chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Polymerase chain reaction
Clinical narrative: Initial report was received 12 October 2012 from a health care professional which identified a patient that was involved in a cluster of approximately 17 patients who tested PCR positive for influenza A/H3 since January. The other patients are captured in cases 2012-05658, 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072, 2012-06073, 2012-09565 and 2012-05659. A female patient had received on 27 October 2011 FLUZONE, lot number UT4998AA (not a valid sanofi pasteur lot number (route and site not reported), and an unspecified amount of time later, the patient tested PCR positive for influenza A/H3. The approximate treatment date and collection date was reported as 26 March 2012. The patient's outcome was reported as recovered. No additional information was provided at the time of the report. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Periarthritis
Clinical narrative: Initial report was received on 15 October 2012 from a consumer that is also the patient. A female patient (date of birth not reported) had received on an unspecified in 2011 FLUZONE SV (lot number, route and site of administration not reported) and two to three days after vaccination experienced an inability to move arm in most directions and was diagnosed with a frozen shoulder. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report was received on 15 October 2012 from a health care professional. A cluster of three unidentified patients had received in October 2012 FLUZONE HIGH-DOSE, lot number U525AA (route, site and exact date of administration not reported) and an unspecified amount of time later the same month experienced redness, swelling and pain at the injection site. The patient's were referred to a physician. One of the patient's was treated for infection and antibiotics. No further information was available at the time of the report. The patient's outcomes were unknown. Documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: By afternoon of vaccine Rt arm redness at injection site by 10/8/12 hot to touch, itchy, red, diameter size of quarter.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Polymerase chain reaction, Vaccination failure
Clinical narrative: Initial report received from a healthcare professional on 01 June 2012, who provided information on this case of one unidentified patient out of a cluster of 10 unidentified patients (previously reported as approximately nine unidentified patients), in case number 2012-05660. Information on the remaining nine patients is captured in case numbers: 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072. The reporter for this case is also the same reporter as case numbers 2012-05658 (six elderly patients) and 2012-05659 (two adolescent patients). The reporter stated, of the cases reported as vaccine failure, one unidentified patient received an injection of FLUZONE, sanofi pasteur Inc., lot number reported as UT443AA in dose form 0.5 milliliter (mL) syringes, single dose syringe (route, site and date of administration were not reported). An unspecified amount of time later, the patient tested PCR positive for influenza A/H3 at the state laboratory, since January. The patient's outcome was not reported. There was no additional individual patient information available. Followup report was received from a healthcare professional on 15 October 2012. The case now met the criteria for an expedited report since receiving patient identity. A 31-year-old male patient received a FLUZONE, lot number UT443AA, on 14 October 2011 (route and site not reported). The patient tested positive with PCR for influenza A/H3N2 on 03 May 2012. The approximate treatment date was 03 May 2012. Pre-existing allergies and medical conditions were not reported. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Polymerase chain reaction, Vaccination failure
Clinical narrative: Initial report received from a healthcare professional on 01 June 2012, who provided information on this case of one unidentified patient out of a cluster of 10 unidentified patients (previously reported as approximately nine unidentified patients), in case number 2012-05660. Information on the remaining nine patients is captured in case numbers: 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06073. The reporter for this case is also the same reporter as case numbers 2012-05658 (six elderly patients) and 2012-05659 (two adolescent patients). The reporter stated, of the cases reported as vaccine failure, one unidentified patient received an injection of FLUZONE, sanofi pasteur Inc., lot number reported as UT434AA in dose form 0.5 mL syringes, single dose syringe (route, site and date of administration were not reported). An unspecified amount of time later, the patient tested PCR positive for influenza A/H3 at the state laboratory, since January. The patient's outcome was not reported. There was no additional individual patient information available. Followup report was received from a healthcare professional on 15 October 2012. The case now met the criteria for an expedited report since receiving patient identity. The patient received the FLUZONE on 04 October 2011 and the approximate treatment date was 08 May 2012. The patient tested positive with PCR for influenza A/H3N2 on 08 May 2012. Within four weeks of vaccination with FLUZONE, the patient received an intramuscular injection of PNEUMO-PS, lot number 0631AA, in the left deltoid on 12 October 2011. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Meningitis viral, Pyrexia
Clinical narrative: Initial report was received from a consumer on 16 October 2012. A 50-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH714AB, on 16 September 2012. Two hours after the vaccine, the patient had a fever of 38.89 degrees Celsius (102 degrees Fahrenheit), went to the hospital and was diagnosed with viral meningitis. The patient had no illness at the time of vaccination and allergies to "BACTIM", DILANTIN, "doxicycline", erythromycin, iodine, codeine and TORADOL. The patient had many doses of influenza vaccine in the past. The patient's outcome was not recovered. Documents held by sender: None.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Polymerase chain reaction, Vaccination failure
Clinical narrative: Initial report received from a healthcare professional on 01 June 2012, who provided information on this case of one unidentified patient out of a cluster of 10 unidentified patients (previously reported as approximately nine unidentified patients), in case number 2012-05660. Information on the remaining nine patients is captured in case numbers: 2012-05660, 2012-06067, 2012-06068, 2012-06070, 2012-06071, 2012-06072, 2012-06073. The reporter for this case is also the same reporter as case numbers 2012-05658 (six elderly patients) and 2012-05659 (two adolescent patients). The reporter stated, of the cases reported as vaccine failure, one unidentified patient received an injection of FLUZONE SV, sanofi pasteur Inc., lot number UH478AC in dose form multi dose vial (MDV), (route, site and date of administration were not reported). An unspecified amount of time later, the patient tested PCR positive for influenza A/H3 at the state laboratory, since January. The patient's outcome was not reported. There was no additional individual patient information available. Follow-up information received from a healthcare professional on 15 October 2012. The patient was female and 6 years of age when she received the FLUZONE SV on 23 November 2011 and 117 days post vaccination had a positive PCR test for influenza A/H3. The patient had a positive rapid flu test in the office (date not provided) and the sample was sent to the state lab where it was also positive (date not provided). The patient had no concurrent illnesses, and was not taking any other medications, and had not received any other vaccination within 4 weeks of 23 November 2011. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Urticaria
Clinical narrative: Patient experienced hives to left arm migrating to left side of neck.  Also had cough.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Face oedema, Headache, Rash
Clinical narrative: Rash on face the evening of 10/30/12. Benadryl was administered orally.  10/31/12 c/o headache and facial edema.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, diarrhea, for two days.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: SIDS.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Death
Clinical narrative: SIDS.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: None noted.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Death
Clinical narrative: None noted.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: Broke out in hives on chest and arm she received vaccine.  Blisters on chest and welt on arm.  Very itchy.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chills, Conjunctivitis, Cough, Dysgeusia
Clinical narrative: Immediate blurred vision, bilateral conjunctivitis, cough, elevated pulse and B/P, later in evening with fever, chills, frequent urination, flu like illness. difference in taste buds.  Symptoms almost disappeared within 24 hours.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Influenza like illness, Pollakiuria, Pyrexia, Vision blurred
Clinical narrative: Immediate blurred vision, bilateral conjunctivitis, cough, elevated pulse and B/P, later in evening with fever, chills, frequent urination, flu like illness. difference in taste buds.  Symptoms almost disappeared within 24 hours.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Started noticing red itchy spots on the backs of the legs. Between 10/11 & 10/12, the hives exploded causing me to seek medical care. Dr. prescribed steroids & antihistamines.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Overall body itch and rash. Benadryl not helping. Atarax 2 10mg/day not helping. Eucerin Calming Creme not helping.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Local swelling
Clinical narrative: Red swollen area on arm measured 8 inches long by 3.5 inches wide.  Also fatigue.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt. had rash within 7 days of receiving flu vaccination. Pt. stated he had a severe rash and went to the ER on 10/25. The ER prescribed: Hydroxyzine HCL 25mg tablet; Menthol+camphor topical lotion; Predisone 20mg tablet; Naproxen 500mg tablet.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Skin warm
Clinical narrative: Skin got very hot, rash appeared all over trunk, back, arms, face, neck, shoulders.  Occurred again on 10/30 and 10/31.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Blood culture negative, Chills, Differential white blood cell count normal, Full blood count normal, Pain
Clinical narrative: Chills, aches, fever 100.3.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Chills, aches, fever 100.3.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Feeling cold, Vomiting
Clinical narrative: Chilling, could not get warm, then diarrhea, then vomiting. No treatment beyond heating pad. Seems to be OK at noontime, 10/31.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Noticed extreme swelling, redness, heat, and complaint of pain of the entire half of his arm (shot had been administered on his upper arm).
Age: 8.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Cellulitis, Erythema, Herpes zoster, Oedema peripheral, Pain in extremity
Clinical narrative: Mother aclled to inform nurse that she had called pediatrician because patient had come home from school and his left arm was swollen and red, hot to touch and painful. Dr. advised her to apply cool compress elevate and Tylenol.  2 days later she took patient in to see dr and was dx with shingles and cellulitis.  Child was put on cephalexin and acyclovir.  This info per mom.  I called to check on child.
Age: 8.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Skin warm
Clinical narrative: Mother aclled to inform nurse that she had called pediatrician because patient had come home from school and his left arm was swollen and red, hot to touch and painful. Dr. advised her to apply cool compress elevate and Tylenol.  2 days later she took patient in to see dr and was dx with shingles and cellulitis.  Child was put on cephalexin and acyclovir.  This info per mom.  I called to check on child.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness and itching around injection site; minor pain. Condition has persisted and redness seems to be spreading.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Oedema, Pain, Pain in extremity
Clinical narrative: Patient noticed Edema/Erythema that night when undressing (reports increasing radius). Patient also describes throbbing pain throughout entire left arm immediately following vaccination which is getting worse as time progresses.  Patient denies nor shows symptoms of any respiratory reactions or further dermal irritation/discoloration. Erythema/Edema marked with time and date, patient told to see provider if size increases or if there are any further issues. Patient being seen by onsite HCP to determine if further care is indicated.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Blood urine present, Haematuria, Ultrasound bladder, Ultrasound kidney
Clinical narrative: Blood in urine.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Urine analysis
Clinical narrative: Blood in urine.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Severe itching over arms, legs, trunk. No rash. Itching not relieved by Benadryl. Prescribed Medrol Dose Pak by PCP.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Dysarthria, Eye pain, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Pt states that it first started with her jaw locking up while brushing teeth/tongue. She states that she had to release her tongue to relieve the sx. Pt states that she developed what she describes as a "charlie-horse like pain in jaw." Sx calmed down and pt went to bed, upon that morning pt noted that her right side of her face felt numb and is if she had anesthesia from dental work on the right side of her face. Pt denies any facial drooping at this time. Pt does state that she has some slurring of speech occasionally, no drooling. She states that when she presses her tongue she can not feel her teeth with it. Pt denies any blurred vision, dizziness/lightheadedness. Pt was advised to not take anymore of this medication. Pt verbalizes understanding. Pt was given a f/u appt with Dr. on 10/29/2012 at 1600. We discussed reasons that pt should seek immediate medical attention. Pt verbalizes understanding.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in jaw, Trismus
Clinical narrative: Pt states that it first started with her jaw locking up while brushing teeth/tongue. She states that she had to release her tongue to relieve the sx. Pt states that she developed what she describes as a "charlie-horse like pain in jaw." Sx calmed down and pt went to bed, upon that morning pt noted that her right side of her face felt numb and is if she had anesthesia from dental work on the right side of her face. Pt denies any facial drooping at this time. Pt does state that she has some slurring of speech occasionally, no drooling. She states that when she presses her tongue she can not feel her teeth with it. Pt denies any blurred vision, dizziness/lightheadedness. Pt was advised to not take anymore of this medication. Pt verbalizes understanding. Pt was given a f/u appt with Dr. on 10/29/2012 at 1600. We discussed reasons that pt should seek immediate medical attention. Pt verbalizes understanding.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Light headed, dizzy, passed out for 1 to 2 seconds.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Lip swelling, Pruritus generalised
Clinical narrative: States she became very anxious, then developed itchiness in left hand which spread to trunk, feet, lower lip and "all over". Denies any shortness of breath. Took Benadryl, but anxiousness increased with lip swelling, so sought treament at local hospital emergency department.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Burning sensation, Pruritus, Rash, Urticaria
Clinical narrative: Large red welts around my trunk (under breasts) some on breast. Small spots on back and abdomen. All itching and burning.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on arms, wrists, armpits, feet, ankles, abdomen, low back, buttocks, legs. Re-occurring daily in evenings, ongoing still. Taking Benadryl in evenings.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on both arms and hands, began hours after injection, and progressively worsened the following day, then remained steady, resolved 10/25/2012. Treatment from pharmacist: Benadryl, and calamine lotion.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Patient describes sensation of numbness in arm receiving immunization. Patient says numbness has not subsided as of date of reporting - 10/30/2012.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 22 October 2012. An 87-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE High-Dose, lot number U4496AA, on 01 October 2012 and the same day her arm was sore and red. The patient was seen by the physician on 03 October 2012 and noted a 1/2 cm area of redness, no fluctuation, mild erythema that was "similar to a first degree burn". Treatment included cephalexin 500 mg. The patient had no illness at the time of vaccination and an allergy to sulfa. The patient's outcome was unknown. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dysphagia, Full blood count, Mobility decreased, Musculoskeletal discomfort
Clinical narrative: Initial report was received on 19 October 2012 from a consumer which is also the patient. A 69 year-old female patient had received on 22 September 2012 an intramuscular left arm injection of FLUZONE High-Dose (lot number not reported). On 23 September 2012, the patient woke up with dry heaves, sore throat and difficulty swallowing. On 26 September 2012, the patient was evaluated by physician for sore throat. On 27 September 2012, the patient woke up with joint pain in ankles, knees, hips, wrist and shoulders. The patient reported that she "could not get out of bed". The patient was advised by physician to take extra strength TYLENOL. On 28 September 2012, the patient went to the ER and was diagnosed with post viral arthralgia or Parvo virus. Treatment included Prednisone for three days and Hydrocodone for pain. On 15 October 2012, the patient was evaluated by a physician for continued joint discomfort. The physician prescribed Prednisone for 14 days. Laboratory test included sed rate, CBC and Rheumatoid factor (results not reported). The patient has a history of biliary cirrhosis, osteoporosis and an allergy to MACRODANTIN. The patient's outcome was not recovered. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Parvovirus infection, Red blood cell sedimentation rate, Retching, Rheumatoid factor
Clinical narrative: Initial report was received on 19 October 2012 from a consumer which is also the patient. A 69 year-old female patient had received on 22 September 2012 an intramuscular left arm injection of FLUZONE High-Dose (lot number not reported). On 23 September 2012, the patient woke up with dry heaves, sore throat and difficulty swallowing. On 26 September 2012, the patient was evaluated by physician for sore throat. On 27 September 2012, the patient woke up with joint pain in ankles, knees, hips, wrist and shoulders. The patient reported that she "could not get out of bed". The patient was advised by physician to take extra strength TYLENOL. On 28 September 2012, the patient went to the ER and was diagnosed with post viral arthralgia or Parvo virus. Treatment included Prednisone for three days and Hydrocodone for pain. On 15 October 2012, the patient was evaluated by a physician for continued joint discomfort. The physician prescribed Prednisone for 14 days. Laboratory test included sed rate, CBC and Rheumatoid factor (results not reported). The patient has a history of biliary cirrhosis, osteoporosis and an allergy to MACRODANTIN. The patient's outcome was not recovered. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Induration, Pain
Clinical narrative: 76 mm red induration, very sore, temp 99.2.
Age: 0.74
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 17 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 22-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3771AA received on 25 January 2011, lot number C3784AA received on 18 May 2011 and lot number C3801AA received on 22 June 2011 (routes and sites of administration not reported). The subject developed a cough on 01 August 2012, approximately 13 months after the last dose. Paroxysmal cough without a whoop began on 02 August 2012. The subject also experienced sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 03 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 03 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 20 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 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: 0.74
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 17 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 22-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3771AA received on 25 January 2011, lot number C3784AA received on 18 May 2011 and lot number C3801AA received on 22 June 2011 (routes and sites of administration not reported). The subject developed a cough on 01 August 2012, approximately 13 months after the last dose. Paroxysmal cough without a whoop began on 02 August 2012. The subject also experienced sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 03 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 03 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 20 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 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: 37.0
Sex: M
Vaccine: TYP, UNK
Symptoms: Body temperature increased, Chills, Diarrhoea, Muscle spasms, Pain
Clinical narrative: Initial case received from a consumer on 17 October 2012. A 37 year old male patient received an intramuscular injection of TYPHIM Vi, lot number not reported on 12 April 2012. The patient was also administered other unspecified travel vaccines on an unspecified date. The patient had no pre-existing medical conditions or known allergies. It was reported that the patient was not ill at the time of vaccination. Concomitant medications were not reported. The patient went on a trip about 3 weeks after vaccination in May 2012. On 19 May 2012, he experienced symptoms of diarrhea, chills, and a temperature of 104F, aches and cramps. The patient was flown back home and hospitalized on 23 May 2012 for an unspecified duration. He was subsequently diagnosed with Typhoid fever on 06 June 2012 by an infectious disease doctor. Relevant diagnostic tests, laboratory data and treatments were not reported. According to the reporter, he is currently without any symptoms and had a full recovery. Date of recovery was not reported. Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: TYP, UNK
Symptoms: Typhoid fever
Clinical narrative: Initial case received from a consumer on 17 October 2012. A 37 year old male patient received an intramuscular injection of TYPHIM Vi, lot number not reported on 12 April 2012. The patient was also administered other unspecified travel vaccines on an unspecified date. The patient had no pre-existing medical conditions or known allergies. It was reported that the patient was not ill at the time of vaccination. Concomitant medications were not reported. The patient went on a trip about 3 weeks after vaccination in May 2012. On 19 May 2012, he experienced symptoms of diarrhea, chills, and a temperature of 104F, aches and cramps. The patient was flown back home and hospitalized on 23 May 2012 for an unspecified duration. He was subsequently diagnosed with Typhoid fever on 06 June 2012 by an infectious disease doctor. Relevant diagnostic tests, laboratory data and treatments were not reported. According to the reporter, he is currently without any symptoms and had a full recovery. Date of recovery was not reported. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator on 22 October 2012. A 23-year-old male subject, with a past medical history of dizziness and fainting spells received a ACAM2000, SP Biologics Co., (lot number not reported) on 20 June 2012; and an ANTHRAX 2, other manufacturer, (lot not reported) on 27 May 2012. Thirteen days post vaccination with ACAM2000 and 37 days post vaccination with ANTHRAX 2, on 03 July 2012, the subject was diagnosed with other specified acute myocarditis. On 30 June 2012, the subject had a electrocardiogram (ECG) with results reported as abnormal. On same day, 30 June 2012, the subject also had a Troponin I laboratory test and an echocardiogram with results that was reported as normal. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Dizziness, Headache, Injection site pain, Migraine
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 22 October 2012. A 75-year-old female patient had received a intramuscular injection in the right arm of FLUZONE High-Dose, lot number U4493AA, on 22 September 2012 and one hour later had a severe headache and pain at the injection site. The headache persisted but the pain at the injection site subsided. The patient was treated with FIORINAL and discontinued after one dose because the patient felt lightheaded. The patient also took TYLENOL extra strength and ATIVAN 0.5 mg. Headaches and tinnitus exacerbated. The patient was seen by a neurologist and treated with prednisone dose pack and CAMBIA powder for migraines. The patient took one dose but it made her headache worse so it CAMBIA powder was discontinued. The prednisone was discontinued after two days. The patient had no illness at the time of vaccination, allergies to AUGMENTIN, CIPRO and Iodine, and a past medical history of tinnitus, gastroesophageal reflux disease (GERD), hiatal hernia and arthritis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 22 October 2012. A 75-year-old female patient had received a intramuscular injection in the right arm of FLUZONE High-Dose, lot number U4493AA, on 22 September 2012 and one hour later had a severe headache and pain at the injection site. The headache persisted but the pain at the injection site subsided. The patient was treated with FIORINAL and discontinued after one dose because the patient felt lightheaded. The patient also took TYLENOL extra strength and ATIVAN 0.5 mg. Headaches and tinnitus exacerbated. The patient was seen by a neurologist and treated with prednisone dose pack and CAMBIA powder for migraines. The patient took one dose but it made her headache worse so it CAMBIA powder was discontinued. The prednisone was discontinued after two days. The patient had no illness at the time of vaccination, allergies to AUGMENTIN, CIPRO and Iodine, and a past medical history of tinnitus, gastroesophageal reflux disease (GERD), hiatal hernia and arthritis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Erythema, Pharyngeal oedema
Clinical narrative: Initial report was received 17 October 2012 from a health care professional. An unidentified patient (age, gender and date of birth not reported) with no concurrent illness, had received an intramuscular injection of FLUZONE, lot number UH719AC on 17 October 2012 and 2-3 minutes after vaccination, had developed symptoms of an anaphylactic reaction. The patient experienced urticaria, erythema, dizziness, throat swelling and shortness of breath. BENADRYL and Solumedrol were administered while at the doctor's office and symptoms began to resolve. All symptoms had subsided within 15 minutes. The patient had a history of allergies to PCN (penicillin), gentamycin and cephalosporins. Relevant diagnostic tests and laboratory data was reported as "none". Outcome was recovered. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Urticaria
Clinical narrative: Initial report was received 17 October 2012 from a health care professional. An unidentified patient (age, gender and date of birth not reported) with no concurrent illness, had received an intramuscular injection of FLUZONE, lot number UH719AC on 17 October 2012 and 2-3 minutes after vaccination, had developed symptoms of an anaphylactic reaction. The patient experienced urticaria, erythema, dizziness, throat swelling and shortness of breath. BENADRYL and Solumedrol were administered while at the doctor's office and symptoms began to resolve. All symptoms had subsided within 15 minutes. The patient had a history of allergies to PCN (penicillin), gentamycin and cephalosporins. Relevant diagnostic tests and laboratory data was reported as "none". Outcome was recovered. Documents held by sender: None.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 17 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 17-month-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 3 doses of PENTACEL; lot number C3784AA on 11 April 2011, lot number C3802AA on 09 June 2011, and lot number C3930AA on 10 August 2011, and one dose of TRIPEDIA; lot number U3749AA received on 09 May 2012 (routes and sites of administration not reported). The subject developed a paroxysmal cough on 01 August 2012, approximately 3 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 20 August 2012. Chest x-ray was negative for pneumonia. Corrective treatment consisted of azithromycin starting on 20 August 2012 for an unknown duration. At the time of final contact on 04 October 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 50 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 17 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 17-month-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 3 doses of PENTACEL; lot number C3784AA on 11 April 2011, lot number C3802AA on 09 June 2011, and lot number C3930AA on 10 August 2011, and one dose of TRIPEDIA; lot number U3749AA received on 09 May 2012 (routes and sites of administration not reported). The subject developed a paroxysmal cough on 01 August 2012, approximately 3 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 20 August 2012. Chest x-ray was negative for pneumonia. Corrective treatment consisted of azithromycin starting on 20 August 2012 for an unknown duration. At the time of final contact on 04 October 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 50 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness and soreness in left arm (vaccine was administered in this arm).  Situation has continued for one week. Patient is taking narcotics (Lortab) and Advil to help with the pain.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Amnesia, Blood test normal, Hallucination, Influenza like illness, Injection site discharge
Clinical narrative: Symptoms:  Fever, Flulike symptoms, lethargic, SEVERE memory loss, SEVERE hallucinations, vomiting. Injection site reactions:  Severe swelling, redness, bruising, blistering at the injection site, oozing, injection site very hard. She was taken to the emergency room Friday night 10/26/2012 at 6:00 for these symptoms.  Injections were given Tuesday morning 10/23/2012.  Followed up with physician who administered injections the following Monday 10/29/2012.  The hallucinations, memory loss, and injections site problems started Tuesday night are continuing through today 10/31/2012.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Symptoms:  Fever, Flulike symptoms, lethargic, SEVERE memory loss, SEVERE hallucinations, vomiting. Injection site reactions:  Severe swelling, redness, bruising, blistering at the injection site, oozing, injection site very hard. She was taken to the emergency room Friday night 10/26/2012 at 6:00 for these symptoms.  Injections were given Tuesday morning 10/23/2012.  Followed up with physician who administered injections the following Monday 10/29/2012.  The hallucinations, memory loss, and injections site problems started Tuesday night are continuing through today 10/31/2012.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Lethargy, Nuclear magnetic resonance imaging brain normal, Pyrexia, Urine analysis normal
Clinical narrative: Symptoms:  Fever, Flulike symptoms, lethargic, SEVERE memory loss, SEVERE hallucinations, vomiting. Injection site reactions:  Severe swelling, redness, bruising, blistering at the injection site, oozing, injection site very hard. She was taken to the emergency room Friday night 10/26/2012 at 6:00 for these symptoms.  Injections were given Tuesday morning 10/23/2012.  Followed up with physician who administered injections the following Monday 10/29/2012.  The hallucinations, memory loss, and injections site problems started Tuesday night are continuing through today 10/31/2012.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Symptoms:  Fever, Flulike symptoms, lethargic, SEVERE memory loss, SEVERE hallucinations, vomiting. Injection site reactions:  Severe swelling, redness, bruising, blistering at the injection site, oozing, injection site very hard. She was taken to the emergency room Friday night 10/26/2012 at 6:00 for these symptoms.  Injections were given Tuesday morning 10/23/2012.  Followed up with physician who administered injections the following Monday 10/29/2012.  The hallucinations, memory loss, and injections site problems started Tuesday night are continuing through today 10/31/2012.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at site of injection from Afluria Influenza Vaccine (R Deltoid). Pt. C/O itching on both arms after injection. Symptoms & redness diminished after being treated with Benadryl 25 mg P.O. times 1, S&S resolved within 20 minutes.  Pt. was monitored in clinic total of 2 hours as she remained stable. Pt was discharged to home in stable condition, itching resolved. Vital Signs Stable, with OTC RX:  Benadryl 25 mg 1 q- 6 PRN. Telephone call F/U 2 days later pt. stated she was feeling great had no additional concerns or questions.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Feeling abnormal, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: "Did not feel myself, felt achy and uncomfortable". Around injection site at upper arm, it is red, tender and warm to the touch.  The redness is about 5 inches in diameter at 1:00 on 10/31/2012.  Pt took 12.5 mg of Benadryl on 10/30/2012 for sleep aid.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: "Did not feel myself, felt achy and uncomfortable". Around injection site at upper arm, it is red, tender and warm to the touch.  The redness is about 5 inches in diameter at 1:00 on 10/31/2012.  Pt took 12.5 mg of Benadryl on 10/30/2012 for sleep aid.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Headache, Pain
Clinical narrative: Headache was worst symptom, also body aches, slight chills, "felt hungover".
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Skin exfoliation, Swelling
Clinical narrative: PAIN AND SWELLING FOR SEVERAL DAYS. QUARTER SIZE PIECE OF SKIN REMOVED WITH BANDAGE REMOVAL.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Confusional state, Headache, Swelling
Clinical narrative: Swelling of Face, Neck, Chest, Back, and leg on left side. Headache, confusion, mild chest pain with in 10 minutes after receiving the vaccine. Benadryl, steroid.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Secretion discharge, Swelling
Clinical narrative: HEADACHE, FATIGUE, NEXT DAY SWELLING AND OOZY.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Muscle twitching, Pain
Clinical narrative: Patient called my pharmacy today at approximately 230 pm to report this incident. They said immediately following instead of having normal soreness the patient began having muscle twitches on arm and chest area. In addition patient has not been able to work due to significant pain. They contacted their NP. She instructed the patient to use heating pads to help with the pain. If it doesn't resolve then she advised him to be seen. He had hydrocodone tablets at home he had been taking since this started, and NP said to continue this at this time.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 22 October 2012. A female patient (age and date of birth not reported) had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced significant swelling to her upper arm and a hot, red indurated area which was itchy and painful. Treatment included a 7 days course of Cefadroxil 500 mg twice daily (BID) and BENADRYL as needed. No additional information was available. The patient's outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Skin warm
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 22 October 2012. A female patient (age and date of birth not reported) had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced significant swelling to her upper arm and a hot, red indurated area which was itchy and painful. Treatment included a 7 days course of Cefadroxil 500 mg twice daily (BID) and BENADRYL as needed. No additional information was available. The patient's outcome was not reported. Documents held by sender: None.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 59 years old female patient with allergy to some antibiotics (unspecified) and no pertinent medical history. On 17-OCT-2012, the patient was vaccinated intramuscular with, 0.5 ml PNEUMOVAX23 (lot not provided). Other suspect therapies included influenza virus vaccine (unspecified) on 17-OCT-2012. Concomitant medications included simvastatin (manufacturer unknown) and ZYRTEC. The consumer stated that on 17-OCT-2012 she received PNEUMOVAX23 in her right arm and the Flu Vaccine (manufacturer unspecified) in her left as concomitantly. On 18-OCT-2012 she developed a high fever 102 F, severe chills, body aches, soreness and tenderness at the injection site. On 19-OCT-2012 her upper right arm became red, hard and painful. The patient went to the doctor on 20-OCT-2012 and was prescribed KEFLEX dosage and ADVIL. No further AE information provided. At the time of the report the patient's adverse events persisted. The relatedness for adverse events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to a 59 years old female patient with allergy to some antibiotics (unspecified) and no pertinent medical history. On 17-OCT-2012, the patient was vaccinated intramuscular with, 0.5 ml PNEUMOVAX23 (lot not provided). Other suspect therapies included influenza virus vaccine (unspecified) on 17-OCT-2012. Concomitant medications included simvastatin (manufacturer unknown) and ZYRTEC. The consumer stated that on 17-OCT-2012 she received PNEUMOVAX23 in her right arm and the Flu Vaccine (manufacturer unspecified) in her left as concomitantly. On 18-OCT-2012 she developed a high fever 102 F, severe chills, body aches, soreness and tenderness at the injection site. On 19-OCT-2012 her upper right arm became red, hard and painful. The patient went to the doctor on 20-OCT-2012 and was prescribed KEFLEX dosage and ADVIL. No further AE information provided. At the time of the report the patient's adverse events persisted. The relatedness for adverse events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to a 59 years old female patient with allergy to some antibiotics (unspecified) and no pertinent medical history. On 17-OCT-2012, the patient was vaccinated intramuscular with, 0.5 ml PNEUMOVAX23 (lot not provided). Other suspect therapies included influenza virus vaccine (unspecified) on 17-OCT-2012. Concomitant medications included simvastatin (manufacturer unknown) and ZYRTEC. The consumer stated that on 17-OCT-2012 she received PNEUMOVAX23 in her right arm and the Flu Vaccine (manufacturer unspecified) in her left as concomitantly. On 18-OCT-2012 she developed a high fever 102 F, severe chills, body aches, soreness and tenderness at the injection site. On 19-OCT-2012 her upper right arm became red, hard and painful. The patient went to the doctor on 20-OCT-2012 and was prescribed KEFLEX dosage and ADVIL. No further AE information provided. At the time of the report the patient's adverse events persisted. The relatedness for adverse events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Tongue discolouration
Clinical narrative: Case number PHEH2012US020375 is an initial spontaneous report received from a nurse on 16 Oct 2012 and with a follow up received on 16 Oct 2012. This case refers to a 50-year-old female patient. The patient was allergic to penicillin. She was vaccinated with FLUVIRIN (batch number: 1206501) intramuscular on 15 Oct 2012 and developed fuzzy tongue, furry and swollen tongue on an unspecified date. She took BENADRYL and was doing fine at the time of this report. The event outcome, seriousness and causality assessment was not reported. No other information was available. Follow up report received on 16 Oct 2012. Updated vaccination route and batch number. Added event swollen tongue.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased, Nausea
Clinical narrative: Patient called clinic, left word that she had a reaction to vaccine received 2 days prior. States she felt pain at time of flu injection, two days later arm became very painful, unable to raise arm, very red and swollen at injection site. She received flu and pneumonia vaccines in left deltoid but believed it was the flu she reacted to. (Received Tdap in right deltoid). Saw PCP 10/29/12, he prescribed Tylenol with Codeine for pain, ibuprofen for inflammation, promethazine for nausea.