chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Abdominal pain, Dizziness, Heart rate decreased, Hypotension, Nausea
Clinical narrative: Pt started feeling lightheaded and nauseated about 2 minutes after getting shot.  Pt turned pale/green. Pt had lower blood pressure and pulse, lightheadedness went away and patient still nausea and abd cramping.  Pt was given 0.3 mg epi and 1000 ml of fluid.
Age: 18.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Pallor, Skin discolouration
Clinical narrative: Pt started feeling lightheaded and nauseated about 2 minutes after getting shot.  Pt turned pale/green. Pt had lower blood pressure and pulse, lightheadedness went away and patient still nausea and abd cramping.  Pt was given 0.3 mg epi and 1000 ml of fluid.
Age: 1.11
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: Fever and blotchy rash over trunk. patient was treated with Benadry.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial test, Burning sensation, Malaise, Pain, Pruritus
Clinical narrative: Painful spreading rash. Burning and itching. Rash started on R buttock, spread across midline to left. Later developed one vessicular lesion on R hand and several vessicles on R leg.Feels achy and sick.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Viral test
Clinical narrative: Painful spreading rash. Burning and itching. Rash started on R buttock, spread across midline to left. Later developed one vessicular lesion on R hand and several vessicles on R leg.Feels achy and sick.
Age: 1.06
Sex: M
Vaccine: FLU3
Symptoms: Amblyopia, Eye operation, Strabismus
Clinical narrative: Child's eyes began to wander/cross, within a week left eye remained crossed.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous
Clinical narrative: On my daughter's left cheek I noticed dozens of pin prick size red dots scattered. Some on her left ear and under her right eye as well. They are flat, do not itch or hurt her. After immediately calling the nurse at the Pediatrician's office and explaining the reaction to her, she asked the doctor. He said it wasn't from the Hep B vaccine. Reactions from that vaccine are hives and rashes. My daughter has never experienced this before and approximately 20 minutes after receiving the vaccine she has these spots on her face.
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site infection, Injection site oedema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer and then from a contactable other HCP. A 54-year-old male patient received PREVNAR 13 (lot#F88044 and Exp date 9.13), at 0.5ml intramuscular single injection in the deltoid muscle of left arm as a health measure on 21Mar2012 10:30. There were no other vaccines given on the same day. Medical history included gout from an unknown date and unknown if ongoing, hypercholesterolaemia from an unknown date and unknown if ongoing. Concomitant medication included colchicine, LIPITOR. The patient previously took tetanus toxoid, typhoid vaccine, hepatitis B vaccine, hepatitis A vaccine and Yellow fever vaccine. There were no other illnesses reported at the time of vaccination. There were no other vaccines taken within the last four weeks. On 21Mar2012, after the injection with PREVNAR 13, the patient experienced pain at the site of injection. The patient experienced left upper arm cellulitis (medically significant) on 22Mar2012. On 27Mar2012, he developed a red patch at the site of injection. The patient also developed infection (non-serious), erythema (non-serious), edema of left upper arm from deltoid muscle down to above elbow (non-serious) on an unspecified date. The events, infection\Cellulitis Lt. Upper arm required an emergency room or doctor visit. Relevant lab data was none. Therapeutic measures were taken as a result of the red patch at the site of injection and cellulitis included treatment with KEFLEX and warm compresses. The clinical outcome of the events is recovered. Follow-up (13Apr2012): New information received from contactable Other HCP includes additional events which upgraded this case to serious, medical history, concomitant medications, clinical course and outcome.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Cellulitis, Fatigue, Injection site discomfort, Injection site erythema
Clinical narrative: Case number PHHY2011US113898 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 434927) website on 30 Dec 2011 2011 and a follow up received from quality assurance department (reference no: 152867) on 13 Apr 2012. This report refers to a 70-year-old male patient. His medical history included pacemaker and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1120401) intramuscularly in to the left arm and PNEUMOVAX 23 (other manufacturer, batch no: 0595AA) intramuscularly in to left arm on 01 Sep 2011. On 02 Sep 2011, his upper left arm was red and swollen and had a lot of pain and discomfort, especially at night. He felt very weak and tired. The patient made an emergency room visit and received antibiotic treatment on 04 Sep 2011. He was diagnosed with cellulitis and was discharged on the same day with prescription for clindamycin. The final outcome was reported as condition unchanged on the date of reporting, 12 Sep 2011. The quality assurance department opened a complaint for this case with reference number 152867. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1120401 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the quality assurance department (reference number: 152867) on 13 Apr 2012. Quality complaint number and batch review report updated.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2011US113898 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 434927) website on 30 Dec 2011 2011 and a follow up received from quality assurance department (reference no: 152867) on 13 Apr 2012. This report refers to a 70-year-old male patient. His medical history included pacemaker and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1120401) intramuscularly in to the left arm and PNEUMOVAX 23 (other manufacturer, batch no: 0595AA) intramuscularly in to left arm on 01 Sep 2011. On 02 Sep 2011, his upper left arm was red and swollen and had a lot of pain and discomfort, especially at night. He felt very weak and tired. The patient made an emergency room visit and received antibiotic treatment on 04 Sep 2011. He was diagnosed with cellulitis and was discharged on the same day with prescription for clindamycin. The final outcome was reported as condition unchanged on the date of reporting, 12 Sep 2011. The quality assurance department opened a complaint for this case with reference number 152867. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1120401 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the quality assurance department (reference number: 152867) on 13 Apr 2012. Quality complaint number and batch review report updated.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, VARCEL, ANTH, SMALL
Symptoms: Cardiac enzymes, Chest pain, Chills, Electrocardiogram, Headache
Clinical narrative: This study case was received from the investigator on 13 April 2012. A 26-year-old male subject who had no significant medical history was found to have acute pericarditis, unspecified and unspecified disease of pericardium 10 days after receiving an injection of ACAM2000, lot number, route and site of administration not reported) and anthrax (manufacturer and lot number) on 23 January 2012. On 03 February 2012 the subject had an abnormal troponin I level of 14.80, an abnormal echocardiogram and an abnormal magnetic resonance imaging (MRI) of the heart. The subject had an electrocardiogram performed but the results were not available. The diagnosis of acute pericarditis, unspecified and unspecified disease of pericardium was made on 02 February 2012. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, VARCEL, ANTH, SMALL
Symptoms: Myocarditis, Pericarditis, Pyrexia, Troponin
Clinical narrative: This study case was received from the investigator on 13 April 2012. A 26-year-old male subject who had no significant medical history was found to have acute pericarditis, unspecified and unspecified disease of pericardium 10 days after receiving an injection of ACAM2000, lot number, route and site of administration not reported) and anthrax (manufacturer and lot number) on 23 January 2012. On 03 February 2012 the subject had an abnormal troponin I level of 14.80, an abnormal echocardiogram and an abnormal magnetic resonance imaging (MRI) of the heart. The subject had an electrocardiogram performed but the results were not available. The diagnosis of acute pericarditis, unspecified and unspecified disease of pericardium was made on 02 February 2012. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, VARCEL, ANTH, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram, Nuclear magnetic resonance imaging abnormal, Pericardial disease, Pericarditis
Clinical narrative: This study case was received from the investigator on 13 April 2012. A 26-year-old male subject who had no significant medical history was found to have acute pericarditis, unspecified and unspecified disease of pericardium 10 days after receiving an injection of ACAM2000, lot number, route and site of administration not reported) and anthrax (manufacturer and lot number) on 23 January 2012. On 03 February 2012 the subject had an abnormal troponin I level of 14.80, an abnormal echocardiogram and an abnormal magnetic resonance imaging (MRI) of the heart. The subject had an electrocardiogram performed but the results were not available. The diagnosis of acute pericarditis, unspecified and unspecified disease of pericardium was made on 02 February 2012. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, VARCEL, ANTH, SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator on 13 April 2012. A 26-year-old male subject who had no significant medical history was found to have acute pericarditis, unspecified and unspecified disease of pericardium 10 days after receiving an injection of ACAM2000, lot number, route and site of administration not reported) and anthrax (manufacturer and lot number) on 23 January 2012. On 03 February 2012 the subject had an abnormal troponin I level of 14.80, an abnormal echocardiogram and an abnormal magnetic resonance imaging (MRI) of the heart. The subject had an electrocardiogram performed but the results were not available. The diagnosis of acute pericarditis, unspecified and unspecified disease of pericardium was made on 02 February 2012. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Catheterisation cardiac, Chest pain
Clinical narrative: 32 y/o patient with history of myocarditis, 12-days following receipt of the smallpox vaccine in APR 2012. [The following information was obtained from phone call communication with local providers and telephone interview with patient on 20 APR 2012.] On 5 APR 2012, patient received her primary SPV in her right arm (15 jabs). At that time, she was in her usual state of good health. Her SPV site was assessed about 7-days post-vaccine as a "take". Patient denies significant redness, swelling, tenderness, streaking surrounding SPV vaccine site. She noted some tenderness of her right axilla. Patient denies fever, chills, and body aches during the first 10 days following vaccine receipt. Around post-vaccination day 1 (PVD-1), patient experienced mild fatigue which resolved over the next few days. On the morning of 17 APR 2012 (PVD-Day 12), patient awoke with new onset constant chest pain/pressure "like elephant sitting on chest". Describes pain as going from "front through my back" and also reports radiation to throat and left jaw. Pain located along left sternal border and under left breast. Patient rated pain intensity as 8/10 on pain scale of 0-10. No changes in character or intensity of pain with position changes, deep breaths, or activity. Patient reports her throat felt "closed off", so her breathing seemed difficult, but she denies being short of breath or winded. Patient denied palpitations but did note that her heart rate was racing. She denies N/V and diaphoresis at time of chest pain, but does report lightheadedness and nausea around 10 APR; describes as feeling "off balance" lasting about 15-20 minutes. Nausea described as stomach unsettled. Symptoms continued intermittently over 1-2 days before resolving, prior to onset of chest pain. Within 30 minutes of onset of chest pain, patient sought evaluation at the local clinic and with complaint of classic angina, was transferred to local ER. At the ER, ECG and lab work was performed. Patient was treated with ASA and Nitroglycerin. Patient was then admitted to Hospital. Communication with Cardiologist, Hospital reveals serial Troponins of 0.5 and increased to 0.7 and 2.9. (Reported as positive, but reference ranges and system used to measure Troponin are currently not known). Dr. also reported patient underwent a cardiac cath, which was normal. Patient's chest pain and associated symptoms resolved about 1-2 hours after receipt of treatment in ER (ASA, NTG), with no recurrence as of 20 APR.
Age: 32.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Abdominal discomfort, Angina pectoris, Axillary pain, Back pain, Balance disorder
Clinical narrative: 32 y/o patient with history of myocarditis, 12-days following receipt of the smallpox vaccine in APR 2012. [The following information was obtained from phone call communication with local providers and telephone interview with patient on 20 APR 2012.] On 5 APR 2012, patient received her primary SPV in her right arm (15 jabs). At that time, she was in her usual state of good health. Her SPV site was assessed about 7-days post-vaccine as a "take". Patient denies significant redness, swelling, tenderness, streaking surrounding SPV vaccine site. She noted some tenderness of her right axilla. Patient denies fever, chills, and body aches during the first 10 days following vaccine receipt. Around post-vaccination day 1 (PVD-1), patient experienced mild fatigue which resolved over the next few days. On the morning of 17 APR 2012 (PVD-Day 12), patient awoke with new onset constant chest pain/pressure "like elephant sitting on chest". Describes pain as going from "front through my back" and also reports radiation to throat and left jaw. Pain located along left sternal border and under left breast. Patient rated pain intensity as 8/10 on pain scale of 0-10. No changes in character or intensity of pain with position changes, deep breaths, or activity. Patient reports her throat felt "closed off", so her breathing seemed difficult, but she denies being short of breath or winded. Patient denied palpitations but did note that her heart rate was racing. She denies N/V and diaphoresis at time of chest pain, but does report lightheadedness and nausea around 10 APR; describes as feeling "off balance" lasting about 15-20 minutes. Nausea described as stomach unsettled. Symptoms continued intermittently over 1-2 days before resolving, prior to onset of chest pain. Within 30 minutes of onset of chest pain, patient sought evaluation at the local clinic and with complaint of classic angina, was transferred to local ER. At the ER, ECG and lab work was performed. Patient was treated with ASA and Nitroglycerin. Patient was then admitted to Hospital. Communication with Cardiologist, Hospital reveals serial Troponins of 0.5 and increased to 0.7 and 2.9. (Reported as positive, but reference ranges and system used to measure Troponin are currently not known). Dr. also reported patient underwent a cardiac cath, which was normal. Patient's chest pain and associated symptoms resolved about 1-2 hours after receipt of treatment in ER (ASA, NTG), with no recurrence as of 20 APR.
Age: 32.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Catheterisation cardiac normal, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: 32 y/o patient with history of myocarditis, 12-days following receipt of the smallpox vaccine in APR 2012. [The following information was obtained from phone call communication with local providers and telephone interview with patient on 20 APR 2012.] On 5 APR 2012, patient received her primary SPV in her right arm (15 jabs). At that time, she was in her usual state of good health. Her SPV site was assessed about 7-days post-vaccine as a "take". Patient denies significant redness, swelling, tenderness, streaking surrounding SPV vaccine site. She noted some tenderness of her right axilla. Patient denies fever, chills, and body aches during the first 10 days following vaccine receipt. Around post-vaccination day 1 (PVD-1), patient experienced mild fatigue which resolved over the next few days. On the morning of 17 APR 2012 (PVD-Day 12), patient awoke with new onset constant chest pain/pressure "like elephant sitting on chest". Describes pain as going from "front through my back" and also reports radiation to throat and left jaw. Pain located along left sternal border and under left breast. Patient rated pain intensity as 8/10 on pain scale of 0-10. No changes in character or intensity of pain with position changes, deep breaths, or activity. Patient reports her throat felt "closed off", so her breathing seemed difficult, but she denies being short of breath or winded. Patient denied palpitations but did note that her heart rate was racing. She denies N/V and diaphoresis at time of chest pain, but does report lightheadedness and nausea around 10 APR; describes as feeling "off balance" lasting about 15-20 minutes. Nausea described as stomach unsettled. Symptoms continued intermittently over 1-2 days before resolving, prior to onset of chest pain. Within 30 minutes of onset of chest pain, patient sought evaluation at the local clinic and with complaint of classic angina, was transferred to local ER. At the ER, ECG and lab work was performed. Patient was treated with ASA and Nitroglycerin. Patient was then admitted to Hospital. Communication with Cardiologist, Hospital reveals serial Troponins of 0.5 and increased to 0.7 and 2.9. (Reported as positive, but reference ranges and system used to measure Troponin are currently not known). Dr. also reported patient underwent a cardiac cath, which was normal. Patient's chest pain and associated symptoms resolved about 1-2 hours after receipt of treatment in ER (ASA, NTG), with no recurrence as of 20 APR.
Age: 32.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Echocardiogram normal, Fatigue, Nausea, Oropharyngeal pain, Pain in jaw
Clinical narrative: 32 y/o patient with history of myocarditis, 12-days following receipt of the smallpox vaccine in APR 2012. [The following information was obtained from phone call communication with local providers and telephone interview with patient on 20 APR 2012.] On 5 APR 2012, patient received her primary SPV in her right arm (15 jabs). At that time, she was in her usual state of good health. Her SPV site was assessed about 7-days post-vaccine as a "take". Patient denies significant redness, swelling, tenderness, streaking surrounding SPV vaccine site. She noted some tenderness of her right axilla. Patient denies fever, chills, and body aches during the first 10 days following vaccine receipt. Around post-vaccination day 1 (PVD-1), patient experienced mild fatigue which resolved over the next few days. On the morning of 17 APR 2012 (PVD-Day 12), patient awoke with new onset constant chest pain/pressure "like elephant sitting on chest". Describes pain as going from "front through my back" and also reports radiation to throat and left jaw. Pain located along left sternal border and under left breast. Patient rated pain intensity as 8/10 on pain scale of 0-10. No changes in character or intensity of pain with position changes, deep breaths, or activity. Patient reports her throat felt "closed off", so her breathing seemed difficult, but she denies being short of breath or winded. Patient denied palpitations but did note that her heart rate was racing. She denies N/V and diaphoresis at time of chest pain, but does report lightheadedness and nausea around 10 APR; describes as feeling "off balance" lasting about 15-20 minutes. Nausea described as stomach unsettled. Symptoms continued intermittently over 1-2 days before resolving, prior to onset of chest pain. Within 30 minutes of onset of chest pain, patient sought evaluation at the local clinic and with complaint of classic angina, was transferred to local ER. At the ER, ECG and lab work was performed. Patient was treated with ASA and Nitroglycerin. Patient was then admitted to Hospital. Communication with Cardiologist, Hospital reveals serial Troponins of 0.5 and increased to 0.7 and 2.9. (Reported as positive, but reference ranges and system used to measure Troponin are currently not known). Dr. also reported patient underwent a cardiac cath, which was normal. Patient's chest pain and associated symptoms resolved about 1-2 hours after receipt of treatment in ER (ASA, NTG), with no recurrence as of 20 APR.
Age: 32.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Palpitations, Tenderness, Throat tightness, Troponin increased
Clinical narrative: 32 y/o patient with history of myocarditis, 12-days following receipt of the smallpox vaccine in APR 2012. [The following information was obtained from phone call communication with local providers and telephone interview with patient on 20 APR 2012.] On 5 APR 2012, patient received her primary SPV in her right arm (15 jabs). At that time, she was in her usual state of good health. Her SPV site was assessed about 7-days post-vaccine as a "take". Patient denies significant redness, swelling, tenderness, streaking surrounding SPV vaccine site. She noted some tenderness of her right axilla. Patient denies fever, chills, and body aches during the first 10 days following vaccine receipt. Around post-vaccination day 1 (PVD-1), patient experienced mild fatigue which resolved over the next few days. On the morning of 17 APR 2012 (PVD-Day 12), patient awoke with new onset constant chest pain/pressure "like elephant sitting on chest". Describes pain as going from "front through my back" and also reports radiation to throat and left jaw. Pain located along left sternal border and under left breast. Patient rated pain intensity as 8/10 on pain scale of 0-10. No changes in character or intensity of pain with position changes, deep breaths, or activity. Patient reports her throat felt "closed off", so her breathing seemed difficult, but she denies being short of breath or winded. Patient denied palpitations but did note that her heart rate was racing. She denies N/V and diaphoresis at time of chest pain, but does report lightheadedness and nausea around 10 APR; describes as feeling "off balance" lasting about 15-20 minutes. Nausea described as stomach unsettled. Symptoms continued intermittently over 1-2 days before resolving, prior to onset of chest pain. Within 30 minutes of onset of chest pain, patient sought evaluation at the local clinic and with complaint of classic angina, was transferred to local ER. At the ER, ECG and lab work was performed. Patient was treated with ASA and Nitroglycerin. Patient was then admitted to Hospital. Communication with Cardiologist, Hospital reveals serial Troponins of 0.5 and increased to 0.7 and 2.9. (Reported as positive, but reference ranges and system used to measure Troponin are currently not known). Dr. also reported patient underwent a cardiac cath, which was normal. Patient's chest pain and associated symptoms resolved about 1-2 hours after receipt of treatment in ER (ASA, NTG), with no recurrence as of 20 APR.
Age: 32.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Catheterisation cardiac, Chest pain, Laboratory test
Clinical narrative: 32 y/o patient with history of myocarditis, 12-days following receipt of the smallpox vaccine in APR 2012. [The following information was obtained from phone call communication with local providers and telephone interview with patient on 20 APR 2012.] On 5 APR 2012, patient received her primary SPV in her right arm (15 jabs). At that time, she was in her usual state of good health. Her SPV site was assessed about 7-days post-vaccine as a "take". Patient denies significant redness, swelling, tenderness, streaking surrounding SPV vaccine site. She noted some tenderness of her right axilla. Patient denies fever, chills, and body aches during the first 10 days following vaccine receipt. Around post-vaccination day 1 (PVD-1), patient experienced mild fatigue which resolved over the next few days. On the morning of 17 APR 2012 (PVD-Day 12), patient awoke with new onset constant chest pain/pressure "like elephant sitting on chest". Describes pain as going from "front through my back" and also reports radiation to throat and left jaw. Pain located along left sternal border and under left breast. Patient rated pain intensity as 8/10 on pain scale of 0-10. No changes in character or intensity of pain with position changes, deep breaths, or activity. Patient reports her throat felt "closed off", so her breathing seemed difficult, but she denies being short of breath or winded. Patient denied palpitations but did note that her heart rate was racing. She denies N/V and diaphoresis at time of chest pain, but does report lightheadedness and nausea around 10 APR; describes as feeling "off balance" lasting about 15-20 minutes. Nausea described as stomach unsettled. Symptoms continued intermittently over 1-2 days before resolving, prior to onset of chest pain. Within 30 minutes of onset of chest pain, patient sought evaluation at the local clinic and with complaint of classic angina, was transferred to local ER. At the ER, ECG and lab work was performed. Patient was treated with ASA and Nitroglycerin. Patient was then admitted to Hospital. Communication with Cardiologist, Hospital reveals serial Troponins of 0.5 and increased to 0.7 and 2.9. (Reported as positive, but reference ranges and system used to measure Troponin are currently not known). Dr. also reported patient underwent a cardiac cath, which was normal. Patient's chest pain and associated symptoms resolved about 1-2 hours after receipt of treatment in ER (ASA, NTG), with no recurrence as of 20 APR.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HIBV, MNQ, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: See attached. 4-23-12 at 115- Pt/pt mom here with friend and RN at clinic. Counseled mom of vaccines and side effects. RN held baby at request of mom. Administered PEDIARIX LAT IM, HIB RAT IM, PREVNAR RLT IM. 1151 Immediately pt right leg from hip to toes turned bright red with small urticaric lesions on top of right foot-leg blanched white with straightening of leg. 1153 ARNP notified and evaluated-per ARNP No evidence of circulation impairment, no rash on chest or abdomen and no respiratory distress noted. 1159 RN called dr-pediatrician office who agreed to see pt at 1:15 4-23-12. 1210 Continued to observe baby-redness in leg lessened and all but one lesion on foot receded. 1215 Noted change "red dots" appearing on right leg, 2 on right arm, 1 on forehead. Instructed pt to go to Emergency Room. 1220 RN followed pt/pt mom to ER. 1240 Pt in medical center ER - pt evaluated - no meds given. ER recommended for pt to be evaluated by an Allergist and have all vaccines administered by an Allergist. Recommended pt to go to dr office for documentation after leaving ER. 1300 Pt discharged from ER. Pt/pt mom accompanied by RN to dr office. Pt not seen in dr office because their insurance will not pay for ER to dr on same day and pt mom could not afford private pat. Pt home with mom. 4-24-12 10:28 Phone call to pt mom - pt mom sts no redness, no warmth, no spots and no fever. Pt is alert, smiling and eating good. Pt moms sts did not have a fever last night. Pt mom counseled if has any changes call clinic or go to ER. Pt mom verbalized understanding.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HIBV, MNQ, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Pallor, Rash erythematous
Clinical narrative: See attached. 4-23-12 at 115- Pt/pt mom here with friend and RN at clinic. Counseled mom of vaccines and side effects. RN held baby at request of mom. Administered PEDIARIX LAT IM, HIB RAT IM, PREVNAR RLT IM. 1151 Immediately pt right leg from hip to toes turned bright red with small urticaric lesions on top of right foot-leg blanched white with straightening of leg. 1153 ARNP notified and evaluated-per ARNP No evidence of circulation impairment, no rash on chest or abdomen and no respiratory distress noted. 1159 RN called dr-pediatrician office who agreed to see pt at 1:15 4-23-12. 1210 Continued to observe baby-redness in leg lessened and all but one lesion on foot receded. 1215 Noted change "red dots" appearing on right leg, 2 on right arm, 1 on forehead. Instructed pt to go to Emergency Room. 1220 RN followed pt/pt mom to ER. 1240 Pt in medical center ER - pt evaluated - no meds given. ER recommended for pt to be evaluated by an Allergist and have all vaccines administered by an Allergist. Recommended pt to go to dr office for documentation after leaving ER. 1300 Pt discharged from ER. Pt/pt mom accompanied by RN to dr office. Pt not seen in dr office because their insurance will not pay for ER to dr on same day and pt mom could not afford private pat. Pt home with mom. 4-24-12 10:28 Phone call to pt mom - pt mom sts no redness, no warmth, no spots and no fever. Pt is alert, smiling and eating good. Pt moms sts did not have a fever last night. Pt mom counseled if has any changes call clinic or go to ER. Pt mom verbalized understanding.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HIBV, MNQ, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: See attached. 4-23-12 at 115- Pt/pt mom here with friend and RN at clinic. Counseled mom of vaccines and side effects. RN held baby at request of mom. Administered PEDIARIX LAT IM, HIB RAT IM, PREVNAR RLT IM. 1151 Immediately pt right leg from hip to toes turned bright red with small urticaric lesions on top of right foot-leg blanched white with straightening of leg. 1153 ARNP notified and evaluated-per ARNP No evidence of circulation impairment, no rash on chest or abdomen and no respiratory distress noted. 1159 RN called dr-pediatrician office who agreed to see pt at 1:15 4-23-12. 1210 Continued to observe baby-redness in leg lessened and all but one lesion on foot receded. 1215 Noted change "red dots" appearing on right leg, 2 on right arm, 1 on forehead. Instructed pt to go to Emergency Room. 1220 RN followed pt/pt mom to ER. 1240 Pt in medical center ER - pt evaluated - no meds given. ER recommended for pt to be evaluated by an Allergist and have all vaccines administered by an Allergist. Recommended pt to go to dr office for documentation after leaving ER. 1300 Pt discharged from ER. Pt/pt mom accompanied by RN to dr office. Pt not seen in dr office because their insurance will not pay for ER to dr on same day and pt mom could not afford private pat. Pt home with mom. 4-24-12 10:28 Phone call to pt mom - pt mom sts no redness, no warmth, no spots and no fever. Pt is alert, smiling and eating good. Pt moms sts did not have a fever last night. Pt mom counseled if has any changes call clinic or go to ER. Pt mom verbalized understanding.
Age: 45.0
Sex: M
Vaccine: MNQ, RAB
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Reported having itchy hives (rash) all over his body from 4/15/12 through 4/19/12. Pt took high doses of Benadryl & loratadine x 3 1/2 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Asthenia, Decreased appetite, Dermatomyositis, Fatigue, Headache
Clinical narrative: Headache, high fever, sleepy, tired, didn't want to eat all the day of. The following day he started breaking out in a rash on his face and hands. Within a few weeks he was starting to complain of being tired and weak, showing signs of weakness, and complaining of the sun being too hot on his skin. After a few months he couldn't climb up a few stairs in the the house up to his room. January 2012 he was diagnosed with Dermatomyositis, after being misdiagnosed for months with hand foot mouth disease. Diagnosed at medical center.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Mobility decreased, Pyrexia, Rash, Somnolence, Temperature intolerance
Clinical narrative: Headache, high fever, sleepy, tired, didn't want to eat all the day of. The following day he started breaking out in a rash on his face and hands. Within a few weeks he was starting to complain of being tired and weak, showing signs of weakness, and complaining of the sun being too hot on his skin. After a few months he couldn't climb up a few stairs in the the house up to his room. January 2012 he was diagnosed with Dermatomyositis, after being misdiagnosed for months with hand foot mouth disease. Diagnosed at medical center.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Autopsy, Death
Clinical narrative: Child was found dead on the morning of 04/14/2012.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Injection site infection
Clinical narrative: Information has been received from a physician concerning a 65 year old male who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# not reported), 0.5 ml, subcutaneously. Subsequently the patient experienced an infection developed at the injection site and was hospitalized. Lab diagnostics performed included: blood work. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood test normal, Dehydration, Electroencephalogram normal, Hypotonia, Lethargy
Clinical narrative: Day after vaccines vomiting went to ER with mild dehydration. Sent home after ER returned 2 days later & admitted with moderate to severe hypotonia. Pt was lethargic & delay response. Pt. has hx of seizures.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Slow response to stimuli, Vomiting
Clinical narrative: Day after vaccines vomiting went to ER with mild dehydration. Sent home after ER returned 2 days later & admitted with moderate to severe hypotonia. Pt was lethargic & delay response. Pt. has hx of seizures.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Blood brain barrier defect, Pruritus generalised, Psychotic disorder
Clinical narrative: In 1997 I was inoculated with an unknown substance without my consent, I believe, in continuance of a research program conducted by a certain agency which began in 2000. My whole body was itchy for 7 years and still is my BBB was penetrated & psychosis ensued.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Acid base balance abnormal, Acidosis, Carbon dioxide decreased, Dehydration, Diarrhoea
Clinical narrative: Received ROTATEQ #2, vomiting began 4/5/12 with diarrhea. Rapid weight loss. Hosp x 2d then home x 24hr - vomiting, diarrhea cont, rehosp -> severe dehydration -> PICU. Still in PICU but better.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intensive care, Laboratory test abnormal, Rotavirus test negative, Vomiting, Weight decreased
Clinical narrative: Received ROTATEQ #2, vomiting began 4/5/12 with diarrhea. Rapid weight loss. Hosp x 2d then home x 24hr - vomiting, diarrhea cont, rehosp -> severe dehydration -> PICU. Still in PICU but better.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Asthenia, Diarrhoea, Erythema, Headache, Nausea
Clinical narrative: 4/20/12 p.m. Mom called to report diarrhea, N/V, sipping fluids. 4/23/12 p.m. Mom called to report 4/21/12 fever 100 degrees, no vomiting; 4/22/12 "feeling better; 4/23/12 HA, ears & cheeks red, fever 101.9 degrees, "weak" eating & drinking well.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: 4/20/12 p.m. Mom called to report diarrhea, N/V, sipping fluids. 4/23/12 p.m. Mom called to report 4/21/12 fever 100 degrees, no vomiting; 4/22/12 "feeling better; 4/23/12 HA, ears & cheeks red, fever 101.9 degrees, "weak" eating & drinking well.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Slow speech, Speech disorder
Clinical narrative: Pts speech changed within a couple of wks after PCV13 was adm. pts; mtr stated that he began to talk very slowly & have much difficulty getting his words out. (Which was a huge change for him). He became ashamed of it & stopped wanting to talk. Mostly, still has some trouble from time to time.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Human chorionic gonadotropin positive, Maternal exposure during pregnancy
Clinical narrative: Patient given immunizations and then had a positive pregnancy test.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Local skin reaction at administration site. Area is about 4 inches in diameter.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Cheilitis, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Sores around lips, red warm area to injection site. Sore to touch injection site & whole arm (especially back of arm) (upper arm).
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: (R) elbow to little finger numbness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site nodule, Oedema peripheral
Clinical narrative: Red swollen arm, knot in center, burning and itching sensation, center is reddish purple and now looks like possible scarring. Patient took BENADRYL and used hydrocortisone cream for relief.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Red swollen arm, knot in center, burning and itching sensation, center is reddish purple and now looks like possible scarring. Patient took BENADRYL and used hydrocortisone cream for relief.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Patient received tdap & meningococcal IM (R) arm on 4/14/12. Reported redness & swelling (R) arm on 4/16/12. Seen by dr for cellulitis. Treated with Cephalexin x 10 days.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Itchy, red, hot, swollen.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Abasia, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Myositis
Clinical narrative: Pt received FLUMIST on 10/15/11 (2011); 3d later developed pain in both upper & lower extremities. Unable to walk. Admitted to hospital on 10/21/11; dx myositis. Treatment: IV hydration and ibuprofen for pain.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Pain in extremity
Clinical narrative: Pt received FLUMIST on 10/15/11 (2011); 3d later developed pain in both upper & lower extremities. Unable to walk. Admitted to hospital on 10/21/11; dx myositis. Treatment: IV hydration and ibuprofen for pain.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: PENTACEL adm in (L) thigh. Next AM, (lt) thigh hard & red. MOTRIN given. Few hrs later (L) thigh none except for hardness at site but (R) thigh & buttock: large hives.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Muscular weakness, Rhabdomyolysis
Clinical narrative: Pt arrived home after receiving vaccine and later that day began experiencing extreme weakness in both LE. After 2 days, pt. developed rhabdomyolysis, was hospitalized, and treated. She recovered and was sent for 1 month of inpatient rehab. for continued LE weakness.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Anaphylactic reaction, Convulsion, Dyskinesia, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: Presented to ED (later the same day) after a seizure and anaphylaxis. About an hour and a half after receiving (Pentacel) per mom, she put him in his high chair and was feeding him when he went stiff, his eyes rolled to the back of his head and his entire body started jerking (he had just put the first piece of corn dog in his mouth). See ENTIRE record (ED Report attached: MRN 002253586 from NCBH)/br
Age: 1.3
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Anaphylactic reaction, Convulsion, Dyskinesia, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: Presented to ED (later the same day) after a seizure and anaphylaxis. About an hour and a half after receiving PENTACEL per mom, she put him in his chair and was feeding him when he went stiff, his eyes rolled to the back of his head and his entire body started jerking (he had just put the first piece of corn dog in his mouth). See ENTIRE record (ED report attached: MRN 002253586).
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site rash, Pyrexia, Rash, Syncope
Clinical narrative: Fever, Syncope at 1215. Fever stayed until 0300 on 08/25/2012.  Rash and raised area 1cm by 3 cm long at injection site.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Pain, Rash papular, Rash pruritic, Scab
Clinical narrative: Student reported on 4/23/12 that he experienced soreness and body aches, an itchy rash which formed bumps and scabs on his abdomen, head, chest, and arms which lasted a week.  The soreness at injection site lasted 3 weeks from day of injection.  He did't return to the clinic at that time, but reported the information at an immunization screening for the 2nd Varicella.  He doesn't know if he had a fever or not.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Telephone call from mom at 4 PM on 4-25-12 reporting patient had fever last evening after vaacines of 101.6(ax). Dosed with Tylenol. Today patient spiked a temp of 105(AX-Reported by mom). When she called the PCP asked that she bring child in to be checked. On arrival temp was 99.8(AX)Child smiling and mother reports no other symptoms noted at home.No problems with first vaccines.
Age: 1.01
Sex: M
Vaccine: MMR, PPV
Symptoms: Urticaria
Clinical narrative: When patient woke up we changed his diaper and noticed hives starting on his bottom and it continuted to spread across his whole body throughout the day. Benadryl helped but didn't completely remove the hives. No fever was present with hives and hives continued on and off until 03/03/2012.
Age: 32.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Rash generalised, Urticaria, Wheezing
Clinical narrative: Developed hives (rash) all over body. Also complained of wheezing. This started between 6 and 7 pm that same day. Took Zyrtec 10 mg po now and Benadryl. Wheezing and hives went away shortly thereafter with no further complaints.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Circadian rhythm sleep disorder, Disturbance in attention, Psychomotor hyperactivity, Restlessness, Sleep disorder
Clinical narrative: oRestlessness, hyperactivity or inability to concentrate (this could be normal; just seemed to get a tad more extensive as gotten older); oSleep disturbances that change wake/sleep pattern; has had different sleep patterns. Would sleep only 6 hrs sometimes or sleep 12 hrs other times.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: left arm swelling, redness and tender to touch. Seen at ER dx with vaccine reation given oral antibiotics Keflex which was completed. and s/s resolved
Age: 53.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Asthenia, Body temperature increased, Dizziness, Injection site pain, Myalgia
Clinical narrative: PT c/o low-grade temp 100.2 at time of visit on 3/25/12, Nausea, Dizziness, Pain at injection same, myalagia, weakness.
Age: 53.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Nausea
Clinical narrative: PT c/o low-grade temp 100.2 at time of visit on 3/25/12, Nausea, Dizziness, Pain at injection same, myalagia, weakness.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm erythema and swelling 6 days after TDAP injection given. Temp 98.8 Lt. deltoid has been "sore" since TDAP given.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram, Fall
Clinical narrative: 9/27 flu shot, 9/29 soreness in thighs, 10/2 numbness, 11/2 Dr. for weakness, & numbness. 11/6 fell & went to ER - diagnosed Guillain Barre Syndrome, given IVIG & Plasmapheresis, 11/27 sent to rehab, 12/27 legs still paralyzed & arms failing & sent to clinic, diagnosed CIDP, given IVIG & steroids, 1/6 sent to rehab, 1/18 some leg movement & able to raise arms over head.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture, Monoplegia
Clinical narrative: 9/27 flu shot, 9/29 soreness in thighs, 10/2 numbness, 11/2 Dr. for weakness, & numbness. 11/6 fell & went to ER - diagnosed Guillain Barre Syndrome, given IVIG & Plasmapheresis, 11/27 sent to rehab, 12/27 legs still paralyzed & arms failing & sent to clinic, diagnosed CIDP, given IVIG & steroids, 1/6 sent to rehab, 1/18 some leg movement & able to raise arms over head.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Pain in extremity, Plasmapheresis, X-ray
Clinical narrative: 9/27 flu shot, 9/29 soreness in thighs, 10/2 numbness, 11/2 Dr. for weakness, & numbness. 11/6 fell & went to ER - diagnosed Guillain Barre Syndrome, given IVIG & Plasmapheresis, 11/27 sent to rehab, 12/27 legs still paralyzed & arms failing & sent to clinic, diagnosed CIDP, given IVIG & steroids, 1/6 sent to rehab, 1/18 some leg movement & able to raise arms over head.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Activities of daily living impaired, Headache, Vision blurred
Clinical narrative: Severe headache - kept out of school 2 days, blurred vision.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling
Clinical narrative: Day 1 - nothing. Day 2 - small round raised bump. Day 3 - 3 x 4 inch red oval rash around red bump. Day 4 - stable - looks same.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hyporesponsive to stimuli
Clinical narrative: Hyporesponsive episode. Possible vasovagal syncope.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Flank pain, Herpes zoster, Rash
Clinical narrative: Patient was given ZOSTAVAX on 04/05/12. She presented with pain (Rt) flank area 04/09/12, she developed rash same area few days. Later presented again 04/17/12 and was diagnosed with shingles. Started on VALTREX.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Dyskinesia, Electroencephalogram normal
Clinical narrative: After vaccination - mom & grandmother noted patient to have move-like startle response while awake & asleep - increasing & every few minutes decreasing after 48 hrs then only at night & resolving. No fever.