chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's medical history was not reported. On 16-OCT-2013 the patient was vaccinated intramuscularly with VAQTA (dose, lot number and expiration date were not reported). No concomitant medications were reported. It was reported that on 16-DEC-2013 the patient received again VAQTA. There were not known adverse effects or product quality complaints. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Tension
Clinical narrative: Pt c/o dizziness tensed body and diaphoretic, passed out - pt recovered - initial VS at 1656 111/58 HR 58 99% RAR. VS 1707 100/62 HR 61 99% RAR - eating sucker, drinking water. Time out at 1721. Left with mother.
Sex: F
Vaccine: MMR
Symptoms: Antibody test abnormal, Incorrect dose administered, Measles antibody negative
Clinical narrative: This spontaneous report was received from a physician, concerning a female nursing student of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unspecified, patient received in childhood first and second dose of M-M-R II, (Lot number, expiration date, dose and route were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, after antibody titers were determined to be low for measles, the student received an additional dose of M-M-R II. After 2-3 months, the antibody titers for measles were found to still be low. An additional dose of M-M-R II was then administered to student but measles antibody titers did not respond and were still low. The patient sought medical attention (unknown type). At the time of the report, the patient had not recovered from measles antibody test low. The relatedness between measles antibody titers low and suspect therapy was not provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a physician, concerning a female nursing student of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unspecified, patient received in childhood first and second dose of MMR II, (Lot number, expiration date, dose and route were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, after antibody titers were determined to be low for measles, the student received an additional dose of MMR II. After 2-3 months, the antibody titers for measles were found to still be low. An additional dose of MMR II was then administered to student but measles antibody titers did not respond and were still low. The patient sought medication attention (unknown type). At the time of the report, the patient had not recovered from measles antibody test low. The relatedness between measles antibody titers low and suspect therapy was not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-JUL-2013, the patient was vaccinated with the first dose of PEDVAXHIB 0.5 ml for each dose, intramuscular. The second dose was administered on 26-SEP-2013, and the third dose was administered on 03-DEC-2013. Lot number was not reported for any dose. No co-suspect and concomitant therapies were reported. The nurse stated that patient received doses of PEDVAXHIB at 2 months, 4 months, then third dose at 7 month (on 03-DEC-2013) but before 12 months. No adverse effects were reported. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site reaction, Pain
Clinical narrative: 12 - 30 - 13 fever 102, soreness, redness, swelling 12 - 31 - 13 Dr appt. temp, 102.4, red blanching blotchiness around injection site, tender to touch  1 - 1 - 14 cellulitis, 1 - 2 - 14, f/u 1 - 3 - 14 f/u 1 - 4 - 14 1 - 6 - 14.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Pallor, Pyrexia, Rash macular, Swelling
Clinical narrative: 12 - 30 - 13 fever 102, soreness, redness, swelling 12 - 31 - 13 Dr appt. temp, 102.4, red blanching blotchiness around injection site, tender to touch  1 - 1 - 14 cellulitis, 1 - 2 - 14, f/u 1 - 3 - 14 f/u 1 - 4 - 14 1 - 6 - 14.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthropathy, Convulsion, Mixed connective tissue disease, Petit mal epilepsy
Clinical narrative: 4-20-11 Patient had seizure and hospitalized. Given KEPPRA for petit mal seizures. Been seeing a neurologist to date. 9-29-13 Joint problems started - hands, arms, knees, etc. Seeing rheumatologist since 10/10/13. Diagnosis - Mixed Connective Tissue Disease.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: Pt in for a well child exam, provider wrote for a PEDIARIX, IPV and PREVNAR to be given, nurse did not realize that PEDIARIX had IPV in it, Pt received 2 IPV vaccines.
Age: 42.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Red warm area inferior to where injection was given.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Diarrhoea, Dyspepsia
Clinical narrative: Patient complains of diarrhea, stomach cramping, and a burning in her stomach like it's "glowing".
Age: 40.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Chills, Decreased appetite, Feeling of body temperature change, Insomnia, Nausea
Clinical narrative: 12:30 am (~8 hours after vaccines) that night, employee stated she had fever/chills sensation (hot/cold) and was unable to sleep. She also had nausea and anorexia.  It was improving by the next day.
Age: 40.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Pyrexia
Clinical narrative: 12:30 am (~8 hours after vaccines) that night, employee stated she had fever/chills sensation (hot/cold) and was unable to sleep. She also had nausea and anorexia.  It was improving by the next day.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Blood test normal, Gait disturbance, Immunology test normal, Myalgia
Clinical narrative: Woke up with extreme joint pain and muscle pain.  It worsened over the next several days until I could hardly walk or sit.  Equally the same on both sided of my body.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Thyroid function test normal
Clinical narrative: Woke up with extreme joint pain and muscle pain.  It worsened over the next several days until I could hardly walk or sit.  Equally the same on both sided of my body.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Pt presented to office 3 days post vaccination stating day after injection site was "swollen", "burning" and "hot". Described on going "itching" at the site exam. Revealed urticaria at injection site and along the rt arm extending to the torso. No sc nodules or induration.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Decreased appetite, Irritability, Vaccination site induration
Clinical narrative: Patient irritable/decreased appetite persisting >1 week after vaccination. Also with 2 hard indurated areas at vaccination site.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus generalised
Clinical narrative: Pt states has severe itching all over body. Started a few days after immunization. Pt states no new meds since vaccine. States has used BENADRYL to help with itching but has had itching for 3 days now.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unknown number of patients of unknown age. Medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with MMR II (lot, dose, and route not reported). Concomitant medication was not reported. ON 06-JAN-2014, improperly stored MME II may have been administered (unknown number of doses, demographics unspecified). No adverse event reported. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Hard, red lump noted rt upper thigh yesterday 10 days after vaccines given. No fever. Non tender. Better today. Measures 4cm x 2cm.
Age: 47.0
Sex: F
Vaccine: HEPA, MMR, TDAP, TYP
Symptoms: Loss of consciousness, Malaise, Presyncope
Clinical narrative: Gave immunizations Typhoid, Tdap, Hep A and MMR. After MMR she said she didn't feel well. She passed out in chair and had what appeared to be a vagal response. In 30-45 sec. she came too. She was assisted to couch where she rested with cool cloth. After 20-30 min.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Patient received vaccine on 2/7/13 and on 2/8/13, the patient calls the nurse reporting that the vaccine injection caused swelling with pain (10/10) and that he had problem moving his arm. He went to urgent care clinic on 2/8/13 where the nurse triaged the situation. Plan of care was alternating warm and cold compress 20 minutes every 2 hours, naproxen for pain control, VICODIN as instruction, and monitor right arm. If the pain and swelling worsen, then go to nearest ER. Follow up with the patient on 2/11/13.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large red swollen area at injection site. Very tender.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dysuria, Lumbar puncture, Myelitis transverse, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Approx. 60 hrs. after vaccine woke up from sound sleep paralyzed from waist down, difficulty urinating went to ER no tests or treatment except for vomiting/nausea. Later was admitted to hospital by Dr. for tests and treatment of transverse myelitis.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis, Vomiting
Clinical narrative: Approx. 60 hrs. after vaccine woke up from sound sleep paralyzed from waist down, difficulty urinating went to ER no tests or treatment except for vomiting/nausea. Later was admitted to hospital by Dr. for tests and treatment of transverse myelitis.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Flushing, Immediate post-injection reaction, Injection site warmth, Nausea
Clinical narrative: Pt c/o of feeling flushed and warmth at the injection site a few seconds after the administration. Pt experienced difficulty breathing, shortness of breath, and "lump in the throat" 0.3 ml of Epinephrine was administered SQ via Epi-Pen. Pt continues to experience the "lump in the throat" for additional 10 minutes. Physician was at the site, 3mg of Zofran was given orally for nausea.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Sensation of foreign body
Clinical narrative: Pt c/o of feeling flushed and warmth at the injection site a few seconds after the administration. Pt experienced difficulty breathing, shortness of breath, and "lump in the throat" 0.3 ml of Epinephrine was administered SQ via Epi-Pen. Pt continues to experience the "lump in the throat" for additional 10 minutes. Physician was at the site, 3mg of Zofran was given orally for nausea.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Flushing, Injection site warmth, Nausea, Sensation of foreign body
Clinical narrative: Pt c/o of feeling flushed and warmth at the injection site a few seconds after the administration. Pt experienced difficulty breathing, shortness of breath, and "lump in the throat" 0.3 ml of Epinephrine was administered SQ via Epi-Pen. Pt continues to experience the "lump in the throat" for additional 10 minutes. Physician was at the site, 3mg of Zofran was given orally for nausea.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lethargy
Clinical narrative: Red, raised, itchy area around injections site. Lethargic.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Pt got shingles vaccine and about 20 min after injections pt felt dizzy. Their BP was 172/76 and 179/81 10 mins later. Called Dr and was told to have pt come in to be seen.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphagia, Pharyngeal oedema
Clinical narrative: Throat swelled until hardly able to swallow. I immediately took Benadryl. Sweling down within an hour.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Syringe issue
Clinical narrative: Pt. says he had strong pain upon injection. The plunger didn't work and was stuck when I gave the injection. I used the other arm and the injection was successful.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender (demographics unspecified). Medical history and drug reactions/allergies were not reported. On an unknown date, two doses of M-M-R II that were improperly stored may have been administered (lot, dose and route not reported). Concomitant medication was not reported. No adverse event reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Injection site erythema, Pyrexia, Swelling
Clinical narrative: Fever, breathing difficulty, redness to insertion site, slight swelling. Mother gave BENADRYL at home.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Blood culture negative, Blood test normal, Body temperature increased, Crying, Diet refusal
Clinical narrative: In the evening of 12/30 infant child developed inconsolable crying and not taking fluid (mother's breast milk) for about 8 hours. Temp was 100.8 degrees F. Mom took him to ER; all work up done finding was negative. Hospital stay for 1 day for observation. Discharged with no apparent findings. Treated with IV fluids, antibiotics and acetaminophen 80 mg/q.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Lumbar puncture normal, X-ray normal
Clinical narrative: In the evening of 12/30 infant child developed inconsolable crying and not taking fluid (mother's breast milk) for about 8 hours. Temp was 100.8 degrees F. Mom took him to ER; all work up done finding was negative. Hospital stay for 1 day for observation. Discharged with no apparent findings. Treated with IV fluids, antibiotics and acetaminophen 80 mg/q.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Local swelling, Pyrexia
Clinical narrative: Swelling of arm, tender & lump in arm, redness from shoulder to elbow lasted a~ 1 week, fever/chills for 2 days, HA x 3 days
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Upper extremity mass
Clinical narrative: Swelling of arm, tender & lump in arm, redness from shoulder to elbow lasted a~ 1 week, fever/chills for 2 days, HA x 3 days
Age: 47.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Numbness hand/arm, pain upper arm, triceps weakness.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Eye discharge, Eyelid oedema, Vomiting
Clinical narrative: First, it became difficult to swallow.  Then my eyes became puffy and oozed whitish pus.  A cough started.  Next vomiting.
Age: 8.0
Sex: F
Vaccine: HEP, IPV, TD, VARCEL
Symptoms: Nausea, Presyncope
Clinical narrative: 1540 Pt c/o nauseated and almost fainted when used restroom with mother.  RN assessed and assisted pt to lay on beb with LE elevated.  Vital sign taken T.98.0 F, BP 77/49, P 64 & RR 20/min. At 1630 clinician examed and spoke to pt.  Pt denied any discomfort at that time then pt released home with parents.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Red Swollen Arm.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: On 6 Jan 14, patient noticed that the injection site was red. On 7 Jan 14, he noticed that his arm stating becoming hot to the touch. On 8 Jan 14, he noticed that the redness had spread to his elbow. Patient went to the emergency room on the night of 8 Jan 14 and was prescribed antibiotics.
Age: 68.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Abdominal pain upper, Arthralgia, Chills, Dizziness, Dizziness postural
Clinical narrative: EARLY PM GOT SWELLING AND REDNESS AT INJECTION SITE. ABOUT 10:30 PM GOT CHILLS WITH SORE SHOULDERS. WENT TO BED WITH SEVERE SHAKING CHILLS. ABOUT 3 AM 01/09/2014 WOKE UP WITH SWEATING, STOMACH CRAMPS, AND NAUSEA.  VERY DIZZY WHEN TRIED TO GET UP. GOT UP AT ABOUT 11:45 AM AND FEEL BETTER BUT STILL HAVE SORE SHOULDERS, ACHY JOINTS AND FEEL FAINT.
Age: 68.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site swelling, Musculoskeletal pain, Nausea
Clinical narrative: EARLY PM GOT SWELLING AND REDNESS AT INJECTION SITE. ABOUT 10:30 PM GOT CHILLS WITH SORE SHOULDERS. WENT TO BED WITH SEVERE SHAKING CHILLS. ABOUT 3 AM 01/09/2014 WOKE UP WITH SWEATING, STOMACH CRAMPS, AND NAUSEA.  VERY DIZZY WHEN TRIED TO GET UP. GOT UP AT ABOUT 11:45 AM AND FEEL BETTER BUT STILL HAVE SORE SHOULDERS, ACHY JOINTS AND FEEL FAINT.
Age: 68.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Tremor
Clinical narrative: EARLY PM GOT SWELLING AND REDNESS AT INJECTION SITE. ABOUT 10:30 PM GOT CHILLS WITH SORE SHOULDERS. WENT TO BED WITH SEVERE SHAKING CHILLS. ABOUT 3 AM 01/09/2014 WOKE UP WITH SWEATING, STOMACH CRAMPS, AND NAUSEA.  VERY DIZZY WHEN TRIED TO GET UP. GOT UP AT ABOUT 11:45 AM AND FEEL BETTER BUT STILL HAVE SORE SHOULDERS, ACHY JOINTS AND FEEL FAINT.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Atrial fibrillation, Cardiac monitoring abnormal, Condition aggravated, Cyanosis, Laboratory test normal
Clinical narrative: Pt became unresponsive and appeared to have stopped breathing. Pt was dusky and blue-purplish in color when seen by physician but quickly regained consciousness and awareness.  Cardiac monitor showed atrial fibrillation with a rapid ventricular response.  There was no angioedema or fever to suggest an allergic response.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Respiratory arrest, Skin discolouration, Unresponsive to stimuli
Clinical narrative: Pt became unresponsive and appeared to have stopped breathing. Pt was dusky and blue-purplish in color when seen by physician but quickly regained consciousness and awareness.  Cardiac monitor showed atrial fibrillation with a rapid ventricular response.  There was no angioedema or fever to suggest an allergic response.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity, X-ray limb
Clinical narrative: Shoulder and upper arm became painful and I was unable to lift my arm without intensifying the pain.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: I woke up lightheaded and dizzy. I rested throughout the day. Dizziness and lightheaded had resolved by the next day.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Generalised erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hot and red with large amount swelling at site. Skin on entire body with redness.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Pt developed hives under her arm, later spread to entire trunk and arms. Over 24 hour period. Benadryl given.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Patient went to the ER on 1-9-2014 with redness and streaking in the left arm. Patient had also received a pneumonia vaccine in the same arm at his physicians office the same day (1-6-2014) that he received his flu vaccine here. Patient was given a prescription for Cephalexin 500mg TID.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Pruritus generalised
Clinical narrative: Noticed pain and itching to injection site immediately but noticed whole body itching by the evening, without noticeable rash.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Headache, Local swelling, Pain in extremity
Clinical narrative: Right arm soreness then 11:00 PM severe shakes and chills, Temp 101.8, headaches, arm swelling. Rt arm still sore 01/08/14.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Right arm soreness then 11:00 PM severe shakes and chills, Temp 101.8, headaches, arm swelling. Rt arm still sore 01/08/14.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient was adminstered Fluzone intradermal vaccine in error. Patient is over age 65 and vaccine is only indicated for that age group.
Age: 23.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Culture urine, Headache, Urinary tract infection, Urine analysis, Vision blurred
Clinical narrative: Clinic NP answers call (08JAN14 at 1047EST) re 24 y/o patient who was leaving on 22JAN14. Patient c/o severe HA's, blurry vision and UTI s/p AVA #1 (04DEC13)- does not want any more AVA's. Patient recently granted exemption from SPV (17DEC13), as patient endorsed h/o "eczema/dermatitis" treated with desonide steroid cream and KENOLOG 40 mg steroid shot. Also has taken VALTREX. Endorses "Yes" on SPV screening form questions #9, 10, 10a, 10b, 10c and 10d.
Age: 27.0
Sex: M
Vaccine: ANTH, FLUX, MEN, MMR, SMALL
Symptoms: Injection site papule, Injection site pustule, Injection site reaction, Injection site vesicles, Keloid scar
Clinical narrative: 27 y/o patient expressing concern re primary SPV site never forming a scab. Received primary SPV (LUE) on 28OCT13, as well as AVA #3, MMR#2, Seasonal Influenza, and MGC ACYW- 135 Diptheria Conj (RUE). Pt states that the SPV site (LUE) formed a papule, then a blister, then a pustule, as expected. He was not aware of a scab forming or falling off. He kept the area covered and dry and removed the Bandaid while in shower. Patted dry and covered with clean Bandaid. Has kept area covered with Bandaid till present. Skin at SPV injection site is completely healed with keloid about size of dime at injection site (LUE).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from health care worker refers to an unknown number of patients of unknown demographics. Patient's concurrent conditions and medical history were not reported. From October-2013 to December-2013, patients were vaccinated with VARIVAX (Merck) (dose, route, frequency and lot were not reported) that may have been improperly stored. No adverse effects were reported. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA, HIBV
Symptoms: Erythema, Papule
Clinical narrative: Multiple erythematous papular-various size on both legs L>R.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient has red area at injection site. Also hot to touch.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Incorrect route of drug administration
Clinical narrative: Medication was given by mistake as a Intradermal injection. MA thought it was a PPD
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Oedema, Pain
Clinical narrative: 8" x 5" Red, swollen, painful area. Edema noted. Pt treated with Bactrin x 7 days.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: The shot was given to me extremely high on my arm and burned really bad.  I have never experienced burning like this and I get a flu shot every year.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain at injection site.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Electromyogram, Guillain-Barre syndrome, Laboratory test, Lumbar puncture, Muscular weakness
Clinical narrative: Of note - the patient also developed a viral-like illness on 12/24 - approx. 2 weeks after the vaccination, and approximately 1 week before the adverse event. The patient initially developed paresthesias and weakness in her lower extremities. This progressed to a diagnosis of Guillain-Barre Syndrome. She was under my care at the hospital starting 1/4.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Nerve conduction studies, Paraesthesia, Viral infection
Clinical narrative: Of note - the patient also developed a viral-like illness on 12/24 - approx. 2 weeks after the vaccination, and approximately 1 week before the adverse event. The patient initially developed paresthesias and weakness in her lower extremities. This progressed to a diagnosis of Guillain-Barre Syndrome. She was under my care at the hospital starting 1/4.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient's vaccinated arm has been sore now since vaccination, a total of 27 days, with no improvement. Pain is tolerable but "annoying".
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Rash all over body. I looked up the rash on line, she had never had a rash. I matched it to an HPV rash, and called doctor immediately. I had never seen it and suspected it was a side effect of the HPV vaccination. The doctor examined, said it had nothing to do with the Gardasil, and said it would clear up. It did clear up - but she has never had another rash since and had never had one before. I feel very lucky given the other much more serious side effects but it was still very scary to see a rash like this appear out of the blue. I did not appreciate the refusal to attach it to the recent vaccination as to me, it was obvious that it was an HPV rash.
Age: 13.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: GAVE FLUCELVAX TO UNDER 18 (NOT FDA APPROVED FOR UNDER 18).
Age: 13.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Injected Flucelvax into under 18, NOT FDA APPROVED FOR UNDER 18.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: ADMINISTERED FLUCELVAX TO 12 YEAR OLD (FDA APPROVED TO OVER 18YO ONLY).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash pruritic
Clinical narrative: Itchy and burning rash along middle of back which was gone by the next morning.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain, Periarthritis, X-ray
Clinical narrative: Frozen shoulder. Intense soreness. Saw Ortho Dr. Had X-ray, had MRI, now in PT. HAVE LOST ALL RANGE OF MOTION, pain won't let up.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Rash erythematous, Rash generalised, Skin exfoliation
Clinical narrative: Severe rash, peeling skin, red bumps. Areas affected: feet, hands, face, ears, neck, upper chest, knees, elbows.
Age: 7.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Gait disturbance, Local swelling, Lymphadenitis
Clinical narrative: Hep B and IPV given 1 - 3 -14 - (L) leg. (L) thigh and leg swelling/limping went to ER 1 - 5 -14 dx acute lymphadenitis.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Headache, Influenza, Malaise, Nasal congestion
Clinical narrative: Nurse note 10/25/13 - 62 y/o male came as walk-in c/o cold like symptoms x6 days since Saturday; sore throat, body ache, headache, nasal congestion, sinus pressure, chest congestion, productive cough, coughing up light brown thick mucus, per patient. he received a flu sot on 10/19/13 and since then felt sick and Sunday he started to have all these symptoms that he mentioned. MD note on 10/25/13 - I recommended he go to the emergency room for some fluid and hydration for a likely flu related reaction to the flu immunization, but he was not interested. Nothing he does not want to go to the emergency room for hydration, I said he can home and he can take Tylenol and Motrin for the discomfort. However, if he gets a high fever, vomiting, diarrhea, or unable to hold down fluids, he will have to come here for hydration and for therapy. I also documented that the influenza shot is not a good medication for him.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Productive cough, Pulmonary congestion
Clinical narrative: Nurse note 10/25/13 - 62 y/o male came as walk-in c/o cold like symptoms x6 days since Saturday; sore throat, body ache, headache, nasal congestion, sinus pressure, chest congestion, productive cough, coughing up light brown thick mucus, per patient. he received a flu sot on 10/19/13 and since then felt sick and Sunday he started to have all these symptoms that he mentioned. MD note on 10/25/13 - I recommended he go to the emergency room for some fluid and hydration for a likely flu related reaction to the flu immunization, but he was not interested. Nothing he does not want to go to the emergency room for hydration, I said he can home and he can take Tylenol and Motrin for the discomfort. However, if he gets a high fever, vomiting, diarrhea, or unable to hold down fluids, he will have to come here for hydration and for therapy. I also documented that the influenza shot is not a good medication for him.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Secretion discharge, Sinus headache
Clinical narrative: Nurse note 10/25/13 - 62 y/o male came as walk-in c/o cold like symptoms x6 days since Saturday; sore throat, body ache, headache, nasal congestion, sinus pressure, chest congestion, productive cough, coughing up light brown thick mucus, per patient. he received a flu sot on 10/19/13 and since then felt sick and Sunday he started to have all these symptoms that he mentioned. MD note on 10/25/13 - I recommended he go to the emergency room for some fluid and hydration for a likely flu related reaction to the flu immunization, but he was not interested. Nothing he does not want to go to the emergency room for hydration, I said he can home and he can take Tylenol and Motrin for the discomfort. However, if he gets a high fever, vomiting, diarrhea, or unable to hold down fluids, he will have to come here for hydration and for therapy. I also documented that the influenza shot is not a good medication for him.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from consumer reporting her sister, a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not provided). Co-suspect and secondary therapies were not reported. On an unspecified date, the patient received ZOSTAVAX and approximately a week and a half after receiving vaccine experience a "small, itchy rash on her back". No medical attention was sought. At the time of the report the outcome was unknown. At the time of the report the outcome was unknown. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Malaise, Pain, Pyrexia, Swelling
Clinical narrative: Fever, chills, swelling, aches, and not feeling well.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Nausea, Pallor
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning a 14 year old male patient with Tourette syndrome. Drug reactions and allergies were not reported. On an unknown dates the patient was vaccinated with GARDASIL dose 1 (lot number J011272, expiration date 21-APR-2016, route and dose were not reported) for the prevention of the Human Papilloma Virus (HPV) virus. On 04-DEC-2013, patient was vaccinated with the 2 dose of GARDASIL. Co-suspect and concomitant therapies were not reported. On 04-DEC.2013, the patient developed dizziness, cold sweats, nausea and was "pale" after receiving the 2nd shot of GARDASIL. The representative did not have specific information about when the 1st shot of GARDASIL was administered and if this patient will receive the 3rd shot of GARDASIL. The patient saw the physician for medical attention. At the time of the report the outcome of the events were reported as recovering.  Treatment and lab diagnostics studies performed were not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Pt felt light headed pt sat down, we have him H2O.
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Biopsy
Clinical narrative: The nurse from dr requested a copy of the VAR. They have sent a sample from the injection off to be tested for cancer.
Age: 1.29
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: 8 x 5 cm area of induration with 12 x 8 cm warmth and erythema area to lt upper thigh. Began x 1 day post 15 mo immunizations. Pt (+) "scratching" at area <2 "small" pink indurated areas also noted to rt upper thigh on exam. TX: BENADRYL every 6 hours prn warm, moist compress.
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received vaccine on 01/07 - temperature started in afternoon on 01/08 (R) arm - at injection site reddened and swollen on am 01/09 2 grams of ANCEF started on 01/09. Infectious. Disease consulted.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a 26 year old female lab technician refers to herself with no medical history. Between the end of October 2013 and the beginning of November 2013, the patient was vaccinated with a dose of GARDASIL (route, dose, lot # and indication not reported) in the left arm. She reported that she developed a sore left arm the day after vaccination with GARDASIL and it lasted about 1 month then recovered. The patient did not seek medical attention and no treatment was given. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent disease were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). Co-suspect and concomitant therapies were not reported. On an unknown date the patient complained that their arm hurts at injection site after administration. At the time of the report the outcome and the action taken was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse refers that the patient received the first dose of RECOMBIVAX HB (route, lot number and expiration date not provided) on 21-MAR-2013 and the second dose of RECOMBIVAX HB on 17-MAY-2013 (route and lot number were not provided). Co-suspect therapies and secondary therapies were not reported. On 23-DEC-2013 the patient was vaccinated with RECOMBIVAX HB, lot number reported as H018635 and expiration date 16-DEC-2013 (route was not reported) dose 3 that was expired. No adverse event reported. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Malaise, Pain, Pyrexia, Swelling
Clinical narrative: Fever, chills, swelling, aches, and not feeling well
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Hyperhidrosis, Induration, Local swelling, Nausea
Clinical narrative: Case number PHHY2012US111221, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 466642) website on 04 Dec 2012 and a follow up received from Quality Assurance Department (QA, reference number: 210160) on 09 Jan 2014: This report refers to 66-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1203801) intramuscularly in the left arm and PNEUMOVAX (other manufacturer, batch number H010515) intramuscularly in the left arm on 06 Sep 2012. On 07 Sep 2012, she experienced arm very painful, felt nauseous, faint, diaphoretic, upper arm became hard and swollen. The outcome of the events was reported as condition unchanged as of 27 Sep 2012. The causality and seriousness of the events was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1203801) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 210160) on 09 Jan 2014: Updated batch review report.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2012US111221, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 466642) website on 04 Dec 2012 and a follow up received from Quality Assurance Department (QA, reference number: 210160) on 09 Jan 2014: This report refers to 66-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1203801) intramuscularly in the left arm and PNEUMOVAX (other manufacturer, batch number H010515) intramuscularly in the left arm on 06 Sep 2012. On 07 Sep 2012, she experienced arm very painful, felt nauseous, faint, diaphoretic, upper arm became hard and swollen. The outcome of the events was reported as condition unchanged as of 27 Sep 2012. The causality and seriousness of the events was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1203801) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 210160) on 09 Jan 2014: Updated batch review report.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea
Clinical narrative: Case number PHHY2012US110971 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 466897) web site on 04 Dec 2012, with a follow up received from the Quality Assurance department (reference number: 210087) on 08 Jan 2014. This report refers to a 71-year-old female patient. Her medical history was not reported and concomitant medications included unspecified blood pressure medications. She was vaccinated with FLUVIRIN (batch number: 1203801) intramuscularly on to right arm on 08 Sep 2012. On the same day she experienced shortness of breath for few minutes. She also had severe lower back pain. She was transported to emergency room. The final outcome of the events was reported as condition unchanged as of 28 Sep 2012. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 1203801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 08 Jan 2014: Updated batch report.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood glucose normal, Dyspnoea, Erythema, Fall, Pallor
Clinical narrative: Case number PHHY2012US110982 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 466905) web site on 04 Dec 2012 with a follow up information received from the quality assurance department (QA reference number: 210089) on 08 Jan 2014. This report refers to 43 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1203801), intramuscularly into right arm and PNEUMOVAX (other manufacturer, batch number: H010515) intramuscularly into the right arm on 11 Sep 2011. On 11 Sep 2012 the patient fell to one side, turned red, had trouble breathing, looked like he was going to vomit, went pale, then came to, was oriented and talking. The medics arrived and the blood pressure was 104/80, blood sugar 148 and heart rate 71. The outcome of the events was recovered. Seriousness and causality assessment was not reported. Upon follow up receipt from the quality assurance department (reference number: 210089), it was reported that based on the documents review, the FLUVIRIN batch number, 1203801 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 08 Jan 2014: Batch summary updated.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Injection site nerve damage, Local swelling, Skin warm
Clinical narrative: Case number PHHY2012US111752, is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number: 469430) received on 04 Dec 2012 and a follow up received from Quality Assurance Department (QA, reference number: 209967) on 09 Jan 2014. This report refers to a 69-year-old male patient. His medical history included diabetes and arthritis and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number 1203801) intramuscularly in the right arm on 12 Sep 2012. On the same day after vaccination, he experienced arm (unspecified) hot and red, his whole left arm was swollen to his wrist and he was experiencing numbness to his fingers. He consulted to physician who told him nurse probably hit nerve during shot. The outcome of the events was reported as completely recovered as of 13 Oct 2012. The seriousness and causality assessment of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1203801) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 209967) on 09 Jan 2014: Updated batch review report.
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Asthenia, Debridement, Injected limb mobility decreased, Musculoskeletal disorder
Clinical narrative: Case number PHHY2013US032586 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483819) website on 04 Apr 2013, with a follow up received from the Quality Assurance department (reference number: 222348) on 08 Jan 2014: This report refers to a 50-year-old male patient. Concomitant medications of this patient included trazodone, atorvastatin and LEVOXYL. He was vaccinated with FLUVIRIN (batch number: 1203801, Expiry date: 31 May 2013) intramuscularly in to left arm on 26 Sep 2012. On 27 Sep 2012, the patient experienced pain and was unable to lift his left arm. Patient consulted with physician as the condition didn't improve and physician said he had a frozen shoulder. Physician prescribed pain medications and patient received physical therapy for 6 weeks with minimal improvement. Patient underwent surgery in the first week of Dec 2012. During surgery, doctors cleaned out the joint which was inflamed (by scraping out the joint). The patient was still unable to raise arm fully and had only 65% functionality and also had loss of strength. The physician recommended a second surgery but the patient was not willing to undergo another surgery. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 1203801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 08 Jan 2014: Updated batch report.
Sex: M
Vaccine: FLU3
Symptoms: Pain, Periarthritis, Shoulder operation
Clinical narrative: Case number PHHY2013US032586 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483819) website on 04 Apr 2013, with a follow up received from the Quality Assurance department (reference number: 222348) on 08 Jan 2014: This report refers to a 50-year-old male patient. Concomitant medications of this patient included trazodone, atorvastatin and LEVOXYL. He was vaccinated with FLUVIRIN (batch number: 1203801, Expiry date: 31 May 2013) intramuscularly in to left arm on 26 Sep 2012. On 27 Sep 2012, the patient experienced pain and was unable to lift his left arm. Patient consulted with physician as the condition didn't improve and physician said he had a frozen shoulder. Physician prescribed pain medications and patient received physical therapy for 6 weeks with minimal improvement. Patient underwent surgery in the first week of Dec 2012. During surgery, doctors cleaned out the joint which was inflamed (by scraping out the joint). The patient was still unable to raise arm fully and had only 65% functionality and also had loss of strength. The physician recommended a second surgery but the patient was not willing to undergo another surgery. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 1203801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 08 Jan 2014: Updated batch report.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2013US139927 is an initial spontaneous report from a Vaccine Adverse Event Reporting System (reference number: 505309) received on 03 Dec 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 268630) on 08 Jan 2014. This report refers to a 70-year-old polymedicated female patient. Her concurrent conditions included Sjogren's, gastrooesophageal reflux disease (GERD) and heart murmur. She was allergic to amitriptyline, ampicillin, lisinopril, tramadol, verapamil, amlodipine and nortriptyline. She was vaccinated with FLUVIRIN (batch number: 13385P) intramuscularly in left arm on 26 Sep 2013. On the same day she was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H022280) intramuscularly in right arm. On 29 Sep 2013, she experienced pain, swelling, redness, hard area and heat to the area where immunization was given. She had a visit to emergency room due to these events. She was diagnosed with cellulitis and was given cephalexin and mupirocin topical ointment as treatment. She had a follow-up appointment with physician on 11 Oct 2013. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 13385P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 268630) on 08 Jan 2014: Updated batch review report.