penicillin and sulfa. On an unknown date (at least 2 years ago) the patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. Concomitant medications included pravastatin sodium and lisinopril. On an unknown date (two weeks after the injection) the patient experienced a blistering rash on her left hand up to her wrist. Her healthcare professional told her that she had shingles. She still had some pain and tingling in her feet. She was treated with a shot of prednisone. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was not provided for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date and route was not reported). No concomitant medications were reported. On an unknown date, the patient developed injection site reactions after receiving PNEUMOVAX 23. The patient had redness and soreness at the injection site. The outcome of the reported events were unknown at the time of this report. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Body temperature increased, Decreased appetite, Discomfort, Erythema nodosum
Clinical narrative: Tues day after - fatigue, H/A, (sensitivity to sunlight). Wed - fever, fatigue, general discomfort, several raised, red (warm) patches on outside of both lower legs. Thurs - went to Dr. at employee health - temp 102.4 - erythema nodosum - suggested I see my physician. Joint pain, loss of appetite and fever. Erythema nodosum eased.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Headache, Photophobia, Pyrexia, Rash erythematous
Clinical narrative: Tues day after - fatigue, H/A, (sensitivity to sunlight). Wed - fever, fatigue, general discomfort, several raised, red (warm) patches on outside of both lower legs. Thurs - went to Dr. at employee health - temp 102.4 - erythema nodosum - suggested I see my physician. Joint pain, loss of appetite and fever. Erythema nodosum eased.
Age: 4.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Dysarthria, VIIth nerve paralysis
Clinical narrative: Facial paralysis; slurred speech.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Maternal exposure during pregnancy, Periarthritis
Clinical narrative: Severe pain at and around injection site. Can not move arm. Frozen shoulder.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Exposure during pregnancy, Injection site pain, Mobility decreased, Periarthritis
Clinical narrative: Severe pain at and around injection site. Can not move arm. Frozen shoulder.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Musculoskeletal pain, Oedema peripheral, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: My arms swelled, developed a rash, and a fever. I had severe pain in my arms and shoulder joints. Then I ran a fever of 104.7 for the four days. I am still having joint pain in my shoulders and itching in my arms. I alternated 800mg ibuprofen and Tylenol as instructed by my doctor.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: My arms swelled, developed a rash, and a fever. I had severe pain in my arms and shoulder joints. Then I ran a fever of 104.7 for the four days. I am still having joint pain in my shoulders and itching in my arms. I alternated 800mg ibuprofen and Tylenol as instructed by my doctor.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Gradual onset of dull ache and pain in left upper arm / shoulder. Pain occurred intermittently initially then increased in frequency and intensity. Within one month I developed limited ROM in left shoulder and continuous pain. I have pain at night, increased when I lay on affected shoulder, I have pain intermittently throughout the day. I am a former nurse and have been treating this pain with alternating ice, heat, Salon Pas topical analgesic patches, and ibuprofen.  In addition, I use physical therapy exercises designed for the Rotator Cuff muscles. I do get some relieve with the above treatments. I am concerned because the pain and limited ROM is not improving - it is worsening.  I am a full time student, unemployed, and do not have insurance to cover cost of physician. I will continue with the above treatment until I am unable to get any relief from pain or limited movement. Note: I have been vaccinated against influenza every year since 2003, with the exception of 2010, and have never had any type of reaction.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Asthenia, Injection site pain, Middle insomnia, Pain in extremity
Clinical narrative: Pain in my left shoulder and arm woke me up and kept me awake all night.  I took two Ibuprofen at 1:30 AM but they didn't seem to help.  This morning I was unable to perform ordinary functions due to pain and weakness.  I took two more Ibuprofen at 7:00 AM with no noticeable improvement.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in my left shoulder and arm woke me up and kept me awake all night.  I took two Ibuprofen at 1:30 AM but they didn't seem to help.  This morning I was unable to perform ordinary functions due to pain and weakness.  I took two more Ibuprofen at 7:00 AM with no noticeable improvement.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Client was vaccinated on the afternoon of Dec. 4th, 2012 with the Meningococcal Vaccine. He received no other vaccines at that time. He denied any fever, or pain since the immunization. On the morning of Dec. 7th, 2012 he stated that he woke up with a rash on his face and his upper arms. He also stated the rash was on his chest and his upper back. He returned to our clinic at approximately 4:00 pm that afternoon. He did have a pinkish red raised rash on his forehead, under both his eyes and on his cheeks, and on his chest, upper back and both arms above the elbows up to his shoulders. He denied pain but stated the rash was extremely itchy. He denied eating any different foods, or taking any other medications since the immunization. He had gone to a pharmacy prior to returning to the clinic. The pharmacist advised him to take Benadryl which he had not yet taken when he returned to our clinic. He was advised to go to a doctor to have the rash checked out, and also advised to take the Benadryl recommended by the pharmacist. The client was called back on Monday, and Tuesday of this week. He was not at home. We were able to make contact with his mother today on Dec. 13th, 2012, he lives with her and she stated that he was doing much better, he was at work and he had been taking the Benadryl recommended by the pharmacist, but he did not go to the doctor. The patient had also denied any known allergies when he was initially interviewd at our clinic.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Diarrhoea, Headache, Pain
Clinical narrative: Soreness, diarrhea, abdominal pain, headache.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site rash, Injection site streaking, Injection site swelling
Clinical narrative: Patient went to local emergency room due to swelling in arm and streaked rash around injection site. Patient phoned pharmacy on 1-7-13 to report event. Patient reported she was diagnosed with cellulitis in the emergency room.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Paralysis
Clinical narrative: Received inj. 5:35 PM on 11/2/2012 - within a few hours became very ill 3:05 AM 11/3/2012 on the floor unable to move paralyzed from the chest down ER visit admitted to hospital stayed in the hospital from 11-3 - 11-9. Transferred to Rehab nursing facility. Released on 11-28-2012.
Age: 52.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site warmth, Pain
Clinical narrative: 1/3/13 Had Tdap & typhoid in left deltoid. C/o 1 hour later began with body aches. Had fever. Left deltoid area warm & redness with swelling to left axilla area. Seen 1/7 area slightly inflamed to left axilla - reddened & warm to touch. Denies further fever. No Re given!
Age: 52.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: 1/3/13 Had Tdap & typhoid in left deltoid. C/o 1 hour later began with body aches. Had fever. Left deltoid area warm & redness with swelling to left axilla area. Seen 1/7 area slightly inflamed to left axilla - reddened & warm to touch. Denies further fever. No Re given!
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Induration, Pain, Pruritus
Clinical narrative: Central induration 5 cm x 4 cm. Peripheral erythema 12 cm x 7 cm. Pain & itching.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Cough, Erythema, Lacrimation increased, Pruritus
Clinical narrative: Extremely red, itchy, burning, water eyes, cough (annoying).
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza A virus test positive
Clinical narrative: Positive test for influenza A.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dysphagia, Dyspnoea, Eye burns, Eye discharge
Clinical narrative: Started with sore throat felt like something was in my throat had a hard time swallowing, eye began to burn bad and turned red also started discharging lots of white stuff from tear ducts, fever started has 101 degress. Started getting tickle in throat started coughing. Then eyes started swelling eyelids got red, then sinus started to swell got very congested nose was burning had hard time breathing thru nose. Nose kept filling up had to keep blowing my nose to get fluid out after about 4 hours the throat started to feel better and by lungs calmed down, went to sleep still woke up with irritated eye a little swollen, sinus was still bothering me a lot of pressure and pain. I called my ENT this morning I will be going into his office in 45 minutes so he can look at me.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye irritation, Eyelid oedema, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Started with sore throat felt like something was in my throat had a hard time swallowing, eye began to burn bad and turned red also started discharging lots of white stuff from tear ducts, fever started has 101 degress. Started getting tickle in throat started coughing. Then eyes started swelling eyelids got red, then sinus started to swell got very congested nose was burning had hard time breathing thru nose. Nose kept filling up had to keep blowing my nose to get fluid out after about 4 hours the throat started to feel better and by lungs calmed down, went to sleep still woke up with irritated eye a little swollen, sinus was still bothering me a lot of pressure and pain. I called my ENT this morning I will be going into his office in 45 minutes so he can look at me.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Sinus headache, Sinusitis, Throat irritation
Clinical narrative: Started with sore throat felt like something was in my throat had a hard time swallowing, eye began to burn bad and turned red also started discharging lots of white stuff from tear ducts, fever started has 101 degress. Started getting tickle in throat started coughing. Then eyes started swelling eyelids got red, then sinus started to swell got very congested nose was burning had hard time breathing thru nose. Nose kept filling up had to keep blowing my nose to get fluid out after about 4 hours the throat started to feel better and by lungs calmed down, went to sleep still woke up with irritated eye a little swollen, sinus was still bothering me a lot of pressure and pain. I called my ENT this morning I will be going into his office in 45 minutes so he can look at me.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Eye discharge, Eye swelling, Oedema peripheral, Wheezing
Clinical narrative: Started with sore throat felt like something was in my throat had a hard time swallowing, eye began to burn bad and turned red also started discharging lots of white stuff from tear ducts, fever started has 101 degress. Started getting tickle in throat started coughing. Then eyes started swelling eyelids got red, then sinus started to swell got very congested nose was burning had hard time breathing thru nose. Nose kept filling up had to keep blowing my nose to get fluid out after about 4 hours the throat started to feel better and by lungs calmed down, went to sleep still woke up with irritated eye a little swollen, sinus was still bothering me a lot of pressure and pain. I called my ENT this morning I will be going into his office in 45 minutes so he can look at me.
Age: 3.0
Sex: M
Vaccine: 6VAX-F, MMRV, PPV
Symptoms: Febrile convulsion, Pallor, Pyrexia, Tremor
Clinical narrative: Child woke up with a fever of 103F. Child was shaking and would not respond to parents. Skin was very pale. Child recovered within minutes. Febrile seizures returned about 3-4 times in the course of the morning. The fever remained high. The febrile seizures did not return in the evening, but the fever remained for about 3 days, staying over 100F.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Person called the Med Det on 8/8/2012 at 7:48a.m., stating that the patient had swelling on his left shoulder and it was swelling up more, also that Pt's shoulder felt hot to touch.  He stated patient had not seeked medical care.  Person asked if we would like to see him. I advised him to start an LOD packet and take the patient to urgent care.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Nerve injury, Pain
Clinical narrative: Patient felt pain and couldn't lift arms for days afterward. Patient had doctor visit and physical exam. Dr. concluded that patient has axillary nerve damage. Patient has been going to physical therapy for the last month which helped but has not completely.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: ? of Brachial Neuritis. Pt got Flu Vax on 8 Nov 2012 pt came in on 19 Nov 2012 for triage. "Starting Sat. AM upon awakening (L) shoulder pain radiating to scapula down to (L) arm to elbow & hand with hand swelling & fingers tingling noted."
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 2 1/2 days after receiving the shingles vaccine I broke out with the shingles.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Haemorrhage subcutaneous, Injection site bruising, International normalised ratio
Clinical narrative: Patient experienced bleeding under skin/bruising at injection site.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Dysarthria, Headache, Hypoaesthesia oral, Syncope
Clinical narrative: Fainted after shot administered, no actual LOC - felt dizzy and sat till felt better approximately 15-20 min. On way home from office developed slurred speech and numb tongue with worsening headache. Pt home tongue and speech improved, but developed worsening headache and vision problem. Headache lasted approximately 2-3 days off and on with vision problem slowly improving till pt felt normal approximately 3-4 days after event.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: Fainted after shot administered, no actual LOC - felt dizzy and sat till felt better approximately 15-20 min. On way home from office developed slurred speech and numb tongue with worsening headache. Pt home tongue and speech improved, but developed worsening headache and vision problem. Headache lasted approximately 2-3 days off and on with vision problem slowly improving till pt felt normal approximately 3-4 days after event.
Age: 6.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, VARCEL
Symptoms: Dry skin, Skin fissures
Clinical narrative: Patient's hands extremely dry / cracking. Father states became that way on 12-15-12. Was seen in clinic on 12-19-12 with no mention of adverse effect to practitioner. Father reported to HD on 12-26-12. Skin very dry on body as well. No rash noted or shortness of breath. Cracked skin only on hands.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Injection site reaction
Clinical narrative: Injection site reaction occurred but nothing more than usual. Intradermal flu is only indicated for 18-64. Doctor is aware but there has been no follow-up by pt's guardian or doctor.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient developed a red rash at injection site about 2 inches long and 1 inch wide. She has been advised to keep it covered and treat with acetaminophen and ice.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 27 December 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had three dose of DAPTACEL; (lot numbers reported as C, lot numbers not reported) on 01 July 2008, 22 August 2008, and 15 October 2008, (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 24 April 2012, approximately three and a half years after the last dose. On 24 April 2012, the subject developed a cough and paroxysmal cough on 02 June 2012 without whoop. Laboratory testing included positive PCR on 06 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of BACTRIM, starting on 08 June 2012 for 14 days. The subject was not hospitalized. At the time of final contact of 26 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 55 days. The subject's outcome was not reported. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 180 cases solicited from the Electronic Disease Surveillance System (EDSS) during the surveillance period from 01 January 2010 to 11 October 2012. These 180 cases represented children who received three or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction
Clinical narrative: Initial report received on 27 December 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had three dose of DAPTACEL; (lot numbers reported as C, lot numbers not reported) on 01 July 2008, 22 August 2008, and 15 October 2008, (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 24 April 2012, approximately three and a half years after the last dose. On 24 April 2012, the subject developed a cough and paroxysmal cough on 02 June 2012 without whoop. Laboratory testing included positive PCR on 06 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of BACTRIM, starting on 08 June 2012 for 14 days. The subject was not hospitalized. At the time of final contact of 26 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 55 days. The subject's outcome was not reported. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 180 cases solicited from the Electronic Disease Surveillance System (EDSS) during the surveillance period from 01 January 2010 to 11 October 2012. These 180 cases represented children who received three or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Fall, Incontinence, Loss of consciousness
Clinical narrative: Around 3:00 AM I woke feeling violently ill - dizzy - vertigo. Tried to walk to bathroom but passed out and fell in bedroom. Husband awoke and helped me to bed. Vomiting ensued. Could not sit upright. Lost bodily control. Severe diarrhea. Husband called clinic at 0700. Symptoms started to subside by mid afternoon. Took another day to recover.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Vertigo, Vomiting
Clinical narrative: Around 3:00 AM I woke feeling violently ill - dizzy - vertigo. Tried to walk to bathroom but passed out and fell in bedroom. Husband awoke and helped me to bed. Vomiting ensued. Could not sit upright. Lost bodily control. Severe diarrhea. Husband called clinic at 0700. Symptoms started to subside by mid afternoon. Took another day to recover.