chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Headache, Induration, Injection site pain
Clinical narrative: Reddened, hard lump, 2 1/2 in. in diameter. Tenderness at site, achy joints, headache. TYLENOL/Ibuprofen for body aches & cold pack for swelling at site.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Mass, Pain
Clinical narrative: Reddened, hard lump, 2 1/2 in. in diameter. Tenderness at site, achy joints, headache. TYLENOL/Ibuprofen for body aches & cold pack for swelling at site.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pain
Clinical narrative: Achy and fatigued on date of injection. OTC pain relievers recommended.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: REDNESS, HEAT, SWELLING AND PRURITUS TREATED WITH BENADRYL
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphonia, Pharyngeal oedema
Clinical narrative: Patient's voice became hoarse and she felt likt her throat was swelling.  Upon exam:  no shortness of breath, no wheezing, no swollen lips/tongue.  Patient reported same symptoms when she received the flu shot this year.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash erythematous, Rash pustular
Clinical narrative: red pustule like spotty rash at abdomen, legs, arms
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Fatigue, Urticaria
Clinical narrative: Hives developed on arm, trunk, and buttocks. Felt short of breath and fatigued.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RV1
Symptoms: Blood calcium normal, Blood magnesium normal, Convulsion, Gaze palsy, Metabolic function test
Clinical narrative: Afebrile seizure beginning with shaking of left leg and eyes rolling back and head falling back
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RV1
Symptoms: Posture abnormal, Tremor
Clinical narrative: Afebrile seizure beginning with shaking of left leg and eyes rolling back and head falling back
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Received shot high on arm. Has pain in left arm and has difficulty in moving arm without pain. Has been to neurologist and had physical therapy for past 3 weeks. Slight improvement.
Age: 5.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Skin warm
Clinical narrative: Vaccinations on 5/24/2011. Onset redness at vaccine site 5/25/11. Redness & induration & warmth increasing on 5/26/11.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Epistaxis, Periorbital oedema, Pruritus
Clinical narrative: Patient received 4 vaccines in bilateral thighs. He left the clinic with father, but returned within 5-10 minutes with epistaxis, pruritus of trunk, sneezing, coughing, breathing problems, periorbital edema, wheezing. BENADRYL given by mouth, then epinephrine via SQ injection. Observed about 60 min with recovery. Prescribed ZANTAC, BENADRYL and ORAPRED. Follow up visit on 5/26, complete recovery.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Sneezing
Clinical narrative: Patient received 4 vaccines in bilateral thighs. He left the clinic with father, but returned within 5-10 minutes with epistaxis, pruritus of trunk, sneezing, coughing, breathing problems, periorbital edema, wheezing. BENADRYL given by mouth, then epinephrine via SQ injection. Observed about 60 min with recovery. Prescribed ZANTAC, BENADRYL and ORAPRED. Follow up visit on 5/26, complete recovery.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Local swelling, Pain, Skin warm
Clinical narrative: Pt came in for PPD reading. Mom stated she had just noticed redness on (L) arm where shots were given. No fever, 3/10 pain, measurements of 90x90, slightly warm, pt's mom was advised to put cold pack in area to help with swelling, and take TYLENOL if any pain.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Thigh swelling, redness, itching. Thigh swelled to almost twice its normal size.
Age: 1.09
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Rash - cheeks, bottom, back, arm.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site warmth, Pain
Clinical narrative: Received vaccine on Mon. 5/23/11 at approximately 11:00am. By early evening, body & headaches presented. By 9:00pm, had fever, body aches, headache, red & hot injection site. Same symptoms on Tues with temp peaking at 103.6 degrees, and Wed until mid-day. Spoke w/ Dr's office - they said if temp gets higher, go to emergency room. By Wed pm, most symptoms were gone except arm pain, which went away by Friday am.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Received vaccine on Mon. 5/23/11 at approximately 11:00am. By early evening, body & headaches presented. By 9:00pm, had fever, body aches, headache, red & hot injection site. Same symptoms on Tues with temp peaking at 103.6 degrees, and Wed until mid-day. Spoke w/ Dr's office - they said if temp gets higher, go to emergency room. By Wed pm, most symptoms were gone except arm pain, which went away by Friday am.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patients' shoulder has been hurting ever since he received his flu shot on 10-6-2010.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Acute tonsillitis, Injection site erythema, Injection site papule, Pyrexia
Clinical narrative: Fever 101-103 5/23/11. Pink pinpoint papules on both thighs lateral aspect 5/24/11. At office visit 5/24/11 acute tonsillitis.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: Inj on 5/27/11 (L) upper arm became red and indurated. Seen by physician on 5/28. Assessed as allergic reaction with cellulitis. Rx'd with KEFLEX & cool compress. 5/31/11 - "Arm improved - still slightly sore" (phone call to patient 2pm).
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Balance disorder, Fatigue, Injection site erythema, Irritability, Pyrexia
Clinical narrative: Fever 5-25-11 - 5-26-11 with redness at site of MMRV. Fatigue, balance issues & fussiness onset in same time period and continue at present.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Swelling & redness. Cellulitis. Ibuprofen 600mg up to three times daily, heat/compress, ROCEPHIN 1gm IM x 2 & Cephalexin 500mg three times a day x 10 dys.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Breast feeding, Crying, Gastrointestinal sounds abnormal, Irritability
Clinical narrative: Mom reports baby to be inconsolably fussy since vaccines, did sleep a little, but unable to breast feed her for more than a couple of minutes and then was inconsolable. Did have 2 BMs since leaving office and returning at 1630 p.m. No fever, hyperactive bowel sounds, quiets for only 30-60 secs then cries. Mom had given TYLENOL before vaccines and again at 1400. Gave BENADRYL 1/2 tsp p.o. at 1640. Sent to hosp. for x-rays to rule out any problems.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: X-ray normal
Clinical narrative: Mom reports baby to be inconsolably fussy since vaccines, did sleep a little, but unable to breast feed her for more than a couple of minutes and then was inconsolable. Did have 2 BMs since leaving office and returning at 1630 p.m. No fever, hyperactive bowel sounds, quiets for only 30-60 secs then cries. Mom had given TYLENOL before vaccines and again at 1400. Gave BENADRYL 1/2 tsp p.o. at 1640. Sent to hosp. for x-rays to rule out any problems.
Age: 1.13
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Local reaction
Clinical narrative: Pt. got local reaction as per Dr. Due to immunizations.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Induration, Pyrexia, Swelling
Clinical narrative: Swelling, induration, fever right arm.
Sex: U
Vaccine: MMR
Symptoms: Deafness
Clinical narrative: Information has been received from a mother whose son who on an unspecified date in approximately 1990 was vaccinated with a dose of MMR II (dose, route and lot number unspecified). The mother reported that the child had hearing loss that occurred some time after getting MMR II. The mother (WAES# 98060321 and another sibling WAES# 98060460) also had a similar reaction of hearing loss. Upon internal review, hearing loss was determined to be an other important medical event. This is one of three reports received from the same source. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Measles, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a seven year old male patient with no drug reactions/allergies, who on 14-JUN-2006 was vaccinated with a first dose of MMR II (Lot # 664800/0775Y), 0.5 mL, subcutaneous into the right arm. Concomitant therapy included DTaP, and poliovirus vaccine inactivated (unspecified). On 14-APR-2010, the patient received the second dose of MMR II (Lot # not provided) and on approximately 26-MAY-2010 (approximately 6 weeks after vaccination), the child developed a maculopapular rash which nurse said looks very much like measles. The rash started in the hairline and was from head to toe. Areas on the face did not blanch but other areas on the body did blanch. Three or four weeks prior to the outbreak, the child was fine, did not act sick , no fever and no prodrome. At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. No further information is available.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old male patient with a sinus infection with a fever on the day of the vaccination, and no drug reaction or allergy who on 14-JUN-2010 was vaccinated SC with a 0.5 ml dose of MMR II (lot# 666510/1624Y). Second suspect therapy included VARIVAX (Merck) and VAQTA (MSD). Concomitant therapy included included PREVNAR and amoxicillin. On 24-JUN-2010 the patient developed measles like rash after receiving MMR II. The patient developed fin pink rash all over the body. The patient did not complain of cough or itchiness. The patient sought medical attention by the physician. No laboratory diagnostic studies were performed. At the time of the report, the patient was recovering. Follow up information has been received from the nurse concerning the 12 month old male patient with 2 siblings, sinus infection at the time of vaccination and no pre existing allergies, birth defects or medical conditions who on 14-JUN-2010 was vaccinated with the first dose of MMR II (lot# 666510/1624Y) in the left thigh SC, the first dose of VARIVAX (Merck) (Lot# 666486/1647Y) in the left thigh SC, the first dose of VAQTA (MSD) (Lot# 667262/0245Z) in the right lateral thigh IM and a third dose of PREVENAR 13 (Lot# WLLE5119Y) in the right lateral thigh IM. The patient came in for routine 12 month checking and remembered above vaccines also given. The patient was prescribed amoxicillin 400/5, 1 tablet, teaspoon, BID x 10 days for sinusitis. (Child afebriled). There was no lab diagnostic test performed. On 28-JUN-2010 the patient was recovered. At the time of the report it was receding. Follow up information has been received from the nurse who reported that on 24-JUN-2010 the patient complained of rash. On 26-JUN-2010 the patient was rechecked and the rash was receding. On 12-JUN-2010, the patient's mother phoned and reported that the patient recovered completely from rash today. The patient was acting fine. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: MMR
Symptoms: Abasia, Arthralgia, Aspiration joint, Blood immunoglobulin G, Joint injection
Clinical narrative: Information has been received from a physician concerning a 58 year old male patient with a pacer placed and a history of pneumonia with multi-organ failure years ago who on 18-MAY-2010, was vaccinated with a dose of MMR II (lot # 665801/1288Y). Concomitant therapy included aspirin. On 24-MAY-2010, the patient experienced pain in the knees and right wrist and stiffness in the knees. The physician stated that the patient started with pain and stiffness in the one knee and then later developed it in another knee. Right now the patient only had 30% motion in the knees. The physician stated the patient now had pain in the right wrist. The patient's pain in the knees and right wrist, stiffness in knees and 30% motion in the knees persisted. The patient contacted physician for adverse events. The reporter felt that the adverse events might be due to MMR II. Follow up information was received from the physician who reported that on 03-MAY-2010, the patient was seen for travel to another place in other country. He received the first dose of IPOL SC into the right arm (lot #A0548) and the second dose of TYPHIM VI IM into the left deltoid (lot # A0412). The patient received the first dose of TYPHIM VI IM into the left deltoid (lot # A0412) on 20-MAY-2008. Titer for measles, mumps and rubella was negative. On 18-MAY-2010 at 09:00, the patient received the first dose of MMR II (lot # 665801/1286Y) SC into the left arm. On 31-MAY-2010 at 20:00 ("approximately 13 days after MMR II (previously reported as 24-MAY-2010), both knees were stiff and the patient was unable to walk. The patient also experienced swelling in joints. The condition worsened one week after to include right wrist pain and stiffness. The patient was requested removal of synovial fluid in left knee and had steroid injection. The patient also experienced elbow pain and stiffness. The patient had 30% both knees circle because of pain. On 04-JUN-2010, the patient had removal of synovial fluid in left knee and was given steroid injection at orthopedics. On 06-JUN-2010, the symptoms resolved. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: MMR
Symptoms: Joint range of motion decreased, Joint stiffness, Joint swelling, Measles antibody negative, Mumps antibody test negative
Clinical narrative: Information has been received from a physician concerning a 58 year old male patient with a pacer placed and a history of pneumonia with multi-organ failure years ago who on 18-MAY-2010, was vaccinated with a dose of MMR II (lot # 665801/1288Y). Concomitant therapy included aspirin. On 24-MAY-2010, the patient experienced pain in the knees and right wrist and stiffness in the knees. The physician stated that the patient started with pain and stiffness in the one knee and then later developed it in another knee. Right now the patient only had 30% motion in the knees. The physician stated the patient now had pain in the right wrist. The patient's pain in the knees and right wrist, stiffness in knees and 30% motion in the knees persisted. The patient contacted physician for adverse events. The reporter felt that the adverse events might be due to MMR II. Follow up information was received from the physician who reported that on 03-MAY-2010, the patient was seen for travel to another place in other country. He received the first dose of IPOL SC into the right arm (lot #A0548) and the second dose of TYPHIM VI IM into the left deltoid (lot # A0412). The patient received the first dose of TYPHIM VI IM into the left deltoid (lot # A0412) on 20-MAY-2008. Titer for measles, mumps and rubella was negative. On 18-MAY-2010 at 09:00, the patient received the first dose of MMR II (lot # 665801/1286Y) SC into the left arm. On 31-MAY-2010 at 20:00 ("approximately 13 days after MMR II (previously reported as 24-MAY-2010), both knees were stiff and the patient was unable to walk. The patient also experienced swelling in joints. The condition worsened one week after to include right wrist pain and stiffness. The patient was requested removal of synovial fluid in left knee and had steroid injection. The patient also experienced elbow pain and stiffness. The patient had 30% both knees circle because of pain. On 04-JUN-2010, the patient had removal of synovial fluid in left knee and was given steroid injection at orthopedics. On 06-JUN-2010, the symptoms resolved. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: Information has been received from a physician concerning a 58 year old male patient with a pacer placed and a history of pneumonia with multi-organ failure years ago who on 18-MAY-2010, was vaccinated with a dose of MMR II (lot # 665801/1288Y). Concomitant therapy included aspirin. On 24-MAY-2010, the patient experienced pain in the knees and right wrist and stiffness in the knees. The physician stated that the patient started with pain and stiffness in the one knee and then later developed it in another knee. Right now the patient only had 30% motion in the knees. The physician stated the patient now had pain in the right wrist. The patient's pain in the knees and right wrist, stiffness in knees and 30% motion in the knees persisted. The patient contacted physician for adverse events. The reporter felt that the adverse events might be due to MMR II. Follow up information was received from the physician who reported that on 03-MAY-2010, the patient was seen for travel to another place in other country. He received the first dose of IPOL SC into the right arm (lot #A0548) and the second dose of TYPHIM VI IM into the left deltoid (lot # A0412). The patient received the first dose of TYPHIM VI IM into the left deltoid (lot # A0412) on 20-MAY-2008. Titer for measles, mumps and rubella was negative. On 18-MAY-2010 at 09:00, the patient received the first dose of MMR II (lot # 665801/1286Y) SC into the left arm. On 31-MAY-2010 at 20:00 ("approximately 13 days after MMR II (previously reported as 24-MAY-2010), both knees were stiff and the patient was unable to walk. The patient also experienced swelling in joints. The condition worsened one week after to include right wrist pain and stiffness. The patient was requested removal of synovial fluid in left knee and had steroid injection. The patient also experienced elbow pain and stiffness. The patient had 30% both knees circle because of pain. On 04-JUN-2010, the patient had removal of synovial fluid in left knee and was given steroid injection at orthopedics. On 06-JUN-2010, the symptoms resolved. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Eyelid oedema, Loss of consciousness, Ocular hyperaemia, Swelling face
Clinical narrative: Information has been received from a physician concerning a 4 year old female with no known illness and pre-existing medical conditions who on 30-JUL-2010 at 17:00 was vaccinated with the second dose of MMR II (lot# 665750/1564Y) in her right arm and the second dose of VARIVAX (Merck) (lot# 666490/1659Y) in her left arm. There was no concomitant therapy. The patient stated that on 30-JUL-2010 the child rolled eyes and started to suffer convulsions. The patient was referred to ER/hospital and had a quick view in hospital. At the time of the report, the outcome of the events was known. Upon internal review, convulsions were determined to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Convulsion, Gaze palsy
Clinical narrative: Information has been received from a physician concerning a 4 year old female with no known illness and pre-existing medical conditions who on 30-JUL-2010 at 17:00 was vaccinated with the second dose of MMR II (lot# 665750/1564Y) in her right arm and the second dose of VARIVAX (Merck) (lot# 666490/1659Y) in her left arm. There was no concomitant therapy. The patient stated that on 30-JUL-2010 the child rolled eyes and started to suffer convulsions. The patient was referred to ER/hospital and had a quick view in hospital. At the time of the report, the outcome of the events was known. Upon internal review, convulsions were determined to be an other important medical event. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: MMR
Symptoms: Ear pain, Pallor, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 10-AUG-2010 was vaccinated with a dose of MMR II and on 12-AUG-2010 was vaccinated with a dose of VARIVAX (Merck). No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received from a physician via medical records which indicated that the patient was a 15 months old female patient with milk allergy who on 15-JUL-2010, was vaccinated with the first dose MMR II (lot # 665205/0873Y) into her left thigh approximately at 10:30 AM. On 24-JUL-2010, the patient experienced fever. On 25-JUL-2010, the patient developed a rash which started on her face and progressed downward. On 27-JUL-2010, the patient was seen in the reporting clinic, it was mentioned that the onset of rash was gradual and lasted several days and had been gradually worsening. Initially, it was not itchy but after the abdomen was itchy. The patient also had fever less than 100 that had resolved over the weekend. The patient was drinking well with good urine output. Upon examination, the patient was positive for fever, for ear pain and rash. Her skin was warm, the rash was described as maculopapular blanching rash discrete lesions numerous on every part of the body including the groin, palms and soles except the mucous membranes. Otherwise the examination was normal. The patient was given BENADRYL with minimal change in rash. She was discharged in stable condition. A final diagnosis of rash-non specific possible MMR II adverse reaction drug rash was made. The case was going to be discussed with the responsible physician for possible hypersensitivity reaction vs. another contributing etiology prior to second MMR II. On an unspecified date, the patient recovered from fever and maculopapular blanching rash discrete lesions numerous on every part of the body. Additional information is not expected.
Age: 1.27
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic, Skin lesion, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 10-AUG-2010 was vaccinated with a dose of MMR II and on 12-AUG-2010 was vaccinated with a dose of VARIVAX (Merck). No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received from a physician via medical records which indicated that the patient was a 15 months old female patient with milk allergy who on 15-JUL-2010, was vaccinated with the first dose MMR II (lot # 665205/0873Y) into her left thigh approximately at 10:30 AM. On 24-JUL-2010, the patient experienced fever. On 25-JUL-2010, the patient developed a rash which started on her face and progressed downward. On 27-JUL-2010, the patient was seen in the reporting clinic, it was mentioned that the onset of rash was gradual and lasted several days and had been gradually worsening. Initially, it was not itchy but after the abdomen was itchy. The patient also had fever less than 100 that had resolved over the weekend. The patient was drinking well with good urine output. Upon examination, the patient was positive for fever, for ear pain and rash. Her skin was warm, the rash was described as maculopapular blanching rash discrete lesions numerous on every part of the body including the groin, palms and soles except the mucous membranes. Otherwise the examination was normal. The patient was given BENADRYL with minimal change in rash. She was discharged in stable condition. A final diagnosis of rash-non specific possible MMR II adverse reaction drug rash was made. The case was going to be discussed with the responsible physician for possible hypersensitivity reaction vs. another contributing etiology prior to second MMR II. On an unspecified date, the patient recovered from fever and maculopapular blanching rash discrete lesions numerous on every part of the body. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient, who on an unspecified date was vaccinated with the first dose of MMR II (Lot # and route not reported) and VARIVAX (Merck) (Lot # and route not reported). On 25-AUG-2010, the patient was vaccinated with 0.5ml second dose of MMR II (Lot # 667318/0440Z) (route not reported) and a second dose of VARIVAX (Merck) (Lot # 666923/0344Z) (route not reported) in the opposite arm. The physician reported that after receiving the second dose, the patient experienced significant redness at the injection side of MMR II and surrounding area. The patient subsequently experienced significant redness at the injection side and surrounding area on the opposite arm while on therapy with VARIVAX (Merck). At the time of the report, the outcome of the patient was no reported. The patient sought unspecified medical attention. Follow-up information has been received from a physician concerning the 13 year old female patient who on 24-AUG-2010 (previously reported as 25-AUG-2010) was vaccinated subcutaneously into the right arm with the second dose of MMR II (Lot # 667318/0440Z). Secondary suspect therapy included subcutaneous vaccination into the left arm with the second dose of VARIVAX (Merck) (Lot # 666923/0344Z). On 25-AUG-2010, the patient developed at the site of VARIVAX (Merck) injection an approximately 7*9 cm area of redness, tender and at the site of MMR II injection an approximately 4*6 cm area of redness, tender. The patient did not require an ER/Dr visit. Patient recovered on an unspecified date. No further information is available.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old patient with not illness at the time of vaccination, and not pre-existing allergies, birth defects or medical conditions, who on 18-AUG-2010 was vaccinated subcutaneously into the right thigh with the first dose of measles virus vaccine live (Lot # 665803/1290Y) in the afternoon. On the same day, the patient received the fourth dose of DAPTACEL (lot#:U3282CA) and the fourth dose of ACTHIB (lot#:UH083AB), both given intramuscularly into the left leg in the afternoon. It was reported per mom that on 01-SEP-2010 the patient developed fever for 2 days and rash for days. On an unspecified date, the patient had recovered from the adverse event. No laboratory tests were performed. The patient did not seek medical attention. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Rash pustular
Clinical narrative: Information has been received from a physician concerning a 20 month old male patient with no pertinent medical history or drug allergies/reactions, who on 02-MAR-2010 was vaccinated with a dose of MMR II (Lot # 663508/1726X), SC. Other suspect therapy administered on the same date included VARIVAX (Merck), therapy route unspecified, and a dose of HAVRIX (Lot # AHAVB312AA), IM. It was reported that the patient on 23-NOV-2010 experienced red pustules in clusters on the left interior lateral thigh after receiving the vaccines previously mentioned. It was also reported that the injection site "could had been on the thigh". At the time of this report, the patient had recovered from the adverse event on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse of the health department concerning a female patient with complaint of getting rashes at time with unknown cause who on 04-JAN-2011 was vaccinated with MMR II (lot # 667730/1045Z, expiration date unspecified) 0.5mL, VARIVAX (Merck) (MSD) and ADACEL concomitantly. On approximately 06-JAN-2011 the patient developed "a cellulitis-like swelling in the arm where the MMR II was given. It was warm to the touch and the swelling spread into her arm and to her breast area. The patient went to an ER at an unspecified hospital but was not admitted". The patient was given 2 medications for the treatment of her adverse events. At the time of report, the outcome of the patient was unknown. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL
Symptoms: Breast swelling, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse of the health department concerning a female patient with complaint of getting rashes at time with unknown cause who on 04-JAN-2011 was vaccinated with MMR II (lot # 667730/1045Z, expiration date unspecified) 0.5mL, VARIVAX (Merck) (MSD) and ADACEL concomitantly. On approximately 06-JAN-2011 the patient developed "a cellulitis-like swelling in the arm where the MMR II was given. It was warm to the touch and the swelling spread into her arm and to her breast area. The patient went to an ER at an unspecified hospital but was not admitted". The patient was given 2 medications for the treatment of her adverse events. At the time of report, the outcome of the patient was unknown. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Areflexia, Asthenia, CSF protein increased, Guillain-Barre syndrome, Laboratory test normal
Clinical narrative: Guillain-Barre; treated with IVIG 0.4gm/kg daily x 5 days.
Age: 40.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Lumbar puncture abnormal, Neuropathy peripheral, Paralysis
Clinical narrative: Guillain-Barre; treated with IVIG 0.4gm/kg daily x 5 days.
Age: 40.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Bacterial test negative, Borrelia test negative, CSF protein increased, CSF test normal, CSF virus no organisms observed
Clinical narrative: Guillain-Barre; treated with IVIG 0.4gm/kg daily x 5 days.
Age: 40.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Chest X-ray normal, Epstein-Barr virus test negative, Full blood count normal, Guillain-Barre syndrome, HIV test negative
Clinical narrative: Guillain-Barre; treated with IVIG 0.4gm/kg daily x 5 days.
Age: 40.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Herpes simplex serology negative, Immunoglobulin therapy, Metabolic function test, Red blood cell sedimentation rate normal
Clinical narrative: Guillain-Barre; treated with IVIG 0.4gm/kg daily x 5 days.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Influenza virus test negative, Pyrexia, Rash generalised, Streptococcus test negative
Clinical narrative: Information has been received from a physician concerning a 12 month old male patient with no pertinent medical history and no drug reactions or allergies who on 16-FEB-2011 was vaccinated with a dose of MMR II (lot# 667246/0907Z). On 23-FEB-2011, the patient developed fever of 104.5F and a rash on his trunk. The patient was examined on 27-FEB-2011, and was found to have a diffuse maculo-papular rash. The physician stated that there was no scleral injection and no Koplik spots. A monospot test was negative. Measles titer and Epstein-Barr titer were pending. A complete blood count revealed white blood cell count of 6.6 with 86% lymph and 14% granulocytes. The patient was examined again on 01-MAR-2011, and the rash was resolving "from the legs up". During that exam, the patient was diagnosed with perianal strep and strep pharyngitis, which was treated with ceftriaxone injection. At the time of the report the patient's perianal strep and strep pharyngitis were unknown. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667246/0907Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Epstein-Barr virus test negative, Full blood count, Granulocyte percentage, Lymphocyte percentage increased, Mononucleosis heterophile test negative
Clinical narrative: Information has been received from a physician concerning a 12 month old male patient with no pertinent medical history and no drug reactions or allergies who on 16-FEB-2011 was vaccinated with a dose of MMR II (lot# 667246/0907Z). On 23-FEB-2011, the patient developed fever of 104.5F and a rash on his trunk. The patient was examined on 27-FEB-2011, and was found to have a diffuse maculo-papular rash. The physician stated that there was no scleral injection and no Koplik spots. A monospot test was negative. Measles titer and Epstein-Barr titer were pending. A complete blood count revealed white blood cell count of 6.6 with 86% lymph and 14% granulocytes. The patient was examined again on 01-MAR-2011, and the rash was resolving "from the legs up". During that exam, the patient was diagnosed with perianal strep and strep pharyngitis, which was treated with ceftriaxone injection. At the time of the report the patient's perianal strep and strep pharyngitis were unknown. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667246/0907Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Perianal streptococcal infection, Pharyngitis streptococcal, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 12 month old male patient with no pertinent medical history and no drug reactions or allergies who on 16-FEB-2011 was vaccinated with a dose of MMR II (lot# 667246/0907Z). On 23-FEB-2011, the patient developed fever of 104.5F and a rash on his trunk. The patient was examined on 27-FEB-2011, and was found to have a diffuse maculo-papular rash. The physician stated that there was no scleral injection and no Koplik spots. A monospot test was negative. Measles titer and Epstein-Barr titer were pending. A complete blood count revealed white blood cell count of 6.6 with 86% lymph and 14% granulocytes. The patient was examined again on 01-MAR-2011, and the rash was resolving "from the legs up". During that exam, the patient was diagnosed with perianal strep and strep pharyngitis, which was treated with ceftriaxone injection. At the time of the report the patient's perianal strep and strep pharyngitis were unknown. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667246/0907Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 12 month old male patient with no pertinent medical history and no drug reactions or allergies who on 16-FEB-2011 was vaccinated with a dose of MMR II (lot# 667246/0907Z). On 23-FEB-2011, the patient developed fever of 104.5F and a rash on his trunk. The patient was examined on 27-FEB-2011, and was found to have a diffuse maculo-papular rash. The physician stated that there was no scleral injection and no Koplik spots. A monospot test was negative. Measles titer and Epstein-Barr titer were pending. A complete blood count revealed white blood cell count of 6.6 with 86% lymph and 14% granulocytes. The patient was examined again on 01-MAR-2011, and the rash was resolving "from the legs up". During that exam, the patient was diagnosed with perianal strep and strep pharyngitis, which was treated with ceftriaxone injection. At the time of the report the patient's perianal strep and strep pharyngitis were unknown. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667246/0907Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a pharmacist concerning one of her 15 months old female twins, with no pertinent medical history, drug reactions or allergies reported, who on 15-MAR-2011 was vaccinated with her first dose of MMR II (Lot #, dose and route not reported). Secondary suspect therapy included VARIVAX (Lot #, dose and route not reported). There was no concomitant medication. The pharmacist reported that on the evening of 17-MAR-2011 the patient was crying inconsolably, and was taken to the emergency room. Unspecified laboratory tests were performed and all came back normal. The pharmacist reported that the patient quieted down following the administration of MOTRIN for the treatment of the adverse event. The pharmacist reported that also on 24-MAR-2011, the patient experienced an afebrile seizure and resulted in the patient being unconscious for five minutes. Pharmacist reported that the other twin tolerated both vaccines without incident. In March 2011, the patient's outcome was recovered. Upon internal review afebrile seizure was considered to be an Other Important medical Event. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Convulsion, Crying, Laboratory test normal, Loss of consciousness
Clinical narrative: Information has been received from a pharmacist concerning one of her 15 months old female twins, with no pertinent medical history, drug reactions or allergies reported, who on 15-MAR-2011 was vaccinated with her first dose of MMR II (Lot #, dose and route not reported). Secondary suspect therapy included VARIVAX (Lot #, dose and route not reported). There was no concomitant medication. The pharmacist reported that on the evening of 17-MAR-2011 the patient was crying inconsolably, and was taken to the emergency room. Unspecified laboratory tests were performed and all came back normal. The pharmacist reported that the patient quieted down following the administration of MOTRIN for the treatment of the adverse event. The pharmacist reported that also on 24-MAR-2011, the patient experienced an afebrile seizure and resulted in the patient being unconscious for five minutes. Pharmacist reported that the other twin tolerated both vaccines without incident. In March 2011, the patient's outcome was recovered. Upon internal review afebrile seizure was considered to be an Other Important medical Event. Additional information has been requested.
Age: 1.69
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Choking, Convulsion, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient was sick with flu like symptoms on 4/4/11 less than three days after her vaccinations (DTaP, Hib, Polio and Pneumococcal).  She has a high fever and was throwing up. She had her first seizure (not known to be a seizure at that time) at 5am on 4/6/11 an ambulance was called and we went to medical center for an evaluation.  We were sent home with a diagnosis of dehydration due to sickness. Patient suffered a second seizure around 4pm of the same day 4/6/11, an ambulance was called and we went to medical center for further medical treatment.  A third seizure happened while at the emergency room around 6pm and she was transferred to another hospital for observation.  She stayed overnight with no more seizures and was sent home the next day with a possible diagnosis of seizures due to a viral type illness.
Age: 1.69
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Convulsion, Dehydration, Influenza like illness, Malaise, Pyrexia
Clinical narrative: Patient was sick with flu like symptoms on 4/4/11 less than three days after her vaccinations (DTaP, Hib, Polio and Pneumococcal).  She has a high fever and was throwing up. She had her first seizure (not known to be a seizure at that time) at 5am on 4/6/11 an ambulance was called and we went to medical center for an evaluation.  We were sent home with a diagnosis of dehydration due to sickness. Patient suffered a second seizure around 4pm of the same day 4/6/11, an ambulance was called and we went to medical center for further medical treatment.  A third seizure happened while at the emergency room around 6pm and she was transferred to another hospital for observation.  She stayed overnight with no more seizures and was sent home the next day with a possible diagnosis of seizures due to a viral type illness.
Age: 1.69
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Vomiting
Clinical narrative: Patient was sick with flu like symptoms on 4/4/11 less than three days after her vaccinations (DTaP, Hib, Polio and Pneumococcal).  She has a high fever and was throwing up. She had her first seizure (not known to be a seizure at that time) at 5am on 4/6/11 an ambulance was called and we went to medical center for an evaluation.  We were sent home with a diagnosis of dehydration due to sickness. Patient suffered a second seizure around 4pm of the same day 4/6/11, an ambulance was called and we went to medical center for further medical treatment.  A third seizure happened while at the emergency room around 6pm and she was transferred to another hospital for observation.  She stayed overnight with no more seizures and was sent home the next day with a possible diagnosis of seizures due to a viral type illness.
Age: 1.92
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Sleep terror
Clinical narrative: Night Terrors from 2:00 AM to 4:00 AM.
Age: 41.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Gastrointestinal disorder, Stool analysis abnormal
Clinical narrative: Within 2 weeks after each of her three vaccinations for hep B, she had a GI episode similar to diverticulitis or colitis.  None of the episodes have received a definitive diagnosis.  She has given a stool sample, which showed nothing except a lack of GI flora.  She has been referred to Dr. for a colonoscopy, not yet scheduled.  She has no history of this type of incident prior to these three--all of which developed 2 weeks after receiving the hep B vaccine.
Age: 29.0
Sex: M
Vaccine: HEPAB, TDAP, TYP
Symptoms: Convulsion
Clinical narrative: Patient had a seizure.
Age: 26.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Nausea/Vomiting/HA/Muscle aches/Fever 102 degree/pain at site of vaccination
Age: 26.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Vomiting
Clinical narrative: Nausea/Vomiting/HA/Muscle aches/Fever 102 degree/pain at site of vaccination
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient noticed swelling on 05/26/2011 late evening around 9.00 pm and started putting ice pack. On Saturday and Sunday pain got worst and patient went to ER and got oral antibiotic and pain medication RX from DR. Her swelling is in control with meds today on 06/01/2011.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Condition aggravated, Sickle cell anaemia with crisis
Clinical narrative: Information has been received from a physician concerning a 11 year old male patient with sickle cell disease who "approximately 2 weeks ago", on approximately 11-MAY-2011 was vaccinated with the first dose of GARDASIL. On approximately 11-MAY-2011, the patient was admitted to a medical center that evening with sickle cell crisis. It was reported that the patient was later transferred to a hospital on an unspecified date. At the time of the report, the patient's present status was unknown. Sickle cell disease was considered to be immediately life-threatening by the physician. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Grand mal convulsion
Clinical narrative: Information has been received from a physician concerning an 18 year old male patient who in April 2011, was vaccinated with the first dose of GARDASIL intramuscularly, ( lot number not reported). There was no concomitant medication. The physician stated that the patient smoked marijuana "after the administration". In approximately April 2011, two weeks after the administration of GARDASIL, the patient had a seizure with tonic clonic activity and had an over night hospital stay. The patient received unspecified treatment. At the time of the report the event improved, although, the patient's status was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a female consumer, for GARDASIL, a Pregnancy Registry product, reporting on herself who on an unspecified date was vaccinated with a dose of GARDASIL (lot# not reported) while she was pregnant. It was reported that on an unspecified date the consumer had a miscarriage. The patient's LMP and EDD were not reported. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Upon internal review, miscarriage was determined to be an other important medical event. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Licensed practical nurse, concerning  her mother or mother in law (this was not specified), who in 2010, last year, was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, dose and route not reported). The LPN reported that the patient now had zoster and on an unknown date, was admitted to hospital, however it was not known whether this was believed to be related to ZOSTAVAX (Merck). Unspecified treatment was given for the event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Posturing, VIIth nerve paralysis
Clinical narrative: Pt. given injection while laying down, stated "was fine" - dangled at side of exam table x 1 min, transferred to chair - several minutes later was pale, side of face drooped, decorticate posturing and slumped down. Transferred by RN & FNP to floor. Recovery in 1 min.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Local reaction, Nodule, Skin warm, Swelling
Clinical narrative: On 5/24 @ 8:30 pm swelling with knot; skin warm to touch. Next morning second knot appeared. "Looked like 2 mosquito bites" per mother.  Mom took patient to MD (on 5/26/11; MD stated "no infection.   Localized reaction". No treatment.  Also no redness noted.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site rash, Injection site swelling, Rash macular
Clinical narrative: That morning his leg had a splotchy rash, but by that afternoon the rash had spread considerably and his leg had doubled in size.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Dry skin, Erythema, Skin exfoliation, Skin warm
Clinical narrative: Inner arm red, heat, dry, scaly. Pharmacist told patient to watch area & seek medical attention if not better. Patient said area was better & would see doctor if got worse. Pharmacist told patient to take BENADRYL & ADVIL. Pharmacist called patient on Saturday & Monday & patient improved. Patient did not see doctor.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Dry skin, Erythema, Skin exfoliation, Skin warm
Clinical narrative: Inner arm red, heat, dry, scaly. Pharmacist told patient to watch area & seek medical attention if not better. Patient said area was better & would see doctor if got worse. Pharmacist told patient to take BENADRYL & ADVIL. Pharmacist called patient on Saturday & Monday & patient improved. Patient did not see doctor.