chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test normal, Nasopharyngitis
Clinical narrative: Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3795AB received on 19 April 2011, lot number C3841AA received on 11 July 2011 and lot number C3923AA received on 07 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and paroxysmal cough (without a whoop) on 30 May 2012, approximately eight months after the last dose. The subject also experienced sleep disturbance and apnea. Laboratory testing included negative PCR on 12 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 13 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3795AB received on 19 April 2011, lot number C3841AA received on 11 July 2011 and lot number C3923AA received on 07 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and paroxysmal cough (without a whoop) on 30 May 2012, approximately eight months after the last dose. The subject also experienced sleep disturbance and apnea. Laboratory testing included negative PCR on 12 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 13 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Cough, Pertussis, Post-tussive vomiting
Clinical narrative: Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of Pertussis disease in a 13-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 16 June 2011, 16 August 2011 and 18 October 2011 (lot numbers, routes and sites of administration not reported). The subject developed a paroxysmal cough with posttussive vomiting on 28 May 2012, approximately six months after the last dose. No laboratory testing was done. Corrective treatments consisted of azithromycin starting on 04 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Pertussis, Polymerase chain reaction positive
Clinical narrative: Initial report received on 22 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3954AB received on 14 July 2011, lot number C3953AA received on 16 September 2011 and lot number C3953AA received on 17 November 2011 (routes and sites of administration not reported). The subject developed a cough on 15 May 2012 and paroxysmal cough (without whoop) on 18 May 2012, approximately six months after the last dose. Laboratory testing included positive PCR on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 12 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction positive
Clinical narrative: Initial report received on 22 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 17-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3603AA received on 07 February 2011, lot number C3805AA received on 20 April 2011 and lot number not reported on 10 June 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 14 May 2012, approximately eleven months after the last dose. On 24 May 2012, the subject developed a paroxysmal cough without a whoop. On the same day, the patient received the fourth dose of PENTACEL (lot number, route and site not reported). The subject also experienced posttussive vomiting. Laboratory testing included positive PCR on 27 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting
Clinical narrative: Initial report received on 22 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 17-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3603AA received on 07 February 2011, lot number C3805AA received on 20 April 2011 and lot number not reported on 10 June 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 14 May 2012, approximately eleven months after the last dose. On 24 May 2012, the subject developed a paroxysmal cough without a whoop. On the same day, the patient received the fourth dose of PENTACEL (lot number, route and site not reported). The subject also experienced posttussive vomiting. Laboratory testing included positive PCR on 27 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Overdose
Clinical narrative: Initial report was received on 03 July 2012 from another manufacturer who considered the report as serious (overdose), report number WAES 1206USA05327. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a registered nurse concerning a patient who on 26-JUN-2012, was vaccinated with a dose of Hib conj vaccine (CMPC) (dose, route and lot number not reported) and during the same visit the patient was vaccinated with a dose of PENTACEL (dose, route and lot number not reported). There were no adverse reactions reported. Additional information has been requested. Documents held by sender: none.
Age: 1.37
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Polymerase chain reaction positive, Post-tussive vomiting
Clinical narrative: Initial report received on 20 June 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of Pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3288AA received on 24 June 2009, lot number C3363AA received on 04 September 2009, lot number C3363AA received on 27 October 2009 and lot number C3552AA received on 08 September 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 07 May 2012, approximately one year and eight months after the last dose. On 10 May 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on  17 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 24 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.37
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 20 June 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of Pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3288AA received on 24 June 2009, lot number C3363AA received on 04 September 2009, lot number C3363AA received on 27 October 2009 and lot number C3552AA received on 08 September 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 07 May 2012, approximately one year and eight months after the last dose. On 10 May 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on  17 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 24 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 6-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 02 December 2011, 03 February 2012 and 04 April 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough and cold-like symptoms on 22 April 2012, approximately 18 days after the last dose. On 25 April 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 26 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 10 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction positive, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 6-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 02 December 2011, 03 February 2012 and 04 April 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough and cold-like symptoms on 22 April 2012, approximately 18 days after the last dose. On 25 April 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 26 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 10 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.82
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 16-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3755AA received on 17 May 2011, lot number C3755AA received on 26 July 2011 and lot number C3796AA received on 25 October 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 25 May 2012, approximately seven months after the last dose. On 25 May 2012, the subject developed a cough and paroxysmal cough on 30 May 2012 without a whoop. Laboratory testing included positive PCR on 01 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 08 June 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: 0.82
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction positive
Clinical narrative: Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 16-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3755AA received on 17 May 2011, lot number C3755AA received on 26 July 2011 and lot number C3796AA received on 25 October 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 25 May 2012, approximately seven months after the last dose. On 25 May 2012, the subject developed a cough and paroxysmal cough on 30 May 2012 without a whoop. Laboratory testing included positive PCR on 01 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 08 June 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: 46.0
Sex: F
Vaccine: RAB
Symptoms: Condition aggravated, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Nausea, no vomiting, muscle aches, lightheadedness, headache worsened. HA was similar as migraine but without usual triggers and lasted much longer - 3 days - not helped with medications. Did not interfere with sleep.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Extra dose administered
Clinical narrative: Double vaccines given, that were not needed.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Patient presented with along with 1 penny sized fluid filled blister with mini blisters around it on the upper left arm. Patient is not reporting having pain. Patient has been afebrile. Area is red and warm to touch. Reaction is not anywhere near where varicella injection was given was also given in the L arm.
Age: 0.45
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Patient has vomited 8x since he had his Rota vaccine this morning. His emesis is stomach contents, white breast milk with curds. He is vomiting a fair amount, no blood, no mucous. UOP is normal. He has not had a BM since he started vomiting and mom has not noticed if he is passing gas but she will monitor for that. His behavior is normal. He vomited after both feeds this morning. Advised mom to try giving Pedialyte instead of breast milk for a few hours. Give a small amount but offer frequently such as 15 ml every 10-15 minutes. If he tolerates that for 2-4 hours she can try increasing the amount. If he tolerates the increase amount of Pedialyte for another 2-4 hours she can go back to breast milk. Told mom that if patient vomits green, is not passing gas or having BM's, or having BM's that are pink and/or mucousy she should call the office or go to ED immediately.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Blood sodium decreased, Burning sensation, Cognitive disorder, Depressed level of consciousness, Encephalitis autoimmune
Clinical narrative: Flu vaccine given on 10/29/13. Patient became very ill in 11/13, but on 12/8/13, he woke up trembling, rash, said body was on fire...after 4 months of loss of weight and cognitive function and then psychosis, patient admitted to Hospital and diagnosed with Auto Immune Limbic Encephalitis. He cannot work and had additional treatments in May of 2015 to reduce infection, but hospitalized again in June 2015 for Low sodium/near comatose. In therapy still after 14 months at TIRR. Steroids, IVIG neuropsych and physical therapy. Still very, very sick. Limbic part of brain controls emotions and he is sometimes in panic mode over simple things. His cognitive function as per test in February was very, very, very low...especially executive function. He used to be a computer genius. Now he can barely comprehend some things that were easy to him before. He cannot INITIATE or think of things to do. He will say, MY MIND IS BLANK. It is heartbreaking. He has had suicidal thoughts and has lost his entire identity. Encephalitis is horrible, because it is sometimes a HIDDEN illness. His last lumbar puncture was May 8, 2015 and infection and auto immune limbic encephalitis still there.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Impaired work ability, Infection, Laboratory test, Lumbar puncture abnormal
Clinical narrative: Flu vaccine given on 10/29/13. Patient became very ill in 11/13, but on 12/8/13, he woke up trembling, rash, said body was on fire...after 4 months of loss of weight and cognitive function and then psychosis, patient admitted to Hospital and diagnosed with Auto Immune Limbic Encephalitis. He cannot work and had additional treatments in May of 2015 to reduce infection, but hospitalized again in June 2015 for Low sodium/near comatose. In therapy still after 14 months at TIRR. Steroids, IVIG neuropsych and physical therapy. Still very, very sick. Limbic part of brain controls emotions and he is sometimes in panic mode over simple things. His cognitive function as per test in February was very, very, very low...especially executive function. He used to be a computer genius. Now he can barely comprehend some things that were easy to him before. He cannot INITIATE or think of things to do. He will say, MY MIND IS BLANK. It is heartbreaking. He has had suicidal thoughts and has lost his entire identity. Encephalitis is horrible, because it is sometimes a HIDDEN illness. His last lumbar puncture was May 8, 2015 and infection and auto immune limbic encephalitis still there.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Mental impairment, Panic reaction, Psychotic disorder, Rash
Clinical narrative: Flu vaccine given on 10/29/13. Patient became very ill in 11/13, but on 12/8/13, he woke up trembling, rash, said body was on fire...after 4 months of loss of weight and cognitive function and then psychosis, patient admitted to Hospital and diagnosed with Auto Immune Limbic Encephalitis. He cannot work and had additional treatments in May of 2015 to reduce infection, but hospitalized again in June 2015 for Low sodium/near comatose. In therapy still after 14 months at TIRR. Steroids, IVIG neuropsych and physical therapy. Still very, very sick. Limbic part of brain controls emotions and he is sometimes in panic mode over simple things. His cognitive function as per test in February was very, very, very low...especially executive function. He used to be a computer genius. Now he can barely comprehend some things that were easy to him before. He cannot INITIATE or think of things to do. He will say, MY MIND IS BLANK. It is heartbreaking. He has had suicidal thoughts and has lost his entire identity. Encephalitis is horrible, because it is sometimes a HIDDEN illness. His last lumbar puncture was May 8, 2015 and infection and auto immune limbic encephalitis still there.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Suicidal ideation, Tremor, Weight decreased
Clinical narrative: Flu vaccine given on 10/29/13. Patient became very ill in 11/13, but on 12/8/13, he woke up trembling, rash, said body was on fire...after 4 months of loss of weight and cognitive function and then psychosis, patient admitted to Hospital and diagnosed with Auto Immune Limbic Encephalitis. He cannot work and had additional treatments in May of 2015 to reduce infection, but hospitalized again in June 2015 for Low sodium/near comatose. In therapy still after 14 months at TIRR. Steroids, IVIG neuropsych and physical therapy. Still very, very sick. Limbic part of brain controls emotions and he is sometimes in panic mode over simple things. His cognitive function as per test in February was very, very, very low...especially executive function. He used to be a computer genius. Now he can barely comprehend some things that were easy to him before. He cannot INITIATE or think of things to do. He will say, MY MIND IS BLANK. It is heartbreaking. He has had suicidal thoughts and has lost his entire identity. Encephalitis is horrible, because it is sometimes a HIDDEN illness. His last lumbar puncture was May 8, 2015 and infection and auto immune limbic encephalitis still there.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Grip strength decreased, Mobility decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Excruciating pain couldn't lift my arm even nor can I lift anything in that hand such as jug of milk.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: Red rash that resembled chicken pox with a low grade fever.  Given Benadryl for itching, Tylenol/Motrin for fever, and used Hydrocortisone Cream for itching.  All with relief of symptoms.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Patient received HPV 9 vaccine on 06/08/2015. Patient did not have allergic reaction in the office. Patient left and went to the bus stop and experienced a seizure. Patient had a follow up with neurology. Can not confirm is this was due to the vaccine.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Rash, Rash vesicular
Clinical narrative: ON 7/29 OR SO HE REPORTED "NERVE SENSITIVITY" WHERE RASH EVENTUALLY APPEARED.  08/01 NOTICED ZOSTER LIKE RASH ON RT. SIDE CHEST/BACK. 08/02 SAW DOCTOR (UNKNOWN).
Age: 20.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Blood pressure decreased, Hyperhidrosis, Syncope, Urinary incontinence
Clinical narrative: Patient had syncopal event; transient low blood pressure; sweaty and spontaneous urination.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Immediately upon administering the influenza vaccine, the patient reported having a headache and feeling tingling on the right side of her face. She later reported that it moved down to her arm and she was having difficulty breathing. I asked her to take a few breaths and she was able to take full breaths and her breathing was not debilitated. I took the patient's blood pressure and it was 114/80. I called the patient's physician and spoke with a Midwife Nurse Practitioner that was on duty that recommended Benadryl 50mg if necessary and to follow-up in a few days. I continued to monitor the patient and gave her a cold compress, water, and elevated her feet. The patient remained seated the entire time. Upon further monitoring the symptoms continued and the patient reported they were getting worse. I called 911 and an emergency response team took her to the hospital.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Asthenia, Dyspnoea, Fatigue, Headache
Clinical narrative: 1324 C/O lack of energy, fatigue, muscle and joint aches, headaches-pain now 3/10. SOB with exertion, Sxs started about 4:00 on day of Vaccine Administration.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia
Clinical narrative: 1324 C/O lack of energy, fatigue, muscle and joint aches, headaches-pain now 3/10. SOB with exertion, Sxs started about 4:00 on day of Vaccine Administration.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient experienced pain in are where she could not move her arm.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Muscular weakness, Myalgia, Pain
Clinical narrative: Sore muscle where vaccine was given.  Hurts to move arm to some positions. Pt. never had redness, swelling, fever or rash and did not have any trouble breathing immediately after the shot or anytime thereafter. Just reports sore, weak muscle from approx. two days after shot was given and continues with these symptoms today.  She works at at fast food restaurant and has not missed any work.  Pt. did not seek medical attention.  Referred to private MD and asked her to call after her appt. with diagnosis and/or treatment.
Age: 38.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Pyrexia
Clinical narrative: 102.6 FEVER for 1 day, low grade fever on day 2.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Vaccine was given that was expired by 2 days.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: L upper arm swollen, red, warm, tissue is hard since onset. Not treated.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Blood gases, Blood test, Chest X-ray, Chills, Computerised tomogram
Clinical narrative: Arm swelling; nauseated; chills; muscle pain, dizziness. This progressed to difficult and painful breathing and severe coughing; vomiting, spiking fevers; increased severity of chills; severe headaches; dx of pneumonia.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Dizziness, Dyspnoea, Headache, Myalgia
Clinical narrative: Arm swelling; nauseated; chills; muscle pain, dizziness. This progressed to difficult and painful breathing and severe coughing; vomiting, spiking fevers; increased severity of chills; severe headaches; dx of pneumonia.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Painful respiration, Peripheral swelling, Pneumonia, Pyrexia
Clinical narrative: Arm swelling; nauseated; chills; muscle pain, dizziness. This progressed to difficult and painful breathing and severe coughing; vomiting, spiking fevers; increased severity of chills; severe headaches; dx of pneumonia.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Arm swelling; nauseated; chills; muscle pain, dizziness. This progressed to difficult and painful breathing and severe coughing; vomiting, spiking fevers; increased severity of chills; severe headaches; dx of pneumonia.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: ELEVATED HIVES/ RASH, TREATED WITH PREDNISONE, BENADRYL AND TRIAMCINOLONE 0.1% CREAM.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given.  Was ordered to give DTaP and gave Tdap.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Bursitis, Injection site injury, Injection site pain, Injection site reaction, Rotator cuff syndrome
Clinical narrative: Right shoulder pain consistent with rotator cuff tendonitis/bursitis. Shoulder Injury Related to Vaccine Administration.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Developed shingle rash on his left arm and left hand. He's currently having nerve pain ever since last Thursday.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness spreading to elbow area, warming/heating up of red area.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased eye contact, Lethargy, Pyrexia, Screaming, Unresponsive to stimuli
Clinical narrative: She fell asleep for 4 hours after the vaccines were administered. Immediately upon awakening she had intermittent periods of high-pitched, inconsolable screaming and lethargy. When she would stop screaming for a minute, I would try to speak to her to get her to interact with me as she had been doing in the weeks before the vaccines, but it was like the lights were on, but nobody was home. No response, no eye contact - nothing. I tried to nurse her, but she was unable to stop crying long enough to latch on. So, I took her back to see her pediatrician. We arrived at his office at 4:20 PM. He said she also had a temperature of 100F under the arm, which is uncommon at that age. The crying upon waking lasted about 24 hours. The lethargy and fever lasted 2 days.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Milk allergy
Clinical narrative: My child received the Rotateq vaccine at both 2 and 4 months. At some point in between those two points she developed blood in her stool. Our (wonderful) pediatrician diagnosed it as cow's milk protein intolerance. I am not sure whether this is vaccine related, but wanted to report that this happened, in case other babies experience the same. I am pro-vaccination, but also suspicious of this vaccine given the timing of it and her symptoms, as well as the fact that it is administered orally and contains bovine cells.
Age: 20.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Blood lactic acid increased, Cellulitis, Leukocytosis, Local reaction, Pain
Clinical narrative: Left arm swelling, high fever, leukocytosis, pain, c/w SIRS/sepsis failed initial ROCEPHIN, admitted treated then with Vancomycin with improvement suspect cellulitis and localized reaction.
Age: 20.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Peripheral swelling, Pyrexia, Sepsis, Systemic inflammatory response syndrome, White blood cell count increased
Clinical narrative: Left arm swelling, high fever, leukocytosis, pain, c/w SIRS/sepsis failed initial ROCEPHIN, admitted treated then with Vancomycin with improvement suspect cellulitis and localized reaction.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage, Injection site cellulitis
Clinical narrative: Initial case was received from a consumer on 04 February 2013. The case represents a cluster of three unidentified patients, same vaccine, same lot number, same adverse event and same reporter. However, lot number does not correspond to product reported. The case is invalid, due to no patient identifiers were reported. Three unidentified patients, (age, birth date and gender not reported) received an injection reported as INFLUENZA VACCINE, Sanofi Pasteur Inc. lot number reported as C4347AA (which corresponds to product ADACEL), (route, site, side, and dose in series not reported) on unspecified days since January 2013. On unspecified dates, the patients developed cellulitis at site of injection. Past medical history, laboratory or diagnostic testing, and treatments were not reported. According to report, none of the patients were hospitalized. The patients' outcomes were not reported. Follow-up information was received from a healthcare professional on 05 February 2013. At least three patients received ADACEL (previously reported as Influenza Vaccine and developed cellulitis. The office said the ADACEL vaccine was warmer than usual upon delivery. Outcome was not reported. Documents held by sender: None.
Age: 56.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Mass, Pruritus, Tenderness
Clinical narrative: Initial report received from a healthcare professional 18 June 2012. This case is linked to case number 2012-06476 and 2012-06477. A 56-year-old patient (gender not specified), whose medical history and concomitant medications were not reported, received a doses of ADACEL vaccine (batch number: C4051AA, route of vaccination not reported) in the left arm on 23 May 2012. On 29 May 2012, the patient had reaction with redness, Lump, itchy and very tenderness. Corrective medications were not reported. As of 18 June 2012, the outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 26 June 2012. It was a cluster of 10 unidentified patients (reported by the same reporter) who each experienced similar adverse events following administration of ADACEL. A cluster of ten patients, whose age, gender, medical history and concomitant medications were not reported, had received ADACEL vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that about 10 patients out of 70 patients vaccinated had experienced swelling, itching, redness and lump at injection site. Laboratory investigations and corrective treatment was not reported. As of 26 June 2012, the outcome was unknown. Documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Chills, Decreased appetite, Fatigue, Vomiting
Clinical narrative: Pt received Hep A and HPV vaccine at approximately 11 AM on 8-6-15-mom called at 4:30 the same day with concerns of chills-decreased appetite and fatigue-pt then had severe vomiting for several hrs and went to ER.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Tremor
Clinical narrative: Initial report received from a consumer who is a also a patient on 05 June 2012. A 61-year-old female patient, with no significant medical history, had received an intramuscular dose of ADACEL in left arm on 01 June 2012 (lot number: unknown). On 01 June 2012 the patient presented soreness at the injection site, On 04 June 2012 it was reported that the patient's fingers on left hand were moving on their own with tremors and it continued throughout the night and next day some of her fingers moved on their own. The corrective treatments and laboratory investigations were not reported. The patient's outcome was not recovered. Documents held by sender: none. Follow up information received on 10 September 2012: The patient had last shot of tetanus vaccine 20 years back. The patient had never received Shingles vaccine. It was unknown if patient had a serious allergy. The patient was not pregnant during the time of report and had no seizure or a brain disorder. The patient had no serious reactions with any previous vaccination. Upon internal review on 21 August 2012, the case 2012-06054 was identified as a duplicate. This case 2012-05828 is considered as the reference case.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Initial report received from a healthcare professional who is also the patient on 23 October 2012. A 54-year-old female patient with medical history of hypertension, high cholesterol and hysterectomy; had received intradermal (ID) ADACEL vaccine (Lot number C4023AA) in left forearm 22 October 2012. The patient also received Tubersol intradermal in right forearm (Lot number not reported) on 23 October 2012. The patient had no illness at the time of vaccination. The patient received ADACEL intradermal instead of intramuscular. Thus ADACEL was adminsitered through wrong route. After 12 hours, the patient had half dollar sized red area with hard lump at injection site. The patient was treated with ice compresses and ibuprofen every 4 hours. Corrective treatment and laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: None. Follow-up information received from a healthcare professional who is also a patient on 11 March 2013. It was reported that on 24 October 2012, patient visited his personal physician and physician given him Prednisone dose pack to take. It was reported that small knot was remained, patient applied Aloe Vera plant to area, spot the reduced. 1/2 CM circle of discoloration remains. On an unspecified date, the patient had recovered from the event.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local reaction, Oedema
Clinical narrative: 8/7/15 Localize reaction to RLE edema and redness of over 4cm in diameter. Prescribed KEFLEX parents instructed to use BENADRYL, MOTRIN, was instructed to take to ER if worsens over the weekend.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 27 February 2013. A 12-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of MENACTRA (Lot number: U4412BA, site of administratoin not reported) on 31 January 2013. The last menstrual period was on 15 November 2012. The patient's estimated date of delivery was reported as 01 July 2013. As of 27 February 2013, the patient had not experienced any adverse events. The patient health was good during pregnancy. Documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 February 2013. A dose of MENACTRA that had expired on 08 February (year not specified) was administered on 11 February (year not specified). No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 9.0
Sex: U
Vaccine: DTAP, IPV, MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 February 2013. A 09-year-old patient was administered MENACTRA, IPOL and DAPTACEL. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 31 January 2013. A 11-year-old male patient, had received subcutaneous dose of MENACTRA vaccine (lot number-U4428AA, site of administration: back part of the L upper extremity), received intramuscularly ADACEL vaccine (lot number: C4311AA, site of administration: left deltoid) and GARDASIL (Manufacturer-MSD, lot number: 0636AE, site of administration: right deltoid) on 28 January 2013. The patient had no illness at the time of vaccination and concomitant medications were not reported. On 30 January 2013, the patient developed large site reaction of redness, swelling and warmth at injection site which had spread to most of the upper left arm. Corrective treatment details included warm compresses, MOTRIN for inflammation and any pain and BENADRYL 25 mg PO q 6hrs. for itching at the site. It was reported as the patient's did not improve from the events physician plan to treat us cellulitis with IV antibiotics. Laboratory details were not reported. At the time of this report, the outcome of the events was unknown. Documents Held by Sender: None.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 15 January 2013. A patient (no information was provided regarding the patient) had received first dose of MENACTRA in July 2012 at an age of 16 years and then received the second dose in December 2012. No adverse event was reported. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 June 2013. It was reported that MENACTRA vaccine was administered to an elderly male patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 January 2013. A patient (No information was provided regarding the patient) had received two doses of MENACTRA within a week due to parent error. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial misuse information received from another manufacturer (service request number 1-6084621271) on 28 January 2013. The information was originally provided to the other manufacturer from a healthcare professional. An adult patient, whose age, medical history and concomitant medications not reported, had received a dose of MENACTRA (batch number, site and route of administration were not reported) on January 2013 (date not specified). The reporter stated that the patient received vaccine 5 days after the expiration date. The vaccine was expired at the end of December 2012 thus leading to expired vaccine used. As per reporter the patient did not experienced any adverse event. Documents held by sender: None.
Age: 1.28
Sex: F
Vaccine: MNQ
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Initial report received on 17 June 2013 and follow up information received on 21 June 2013 from an investigator participating in a study. A 15-month-old female subject had febrile seizure on 17 June 2013 i.e. 06 days after receiving second intramuscular dose of the study vaccine MENACTRA in the right thigh on 11 June 2013 (Batch number U4331AA). The subject received first intramuscular dose of the study vaccine MENACTRA in the right thigh on 05 December 2012 (Batch number U4331AA). The subject had current herpangina infection and past  history of febrile seizure. The subject was concomitantly on MOTRIN 160 mg/5ml per OS for fever from 17 June 2013. The subject was very tired day prior to SAE became fussy at about 12:30. Her parents took temperature at about 01:30 which was 101.0 F tympanic. She had fever on 17 June 2013. Her parents gave her MOTRIN. At 02:00, the subject had seizure that lasted about 4 minutes. Her parent rechecked temperature, which was 103.5 F tympanic. Parent gave her MOTRIN at 05:00 and 08:30. The subject had another seizure at 09:45 that lasted 5 minutes and temperature at that time was 102.7 F tympanic. She was seen at provider's office at 11:00, with a fever of 102.7 F documented. Lab investigations were not performed. The subject received corrective treatment with TYLENOL every 4 hours for 24 hours and ADVIL every 6 hours and push fluids. The event of febrile seizure was resolved on 17 June 2013. The outcome of the associated symptom of fever was not reported. The event of febrile seizure was considered important medical event "as per protocol seizure". The event of febrile seizure was not related to the study vaccine or to the trial procedures. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: None. Follow up information received on 11 July 2013. The associated symptom of fever resolved on 18 June 2013. This case is linked with AER# 2013-04026 (SAE# Febrile seizure from 12 March 2013 to 13 March 2013). Follow up information received on 27 August 2013: The subject was concomitantly on MOTRIN till 19 June 2013. She also received TYLENOL from 17 June 2013 to 19 June 2013, per OS, dosage: unknown, for fever. The associated symptom of fever resolved on 17 June 2013 and not on 18 June 2013 as reported earlier.
Age: 1.3
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 07 June 2013. MENACTRA was given to a 15-month-old child who didn't require it. No adverse event was reported. List of documents held by sender: none.