chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Cerebrovascular accident, Encephalitis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on an unknown date was vaccinated with GARDASIL. The first dose was received at another clinic but it was not sure about the second dose. The physician reported that the patient had cerebritis and inflammation of the brain after each GARDASIL shot. It was reported that the doctors concurred that the patient had a stroke. The patient was hospitalized (duration unspecified) and cerebritis and inflammation of the brain and stroke were considered to be immediately life-threatening. The outcome was not reported. The patient sought medical attention, "saw doctor and hospital". Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Pneumonia, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who was vaccinated with two doses of ROTATEQ. The physician believes the patient received dose # 2 about a month ago when the child was around 4 months of age. It was reported that the patient "very likely with SCIDS" that is being evaluated now experienced copious, persistent diarrhea and rotavirus positive by EIA. It is not sure if this was related to the vaccine or if the virus is the vaccine type virus. It is in the process of seeing if this can be determined by additional lab testing. Also reported by the physician on 15-SEP-2008, the patient was currently hospitalized with pneumonia. Additional information has been requested.  11/12/2008 MR received for DOS 9/1-10/10/2008 with D/C DX: SCID, Myelodysplasias, hx of pseudomonas pneumonia and poor weight gain and pseudomonas conjunctivitis. Pt presented to ER with Increased WOB with nasal flaring and perioral cyanosis following a 3-4 day hx of diarrhea, decreased appetite and increased brown spots on the skin.  Concern on admission for immunological etiology due to thrombocytopenia, neutropenia, and worsening respiratory status. Tx with multiple abx for pseudomonas and fungal prophylaxis. Longstanding diarrhea, Rotavirus (+) thought to be 2' to vaccine admin. Given PRBCs, Neupogen and IVIG. NJ feeds due to poor oral motor skills. Edema tx with Lasix. Acute renal failure 2' gent.  Work of breathing and hypoxia improved as pneumonia resolved. Has had diarrhea continuously since admission, some days more severe than others.  On TPN. Transfered awaiting bone marrow transplant.
Age: 0.3
Sex: F
Vaccine: RV5, RV5
Symptoms: Dehydration, Diarrhoea, Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who was vaccinated with two doses of ROTATEQ. The physician believes the patient received dose # 2 about a month ago when the child was around 4 months of age. It was reported that the patient "very likely with SCIDS" that is being evaluated now experienced copious, persistent diarrhea and rotavirus positive by EIA. It is not sure if this was related to the vaccine or if the virus is the vaccine type virus. It is in the process of seeing if this can be determined by additional lab testing. Also reported by the physician on 15-SEP-2008, the patient was currently hospitalized with pneumonia. Additional information has been requested.  11/12/2008 MR received for DOS 9/1-10/10/2008 with D/C DX: SCID, Myelodysplasias, hx of pseudomonas pneumonia and poor weight gain and pseudomonas conjunctivitis. Pt presented to ER with Increased WOB with nasal flaring and perioral cyanosis following a 3-4 day hx of diarrhea, decreased appetite and increased brown spots on the skin.  Concern on admission for immunological etiology due to thrombocytopenia, neutropenia, and worsening respiratory status. Tx with multiple abx for pseudomonas and fungal prophylaxis. Longstanding diarrhea, Rotavirus (+) thought to be 2' to vaccine admin. Given PRBCs, Neupogen and IVIG. NJ feeds due to poor oral motor skills. Edema tx with Lasix. Acute renal failure 2' gent.  Work of breathing and hypoxia improved as pneumonia resolved. Has had diarrhea continuously since admission, some days more severe than others.  On TPN. Transfered awaiting bone marrow transplant.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Hypotonic-hyporesponsive episode
Clinical narrative: Initial report received on 16 September 2008 from a healthcare professional. A 2 month old male patient, whose medical history was unknown, received a first dose of PENTACEL (route, site and lot number unknown) on an unknown date. Within 30 minutes of administration, the patient developed a hypotonic hyporesponsive response. The patient was taken to the emergency room by ambulance. Corrective treatment was not reported. The patient's recovery status was reported as unknown.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Electroencephalogram normal, Mental status changes, Pyrexia
Clinical narrative: Patient had fever and a period of decreased mental status in which he responded only to painful stimuli. Parents called 911 and patient was admitted. Recovered well. 12/19/08-records received on 9/19/08-presented with new onset of fever and lethargy and excessive sleepiness. 1/12/09-records received for DOS 9/20-9/21/09-DC DX: Fever possible vaccine related. Presented to ED with C/O difficult to arouse and increased sleepiness.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Arthralgia, Bone pain, Cardiovascular disorder, Erectile dysfunction, Gastrointestinal disorder
Clinical narrative: Great pains in all joints, wrists, shoulders, cervical & lumbosacral DJD, neck, bones, mental disorders, erectile dysfunction. Both rotator cuffs shattered. Gastrointetinal disorders. Cardiovascular disease. Can't sleep and subjected to many medications.  11/20/08-records received for DOs 6/2/08-DX:Major depressive disorder,recurrent, severe. Coronary artery disease. Percuntaneous cath with stent. Hypertension. Chronic back pain. Overweight. Hepatitis B.Male erectile disorder.Impaired fasting glucose. Hypertropy benign of prostate. Osteoarthrosis. Multipe joint pain since 9/92. Dizziness episodes since 1/94. Blurred vision since 8/93. Insomnia 5/91. Post Gulf War.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Insomnia, Intervertebral disc degeneration, Mental disorder, Rotator cuff syndrome
Clinical narrative: Great pains in all joints, wrists, shoulders, cervical & lumbosacral DJD, neck, bones, mental disorders, erectile dysfunction. Both rotator cuffs shattered. Gastrointetinal disorders. Cardiovascular disease. Can't sleep and subjected to many medications.  11/20/08-records received for DOs 6/2/08-DX:Major depressive disorder,recurrent, severe. Coronary artery disease. Percuntaneous cath with stent. Hypertension. Chronic back pain. Overweight. Hepatitis B.Male erectile disorder.Impaired fasting glucose. Hypertropy benign of prostate. Osteoarthrosis. Multipe joint pain since 9/92. Dizziness episodes since 1/94. Blurred vision since 8/93. Insomnia 5/91. Post Gulf War.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arnold-Chiari malformation, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Patient had multiple "black out" episodes without loss of consciousness.  Evaluated by cardiology and neurology without being given a diagnosis.  Treated as orthostatic hypotension.  First episode 1 1/2 months after 3rd Gardasil.  9/30/08 Reviewed PCP medical records of 12/11/07-5/15/2008. Records reveal patient experienced low grade temp w/cough & congestion x 1 week on 12/11/07.  Exam revealed rhonchi/rales & sore throat.  Dx w/bronchitis & possible pneumonia.  Tx w/antibiotics.  RTC 1/22/08, had seen eye surgeon day before due to having trouble w/vision & black out spells.  Dx w/near syncope.  Referred for EKG/EEG.  RTC 5/15/08 w/sore throat, fever, HA x 2 days.  Dx w/pharyngitis.  10/7/08 Reviewed hospital lab reports of 2/14-3/4/2008.  10/24/08 Reviewed cardiac consultant records of 5/14- FINAL DX: none provided Records reveal patient experienced recurrent pre syncope attacks w/blackouts since 9/2007.  Neuro & ophtho consults had been done & were WNL.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Orthostatic hypotension
Clinical narrative: Patient had multiple "black out" episodes without loss of consciousness.  Evaluated by cardiology and neurology without being given a diagnosis.  Treated as orthostatic hypotension.  First episode 1 1/2 months after 3rd Gardasil.  9/30/08 Reviewed PCP medical records of 12/11/07-5/15/2008. Records reveal patient experienced low grade temp w/cough & congestion x 1 week on 12/11/07.  Exam revealed rhonchi/rales & sore throat.  Dx w/bronchitis & possible pneumonia.  Tx w/antibiotics.  RTC 1/22/08, had seen eye surgeon day before due to having trouble w/vision & black out spells.  Dx w/near syncope.  Referred for EKG/EEG.  RTC 5/15/08 w/sore throat, fever, HA x 2 days.  Dx w/pharyngitis.  10/7/08 Reviewed hospital lab reports of 2/14-3/4/2008.  10/24/08 Reviewed cardiac consultant records of 5/14- FINAL DX: none provided Records reveal patient experienced recurrent pre syncope attacks w/blackouts since 9/2007.  Neuro & ophtho consults had been done & were WNL.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Information has been received from a registered nurse concerning a female (age unknown) who, on an unspecified date "a while back", was vaccinated with a dose of ZOSTAVAX. Subsequently, "a while back", the patient developed severe redness. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of two reports relieved from the same source.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Rash
Clinical narrative: Rash on face, swelling of bilateral eyes
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Irritability, Pyrexia
Clinical narrative: After both sets of shots, 2 and 4 month set, he had a fever 102, excessive diarrhoea, extreme fussiness.  Lasted 3-4 days and resolved.
Age: 32.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity, Skin warm, Sleep disorder, Tenderness
Clinical narrative: Noticed soreness left arm after Tdap, awoke me out of sleep, hard to move left arm above head.  Ibuprofen 600 mg 6:30AM, iced after got to work.  9/16 warmth left deltoid to touch, tenderness mid left deltoid, T 97.6.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4, MMR, MNQ
Symptoms: Expired drug administered
Clinical narrative: No adverse/reactions, no treatment *Expired hepatitis B vaccine*
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: Redness injection site.  Flu like symptoms.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Head titubation, Tic
Clinical narrative: Head nodding tic disorder starting about 5 days following vaccine - no reaction.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Vertigo, Vomiting
Clinical narrative: Severe incapacitating vertigo, vomiting intermittent sever headache, significant injection site pain
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Fall, Rash
Clinical narrative: Client was given HPV and varicella vaccines. Approximately 15 minutes later - Mother described her daughter as "felt dizzy, then fell to her knees". Client was noted to have diffuse pink, flat, pinpoint spots on several areas over arms and upper torso, including but not limited to injection sites. No urticaria or edema noted. Vital signs slight elevated. All symptoms resolved within 30 minutes.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash consistent with erythema multiforme.  Started 10 days after vaccines.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Paraesthesia
Clinical narrative: Patient reported at a well visit on 9/15/08 that she has had tingling and skin color change (pale) since her 2nd Gardasil - she also plays volleyball.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient given BOOSTRIX (TDAP) instead of ADACEL (TDAP). There was no adverse reaction.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Cold sweat, Dyskinesia, Feeling cold, Pallor
Clinical narrative: 0955-Tdap and MCV administered as below in #13. 1000 - Patient began to look pale, became cold and clammy, weak, and upper extremities began to jerk involuntarily. B/P-60/46, HR-52, RR-16. Placed head down between legs. 1015 - B/P-90/60, HR-62, RR-17. "Feeling better."
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: "none"
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient reported today (9-11-08) to clinic for pregnancy test results positive.
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Cataract, Injection site pruritus, Injection site swelling, Oedema peripheral
Clinical narrative: 3-4 days after Td injection, pt noticed itching at injection site. By the next day, swelling of upper left arm began. At time of this report, pt states swelling has been increasing. In comparison to rt upper arm, swelling is seen at injection site in moderate amt. Swelling present in bicep area in greater amt approx 3 cm at bicep only. No redness or heat noted.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Urticaria
Clinical narrative: Wheals flare on body, mostly on legs.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Tenderness
Clinical narrative: Redness and swelling at site right deltoid. Very tender to touch. itchy Seen in Dr. office 9-11-08
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cold compress therapy, Erythema, Oedema peripheral
Clinical narrative: Right arm is red and swollen, patient not bothered by left. Advised cool compresses.
Age: 1.59
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema
Clinical narrative: 9/19/2008 4:50 pm. Right thigh has an erythema and that measures 45x40 mm. There is a hard one that measures 11 mm.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Lipoma, Muscle twitching, Myalgia, Rash, Skin nodule
Clinical narrative: Reported that with AVA # 1 in Dec 1990 he developed a small knot in his left arm that never went away. He received AVA # 2 in the left arm but denied any lumps with the second injection. He reported that the lump was tender and in 1998 it doubled in size and was visible. He stated that it continued to enlarge and bother him until he had it removed in May 08. He denies any unusual scarring or wound healing and reported he had another lump that was removed at the same time from his buttock following a game globulin injection. In addition to his lipoma, the "patient" also reported that shortly following AVA # 2, he developed a rash on his arm near the injection site. He stated this rash lasted for 1.5 years and cleared after he was given some cream that was prescribed. Rash was confined to left arm only, and he denied any further reoccurrences since that time. He also reported that with each AVA he developed muscle aches in his left arm that was also associated with occasional twitching. Pain would last a couple of hours and will subside on its own. He now has less episodes of pain and twitching and stated they may occur about per month. Symptoms: Nodule, subcutaneous, Dermatitis, focal, Muscle Spasm, Muscle Pain.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Tenderness
Clinical narrative: Reported that with AVA # 1 in Dec 1990 he developed a small knot in his left arm that never went away. He received AVA # 2 in the left arm but denied any lumps with the second injection. He reported that the lump was tender and in 1998 it doubled in size and was visible. He stated that it continued to enlarge and bother him until he had it removed in May 08. He denies any unusual scarring or wound healing and reported he had another lump that was removed at the same time from his buttock following a game globulin injection. In addition to his lipoma, the "patient" also reported that shortly following AVA # 2, he developed a rash on his arm near the injection site. He stated this rash lasted for 1.5 years and cleared after he was given some cream that was prescribed. Rash was confined to left arm only, and he denied any further reoccurrences since that time. He also reported that with each AVA he developed muscle aches in his left arm that was also associated with occasional twitching. Pain would last a couple of hours and will subside on its own. He now has less episodes of pain and twitching and stated they may occur about per month. Symptoms: Nodule, subcutaneous, Dermatitis, focal, Muscle Spasm, Muscle Pain.
Age: 1.8
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Somnolence
Clinical narrative: Mother brought child to ER on 8/26/2008 because child appeared very sleepy since receiving DTaP on 8/25/2008. The mother also stated that --
Age: 1.4
Sex: F
Vaccine: DTAPH
Symptoms: Erythema, Pallor, Rash papular, Swelling
Clinical narrative: Large, localized red, swollen area left thigh laterally.  Blanches with pressure.  No tenderness with few tiny papules.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Expired drug administered
Clinical narrative: No adverse event/ no treatment given. Expired HBV given
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Patient developed a 5 cm x 5 cm red, warm area on 9-12-08 on anterior upper right thigh.  Tx consisted of advising parent to do warm compresses Q.I.D. and to follow up if symptoms persist or worsen.
Age: 1.6
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Mother (Foster) called reported hives on face approximately 3PM - No UR distress - Enc. to monitor, give Benadryl - Denies symptoms after 1st HepA- Denies known exposure to New soaps, foods, etc. 9/12/08 AM symptoms resolved after given Benadryl
Age: 1.4
Sex: M
Vaccine: PPV
Symptoms: Balance disorder, Fall, Fatigue, Gait disturbance, Irritability
Clinical narrative: Fever 101 x 4 days.  Has gotten 4 teeth in past week.  Increased fatigue and lethargy x 5 days.  Increased irritability x 4 days.  Began dragging feet, tripping and falling x 3 days.
Age: 1.4
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever 101 x 4 days.  Has gotten 4 teeth in past week.  Increased fatigue and lethargy x 5 days.  Increased irritability x 4 days.  Began dragging feet, tripping and falling x 3 days.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus, Swelling
Clinical narrative: 17 cm x 16 cm area of redness, swelling to elbow.  Indurated, itches, swelling.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Approximately 24 hours after receiving HEP A #2, developed hives on lower arms and lower legs and tip of head.  I saw her at 48 hours post vaccination - had gotten Benadryl 25 ml and was better - hives noted on forearms.
Age: 25.0
Sex: M
Vaccine: DT, MMR
Symptoms: Headache, Pyrexia, Rash, Urticaria
Clinical narrative: Fever, headache, hives, small red raised rash on arms and trunk of body.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Papular rash on trunk, buttocks and legs. Complained of itching. Calamine lotion and Atarax prn.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient states 1 week after receiving smallpox his and turned red and was swollen around the area. Patient directed to use warm compress and see Dr. if problem worsens.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives 1 wk out of shot
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Lymphadenopathy
Clinical narrative: Within 24 hours, I developed severe headache, dizziness, nausea, fever, chills, sweats, sore throat, and tender axillary lymphadenopathy on the arm that vaccine was administered, diffuse myalgias.  Vaccine related event was rapid onset (within 24hrs) and rapid offset (80% better 12-16 hours later).  Treated with acetaminophen only.
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Myalgia, Nausea, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Within 24 hours, I developed severe headache, dizziness, nausea, fever, chills, sweats, sore throat, and tender axillary lymphadenopathy on the arm that vaccine was administered, diffuse myalgias.  Vaccine related event was rapid onset (within 24hrs) and rapid offset (80% better 12-16 hours later).  Treated with acetaminophen only.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Received Varivax#2 on 9/11/08. On 9/14/08, developed varicella lesions and fever to 103.2. Seen on 9/15 with approx 30-40 lesions. Seen again 9/17 with approx 100 lesions. Fever lasted 2-3 days. Had received Varivax#1 at 12m/o.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 9/19/08 MOM PHONED AND CHILD'S RT. ARM IS REDDENED AND WARM TO TOUCH.  THE REDNESS BEGAN EARLY THIS AM. CHILD BROUGHT TO HD AND RT. DELTOID AREA IS RED, WARM TO TOUCH.  NO MEDS HAVE BEEN GIVEN, GABVE MOTHER ACETOMINOPHEN AND INSTRUCTIONS TO GIVE EVERY 4 TO 6 HOURS WHILE AWAKE FOR NEXT 24-48 HOURS.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Pruritus generalised
Clinical narrative: Mom called Friday 9-19-08 stating her son had swollen and red upper right arm where he had received varicella vaccine and was also having generalized itching but did not have a rash. She took him to see family doctor and he said it was a reaction to vaccine but there was no infection, instucted mom to give benedryl for itching. Mom states today he is no longer itching and arm is not longer red and swollen, only a small bruise at injection site.
Age: 1.33
Sex: M
Vaccine: HEP, PNC
Symptoms: Urticaria, Varicella
Clinical narrative: Hives and few scattered chicken pox. Epipen prescribed.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Zoster vaccine administered 08//28/2008  A week later a blister developed on my left side. It is the size of a 50 cent piece, bright red with smaller blisters within. As of today it is still pronounced with micro blisters surounding it. The blisters have broken from friction of clothing but have never become really pussing or leaked fluid in a noticable amount.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Neck pain, Pain
Clinical narrative: 4 hours after injection, sharp pains in head and neck. 10 hours after injection chills and all over body pain. 18 hours after injection pain is less.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Lip swelling, Swelling face
Clinical narrative: I was taking the oral typhoid fever vaccine - Vivotif.  The 3rd dosage, my lip and check swelled up.  I took benadryl to stop this, but the swelling/thickness in my check lasted for a day.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Patient's arm became red, hot and swollen for a week
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pT. CALLED DAY AFTER VACCINATION AND STATED THAT SHE HAD SOME SWELLING AND REDNESS AND MINOR PAIN AT INJECTION SITE. told her cold compress and keep an eye on it. came by pharmacy monday morning (3 days after injection) and had been to the dr. which gave her antibiotics to treat cellulitis. Her arm was very red, swollen, and very tender to the touch. Will follow up with dr. if she does not improve.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: pT. CALLED DAY AFTER VACCINATION AND STATED THAT SHE HAD SOME SWELLING AND REDNESS AND MINOR PAIN AT INJECTION SITE. told her cold compress and keep an eye on it. came by pharmacy monday morning (3 days after injection) and had been to the dr. which gave her antibiotics to treat cellulitis. Her arm was very red, swollen, and very tender to the touch. Will follow up with dr. if she does not improve.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Constant headache for 24 hours
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria, Local reaction, Rash macular
Clinical narrative: On day of vaccination, 9/18/08; immediately post vaccination with varivax to the right arm-deltoid area ; developed redness/ "splotchy: hive like reaction localized to varivax injection site.Patient noted today that 1-2 days later (9/19 - 9/20/08), increased swelling- per mother "like giant hive" and developed hives on that right arm and on back. Seen today 9/22/08 and symptoms have resolved other than localized reaction still around sit of varivax injection. Per mother, much better today than past two days.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Swelling, Urticaria
Clinical narrative: On day of vaccination, 9/18/08; immediately post vaccination with varivax to the right arm-deltoid area ; developed redness/ "splotchy: hive like reaction localized to varivax injection site.Patient noted today that 1-2 days later (9/19 - 9/20/08), increased swelling- per mother "like giant hive" and developed hives on that right arm and on back. Seen today 9/22/08 and symptoms have resolved other than localized reaction still around sit of varivax injection. Per mother, much better today than past two days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness swelling L arm
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Nausea, Pain in extremity, Swelling
Clinical narrative: About 4 hours after receiving the vaccine, patient had chills, nausea, left arm pain and swelling.  She was unable to move her left arm without significant pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pt in er 9/21/2008 with complaints of pain at injection site lt deltoid. dr  seen pt in er assessment: local erythema at injection site. local care to site discussed
Age: 1.3
Sex: M
Vaccine: DTAP, MMR
Symptoms: Irritability, Measles antibody, Pyrexia, Rash, Rash erythematous
Clinical narrative: Pt is a 15-month-old male brough in my mom for a rash.  Mom is concerend that is may be due to one of his immunizations.  He was in for a 15 month well child check on 08/25/2008 at which time he received his MMR and DTaP.  At that point, he had a diaper rash that looked like yeast, otherwise his examination was completely unremarkable and he was not ill in any way.  The day following his immunizations, he developed a fever and ran a fever for fice days and it did get up to 103.  After the fifth day, his fever did go away; however, then on 9/3 in the evening mom noticed just a slight rash on his stomach.  She describes it as samll, red dots that were light in nature.  She put him to bed and when he awoke the next morning, the rash was gone; however yesterday on 9/7/08, he developed a rash once again on his stomach and back that seems to bother him.  He seems to be scratching and rubbing at his skin and it has now progressed and is starting to creep up onton the back of his head.  He seems more irritable.  He has not had any further fevers.  He has not had any redness to his eyes or drainage from his eyes.  He has not had any runny nose and has not had any cough.  He continues to eat well.  No one else in the home has been sick and he only goes to a drop-in daycare one day a week while mom works out.   Exam reveals erythematous papules covering his entire trunk ranging in size from a few pinpoint, mainly 3 millimeters in diameter, and some are confluent.  They cover his entire abdomen, back, up onto the back of his neck and into the hairline, and a few on his cheeks.  A few of them also go down onto his legs and arms, but definitely not as prevalent as on his trunk.  There are no pustules and there are no vesicles.  These are dry lesions.
Age: 1.3
Sex: M
Vaccine: DTAP, MMR
Symptoms: Rash papular
Clinical narrative: Pt is a 15-month-old male brough in my mom for a rash.  Mom is concerend that is may be due to one of his immunizations.  He was in for a 15 month well child check on 08/25/2008 at which time he received his MMR and DTaP.  At that point, he had a diaper rash that looked like yeast, otherwise his examination was completely unremarkable and he was not ill in any way.  The day following his immunizations, he developed a fever and ran a fever for fice days and it did get up to 103.  After the fifth day, his fever did go away; however, then on 9/3 in the evening mom noticed just a slight rash on his stomach.  She describes it as samll, red dots that were light in nature.  She put him to bed and when he awoke the next morning, the rash was gone; however yesterday on 9/7/08, he developed a rash once again on his stomach and back that seems to bother him.  He seems to be scratching and rubbing at his skin and it has now progressed and is starting to creep up onton the back of his head.  He seems more irritable.  He has not had any further fevers.  He has not had any redness to his eyes or drainage from his eyes.  He has not had any runny nose and has not had any cough.  He continues to eat well.  No one else in the home has been sick and he only goes to a drop-in daycare one day a week while mom works out.   Exam reveals erythematous papules covering his entire trunk ranging in size from a few pinpoint, mainly 3 millimeters in diameter, and some are confluent.  They cover his entire abdomen, back, up onto the back of his neck and into the hairline, and a few on his cheeks.  A few of them also go down onto his legs and arms, but definitely not as prevalent as on his trunk.  There are no pustules and there are no vesicles.  These are dry lesions.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: approx. 18 hrs after DTaP vaccine Pt mother noticed R-arm swelling, eryth, subjective fever, full ROM and NTTP R-arm.
Age: 1.75
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Induration, Local reaction, Pruritus
Clinical narrative: LOCALIZED REDNESS AND INDURATION TO LEFT LATERAL THIGH, COMPLAINS OF ITCHING
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, JEV, SMALL
Symptoms: Eye pain, Headache, Lymph node pain, Mass, Pain in jaw
Clinical narrative: 20 Y/O Male presented to a Corpsman with c/c of bump on his left forhead 1 1/2" above his eyebrow. Pt stated that he was experiencing h/a, pain behind the eyes, jaw pain, and lymph node pain in the neck. Pt received the smallpox vaccine 13 days prior, with no reaction when checked on the 12th. An occlusive dressing was placed over the affected site, and the PT was given direction to follow a strict hygiene regimen. Pt was also informed to report to sick call daily for dressing changes, along with a follow up to observe any changes in the lesion.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: PATIENT HAD SWELLING AND LOCAL FEVER AT SITE OF INJECTION MEASURING 3 X 5 INCHES THAT OCCURRED APPROX. 5 HRS AFTER ZOSTAVAX WAS ADMINISTERED.  PHYSICIAN PRESCRIBED CLINDAMYCIN (7 DAY COURSE) THERAPY ON 9/22/08
Age: 3.0
Sex: M
Vaccine: FLUN3, MMR, FLUN3, MMR
Symptoms: Blister, Conjunctival hyperaemia, Depressed level of consciousness, Erythema, Urticaria
Clinical narrative: MMR and FLUMIST given.  10 minutes after leaving clinic patient returned with MD sensorium, Injection of eyes, erythema, neck, chest, hives trunk, blister with approximately 2 cm at MMR site.  2 dose 0.2 ml Epi + O2 5L; Benadryl 25 mg x 1: 911 transport ER.
Age: 3.0
Sex: M
Vaccine: FLUN3, MMR, FLUN3, MMR
Symptoms: Depressed level of consciousness, Erythema, Injection site reaction, Staring, Urticaria
Clinical narrative: MMR and FLUMIST given.  10 minutes after leaving clinic patient returned with MD sensorium, Injection of eyes, erythema, neck, chest, hives trunk, blister with approximately 2 cm at MMR site.  2 dose 0.2 ml Epi + O2 5L; Benadryl 25 mg x 1: 911 transport ER.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: (+) red, swollen tender about 4x5 cm on (R) arm.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctival hyperaemia, Periorbital oedema
Clinical narrative: Periabrital edema, ud conjunctive, throat tightness, stating 3 hours after injection.  Prescribed Medimune H1 + H2
Age: 54.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Headache, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Patient complained of fever a few hours after receiving MENACTRA. Took "Theraflu" complained of headache the following day. Took "immune booster". Fever gone after 48 hours. Still has headache today. States arm red, swollen and sore. No drainage: Advised to seek MD advise. *Advised to stop taking Theraflu - take Tylenol of Motrin instead.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness, Dizziness, Vision blurred
Clinical narrative: Pt developed blurry vision in (R) eye, loss of vision in (R) eye temporarily. Pt also c/o dizziness 3 min after vaccine.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient had pneumonia vaccine on 9/18/08.  On 9/19/08 contacted office, area raised, warm and reddened.  Patient also complained of pain.  Patient instructed to take Benadryl and Rx for ultram given.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Five vaccines were administered and within 3-5 minutes pt broke out in whelps. Whelps started on face and then covered whole body. Feet were itching and whelps also. Pt complained with tongue itching and lips were swollen. No respiratory distress. Benadryl given I.M. Five minutes after onset of reaction, pt remained for 1 hour in office.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Fatigue, Influenza like illness, Platelet count decreased, Rash papular
Clinical narrative: Varicella-Flu-like symptoms beginning 8/11, Tmax 102, 8/14 Diffuse pruritic papular vesicular rash c/w varicella. Treated with VALTREX x 5 day, CXR (-), fatigue and rash resolved over 2 weeks.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular, White blood cell count decreased
Clinical narrative: Varicella-Flu-like symptoms beginning 8/11, Tmax 102, 8/14 Diffuse pruritic papular vesicular rash c/w varicella. Treated with VALTREX x 5 day, CXR (-), fatigue and rash resolved over 2 weeks.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Influenza like illness, Injection site rash, Varicella
Clinical narrative: Varicella-Flu-like symptoms beginning 8/11, Tmax 102, 8/14 Diffuse pruritic papular vesicular rash c/w varicella. Treated with VALTREX x 5 day, CXR (-), fatigue and rash resolved over 2 weeks.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh red and swollen seen by Dr. and treated with ice, hydrocortisone cream and KEFLEX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Excessive erythema, edema, induration to site.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: Developed hives on trunk of body approximately 4-6 hours post vaccination.  Hives were relieved with Benadryl and lasted approximately 48 hours.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Asthma, Dizziness, Fatigue, Headache
Clinical narrative: Rash-swelling of body- severe rush that doesn't go away - body pains- tired a lot headaches every day periods a lot more of them 3 weeks at a time
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Menstruation irregular, Rash generalised, Swelling
Clinical narrative: Rash-swelling of body- severe rush that doesn't go away - body pains- tired a lot headaches every day periods a lot more of them 3 weeks at a time
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy skin, Blood test, Fatigue, Headache, Pain
Clinical narrative: Rash-swelling of body- severe rush that doesn't go away - body pains- tired a lot headaches every day periods a lot more of them 3 weeks at a time
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Swelling
Clinical narrative: Rash-swelling of body- severe rush that doesn't go away - body pains- tired a lot headaches every day periods a lot more of them 3 weeks at a time
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Arthritis, Blood calcium normal, Blood magnesium normal, Blood phosphorus normal
Clinical narrative: Information has been received from a physician concerning a 65 year old male who in August 2008 was vaccinated with ZOSTAVAX.  Concomitant therapy included PROTONIX, lovastatin (manufacturer not reported), CELEXA, metoprolol and aspirin.  On 03-SEP-2008, approximately 2 weeks after vaccination, the patient developed arthritis in one hand.  The patient then developed general fatigue and neck and scalp pain.  The arthritis from the one hand then moved to the other hand.  The patient visited the physician's office.  Laboratory tests performed included complete blood count (normal), calcium/magnesium/phosphorus (normal), sedimentation rate 59, C-reactive protein 200, antinuclear antibody positive, and rheumatoid factor negative.  The reporting physician felt the patient developed symptoms of polymyalgia and or temporal arthritis.  As of the reporting date, the events were ongoing.  The physician considered the events to be disabling and immediately life-threatening.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Fatigue, Full blood count normal, Myalgia, Neck pain
Clinical narrative: Information has been received from a physician concerning a 65 year old male who in August 2008 was vaccinated with ZOSTAVAX.  Concomitant therapy included PROTONIX, lovastatin (manufacturer not reported), CELEXA, metoprolol and aspirin.  On 03-SEP-2008, approximately 2 weeks after vaccination, the patient developed arthritis in one hand.  The patient then developed general fatigue and neck and scalp pain.  The arthritis from the one hand then moved to the other hand.  The patient visited the physician's office.  Laboratory tests performed included complete blood count (normal), calcium/magnesium/phosphorus (normal), sedimentation rate 59, C-reactive protein 200, antinuclear antibody positive, and rheumatoid factor negative.  The reporting physician felt the patient developed symptoms of polymyalgia and or temporal arthritis.  As of the reporting date, the events were ongoing.  The physician considered the events to be disabling and immediately life-threatening.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Temporal arteritis
Clinical narrative: Information has been received from a physician concerning a 65 year old male who in August 2008 was vaccinated with ZOSTAVAX.  Concomitant therapy included PROTONIX, lovastatin (manufacturer not reported), CELEXA, metoprolol and aspirin.  On 03-SEP-2008, approximately 2 weeks after vaccination, the patient developed arthritis in one hand.  The patient then developed general fatigue and neck and scalp pain.  The arthritis from the one hand then moved to the other hand.  The patient visited the physician's office.  Laboratory tests performed included complete blood count (normal), calcium/magnesium/phosphorus (normal), sedimentation rate 59, C-reactive protein 200, antinuclear antibody positive, and rheumatoid factor negative.  The reporting physician felt the patient developed symptoms of polymyalgia and or temporal arthritis.  As of the reporting date, the events were ongoing.  The physician considered the events to be disabling and immediately life-threatening.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 2 month old female who, on 18-AUG-2008, was vaccinated with a first dose of ROTATEQ, oral.  Three days later, on 21-AUG-2008, the patient experienced hematochezia which was described as "light spotting".  One week later, on 28-AUG-2008 the patient again experienced hematochezia also described as "light spotting".  Unspecified medical attention was sought.  Subsequently, the patient recovered from both events of hematochezia (dates unknown).  No product quality complaints were involved.  Hematochezia was considered to be an other important medical event.  Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 16 year old male patient with allergic reaction to antibiotics (amoxicillin, "mycins" and sulfonamide) and lupus erythematosus who on 26-DEC-2002 was vaccinated into left deltoid with a dose of 0.5 mL of PNEUMOVAX 23, lot # 644217/1026M.  Concomitant therapy included PLAQUENIL, lisinopril (manufacturer unknown), aspirin and unspecified therapies. The reporting nurse reported that the patient developed "pneumococcal problem" and was in the hospital at this time. No other information to report at this time. The outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 16 year old female who in the beginning of April 2008 was vaccinated with the first dose of GARDASIL.  It was reported that the patient experienced seizure, no time frame provided, and was hospitalized for a week to 10 days.  As of 16-SEP-2008, the outcome was unknown.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Full blood count normal, Laboratory test normal, Pharyngitis, Rash
Clinical narrative: Information has been received from a  physician concerning a 23 year old female with a history of endometriosis who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included ALLEGRA-D and YAZ. The patient developed pharyngitis followed by a rash after receiving her first dose of GARDASIL. The patient was treated by her family physician (not this physician) with steroids. After this treatment the patient experienced weight gain, syncope and possible seizure. The patient was evaluated in an emergency room for syncope and possible seizure. A complete blood cell count (CBC) and blood chemistry panel were performed and the results were within normal limits. At the time of reporting the patient continued to experience some lightheadedness and her weight was still greater than it was prior to receiving GARDASIL. The pharyngitis and rash had been resolved. Upon internal review possible seizure was considered to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Weight increased
Clinical narrative: Information has been received from a  physician concerning a 23 year old female with a history of endometriosis who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included ALLEGRA-D and YAZ. The patient developed pharyngitis followed by a rash after receiving her first dose of GARDASIL. The patient was treated by her family physician (not this physician) with steroids. After this treatment the patient experienced weight gain, syncope and possible seizure. The patient was evaluated in an emergency room for syncope and possible seizure. A complete blood cell count (CBC) and blood chemistry panel were performed and the results were within normal limits. At the time of reporting the patient continued to experience some lightheadedness and her weight was still greater than it was prior to receiving GARDASIL. The pharyngitis and rash had been resolved. Upon internal review possible seizure was considered to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 14 year old female who in September 2007, was injected with her third dose of GARDASIL (lot number and site not reported). The patient completed all three doses of GARDASIL last year. The patient now has been experiencing seizures. There is no further information was provided. Upon internal review seizures were considered an other important event. Unspecified medical attention was sought. Additional information has been requested.  12/02/08  Reviewed ER medical records of 08/12/2008. FINAL DX: juvenile myoclonic epilepsy Records reveal patient experienced 2-3 min of generalized tonic-clonic seizure activity & bit her tongue.  Neuro consult done.  Tx w/antiseizure meds & d/c to home for neuro f/u as outpatient.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse for the Pregnancy Registry for GARDASIL concerning a 22 year old female who on 31-JUL-2008 was vaccinated with the first dose of GARDASIL (lot# 0250X) I.M. in a deltoid.  The patient's pregnancy was terminated on 30-AUG-2008 or 31-AUG-2008.  The patient's LMP was 23-JUL-2008 and EDD 29-APR-2009. No adverse symptoms.  The lab test performed was urine pregnancy.  Upon internal review, the patient's pregnancy was terminated was considered an other important medical event.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Congenital anomaly, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan abnormal
Clinical narrative: Initial and follow-up information has been received from a 25 year old female consumer with allergy to PERCOCET, for the Pregnancy Registry for GARDASIL, who on 08-NOV-2007 was vaccinated with the first 0.5 ml dose of GARDASIL. On 08-JAN-2008 the patient was vaccinated with the second dose of GARDASIL. As of 25-FEB-2008, the patient reported that she was 10 weeks pregnant. The patient reported in follow-up that on 16-SEP-2008 she delivered a healthy 8 pounds 13 ounces boy. The baby had a complete unilateral cleft lip and palate, which was diagnosed prenatally on ultrasound. The patient reported that she was prepared for this finding and she had already scheduled follow-up for the baby for surgery (dates not provided). The patient reported that both she and the baby were doing well, no problems for herself. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a 23 year old female with a shellfish allergy who on 15-FEB-2008 was vaccinated with the first dose of GARDASIL.  The patient found out on 19-FEB-2008 that she was pregnant.  Her LMP is estimated as 19-JAN-2008.  Follow up information has been received from a 23 year old female that reported that in March 2008, she had a miscarriage.  She said she was fine now, and doing well.  Upon internal review miscarriage was determined to be an other important medical event.  Additional information is not expected.
Sex: F
Vaccine: IPV
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Initial report was received on 12 September 2008 from another manufacturer who received the report from the patient's parent.  A female patient was reported to have developed pneumonia on an unspecified amount of time after she had received a polio immunization (manufacturer, lot number, route/site not reported).  The patient experienced a fever (temperature and date of onset not reported) which lasted seven to ten days and had been hospitalized.  No additional information was provided.