chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 19 February 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 2 doses of PENTACEL; lot number C3498AA received on 22 December 2009 and lot number C3226AA received on 11 March 2009, and 2 doses of DAPTACEL; lot number C2956AA received on 12 November 2008 and lot number C2957AA received on 12 January 2009 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 16 January 2013, approximately three years after the last dose. On 17 January 2013, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 17 January 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 17 January 2013 for five days. The subject was not hospitalized. At the time of final contact on 30 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 19 February 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 2 doses of PENTACEL; lot number C3498AA received on 22 December 2009 and lot number C3226AA received on 11 March 2009, and 2 doses of DAPTACEL; lot number C2956AA received on 12 November 2008 and lot number C2957AA received on 12 January 2009 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 16 January 2013, approximately three years after the last dose. On 17 January 2013, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 17 January 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 17 January 2013 for five days. The subject was not hospitalized. At the time of final contact on 30 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 19 February 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 10-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance Study (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4131AA received on 23 March 2012, lot number C4182AA received on 25 May 2012, and lot number C4270AA received on 27 July 2012. (Routes and sites of administration not reported). The subject developed a cough on 01 December 2012, approximately 4 months after the last dose, and a paroxysmal cough without a whoop on 10 December 2012. The subject also developed cold like symptoms on 05 December 2012, posttussive vomiting, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 12 December 2012. Chest x-ray findings were unknown. Corrective treatments consisted of azithromycin starting on 12 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 22 January 2013, the subject's cough was not persisting. The duration of the cough was reported at that time as 32 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 19 February 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 10-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance Study (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4131AA received on 23 March 2012, lot number C4182AA received on 25 May 2012, and lot number C4270AA received on 27 July 2012. (Routes and sites of administration not reported). The subject developed a cough on 01 December 2012, approximately 4 months after the last dose, and a paroxysmal cough without a whoop on 10 December 2012. The subject also developed cold like symptoms on 05 December 2012, posttussive vomiting, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 12 December 2012. Chest x-ray findings were unknown. Corrective treatments consisted of azithromycin starting on 12 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 22 January 2013, the subject's cough was not persisting. The duration of the cough was reported at that time as 32 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Irritability
Clinical narrative: DTaP & Hib given on 2/26/13. Baby fussy & irritable. Imms given on Tuesday. Resolved on Saturday 3/2/13.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Contusion, Haematoma, Musculoskeletal pain, Neck pain
Clinical narrative: Hematoma, bruising. Severe pain in left arm by following morning. Chronic pain in arms, shoulders and neck still (5 months later). Naproxen, tramadol. MRI's & x-rays.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendonitis, X-ray
Clinical narrative: Hematoma, bruising. Severe pain in left arm by following morning. Chronic pain in arms, shoulders and neck still (5 months later). Naproxen, tramadol. MRI's & x-rays.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Dyspnoea, Erythema, Lip swelling, Pruritus, Swelling face
Clinical narrative: 11 am Vaccines administered. 11:15 Developed gen pruritus, throat tightening & SOB. Which resolved spontaneously. 12:00 Went to lunch, ate pizza, then developed facial & lip swelling with erythema.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Throat tightness
Clinical narrative: 11 am Vaccines administered. 11:15 Developed gen pruritus, throat tightening & SOB. Which resolved spontaneously. 12:00 Went to lunch, ate pizza, then developed facial & lip swelling with erythema.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Lip swelling, Urticaria
Clinical narrative: 11 am Vaccines administered. 11:15 Developed gen pruritus, throat tightening & SOB. Which resolved spontaneously. 12:00 Went to lunch, ate pizza, then developed facial & lip swelling with erythema.
Age: 0.55
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Crying, Pyrexia
Clinical narrative: Received DTAP, Hib, Hep B, PCV 12, IPV and afterwards developed fever, and it was 104 to 105 degrees with non-stop crying per mom on 3-1-13. Referred to take to MD. F/U on 3/14/13 didn't take to MD fever broke turned around after talking with nurse per mom.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Rash
Clinical narrative: Rash on back & muscle spasms. Hydroxyzine pamoate 25mg. Methylprednisolone acetate 80mg/ml office admin.
Age: 27.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Erythematous macular rash on truck, legs and arms.  Treatment:  Already is on Allegra D daily.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm, Vaccination complication
Clinical narrative: Pt.came into Health Center c/o reaction to PPV23 vaccine. Area assessed by RN, CHN. Area very red, inflammed and warm to touch. Redness starts from area of injection and has spread down to antecubital area - 7.5 inches in length. It has encompassed the arm and has spread 7 inches in width. Area marked and dated. Instructed pt. to go to PCP 02/28/13 to have arm evaluated. Pt. verbalized understanding per RN.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS OF LEFT ARM, SWELLING EXTENDING TO THE ELBOW, PAIN, WARMTH, DIAGNOSED AS CELLULITIS BY ER PHYSICIAN.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Woke up in the middle of the night with vomiting, diarrhea, and headache.  The injection site was red, raised and extremely sore to move at all.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Vomiting
Clinical narrative: Woke up in the middle of the night with vomiting, diarrhea, and headache.  The injection site was red, raised and extremely sore to move at all.
Age: 1.15
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash generalised
Clinical narrative: 9 days after being vaccinated, patient had a 102* fever. The next day his fever was 101* and he broke out in 1-2 dozen red, raised spots on his trunk. The third day, March 3, he had no fever and hundreds of red, raised pimply type spots all over his body. They appeared in waves through out the day. Day 4 is today and he woke up with dozens of new spots on his face, neck and scalp. He has spots over his entire body, including genitals, feet, limbs, and hands. He isn't in any discomfort or itching.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching/Hives.
Age: 1.54
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling to injection site, L thigh.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: FEVER, CHILLS, NAUSEA, ITCHING AT INJECTION SITE, SWOLLEN AT INJECTION SITE, REDNESS AT INJECTION SITE, TIREDNESS.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: FEVER, CHILLS, NAUSEA, ITCHING AT INJECTION SITE, SWOLLEN AT INJECTION SITE, REDNESS AT INJECTION SITE, TIREDNESS.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Abnormal behaviour, Body temperature increased, Full blood count normal, Gaze palsy, Liver function test normal
Clinical narrative: At approximately 2100 patients mother heard child "struggling to cry" over the baby monitor. Upon entering the room the parent states the childs torso was still eyes were rolled back and left arm and leg were twitching. Father of patient came into room noting all four limbs were shaking/twitching. Episode lasted approximatly 2-3 minutes and child was not"acting like usual" after and parents transported to closest ED. On call pediatrician reccomended over night observation and mother of patient requested a transfer to another hospital. Patient afebrile at time of arrival at ED, temp did increase during visit to 100.3 at 2330.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Metabolic function test normal, Muscle twitching, Tremor
Clinical narrative: At approximately 2100 patients mother heard child "struggling to cry" over the baby monitor. Upon entering the room the parent states the childs torso was still eyes were rolled back and left arm and leg were twitching. Father of patient came into room noting all four limbs were shaking/twitching. Episode lasted approximatly 2-3 minutes and child was not"acting like usual" after and parents transported to closest ED. On call pediatrician reccomended over night observation and mother of patient requested a transfer to another hospital. Patient afebrile at time of arrival at ED, temp did increase during visit to 100.3 at 2330.
Age: 0.81
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Convulsion, Hypokinesia, Lethargy, Pyrexia, Vomiting
Clinical narrative: Pt's dad called to report pt convulsing, "can't move his legs", high fever, vomiting, lethargy. Directed parent to take child to ER.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Severe itching all over body.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: FEVER TO 103, CHILLS, NAUSEA.
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. About a month ago on an unknown date in January 2013 the patient was vaccinated with PNEUMOVAX 23 (lot # was not reported. Please add: Route of administration was not provided). On an unknown date in 2013 the patient developed a swollen arm which hurt up to her armpit. It was not reported whether the patient sought medical attention. The outcome of the adverse event was unknown. Additional information will be requested.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Mother reports erythematous area on (R) thigh 1 day post-vaccine. In clinic 2/21/13, upper/medial (R) thigh shows erythematous patch approx 2 inches in diameter. No fever, exudate, induration. Advised ice packs, f/u PRN.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Saturday morning, woke up with very itchy left shoulder and intense pain. Itchiness & pain lasted all weekend. Put ice pack on Sat. & Sun.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from an other health professional refers to a 15 or 16 year old female patient. On 10-JAN-2013 (reported as 6 weeks ago) the patient was vaccinated with the first dose of GARDASIL. On 11-JAN-2013, reported as the next day, the patient experienced hives. The reporter implied that the patient would not return for the next dose. It was unknown if the patient sought medical attention. The health professional believed that the patient had recovered from hives. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age with no pertinent medical history and no drug reactions/allergies. On 15-FEB-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously. There was no concomitant medication. In February 2013, a few days after she received ZOSTAVAX, the patient developed an injection site rash that was warm to touch. The pharmacist declined VZVIP packet. The patient contacted pharmacist for medical attention. No treatment was given for the events. No lab diagnostics studies were performed. The outcome of injection site rash that was warm to touch was reported as not recovered. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMRV, PNC13
Symptoms: Erythema, Joint swelling, Serum sickness
Clinical narrative: Serum sickness secondary to Hep B #2: redness & swelling to both ankles, R > L; started on 2/26/13. OV on 3/4/13 with some improvement now.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular, Skin irritation
Clinical narrative: This spontaneous report as received from a 66 year old male patient who was a pharmacist via company representative referred to himself. In June 2012 the patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified). In November 2012 (exact date unspecified) he developed a chicken pox like rash on both arms that was itchy (when scratched it became irritated). The chicken pox rash resolved after a couple of weeks(date unspecified). Patient did not seek medical attention. No treatment was given for the events. The relationship was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On an unknown date(reported as a long time ago), the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient experienced rash. The outcome of rash was reported as recovered. Additional information is not expected.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to an 84 year old male patient with unspecified cardiac issue. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose and lot# not reported) subcutaneously. While on ZOSTAVAX, the patient developed shingles. The patient sought unspecified medical attention. At the time of reporting, the outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 27-FEB-2013, the patient was vaccinated subcutaneously with an expired dose of 0.65 milliliter(ml) ZOSTAVAX (lot # 671663/1159AA, expiry:18-OCT-2012). No concomitant medications were reported. Patient did not seek medical attention. No treatment was received. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that the patient was vaccinated with the first dose of GARDASIL on 20-JUL-2012, with the second dose on 27-DEC-2012 and with the third dose on 18-FEB-2013. NO dosage information or route of administration was reported. No lot numbers or expiration dates were reported. No adverse events were reported. No further information was provided. Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: HEPA
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (Bachelor of Science in Nursing) refers to a 18 month old patient. It was reported that on 22-FEB-2013 the patient was vaccinated with VAQTA (lot # 667534/0415Z, 25/0.5 U/ml, 0.5 ml dose, intramuscular route) that had expired on 13-FEB-2013. No other suspect or concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physicians assistant refers to a 20 year old patient. In approximately 2010, stated as over 3 years ago on an unspecified date, the patient was vaccinated with GARDASIL for the second dose. In approximately 2010 on an unknown date the patient experienced the 2nd dose was given over 3 years ago on an unspecified date (Inappropriate schedule of vaccine administered). No further information available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 60 year old female patient regarding herself with no allergies. On 29-JAN-2013, the patient was vaccinated with a single dose of ZOSTAVX (expiry date, lot number and dose were not reported) subcutaneous in the right arm. Concomitant therapies included EVISTA, hydrochlorothiazide and potassium (unspecified). After getting the vaccine patient got a bump and itchiness at the insertion site on her right arm on 30-JAN-2013. The patient described it as raised and about 1 and a half inches long and became 3 inches in area. The patient sought no medical attention and no treatment was given for the events. Approximately on 06-FEB-2013 (reported as after 1 week), the events were recovered/resolved except for an outline at the insertion site. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot number, expiry date and route unspecified). No concomitant medications were reported. On an unknown date, the patient developed a zoster like rash about 2 weeks after getting ZOSTAVAX. The patient sought an unspecified medical attention. The patient was treated with unspecified antivirals. It was unspecified if any lab tests were performed. The outcome of a zoster like rash was unknown. The relatedness for zoster like rash was unknown for ZOSTAVAX. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus generalised
Clinical narrative: This spontaneous report as received regarding a 70 years old female patient from her friend. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route were not reported). On an unknown date, the patient developed an itch and pain all over the body. The outcome of itch and pain all over the body was unknown. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parent self reported; followed up with physician. Per T.C. to doctor's office, no lab work, no treatment was given. Per doctor's office (R) thigh had redness and swelling the size of a dime.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner (NP) refers to a patient of unknown age. The patient was vaccinated with a first dose of GARDASIL on 27-JAN-2012, a second dose of GARDASIL on an unspecified day in April 2012 and a third dose of GARDASIL on 31-JUL-2012. The NP reported the second dose was administered while the patient was away at college and she just learned that this dose was not stored properly, as well as administered on time. No adverse symptoms reported. NP was unable to provide the improper storage details, lot #/expiration date for the GARDASIL in question. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a registered nurse refers to a teenager female patient. On an unknown date, the patient was vaccinated with (Merck) VARIVAX (dose, route and lot number were not provided). On an unknown date, the patient who received (Merck) VARIVAX in the past (unspecified number of doses) had developed chickenpox. The outcome of chickenpox was reported as recovered on unspecific date. The event of chickenpox was unknown related to (Merck) VARIVAX. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral test
Clinical narrative: Information has been received from a medical assistant regarding a 14 year old male patient with asthma, SUPRAX allergy and AUGMENTIN allergy. On 31-JUL-1999, the patient was vaccinated with the first dose of (Merck) VARIVAX (dose and route was not provided) (lot number 0300J, expiration date unknown) and on 21-MAY-2007, was vaccinated with the second dose of (Merck) VARIVAX (dose, route, lot number and expiration date were not provided). Concomitant therapies included PROAIR, albuterol, PULMICORT and SINGULAIR. On or around 13-FEB-2013, the patient developed shingles. The patient was treated with VALTREX for the adverse event. Viral culture was performed (result was not provided). The patient sought medical attention, patient presented at the physician's office. The outcome of shingles was unknown. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Syncope
Clinical narrative: Vasovagal syncope after FLUZONE, GARDASIL.
Age: 1.01
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever 3.1.13 & red spots on left arm 3/3/13.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling, Vaccination site erythema, Vaccination site haemorrhage
Clinical narrative: (L) upper arm red and swollen blood shot out put ice on and TYLENOL with detailed instruction.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Vaccination site swelling
Clinical narrative: (L) upper arm red and swollen blood shot out put ice on and TYLENOL with detailed instruction.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Swelling face
Clinical narrative: Rashes to facial and neck area, swelling to facial areas.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 12 year old female patient. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route were not reported). It was reported that the patient received her first dose of GARDASIL on an unspecified date, and one month after vaccination, the patient developed Bell's Palsy. Patient sought medical attention at emergency room. At the time of the report, patient's outcome was unknown. The relation between medication and event was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: At area of injection - red, itching swollen area - ended up being up the size of patient's hand - started to resolve 3/3/3013 in the afternoon.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC13, VARCEL
Symptoms: Computerised tomogram normal, Hyperaesthesia, Injection site discolouration, Injection site reaction, X-ray limb normal
Clinical narrative: Indentation at the injection site with a purple center, that is very sensitive to touch. Client has had and X-ray and CT scan of the right thigh, both were normal. Client is receiving physical therapy to help desensitizes the area.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain upper, Diarrhoea haemorrhagic, Intussusception, Pain, Stool analysis normal
Clinical narrative: Bloody diarrhea tested poop for answers then the test were negative and then severe pain started with belly pain and was sent to another dr. then sent to the hospital for intussusception.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: SWELLING, REDNESS, PRURITIS TO LEFT UPPER ARM WHERE VACCINES WERE ADMINISTERED.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Chills, low frade fever, injection site red, swollen, painful, rash at site.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Chills, low frade fever, injection site red, swollen, painful, rash at site.
Age: 1.06
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: Erythema, Induration, Swelling, Tenderness, Urticaria
Clinical narrative: Within 2 minutes of vaccine administration there was a 4cm area of induration, erythema and tenderness. Just lateral to the injection site there was a small hive 1cm in size, raised. Benadryl was given and the hive improved and so did the size of the induration.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 5cm X 3cm area of redness note at the varicella site on the left arm. Mom gave Benadryl and applied cold compresses and came into office for eval.
Age: 1.07
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Macule, Papule, Rash, Rash vesicular, Scab
Clinical narrative: RASH TO ABDOMEN NOTED BY MOM 2/22/13. LINEAR CONFLUENT MACULES AND PAPULES IN VARYING STAGES WITH SOME SCABBING/CRUSTING OF LESIONS. LESIONS APPEAR ONLY ON LEFT SIDE OF BODY ON BUTTOCKS, ABDOMEN AND LEG. QUESTIONABLE FEW VESICULAR LESIONS. SUPPORTIVE CARE ONLY AT THIS TIME. MAY USE CALAMINE LOTION, OATMEAL BATH, OR OTC BENADRYL. NO NEED FOR ACYCLOVIR. CONTINUE TO MONITOR. POSSIBLE DX INCLUDES: SCABIES, ECZEMA HERPETICUM, RHUS DERMATITIS, OR MEASLES (DOUBT).
Age: 1.07
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Skin lesion
Clinical narrative: RASH TO ABDOMEN NOTED BY MOM 2/22/13. LINEAR CONFLUENT MACULES AND PAPULES IN VARYING STAGES WITH SOME SCABBING/CRUSTING OF LESIONS. LESIONS APPEAR ONLY ON LEFT SIDE OF BODY ON BUTTOCKS, ABDOMEN AND LEG. QUESTIONABLE FEW VESICULAR LESIONS. SUPPORTIVE CARE ONLY AT THIS TIME. MAY USE CALAMINE LOTION, OATMEAL BATH, OR OTC BENADRYL. NO NEED FOR ACYCLOVIR. CONTINUE TO MONITOR. POSSIBLE DX INCLUDES: SCABIES, ECZEMA HERPETICUM, RHUS DERMATITIS, OR MEASLES (DOUBT).
Age: 37.0
Sex: F
Vaccine: FLUN3
Symptoms: Anaphylactic reaction, Condition aggravated
Clinical narrative: PT CHOSE FLU MIST OVER IM FLU VACCINE, DUE TO PREVIOUS ANAPHYLACTIC REACTION TO INJECTIBLE.  PT BECAME ANAPHYLACTIC 30 MINUTES AFTER RECEIVING FLU MIST NASAL SPRAY.
Age: 35.0
Sex: M
Vaccine: TTOX
Symptoms: Disturbance in attention, Dizziness, Fatigue, Pain in extremity
Clinical narrative: DIZZINESS, DIFFICULTY CONCENTRATING, TIRED AND SORENESS IN ARM.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, MMRV, MNQ
Symptoms: Convulsion, Unresponsive to stimuli
Clinical narrative: PATIENT SLUMPED OVER WHILE SITTING.  WOULD NOT RESPOND.  SHE WAS THEN LAID BACK ON EXAM TABLE WHEN SHE HAD A SEIZURE ABOUT 30 SECONDS LONG.  THE PROVIDERS WERE THEN CALLED IMMEDIATELY INTO ROOM FOR EVALUATION.  PATIENT DID NOT COMPLETELY REGAIN FULL RECOVERY.  THE AMBULANCE WAS CALLED TO TRANSPORT PATIENT TO THE ER FOR FURTHER EVALUATION.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Parents called that she had large local swelling and warmth at site of injection.  Was itching at the time.  Advised to give Benadryl and use cool compress.  Swelling resolved mostly after 3 days upon follow up.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intensive care, Intussusception, Irritability
Clinical narrative: This patient presented with fussiness and a bloody diaper and was found to have intussusception which could not be corrected with contrast enema and required surgical reduction.  No ischemia or necrosis was found.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Surgery, Ultrasound abdomen abnormal
Clinical narrative: This patient presented with fussiness and a bloody diaper and was found to have intussusception which could not be corrected with contrast enema and required surgical reduction.  No ischemia or necrosis was found.
Age: 1.25
Sex: F
Vaccine: FLUX
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Acute Disseminated Encephalomyelitis.
Age: 0.97
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Received vaccine on 1-31-13, and the next morning pt came into office with rash to legs, back, and neck regions.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling Rt deltoid area 5 cm x 5 cm, itching with erythema no induration.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram, Aspiration bone marrow, Blood test, Dizziness, Nausea
Clinical narrative: This spontaneous report as received from a 78 year old female consumer with no pertinent medical history and allergy to hydralazine and COREG reporting on herself. On 01-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). Concomitant therapies included lisinopril (manufacturer unknown) and NORVASC. The consumer reported that on 18-JAN-2013, she was admitted to hospital overnight for an episode of dizziness. Her head was spinning and she suffered from nausea. She also reported that at that time it was found her platelet count jumped to over 1 million. The patient was treated with baby aspirin per day for the adverse events. A blood work, bone marrow aspiration, MRA and brain scan were performed (results not provided). The outcome of dizziness, platelet count jumped to over 1 million, nausea and head was spinning was reported as not recovered/not resolved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Platelet count increased, Scan brain, Vertigo
Clinical narrative: This spontaneous report as received from a 78 year old female consumer with no pertinent medical history and allergy to hydralazine and COREG reporting on herself. On 01-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). Concomitant therapies included lisinopril (manufacturer unknown) and NORVASC. The consumer reported that on 18-JAN-2013, she was admitted to hospital overnight for an episode of dizziness. Her head was spinning and she suffered from nausea. She also reported that at that time it was found her platelet count jumped to over 1 million. The patient was treated with baby aspirin per day for the adverse events. A blood work, bone marrow aspiration, MRA and brain scan were performed (results not provided). The outcome of dizziness, platelet count jumped to over 1 million, nausea and head was spinning was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Asthenia, Muscular weakness, Tachycardia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender unknown who on 22-JAN-2013 was vaccinated with a first 0.5 ml dose of MMR II subcutaneously (anatomical location was not provided) lot number H012142 expiration date unknown. On 22-FEB-2012 was vaccinated with a 0.5 ml second dose of MMR II subcutaneously (anatomical location not provided) lot number reported as H012569 expiration date not provided. In February 2013 the patient experienced general weakness, lower extremity weakness and tachycardia. The patient also stated that they had similar symptoms approximately in January 2013 after receiving the first dose of MMR II. The patient sought medical attention and was referred to an unspecified workers comp physician with a follow up for an unspecified neurologist. The patient was still awaiting results. The outcome of general weakness, lower extremity weakness and tachycardia after the vaccination with the second dose of MMR II was unknown. The relatedness for general weakness, lower extremity weakness and tachycardia was unknown for MMR II. The primary reporter specifically stated that due to the scheduled neurologist appointment, the adverse event of general weakness, lower extremity weakness and tachycardia were considered "significant disability or incapacity". Additional information has been requested. This is one of several reports received from the same source.
Age: 43.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Increased upper airway secretion, Mobility decreased, Pain, Painful respiration
Clinical narrative: PREVNAR 13 given 2-26-13. Client reports he started aching all over that afternoon. The next day he had a headache and his whole body started aching. His lungs hurt on inspiration & expiration, he is sneezing a lot & has lots of mucous. Could not get out of bed whole weekend. To call PCP.
Age: 43.0
Sex: M
Vaccine: PNC13
Symptoms: Sneezing
Clinical narrative: PREVNAR 13 given 2-26-13. Client reports he started aching all over that afternoon. The next day he had a headache and his whole body started aching. His lungs hurt on inspiration & expiration, he is sneezing a lot & has lots of mucous. Could not get out of bed whole weekend. To call PCP.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Rash pruritic, Scab
Clinical narrative: Broke out with itchy bumps 2/18/13. Received VARIVAX 1/31/13 no fever, no malaise. Scabbed over found out, 2/10 she was pregnant did not know at time of injection.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Insomnia, Myalgia, Pain
Clinical narrative: Muscle aches from (L) shoulder down to his (L) hand. Unable to lift arm without extreme pain - unable to sleep.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Fatigue, Feeling hot, Irritability
Clinical narrative: Weakness, weight loss, fatigue, feeling faint, feeling irritable, sensation of warmth.
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Product quality control issue, Syringe issue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 27-FEB-2013 the patient was vaccinated with the second dose of GARDASIL (lot # reported as H019495, expiry date reported as 15-AUG-2015). During administration of the dose of GARDASIL, the dose leaked from the tip of the syringe. PQC was filed. Healthcare worker reported that a second GARDASIL syringe was used to complete the vaccination. Healthcare worker reported that this vaccination was the second dose in the GARDASIL immunization series for this patient. No adverse effect was reported. It was unspecified whether the patient sought for medical attention. It was also reported that the product was a prefilled GARDASIL syringe. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient administered her first dose of GARDASIL in January 2010 and her second dose in January 2012 intramuscularly (dose and lot # not reported). No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) concerning a 12 months old patient (gender not reported) who on 29-JAN-2013, was vaccinated with a dose of PROQUAD (Lot not reported), 0.5 ml, subcutaneous and VARIVAX (lot number, dose and route not reported) during the same office visit. No adverse effect was reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old female patient with no drug reactions or allergies who on 10-JAN-2013, was vaccinated with a dose of ZOSTAVAX (lot # H019035, expiration date 17-JAN-2014) subcutaneously. The pharmacist reported that one month ago in approximately January 2013 after receiving the dose of ZOSTAVAX, the patient developed pain at the injection site. It was reported the patient sought medical attention (the patient saw the pharmacist). No lab diagnostic test was performed. No treatment was given for the adverse event. The outcome of pain at the injection site was reported as not recovered/not resolved. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a physician's assistant refers to an 80 year old female patient. On 26-DEC-2012, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported). The physician reported that on 15-FEB-2013, the patient appeared at her office with a rash and a pain consistent with shingles. The patient was treated with acyclovir. The outcome of shingles was reported as recovered/resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye infection, Influenza, Pain, Rash erythematous
Clinical narrative: Flu symptoms began one day after receiving Flu shot. Eye infection, and skin anomalies (red bumps on scalp) itchy & painful and irritations of skin (redness). Still have red bumps on scalp itchy & painful.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Skin disorder, Skin irritation
Clinical narrative: Flu symptoms began one day after receiving Flu shot. Eye infection, and skin anomalies (red bumps on scalp) itchy & painful and irritations of skin (redness). Still have red bumps on scalp itchy & painful.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Condition aggravated, Cough, Juvenile arthritis, Pain
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with a history of rheumatoid arthritis and no drug reactions/allergies. On 14-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported) for sexually active. On 15-FEB-2013, the patient developed a flair up of her rheumatoid arthritis, as well as joint pain, body aches, a cough and nasal congestion. The patient took ENBREL (manufacturer unknown) as needed for rheumatoid arthritis, but had not been complaint with taking this medication. The patient was ENBREL and TESSALON PERLES for this patient current symptoms. The patient sought unspecified medical attention. No lab diagnostics studies were performed. At the time of reporting, the patient outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Condition aggravated, Cough, Nasal congestion, Pain
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with a history of rheumatoid arthritis and no drug reactions/allergies. On 14-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported) for sexually active. On 15-FEB-2013, the patient developed a flair up of her rheumatoid arthritis, as well as joint pain, body aches, a cough and nasal congestion. The patient took ENBREL (manufacturer unknown) as needed for rheumatoid arthritis, but had not been complaint with taking this medication. The patient was ENBREL and TESSALON PERLES for this patient current symptoms. The patient sought unspecified medical attention. No lab diagnostics studies were performed. At the time of reporting, the patient outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rheumatoid arthritis
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with a history of rheumatoid arthritis and no drug reactions/allergies. On 14-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported) for sexually active. On 15-FEB-2013, the patient developed a flair up of her rheumatoid arthritis, as well as joint pain, body aches, a cough and nasal congestion. The patient took ENBREL (manufacturer unknown) as needed for rheumatoid arthritis, but had not been complaint with taking this medication. The patient was ENBREL and TESSALON PERLES for this patient current symptoms. The patient sought unspecified medical attention. No lab diagnostics studies were performed. At the time of reporting, the patient outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as a license practical nurse) refers to a 16 year old female patient. On 24-OCT-2012, the patient was vaccinated with dose 3 GARDASIL (lot#, expiration date and route not reported). Patient received fourth dose of GARDASIL on 27-FEB-2013. No further information is available. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Headache, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Varicella & Tdap given on 2/27/13 in (L) arm. Patient pulled away when varicella injection given so nurse had to re enter the needle. Patients arm hurt after the immunizations. On 2/28 felt slightly faint and had headache. That evening noted to have redness & swelling of the varicella immunisation site. Even showed 10 cm area erythema & slight induration. No treatment.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pain in extremity, Syncope
Clinical narrative: Varicella & Tdap given on 2/27/13 in (L) arm. Patient pulled away when varicella injection given so nurse had to re enter the needle. Patients arm hurt after the immunizations. On 2/28 felt slightly faint and had headache. That evening noted to have redness & swelling of the varicella immunisation site. Even showed 10 cm area erythema & slight induration. No treatment.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHEH2013US005126, is an initial spontaneous report received from a physician via sales representative on 28 Feb 2013: This report refers to 12-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A12002, Expiry date: Oct 2014) and Tdap (batch number and manufacturer unknown) on 31 Jan 2013. On 25 Feb 2013, she developed symptoms of Guillain barre syndrome. The patient was hospitalized on an unspecified date. The outcome of the event was not reported as of 01 Mar 2013. Causality of the event was not reported.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Headache, Hypoacusis, Vision blurred
Clinical narrative: Case number PHEH2013US005126, is an initial spontaneous report received from a physician via sales representative on 28 Feb 2013: This report refers to 12-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A12002, Expiry date: Oct 2014) and Tdap (batch number and manufacturer unknown) on 31 Jan 2013. On 25 Feb 2013, she developed symptoms of Guillain barre syndrome. The patient was hospitalized on an unspecified date. The outcome of the event was not reported as of 01 Mar 2013. Causality of the event was not reported.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Received MENVEO vaccine on 1/31/13, 2/25/13 c/o headache, blurred vision & felt faint - no LOC 2/26/13 - weakness, hearing muffled. 2/27/13 dizziness & weakness - To ER for possible Guillain Barre.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Headache, Hypoacusis, Vision blurred
Clinical narrative: Received MENVEO vaccine on 1/31/13, 2/25/13 c/o headache, blurred vision & felt faint - no LOC 2/26/13 - weakness, hearing muffled. 2/27/13 dizziness & weakness - To ER for possible Guillain Barre.