chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: HEP, MMR, MNQ, TDAP, VARCEL
Symptoms: Erythema, Pruritus, Rash papular
Clinical narrative: The morning following vaccine administration client's (L) arm was, "itching, red, and had rash with bumps". Symptoms persisted 3 to 4 days, at which time, client applied topical hydrocortisone to affected area & began taking PO BENADRYL.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma
Clinical narrative: Information has been received from a medical assistant concerning one of her cousin's female co-workers who on an unspecified date, was vaccinated with a dose of GARDASIL (lot number, dose and route not reported). The medical assistant reported that on an unspecified date the patient developed cervical cancer. The patient was vaccinated in the military. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. This is one of several reports received from the same source. Upon internal review, patient developed cervical cancer was determined to be an other important medical event. Additional information has been requested.
Age: 1.97
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA
Symptoms: Condition aggravated, Convulsion, Intensive care, Pyrexia
Clinical narrative: Child has Wolf-Hirschhorn syndrome and seizure disorder. Evening after vaccines had fever and seizure. Went to ER, then transferred to another hospital PICU.
Age: 25.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Chills, Dizziness postural, Headache, Pain in extremity, Paraesthesia
Clinical narrative: The morning following injections, client states, "I had a low grade fever with chills & my head was pounding in the back. My left arm wastingly & hurting down to the fingertips. I was dizzy when I stood up" x 2days, "as if my arm was asleep", client took TYLENOL q 6 hrs x 2days.
Age: 25.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Pyrexia
Clinical narrative: The morning following injections, client states, "I had a low grade fever with chills & my head was pounding in the back. My left arm wastingly & hurting down to the fingertips. I was dizzy when I stood up" x 2days, "as if my arm was asleep", client took TYLENOL q 6 hrs x 2days.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Capnogram normal, Chest pain, Cyanosis, Dyspnoea, End-tidal CO2 increased
Clinical narrative: App. 4:10 p.m., client returned to clinic c/o shortness of breath and chest pain. A coarse, respiratory stridor was audible during conversation. Client was taken to lab room and seated. Per protocol, .3 cc of epinephrine 1:1000 was administered, S.Q. Immediately following, Diphenhydramine (50 mg/ml) 1 ml. was administered IM, after no improvement was noted, 911 was called. Patient drove herself several blocks back to clinic from college approx 30 min after receiving first dose each of MCV4 and HPV vaccines. Moderate distress and coarse inspiratory stridor was observed while speaking and accompanied reports of shortness of breath, feeling of throat swelling and chest pain. Pt. remained conscious and coherent without signs of rash, cyanosis or expiratory delay throughout treatment with 0.3 cc of 1:1000 EPI times 2 doses followed by BENADRYL 50 mg IM. EMS was called via 911 when symptoms failed to improve. Pulse ox showed SAO2 was 99 or 100 on each recording. She was given O2, ATROVENT neb and SOLUMEDROL again without significant improvement in complaints. End tidal CO2 remained ~33 and capnogram waveform was not suggestive of bronchospasm. She was then transported non-emergently by EMS to ED. Physician confirmed previous findings on arrival and described her breathing as "almost stridor". Therapeutic trials of RACEMIC and IV EPI and albuterol also did not relieve symptoms. Pt did not become cyanotic or fatigued but continued complaints of difficulty breathing prompted Anesthesia consult. As a precaution and in order to gain control of her airway she was sedated with Propophol and intubated. Patient remained in ICU over night and extubated the following morning. Extubation was followed by resumption of similar symptoms which were managed with VALIUM. Patient was discharged to home the following morning.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Endotracheal intubation, Fatigue, Intensive care, Pharyngeal oedema, Stridor
Clinical narrative: App. 4:10 p.m., client returned to clinic c/o shortness of breath and chest pain. A coarse, respiratory stridor was audible during conversation. Client was taken to lab room and seated. Per protocol, .3 cc of epinephrine 1:1000 was administered, S.Q. Immediately following, Diphenhydramine (50 mg/ml) 1 ml. was administered IM, after no improvement was noted, 911 was called. Patient drove herself several blocks back to clinic from college approx 30 min after receiving first dose each of MCV4 and HPV vaccines. Moderate distress and coarse inspiratory stridor was observed while speaking and accompanied reports of shortness of breath, feeling of throat swelling and chest pain. Pt. remained conscious and coherent without signs of rash, cyanosis or expiratory delay throughout treatment with 0.3 cc of 1:1000 EPI times 2 doses followed by BENADRYL 50 mg IM. EMS was called via 911 when symptoms failed to improve. Pulse ox showed SAO2 was 99 or 100 on each recording. She was given O2, ATROVENT neb and SOLUMEDROL again without significant improvement in complaints. End tidal CO2 remained ~33 and capnogram waveform was not suggestive of bronchospasm. She was then transported non-emergently by EMS to ED. Physician confirmed previous findings on arrival and described her breathing as "almost stridor". Therapeutic trials of RACEMIC and IV EPI and albuterol also did not relieve symptoms. Pt did not become cyanotic or fatigued but continued complaints of difficulty breathing prompted Anesthesia consult. As a precaution and in order to gain control of her airway she was sedated with Propophol and intubated. Patient remained in ICU over night and extubated the following morning. Extubation was followed by resumption of similar symptoms which were managed with VALIUM. Patient was discharged to home the following morning.
Age: 19.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Loss of consciousness for 1 minute.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT DEVELOPED HEAT & SORENESS AT INJECTION SITE FOLLOWED BY SHINGLES DEVELOPING AROUND THE INJECTION SITE ON 12/8/2011.  AS OF 12/13/2011 AT 4PM PATIENT HAS A RED FLARE OF SHINGLES AT THE INJECTION SITE (2 INCH DIAMETER) ALONG WITH SHINGLES PROGRESSING ALONG THE LEFT LOWER ARM.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Severe vomiting and diarrhea over 12 hours, similar to food poisoning.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Tenderness
Clinical narrative: Right arm redness, tender, fever and pain after Pneumovax injection after 12/09/11.
Age: 7.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 84.0
Sex: U
Vaccine: FLUX
Symptoms: Ageusia, Anosmia, Colitis, Decreased appetite, Epistaxis
Clinical narrative: Head ache; colitis - bloody mucus discharge; cough with phlegm; loss of sense of smell & taste; loss of appetite.
Age: 84.0
Sex: U
Vaccine: FLUX
Symptoms: Headache, Productive cough
Clinical narrative: Head ache; colitis - bloody mucus discharge; cough with phlegm; loss of sense of smell & taste; loss of appetite.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Diarrhoea, Dizziness, Headache, Increased upper airway secretion
Clinical narrative: No treatment. Patient experienced nausea, diarrhea, severe headache, convulsions, spasms, & shaking. She also had a slight fever. Pt said she had a ball of phlegm in her throat too, she was also dizzy.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Nausea, Pyrexia, Tremor
Clinical narrative: No treatment. Patient experienced nausea, diarrhea, severe headache, convulsions, spasms, & shaking. She also had a slight fever. Pt said she had a ball of phlegm in her throat too, she was also dizzy.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Contusion, Diarrhoea, Frostbite, Influenza like illness, Oedema peripheral
Clinical narrative: Arm was bruised & swollen. Patient had diarrhea & flu-like symptoms the next day. After getting immunizations he might have gotten frostbite from hunting.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal discomfort, Diarrhoea, Hallucination, Mucous stools, Neuropathy peripheral
Clinical narrative: Extreme peripheral neuropathy feet - diarrhea - upset stomach - 103 degrees F fever - shakes - some hallucinations - very watery BM - extreme amount of mucus. Never again!
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pneumonia, Pyrexia, Tremor
Clinical narrative: Extreme peripheral neuropathy feet - diarrhea - upset stomach - 103 degrees F fever - shakes - some hallucinations - very watery BM - extreme amount of mucus. Never again!
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hallucination, Insomnia, Neuropathy peripheral, Pneumonia, Sinus disorder
Clinical narrative: Extreme peripheral neuropathy feet - diarrhea - upset stomach - 103 degrees F fever - shakes - some hallucinations - very watery BM - extreme amount of mucus. Never again!
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Patient given PNEUMOVAX shot Friday 12-2-11 at approximately 10:40 AM. Patient came to store today 12-6-11 to inform me that she has pain from shot that lasted until Sunday 12-4-11. She also experienced swelling in left arm & redness. She is doing better today.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site reaction, Injection site vesicles, Laceration
Clinical narrative: Given PM of 11/30/11 came back 12/3/11 said had small blister like on upper arm, little red size of 1/2 dime had used NEOSPORIN. Told see Dr if not better saw Dr on 12/5 used BACTROBAN oint. It was 1 1/2" from injection site: where he pulled Band Aid off. Shape was shape of end of Band Aid said burned.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Pt. seen in office 3 days after receiving injection with red & swollen, tender area where received injection. Doctor advise ice, elevate & give 24 hours to rule out reaction vs cellulitis. Next day pt arm somewhat less red/swollen, dx reaction localized to vaccine.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness
Clinical narrative: Received vaccine 12/5/2011 - stiff neck & unable to bend noted last night - was seen in ER - given oral Ibuprofen - sent to ER today 12/7/2011.
Age: 1.84
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Staring, Vomiting
Clinical narrative: Mother states she woke up during the night (3 AM) and daughter was starring into space (2 min.). Mother called 911. Daughter had 104 fever, vomited then given TYLENOL. EMT left after about 15 minutes. No lasting effects.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient noticed rash on scalp developed within a few days after flu shot, but could not say exactly when it had started. Rash has lasted about a month before coming back to pharmacy.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Body temperature increased, Chills, Erythema, Feeling hot, Induration
Clinical narrative: 8 hrs after receiving flu vax & PNEUMOVAX in (R) arm she developed temp 100.6 & pain, pain, swelling, erythema increased & assoc. with chills. Today area of injections 40 cm swelling, erythema & at 20 cm below this similar sized area of erythema, warmth, induration. No vaccine given at this site.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain, Swelling
Clinical narrative: 8 hrs after receiving flu vax & PNEUMOVAX in (R) arm she developed temp 100.6 & pain, pain, swelling, erythema increased & assoc. with chills. Today area of injections 40 cm swelling, erythema & at 20 cm below this similar sized area of erythema, warmth, induration. No vaccine given at this site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Patchy red hives on upper extremity around injection site.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TYP, YF
Symptoms: Urticaria
Clinical narrative: Broke out in hives 37 hrs after vaccinations. Hives systemic - worse on face. Parent gave dose BENADRYL - hives resolved for couple hours - then came back. Parent gave 2nd dose BENADRYL - hives resolved. Hives continue to return daily in the evenings - takes BENADRYL - they resolve.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Maternal exposure during pregnancy
Clinical narrative: Pt. received Tdap vaccine 12/5/11 at 1031am. At 1900, pt reported feeling "hot" oral temp 100.4. Pt was assessed in triage. No tx. Sent home with instructions. Afebrile since 1200am 12/6/11.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Per client "redness throughout thigh and up onto hip" blotches around body" "15-20 min after vaccine given," client returned to clinic. Visualized injection sight. Slight pinkness noted around site. No swelling or heat noted. No "blotches" noted on surrounding skin. Sight reported was (R) thigh.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash erythematous, Rash generalised
Clinical narrative: Rash all over body, red small bumps with red lines. Pt. not itchy. Dr ordered BENADRYL.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain lower, Full blood count normal, Metabolic function test, Urine analysis normal
Clinical narrative: Abdominal pain transcend, lower quads. U/A, CBC, CMP - normal.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: 2009 - cold sores (oral) 2 wk antiviral & topical med. 2010 - shingles - 2 wk antiviral tx.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Demyelinating polyneuropathy, Electromyogram abnormal, Nerve conduction studies abnormal
Clinical narrative: Mild Acute Demyelinating Polyneuropathy symptoms developed 1-2 wks after flu shot 10/15/2010.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Computerised tomogram head, Computerised tomogram normal, Dizziness, Dyskinesia
Clinical narrative: Started feeling very tired and achy at first at about 1530, then head felt cloudy, dizzy, very weak, like I could pass out at about 1700-1900. At 2000-2100, I tried to sleep, but kept waking feeling restless and muscles were twitchy. Started having involuntary movements (dystonia) of my arm and face, facial grimacing, then my head and upper shoulders, legs. Went to ER, where I was given Ativan for possible seizures. Then husband took me to our hospital for further evaluation. MRI and CT scans were done of my head, which were normal. Neurologist requested EEG which I don't know results of. I am to follow-up with Neurologist on 12/16/11. I continue to have slight dystonia and muscle weakness, tiredness. I called health care provider who gave the vaccine to repost the issue.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Dystonia, Electroencephalogram, Fatigue, Feeling abnormal, Grimacing
Clinical narrative: Started feeling very tired and achy at first at about 1530, then head felt cloudy, dizzy, very weak, like I could pass out at about 1700-1900. At 2000-2100, I tried to sleep, but kept waking feeling restless and muscles were twitchy. Started having involuntary movements (dystonia) of my arm and face, facial grimacing, then my head and upper shoulders, legs. Went to ER, where I was given Ativan for possible seizures. Then husband took me to our hospital for further evaluation. MRI and CT scans were done of my head, which were normal. Neurologist requested EEG which I don't know results of. I am to follow-up with Neurologist on 12/16/11. I continue to have slight dystonia and muscle weakness, tiredness. I called health care provider who gave the vaccine to repost the issue.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Muscle twitching, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Pain
Clinical narrative: Started feeling very tired and achy at first at about 1530, then head felt cloudy, dizzy, very weak, like I could pass out at about 1700-1900. At 2000-2100, I tried to sleep, but kept waking feeling restless and muscles were twitchy. Started having involuntary movements (dystonia) of my arm and face, facial grimacing, then my head and upper shoulders, legs. Went to ER, where I was given Ativan for possible seizures. Then husband took me to our hospital for further evaluation. MRI and CT scans were done of my head, which were normal. Neurologist requested EEG which I don't know results of. I am to follow-up with Neurologist on 12/16/11. I continue to have slight dystonia and muscle weakness, tiredness. I called health care provider who gave the vaccine to repost the issue.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Poor quality sleep
Clinical narrative: Started feeling very tired and achy at first at about 1530, then head felt cloudy, dizzy, very weak, like I could pass out at about 1700-1900. At 2000-2100, I tried to sleep, but kept waking feeling restless and muscles were twitchy. Started having involuntary movements (dystonia) of my arm and face, facial grimacing, then my head and upper shoulders, legs. Went to ER, where I was given Ativan for possible seizures. Then husband took me to our hospital for further evaluation. MRI and CT scans were done of my head, which were normal. Neurologist requested EEG which I don't know results of. I am to follow-up with Neurologist on 12/16/11. I continue to have slight dystonia and muscle weakness, tiredness. I called health care provider who gave the vaccine to repost the issue.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Infection, Pain, Swelling
Clinical narrative: Infection, red, swelling, sore. Antibiotics.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pain in right arm into right side of neck. Referral to Neurologist.
Age: 52.0
Sex: M
Vaccine: HEPAB
Symptoms: Acute hepatic failure, Alanine aminotransferase increased, Analgesic drug level therapeutic, Aspartate aminotransferase increased, Computerised tomogram abnormal
Clinical narrative: Acute hepatic failure, question etiology, r/o relationship to recent Hepatitis A and Hepatits B vaccinations.
Age: 52.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatic steatosis, Hepatitis C antibody positive, International normalised ratio increased, Terminal state, White blood cell count increased
Clinical narrative: Acute hepatic failure, question etiology, r/o relationship to recent Hepatitis A and Hepatits B vaccinations.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Received DTap instead of TD.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Joint swelling, Pain in extremity
Clinical narrative: The day following vaccine administration patient awakened with bilateral heel pain which progressed to pain in both ankles, wrist and left elbow over 24-72 hours.  Swelling in these joints noted 48-72 hours prior to presentation on 12/14/2011. Patient self-treatd with ibuprofen for pain. No fevers, muscle aches or fatigue.
Age: 1.04
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Post-HepA, MMR, varicella & flue immunization, red truncal papular rash with fever 11 days post vaccines.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Tenderness
Clinical narrative: Tender to the touch, bruising.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Guillain-Barre syndrome, Oedema peripheral
Clinical narrative: Deep low pitch cough uncontrollable, right arm swelling (Guillain Barre Syndrome) per Dr.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: PT became ill and reported to have gone to the ER.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Laceration, Tooth loss
Clinical narrative: Pt waled 100 ft and dropped. He lacerated his chin 1" deep cut, lost tooth.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Injection site haematoma, Injection site mass, Injection site swelling
Clinical narrative: Patient's arm immediately became red and site began to bruise instantly. Her arm swelled at the injection site and a lump formed. Patient was given 10ml of BENADRYL and an ice pack was applied to her arm. After several mins her arm looked and felt better.
Sex: M
Vaccine: HEPA
Symptoms: Blood creatine phosphokinase increased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of elevated creatine kinase value in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of HAVRIX (unknown details). On 10 December 2011, at an unspecified time after vaccination with HAVRIX, the subject experienced elevated creatine kinase value. The pharmacist stated that the physician who asked him did not think "it could have been anything else that elevated the CK". The pharmacist also reported that he was unsure if the elevated creatine kinase value was the cause of the current hospital admission. No further details were provided. The subject was hospitalised. At the time of reporting the outcome of the event was unspecified.
Age: 27.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Patient reported experiencing hives on body beginning 1-2 days after vaccination and continuing x 1 wk. Still has hives as of 11/16/11.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Nuclear magnetic resonance imaging normal, Oedema peripheral, Pain in extremity
Clinical narrative: Arm swollen, red, painful down arm. Had MRI, no blood clot. On antibiotics.
Age: 36.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Injection site pain
Clinical narrative: Pain at shot site.
Age: 63.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Body temperature, Cough, Dyspnoea, Hypoaesthesia, Injection site pruritus
Clinical narrative: Coughing, wheezing, trouble breathing, temperature, numbness in hands, a lot of swelling and itching at injection site. Lasted about 6-7 hours and then I started to get better and was able to breathe normally & temp went down.
Age: 63.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Injection site swelling, Wheezing
Clinical narrative: Coughing, wheezing, trouble breathing, temperature, numbness in hands, a lot of swelling and itching at injection site. Lasted about 6-7 hours and then I started to get better and was able to breathe normally & temp went down.
Age: 36.0
Sex: M
Vaccine: FLU3, IPV, TDAP
Symptoms: Cough, Pain, Respiratory tract congestion, Somnolence
Clinical narrative: Awakened with congestion, cough, drowsiness and body aches.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Flank pain
Clinical narrative: PT HAD PAIN ON HER RIGHT SIDE.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Swelling face
Clinical narrative: Facial swelling & itching the next day after vaccination. Pt took a generic BENADRYL 25 mg.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Red rash with warmth to injection site of right upper arm. Fever, fatigue. Stuffy nose, chills.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: Red rash with warmth to injection site of right upper arm. Fever, fatigue. Stuffy nose, chills.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased
Clinical narrative: Paraplegic received flu shot 10/18/11. Returned to Dr on 10/26 with c/o unable to use his hands. No grip.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase increased, Muscular weakness, Pain in extremity
Clinical narrative: Pain and weakness to the lower extremities.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Very painful in left arm in shoulder area. Hurts to move.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Soreness in the injection site and swollen lymph nodes.  Patient has called several times to update department that soreness still exists and that lymph nodes are still swollen.  Last call 12/14/11.  We reported this to our State Immunization program as well as updated our county health officer.  Patient did travel out of the county after receiving the vaccination.  We followed up with the patient by phone calls.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: Client received a MCV4 vaccine for college entrance requirement.  He left the clinic without any signs/symptoms of distress and drove approximately 15-20 minutes when he stated to his father that he passed out and was involved in a MVA.  Father is concerned that the vaccine caused his loss of consciousness.  The Police and Fire Dept. responded to the accident scene, but the client refused transport to the hospital.  Father stated he sent a text to his girlfriend at 4:11 pm and then another text was sent at 4:28 pm.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Pain
Clinical narrative: IN OCTOBER SHE STARTED HAVING BODY ACHES AND STOMACH PAIN. ABOUT TWO DAYS AGO THE SYMPTOMS STARTED HAPPENING AGAIN.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Vomiting for 5 hours.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Crying, Diet refusal, Musculoskeletal stiffness, Screaming
Clinical narrative: Screaming, extreme crying, entire body stiffening for over 3 hours. Didn't appear to be seizure-like, but body was very stiff and would not relax. Gave Tylenol to try and ease pain if there was any. Did not help. Would not nurse or be comforted in any way.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arteriosclerosis, Arthropathy, Nerve injury
Clinical narrative: Client reports: pinched nerve in spine, degradation of hip joint, atherosclerosis. First doctor visit 10/7/09. Client concerned about receiving Zoster vaccine with history of lymphoma. Lymphoma treated in 1984. Client has talked with manufacturer.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood cholesterol increased, Blood triglycerides increased, Focal segmental glomerulosclerosis, Nephrotic syndrome, Protein urine present
Clinical narrative: Pt developed nephrotic syndrome 8/11/11. Has been resistant to standard treatment. Nephrologists now think it is focal segmental glomerulosclerosis. Mom is concerned that her 3rd GARDASIL shot given at her well check 5/25/11 could be causally related. She had a normal urinalysis at her well check 5/25/11.
Age: 87.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Chills, Injection site pain, Pain
Clinical narrative: 2 days after the pneumonia/flu shots patient complained of severe continued body aches and chills. At times has severe pain in the spot where the pneumonia shot was given. He continues to have chills and body aches. Has been to ER and they did blood work and a good exam and sent him home. Has a pneumonia shot about 18 years ago. Went to ER.
Age: 13.0
Sex: F
Vaccine: FLUX, HEPA, HPV4
Symptoms: Antinuclear antibody, Blood folate, Computerised tomogram, Dizziness, Dyskinesia
Clinical narrative: DIZZINESS, SWELLING OF FACE AND NECK, SEVERE 24/7 HEADACHES, LACK OF FOCUS, SEIZURE LIKE SYMPTOMS, FAINTING, MUSCLE TWITCHING AND JERKING, NAUSEA.
Age: 13.0
Sex: F
Vaccine: FLUX, HEPA, HPV4
Symptoms: Electroencephalogram, Full blood count, Headache, Local swelling, Muscle twitching
Clinical narrative: DIZZINESS, SWELLING OF FACE AND NECK, SEVERE 24/7 HEADACHES, LACK OF FOCUS, SEIZURE LIKE SYMPTOMS, FAINTING, MUSCLE TWITCHING AND JERKING, NAUSEA.
Age: 13.0
Sex: F
Vaccine: FLUX, HEPA, HPV4
Symptoms: Nausea, Nuclear magnetic resonance imaging, Red blood cell sedimentation rate, Seizure like phenomena, Swelling face
Clinical narrative: DIZZINESS, SWELLING OF FACE AND NECK, SEVERE 24/7 HEADACHES, LACK OF FOCUS, SEIZURE LIKE SYMPTOMS, FAINTING, MUSCLE TWITCHING AND JERKING, NAUSEA.
Age: 13.0
Sex: F
Vaccine: FLUX, HEPA, HPV4
Symptoms: Syncope, Vision blurred, Vitamin B12
Clinical narrative: DIZZINESS, SWELLING OF FACE AND NECK, SEVERE 24/7 HEADACHES, LACK OF FOCUS, SEIZURE LIKE SYMPTOMS, FAINTING, MUSCLE TWITCHING AND JERKING, NAUSEA.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Eye pruritus, Lacrimation increased, Throat tightness, Wheezing
Clinical narrative: Itchy watery eyes; throat feeling closed off; wheezing, hard to breathe.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: CSF protein, Hypoaesthesia, Laboratory test, Lumbar puncture, Muscular weakness
Clinical narrative: Initially my toes were numb on both feet, and within a day quickly progressing to weakness and heaviness in legs and then numbness in fingertips.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve conduction studies, Sensation of heaviness
Clinical narrative: Initially my toes were numb on both feet, and within a day quickly progressing to weakness and heaviness in legs and then numbness in fingertips.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Lymphadenopathy, Serum sickness, Splenomegaly, Thrombocytopenia
Clinical narrative: Lymphadenopathy, thrombocytopenia, splenomegaly, acute serum sickness syndrome.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Full blood count normal, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Presented to office 12/09/11 with erythema, edema, pain (L) arm - shoulder to lower elbow. Pt states began several hrs after received PNEUMOVAX (presented to office approximately 27 hrs after adm). Rx given KEFLEX 500 mg QID x 10 D.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Hard, small nodule at injection site, mildly sore, pinkness around 6 inches long after 2 days after injection 12/6/11 - counseled pt to use BENADRYL on 12/9/11. Called pt on 12/10 & she says it's almost gone.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Generalised erythema
Clinical narrative: 3 hours after vaccine pt said she was red all over and felt "out of it". Sent pt to the ER.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Called on 12/14/11 to report itching & rash to BLE following day of injection (12/8). "Red dots, itches, below knee, shin, primarily at sock line". Denies any other symptoms. Instructed to apply BENADRYL or take po. Has scheduled Dr. appt.
Age: 1.0
Sex: F
Vaccine: HEP, HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: None.
Age: 79.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Blood test, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Requested Tetanus shot did not receive requested shot - not informed or asked to change. Ordered by Dr. Given by nurse in left deltoid.
Age: 79.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Heart rate increased, Nausea, Pallor, Pyrexia, Wheezing
Clinical narrative: Requested Tetanus shot did not receive requested shot - not informed or asked to change. Ordered by Dr. Given by nurse in left deltoid.
Age: 79.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vaccination complication, Wrong drug administered
Clinical narrative: Requested Tetanus shot did not receive requested shot - not informed or asked to change. Ordered by Dr. Given by nurse in left deltoid.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute promyelocytic leukaemia, Anaemia, Night sweats, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with PHENERGAN allergy and a history of hypothyroidism, partial thyroidectomy in 2006, total thyroidectomy in 2007 and benign thyroid nodule who on 14-FEB-2007 was vaccinated IM into gluteus maximus with the first dose of GARDASIL (lot # 653978/0955F). Concomitant therapy included LEVOXYL and DEPO-PROVERA. The patient was diagnosed with acute promyelocytic leukemia (APL) on 11-MAR-2007. No family history. Acute onset, no tangible symptoms until roughly 10 days before diagnosis (anemia, fever, night sweats). Consultant records (hematology/oncology) showed diagnosis: APL. The patient was diagnosed with acute promyelocytic leukaemia on 11-MAR-2007 accompanied by mild disseminated intravascular coagulation (DIC). Several office visits for chemotherapy. The patient had received induction, consolidation and maintenance therapy; presently in histologic and molecular remission. The patient underwent several bone marrow aspirations. The patient was being monitored as outpatient. Obstetrics and gynecology records on 05-MAR-2007 showed well woman exam. No health issues documented. Labs/diagnostics in March 2007 included: WBC 0.5 K/mm3 (low), hemoglobin 8.0 g/dL (low), hematocrit 21.4% (low), platelet 10 k/mm3 (low), neutrophil 12% (low), lymphocyte 80% (high), blast 70% (high), AST 87 U/L (high), ALT 149 U/L (high). Bone marrow aspirate: no abnormal myeloid cell population identified. CT of chest, abdomen and pelvis showed pleural effusion with bilateral lower lobe atelectasis vs consolidation; periportal oedema of liver; ascites in pelvis; left adnexal cyst. Numerous additional tests related to monitoring of health condition were performed since diagnosis. The status of the patient was unknown at the time of this report. APL, DIC, several bone marrow aspirations, chemotherapy, anemia, fever and night sweats were considered to be immediately life-threatening by the agency. The original reporting source was not provided. The VAERS ID is 434266. No further information is available. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute promyelocytic leukaemia, Adnexa uteri cyst, Alanine aminotransferase increased, Anaemia, Ascites
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with PHENERGAN allergy and a history of hypothyroidism, partial thyroidectomy in 2006, total thyroidectomy in 2007 and benign thyroid nodule who on 14-FEB-2007 was vaccinated IM into gluteus maximus with the first dose of GARDASIL (lot # 653978/0955F). Concomitant therapy included LEVOXYL and DEPO-PROVERA. The patient was diagnosed with acute promyelocytic leukemia (APL) on 11-MAR-2007. No family history. Acute onset, no tangible symptoms until roughly 10 days before diagnosis (anemia, fever, night sweats). Consultant records (hematology/oncology) showed diagnosis: APL. The patient was diagnosed with acute promyelocytic leukaemia on 11-MAR-2007 accompanied by mild disseminated intravascular coagulation (DIC). Several office visits for chemotherapy. The patient had received induction, consolidation and maintenance therapy; presently in histologic and molecular remission. The patient underwent several bone marrow aspirations. The patient was being monitored as outpatient. Obstetrics and gynecology records on 05-MAR-2007 showed well woman exam. No health issues documented. Labs/diagnostics in March 2007 included: WBC 0.5 K/mm3 (low), hemoglobin 8.0 g/dL (low), hematocrit 21.4% (low), platelet 10 k/mm3 (low), neutrophil 12% (low), lymphocyte 80% (high), blast 70% (high), AST 87 U/L (high), ALT 149 U/L (high). Bone marrow aspirate: no abnormal myeloid cell population identified. CT of chest, abdomen and pelvis showed pleural effusion with bilateral lower lobe atelectasis vs consolidation; periportal oedema of liver; ascites in pelvis; left adnexal cyst. Numerous additional tests related to monitoring of health condition were performed since diagnosis. The status of the patient was unknown at the time of this report. APL, DIC, several bone marrow aspirations, chemotherapy, anemia, fever and night sweats were considered to be immediately life-threatening by the agency. The original reporting source was not provided. The VAERS ID is 434266. No further information is available. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Aspartate aminotransferase increased, Aspiration bone marrow normal, Atelectasis, Biopsy bone marrow normal, Blast cells present
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with PHENERGAN allergy and a history of hypothyroidism, partial thyroidectomy in 2006, total thyroidectomy in 2007 and benign thyroid nodule who on 14-FEB-2007 was vaccinated IM into gluteus maximus with the first dose of GARDASIL (lot # 653978/0955F). Concomitant therapy included LEVOXYL and DEPO-PROVERA. The patient was diagnosed with acute promyelocytic leukemia (APL) on 11-MAR-2007. No family history. Acute onset, no tangible symptoms until roughly 10 days before diagnosis (anemia, fever, night sweats). Consultant records (hematology/oncology) showed diagnosis: APL. The patient was diagnosed with acute promyelocytic leukaemia on 11-MAR-2007 accompanied by mild disseminated intravascular coagulation (DIC). Several office visits for chemotherapy. The patient had received induction, consolidation and maintenance therapy; presently in histologic and molecular remission. The patient underwent several bone marrow aspirations. The patient was being monitored as outpatient. Obstetrics and gynecology records on 05-MAR-2007 showed well woman exam. No health issues documented. Labs/diagnostics in March 2007 included: WBC 0.5 K/mm3 (low), hemoglobin 8.0 g/dL (low), hematocrit 21.4% (low), platelet 10 k/mm3 (low), neutrophil 12% (low), lymphocyte 80% (high), blast 70% (high), AST 87 U/L (high), ALT 149 U/L (high). Bone marrow aspirate: no abnormal myeloid cell population identified. CT of chest, abdomen and pelvis showed pleural effusion with bilateral lower lobe atelectasis vs consolidation; periportal oedema of liver; ascites in pelvis; left adnexal cyst. Numerous additional tests related to monitoring of health condition were performed since diagnosis. The status of the patient was unknown at the time of this report. APL, DIC, several bone marrow aspirations, chemotherapy, anemia, fever and night sweats were considered to be immediately life-threatening by the agency. The original reporting source was not provided. The VAERS ID is 434266. No further information is available. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chemotherapy, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Disseminated intravascular coagulation, Haematocrit decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with PHENERGAN allergy and a history of hypothyroidism, partial thyroidectomy in 2006, total thyroidectomy in 2007 and benign thyroid nodule who on 14-FEB-2007 was vaccinated IM into gluteus maximus with the first dose of GARDASIL (lot # 653978/0955F). Concomitant therapy included LEVOXYL and DEPO-PROVERA. The patient was diagnosed with acute promyelocytic leukemia (APL) on 11-MAR-2007. No family history. Acute onset, no tangible symptoms until roughly 10 days before diagnosis (anemia, fever, night sweats). Consultant records (hematology/oncology) showed diagnosis: APL. The patient was diagnosed with acute promyelocytic leukaemia on 11-MAR-2007 accompanied by mild disseminated intravascular coagulation (DIC). Several office visits for chemotherapy. The patient had received induction, consolidation and maintenance therapy; presently in histologic and molecular remission. The patient underwent several bone marrow aspirations. The patient was being monitored as outpatient. Obstetrics and gynecology records on 05-MAR-2007 showed well woman exam. No health issues documented. Labs/diagnostics in March 2007 included: WBC 0.5 K/mm3 (low), hemoglobin 8.0 g/dL (low), hematocrit 21.4% (low), platelet 10 k/mm3 (low), neutrophil 12% (low), lymphocyte 80% (high), blast 70% (high), AST 87 U/L (high), ALT 149 U/L (high). Bone marrow aspirate: no abnormal myeloid cell population identified. CT of chest, abdomen and pelvis showed pleural effusion with bilateral lower lobe atelectasis vs consolidation; periportal oedema of liver; ascites in pelvis; left adnexal cyst. Numerous additional tests related to monitoring of health condition were performed since diagnosis. The status of the patient was unknown at the time of this report. APL, DIC, several bone marrow aspirations, chemotherapy, anemia, fever and night sweats were considered to be immediately life-threatening by the agency. The original reporting source was not provided. The VAERS ID is 434266. No further information is available. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haemoglobin decreased, Laboratory test abnormal, Lung consolidation, Lymphocyte percentage increased, Neutrophil percentage decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with PHENERGAN allergy and a history of hypothyroidism, partial thyroidectomy in 2006, total thyroidectomy in 2007 and benign thyroid nodule who on 14-FEB-2007 was vaccinated IM into gluteus maximus with the first dose of GARDASIL (lot # 653978/0955F). Concomitant therapy included LEVOXYL and DEPO-PROVERA. The patient was diagnosed with acute promyelocytic leukemia (APL) on 11-MAR-2007. No family history. Acute onset, no tangible symptoms until roughly 10 days before diagnosis (anemia, fever, night sweats). Consultant records (hematology/oncology) showed diagnosis: APL. The patient was diagnosed with acute promyelocytic leukaemia on 11-MAR-2007 accompanied by mild disseminated intravascular coagulation (DIC). Several office visits for chemotherapy. The patient had received induction, consolidation and maintenance therapy; presently in histologic and molecular remission. The patient underwent several bone marrow aspirations. The patient was being monitored as outpatient. Obstetrics and gynecology records on 05-MAR-2007 showed well woman exam. No health issues documented. Labs/diagnostics in March 2007 included: WBC 0.5 K/mm3 (low), hemoglobin 8.0 g/dL (low), hematocrit 21.4% (low), platelet 10 k/mm3 (low), neutrophil 12% (low), lymphocyte 80% (high), blast 70% (high), AST 87 U/L (high), ALT 149 U/L (high). Bone marrow aspirate: no abnormal myeloid cell population identified. CT of chest, abdomen and pelvis showed pleural effusion with bilateral lower lobe atelectasis vs consolidation; periportal oedema of liver; ascites in pelvis; left adnexal cyst. Numerous additional tests related to monitoring of health condition were performed since diagnosis. The status of the patient was unknown at the time of this report. APL, DIC, several bone marrow aspirations, chemotherapy, anemia, fever and night sweats were considered to be immediately life-threatening by the agency. The original reporting source was not provided. The VAERS ID is 434266. No further information is available. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Night sweats, Periportal oedema, Platelet count decreased, Pleural effusion, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with PHENERGAN allergy and a history of hypothyroidism, partial thyroidectomy in 2006, total thyroidectomy in 2007 and benign thyroid nodule who on 14-FEB-2007 was vaccinated IM into gluteus maximus with the first dose of GARDASIL (lot # 653978/0955F). Concomitant therapy included LEVOXYL and DEPO-PROVERA. The patient was diagnosed with acute promyelocytic leukemia (APL) on 11-MAR-2007. No family history. Acute onset, no tangible symptoms until roughly 10 days before diagnosis (anemia, fever, night sweats). Consultant records (hematology/oncology) showed diagnosis: APL. The patient was diagnosed with acute promyelocytic leukaemia on 11-MAR-2007 accompanied by mild disseminated intravascular coagulation (DIC). Several office visits for chemotherapy. The patient had received induction, consolidation and maintenance therapy; presently in histologic and molecular remission. The patient underwent several bone marrow aspirations. The patient was being monitored as outpatient. Obstetrics and gynecology records on 05-MAR-2007 showed well woman exam. No health issues documented. Labs/diagnostics in March 2007 included: WBC 0.5 K/mm3 (low), hemoglobin 8.0 g/dL (low), hematocrit 21.4% (low), platelet 10 k/mm3 (low), neutrophil 12% (low), lymphocyte 80% (high), blast 70% (high), AST 87 U/L (high), ALT 149 U/L (high). Bone marrow aspirate: no abnormal myeloid cell population identified. CT of chest, abdomen and pelvis showed pleural effusion with bilateral lower lobe atelectasis vs consolidation; periportal oedema of liver; ascites in pelvis; left adnexal cyst. Numerous additional tests related to monitoring of health condition were performed since diagnosis. The status of the patient was unknown at the time of this report. APL, DIC, several bone marrow aspirations, chemotherapy, anemia, fever and night sweats were considered to be immediately life-threatening by the agency. The original reporting source was not provided. The VAERS ID is 434266. No further information is available. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.