chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypotonia, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: SWELLING ON HER RIGHT UPPER LATERAL THIGH ABOUT 2 CM, ALSO DEVELOPED A FEVER UP TO 101.5 RESOLVED WITH TYLENOL SWOLLEN, PAINFUL, LIMPING WHEN WALKING.
Age: 1.27
Sex: F
Vaccine: MMR
Symptoms: Computerised tomogram, Convulsion
Clinical narrative: Seizures
Age: 35.0
Sex: F
Vaccine: HEPA, JEV1, RAB, TDAP, JEV1
Symptoms: Blood glucose decreased, Convulsion
Clinical narrative: Seizure
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling, pain at site approx 10 cm diameter, fever began 20 hours later lasted 12 hours.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Blood pressure increased, Eczema, Fatigue, Flushing
Clinical narrative: Pain in arms, hands, shoulders, neck, head, legs, feet. Constant sore throat, blood pressure spike, eczema, fatigue, flushing, weakness, malaise, headache, insomnia, migraine, neuropathy, muscle weakness.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Insomnia, Malaise, Migraine, Muscular weakness
Clinical narrative: Pain in arms, hands, shoulders, neck, head, legs, feet. Constant sore throat, blood pressure spike, eczema, fatigue, flushing, weakness, malaise, headache, insomnia, migraine, neuropathy, muscle weakness.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Neuropathy peripheral, Oropharyngeal pain, Pain, Streptococcus test negative
Clinical narrative: Pain in arms, hands, shoulders, neck, head, legs, feet. Constant sore throat, blood pressure spike, eczema, fatigue, flushing, weakness, malaise, headache, insomnia, migraine, neuropathy, muscle weakness.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: PAIN ELBOWS AND KNEES ABOUT 2 HOURS AFTER IMMUNIZATION GIVEN.  TOOK 2 ADVIL TID, MUCH IMPROVEMENT BY AM. WE SAW PATIENT IN OUR OFFICE AT 10:30 ON 5/20/10. ADVISED TO CONTINUE ADVIL 2 TABS TID AND WE ARE REPORTING TO VAERS.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Ear pain, Eye pain, Fatigue
Clinical narrative: 05/15/2010 tired, headache. 05/16/2010 migraine, blurred vision, vertigo, ear ache/buzzing and eye pain, high blood pressure, tired and muscle pain, nausea, went back to clinic they gave 2 anti migraine pills (Zomig). Migraine improved for some hours. 05/17/2010 neck pain, migraine, vertigo, blurred vision, muscle pain, hard to breath, nausea, low fever. 05/18/2010 severe muscle pain and migraine, vertigo, and nausea, low fever, hard to breathe. 05/19/2010 severe muscle pain, hard to breathe, vertigo, low fever. 05/20/2010 went to other doctor, got steroid shot, started to improve regarding muscle pain, fever, vertigo and migraine. 05/21/2010 still muscle pain and tired, neck pain and hard to breathe. 05/22/2010 return to work but with dizziness and muscle pain and low fever.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypertension, Migraine, Myalgia, Nausea
Clinical narrative: 05/15/2010 tired, headache. 05/16/2010 migraine, blurred vision, vertigo, ear ache/buzzing and eye pain, high blood pressure, tired and muscle pain, nausea, went back to clinic they gave 2 anti migraine pills (Zomig). Migraine improved for some hours. 05/17/2010 neck pain, migraine, vertigo, blurred vision, muscle pain, hard to breath, nausea, low fever. 05/18/2010 severe muscle pain and migraine, vertigo, and nausea, low fever, hard to breathe. 05/19/2010 severe muscle pain, hard to breathe, vertigo, low fever. 05/20/2010 went to other doctor, got steroid shot, started to improve regarding muscle pain, fever, vertigo and migraine. 05/21/2010 still muscle pain and tired, neck pain and hard to breathe. 05/22/2010 return to work but with dizziness and muscle pain and low fever.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pyrexia, Tinnitus, Vertigo, Vision blurred
Clinical narrative: 05/15/2010 tired, headache. 05/16/2010 migraine, blurred vision, vertigo, ear ache/buzzing and eye pain, high blood pressure, tired and muscle pain, nausea, went back to clinic they gave 2 anti migraine pills (Zomig). Migraine improved for some hours. 05/17/2010 neck pain, migraine, vertigo, blurred vision, muscle pain, hard to breath, nausea, low fever. 05/18/2010 severe muscle pain and migraine, vertigo, and nausea, low fever, hard to breathe. 05/19/2010 severe muscle pain, hard to breathe, vertigo, low fever. 05/20/2010 went to other doctor, got steroid shot, started to improve regarding muscle pain, fever, vertigo and migraine. 05/21/2010 still muscle pain and tired, neck pain and hard to breathe. 05/22/2010 return to work but with dizziness and muscle pain and low fever.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DPP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right thigh with 20x16cm area of erythema and induration, non tender, slightly warm. Pt is ambulatory and eating and sleeping well.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DPP, HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Right thigh with 20x16cm area of erythema and induration, non tender, slightly warm. Pt is ambulatory and eating and sleeping well.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DPP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 5/17: Swelling the diameter of softball accompanied by redness, heat, firmness, raised area on right thigh surrounding site. Complained of pain and mild itching. No fever. No other side effects. Treated with Motrin, Tylenol, Benadryl, and ice packs during 24 hour period. 5/19: Swelling expanded to 20cm x 16cm. Still raised, red, warm. Pain somewhat diminished from 5/18. Treated with Motrin, Tylenol, Benadryl, and ice packs during 24 hour period. Called nurse hotline who recommended we take her back to clinic. 5/20: Same diameter as 5/19. Center becoming "bruised" instead of red. Still swollen, raised, red, warm. Pain less than day before. Still no additional side effects. Called clinic and was seen by doctor at 10:30.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DPP, HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: 5/17: Swelling the diameter of softball accompanied by redness, heat, firmness, raised area on right thigh surrounding site. Complained of pain and mild itching. No fever. No other side effects. Treated with Motrin, Tylenol, Benadryl, and ice packs during 24 hour period. 5/19: Swelling expanded to 20cm x 16cm. Still raised, red, warm. Pain somewhat diminished from 5/18. Treated with Motrin, Tylenol, Benadryl, and ice packs during 24 hour period. Called nurse hotline who recommended we take her back to clinic. 5/20: Same diameter as 5/19. Center becoming "bruised" instead of red. Still swollen, raised, red, warm. Pain less than day before. Still no additional side effects. Called clinic and was seen by doctor at 10:30.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Localized redness and swelling approx. 7cm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Fall, Oedema peripheral, Similar reaction on previous exposure to drug, Skin warm
Clinical narrative: On 4/17/10 patient fell 5-6 feet, landed on right shoulder and taken to ER for eval. In ER it was noted that right arm was erythematous, swollen and warm to touch. Determined it was probably related to the vaccines he received 4/16/10. Admitted and started on IV antibiotics. it was unclear if this was a cellulitis or just an inflammatory reaction-no cultures were obtained. Mom states daughter reacted similarly to her final round of vaccines.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Immediate post-injection reaction, Oedema peripheral, Pain in extremity
Clinical narrative: 5/5/10 post vaccine arm red and sore. 5/6/10 arm red and swollen. 5/7/10 red and swollen measured by school nurse 2" x 4" area.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Drug exposure during pregnancy, Periorbital oedema, Reaction to preservatives
Clinical narrative: Initial report was received 21 April 2010 from the patient (she is also an RN). A 37 year old female patient was 7 months pregnant when she received an injection of INFLUENZA VACCINE (manufacturer unknown, lot number unknown) in "maybe" September 2009 and an injection of PANDEMIC INFLUENZA VACCINE (manufacturer unknown, lot number unknown) on an unspecified date. The patient experienced on an unspecified date, periorbital edema for approximately 5 months post vaccinations. The patient had no illness and no known allergies at the time of the vaccinations. After the vaccinations, she was diagnosed by an allergist with thimerosal allergy. Her medical history included hypothyroidism and 3 previous pregnancies with full term normal deliveries. Concomitant medications included SYNTHROID. On 29 November 2009 the patient delivered a normal full term baby (gestation and gender not reported). She received a TUBERSOL injection in February 2010. As of this report the periorbital edema had not resolved. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Injection site erythema, Injection site induration, Paraesthesia
Clinical narrative: A 40-year-old female patient, with medical history of spondyloarthropathy and herpes zoster virus infection, had received an injection of influenza A/H1N1 vaccine, form unknown manufacturer (lot number, route and injection site unknown) on 23 April 2010. She was receiving methotrexate and indomethacin for spondyloarthropathy concomitantly. The day of vaccination, the patient presented with hardness and erythema at the injection site. Local hardness lasted one day and local erythema 2 days. On 25 April 2010, i.e. 2 days after vaccination, she experienced paresthesia on her right thumb that ceased on 07 April  2010. No therapy was prescribed.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Infection, Pyrexia, Tenderness
Clinical narrative: 4/30/10 Received TC from school nurse, stating child had extremely red, tender left arm and redness extended down arm and fever. Advised her to inform parent to take child to PMD. ASAP for evaluation - seen by Dr. 4/30 who states area is infected and prescribed antibiotics. Seen and tx by PMD. To see Dr again Monday 5/3/10.
Age: 83.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Neck pain, Paraesthesia
Clinical narrative: Case received from a healthcare professional through the VIS Sanofi Pasteur on 27 April 2010 under the reference number BR2010-101.  An 83-year-old male patient with a medical history of hypertension and cardiopathy had received his injection of PANDEMIC INFLUENZA VACCINE from a non-reported manufacturer on 23 April 2010 in the left arm (batch number, number in series, route of vaccination not reported).  On 27 April 2010, i.e. 4 days after the vaccination, the patient experienced pain on the cervical area (neck) and upper right member, paresthesia on the right leg and arm and tingling on the right "tumb" of the foot and hand.  According to the reporter the patient had no previous neurologic illness.  The patient was not hospitalized.  He did not receive any corrective treatment.  The patient had not recovered at the time of the report.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Full blood count normal, Influenza serology negative, Metabolic function test normal
Clinical narrative: Patient took TDAP at approx 10:30 AM on 4-7-10. Woke up at approx 11:30 pm with 104 temp, shaking, chills and body aches. Started alternating TYLENOL with Ibuprofen and temp lowered 101. Went to MD on 4-8-10. Temp still 100 with TYLENOL and MOTRIN, CBB, BMP and flu test >Neg. was given ROCEPHIN, DECADRON and PHENERGAN injection.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Tremor
Clinical narrative: Patient took TDAP at approx 10:30 AM on 4-7-10. Woke up at approx 11:30 pm with 104 temp, shaking, chills and body aches. Started alternating TYLENOL with Ibuprofen and temp lowered 101. Went to MD on 4-8-10. Temp still 100 with TYLENOL and MOTRIN, CBB, BMP and flu test >Neg. was given ROCEPHIN, DECADRON and PHENERGAN injection.
Age: 29.0
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Asthma, Dyspnoea, Headache, Hypertension, Oropharyngeal pain
Clinical narrative: Case received from a healthcare professional on 30 April 2010 under the local reference number BR2010-103. A 29-year-old female patient, with an unknown personal and family medical history, had received her dose of Influenza A/H1N1 vaccine (manufacturer not reported, batch number, route and anatomical site of administration unknown on 10 April 2010. The patient had no reported concomitant therapy. On 10 April 2010, post-vaccination, the patient experienced sore throat and fever. She was seen in the hospital and received LORATADINE and DECADRON on 10 April 2010. It was not known whether she was hospitalized or not. On 22 April 2010, she developed hypertension, body ache, headache, breathing difficulty and asthmatic crisis sensation. There was no local reaction. The patient started on CEPHALEXIN from 25 April 2010 to 02 May 2010. The outcome was "ongoing" at the time of the report. List of documents held by sender: none.
Age: 29.0
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Pain, Pyrexia
Clinical narrative: Case received from a healthcare professional on 30 April 2010 under the local reference number BR2010-103. A 29-year-old female patient, with an unknown personal and family medical history, had received her dose of Influenza A/H1N1 vaccine (manufacturer not reported, batch number, route and anatomical site of administration unknown on 10 April 2010. The patient had no reported concomitant therapy. On 10 April 2010, post-vaccination, the patient experienced sore throat and fever. She was seen in the hospital and received LORATADINE and DECADRON on 10 April 2010. It was not known whether she was hospitalized or not. On 22 April 2010, she developed hypertension, body ache, headache, breathing difficulty and asthmatic crisis sensation. There was no local reaction. The patient started on CEPHALEXIN from 25 April 2010 to 02 May 2010. The outcome was "ongoing" at the time of the report. List of documents held by sender: none.
Age: 0.44
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Pt's mother states baby had high fever, crying for several weeks after last vacc 1-5-10.  Mother reported this to her PMD and he advised no further vaccine containing PERTUSSIS.  Fever Tx'd with TYLENOL.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Neck itching. Right arm swollen.
Age: 66.0
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Musculoskeletal pain
Clinical narrative: After two weeks vaccine the top of the shoulder got pain and the wrist left hand very weakness up to now.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Low grade fever, chills, headache, fatigue, joint pain, nausea, diarrhea, swelling in both sides of neck.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Nausea, Pyrexia
Clinical narrative: Low grade fever, chills, headache, fatigue, joint pain, nausea, diarrhea, swelling in both sides of neck.
Age: 0.19
Sex: F
Vaccine: DTAP, HEP, PPV, RVX
Symptoms: Lethargy, Vomiting
Clinical narrative: Bad vomiting. Was lethargic for 3 days.
Age: 1.28
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pyrexia
Clinical narrative: After VAR given on LL child developed fevers and "blister like bumps over LL/torso/face". Call made to HD.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Gastrointestinal stoma complication
Clinical narrative: Information has been received from a physician concerning a 9 week old male patient with Hirschsprung's disease, a history of ileostomy and no known drug reactions/allergies who on 03-MAY-2010 was vaccinated with a 2 ml PO dose of ROTATEQ (lot# 665169/0018Z). There was no concomitant medication. On 06-MAY-2010 the patient experienced large amounts of "out put" from the ileostomy and dehydration after receiving ROTATEQ and was hospitalized. Medical attention was sought by an office visit. The patient received treatment with intravenous fluids. At the time of the report, the patient had not recovered. The reporting physician considered large amounts of "out put" from the ileostomy and dehydration to be disabling and other important medical events. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction, Asthenia, Dysgeusia, Dysphagia, Dyspnoea
Clinical narrative: Information has been received from a 39 year old female consumer with penicillin allergy and no pertinent medical history, who on 03-May-2010 was vaccinated with a dose of MMR II (lot# 666293/1740Y). Concomitant therapy included INDERAL, NORVASC and DIOVAN. It was reported that the patient had an anaphylactic reaction after receiving MMR II vaccine. The patient could not breathe and swallow. She had puffy eyes, tasted metals and was very weak. The patient went to the emergency room in an ambulance but was released 5 hours later. Then, the patient started to have heavy menstruation. It had been longer and heavier than normal. Her gums were also bleeding. At the time of the report, the patient had not recovered. Upon internal review anaphylactic reaction was considered to be an other important medical event. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Eyelid oedema, Gingival bleeding, Menorrhagia
Clinical narrative: Information has been received from a 39 year old female consumer with penicillin allergy and no pertinent medical history, who on 03-May-2010 was vaccinated with a dose of MMR II (lot# 666293/1740Y). Concomitant therapy included INDERAL, NORVASC and DIOVAN. It was reported that the patient had an anaphylactic reaction after receiving MMR II vaccine. The patient could not breathe and swallow. She had puffy eyes, tasted metals and was very weak. The patient went to the emergency room in an ambulance but was released 5 hours later. Then, the patient started to have heavy menstruation. It had been longer and heavier than normal. Her gums were also bleeding. At the time of the report, the patient had not recovered. Upon internal review anaphylactic reaction was considered to be an other important medical event. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dry mouth, Dysphagia, Feeling hot, Paraesthesia, Pyrexia
Clinical narrative: Patient received H1N1 vaccination at the clinic following signed consent.  Following immunization at about 11:50 am she started complaining of feeling warm at about noon.  She was alert, oriented and without distress.  Vitals:  BP 130/80, T- 97 degrees F. Pulse and heart rate regular.  She rested and we observed her.  At 12:10 pm BP 130/80, HR 80, RR 18 and no distress.  At 12:20, vital signs the same, C/O tingling feeling on hands, on and off and started complaining of dry mouth.  Taken to rest in health office bed with legs elevated.  At this time, BP 150/100, respiration rate normal, verbal and alert.  Dr. was contacted.  Pt. compained of dry mouth, throat and difficulty swallowing.  Emergency medicine administered: Epinephrine and Benadryl as per protocol.  Emergency Medical Services was activated (911 was called, arrived and took over care.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Reported to ED with rash on 5/16/2010 to right side of neck and head that was there for about 1 week. Treated in ED with acyclovir.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Fatigue, Hypoaesthesia, Increased tendency to bruise, Migraine
Clinical narrative: Information has been received from a female consumer concerning her 12 year old daughter with allergic reaction to antibiotics (amoxicillin) and no pertinent medical history reported who received the first dose of GARDASIL vaccine "3 years ago", in approximately April 2007. It was reported that the patient had all three doses of GARDASIL vaccine (dates not specified). According to the reporter "2 and a half years ago", on approximately November 2007, the patient experienced temporary paralysis from the waist down, migraines for three months straight that progressively got worse. She was tired all the time and went from an active person to someone who could barely get out of bed. The patient also bruised easily, was shaky, sometimes had no feeling in her arms and legs and had high fevers. The consumer stated that the doctors said that "it was all in the patient's head". The patient was going to see a neurologist, possibly in July 2010. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. No diagnostic tests were performed. Upon internal review temporary paralysis from the waist down was determined to be another important medical event. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination, lot numbers, dates of events. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Paralysis, Pyrexia, Tremor
Clinical narrative: Information has been received from a female consumer concerning her 12 year old daughter with allergic reaction to antibiotics (amoxicillin) and no pertinent medical history reported who received the first dose of GARDASIL vaccine "3 years ago", in approximately April 2007. It was reported that the patient had all three doses of GARDASIL vaccine (dates not specified). According to the reporter "2 and a half years ago", on approximately November 2007, the patient experienced temporary paralysis from the waist down, migraines for three months straight that progressively got worse. She was tired all the time and went from an active person to someone who could barely get out of bed. The patient also bruised easily, was shaky, sometimes had no feeling in her arms and legs and had high fevers. The consumer stated that the doctors said that "it was all in the patient's head". The patient was going to see a neurologist, possibly in July 2010. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. No diagnostic tests were performed. Upon internal review temporary paralysis from the waist down was determined to be another important medical event. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination, lot numbers, dates of events. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Fainting episode 2 hours HPV.
Age: 0.55
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Rash, Rash erythematous
Clinical narrative: Had "red patchy rash on body's trunk" that lasted for 1 wk post onset .
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Skin warm
Clinical narrative: 4 inch long, 1 inch wide red, slightly warm, headache.
Age: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chills, Feeling cold, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Sharp shooting pains in the back of head & ear - numb & tingling feeling on left side of face. Experienced cold chills last night.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: 2 day history of bumps on legs and arms, itchy, using Calamine lotion and antibiotic cream at home. Added BENADRYL for itching.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Dermatitis infected, Rash erythematous, Rash pruritic, Scab
Clinical narrative: Rash started on legs then spread to arms then face. Some scabbed, some new, itchy and red. Placed on BACTROBAN and clindamycin as appeared superinfected. Approximately 6 weeks after VARIVAX given.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Feeling cold, Headache, Injection site erythema, Injection site pain
Clinical narrative: 5/19/10 - Fever/chills, not eating, sleepy, pain at site of injection, 1/4 size swelling, redness, headache. Body is warm from head to abdomen and cold from knees to toes. Inner thighs warm, outer thighs cold.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Pyrexia, Skin warm, Somnolence
Clinical narrative: 5/19/10 - Fever/chills, not eating, sleepy, pain at site of injection, 1/4 size swelling, redness, headache. Body is warm from head to abdomen and cold from knees to toes. Inner thighs warm, outer thighs cold.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid redness and swelling.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Body aches the day after TDAP administration.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Red, swollen arm, no constitutional symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Oral herpes
Clinical narrative: 5/15/10 Patient received ZOSTAVAX and 5/20/10 patient called stating she has a "red bump" and itching at injection site, also patient had developed a cold sore which she indicated was bothersome.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Anaphylactic reaction, Face oedema, Urticaria, Wheezing
Clinical narrative: Vaccines administered at 11:00 a.m. Child returned at 12:15 with facial edema, urticaria, and wheezing c/w anaphylactic rxn. Sent to ER. for immediate care.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site warmth, Irritability
Clinical narrative: On 5/19, the day after the vaccine, he developed a warm, erythematous area around the injection sites. He was slightly irritable occasionally but otherwise fine - no fever, nausea, vomiting, diarrhea. He has been active, playful, normal appetite, intake and output. On exam, 10cm x 10cm area of rxn ( L ) ant. thigh.
Age: 0.76
Sex: M
Vaccine: HEP, PNC
Symptoms: Wrong drug administered
Clinical narrative: Incorrect immunization given.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Swelling
Clinical narrative: Raised half dollar sized area, red in center on 5-19-10 @ 10:AM. On 5-20-10 @ 6:30AM noticed seizure had enlarged to 4.5" x 3.5" of redness with blisters in center measuring 1"x 1".
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Culture stool, Decreased appetite, Diarrhoea, Irritability, Pyrexia
Clinical narrative: Received ROTATEQ vaccine on 5/12/10. Fever of 101.7 ( R ) and watery mustard yellow x 4 on 5/20/10. Seen in our office on 5/20/10. Stool sample sent to Lab for Rotazyme and stool culture. /Patient also with decreased appetite cranky & sleepy.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Somnolence
Clinical narrative: Received ROTATEQ vaccine on 5/12/10. Fever of 101.7 ( R ) and watery mustard yellow x 4 on 5/20/10. Seen in our office on 5/20/10. Stool sample sent to Lab for Rotazyme and stool culture. /Patient also with decreased appetite cranky & sleepy.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Faeces discoloured, Hypersomnia, Irritability
Clinical narrative: 5/13/10-watery, loose stools x 4, 5/14/10 x 9 stools diarrhea-seen at site 5/14/10 - stool was + pos. for occult blood. 5/15/10 - 5/16/10 3-4 per day green watery stools. Seen in office 5/18/10 with increased spitting. Seen 5/20/10 with increased sleeping, fussy and fever 99.7 ( R ). Labs for stool culture/Rotavirus 5/19/10 to Lab.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Occult blood positive, Pyrexia, Rotavirus test
Clinical narrative: 5/13/10-watery, loose stools x 4, 5/14/10 x 9 stools diarrhea-seen at site 5/14/10 - stool was + pos. for occult blood. 5/15/10 - 5/16/10 3-4 per day green watery stools. Seen in office 5/18/10 with increased spitting. Seen 5/20/10 with increased sleeping, fussy and fever 99.7 ( R ). Labs for stool culture/Rotavirus 5/19/10 to Lab.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling of ( L ) arm, erythema of ( L ) arm.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Dyspnoea, Infectious mononucleosis, Influenza like illness, Nausea
Clinical narrative: Patient received dose #1 GARDASIL on 10/29/9 - mother stated pt had flu-like s/s for 2 days post injection, did not report such to our office until after 2nd immuz. On 12/29/2009 received 2nd GARDASIL injection (diagnosed with mononucleosis on 12/4/2009), developed CP, SOB, nausea, vomiting on 2/5/10. Seen by Dr (cardiologist) dx with pericarditis, placed on ibuprofen 800 mg PO TID and taken out of sports, spoke to mother on 2/10/10 - Patient better, mother convinced recurrent s/s related to adverse effect from #2 GARDASIL.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pericarditis, Vomiting
Clinical narrative: Patient received dose #1 GARDASIL on 10/29/9 - mother stated pt had flu-like s/s for 2 days post injection, did not report such to our office until after 2nd immuz. On 12/29/2009 received 2nd GARDASIL injection (diagnosed with mononucleosis on 12/4/2009), developed CP, SOB, nausea, vomiting on 2/5/10. Seen by Dr (cardiologist) dx with pericarditis, placed on ibuprofen 800 mg PO TID and taken out of sports, spoke to mother on 2/10/10 - Patient better, mother convinced recurrent s/s related to adverse effect from #2 GARDASIL.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Chest pain, Condition aggravated, Dyspnoea, Infectious mononucleosis
Clinical narrative: Patient received dose #1 GARDASIL on 10/29/9 - mother stated pt had flu-like s/s for 2 days post injection, did not report such to our office until after 2nd immuz. On 12/29/2009 received 2nd GARDASIL injection (diagnosed with mononucleosis on 12/4/2009), developed CP, SOB, nausea, vomiting on 2/5/10. Seen by Dr (cardiologist) dx with pericarditis, placed on ibuprofen 800 mg PO TID and taken out of sports, spoke to mother on 2/10/10 - Patient better, mother convinced recurrent s/s related to adverse effect from #2 GARDASIL.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Influenza like illness, Nausea, Pericarditis, Vomiting
Clinical narrative: Patient received dose #1 GARDASIL on 10/29/9 - mother stated pt had flu-like s/s for 2 days post injection, did not report such to our office until after 2nd immuz. On 12/29/2009 received 2nd GARDASIL injection (diagnosed with mononucleosis on 12/4/2009), developed CP, SOB, nausea, vomiting on 2/5/10. Seen by Dr (cardiologist) dx with pericarditis, placed on ibuprofen 800 mg PO TID and taken out of sports, spoke to mother on 2/10/10 - Patient better, mother convinced recurrent s/s related to adverse effect from #2 GARDASIL.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythema, redness at site of injection extending 6" x 3" of right upper arm 24 hours after vaccine administration.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: PT. PRESENTED TO HEALTH DEPT. ON 05/20/2010 @ 11AM WITH C/O PAIN AT DISTAL END OF LEFT DELTOID. PT STATED THAT IT HAS HURT SINCE RECEIVING THE VACCINE. SITE BECAME RED AND SWOLLEN, LASTING A FEW DAYS, AND SHE WAS UNABLE TO SLEEP ON HER LEFT SIDE DUE TO PAIN. SWELLING HAS SINCE RESOLVED BUT PAIN REMAINS. PAIN IS NOT CONSTANT BUT IS PAINFUL TO TOUCH. SITE APPEARS CLEAR, NOT RED OR SWOLLEN.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Adverse reaction, Malaise, Oropharyngeal pain, Pruritus generalised
Clinical narrative: I had sore throat, malaise and mild fever about 4 hours after the shot. This lasted for 3 days. On the 4th day post vaccine shot, I had generalized itchiness on my trunk. Scratching on it made me realize 2 days later that I had developed generalized and countless irregularly shaped vesicular rashes roughly measuring 1cm by 0.5 cm each)including multiple erythematous "office-needle" head sized (kind of papular) rashes as well. The vesicular rashes were in some kind of evolution and some of them were drying up and forming scabs and scales. I reported to my doctors office on 05/13/2010. The doctor explained that it was an adverse reaction and said to stay away from work for 5 days. I did not receive any treatment but was told to get some antihistamines for the itching. These rashes have persisted till date and new ones are forming. I have for the past 2 days used Bond medicated powder on my skin before sleep and they appear to be helping but new rashes are coming out and I have been missing work and losing money.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: I had sore throat, malaise and mild fever about 4 hours after the shot. This lasted for 3 days. On the 4th day post vaccine shot, I had generalized itchiness on my trunk. Scratching on it made me realize 2 days later that I had developed generalized and countless irregularly shaped vesicular rashes roughly measuring 1cm by 0.5 cm each)including multiple erythematous "office-needle" head sized (kind of papular) rashes as well. The vesicular rashes were in some kind of evolution and some of them were drying up and forming scabs and scales. I reported to my doctors office on 05/13/2010. The doctor explained that it was an adverse reaction and said to stay away from work for 5 days. I did not receive any treatment but was told to get some antihistamines for the itching. These rashes have persisted till date and new ones are forming. I have for the past 2 days used Bond medicated powder on my skin before sleep and they appear to be helping but new rashes are coming out and I have been missing work and losing money.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Epstein-Barr virus antibody positive, Lymphadenopathy, Skin papilloma
Clinical narrative: After 3rd Gardasil shot had swollen lymph under arm then got a planters wart on foot had it removed then both lymph nodes in throat swelled took blood work many times showing lymphs high and then found Epstein Barr after 4th bloodwork.
Age: 10.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Expired drug administered
Clinical narrative: Vaccine administered expired March 19, 2010; this was discovered after injection.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Muscular weakness, Pain, Pruritus
Clinical narrative: Swelling on left shoulder approx twice the normal size by 0500 the next morning 19May2010.  Itchy feeling, and moderate pain, and muscle weakness.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: PT EXPERIENCED NAUSEA AND VOMITING DAY OF VACCINATION AND HAD DIARRHEA NAUSEA AND VOMITING THE DAY AFTER
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Per mother's report, client had injection site pain x 2 days following vaccination, followed by 2 days pain free. 5 days following vaccination, client began to have arm pain. By day 8 following vaccination, client's arm was red, swollen and warm to the touch from collarbone to wrist and into her fingers. On day 9 following vaccination, client was seen by physician on call for Dr' (other Dr. is her PCP) and was diagnosed with cellulitis. She was prescribed Bactrim x 10 days at that time. She has had some decrease in symptoms since starting antibiotics.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Urine analysis normal
Clinical narrative: Per mother's report, client had injection site pain x 2 days following vaccination, followed by 2 days pain free. 5 days following vaccination, client began to have arm pain. By day 8 following vaccination, client's arm was red, swollen and warm to the touch from collarbone to wrist and into her fingers. On day 9 following vaccination, client was seen by physician on call for Dr' (other Dr. is her PCP) and was diagnosed with cellulitis. She was prescribed Bactrim x 10 days at that time. She has had some decrease in symptoms since starting antibiotics.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody negative, Arthralgia, Blood count normal, Borrelia test negative, C-reactive protein normal
Clinical narrative: On Day 11 after the MMR shot, my neck lymph nodes got enlarged and painful. Shortly after, I got a mild rash. This didn't concern me too much. However, since 05/01/2010 - currently, I've been experiencing severe arthritis issues in all joints (fingers, wrists, feet, knees). I was given prednisone by my PCP for 10 days which helped, however, I have fluids accumulated in my joints (especially my left knee), it's still swollen. I've been limping for the past 3 weeks, due to swelling and pain / discomfort, not able to bend my knee or do much of any activities. There has not been any injury of any kind. I understand that especially women often have these side effects (painful and swollen joints - rubella part of the vaccine), based on the research I did.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Gait disturbance, Joint swelling, Lymph node pain, Lymphadenopathy, Rash
Clinical narrative: On Day 11 after the MMR shot, my neck lymph nodes got enlarged and painful. Shortly after, I got a mild rash. This didn't concern me too much. However, since 05/01/2010 - currently, I've been experiencing severe arthritis issues in all joints (fingers, wrists, feet, knees). I was given prednisone by my PCP for 10 days which helped, however, I have fluids accumulated in my joints (especially my left knee), it's still swollen. I've been limping for the past 3 weeks, due to swelling and pain / discomfort, not able to bend my knee or do much of any activities. There has not been any injury of any kind. I understand that especially women often have these side effects (painful and swollen joints - rubella part of the vaccine), based on the research I did.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Rheumatoid factor negative
Clinical narrative: On Day 11 after the MMR shot, my neck lymph nodes got enlarged and painful. Shortly after, I got a mild rash. This didn't concern me too much. However, since 05/01/2010 - currently, I've been experiencing severe arthritis issues in all joints (fingers, wrists, feet, knees). I was given prednisone by my PCP for 10 days which helped, however, I have fluids accumulated in my joints (especially my left knee), it's still swollen. I've been limping for the past 3 weeks, due to swelling and pain / discomfort, not able to bend my knee or do much of any activities. There has not been any injury of any kind. I understand that especially women often have these side effects (painful and swollen joints - rubella part of the vaccine), based on the research I did.
Age: 29.0
Sex: M
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Erythema at site, pruritic rash at site.
Age: 58.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: Arthritic pain in one hand occurring intermittently over two weeks, sufficient at night to affect sleep. No other symptoms. Resolved completely after two weeks.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Acute/violent emesis four times and watery, non-bloody diarrhea.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Chills, Epistaxis, Pyrexia, Sensation of heaviness
Clinical narrative: HIGH FEVER 101.4, HEAVINESS/WEAKNESS, CHILLS, BLOODY NOSE (AWOKE). ALL SYMPTOMS DISAPPEARED WITHIN 24 HOURS.
Age: 1.24
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration (7 - 8mm in diameter) and erythema adjacent to injection site on R thigh.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Bronchospasm, Chest discomfort, Dizziness exertional, Dyspnoea, Exercise tolerance decreased
Clinical narrative: On 11/5/09 received HPV#1, MCV4, Tdap, FluMist. On 11/10/09 experienced hard time catching breath, chest tightness, and dizziness while doing a long distance run.  Dx with bronchspasm on 11/16/09. Given Proventil inhaler for excercise induced bronchospasm. Continued to complain of fatigue and reduced endurance during endurance sport activities. Got HPV#2 on 1/7/10 with no problems.  Got HPV#3 5/6/10. On 5/17/10 at 10:00AM experienced itchy, full body rash which was red blotchy raised with small welts.  Took Benadryl the rest of the day and night.  The next morning at 7:00 the rach was mostly gone.  Continues to be fatigued.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Fatigue, Pruritus, Rash generalised, Rash macular, Rash papular
Clinical narrative: On 11/5/09 received HPV#1, MCV4, Tdap, FluMist. On 11/10/09 experienced hard time catching breath, chest tightness, and dizziness while doing a long distance run.  Dx with bronchspasm on 11/16/09. Given Proventil inhaler for excercise induced bronchospasm. Continued to complain of fatigue and reduced endurance during endurance sport activities. Got HPV#2 on 1/7/10 with no problems.  Got HPV#3 5/6/10. On 5/17/10 at 10:00AM experienced itchy, full body rash which was red blotchy raised with small welts.  Took Benadryl the rest of the day and night.  The next morning at 7:00 the rach was mostly gone.  Continues to be fatigued.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: On 11/5/09 received HPV#1, MCV4, Tdap, FluMist. On 11/10/09 experienced hard time catching breath, chest tightness, and dizziness while doing a long distance run.  Dx with bronchspasm on 11/16/09. Given Proventil inhaler for excercise induced bronchospasm. Continued to complain of fatigue and reduced endurance during endurance sport activities. Got HPV#2 on 1/7/10 with no problems.  Got HPV#3 5/6/10. On 5/17/10 at 10:00AM experienced itchy, full body rash which was red blotchy raised with small welts.  Took Benadryl the rest of the day and night.  The next morning at 7:00 the rach was mostly gone.  Continues to be fatigued.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Pruritus, Similar reaction on previous exposure to drug, Urticaria
Clinical narrative: Patient called the Immunization Clinic from her work and approximately 12:45 on 4/27/2010 and stated that around 11:00 that morning she began to feel "itchy" all over.  Pt. states she looked down at her lower arms and noted hives on her left arm.  Pt stated she continued to feel itchy and took Benadryl 25 mg by mouth at approximately 11:05 and noted the hives had spread to the right lower arm.  Patient denied nausea, dysphagia, dyspnea, edema of face/hands, or feeling of impending doom.  Patient sounded alert and oriented to time, place, and person.  Pt was instructed to go to the emergency room.  Patient stated she really didn't want to.  Patient stated this had happened before with a flu shot and she took Benadryl 25 mg every 4 to 6 hours for 72 hours and she felt fine.  She stated she planned on doing that this time too.  Patient was strongly encouraged to go to the nearest E.R. and was intructed on the symptoms, treatment and outcome of anaphylaxis.  Patient verbalized understanding of all information and stated she would go in if it got any worse. Patient again instructed on the importance of seeking medical help and also following up with her primary care provider to see if she needed to get a referral to an allergist for evaluation.  Patient instructed she was not to receive any more immunizations until she saw her medical provider.
Age: 57.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Abdominal pain, Dehydration, Diarrhoea, Headache, Nausea
Clinical narrative: Initally nausea then fever and headache followed a day later by abdominal cramps and diarrhea with dehydration.
Age: 57.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Initally nausea then fever and headache followed a day later by abdominal cramps and diarrhea with dehydration.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 7cm x 3 1/2 NMO red minimally indurated not around.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 7cm x 3 1/2 NMO red minimally indurated not around.
Age: 1.12
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blood immunoglobulin A, Blood immunoglobulin E, Dehydration, Diarrhoea, Differential white blood cell count
Clinical narrative: Mother states fever up to 103.8 off & on from Tues to Sat 5-11 -> 5/15 states started within 36 hrs after vaccine; developed rash (faint pink) on Thurs 5/13; developed diarrhea & dehydration on Thurs.
Age: 1.12
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Full blood count, Laboratory test, Pyrexia, Rash erythematous
Clinical narrative: Mother states fever up to 103.8 off & on from Tues to Sat 5-11 -> 5/15 states started within 36 hrs after vaccine; developed rash (faint pink) on Thurs 5/13; developed diarrhea & dehydration on Thurs.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Pruritus, Rash, Urticaria
Clinical narrative: Initial report was received on 29 September 2009 from a health care professional which involved a cluster of two patients. The second patient has been captured in case number 2009-04130. An 81-year-old male patient who had been taking PLAVIX, baby aspirin and an unspecified blood pressure medication concomitantly, had received a first dose left arm injection (route not reported) of FLUZONE SV 2009-2010, lot number U3199AA on 25 September 2009 at 2:00 PM, and an unspecified amount of time later on the day of vaccination, he experienced "quite a bit of bleeding at the injection site and down the arm". He also developed itching at the injection site and at the neck area. The patient had no concurrent illness, and two weeks prior to vaccination, he had nose surgery performed. The event did not require a doctor's visit and relevant laboratory and diagnostic testing was reported as "none". At the time of the report, the patient's recovery status was unknown. Follow-up information received on 20 October 2009 from a health care professional. FLUZONE SV 2009-2010 had been administered intramuscularly (arm). According to the reporter, the patient was not one of their regular patients and the name of the blood pressure medication the patient had been taking concomitantly was unknown. Symptoms began within 24 hours after vaccination. The reporter noted that the patient was symptomatic when they presented (date not reported) and he was instructed to follow up with his physician to rule out infection if the symptoms persisted for another 48 hours. According to the reporter, the etiology, diagnosis, event duration and the patient's recovery status were all unknown. Follow-up information was received on 10 May 2010 from a patient. Upon receipt of this information it was determined that the case meets seriousness criteria and it has been upgraded to serious. The patient stated the injection site itching and neck itching onset was at 3:00 PM 25 September 2009 and lasted about one week. He indicated that there was no "bleeding" at the injection site and down the arm, as was previously reported, but an additional event of rash was reported. He also stated that "6 months after", he developed hives "over open body" and was hospitalized twice on unspecified dates. The physician discontinued all medications and it took two months for the hives to go away. The patient recovered on an unspecified date. The reporter for this case is the same as case numbers 2009-04130 and 2009-04131. Documents held by sender: none.