chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Sputum discoloured, White blood cell count normal
Clinical narrative: This case was reported by a physician, who was also the subject, and described the occurrence of pneumonia in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), BOOSTRIX. Medical history included the subject receiving a flu vaccine (unspecified manufacturer) many years ago, but only reaction was local effects. Concurrent medical conditions included dry mouth and thirst. Concurrent medications included multivitamins (daily multivitamin). On 02 October 2012, the subject had a general wellness check-up and wellness lab tests and both were within normal limits. She had no cardiovascular or respiratory problems. On 2 October 2012 at 11:00 the subject received dose of FLUARIX (details unknown, left deltoid) and dose of BOOSTRIX (details unknown, left deltoid). The vaccines were administered as one vaccine under the other. On 2 October 2012, hours after vaccination with BOOSTRIX and FLUARIX, the subject experienced malaise, nausea, vomiting, insomnia, pleurisy, couldn't sleep on one side due to pain and dyspnea, headache, weakness, chills, and dizziness. On the same day as the vaccinations (2 October 2012), she experienced pneumonia. On 3 October 2012, less than 24 hours after vaccination with BOOSTRIX and FLUARIX, she experienced fever, difficulty breathing, hypotension and coughing blood. The subject was hospitalised. Relevant test results included chest x-ray which showed right-sided pneumonia. No cultures were obtained. The subject was treated with intravenous fluid(s) (IV fluids), anti-nausea drugs (nausea medication (unknown)), antibiotics (IV antibiotics) and azithromycin. At the time of reporting the events were gradually resolving. The vaccination courses with FLUARIX and BOOSTRIX were discontinued. It was reported that on 02 October 2012, the subject received the FLUARIX and BOOSTRIX and then immediately went downstairs to the clinic lab and had wellness lab tests and results were within normal limits. She left the clinic by 12:00 to go home over 45 minutes. By afternoon, she felt malaise. Then by evening, she developed nausea, vomiting, insomnia, pleuresy, and couldn't sleep on one side due to pain and dyspnea. Then, the nausea worsened, with severe headache, weakness, chills, and dizziness. On the morning of 03 October 2012, less than 24 hours after wellness check-up, she went to the emergency room and was hospitalized for pneumonia with 102.4 degrees Fahrenheit fever, difficulty breathing, hypotension, blood pressure 79/50, and coughing blood. There was no other cough. In hospital, treatment included IV fluids, anti-nausea medications, iv antibiotics, and she went home with oral azithromycin. She was discharged on 04 October 2012 and "now gradually resolving". The discharge diagnosis was pneumonia.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Asthenia, Chest X-ray abnormal, Chills, Dizziness, Dyspnoea
Clinical narrative: This case was reported by a physician, who was also the subject, and described the occurrence of pneumonia in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), BOOSTRIX. Medical history included the subject receiving a flu vaccine (unspecified manufacturer) many years ago, but only reaction was local effects. Concurrent medical conditions included dry mouth and thirst. Concurrent medications included multivitamins (daily multivitamin). On 02 October 2012, the subject had a general wellness check-up and wellness lab tests and both were within normal limits. She had no cardiovascular or respiratory problems. On 2 October 2012 at 11:00 the subject received dose of FLUARIX (details unknown, left deltoid) and dose of BOOSTRIX (details unknown, left deltoid). The vaccines were administered as one vaccine under the other. On 2 October 2012, hours after vaccination with BOOSTRIX and FLUARIX, the subject experienced malaise, nausea, vomiting, insomnia, pleurisy, couldn't sleep on one side due to pain and dyspnea, headache, weakness, chills, and dizziness. On the same day as the vaccinations (2 October 2012), she experienced pneumonia. On 3 October 2012, less than 24 hours after vaccination with BOOSTRIX and FLUARIX, she experienced fever, difficulty breathing, hypotension and coughing blood. The subject was hospitalised. Relevant test results included chest x-ray which showed right-sided pneumonia. No cultures were obtained. The subject was treated with intravenous fluid(s) (IV fluids), anti-nausea drugs (nausea medication (unknown)), antibiotics (IV antibiotics) and azithromycin. At the time of reporting the events were gradually resolving. The vaccination courses with FLUARIX and BOOSTRIX were discontinued. It was reported that on 02 October 2012, the subject received the FLUARIX and BOOSTRIX and then immediately went downstairs to the clinic lab and had wellness lab tests and results were within normal limits. She left the clinic by 12:00 to go home over 45 minutes. By afternoon, she felt malaise. Then by evening, she developed nausea, vomiting, insomnia, pleuresy, and couldn't sleep on one side due to pain and dyspnea. Then, the nausea worsened, with severe headache, weakness, chills, and dizziness. On the morning of 03 October 2012, less than 24 hours after wellness check-up, she went to the emergency room and was hospitalized for pneumonia with 102.4 degrees Fahrenheit fever, difficulty breathing, hypotension, blood pressure 79/50, and coughing blood. There was no other cough. In hospital, treatment included IV fluids, anti-nausea medications, iv antibiotics, and she went home with oral azithromycin. She was discharged on 04 October 2012 and "now gradually resolving". The discharge diagnosis was pneumonia.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Haemoptysis, Headache, Hypotension, Insomnia, Laboratory test normal
Clinical narrative: This case was reported by a physician, who was also the subject, and described the occurrence of pneumonia in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), BOOSTRIX. Medical history included the subject receiving a flu vaccine (unspecified manufacturer) many years ago, but only reaction was local effects. Concurrent medical conditions included dry mouth and thirst. Concurrent medications included multivitamins (daily multivitamin). On 02 October 2012, the subject had a general wellness check-up and wellness lab tests and both were within normal limits. She had no cardiovascular or respiratory problems. On 2 October 2012 at 11:00 the subject received dose of FLUARIX (details unknown, left deltoid) and dose of BOOSTRIX (details unknown, left deltoid). The vaccines were administered as one vaccine under the other. On 2 October 2012, hours after vaccination with BOOSTRIX and FLUARIX, the subject experienced malaise, nausea, vomiting, insomnia, pleurisy, couldn't sleep on one side due to pain and dyspnea, headache, weakness, chills, and dizziness. On the same day as the vaccinations (2 October 2012), she experienced pneumonia. On 3 October 2012, less than 24 hours after vaccination with BOOSTRIX and FLUARIX, she experienced fever, difficulty breathing, hypotension and coughing blood. The subject was hospitalised. Relevant test results included chest x-ray which showed right-sided pneumonia. No cultures were obtained. The subject was treated with intravenous fluid(s) (IV fluids), anti-nausea drugs (nausea medication (unknown)), antibiotics (IV antibiotics) and azithromycin. At the time of reporting the events were gradually resolving. The vaccination courses with FLUARIX and BOOSTRIX were discontinued. It was reported that on 02 October 2012, the subject received the FLUARIX and BOOSTRIX and then immediately went downstairs to the clinic lab and had wellness lab tests and results were within normal limits. She left the clinic by 12:00 to go home over 45 minutes. By afternoon, she felt malaise. Then by evening, she developed nausea, vomiting, insomnia, pleuresy, and couldn't sleep on one side due to pain and dyspnea. Then, the nausea worsened, with severe headache, weakness, chills, and dizziness. On the morning of 03 October 2012, less than 24 hours after wellness check-up, she went to the emergency room and was hospitalized for pneumonia with 102.4 degrees Fahrenheit fever, difficulty breathing, hypotension, blood pressure 79/50, and coughing blood. There was no other cough. In hospital, treatment included IV fluids, anti-nausea medications, iv antibiotics, and she went home with oral azithromycin. She was discharged on 04 October 2012 and "now gradually resolving". The discharge diagnosis was pneumonia.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Malaise, Nausea, Pain, Pleurisy, Pneumonia
Clinical narrative: This case was reported by a physician, who was also the subject, and described the occurrence of pneumonia in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), BOOSTRIX. Medical history included the subject receiving a flu vaccine (unspecified manufacturer) many years ago, but only reaction was local effects. Concurrent medical conditions included dry mouth and thirst. Concurrent medications included multivitamins (daily multivitamin). On 02 October 2012, the subject had a general wellness check-up and wellness lab tests and both were within normal limits. She had no cardiovascular or respiratory problems. On 2 October 2012 at 11:00 the subject received dose of FLUARIX (details unknown, left deltoid) and dose of BOOSTRIX (details unknown, left deltoid). The vaccines were administered as one vaccine under the other. On 2 October 2012, hours after vaccination with BOOSTRIX and FLUARIX, the subject experienced malaise, nausea, vomiting, insomnia, pleurisy, couldn't sleep on one side due to pain and dyspnea, headache, weakness, chills, and dizziness. On the same day as the vaccinations (2 October 2012), she experienced pneumonia. On 3 October 2012, less than 24 hours after vaccination with BOOSTRIX and FLUARIX, she experienced fever, difficulty breathing, hypotension and coughing blood. The subject was hospitalised. Relevant test results included chest x-ray which showed right-sided pneumonia. No cultures were obtained. The subject was treated with intravenous fluid(s) (IV fluids), anti-nausea drugs (nausea medication (unknown)), antibiotics (IV antibiotics) and azithromycin. At the time of reporting the events were gradually resolving. The vaccination courses with FLUARIX and BOOSTRIX were discontinued. It was reported that on 02 October 2012, the subject received the FLUARIX and BOOSTRIX and then immediately went downstairs to the clinic lab and had wellness lab tests and results were within normal limits. She left the clinic by 12:00 to go home over 45 minutes. By afternoon, she felt malaise. Then by evening, she developed nausea, vomiting, insomnia, pleuresy, and couldn't sleep on one side due to pain and dyspnea. Then, the nausea worsened, with severe headache, weakness, chills, and dizziness. On the morning of 03 October 2012, less than 24 hours after wellness check-up, she went to the emergency room and was hospitalized for pneumonia with 102.4 degrees Fahrenheit fever, difficulty breathing, hypotension, blood pressure 79/50, and coughing blood. There was no other cough. In hospital, treatment included IV fluids, anti-nausea medications, iv antibiotics, and she went home with oral azithromycin. She was discharged on 04 October 2012 and "now gradually resolving". The discharge diagnosis was pneumonia.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Pyrexia, Sleep disorder, Vomiting
Clinical narrative: This case was reported by a physician, who was also the subject, and described the occurrence of pneumonia in a 55-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), BOOSTRIX. Medical history included the subject receiving a flu vaccine (unspecified manufacturer) many years ago, but only reaction was local effects. Concurrent medical conditions included dry mouth and thirst. Concurrent medications included multivitamins (daily multivitamin). On 02 October 2012, the subject had a general wellness check-up and wellness lab tests and both were within normal limits. She had no cardiovascular or respiratory problems. On 2 October 2012 at 11:00 the subject received dose of FLUARIX (details unknown, left deltoid) and dose of BOOSTRIX (details unknown, left deltoid). The vaccines were administered as one vaccine under the other. On 2 October 2012, hours after vaccination with BOOSTRIX and FLUARIX, the subject experienced malaise, nausea, vomiting, insomnia, pleurisy, couldn't sleep on one side due to pain and dyspnea, headache, weakness, chills, and dizziness. On the same day as the vaccinations (2 October 2012), she experienced pneumonia. On 3 October 2012, less than 24 hours after vaccination with BOOSTRIX and FLUARIX, she experienced fever, difficulty breathing, hypotension and coughing blood. The subject was hospitalised. Relevant test results included chest x-ray which showed right-sided pneumonia. No cultures were obtained. The subject was treated with intravenous fluid(s) (IV fluids), anti-nausea drugs (nausea medication (unknown)), antibiotics (IV antibiotics) and azithromycin. At the time of reporting the events were gradually resolving. The vaccination courses with FLUARIX and BOOSTRIX were discontinued. It was reported that on 02 October 2012, the subject received the FLUARIX and BOOSTRIX and then immediately went downstairs to the clinic lab and had wellness lab tests and results were within normal limits. She left the clinic by 12:00 to go home over 45 minutes. By afternoon, she felt malaise. Then by evening, she developed nausea, vomiting, insomnia, pleuresy, and couldn't sleep on one side due to pain and dyspnea. Then, the nausea worsened, with severe headache, weakness, chills, and dizziness. On the morning of 03 October 2012, less than 24 hours after wellness check-up, she went to the emergency room and was hospitalized for pneumonia with 102.4 degrees Fahrenheit fever, difficulty breathing, hypotension, blood pressure 79/50, and coughing blood. There was no other cough. In hospital, treatment included IV fluids, anti-nausea medications, iv antibiotics, and she went home with oral azithromycin. She was discharged on 04 October 2012 and "now gradually resolving". The discharge diagnosis was pneumonia.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Emotional distress, Opisthotonus, Pyrexia
Clinical narrative: Fever of 102.5, Non stop crying for over 3 hours, Arching of back, unconsolable. I called the pediatrician after hours care and the doctor told me to wait it out and then decided that I should take him to the hospital to be safe. I took him to the hospital that night and they kept us for a few hours and he finally calmed down and fell asleep. They gave him Tylenol.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: High fever and body aches 12 hours after injection. Headache 6 hours after injection continuing up to 48 hours. Extreme pain in arm 48 hours after with pain increasing.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Very painful rash and bumps later diagnosed as shingles. Pain began after the immunization was administered. Pain still persists till this day.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Eye discharge, Eye irritation, Eye pruritus, Eye swelling
Clinical narrative: SEVERE DIZZINESS - ROOM SPINNING WITHIN 30 MINUTES OF THE VACCINE ADMINISTRATION. SEVERE NAUSEA AND REFLUX. SEVERE EYE IRRITATION, BURNING, ITCHING, DISCHARGE, BLOODSHOT EYES, AND EYE SWELLING. MALAISE, SEVERE LETHARGY.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Gastrooesophageal reflux disease, Lethargy, Malaise, Nausea, Ocular hyperaemia
Clinical narrative: SEVERE DIZZINESS - ROOM SPINNING WITHIN 30 MINUTES OF THE VACCINE ADMINISTRATION. SEVERE NAUSEA AND REFLUX. SEVERE EYE IRRITATION, BURNING, ITCHING, DISCHARGE, BLOODSHOT EYES, AND EYE SWELLING. MALAISE, SEVERE LETHARGY.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: SEVERE DIZZINESS - ROOM SPINNING WITHIN 30 MINUTES OF THE VACCINE ADMINISTRATION. SEVERE NAUSEA AND REFLUX. SEVERE EYE IRRITATION, BURNING, ITCHING, DISCHARGE, BLOODSHOT EYES, AND EYE SWELLING. MALAISE, SEVERE LETHARGY.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Joint range of motion decreased, Musculoskeletal stiffness, Oedema peripheral, Pain
Clinical narrative: Fever (that was usual) and left arm where shot was given was stiff and achy. NOT the injection site but the actual shoulder/neck area. Saw my PCM on 10/01/2012 after the pain was persistent, not improving, swollen and hot. Was told it was and infection and started treatment, a course of antibiotics (CEPHALEXIN 500MG) for 10 days. Still taking antibiotics but swelling has gone and most of my range of motion has returned. Occasional weakness and pain still.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Skin warm
Clinical narrative: Fever (that was usual) and left arm where shot was given was stiff and achy. NOT the injection site but the actual shoulder/neck area. Saw my PCM on 10/01/2012 after the pain was persistent, not improving, swollen and hot. Was told it was and infection and started treatment, a course of antibiotics (CEPHALEXIN 500MG) for 10 days. Still taking antibiotics but swelling has gone and most of my range of motion has returned. Occasional weakness and pain still.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pruritus
Clinical narrative: Generalized pruritis, dizziness, ?? facial swelling.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain starting 2/3 days after shot and continued to worsen.  Doctor Visit 10/4 prescribed Meloxicam with referral to ortho if symptoms persist.  At this time (10/11) not pain free but improving.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Crying, Dyspnoea, Fear, Pain
Clinical narrative: States about 4 hrs after receiving the vaccine, woke up with cough and "respiratory distress", could not lay down.  States she took ibuprofen and some cough syrup, had her husband observe her, was frightened and crying which made her respirations more difficult.  Was able to fall back asleep in a sitting position, slept about 3.5 more hours and now feels ok except for feeling general aches.  Denies any further respiratory symptoms, denies fever.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory distress
Clinical narrative: States about 4 hrs after receiving the vaccine, woke up with cough and "respiratory distress", could not lay down.  States she took ibuprofen and some cough syrup, had her husband observe her, was frightened and crying which made her respirations more difficult.  Was able to fall back asleep in a sitting position, slept about 3.5 more hours and now feels ok except for feeling general aches.  Denies any further respiratory symptoms, denies fever.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection site is sore, hard, achy, painful, red and swollen.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, TDAP, HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: Lightheadedness, vomited x 1.  Pt developed lightheadedness following immunizations, this resolved and pt sent home. About 45 minutes following immunizations pt vomited x 1.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, TDAP, HPV4
Symptoms: Vomiting
Clinical narrative: Lightheadedness, vomited x 1.  Pt developed lightheadedness following immunizations, this resolved and pt sent home. About 45 minutes following immunizations pt vomited x 1.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Palpitations
Clinical narrative: Patient reports "such bad heart palpitations I thought I was going to die". She called her "anxiety doctor" because she said that she had no primary care doctor. The palpitations were so bad she thought she might go to the ER. Then they stopped.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Cheilitis, Food allergy, Headache, Lip haemorrhage, Oral pain
Clinical narrative: Swollen lips, mouth sore, lips reddened and look like they are bleeding, feel "grainy", headache.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Paraesthesia
Clinical narrative: Tingling starting in left arm and then progressed to right arm. Pt states "felt strange". VS 152/96-P-68 at onset, VS 178/84-P-64 after 20 min.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: 10/2/12 Pneumonia vaccine was given to pt. 2 days later saw MD for sore left arm. Left arm examined and noted to be red and hot over 8x6 cm area.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 25 September 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 12 month old, male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of PENTACEL: lot number C3926AC received on 12 July 2011, and lot number C3930AA received on 13 September 2011 and 14 November 2011 (route and sites of administration not reported). The subject developed a cough on 21 May 2012, approximately 6 months after the last dose. On 09 June 2012, he developed a paroxysmal cough without a whoop. He also experienced apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 13 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 13 June 2012. The subject was not hospitalized. At the time of final contact on 19 June 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: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 25 September 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 12 month old, male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of PENTACEL: lot number C3926AC received on 12 July 2011, and lot number C3930AA received on 13 September 2011 and 14 November 2011 (route and sites of administration not reported). The subject developed a cough on 21 May 2012, approximately 6 months after the last dose. On 09 June 2012, he developed a paroxysmal cough without a whoop. He also experienced apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 13 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 13 June 2012. The subject was not hospitalized. At the time of final contact on 19 June 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: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 25 September 2012 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis disease in an 2 year old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System database. The subject's vaccine history included 3 doses of PENTACEL: lot number C3614AA on 12 July 2010, lot number C3657AA on 17 September 2010, lot number C3716AB on 17 November 2010 (site and route of administration not reported). On 04 June 2012, the subject developed a cough, approximately 19 months after the last dose. On 11 June 2012, she developed a paroxysmal cough with a whoop. She also experienced apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 25 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 26 June 2012. The subject was not hospitalized. At the time of final contact on 29 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 25 September 2012 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis disease in an 2 year old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System database. The subject's vaccine history included 3 doses of PENTACEL: lot number C3614AA on 12 July 2010, lot number C3657AA on 17 September 2010, lot number C3716AB on 17 November 2010 (site and route of administration not reported). On 04 June 2012, the subject developed a cough, approximately 19 months after the last dose. On 11 June 2012, she developed a paroxysmal cough with a whoop. She also experienced apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 25 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 26 June 2012. The subject was not hospitalized. At the time of final contact on 29 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.01
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 25 September 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 4 year old, male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of PENTACEL: lot number C3199AA on 10 October 2008, lot number C3183AA on 11 December 2008, and lot number C3180AA on 12 February 2009; and 1 dose of DAPTACEL (lot number C2999AA) received on 12 August 2009. Approximately 3 years after the last dose, on 05 August 2012, the subject developed cold-like symptoms followed by a cough that began on 08 August 2012. He then developed a paroxysmal cough without a whoop on 13 August 2012. He also experienced posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 22 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 22 August 2012. The subject was not hospitalized. At the time of final contact on 19 September 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.01
Sex: M
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 25 September 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 4 year old, male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of PENTACEL: lot number C3199AA on 10 October 2008, lot number C3183AA on 11 December 2008, and lot number C3180AA on 12 February 2009; and 1 dose of DAPTACEL (lot number C2999AA) received on 12 August 2009. Approximately 3 years after the last dose, on 05 August 2012, the subject developed cold-like symptoms followed by a cough that began on 08 August 2012. He then developed a paroxysmal cough without a whoop on 13 August 2012. He also experienced posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 22 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 22 August 2012. The subject was not hospitalized. At the time of final contact on 19 September 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 38.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Encephalitis
Clinical narrative: This study case was received from the investigator in a trial on 26 September 2012. A 38 year-old male subject (medical history not available) was found to have an unspecified cause of encephalitis two days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax 2 (manufacturer, lot number, route and site of administration not reported) on 08 February 2012. Relevant laboratory and diagnostic testing was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 28 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-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 4 doses of DAPTACEL: lot number C2933AB on 07 April 2008, lot number C2934BA on 11 June 2008, lot number C2934AA on 05 August 2008, and lot number C3082AA on 19 May 2009 (routes and sites of administration not reported). The subject developed a cough on 05 September 2012, approximately 3 years after the last dose. The subject also developed catarrhal illness, a paroxysmal cough with a whoop, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 10 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 10 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 19 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 28 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-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 4 doses of DAPTACEL: lot number C2933AB on 07 April 2008, lot number C2934BA on 11 June 2008, lot number C2934AA on 05 August 2008, and lot number C3082AA on 19 May 2009 (routes and sites of administration not reported). The subject developed a cough on 05 September 2012, approximately 3 years after the last dose. The subject also developed catarrhal illness, a paroxysmal cough with a whoop, apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 10 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 10 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 19 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP, SMALL, YF
Symptoms: Encephalitis, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This study case was received from the investigator in a trial on 27 September 2012. A 35 year-old female subject (medical history was not available) was found to have other causes of encephalitis three days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported), Yellow Fever vaccine (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hep B -Adult 1 (manufacturer, lot number, route and site of administration not reported) on 08 January 2012. Relevant laboratory data included: a normal MRI (brain) on 08 February 2012. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 1.0
Sex: M
Vaccine: DTAPH
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 25 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 3 year old, male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of PENTACEL: lot number C3306AA on 17 August 2009, lot number C3432AB on both 19 October 2009 and 02 December 2009; and 1 dose of TRIHIBIT (lot number U3009BA) on 02 June 2010 (site and route of administration not reported). Approximately two years after the TRIHIBIT dose, on 05 September 2012, he developed a paroxysmal cough. He also experienced sleep disturbance (onset date not reported). Laboratory testing included positive PCR on 07 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 07 September 2012. The subject was not hospitalized. At the time of final contact on 21 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.0
Sex: M
Vaccine: DTAPH
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 25 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 3 year old, male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of PENTACEL: lot number C3306AA on 17 August 2009, lot number C3432AB on both 19 October 2009 and 02 December 2009; and 1 dose of TRIHIBIT (lot number U3009BA) on 02 June 2010 (site and route of administration not reported). Approximately two years after the TRIHIBIT dose, on 05 September 2012, he developed a paroxysmal cough. He also experienced sleep disturbance (onset date not reported). Laboratory testing included positive PCR on 07 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 07 September 2012. The subject was not hospitalized. At the time of final contact on 21 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Angina pectoris
Clinical narrative: This study case was received from the investigator on 27 September 2012. A 37 year-old female subject (medical history not reported) was found to have other and unspecified angina pectoris 24 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and TYPHIM VI (manufacturer, lot number, route and site of administration not reported) on 14 February 2012. Relevant laboratory data was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram, Pericardial disease, Troponin I
Clinical narrative: This study case was received from the investigator on 27 September 2012. A 19 year-old male subject was found to have unspecified disease of pericardium nine days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 19 March 2012. The subject also had ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and TYPHIM VI (manufacturer, lot number, route and site of administration not reported) on 07 March 2012. Troponin I and ECG results not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Pericardial disease, Pericarditis
Clinical narrative: This study case was received from the investigator on 27 September 2012. A 22 year-old male subject was found to have other acute pericarditis, unspecified disease of pericardium and non-specific myocarditis 12, 12 and 15 days respectively after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 03 May 2012. On 10 April 2012 the subject was also vaccinated with ANTHRAX 2 (manufacturer, lot number, route and site of administration not reported), Japanese Encephalitis 2 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 00.05 on 18 May 2012, a normal ECG on 15 May 2012 and a normal Echocardiogram on 18 May 2012. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator on 27 September 2012. A 22 year-old male subject was found to have other acute pericarditis, unspecified disease of pericardium and non-specific myocarditis 12, 12 and 15 days respectively after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 03 May 2012. On 10 April 2012 the subject was also vaccinated with ANTHRAX 2 (manufacturer, lot number, route and site of administration not reported), Japanese Encephalitis 2 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 00.05 on 18 May 2012, a normal ECG on 15 May 2012 and a normal Echocardiogram on 18 May 2012. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiac imaging procedure, Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Nuclear magnetic resonance imaging
Clinical narrative: This study case was received from the investigator on 27 September 2012. A 20 year-old male subject was found to have non-specific myocarditis 15 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 09 May 2012. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 01.22 on 19 May 2012, an abnormal ECG on 30 May 2012, a normal Echocardiogram on 19 May 2012 and results of an MRI (heart) not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator on 27 September 2012. A 20 year-old male subject was found to have non-specific myocarditis 15 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 09 May 2012. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 01.22 on 19 May 2012, an abnormal ECG on 30 May 2012, a normal Echocardiogram on 19 May 2012 and results of an MRI (heart) not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 27 September 2012. A 22 year-old male subject was found to have non-specific myocarditis 15 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 15 May 2012. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 29.70 on 29 May 2012. ECG, and Echocardiogram results were not available. Treatment were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Echocardiogram, Electrocardiogram abnormal, Myocardial infarction, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 27 September 2012. A 27 year-old male subject was found to have a subendocardial infarction and chest pain, unspecified 11 and 12 days respectively after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and TYPHIM VI (manufacturer, lot number, route and site of administration not reported) on 11 April 2012. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 00.57 on 21 April 2012 and an abnormal ECG on 21 April 2012. Echocardiogram result was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data-mining, non-interventional) study. Documents held by sender: none.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram, Lumbar puncture, Myocarditis, Nuclear magnetic resonance imaging brain
Clinical narrative: This study case was received from the investigator in a trial on 27 September 2012. A 31-year-old male subject with no reported medical history was found to have non-specific myocarditis 26 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 March 2012. Concomitant vaccinations included typhoid vaccine and anthrax vaccine both administered on 14 February 2012. Laboratory data including Troponin I, ECG, Echocardiogram, MRI (brain, spinal cord, heart) and Lumbar puncture were not available at the time of reporting. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Nuclear magnetic resonance imaging spinal cord, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 27 September 2012. A 31-year-old male subject with no reported medical history was found to have non-specific myocarditis 26 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 March 2012. Concomitant vaccinations included typhoid vaccine and anthrax vaccine both administered on 14 February 2012. Laboratory data including Troponin I, ECG, Echocardiogram, MRI (brain, spinal cord, heart) and Lumbar puncture were not available at the time of reporting. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Diag. Guillain Barre Syndrome. Remains in hospital since April 13, 2012.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Ear discomfort
Clinical narrative: Feeling light headed 5 minutes after vaccine given, diminished but five minutes after that, lightheadedness came back again also reported blocked, pressure feeling in ears. States few years back reacted to flu vaccine with weight gain, fluid retention.
Age: 33.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis
Clinical narrative: Presented to ER and diagnosed with cellulites, given antibiotics.