chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Allergy to vaccine, Auricular swelling, Eczema, External ear inflammation, Eye swelling
Clinical narrative: Initial report was received from a health care professional on 16 August 2010 with additional information received on 18 August 2010. An 11 year old female patient with a past medical history of asthma, acne, eczema of the shins and a positive PPD in 2006 which was treated with INH, had received on 03 May 2010 injections of MENACTRA, lot number U3362AA and ADACEL, lot number C3446AA (routes and sites of administration not reported). The patient developed bumps on her hands, itchy, swollen and inflamed ears, swollen eyes, a bad flare up of eczema and a rash on her face, neck and shins on 07 May 2010. The patient was seen by her physician and treated with prednisone on 10 May 2010. She reported the rash was still present on 13 May 2010. The patient was seen again on 15 May 2010 at which time she was diagnosed with secondary impetigo and treated with AUGMENTIN. The patient was seen by an allergist on 19 May 2010 and was diagnosed with an "allergy to the vaccine". The patient was reported to have recovered. No further information was available at the time of this report. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Impetigo, Pruritus, Rash
Clinical narrative: Initial report was received from a health care professional on 16 August 2010 with additional information received on 18 August 2010. An 11 year old female patient with a past medical history of asthma, acne, eczema of the shins and a positive PPD in 2006 which was treated with INH, had received on 03 May 2010 injections of MENACTRA, lot number U3362AA and ADACEL, lot number C3446AA (routes and sites of administration not reported). The patient developed bumps on her hands, itchy, swollen and inflamed ears, swollen eyes, a bad flare up of eczema and a rash on her face, neck and shins on 07 May 2010. The patient was seen by her physician and treated with prednisone on 10 May 2010. She reported the rash was still present on 13 May 2010. The patient was seen again on 15 May 2010 at which time she was diagnosed with secondary impetigo and treated with AUGMENTIN. The patient was seen by an allergist on 19 May 2010 and was diagnosed with an "allergy to the vaccine". The patient was reported to have recovered. No further information was available at the time of this report. Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Facial palsy
Clinical narrative: Right-sided Bell's Palsy - currently being treated with 10 day course of oral steroids. Do not know if will have complete resolution of facial paralysis or if will have some residual defect.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Complained of pain and weakness in left arm shortly after receiving immunization.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Antineutrophil cytoplasmic antibody, Antinuclear antibody, Complement factor, Full blood count normal, International normalised ratio
Clinical narrative: Petechial rash noted in the lower legs (mostly anterior shins). Seen at ER and diagnosed with "vasculitis". Labs ordered (CBC/CMP/PT/INR wnl). other labs pending. Came to see me 8/24/10 for new rash, now raised, tender and reddish. Again petechial. Started on prednisone 20 mg daily. Case discussed with rheumatology, who will check patient in few days.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Metabolic function test, Petechiae, Prothrombin time normal, Rash erythematous, Tenderness
Clinical narrative: Petechial rash noted in the lower legs (mostly anterior shins). Seen at ER and diagnosed with "vasculitis". Labs ordered (CBC/CMP/PT/INR wnl). other labs pending. Came to see me 8/24/10 for new rash, now raised, tender and reddish. Again petechial. Started on prednisone 20 mg daily. Case discussed with rheumatology, who will check patient in few days.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Vasculitis
Clinical narrative: Petechial rash noted in the lower legs (mostly anterior shins). Seen at ER and diagnosed with "vasculitis". Labs ordered (CBC/CMP/PT/INR wnl). other labs pending. Came to see me 8/24/10 for new rash, now raised, tender and reddish. Again petechial. Started on prednisone 20 mg daily. Case discussed with rheumatology, who will check patient in few days.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Dizziness, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: When mom woke pt up this am c/o dizziness and itching arm where HepB injection was given. Child went to school, they called and stated that child was c/o dizziness, abdominal pain, site red, warm to touch, itching and hard.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Injection site warmth
Clinical narrative: When mom woke pt up this am c/o dizziness and itching arm where HepB injection was given. Child went to school, they called and stated that child was c/o dizziness, abdominal pain, site red, warm to touch, itching and hard.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Feeling jittery, Headache, Myalgia, Nausea
Clinical narrative: Initial case received from a health care professional on 18 August 2010. An 18-year-old female patient received an injection of MENACTRA (lot number U3509AA) on 30 July 2010. Medical history included anxiety, depression, obesity, hypercholesterolemia, chest pain, vulvodynia, and an allergy to OMNICEF. Concomitant medications included "MYRALAX", LUVOX, CYMBALTA, SEROQUEL, gabapentin, CRESTOR, NEXIUM, ZYRTEC, and naproxen. Approximately 5 days post-vaccination, the patient was hospitalized with complaints of headache, neck pain, chills, nausea, vertigo, visual disturbance, myalgia, and jitteriness. She was released from the hospital on 18 August 2010. The reporter noted that the patient continued to experience symptoms, although it was unknown which symptoms were ongoing.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Neck pain, Vertigo, Visual impairment
Clinical narrative: Initial case received from a health care professional on 18 August 2010. An 18-year-old female patient received an injection of MENACTRA (lot number U3509AA) on 30 July 2010. Medical history included anxiety, depression, obesity, hypercholesterolemia, chest pain, vulvodynia, and an allergy to OMNICEF. Concomitant medications included "MYRALAX", LUVOX, CYMBALTA, SEROQUEL, gabapentin, CRESTOR, NEXIUM, ZYRTEC, and naproxen. Approximately 5 days post-vaccination, the patient was hospitalized with complaints of headache, neck pain, chills, nausea, vertigo, visual disturbance, myalgia, and jitteriness. She was released from the hospital on 18 August 2010. The reporter noted that the patient continued to experience symptoms, although it was unknown which symptoms were ongoing.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site streaking, Lip swelling, Oedema mouth
Clinical narrative: Initial report was received 18 August 2010 from a healthcare professional. An adult female patient (age not reported) had received an injection of FLUZONE SV, lot number U216EA during 2006 (lot number invalid; route, site and exact date of administration not reported) and an unspecified amount of time later, she developed a swollen mouth, swollen lips and a red streak from the injection site down the arm. An unspecified amount of time later, the patient recovered. Documents held by sender: None.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Carcinoma in situ, Cervical dysplasia, Human papilloma virus test positive, Loop electrosurgical excision procedure
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who was vaccinated with three doses of GARDASIL in the physician's office in 2007. It was reported that the patient now had cancer. She visited the physician's practice within the last 3 week, in approximately July 2010, and was presented with cervical dysplasia, abnormal Pap smear, positive HR-HPV, biopsy came back as carcinoma in situ (CIS). She had the loop electrosurgical excision procedure (LEEP). At the time of the report, the patient's outcome was unknown. Upon internal review, carcinoma in situ (CIS) was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Neoplasm malignant, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who was vaccinated with three doses of GARDASIL in the physician's office in 2007. It was reported that the patient now had cancer. She visited the physician's practice within the last 3 week, in approximately July 2010, and was presented with cervical dysplasia, abnormal Pap smear, positive HR-HPV, biopsy came back as carcinoma in situ (CIS). She had the loop electrosurgical excision procedure (LEEP). At the time of the report, the patient's outcome was unknown. Upon internal review, carcinoma in situ (CIS) was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Haematochezia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning a 9 week old female baby with milk protein allergy who on 05-APR-2010 and 07-JUN-2010 was vaccinated with the first (lot # not reported) and the second dose (lot # 664067/0318Y, expiration date 12-DEC-2010) of ROTATEQ, respectively. Concomitant therapy included PENTACEL and PREVNAR. At the baby's six month visit, her mother told the office that for the 24-36 hours following both the first and second doses of ROTATEQ (on approximately 05-APR-2010 and 07-JUN-2010, respectively), the baby had blood in her stool. No other signs or symptoms were reported. No testing was done. No treatment was needed, and the baby was fine. The third dose of ROTATEQ was to be given. Subsequently (in 2010), the patient recovered from blood in her stool. Upon internal review, the two episodes of blood in stool were considered to be other important medical events. No further information is available.
Age: 0.02
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Cyanosis, Irritability, Pyrexia, Rash, Rash generalised
Clinical narrative: perioral rash with blue tinge to lips, full body rash and low grade fever, fussiness
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Chest discomfort, Flank pain, Headache
Clinical narrative: severe headached, right temporal area, right neck, upper back, right shoulder, right flank pain, tightness of chest, joint pains
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: severe headached, right temporal area, right neck, upper back, right shoulder, right flank pain, tightness of chest, joint pains
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old male patient with a history of previous bouts of shingles who on 15-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck). On 24-JUN-2010 the patient had a mild outbreak of shingles post vaccination. The pharmacist stated the patient might have been on valacyclovir therapy the day before vaccination, and the patient continued valacyclovir therapy 9 days after the ZOSTAVAX (Merck) vaccination. The pharmacist stated the patient had a mild outbreak and did not have Neuralgia episode (like he usually does) before the shingles outbreak. The patient sought unspecified medical attention. At the time of the report, the patient status was unknown. Follow-up information received from the pharmacist on 06-JUL-2010. The pharmacist stated that the patient took MEDROL dose pack 5 days after receiving ZOSTAVAX (Merck). Follow-up information has been received from the pharmacist concerning the 73 year old male with a history of shingles (recurrent bouts for years) and unknown history of chicken pox (likely in childhood) and no known illness at time of vaccination who on 15-JUN-2010 at 11:00 AM was vaccinated subcutaneously at left arm with the first 0.65 mL dose of ZOSTAVAX (Merck) (LOT# 665514/0145Z). Concomitant therapies were unknown except VALTREX. On approximately 25-JUN-2010 at unknown time (previously reported as 24-JUN-2010), the patient came down with a case of shingles about 7-10 days after the vaccine. The patient noted the lesions were in lumbar-sacral area at the same site as recurrent infections in the past. He did not get his usual neuralgia, and he had fewer lesions than previous outbreaks. Patient also reported minimal pain and recovered. The pharmacist was not aware any relevant diagnostics test or laboratory data. The patient was seen for other pain and was prescribed a MEDROL dose pack 5 days post vaccination (MEDROL dose pack was 6 day treatment). On an unspecified date, the patient recovered from shingles. A specimen was not collected for PCR and no photo was taken. The pharmacist considered shingles to be an other important medical event due to the patient required medical/surgical intervention to prevent the adverse event. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Apgar score normal, Congenital anomaly, Dacryostenosis acquired, Drug exposure during pregnancy, Eye discharge
Clinical narrative: Information has been received from a medical assistant via medical records concerning a female baby whose mother was vaccinated with the first dose of VARIVAX (Merck) (Lot # 659932/1790U) on 22-APR-2008. It was reported that the baby was born on 17-JAN-2009, at 39 weeks of gestation, via spontaneous vaginal delivery, 7 pounds and 3 ounces, weight was 50.8 cm; head circumference 33.7 cm. The baby did not require any extraordinary means of resuscitation at delivery. The apgars were 9 and 9. The initial newborn examination was essentially within normal limits. The baby's blood type was O positive. It was reported that the baby voided and stooled within 24 hours. The baby did receive hepatitis B virus vaccine rHBsAg (manufacturer unknown) prior to release. It was reported that on 21-JAN-2009, baby noted to have scant scleral icterus (outcome unknown). On 05-FEB-2009 (also reported as 05-FEB-2008) the baby had occasional eye crusting, baby was also noted to have some nasal congestion starting on approximately 30-JAN-2009. On 19-MAR-2009, the baby's eye was still goopy at times but was better than previous, on exam tearing was noted in left eye. Lacrimal duct stenosis was discussed at length with the patient's mother. At the time of the report the outcome of the patient was not reported, Lacrimal duct stenosis was considered to be a congenital anomaly. The mother's experiences were captured in WAES # 0806USA01108. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Eyelid margin crusting, Lacrimation increased, Nasal congestion, Ocular icterus
Clinical narrative: Information has been received from a medical assistant via medical records concerning a female baby whose mother was vaccinated with the first dose of VARIVAX (Merck) (Lot # 659932/1790U) on 22-APR-2008. It was reported that the baby was born on 17-JAN-2009, at 39 weeks of gestation, via spontaneous vaginal delivery, 7 pounds and 3 ounces, weight was 50.8 cm; head circumference 33.7 cm. The baby did not require any extraordinary means of resuscitation at delivery. The apgars were 9 and 9. The initial newborn examination was essentially within normal limits. The baby's blood type was O positive. It was reported that the baby voided and stooled within 24 hours. The baby did receive hepatitis B virus vaccine rHBsAg (manufacturer unknown) prior to release. It was reported that on 21-JAN-2009, baby noted to have scant scleral icterus (outcome unknown). On 05-FEB-2009 (also reported as 05-FEB-2008) the baby had occasional eye crusting, baby was also noted to have some nasal congestion starting on approximately 30-JAN-2009. On 19-MAR-2009, the baby's eye was still goopy at times but was better than previous, on exam tearing was noted in left eye. Lacrimal duct stenosis was discussed at length with the patient's mother. At the time of the report the outcome of the patient was not reported, Lacrimal duct stenosis was considered to be a congenital anomaly. The mother's experiences were captured in WAES # 0806USA01108. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Irritability, Local reaction, Skin warm
Clinical narrative: Child was fussy on 8-17-10 (bed time) woke up with redness on left deltoid area. No fever 5x7cm are red & warm. No respiratory distress. 8/18/10 - Local reaction to PCV 13 pt stable on MOTRIN 100mg every 6 hrs (10mL) x 1 week & ice F/u 3 to 4 days.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling and warm to touch at injection site, cold compress to site. 7 out of 28 students had same reaction.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling and warm to touch at injection site, cold compress to site. 7 out of 28 students had same reaction.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling and warm to touch at injection site, cold compress to site. 7 out of 28 students had same reaction.
Age: 0.29
Sex: M
Vaccine: HIBV, PPV
Symptoms: Crying, Pain, Screaming
Clinical narrative: All of a sudden started high pitched screaming in pain cry and was completely inconsolable.  We called the Dr within 5 mins and then decided to go the the ER after 30 Mins, the crying lasted 1 hour.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling and warm to touch at injection site, cold compress to site. 7 out of 28 students had same reaction.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling and warm to touch at injection site, cold compress to site. 7 out of 28 students had same reaction.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling and warm to touch at injection site, cold compress to site. 7 previosly reported now 8 out of 28 students had same reaction.
Age: 1.0
Sex: F
Vaccine: MMR, UNK, VARCEL
Symptoms: Urticaria
Clinical narrative: urticaria
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Activities of daily living impaired, Headache, Malaise, Migraine, Nausea
Clinical narrative: Patient's parent reports that patient c/o of not feeling well the day  following the shot.  2 days later, she c/o of a vague headache.  The H/A continued through the weekend and then she began to have nausea and vomiting.  She missed 3 days of school last week and was unable to go to school on Monday too.  During the course of a week she was taken to Dr. and with unfounded results.  The parents then called the Health Dept on 8/23/10, thinking it may be from shots.  We took the information and referred back to the Dr.  Family states that the Dr. is treating her for a migraine.  8/25/10 the father called again to report that the h/a remains and she is now having tingling in her lips and feet.  She has been back to the Dr. but family reports that he has no reason why she would be feeling poorly.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Paraesthesia, Paraesthesia oral, Vomiting
Clinical narrative: Patient's parent reports that patient c/o of not feeling well the day  following the shot.  2 days later, she c/o of a vague headache.  The H/A continued through the weekend and then she began to have nausea and vomiting.  She missed 3 days of school last week and was unable to go to school on Monday too.  During the course of a week she was taken to Dr. and with unfounded results.  The parents then called the Health Dept on 8/23/10, thinking it may be from shots.  We took the information and referred back to the Dr.  Family states that the Dr. is treating her for a migraine.  8/25/10 the father called again to report that the h/a remains and she is now having tingling in her lips and feet.  She has been back to the Dr. but family reports that he has no reason why she would be feeling poorly.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Feeling abnormal, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Shortly after receiving Zostavax patient started to feel "strange" and then started to shake and continued for approx 15 minutes.  Pt's blood pressure became elevated to 184/89.  Over the course of 30 min pt's blood pressure decreased to 165/82. Pt states that her systolic BP is 120 or lower.  Developed rt arm soreness, red, swollen, hard and warm area at injection site on 8/20/10.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Tremor
Clinical narrative: Shortly after receiving Zostavax patient started to feel "strange" and then started to shake and continued for approx 15 minutes.  Pt's blood pressure became elevated to 184/89.  Over the course of 30 min pt's blood pressure decreased to 165/82. Pt states that her systolic BP is 120 or lower.  Developed rt arm soreness, red, swollen, hard and warm area at injection site on 8/20/10.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Fall, Muscle rigidity
Clinical narrative: Nurse administered vaccination at 1355, patient put her own bandaids on and seemed fine. She then got off table and sat in chair, sister was then put on table for vaccinations. Sister was given her vaccinations, at that time patient had fallen off chair and was on the floor. Nurse picked picked patient up and put her on the exam table and checked for breathing. Patient was breathing, nurse then called for assistance, patient was rigid throughout her body for about 1-3 minutes. Given ice pack and juice, after examination from physician. Patient recovered and left office approximately 1 hour later.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Injection site reaction, Malaise, Myalgia
Clinical narrative: Headaches, muscle ache at injection site, nausea, and vomiting last night, this am pt had temperature 102.5 and not feeling well.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Headaches, muscle ache at injection site, nausea, and vomiting last night, this am pt had temperature 102.5 and not feeling well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Pt had erythema and hives on Left Leg
Age: 68.0
Sex: M
Vaccine: PPV, TD, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pneu poly vaccine administered along with a Td, Zostavax and a TB Skin Test. Client reported redness to area (left arm). Pneu poly given at this site. Client states no cold/warm compresses were applied on the day of. Clent denies any pain, headache, area not warm to touch during the assessment.  Assessment done 6/10/2010.  Client will see physician for a medical evaluation and contact Clinic afterwards.  Follow-up done 4 days after adverse event began and he stated his arm was fine and did not go see the doctor.
Age: 1.05
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Seen at the clinic with 3 day hx of fever and injection site redness and swelling. Injections given on 8/13/2010. Mom applied warm soaks. Provider prescribed Cephalexin Monohydrate and Motrin with a re-evaluation appointment in 2 days for diagnosis of cellulitis.
Age: 1.78
Sex: M
Vaccine: FLU(H1N1), PNC13
Symptoms: Decreased appetite, Pyrexia, Rash generalised
Clinical narrative: Rash on body and extremities appears and then disappears.  Fever of 101 06/26/2010.  Fever of 101 06/26-27. No fever today, loss of appetite.  Four days later, follow-up done.  The father states that the rash looked like small bumps (like ant bites. Fever up to 101 & 102. That mornig the child was going to the doctor, the rash went away completely and having no fever.  Dr's appt cancelled.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Bursitis, Joint range of motion decreased, Musculoskeletal pain, Neck pain
Clinical narrative: SHoulder Neck Hand joint pain for 7 days went to MD.  Diagnosis Bursitis, use Ibuprofen 800 mg every 8 hours and topical analgesic as needed.  Improved range of motion 08/25/2010.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: SHoulder Neck Hand joint pain for 7 days went to MD.  Diagnosis Bursitis, use Ibuprofen 800 mg every 8 hours and topical analgesic as needed.  Improved range of motion 08/25/2010.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperaesthesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Painful upper extremity, unable to move arm in any direction and is unable to apply any pressure without pain.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: fever 102.5, coming down to 98 but then returns, is taking Tylenol
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased, Muscle tightness, Pyrexia
Clinical narrative: Fever, swelling and redness at injection site 2 days with complaint of constant muscle tightness to upper lt back and neck with decreased range of motion in neck
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Injection site pain, Lymphadenopathy, Muscle spasms
Clinical narrative: Dull pain to injection site developed 6 days later with muscle spasms in neck radiating into rt shoulder. Seen at Urgent Care on 07/24: off work 1 week, started on Flexeril and Ibuprofen. Returned to Urgent Care 07/28: muscle spasms continue and lymph node swelling below rt ear developed. Continues to have muscle spasms on rt neck and shoulder. Alternating cold and hot packs to sites.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Unable to use rt arm due to severe pain and soreness for 2 days
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity
Clinical narrative: redness to injection site for 3 days with significant pain and swelling to rt arm for 7 - 10 days
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Culture urine, Pyrexia
Clinical narrative: Fever to Tm 103 x >48 hours. ER visit at 24 hours of fever. MD visit at 48 hours of fever.
Age: 68.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Acquired haemophilia, Activated partial thromboplastin time prolonged, Coagulation factor VIII level decreased, Coagulation factor inhibitor assay, Coagulopathy
Clinical narrative: Initial report received from health authority (121801) on 11 Aug 2010: This patient with previous history of seasonal vaccination in Nov 2009 was vaccinated with S-OIV FOCETRIA (batch number: 090802) on 15 Dec 2009. Fifteen days after the vaccination, the patient experienced dizziness and bleeding from teeth. One week later, the patient experienced hemorrhage from an eye. In the beginning of Jan 2010, the patient experienced again bleeding from teeth and went to a dentist who prescribed an unspecified antibiotic. After that, the patient was hospitalized on an unspecified date. Again in Jan 2010, the patient experienced bleeding from teeth, pain in superior limb, red eyes and dark arms. A blood test was performed which indicated partial thromboplastin time of 58 and the patient was diagnosed with acquired hemophilia. As corrective measure, the patient was treated with cortisone and ENDOXAN. Final outcome of the events was reported as complete recovery on 01 Mar 2010. This report combines follow-up information received from the Health Authority on 18 Aug 2010 and Internal review done on 23 Aug 2010 of the information received on 11 Aug 2010: In the end of Jan 2010, the patient presented with clinical and laboratory findings of acquired hemophilia, characterized by the acute onset of cutaneous hemorrhagic manifestations and coagulation alterations which included APTT prolongation of 50 seconds, clotting factor VII reduced to less than 1% and presence of a high inhibitor titre (128 Bethesda Units). For this reason, the patient was hospitalized and was treated with activated recombinant factor VII and also received an immunosuppressive therapy with cortisone and cyclophosphamide. Subsequently, no major hemorrhagic events occurred and 2 months after therapy start, coagulative state became normal. During hospitalization, the principal cause of acquired hemophilia including neoplasia and systemic autoimmune diseases were excluded. The absence of underlying causes and the quick resolution of the patient's laboratory findings, as well as the temporal relationship suggested a possible correlation with vaccination previously performed. After internal review, the seasonal flu vaccine (manufacturer unknown) received in Nov 2009 was also considered as co-suspect drug as it might have contributed to the event.
Age: 68.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Eye haemorrhage, Gingival bleeding, Ocular hyperaemia, Pain in extremity
Clinical narrative: Initial report received from health authority (121801) on 11 Aug 2010: This patient with previous history of seasonal vaccination in Nov 2009 was vaccinated with S-OIV FOCETRIA (batch number: 090802) on 15 Dec 2009. Fifteen days after the vaccination, the patient experienced dizziness and bleeding from teeth. One week later, the patient experienced hemorrhage from an eye. In the beginning of Jan 2010, the patient experienced again bleeding from teeth and went to a dentist who prescribed an unspecified antibiotic. After that, the patient was hospitalized on an unspecified date. Again in Jan 2010, the patient experienced bleeding from teeth, pain in superior limb, red eyes and dark arms. A blood test was performed which indicated partial thromboplastin time of 58 and the patient was diagnosed with acquired hemophilia. As corrective measure, the patient was treated with cortisone and ENDOXAN. Final outcome of the events was reported as complete recovery on 01 Mar 2010. This report combines follow-up information received from the Health Authority on 18 Aug 2010 and Internal review done on 23 Aug 2010 of the information received on 11 Aug 2010: In the end of Jan 2010, the patient presented with clinical and laboratory findings of acquired hemophilia, characterized by the acute onset of cutaneous hemorrhagic manifestations and coagulation alterations which included APTT prolongation of 50 seconds, clotting factor VII reduced to less than 1% and presence of a high inhibitor titre (128 Bethesda Units). For this reason, the patient was hospitalized and was treated with activated recombinant factor VII and also received an immunosuppressive therapy with cortisone and cyclophosphamide. Subsequently, no major hemorrhagic events occurred and 2 months after therapy start, coagulative state became normal. During hospitalization, the principal cause of acquired hemophilia including neoplasia and systemic autoimmune diseases were excluded. The absence of underlying causes and the quick resolution of the patient's laboratory findings, as well as the temporal relationship suggested a possible correlation with vaccination previously performed. After internal review, the seasonal flu vaccine (manufacturer unknown) received in Nov 2009 was also considered as co-suspect drug as it might have contributed to the event.
Age: 68.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Skin discolouration
Clinical narrative: Initial report received from health authority (121801) on 11 Aug 2010: This patient with previous history of seasonal vaccination in Nov 2009 was vaccinated with S-OIV FOCETRIA (batch number: 090802) on 15 Dec 2009. Fifteen days after the vaccination, the patient experienced dizziness and bleeding from teeth. One week later, the patient experienced hemorrhage from an eye. In the beginning of Jan 2010, the patient experienced again bleeding from teeth and went to a dentist who prescribed an unspecified antibiotic. After that, the patient was hospitalized on an unspecified date. Again in Jan 2010, the patient experienced bleeding from teeth, pain in superior limb, red eyes and dark arms. A blood test was performed which indicated partial thromboplastin time of 58 and the patient was diagnosed with acquired hemophilia. As corrective measure, the patient was treated with cortisone and ENDOXAN. Final outcome of the events was reported as complete recovery on 01 Mar 2010. This report combines follow-up information received from the Health Authority on 18 Aug 2010 and Internal review done on 23 Aug 2010 of the information received on 11 Aug 2010: In the end of Jan 2010, the patient presented with clinical and laboratory findings of acquired hemophilia, characterized by the acute onset of cutaneous hemorrhagic manifestations and coagulation alterations which included APTT prolongation of 50 seconds, clotting factor VII reduced to less than 1% and presence of a high inhibitor titre (128 Bethesda Units). For this reason, the patient was hospitalized and was treated with activated recombinant factor VII and also received an immunosuppressive therapy with cortisone and cyclophosphamide. Subsequently, no major hemorrhagic events occurred and 2 months after therapy start, coagulative state became normal. During hospitalization, the principal cause of acquired hemophilia including neoplasia and systemic autoimmune diseases were excluded. The absence of underlying causes and the quick resolution of the patient's laboratory findings, as well as the temporal relationship suggested a possible correlation with vaccination previously performed. After internal review, the seasonal flu vaccine (manufacturer unknown) received in Nov 2009 was also considered as co-suspect drug as it might have contributed to the event.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site swelling, Ultrasound scan abnormal, Venous occlusion
Clinical narrative: Left arm swelling causing venous obstruction left brachial vein noted on ultrasound.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Sensation of heaviness
Clinical narrative: Pt came to pharmacy on 8/25 night and complained that her left arm felt heavy since the flu shot on 8/21/10 and hard to lift and the degree does not decrease.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: When patient woke up - area was swollen. Left - PNEUMOVAX. Heat and cold compress - 10 minutes per 40 minutes. IBU - 200 mg - BID.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Dyspnoea
Clinical narrative: Patient had trouble breathing/had asthma attack at least 15 minutes after injection. Gave BENADRYL & 1 dose of EPIPEN 0.3, nurse in clinic also administered pt's albuterol inhaler to her & Dexamethasone 0.5 mg/ml - she gave her 20 ml. 911 was called & they took pt to hospital after breathing was stabilized.
Age: 12.0
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Right arm swelling.
Age: 1.28
Sex: M
Vaccine: DTAP, MMR, PNC13
Symptoms: Urticaria
Clinical narrative: Urticarial rash.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Body temperature increased, Dyspnoea, Pain
Clinical narrative: Temp 102.8 3AM decreased 101 after Acetaminophen mild SOB continued throughout next day body aching (Ribs).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Redness 13x17cm swollen edges of redness whelped hive-like warm to touch Lt leg.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3" x 3" redness & swelling 2 days after vaccine. Redness down/improved within next 48 hrs. Lt leg.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature normal, Chest pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 08/20/10 TDAP received. Experienced left deltoid pain. Pain continued daily. 8/22/10 Pain at left deltoid, redness and swelling area warm to touch. 8/24/10 Pain, redness, swelling in left deltoid. Chest pain in midsternum area. 8/25/10 Pain, swelling, redness in left deltoid, chest pain in midsternum area. Itching all over. No rash.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pruritus generalised
Clinical narrative: 08/20/10 TDAP received. Experienced left deltoid pain. Pain continued daily. 8/22/10 Pain at left deltoid, redness and swelling area warm to touch. 8/24/10 Pain, redness, swelling in left deltoid. Chest pain in midsternum area. 8/25/10 Pain, swelling, redness in left deltoid, chest pain in midsternum area. Itching all over. No rash.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Pt and mom reported to RN that he had a previous episode of fainting on 6/22/10 after receiving GARDASIL and MENACTRA. Had pt sitting for GARDASIL #2. Fainted within 1 minute and came to within 1 minute. Kept at chair for 30 min & able to walk out & OK.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: 1 day after TDAP developed stiff, painful, hot area at site of shot. Next day area became red 11 X 12cm. Afebrile. Treated with KEFLEX 500 mg TID X 10d.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Pallor
Clinical narrative: Pt. briefly pale, weak & lightheaded after vaccine being given. Very nervous prior to injection. Laid down on exam table from few minutes. Drank cool water & had lollipop. Sat up & continued to wait for sisters appt. x 30 min.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (TDAP) Lt arm (deltoid) area red swollen warm to touch.
Sex: U
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: 2 X 2" red, swelling & warm area at site of injection; + nausea.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Lip swelling, Urticaria
Clinical narrative: Developed urticaria, swelling of lips 6-8 hours after receiving vaccine. Denies wheezing or shortness of breath.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Vaccination site erythema, Vaccination site pain
Clinical narrative: Swelling & vesicles & redness & pain of arm at vaccine site 7/29/10. Opposite arm & upper chest with vesicles/rash of zoster/shingles approximately 8/20/10.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling, Vaccination site vesicles
Clinical narrative: Swelling & vesicles & redness & pain of arm at vaccine site 7/29/10. Opposite arm & upper chest with vesicles/rash of zoster/shingles approximately 8/20/10.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Asthenia, Full blood count normal, Gait disturbance, Injection site urticaria, Muscular weakness
Clinical narrative: 6/28/10- Pt received MMR, VARIVAX, and PREVNAR. 7/7/10- Onset of rash on face, progressed to neck and torso next day. Also, mom reports "whelps" on right leg. 7/8/10 - Pt. developed wide, "wobbly" gait. 7/9/10- Developed central weakness, eg.- falling backwards while sitting. 7/11/10 Improved, running around and playful, but mom feels his gait is still slightly wide. 7/15/10-Gait and personality back to normal per mom.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: 6/28/10- Pt received MMR, VARIVAX, and PREVNAR. 7/7/10- Onset of rash on face, progressed to neck and torso next day. Also, mom reports "whelps" on right leg. 7/8/10 - Pt. developed wide, "wobbly" gait. 7/9/10- Developed central weakness, eg.- falling backwards while sitting. 7/11/10 Improved, running around and playful, but mom feels his gait is still slightly wide. 7/15/10-Gait and personality back to normal per mom.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Mass, Oedema, Pain, Pruritus
Clinical narrative: Onset of redness, swelling, pain, itch within 4-5 hrs of receiving her first 6 AVA SQ.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Onset of redness, swelling, pain, itch within 4-5 hrs of receiving her first 6 AVA SQ.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, myalgias - 24hr of Sx. E.D evaluation and observation T  103-104.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild swelling redness left anterior thigh.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Headache, Paraesthesia
Clinical narrative: Within 15 min. after vaccine pt. reports tingling in upper arm (L), dizziness & headache at the top of her head BP 128/76 - pt. took 2 MOTRIN and felt headache relief within 5 min.
Age: 69.0
Sex: F
Vaccine: DT
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to injection area treatment- KEFLEX 500mg TID x 14 days.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Swelling at site of injection with urticaria over arm and abdomen and neck & face.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: (L) arm red, swollen with pain started BACTRIM DS tabs 1 tab po BID x 7 days.
Age: 5.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Varicella breakthrough. Had 2 doses of VARIVAX (3/21/05 & 8/28/09). Seen in our office with > 50 vesicles. Diagnosed with Varicella on 8/23/10.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever 103.9 - Febrile seizure approx 36 hr post vaccine. ER visit - released to parents. Seizure lasting 2-3 min. per mother.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Chills, Heart rate increased, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: Fever of 102, fast heat beat, shivering, sweating, pain at the injection sight
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Rash erythematous
Clinical narrative: Patient came in with redness, red bumps on extremities, face, neck, chest and back. The smallpox vaccine also moved to the opposite arm.
Age: 1.27
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Rash with measles-like appearance.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dizziness, Headache, Nausea
Clinical narrative: 4hr after dizzy -lightheaded- headache. Stomach nausea with temp.
Age: 14.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Father states he noticed heat bumps around neck and predominantly on the neck. Also noticed facial heat bumps on 8/20/10. On 8/22/10 obvious hives was present on neck and face. Immunization department notified on 8/23/10. BENADRYL 1 pill by mouth 8/24/10 - 08/25/10. Candacil Powder applied 8/22/10 - present.
Age: 38.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injected limb mobility decreased, Limb discomfort, Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: Pain and weakness in arm the evening after immunization resolved after a day or two then returned.  Now discomfort disturbing sleep and having difficulty using the arm.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Oral pruritus
Clinical narrative: itching of lips
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme (minor) - tx = SOLU MEDROL 125mg MEDROL dose pak cetirizine 10mg ranitidine 150mg. See notes.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Tremor
Clinical narrative: Chills, shaking, SOB.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hot flush, Tremor
Clinical narrative: Headache, hot flash (warm), and a little dizzy/shaky.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Rash
Clinical narrative: Rash noted on face, arms and legs.  Slightly raised area on L arm where Varicella was given.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Loss of consciousness, Pallor, Vomiting
Clinical narrative: Pt received Hep A And Hep B vaccine (child). Pt got pale and passed out for a few seconds on chair.  Pt vomited, First responders were called.  Pt was placed on exam table elevated feet. cold packs were placed.  Vitals were normal. Pt was observed for 30 minutes then released.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatinine normal, Dizziness, Full blood count, Haematocrit decreased, Haemoglobin normal
Clinical narrative: Pain, redness, itching, and swelling in left arm.  Dizziness.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Metabolic function test
Clinical narrative: Pain, redness, itching, and swelling in left arm.  Dizziness.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Neutrophil percentage, Platelet count normal, White blood cell count normal
Clinical narrative: Pain, redness, itching, and swelling in left arm.  Dizziness.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Diarrhoea, Electroencephalogram normal, Febrile convulsion, Pyrexia
Clinical narrative: Seizure (febrile?) - went to Emergency Room on 6/26/10. Fever of 101 degrees diarrhea x 1 on 6/25/10.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Wrong drug administered
Clinical narrative: The Pneumococcal vaccine was placed with the Flu vaccine by the other pharmacist. When I came on duty the tech ask me to do a Flu shot. I grabbed the open vial out of the same place as always. It was the wrong vaccine I gave the correct vaccine later the same day.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Chest X-ray normal, Convulsion, Full blood count normal, Metabolic function test, Musculoskeletal stiffness
Clinical narrative: Within 2 days baby had a seizure, stiffened body and seen in ER. Basic labs CBC, U/A, BMP, CXR - WNL.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Urine analysis normal
Clinical narrative: Within 2 days baby had a seizure, stiffened body and seen in ER. Basic labs CBC, U/A, BMP, CXR - WNL.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Wrong drug administered
Clinical narrative: The Pneumococcal vaccine was placed with the Flu vaccine by the other pharmacist. When I came on duty the tech ask me to do a Flu shot. I grabbed the open vial out of the same place as always and it was the wrong vaccine. I later gave correct vaccine later the same day.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Approximately 8x10cm area of erythema at (R) lateral upper arm w/ warmth, tenderness. Advised cool packs, APAP. ?Cellulitis --> BACTRIM 120mg TMP PO bid x 10 days. Discussed signs/sx of possible worsening cellulitis to monitor at home.
Age: 1.7
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema, swelling, rt arm non tender.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 48 hrs. post Varicella #2 vaccine pt developed swelling, redness in (L) upper arm, site of vaccination.
Age: 1.67
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema, swelling rt arm non tender.
Age: 46.0
Sex: M
Vaccine: YF
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Myalgias, fever, arthralgias x 72 hours.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Pt. described reaction as: itching hands in 10-20 mins. after injection. Next morning woke up with bilateral hand and wrist edema. No other symptoms. Treated with SOLU-MEDROL 125 mg and BENADRYL 25 mg.