chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Burning sensation, Laboratory test, Lumbar puncture, Myalgia
Clinical narrative: Case number PHEH2012US020404, is combined initial spontaneous report received from a nurse on 16 Oct 2012 and 17 Oct 2012. This report refers to a 31 year old male patient. His medical history and concomitant medications were not reported. Nurse stated that the patient had received the INFLUENZA for the past 10 years without any symptoms or reactions. He was vaccinated with FLUVIRIN (batch number: 1206901), intramuscular on 03 Oct 2012. On the same day of vaccination the patient experienced joint pain in lower back and legs, with a constant burning in the thighs, myalgia and flu like symptoms. The patient consulted a primary care physician and a rheumatologist. The patient was admitted to the hospital on an unspecified date. It was reported that, he had a lumbar puncture scheduled but it was not reported, whether scheduled tests were performed. It was reported that, the patient was still in hospital as of 17 Oct 2012. Event outcome, seriousness and causality were not reported.
Age: 31.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Burning sensation, Influenza like illness, Myalgia
Clinical narrative: Case number PHEH2012US020404, is combined initial spontaneous report received from a nurse on 16 Oct 2012 and 17 Oct 2012. This report refers to a 31 year old male patient. His medical history and concomitant medications were not reported. Nurse stated that the patient had received the INFLUENZA for the past 10 years without any symptoms or reactions. He was vaccinated with FLUVIRIN (batch number: 1206901), intramuscular on 03 Oct 2012. On the same day of vaccination the patient experienced joint pain in lower back and legs, with a constant burning in the thighs, myalgia and flu like symptoms. The patient consulted a primary care physician and a rheumatologist. The patient was admitted to the hospital on an unspecified date. It was reported that, he had a lumbar puncture scheduled but it was not reported, whether scheduled tests were performed. It was reported that, the patient was still in hospital as of 17 Oct 2012. Event outcome, seriousness and causality were not reported.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anti-thyroid antibody negative, Antinuclear antibody negative, Blood immunoglobulin E normal, Blood thyroid stimulating hormone normal, C1 esterase inhibitor test
Clinical narrative: Initial case received from a health care professional on 09 October 2012. The female patient, age 42 whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID vaccine intradermally on 24 September 2012 (lot number UT4470AA, expiry 20 March 2013) into left deltoid. Within 48 hours of vaccination, the patient developed generalized urticaria bumps. The patient experienced nausea, vision changes and was diaphoretic with a B/P of 78/43 at 60 hours later. The patient was transported by emergency measures to the hospital and was treated with IV saline, BENADRYL and SOLUMEDROL. Details of treatments were not provided. Lab work and an EKG were performed, but test results were not reported. The patient was prescribed Prednisone, details not provided. That evening, generalized hives returned and on 29 September 2012 her right eye was swollen shut. On 04 October 2012 the hives continued and the BENADRYL treatment was discontinued. The patient was prescribed ZANTAC, ATARAX (reported as ATTERAX) and ZYRTEC. On 06 October 2012, the patient experienced angioedema and her lips and tongue were swollen. An appointment with an allergist was scheduled for 10 October 2012. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Carbohydrate antigen 125 normal, Complement factor normal, Eye swelling, Full blood count normal, Hypotension
Clinical narrative: Initial case received from a health care professional on 09 October 2012. The female patient, age 42 whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID vaccine intradermally on 24 September 2012 (lot number UT4470AA, expiry 20 March 2013) into left deltoid. Within 48 hours of vaccination, the patient developed generalized urticaria bumps. The patient experienced nausea, vision changes and was diaphoretic with a B/P of 78/43 at 60 hours later. The patient was transported by emergency measures to the hospital and was treated with IV saline, BENADRYL and SOLUMEDROL. Details of treatments were not provided. Lab work and an EKG were performed, but test results were not reported. The patient was prescribed Prednisone, details not provided. That evening, generalized hives returned and on 29 September 2012 her right eye was swollen shut. On 04 October 2012 the hives continued and the BENADRYL treatment was discontinued. The patient was prescribed ZANTAC, ATARAX (reported as ATTERAX) and ZYRTEC. On 06 October 2012, the patient experienced angioedema and her lips and tongue were swollen. An appointment with an allergist was scheduled for 10 October 2012. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lip swelling, Metabolic function test, Metabolic function test normal, Oedema peripheral, Red blood cell sedimentation rate normal
Clinical narrative: Initial case received from a health care professional on 09 October 2012. The female patient, age 42 whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID vaccine intradermally on 24 September 2012 (lot number UT4470AA, expiry 20 March 2013) into left deltoid. Within 48 hours of vaccination, the patient developed generalized urticaria bumps. The patient experienced nausea, vision changes and was diaphoretic with a B/P of 78/43 at 60 hours later. The patient was transported by emergency measures to the hospital and was treated with IV saline, BENADRYL and SOLUMEDROL. Details of treatments were not provided. Lab work and an EKG were performed, but test results were not reported. The patient was prescribed Prednisone, details not provided. That evening, generalized hives returned and on 29 September 2012 her right eye was swollen shut. On 04 October 2012 the hives continued and the BENADRYL treatment was discontinued. The patient was prescribed ZANTAC, ATARAX (reported as ATTERAX) and ZYRTEC. On 06 October 2012, the patient experienced angioedema and her lips and tongue were swollen. An appointment with an allergist was scheduled for 10 October 2012. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rheumatoid factor negative, Swollen tongue, Urticaria
Clinical narrative: Initial case received from a health care professional on 09 October 2012. The female patient, age 42 whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID vaccine intradermally on 24 September 2012 (lot number UT4470AA, expiry 20 March 2013) into left deltoid. Within 48 hours of vaccination, the patient developed generalized urticaria bumps. The patient experienced nausea, vision changes and was diaphoretic with a B/P of 78/43 at 60 hours later. The patient was transported by emergency measures to the hospital and was treated with IV saline, BENADRYL and SOLUMEDROL. Details of treatments were not provided. Lab work and an EKG were performed, but test results were not reported. The patient was prescribed Prednisone, details not provided. That evening, generalized hives returned and on 29 September 2012 her right eye was swollen shut. On 04 October 2012 the hives continued and the BENADRYL treatment was discontinued. The patient was prescribed ZANTAC, ATARAX (reported as ATTERAX) and ZYRTEC. On 06 October 2012, the patient experienced angioedema and her lips and tongue were swollen. An appointment with an allergist was scheduled for 10 October 2012. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Angioedema, Electrocardiogram, Eyelid oedema, Hyperhidrosis, Laboratory test
Clinical narrative: Initial case received from a health care professional on 09 October 2012. The female patient, age 42 whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID vaccine intradermally on 24 September 2012 (lot number UT4470AA, expiry 20 March 2013) into left deltoid. Within 48 hours of vaccination, the patient developed generalized urticaria bumps. The patient experienced nausea, vision changes and was diaphoretic with a B/P of 78/43 at 60 hours later. The patient was transported by emergency measures to the hospital and was treated with IV saline, BENADRYL and SOLUMEDROL. Details of treatments were not provided. Lab work and an EKG were performed, but test results were not reported. The patient was prescribed Prednisone, details not provided. That evening, generalized hives returned and on 29 September 2012 her right eye was swollen shut. On 04 October 2012 the hives continued and the BENADRYL treatment was discontinued. The patient was prescribed ZANTAC, ATARAX (reported as ATTERAX) and ZYRTEC. On 06 October 2012, the patient experienced angioedema and her lips and tongue were swollen. An appointment with an allergist was scheduled for 10 October 2012. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lip swelling, Nausea, Swollen tongue, Urticaria, Visual impairment
Clinical narrative: Initial case received from a health care professional on 09 October 2012. The female patient, age 42 whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID vaccine intradermally on 24 September 2012 (lot number UT4470AA, expiry 20 March 2013) into left deltoid. Within 48 hours of vaccination, the patient developed generalized urticaria bumps. The patient experienced nausea, vision changes and was diaphoretic with a B/P of 78/43 at 60 hours later. The patient was transported by emergency measures to the hospital and was treated with IV saline, BENADRYL and SOLUMEDROL. Details of treatments were not provided. Lab work and an EKG were performed, but test results were not reported. The patient was prescribed Prednisone, details not provided. That evening, generalized hives returned and on 29 September 2012 her right eye was swollen shut. On 04 October 2012 the hives continued and the BENADRYL treatment was discontinued. The patient was prescribed ZANTAC, ATARAX (reported as ATTERAX) and ZYRTEC. On 06 October 2012, the patient experienced angioedema and her lips and tongue were swollen. An appointment with an allergist was scheduled for 10 October 2012. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Blood test, Chest X-ray, Chest discomfort, Dysphonia
Clinical narrative: ER 9-27-2012 SOB, with chest heaviness, abnormal HR, eyes bloodshot red with heavy crusting, numb lips, tongue, severe headache, swollen eyes. Raspy voice-to point of not being able to talk. Neck stiffness. Lately, leg spasms going into feet light sensitivity.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram, Eye swelling, Eyelid margin crusting, Headache
Clinical narrative: ER 9-27-2012 SOB, with chest heaviness, abnormal HR, eyes bloodshot red with heavy crusting, numb lips, tongue, severe headache, swollen eyes. Raspy voice-to point of not being able to talk. Neck stiffness. Lately, leg spasms going into feet light sensitivity.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate abnormal, Hypoaesthesia oral, Muscle spasms, Musculoskeletal stiffness, Ocular hyperaemia
Clinical narrative: ER 9-27-2012 SOB, with chest heaviness, abnormal HR, eyes bloodshot red with heavy crusting, numb lips, tongue, severe headache, swollen eyes. Raspy voice-to point of not being able to talk. Neck stiffness. Lately, leg spasms going into feet light sensitivity.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia
Clinical narrative: ER 9-27-2012 SOB, with chest heaviness, abnormal HR, eyes bloodshot red with heavy crusting, numb lips, tongue, severe headache, swollen eyes. Raspy voice-to point of not being able to talk. Neck stiffness. Lately, leg spasms going into feet light sensitivity.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Lip swelling, Pyrexia
Clinical narrative: Initial case received from a health care professional on 09 October 2012. The male patient, age 60, whose medical history was reported as having received treatment for low testosterone on an unspecified date and no known allergies received a dose of FLUZONE ID intradermally on 05 October 2012 (lot number UT4463AA, expiry 25 March 2013) into the left arm. Within 3 hours of vaccination, the patient developed a fever of 102.5 and redness and soreness at the injection site. The patient was seen by the physician on an unspecified date with redness on entire left arm and anterior chest and a fever. The patient was treated with BENADRYL and antibiotics, details not specified. On the day of the report (09 October 2012), the patient was seen by the physician and was experiencing swollen lips and a feeling of her "throat closing". Concomitant medications and lab results were not reported. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Throat tightness
Clinical narrative: Initial case received from a health care professional on 09 October 2012. The male patient, age 60, whose medical history was reported as having received treatment for low testosterone on an unspecified date and no known allergies received a dose of FLUZONE ID intradermally on 05 October 2012 (lot number UT4463AA, expiry 25 March 2013) into the left arm. Within 3 hours of vaccination, the patient developed a fever of 102.5 and redness and soreness at the injection site. The patient was seen by the physician on an unspecified date with redness on entire left arm and anterior chest and a fever. The patient was treated with BENADRYL and antibiotics, details not specified. On the day of the report (09 October 2012), the patient was seen by the physician and was experiencing swollen lips and a feeling of her "throat closing". Concomitant medications and lab results were not reported. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased, Dyspnoea, Electrocardiogram normal, Heart rate increased, Panic attack
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 11 October 2012. A 30-year-old female patient received an injection of INFLUENZA VACCINE, manufacturer unknown (lot number, route, site, side and dose in series not reported) on 03 October 2012. On 05 October 2012, two days post vaccination she reported adverse event onset. On 07 October 2012, four days after vaccination, the patient went to the emergency room (ER) and was told she "had a panic attack", was given XANAX and sent home. On 08 October 2012, five days after vaccination, she went back to the ER because she "could not breathe". She was told it was a "panic attack and heart rate and blood pressure (BP) went up". X-rays (site unspecified) and electrocardiogram (EKG) were all negative. On 10 October 2012, she went to the doctor office to tell him what happened. Her doctor said it was not anxiety and had to do with her heart and he told her to come back for more EKGs. The patient reported she used her boyfriend's nebulizer treatment on unspecified date. The patient had a medical history of hypertension (HTN), hypercholesterol, vitamin deficiency and an ulcer. The report stated no known allergies, other than a "pain killer" (not specified). She denied any illness at time of vaccination. The patient's outcome was not reported. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray normal
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 11 October 2012. A 30-year-old female patient received an injection of INFLUENZA VACCINE, manufacturer unknown (lot number, route, site, side and dose in series not reported) on 03 October 2012. On 05 October 2012, two days post vaccination she reported adverse event onset. On 07 October 2012, four days after vaccination, the patient went to the emergency room (ER) and was told she "had a panic attack", was given XANAX and sent home. On 08 October 2012, five days after vaccination, she went back to the ER because she "could not breathe". She was told it was a "panic attack and heart rate and blood pressure (BP) went up". X-rays (site unspecified) and electrocardiogram (EKG) were all negative. On 10 October 2012, she went to the doctor office to tell him what happened. Her doctor said it was not anxiety and had to do with her heart and he told her to come back for more EKGs. The patient reported she used her boyfriend's nebulizer treatment on unspecified date. The patient had a medical history of hypertension (HTN), hypercholesterol, vitamin deficiency and an ulcer. The report stated no known allergies, other than a "pain killer" (not specified). She denied any illness at time of vaccination. The patient's outcome was not reported. Documents held by sender: None.
Age: 1.74
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray abnormal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in the two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received three doses of PENTACEL; lot number C3545AA on 09 December 2009, lot number C3541AA on 16 February 2010, and lot number C3579AA on 08 April 2010, and one dose of DAPTACEL; lot number C3577AA received on 05 July 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 21 August 2012, approximately 14 months after the last dose, and a paroxysmal cough with a whoop on 25 August 2012. The subject also developed posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 26 August 2012. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 27 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 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: 1.74
Sex: F
Vaccine: DTAP
Symptoms: Pneumonia, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in the two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received three doses of PENTACEL; lot number C3545AA on 09 December 2009, lot number C3541AA on 16 February 2010, and lot number C3579AA on 08 April 2010, and one dose of DAPTACEL; lot number C3577AA received on 05 July 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 21 August 2012, approximately 14 months after the last dose, and a paroxysmal cough with a whoop on 25 August 2012. The subject also developed posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 26 August 2012. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 27 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 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: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 11 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three-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 three doses of PENTACEL: lot number C3397AB was received on 05 October 2009 and again on 09 December 2009, and lot number C3498AA was received on 08 February 2010; and one dose of DAPTACEL, lot number C3473AA received on 17 November 2010 (routes and sites of administration not reported). The subject developed a paroxysmal cough with whoop on 14 September 2012, approximately 21 months after the last dose. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 18 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 19 September 2012 for five days. The subject was not hospitalized. At the time of final contact on 01 October 2012, the subject's cough was still persisting. The duration of cough was reported at that time as 17 days. The subject's outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 11 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three-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 three doses of PENTACEL: lot number C3397AB was received on 05 October 2009 and again on 09 December 2009, and lot number C3498AA was received on 08 February 2010; and one dose of DAPTACEL, lot number C3473AA received on 17 November 2010 (routes and sites of administration not reported). The subject developed a paroxysmal cough with whoop on 14 September 2012, approximately 21 months after the last dose. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 18 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 19 September 2012 for five days. The subject was not hospitalized. At the time of final contact on 01 October 2012, the subject's cough was still persisting. The duration of cough was reported at that time as 17 days. The subject's outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Excoriation, Full blood count abnormal, Injection site cellulitis, Injection site erythema, Scab
Clinical narrative: Right thigh had redness and cellulitis of size 20 x 20 cm. Small abrasion overlying with a scab. Warm to touch, mildly tender.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Skin warm, Tenderness, White blood cell count normal
Clinical narrative: Right thigh had redness and cellulitis of size 20 x 20 cm. Small abrasion overlying with a scab. Warm to touch, mildly tender.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 11 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL, lot number C3434AA received on 18 August 2009, lot number C3498AA received on 23 October 2009 and again on 08 January 2010; and 1 dose of DAPTACEL, lot number C3449BA received on 21 December 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 10 September 2012, approximately 21 months after the last dose, and a paroxysmal cough without a whoop on 23 September 2012. The subject also developed posttussive vomiting, apnea, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 08 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL, lot number C3434AA received on 18 August 2009, lot number C3498AA received on 23 October 2009 and again on 08 January 2010; and 1 dose of DAPTACEL, lot number C3449BA received on 21 December 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 10 September 2012, approximately 21 months after the last dose, and a paroxysmal cough without a whoop on 23 September 2012. The subject also developed posttussive vomiting, apnea, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 08 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Administration site pain, Hypersensitivity, Inadequate aseptic technique in use of product, Injected limb mobility decreased, Injection site rash
Clinical narrative: PNEUMOVAX was suggested to me as I developed pneumonia twice this summer. The subcutaneous injection was administered on Tuesday October 9th at approximately 5pm. Note, the nurse administering the injection did not clean the area prior to administration - this potentially could have caused the reaction. By late in the evening I was experiencing minor pain at the site of administration; which is expected with any vaccination. After 24 hours a rash had developed around the site, same rash was approximately 2 inches by two inches in size. After 72 hours the rash had covered the majority of the deltoid area, extending to the elbow. I was unable to move the arm due to pain, and became febrile. I was seen multiple times in emergc as Doctors believed it was an allergic reaction and chose to initially treat it with BENDARYL. After 24 hours of BENADRYL - with no improvement, in fact, the rash had spread further and had started to raise in different areas, appeared to bubble, doctors decided to try oral KEFLEX. After three doses of this antibiotic, the rash continued to spread and my fever remained high, I was then put on IV Cefazolin and remained on this for 4 days. During this time I was in and out of the hospital and seen by a home care nurse. After 4 days of this medication the IV was discontinued. I am currently, again on oral KEFLEX. The site appearance and pain continues to improve. Please note: I was unable to continue to the next screen in this questionnaire without selecting every option in the questions above. To clarify and provide the proper responses: 1. Adverse Event, Product Use Error. 2. Hospitalization- initial or prolonged.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Neutrophil count increased, Pyrexia, White blood cell count increased
Clinical narrative: PNEUMOVAX was suggested to me as I developed pneumonia twice this summer. The subcutaneous injection was administered on Tuesday October 9th at approximately 5pm. Note, the nurse administering the injection did not clean the area prior to administration - this potentially could have caused the reaction. By late in the evening I was experiencing minor pain at the site of administration; which is expected with any vaccination. After 24 hours a rash had developed around the site, same rash was approximately 2 inches by two inches in size. After 72 hours the rash had covered the majority of the deltoid area, extending to the elbow. I was unable to move the arm due to pain, and became febrile. I was seen multiple times in emergc as Doctors believed it was an allergic reaction and chose to initially treat it with BENDARYL. After 24 hours of BENADRYL - with no improvement, in fact, the rash had spread further and had started to raise in different areas, appeared to bubble, doctors decided to try oral KEFLEX. After three doses of this antibiotic, the rash continued to spread and my fever remained high, I was then put on IV Cefazolin and remained on this for 4 days. During this time I was in and out of the hospital and seen by a home care nurse. After 4 days of this medication the IV was discontinued. I am currently, again on oral KEFLEX. The site appearance and pain continues to improve. Please note: I was unable to continue to the next screen in this questionnaire without selecting every option in the questions above. To clarify and provide the proper responses: 1. Adverse Event, Product Use Error. 2. Hospitalization- initial or prolonged.
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Erythema, Immediate post-injection reaction, Injection site cellulitis, Injection site nodule
Clinical narrative: Initial information received from a consumer (pharmacy technician) on 08 October 2012. A female patient in her 50's (age and date of birth not reported) received a dose of Tetanus Toxoid Adsorbed Preservative-free, lot number U3919AA, intramuscularly in the left deltoid on 02 October 2012. The patient had no past medical history and no known allergies. Following administration of the vaccine, the patient immediately felt faint and developed redness and pain in the left arm. The arm continued to be sore and painful. The patient was hospitalized from 03 October 2012 through 08 October 2012 and was diagnosed with cellulitis at the site. The patient was discharged on ZITHROMAX. Her arm continues to be sore and painful with a "knot" at the site. The patient had not recovered at the time of this report. Documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Pain in extremity
Clinical narrative: Initial information received from a consumer (pharmacy technician) on 08 October 2012. A female patient in her 50's (age and date of birth not reported) received a dose of Tetanus Toxoid Adsorbed Preservative-free, lot number U3919AA, intramuscularly in the left deltoid on 02 October 2012. The patient had no past medical history and no known allergies. Following administration of the vaccine, the patient immediately felt faint and developed redness and pain in the left arm. The arm continued to be sore and painful. The patient was hospitalized from 03 October 2012 through 08 October 2012 and was diagnosed with cellulitis at the site. The patient was discharged on ZITHROMAX. Her arm continues to be sore and painful with a "knot" at the site. The patient had not recovered at the time of this report. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Abasia, Gait disturbance, Guillain-Barre syndrome, Hypokinesia
Clinical narrative: Flu shot - got shot - 3 days could not walk went to hospital it turned into Guillain Barr Syndrome. Could not walk for 3 months. Still don't walk too good. In hospital 15 days could not walk or move.
Sex: M
Vaccine: TDAP
Symptoms: Biopsy, Erythema multiforme
Clinical narrative: Initial report was received from a consumer, who was also the patient's wife, on 08 October 2012. A male patient had received an intramuscular injection of ADACEL, lot number C4149AA (site and date of administration not reported). Fifteen days post-vaccination, the patient had a severe outbreak of erythema multiforme. A biopsy was done but the results were not available at the time of the report. No additional information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Dysarthria, Headache, Hypoaesthesia, Lumbar puncture normal
Clinical narrative: Within 2 hours of receiving flu vaccine, client was observed by parents to have (L) sided facial drooping, (L) arm numbness, drowsiness, & c/o headache. Brought to ER by mother at 4 pm with reported slurred speech & muscle spasms. Hospitalized overnight for testing per mother.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Nuclear magnetic resonance imaging normal, Somnolence, VIIth nerve paralysis
Clinical narrative: Within 2 hours of receiving flu vaccine, client was observed by parents to have (L) sided facial drooping, (L) arm numbness, drowsiness, & c/o headache. Brought to ER by mother at 4 pm with reported slurred speech & muscle spasms. Hospitalized overnight for testing per mother.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU3, MMR, SMALL
Symptoms: Blood culture, Brain oedema, CSF lymphocyte count increased, CSF white blood cell count increased, Chest X-ray
Clinical narrative: Altered mental status, nonverbal, arouses to painful stimuli, increased ICP. Cerebral edema on CT scan. L.P.: 14.7 WBC / 85% lymphocytes. Sterile at day 43. Required mechanical ventilation.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU3, MMR, SMALL
Symptoms: Computerised tomogram head abnormal, Drug screen negative, Intracranial pressure increased, Mechanical ventilation, Mental status changes
Clinical narrative: Altered mental status, nonverbal, arouses to painful stimuli, increased ICP. Cerebral edema on CT scan. L.P.: 14.7 WBC / 85% lymphocytes. Sterile at day 43. Required mechanical ventilation.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU3, MMR, SMALL
Symptoms: Unresponsive to stimuli, Viral test
Clinical narrative: Altered mental status, nonverbal, arouses to painful stimuli, increased ICP. Cerebral edema on CT scan. L.P.: 14.7 WBC / 85% lymphocytes. Sterile at day 43. Required mechanical ventilation.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Chills, Cough, Fatigue, Headache
Clinical narrative: Sun 10/07/2012 day 3 fatigue, muscle aches. Mon 10/08/2012 day 4 headache, chills, extreme fatigue, weakness, muscle aches, 100.9 F temp. Tues 10/09/2012 day 5 fatigue, muscle aches, 100.9 temp. Wed 10/10/2012 day 6 dry cough, HA, fatigue. Thur 10/11/2012 day 7 dry cough, HA, fatigue, slight runny nose. Fri 10/12/2012 day 8 dry cough, fatigue, slight runny nose. Sat 10/13/2012 day 9 fatigue, dry cough, neck pain (probably from coughing all the time). Sun 10/14/2012 day 10 vomiting, neck pain, dry cough, extreme fatigue. Mon 10/15/2012 day 11 fatigue, beginning of cough productive of yellow sputum. Tues 10/16/2012 day 12 frequent coughing productive of yellow sputum, sore throat, fatigue. Wed 10/17/2012 day 13 frequent coughing productive of yellow sputum, sore throat, fatigue. Thur 10/18/2012 day 14 frequent coughing productive of yellow sputum, sore throat, fatigue. Fri 10/19/2012 day 15 lingering frequent cough productive of yellow sputum, resolving fatigue. I suppose this is an "FYI" Report, as it doesn't constitute an "adverse" or serious reaction, however, I must say I have been completely startled and angered by this ongoing cascade of symptoms, I missed 1 1/2 days of work, and have been functioning at 50% on all of the other days. Of course, one cannot conclude that FLUMIST caused all or any of these symptoms. I have not sought treatment by a healthcare provider, as it would be pointless, and have employed numerous home remedies/over the counter treatments to try to deal with symptoms. As far as my own personal opinion about it, I will never opt for FLUMIST again, nor recommend it to any adults that I know personally. As I am an Immunization Nurse at Health Dept., it will not bias the information I give to our clients, which is the information on the VIS.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Myalgia, Neck pain, Oropharyngeal pain, Productive cough, Rhinorrhoea
Clinical narrative: Sun 10/07/2012 day 3 fatigue, muscle aches. Mon 10/08/2012 day 4 headache, chills, extreme fatigue, weakness, muscle aches, 100.9 F temp. Tues 10/09/2012 day 5 fatigue, muscle aches, 100.9 temp. Wed 10/10/2012 day 6 dry cough, HA, fatigue. Thur 10/11/2012 day 7 dry cough, HA, fatigue, slight runny nose. Fri 10/12/2012 day 8 dry cough, fatigue, slight runny nose. Sat 10/13/2012 day 9 fatigue, dry cough, neck pain (probably from coughing all the time). Sun 10/14/2012 day 10 vomiting, neck pain, dry cough, extreme fatigue. Mon 10/15/2012 day 11 fatigue, beginning of cough productive of yellow sputum. Tues 10/16/2012 day 12 frequent coughing productive of yellow sputum, sore throat, fatigue. Wed 10/17/2012 day 13 frequent coughing productive of yellow sputum, sore throat, fatigue. Thur 10/18/2012 day 14 frequent coughing productive of yellow sputum, sore throat, fatigue. Fri 10/19/2012 day 15 lingering frequent cough productive of yellow sputum, resolving fatigue. I suppose this is an "FYI" Report, as it doesn't constitute an "adverse" or serious reaction, however, I must say I have been completely startled and angered by this ongoing cascade of symptoms, I missed 1 1/2 days of work, and have been functioning at 50% on all of the other days. Of course, one cannot conclude that FLUMIST caused all or any of these symptoms. I have not sought treatment by a healthcare provider, as it would be pointless, and have employed numerous home remedies/over the counter treatments to try to deal with symptoms. As far as my own personal opinion about it, I will never opt for FLUMIST again, nor recommend it to any adults that I know personally. As I am an Immunization Nurse at Health Dept., it will not bias the information I give to our clients, which is the information on the VIS.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Sputum discoloured, Vomiting
Clinical narrative: Sun 10/07/2012 day 3 fatigue, muscle aches. Mon 10/08/2012 day 4 headache, chills, extreme fatigue, weakness, muscle aches, 100.9 F temp. Tues 10/09/2012 day 5 fatigue, muscle aches, 100.9 temp. Wed 10/10/2012 day 6 dry cough, HA, fatigue. Thur 10/11/2012 day 7 dry cough, HA, fatigue, slight runny nose. Fri 10/12/2012 day 8 dry cough, fatigue, slight runny nose. Sat 10/13/2012 day 9 fatigue, dry cough, neck pain (probably from coughing all the time). Sun 10/14/2012 day 10 vomiting, neck pain, dry cough, extreme fatigue. Mon 10/15/2012 day 11 fatigue, beginning of cough productive of yellow sputum. Tues 10/16/2012 day 12 frequent coughing productive of yellow sputum, sore throat, fatigue. Wed 10/17/2012 day 13 frequent coughing productive of yellow sputum, sore throat, fatigue. Thur 10/18/2012 day 14 frequent coughing productive of yellow sputum, sore throat, fatigue. Fri 10/19/2012 day 15 lingering frequent cough productive of yellow sputum, resolving fatigue. I suppose this is an "FYI" Report, as it doesn't constitute an "adverse" or serious reaction, however, I must say I have been completely startled and angered by this ongoing cascade of symptoms, I missed 1 1/2 days of work, and have been functioning at 50% on all of the other days. Of course, one cannot conclude that FLUMIST caused all or any of these symptoms. I have not sought treatment by a healthcare provider, as it would be pointless, and have employed numerous home remedies/over the counter treatments to try to deal with symptoms. As far as my own personal opinion about it, I will never opt for FLUMIST again, nor recommend it to any adults that I know personally. As I am an Immunization Nurse at Health Dept., it will not bias the information I give to our clients, which is the information on the VIS.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Soreness on Left arm, hard to move. Extreme fatigue.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Swelling, Tenderness
Clinical narrative: Redness, swelling, tenderness, pain at injection site in left deltoid.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Erythema, Headache, Myalgia, Oedema
Clinical narrative: Local erythema, edema, muscle aches, paresthesia, arthralgia, headaches.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Paraesthesia
Clinical narrative: Local erythema, edema, muscle aches, paresthesia, arthralgia, headaches.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: Patient states she woke up and she had 101.5 fever and chills.  She also described the injected area as scarlet red and swollen.  No pain. She applied hydrocortisone 1% on the area for a few days and the rash went away along with the fever.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: Shoulder pain, capsulitis, limited ROM.  Sx currently lasting 8 days.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Patient was standing and felt dizzy. He felt as if he was going to pass out. He was taken to an exam room, layed flat on a exam table, he was given Orange Juice. His b/p was 110/62. After 10 minutes he was sitting up and felt better. He slowly stood up and remained in the same standing position for 2 minutes where he felt good enough to leave the clinic.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Eyelid function disorder, Hypoaesthesia oral, Neuritis, Nuclear magnetic resonance imaging abnormal, Paralysis
Clinical narrative: Started with a numb tongue and eventually could not close Right eye. Was admitted on 17 OCT to rule out other possible conditions only.  DX of Bells Palsy on Right and 5th nerve palsy on the left side of his face.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: VIIth nerve paralysis
Clinical narrative: Started with a numb tongue and eventually could not close Right eye. Was admitted on 17 OCT to rule out other possible conditions only.  DX of Bells Palsy on Right and 5th nerve palsy on the left side of his face.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Syncope, Vomiting
Clinical narrative: Patient had an approximately 15 second syncopal episode immediately after vaccine was injected.  Upon awakening vomited 30cc clear fluid.  Patient was given cool washcloth and assisted to lay down on exam table.  Patient was given saltine crackers and water approx 10 minutes after episode and monitored for a total of 30 minutes.  Patient was ambulatory and stated she did not feel lightheaded or dizzy when she left the facility.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: HIVES OVER AND AROUND THE SITE.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: RASH ON FACE. WENT TO URGENT CARE @ 11:30 AM. TOLD TO TAKE ANTIHISTIMINES.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Erythema, Injection site erythema, Oedema peripheral, Skin warm
Clinical narrative: Red spot at the injection site, swelling, redness decending to the wrist from deltoid, warm to touch.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Injection site swelling, Oedema peripheral, Skin warm, Syncope
Clinical narrative: Red spot at the injection site, swelling, redness decending to the wrist from deltoid, warm to touch.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Computerised tomogram head, Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Pt describing headache, numbness to face and weakness to extremities. Was taken directly to ER by parent and evaluated at Hosp. dx with migrain, CT scan of head done and sent home. Spoke with our office 9/28/12 with continuing s/s and was referred back to ER. Seen at another hospital then transferred to final hospital for admission.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Migraine, Muscular weakness
Clinical narrative: Pt describing headache, numbness to face and weakness to extremities. Was taken directly to ER by parent and evaluated at Hosp. dx with migrain, CT scan of head done and sent home. Spoke with our office 9/28/12 with continuing s/s and was referred back to ER. Seen at another hospital then transferred to final hospital for admission.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Headache
Clinical narrative: Intermittent facial flushing, feeling warm and over heated for 3 days, 4th day L sided headache.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Immediate post-injection reaction, Local reaction, Wheezing
Clinical narrative: Localized reaction immediately after injection given.  Wheezing and shortness of breath at 09:00 PM.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: BRUISING AND SWELLING AT INJECTION SITE. INJESTION SITE IS RED AND WARM. RAISED AREA APPROXIMATELY 3 INCHES IN DIAMETER. NAUSEA AND VOMITING X1 DAY.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: BRUISING AND SWELLING AT INJECTION SITE. INJESTION SITE IS RED AND WARM. RAISED AREA APPROXIMATELY 3 INCHES IN DIAMETER. NAUSEA AND VOMITING X1 DAY.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site discomfort, Injection site pain
Clinical narrative: Reports soreness and discomfort at injection site.  Returned to clinic several days later with complaint of "my arm feels like it is going to fall off," and "feels like something is torn."
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, CSF test, Endotracheal intubation, Intensive care, Mental status changes
Clinical narrative: Patient was vaccinated on 9/14/12 (flu vaccine). She was admitted with altered mental status on 9/22/12 that soon required intubation & intensive care unit transfer. MRI brain shows white matter lesions diffuse. We think it's probably ADEM (Acute Demyelinating).
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain abnormal, White matter lesion
Clinical narrative: Patient was vaccinated on 9/14/12 (flu vaccine). She was admitted with altered mental status on 9/22/12 that soon required intubation & intensive care unit transfer. MRI brain shows white matter lesions diffuse. We think it's probably ADEM (Acute Demyelinating).
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea
Clinical narrative: Given flu vaccine 10-16-12 that evening and next am SOB, cough - needed nebulizer tx.