chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 02-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. In February 2013 (sometime last week), the patient developed naturally occurring shingles (wild-type). A couple days later she visited a clinic and a nurse practitioner administered a dose of ZOSTAVAX to her and prescribed an unspecified antiviral medication. At an unspecified time after vaccination the patient's shingles symptoms worsened. It is unspecified if the patient started taking the antiviral medication. Physician refused to provide further information on the patient and the specific symptoms. The outcome of the event was reported as not recovered. The relatedness of the event with ZOSTAVAX was not provided. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 years old female patient. There was no medical history, drug reactions/allergies. On 15-JAN-2013, the patient was vaccinated with ZOSTAVAX (lot # H018799; exp. date: 15-JAN-2014), (dose and route not reported). No other co-suspects were reported. Concomitant therapy included ascorbic acid, cyanocobalamin, ferrous fumarate, FERROGELS FORTE, acetaminophen, butalbital, FIORICET, amitriptyline hydrochloride (manufacturer unknown) and MAXALT. In January 2013 a couple of days after the administration of ZOSTAVAX, the patient experienced what seems to be nerve pain from her lower back down to the tips of her toes, a couple of days after administration of ZOSTAVAX. The patient went away within the last several days. The patient sought medical attention. No treatment was given for the event. On an unknown date, the patient recovered from the event. The relatedness of the event with ZOSTAVAX was not provided. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Initial information has been received from a physician via field representative concerning her father, a 71 years old male patient with an unspecified pertinent medical history or drug reactions/allergies. On an unspecified date of October 2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unspecified date in December 2012 the patient developed shingles. The rash presented along the thoracic dermatome. The patient was treated with anti-viral medication and on an unspecified date, the patient recovered. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Injection site swelling, Myalgia, Nausea
Clinical narrative: Swelling of arm about 4 inches below injection site. Followed by joint and muscle aches. Fatigue, nausea lasting about 12 hours, then only the swelling and tender to touch lasting for 3 or more days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling of arm about 4 inches below injection site. Followed by joint and muscle aches. Fatigue, nausea lasting about 12 hours, then only the swelling and tender to touch lasting for 3 or more days.
Age: 1.42
Sex: F
Vaccine: FLUX, MMR
Symptoms: Crying, Irritability, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: Fever of 102.4 within 14 hours of vaccine.  Runny nose, fever continued for several days.  On 02/04/2013 viral rash covering entire body and fever of 101 and required Emergency Room visit.  Rash was visible for one week.  Change in child's disposition.  Very irritable, sleep disturbances and crying.
Age: 1.42
Sex: F
Vaccine: FLUX, MMR
Symptoms: Sleep disorder, Viral rash
Clinical narrative: Fever of 102.4 within 14 hours of vaccine.  Runny nose, fever continued for several days.  On 02/04/2013 viral rash covering entire body and fever of 101 and required Emergency Room visit.  Rash was visible for one week.  Change in child's disposition.  Very irritable, sleep disturbances and crying.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient returned to clinic with reports of redness and swelling at the site of injection, but also complained that she woke up with the swollen nodes. On exam, patient was noted to have very swollen and tender supraclavicular lymph nodes. Advised patient to treat symptomatically with cool compresses and ibuprofen and to follow-up with primary care physician for worsening symptoms or persistent swollen nodes.
Age: 56.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Blood creatine phosphokinase decreased, Neurological examination abnormal, Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: Tremors in hands extended to whole body. Neurologist recommended Clonazepam but patient could not tolerate it.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash erythematous
Clinical narrative: Symptoms: Tingling. Signs: Red rash. Time course: 2 days.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscular weakness
Clinical narrative: Weakness in both arms and legs, worse in arms then legs, has slowly resolved over 2 weeks.  Still some weakness in left arm (where vaccine was given) on 2/8.  Pt did call MD on 2/4/2013 but symptoms were resolving.  Came in 2/8/13 for reassurance.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Burning sensation, Chest discomfort, Dysphonia, Erythema
Clinical narrative: Hands and feet bright red, inflamed and swollen with severe burning and itching, joints, esp knees, birght red and swollen, face and upper chest red and flushed, hoarse voice, pressure on chest in back.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Inflammation, Joint swelling, Oedema peripheral, Pruritus
Clinical narrative: Hands and feet bright red, inflamed and swollen with severe burning and itching, joints, esp knees, birght red and swollen, face and upper chest red and flushed, hoarse voice, pressure on chest in back.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: While patient was waiting after receiving her AFLURIA shot, approx 10 min she complained of a tingling to nose. I gave her some of BENADRYL and observed her another 5 min. She showed no signs of anaphylaxis (swelling, DIB) I asked patient if she wanted an ambulance, she declined and said she would proceed to Emerg. on her own across the street from our pharmacy. The Dr. called me 10 min later said they gave her an EPIPEN & steroids no other signs of anaphylaxis and would be releasing her.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 8 cm x 5 cm erythematous, edematous area on (L) thigh area started 2/8/13.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Left arm is swollen and red, 48 hrs. post vaccination, site of redness seems to have grown, painful - has increased since day of administration.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Throat irritation, Tic
Clinical narrative: Vocal tic (repeated word and throat clearing) numerous times a day (approximately 75-100) every day.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal distension, Intussusception, Irritability, Somnolence, Ultrasound abdomen abnormal
Clinical narrative: Pt with sleepiness, fussy, abd distention and vomiting.  Diagnosed 2/9/13 with intussuception.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Pt with sleepiness, fussy, abd distention and vomiting.  Diagnosed 2/9/13 with intussuception.
Age: 59.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Dysphagia, Hypoaesthesia
Clinical narrative: Pt began c/o facial numbness and difficulty swallowing.  Pt sent to ER immediately.  Symptoms began to wane on own in ER, and no epinephrine was administered.  Pt was d/c'd from ER within 30 mins without requiring treatment.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Burning sensation, Chest pain, Erythema, Insomnia
Clinical narrative: Burning, under right arm down right side from shoulder blade to chest. I have burning inside, with no breakout of rash. There is swelling of the area, and when I get out of a hot shower you can see a slight redness and outline of the painful area. The pain is steady and strong and I have trouble sleeping and miss work. My pain is most severe where my arm hits my side and hurts when I breath.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Nerve compression, Pain, Swelling
Clinical narrative: Burning, under right arm down right side from shoulder blade to chest. I have burning inside, with no breakout of rash. There is swelling of the area, and when I get out of a hot shower you can see a slight redness and outline of the painful area. The pain is steady and strong and I have trouble sleeping and miss work. My pain is most severe where my arm hits my side and hurts when I breath.
Age: 26.0
Sex: M
Vaccine: IPV, MMR, TDAP
Symptoms: Dizziness, Pallor, Tonic clonic movements, Urinary incontinence
Clinical narrative: Patient became faint and pale. About 2 minutes later, after patient was seated, patient began have tonic clonic type activity and became incontinent of urine. Lasted about 30 seconds. About 5 minutes later patient had a similar episode that also lasted about 30 seconds. Patient became alert after both episodes and was able to answer questions appropriately.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Very high fever developed within hours of vaccine, no previous sign of illness, no other symptoms developed other than fever.  Highest recorded temp 105.5, fever lasted 4 days.
Age: 29.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Tenderness
Clinical narrative: I woke up with acute pain at the injection site and radiating from the shoulder to elbow. It was extremely painful to use my arm or even touch it. My left arm, where the injection site took place, was nearly immobilized by the pain. I went to an urgent care facility and was prescribed hi-dose naproxen and to use a cold compress. After 24 hours the pain lessened, but was still severe. I returned to my primary care doctor, who prescribed antibiotics in case of infection, which were not effective. Over time the pain gradually subsided, but I still have daily pain (to a much lesser degree) at the injection site 4 months later.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Cheilitis, Lip swelling, Paraesthesia oral
Clinical narrative: Swollen lips. Bumps on lips. Tingling lips. Treatment was a shot of allergy medication.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspepsia, Headache, Pain, Rash
Clinical narrative: Day of immunization - mild aches pains/headache - took Advil and went to bed. Next day - rash/hives - tried treating with Claritin which helped for 36 hours; then awoke with severe hives & heartburn & mild chest pain - went to ER - treated with Zyrtec, Prednisone 40mg then 20mg every day for 5 days; Pepcid for heartburn.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Day of immunization - mild aches pains/headache - took Advil and went to bed. Next day - rash/hives - tried treating with Claritin which helped for 36 hours; then awoke with severe hives & heartburn & mild chest pain - went to ER - treated with Zyrtec, Prednisone 40mg then 20mg every day for 5 days; Pepcid for heartburn.
Age: 0.58
Sex: M
Vaccine: DTAP, HEP, OPV, PPV, RVX
Symptoms: Crying, Diet refusal, Insomnia, Irritability, Mucous stools
Clinical narrative: Started as fussy, low fever and would not eat. Progressed to screaming crying for hours, didn't sleep for 13 hrs straight, mucus in stool, fever of 103 at one point for a few mins but went down to 101.5  This lasted ALL DAY AND NIGHT Friday and Saturday. Sunday started feeling much better, almost back to normal.
Age: 0.58
Sex: M
Vaccine: DTAP, HEP, OPV, PPV, RVX
Symptoms: Pyrexia, Screaming
Clinical narrative: Started as fussy, low fever and would not eat. Progressed to screaming crying for hours, didn't sleep for 13 hrs straight, mucus in stool, fever of 103 at one point for a few mins but went down to 101.5  This lasted ALL DAY AND NIGHT Friday and Saturday. Sunday started feeling much better, almost back to normal.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Anxiety, Asthenia, Dizziness, Hypoaesthesia, Presyncope
Clinical narrative: Subjective dizziness, weakness, numbness with normal vital signs and physical exam throughout.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Chest X-ray, Cyanosis, Electrocardiogram, Influenza virus test, Lethargy
Clinical narrative: Child screamed a high pitched squeal, went pale and then a gray/blue color.  Was lethargic and glazed over eyes, slow breathing.  Called 9-1-1.  Took child to Hospital--and they performed every test to rule out everything.  (Episode happened again while in Emergency room.)  Monitored for 2 days in hospital with cause documented as reaction to immunization shots.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Pallor, Respiratory rate decreased, Respiratory syncytial virus test, Screaming, Sleep study
Clinical narrative: Child screamed a high pitched squeal, went pale and then a gray/blue color.  Was lethargic and glazed over eyes, slow breathing.  Called 9-1-1.  Took child to Hospital--and they performed every test to rule out everything.  (Episode happened again while in Emergency room.)  Monitored for 2 days in hospital with cause documented as reaction to immunization shots.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Staring
Clinical narrative: Child screamed a high pitched squeal, went pale and then a gray/blue color.  Was lethargic and glazed over eyes, slow breathing.  Called 9-1-1.  Took child to Hospital--and they performed every test to rule out everything.  (Episode happened again while in Emergency room.)  Monitored for 2 days in hospital with cause documented as reaction to immunization shots.
Age: 80.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms aching joints, weakness, muscle aches, mild head ache. Felt like I had aged 10 years.  Went back to clinic.  No treatment. A/o 2/10/13 above systoms still persist.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. came in to walgreens pharmacy on 2/9 at 4 pm complaining of redness/discomfort at the injection site. Upon inspection of site, possible cellulitis (redness, swelling, warm to touch approx 3-4" diam.)
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site pain, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Dr stated that the patient experienced mild muscle aches after receiving the flu sot on 1/19/13. The aches were relieved 24-36 hours later. She also experienced a mild temperature of 99.7 degrees F & had a sore deltoid muscle where the vaccine was administered. The Dr then stated that after consulting her notes, the patient's sore arm felt better after a couple of weeks, then began to hurt again. She saw the Dr on 2/1/13 w/ limited range of motion & terrible arm pain requiring pain medication (unknown what kind) & NSAIDS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 60-year-old female patient regarding herself. On an unknown date in October 2009 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported) subcutaneously. On an unknown date in February 2012 the patient got the shingles after getting ZOSTAVAX. She stated it was on her left side, jaw to ear, almost to her eye. The outcome of the reported event was unknown. No laboratory diagnostic studies were performed. The patient sought an unspecified medical attention for the event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 2 patients of unknown. On an unknown date the 2 patients were vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX23 (lot # 0709AE, expiry date on 04-JAN-2014) in the arm. With 24 hours after vaccination, the 2 patients experienced redness and swelling of arm at the injection site, fever and nausea. Action taken regarding PNEUMOVAX23 was not reported. The outcome of all events is unknown. The 2 patients sought unspecified medical attention. The relationship between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Blister, Condition aggravated, Eczema, Injection site pruritus, Pruritus
Clinical narrative: This 51 year old male received 9 Anthrax (AVA) vaccinations: 1/29/2000 (FAV031), 2/10/2000 (FAV031), 2/27/2000 (FAV031), 1/4/2003 (FAV066), 8/12/2003 (FAV076), 6/5/2004 (FAV083), 4/27/2009 (FAV164), 1/21/2011 (FAV265), and 1/26/2012 (FAV305). He remembers after receipt of 2000 through 2009 AVA vaccinations the injection site and deltoid muscle was sore and red for a few days and resolved spontaneously without treatment. No medical care was sought. However about 24 hours after receipt of 1/21/2011 AVA vaccine [#8] and influenza (SP U3788AA) he reported an itchy fluid filled bump to webbing between right index and middle finger. He took some clippers and clipped it off and treated with antibiotic ointment and band-aid. Later that day this area had a flat red itchy macular "rash"/patch that took 2-3 weeks to resolve treating with topical hydrocortisone cream. He denied any exposure to new soaps, detergents, bandages, adhesives, foods, paints, etc. Approximately 1 month later, this same red itchy macular rash returned to posterior right elbow (about 2 inch oval diameter) that extended toward his wrist. This rash lasted about 2-3 months treating with hydrocortisone cream. His next episode was to RLQ anterior hip just above waist band a few months later. He self treated. He ultimately sought medical care for this selective one site rash outbreak with PCP (date unknown) and given oral prednisone with full resolution of rash. He remembers the next outbreak being in July 2011 while out of the country with rash to right side of neck (similar appearance). He was wearing a gold chain and removed. He reports being seen by providers and given topical cream with diagnosis of eczema. On 1/26/2012 he received Tdap (SP C3941AA) and AVA #9 vaccine. He reported about 24 hours later this AVA vaccination site was painful (5/10), red, swollen (1-2x larger than prior vaccinations) to include entire deltoid muscle and it itched. On 2/18/2012 he presented to medical with rash x 7 days to right elbow and ribs. Providers to 2/18/2012 described "red raised macular rash 2 cm diameter to right flank and axillary line at level of nipple with 1 cm diameter rash on right elbow". He was treated with topical steroid cream. On 2/24/2012 providers document this rash "persisted to bilateral elbows and right flank" and was given 6 day course of oral steroids. Symptoms fully resolved by 2/28/2012. His rash returned in June/July 2012 to right waist and has been there for 6 months. He received annual influenza vaccine 10/13/2012 without any change in rash site or other adverse reactions. Patient is due for annual AVA booster in Jan 2013 and is requesting exemption due to this rash.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Rash generalised, Rash macular, Rash pruritic, Vaccination site erythema, Vaccination site pain
Clinical narrative: This 51 year old male received 9 Anthrax (AVA) vaccinations: 1/29/2000 (FAV031), 2/10/2000 (FAV031), 2/27/2000 (FAV031), 1/4/2003 (FAV066), 8/12/2003 (FAV076), 6/5/2004 (FAV083), 4/27/2009 (FAV164), 1/21/2011 (FAV265), and 1/26/2012 (FAV305). He remembers after receipt of 2000 through 2009 AVA vaccinations the injection site and deltoid muscle was sore and red for a few days and resolved spontaneously without treatment. No medical care was sought. However about 24 hours after receipt of 1/21/2011 AVA vaccine [#8] and influenza (SP U3788AA) he reported an itchy fluid filled bump to webbing between right index and middle finger. He took some clippers and clipped it off and treated with antibiotic ointment and band-aid. Later that day this area had a flat red itchy macular "rash"/patch that took 2-3 weeks to resolve treating with topical hydrocortisone cream. He denied any exposure to new soaps, detergents, bandages, adhesives, foods, paints, etc. Approximately 1 month later, this same red itchy macular rash returned to posterior right elbow (about 2 inch oval diameter) that extended toward his wrist. This rash lasted about 2-3 months treating with hydrocortisone cream. His next episode was to RLQ anterior hip just above waist band a few months later. He self treated. He ultimately sought medical care for this selective one site rash outbreak with PCP (date unknown) and given oral prednisone with full resolution of rash. He remembers the next outbreak being in July 2011 while out of the country with rash to right side of neck (similar appearance). He was wearing a gold chain and removed. He reports being seen by providers and given topical cream with diagnosis of eczema. On 1/26/2012 he received Tdap (SP C3941AA) and AVA #9 vaccine. He reported about 24 hours later this AVA vaccination site was painful (5/10), red, swollen (1-2x larger than prior vaccinations) to include entire deltoid muscle and it itched. On 2/18/2012 he presented to medical with rash x 7 days to right elbow and ribs. Providers to 2/18/2012 described "red raised macular rash 2 cm diameter to right flank and axillary line at level of nipple with 1 cm diameter rash on right elbow". He was treated with topical steroid cream. On 2/24/2012 providers document this rash "persisted to bilateral elbows and right flank" and was given 6 day course of oral steroids. Symptoms fully resolved by 2/28/2012. His rash returned in June/July 2012 to right waist and has been there for 6 months. He received annual influenza vaccine 10/13/2012 without any change in rash site or other adverse reactions. Patient is due for annual AVA booster in Jan 2013 and is requesting exemption due to this rash.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccination site swelling
Clinical narrative: This 51 year old male received 9 Anthrax (AVA) vaccinations: 1/29/2000 (FAV031), 2/10/2000 (FAV031), 2/27/2000 (FAV031), 1/4/2003 (FAV066), 8/12/2003 (FAV076), 6/5/2004 (FAV083), 4/27/2009 (FAV164), 1/21/2011 (FAV265), and 1/26/2012 (FAV305). He remembers after receipt of 2000 through 2009 AVA vaccinations the injection site and deltoid muscle was sore and red for a few days and resolved spontaneously without treatment. No medical care was sought. However about 24 hours after receipt of 1/21/2011 AVA vaccine [#8] and influenza (SP U3788AA) he reported an itchy fluid filled bump to webbing between right index and middle finger. He took some clippers and clipped it off and treated with antibiotic ointment and band-aid. Later that day this area had a flat red itchy macular "rash"/patch that took 2-3 weeks to resolve treating with topical hydrocortisone cream. He denied any exposure to new soaps, detergents, bandages, adhesives, foods, paints, etc. Approximately 1 month later, this same red itchy macular rash returned to posterior right elbow (about 2 inch oval diameter) that extended toward his wrist. This rash lasted about 2-3 months treating with hydrocortisone cream. His next episode was to RLQ anterior hip just above waist band a few months later. He self treated. He ultimately sought medical care for this selective one site rash outbreak with PCP (date unknown) and given oral prednisone with full resolution of rash. He remembers the next outbreak being in July 2011 while out of the country with rash to right side of neck (similar appearance). He was wearing a gold chain and removed. He reports being seen by providers and given topical cream with diagnosis of eczema. On 1/26/2012 he received Tdap (SP C3941AA) and AVA #9 vaccine. He reported about 24 hours later this AVA vaccination site was painful (5/10), red, swollen (1-2x larger than prior vaccinations) to include entire deltoid muscle and it itched. On 2/18/2012 he presented to medical with rash x 7 days to right elbow and ribs. Providers to 2/18/2012 described "red raised macular rash 2 cm diameter to right flank and axillary line at level of nipple with 1 cm diameter rash on right elbow". He was treated with topical steroid cream. On 2/24/2012 providers document this rash "persisted to bilateral elbows and right flank" and was given 6 day course of oral steroids. Symptoms fully resolved by 2/28/2012. His rash returned in June/July 2012 to right waist and has been there for 6 months. He received annual influenza vaccine 10/13/2012 without any change in rash site or other adverse reactions. Patient is due for annual AVA booster in Jan 2013 and is requesting exemption due to this rash.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of hives in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included diabetes. On 17 October 2012 between 11:30 to 12:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, left deltoid). On 17 October 2012, less than a day after vaccination with FLULAVAL, the subject experienced "itching and hives all over her body". The subject self-treated with BENADRYL. The itching and hives "cleared up a little". At the time of reporting the events were improved. The nurse reported two cases of adverse experiences with FLULAVAL. See case A0998209A for details. The nurse expects the hives will come back once the BENADRYL wears off based on her experience with case A0998209A. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of hive in a 64-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 24 October 2012 the subject received a dose of FLULAVAL (.5 ml, unknown route, unknown arm). On 25 October 2012, 24 hours after vaccination with FLULAVAL the subject experienced hives, whole body hives and itching. The subject "did not take anything to treat the side effects and stated that she just tried not to scratch." The healthcare professional (nurse) considered the events to be probably related to vaccination with FLULAVAL. At the time of reporting the events were unresolved.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Injection was given in my shoulder. Continuous shoulder pain. Possible tendon damage at site of injection. Pain began upon injection & became increasingly severe requiring medical attention. To date, pain continues to persist, interfering & limiting daily activities. Injury requires on-going assessment.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Musculoskeletal pain
Clinical narrative: Injection was given in my shoulder. Continuous shoulder pain. Possible tendon damage at site of injection. Pain began upon injection & became increasingly severe requiring medical attention. To date, pain continues to persist, interfering & limiting daily activities. Injury requires on-going assessment.
Age: 1.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Blood test, Convulsion, Pyrexia, X-ray normal
Clinical narrative: Seizure and a Fever 102.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram normal, Headache
Clinical narrative: This study case was received from the investigator in the trial on 31 January 2013. A 21-year-old male subject had received the ACAM2000 (lot number, route and site not reported) on 14 January 2013. The subject had also received the following vaccinations in December 2012 on an unknown day: anthrax vaccine (manufacturer, lot number, route and site not reported) and influenza vaccine (manufacturer, lot number, route and site not reported). On 24 January 2013, the subject with a negative cardiac history and prednisone allergy presented with onset of constant chest pain, chest pressure, shortness of breath, and heart palpitations, all with the onset date of 16 January 2013 and ongoing, and all were considered possibly related by investigator. The chest pain felt "consolidated" in the middle of the chest and did not radiate. Nothing made the symptom better or worse. On the Wong-Baker FACES Pain Rating Scale, the subject reported a rating of 2 out of 5 for chest pain. The chest pressure was centralized and did not get better or worse and did not radiate. The subject also experienced headache on 14 January 2013 (possibly related), itching around the vaccine site on 18 January 2013 (very likely related), and swollen lymph node on left axilla vaccine side on 21 January 2013 (very likely related). These events were all ongoing. The subject was taking concomitant medications ibuprofen since 23 January 2013 for swollen lymph node and BENADRYL since 23 January 2013 for itching around vaccine site. The rapid and lab troponin and electrocardiogram (ECG) were normal on 24 January 2013. The subject did not feel like he had a cold or flu. The subject's outcome was not recovered. According to the investigator, the event of possible myopericarditis was considered possibly related to vaccination. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pruritus, Lymphadenopathy, Palpitations, Troponin normal
Clinical narrative: This study case was received from the investigator in the trial on 31 January 2013. A 21-year-old male subject had received the ACAM2000 (lot number, route and site not reported) on 14 January 2013. The subject had also received the following vaccinations in December 2012 on an unknown day: anthrax vaccine (manufacturer, lot number, route and site not reported) and influenza vaccine (manufacturer, lot number, route and site not reported). On 24 January 2013, the subject with a negative cardiac history and prednisone allergy presented with onset of constant chest pain, chest pressure, shortness of breath, and heart palpitations, all with the onset date of 16 January 2013 and ongoing, and all were considered possibly related by investigator. The chest pain felt "consolidated" in the middle of the chest and did not radiate. Nothing made the symptom better or worse. On the Wong-Baker FACES Pain Rating Scale, the subject reported a rating of 2 out of 5 for chest pain. The chest pressure was centralized and did not get better or worse and did not radiate. The subject also experienced headache on 14 January 2013 (possibly related), itching around the vaccine site on 18 January 2013 (very likely related), and swollen lymph node on left axilla vaccine side on 21 January 2013 (very likely related). These events were all ongoing. The subject was taking concomitant medications ibuprofen since 23 January 2013 for swollen lymph node and BENADRYL since 23 January 2013 for itching around vaccine site. The rapid and lab troponin and electrocardiogram (ECG) were normal on 24 January 2013. The subject did not feel like he had a cold or flu. The subject's outcome was not recovered. According to the investigator, the event of possible myopericarditis was considered possibly related to vaccination. Documents held by sender: None.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apparent life threatening event, Blood culture, Bordetella test, Full blood count, Gastrooesophageal reflux disease
Clinical narrative: ALTE - day of first immunizations. Oxygen. GERD medication.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lumbar puncture, Respiratory syncytial virus test, Urine analysis
Clinical narrative: ALTE - day of first immunizations. Oxygen. GERD medication.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous consumer report (initial receipt 28-Jan-2013) concerns a 47 year old male patient. On 17-Jan-2013, the patient received one injection of AFLURIA (batch 06949211A). On 26-Jan-2013, the patient developed Bell's Palsy. The patient's entire left side of his face is paralysed. The patient went to the ER (emergency room) and was treated with steroids and anti-virals. The event outcome was recovering.
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Fatigue, Myalgia, Pain, Sleep disorder
Clinical narrative: This consumer report (initial receipt 16-Jan-2013) concerns a female patient. The patient always received a flu shot in previous years and never had an issue. The patient was in perfect health prior to receiving this flu shot. In the fourth week of Nov-2012 the patient received AFLURIA (batch number not specified). After receiving the vaccine the patient felt extreme exhaustion and body and muscle aches that were severe enough to wake her up in the night. The patient stated that her pharmacist suspected that the symptoms were related to Guillain-Barre syndrome however her primary care physician did not suspect this. The patient received a full physical in Jan-2013 and had various unspecified blood work, the results of which did not reveal a possible diagnosis. No further information was provided. FUP (30-Jan-2013): After internal case review, events of extreme exhaustion, body and muscle aches, waking up in the night were changed from listed to unlisted with change in overall case listedness.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Erythema, Headache, Injection site pain
Clinical narrative: Developed pain at injection site, knot in arm, redness going down arm to elbow.  Also headache, nausea, joint aches, 101 fever, stomach cramps.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Nodule, Pyrexia
Clinical narrative: Developed pain at injection site, knot in arm, redness going down arm to elbow.  Also headache, nausea, joint aches, 101 fever, stomach cramps.
Age: 19.0
Sex: F
Vaccine: HEP, HPV4, TDAP
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt received three Vaccines. Hep B, HPV, and Tdap. These were given at approx. 3:30PM. She became lighted and diaphoretic. Placed on exam table, Bp was taken at 3:33 102/68, pulse 96. Continued to monitor. Unable to tolerate sitting position. Layed her back down Bp@ 3:50PM was 94/78, Pulse 98. ER called @ 4:00PM. Arrived in ER @4:00PM. Per Patient request Mother notified.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Large, 3 inch diameter area of induration and erythema, warm and tender to touch. Symptoms still present after 3 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Rednesss (approx. 3 inches X 3 inches), induration (approx. 4 inches X 6 inches), warmth, and severe itching.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives with itching and redness of face. Responded well to Benadryl dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Parent reported at 3:55 that patient with c/o right arm swollen and full feeling without redness.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Erythema, Feeling hot, Induration, Infection, Swelling
Clinical narrative: FEEL HARD HOT AND RED. SWELL LIKE GOLF BALL. MD SAID IT IS INFECTED.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: FEEL HARD HOT AND RED. SWELL LIKE GOLF BALL. MD SAID IT IS INFECTED.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Erythema, Feeling hot, Induration, Infection, Swelling
Clinical narrative: Site started itching and felt swollen, so checked site in mirror & saw it had a large (2-inch diameter) red mark just below injection site.  Began using hydro-cortisone cream & taking Benadryl capsules the next day.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site started itching and felt swollen, so checked site in mirror & saw it had a large (2-inch diameter) red mark just below injection site.  Began using hydro-cortisone cream & taking Benadryl capsules the next day.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Laboratory test, Rash macular, Swelling
Clinical narrative: Previous pnuemonia vaccination reported by client on consent. Client stated that at onset of adverse event, 2/6/2103 4:00 pm, she noticed at 3-4 inch diameter of redness below the injection site. Client stated that she took one Benadryl when she got home. When she woke up the next morning, 2/7/2013, she noticed redness and swelling half way down to elbow. At 3:00 pm, 2/7/13, her arm remained red and swollen. At this time she saw MD, who assessed the client and drew a line around the redness and swelling. Client was told that if the redness and swelling exceeded beyond the drawn line to see her doctor. At 3:20 pm, 2/7/2013, she left home and arrived at urgent care. At this point the redness and swelling had exceeded beyond the elbow. Client had lab tests drawn (unknown lab test per client. She received a prescription for Prednisone to take 2 times a day for three days (unknown dosage per client), and Cefadroxil 500 mg to take over ten days. As of today, 2/11/2013 the client stated that she has "blotching" to the area and that there has been improvement related to the adverse reaction. She had been advised to go to a follow-up appointment on 2/11/2013 as a result of the reaction and she did not go the appointment by personal choice.
Age: 1.75
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Hypersensitivity, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Patient's mother states child developed a fever on the evening of 2-6-13. She's not sure how high the fever was because her thermometer wasn't working. Mother said child developed an itchy rash during the day on 2-7-13 all over body. She brought child to Health Clinic. It was believed to be an allergic reaction and Prednisone was prescribed. Child took Prednisone for 3 days and it cleared the rash up.
Age: 42.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Arthralgia, Erythema, Fatigue, Myalgia, Swelling
Clinical narrative: Extreme tenderness, swelling, redness left arm since 24 hours after vaccination. Also, joint pain, muscle achiness, fatigue.
Age: 42.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Tenderness
Clinical narrative: Extreme tenderness, swelling, redness left arm since 24 hours after vaccination. Also, joint pain, muscle achiness, fatigue.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a female patient of unknown age with no pertinent medical history and no drug reaction or allergies. In 2009, the patient was vaccinated with live ZOSTAVAX lot # 665306/1150Y exp. 13-FEB-2011, 0.65 ml, subcutaneous (site of administration not reported). There was no concomitant medication. The reporter stated that the patient came down with a case in approximately November 2012 ("about 2 months ago"). The patient was treated with medications (unspecified) for shingles but she came down with another case of shingles in approximately December 2012 ("3 weeks after her first episode"). The reporter suspected that live ZOSTAVAX the patient received back in 2009 might have been improperly stored in a refrigerator for unspecified amount of time, and was administered to patient. The reporter did not have detailed temperature excursion information. The patient sought medical attention by an office visit. There was no laboratory tests performed. The outcome of shingles is unknown. The causality for shingles was not reported for live ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other Healthcare Worker (also reported to be Office Manager) refers to a patient of unknown age or gender. Due to a human error, the patient, who was intended to receive PNEUMOVAX, was inadvertently administered with RECOMBIVAX HB lot # 1106AA (expiry date unknown), 1 ml, intramuscular, Vaccination administered on on 24-SEP-2012. No adverse effects reported. No further information provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-JAN-2013, the patient was vaccinated with live ZOSTAVAX (dose, route, site of administration and lot # not reported). The pharmacist reported that the patient took an unspecified antiviral about 4 hours before the patient was vaccinated with live ZOSTAVAX. There was no adverse event reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Surgery
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. Approximately on 02-FEB-2013(reported as 5 days ago), an unspecified patient was vaccinated with a dose of live ZOSTAVAX(lot number, expiry date, route and dose were not reported).Approximately on an unknown date in February 2013, the patient was having an unspecified surgery unrelated to live ZOSTAVAX. Action taken with live ZOSTAVAX was not applicable.It was unspecified if patient sought medical attention. The outcome of unspecified surgery was unknown. The reporter considered unspecified surgery as not related to live ZOSTAVAX. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 75 year old female patient with no known drug reactions/allergies and pertinent medical history.  On 03-FEB-2013 the patient was vaccinated with a dose of live ZOSTAVAX (lot # H018092).  On 04-FEB-2013, 2 days after onset of therapy the patient developed an injection site reaction at the site where live ZOSTAVAX was administered. The injection site reaction was described as a red area about 2 inches in diameter at the injection site without itching and not warm to the touch. No lab diagnostics studies were performed. At the time of reporting, the outcome was reported as not recovered/not resolved. The patient sought medical attention by contacting the pharmacist. The relationship between the event and live ZOSTAVAX was not reported. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MMR, VARCEL
Symptoms: Exposure during pregnancy, Live birth
Clinical narrative: This spontaneous retrospective pregnancy report was received from a registered nurse refers to an approximately 17-year-old female patient. On an unknown date in December 2011 the patient was vaccinated with a dose of 0.5 milliliter (ml) live (Merck) VARIVAX (lot# 0711AA, expiration date 09-JAN-2011) subcutaneously. Other suspect therapies included M-M-R II (lot#, expiration date and route not reported) on 09-JAN-2012 and GARDASIL (lot#, expiration date and route not reported) on 09-JAN-2012. The patient became pregnant on an unknown date, The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) is not known. Patient was vaccinated before realizing she was pregnant. The patient gave birth on an unspecified date after carrying the baby full term. Nurse reported that the baby was healthy and suffered no known complications. No further information available. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 65-year-old female patient with no pertinent medical history. Current conditions included allergy to penicillin, phenothiazine and clavulanic acid. On 09-JAN-2013 the patient was vaccinated with a dose of live ZOSTAVAX (lot # H018798. expiration date 15-JAN-2014, route not reported). Approximately on 09-JAN-2013 a patient developed injection site reactions after vaccination with live ZOSTAVAX. The patient had a red raised dime size area at the injection site. The patient had itching at the injection site which began shortly after vaccination, went away and then returned. The events did not resolve at the time of this report. No treatment was given for the event. The patient contacted the pharmacist and sought medical attention. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of M-M-R II (lot#, expiration date and route not reported). The vaccine was exposed to an unsupported temperature  excursion (48.9 Fahrenheit (F) for 10 days). No adverse effect reported. No further information is available. This is one of the reports from the same reporter. Additional information has been requested.
Age: 0.43
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an Office Manager refers to a 17 week old patient of unknown gender. On 25-JAN-2013, the patient was vaccinated with live, oral ROTATEQ dose 1 , 2 ml, oral (lot # reported as 0285AE, exp. 31-OCT-2013). The reporter stated that the patient received the first dose of live, oral ROTATEQ at age of 17 weeks old. No adverse effects have been reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Injection site has rash and swollen to silver dollar size. Apply cold compress and take BENADRYL as directed.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia, Syncope
Clinical narrative: He got the shot 4:00pm on a Thursday 1-31-13. By evening he had chills the next day same thing and aches all over by Fri 2-1-13 at 7:00pm. His fever was 102.5. He fainted twice took him to the hospital. They hydrated him and release him. Dr said it was definitely the shot he received on Thursday.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) upper arm, lateral subcutaneous injection site. 2 inch x 1 1/2 inch dark red, warm to touch, 2 smaller areas within the site appear raised, possibly pre-blister. The entire area measurement is 4 1/2 inch x 2 inch. Painful to touch.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site pallor, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: Erythematous, warm, tight skin extending circumferentially from center injection site with mild blanching centrally (8 cm in diameter).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pruritus, Rash
Clinical narrative: Inflammation, swelling, redness around injection site. Large area, itching, extending down to elbow rash appeared 2nd day.
Age: 66.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site rash, Pruritus, Rash, Skin irritation
Clinical narrative: Initially presented with injection site reaction, a red rash on left arm. Rash/irritation progressed to face, patient developed itchiness on facial area. Patient was told to take BENADRYL tablets, follow up w/PCP.