chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Oxygen saturation decreased, Pyrexia, Tachycardia, White blood cell count increased
Clinical narrative: 56 YO F with poorly controlled DM/HTN, HL, HCV, depression with self mutilation, presented to the emergency room with fever and altered mental status. Per family, on 09/13 the pt was in regular state of health, presented to the clinic for prescription refills of amitriptyline, gabapentin and trazodone. She then took an unkown quantity of pills throughout the day and slept for the remainder of the day. She woke up the following day abruptly with altered mental status, confusion, agitation, talking to inanimate objects, so the family called EMS. In the ED the patient had low back pain, fever to 40.4 C, tachycardia, PO2=88. CXR  showed perihilar infiltrate and increased interstitial markings. Leucocytosis to 17.7. An LP was performed and later the pt was found to obtunded with increased CO2, so she was intubated. She was then admitted to the medical ICU. Where she improved and then walked out AMA today (2 days later). The patient told the medical resident that she had received 2 flu shots prior to the event. The local pharmacy has a record of giving 1 Flu vaccine to her on 09/13 (lot 111776P, exp 03/31/2011/Novartis/Fluvirin).
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen Red Hot to Touch
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Myalgia, Pyrexia, Tremor
Clinical narrative: Fever, myalgias, shaking chills.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache--which did not go away with rest or eating something; took Ibuprofen 600mg at 6:00pm. Ibuprofen helped, but headache lingered until bedtime at 10:00pm. No headache this morning 9-17-2010.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling of injection area, pain and fever & chills for 2 days. Required analgesics and limited activity.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Redness, swelling of injection area, pain and fever & chills for 2 days. Required analgesics and limited activity.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Localized reaction- bicep region area 10cm w x 13cm L no systemic signs.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Dysphagia, Erythema, Headache, Hypoaesthesia
Clinical narrative: Numbness in left arm, redness/pain in muscle. Headaches. Difficulty swallowing. Diarrhea.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myalgia
Clinical narrative: Numbness in left arm, redness/pain in muscle. Headaches. Difficulty swallowing. Diarrhea.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Diarrhoea, Dizziness, Dysphagia, Erythema
Clinical narrative: Numbness in left arm, redness/pain in muscle. Headaches. Difficulty swallowing. Diarrhea.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Hypoaesthesia, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: Numbness in left arm, redness/pain in muscle. Headaches. Difficulty swallowing. Diarrhea.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Weight decreased
Clinical narrative: Numbness in left arm, redness/pain in muscle. Headaches. Difficulty swallowing. Diarrhea.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Pt complained of low grade fever starting the day after administration (9/8/10) and lasting at least through 9/17/10.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Pain in extremity
Clinical narrative: A large "knot" developed on the patient's neck on the same side as the shot also her arm is still sore after several days "knot" is not painful, but soft to touch, pt calling MD for follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication
Clinical narrative: Pt complained of the sensation of bugs crawling on her back and arms which began the evening after receiving ZOSTAVAX. It is transient and intermittent. She has not sought medical attention, but will follow up if it worsens or does not resolve. She asked that it be reported.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Injection site erythema, Injection site induration, Injection site joint pain, Injection site warmth
Clinical narrative: Back and joint pain, especially in (L) upper arm 3 cm red, firm warm area surrounding injection site.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Head injury, Loss of consciousness
Clinical narrative: The Patient lost consciousness and hit her head on the floor.  After a few seconds she woke up. She was taken to the ER and released.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blister
Clinical narrative: Blister
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Cellulitis left upper arm at injection site
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Had a seizure.  EEG normal CT scan normal lab normal went to ER by ambulance. Had another seizure on 08/31/2010.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Had a seizure.  EEG normal CT scan normal lab normal went to ER by ambulance. Had another seizure on 08/31/2010.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Lip swelling, Pruritus, Swelling face
Clinical narrative: Patient reported facial swelling on the right side of her face and lip swelling on the left side of her lip and chin. Also reported itching systemically. Patient stated that she saw her physician and was told to take Benadryl. Symptoms resolved in two days.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy, Neck mass, Neck pain
Clinical narrative: c/o sudden pain to L anterior neck within 4 hrs after injection. By 9/17 noted to have mass to L anterior cervical neck, suspected lymph node. Advised to take OTC ibuprofen tid for the next 48hrs and to call back if develops significant SOB/weakness/extending rash of the arm.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: fever 101.1, weakness, achy
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site streaking
Clinical narrative: Redness around injection site, red streaks round site, itching
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: 2 days of increasing redness upt to 3x4 cm, swelling, and tenderness.  Treated for cellulitis with Duracef.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: Arm swelled up at injection site, formed little red blotchy rash on face that lasted couple of days, formed fever of 99 and cough that was treated with cough medicine.  Saw PCP 6 days later.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Arm swelled up at injection site, formed little red blotchy rash on face that lasted couple of days, formed fever of 99 and cough that was treated with cough medicine.  Saw PCP 6 days later.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Burning sensation, Chest pain, Cough, Nausea, Pain
Clinical narrative: About 2 hours after receiving the vaccine, my lungs started "burning".  I also began to cough a lot - non-productive so far.   I am getting more "sore" in my lungs, I feel slightly nauseated and achy all over.
Age: 58.0
Sex: M
Vaccine: FLU3, IPV
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Dizziness, light headedness, tingling in extremities.
Age: 84.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Heart rate increased, Pyrexia
Clinical narrative: Rapid heart rate 93 per min. fever of 100, head ache.
Age: 84.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Headache, Lethargy, Myalgia, Pyrexia
Clinical narrative: Rapid heart rate 93 per min. fever of 100, head ache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Per mom, pt complained of pain in left arm where shots were given. Redness noted today and swelling. No fever noted, no streaking noted. MD looked at it and was told to keep an eye on it over the weekend. If it gets any bigger or any streaks presents itself, then call the after hrs. clinic or go to the ER.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: 8cm x 4.5cm erythema, tender, pruritic
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Skin warm
Clinical narrative: 12.5cm x 6cm area of erythema, very warm to touch, nontender, nonpruritic. Benadryl OTC
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Left arm IM injection of Pneumovax:  Two red "streaks" horizontally at injection site, 1-1.5" length, raised, not itchy.
Age: 53.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inflammation, Lymphadenopathy
Clinical narrative: All lymph nodes were swollen. I was dignosis was Inflammatory response.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Musculoskeletal pain, Paraesthesia oral
Clinical narrative: Right shoulder pain, numbness, tingling in his lips.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient experienced redness & swelling all down the under side of his  arm (right arm only). As of 9/18/10 it was still spreading. Was taking BENADRYL. Advised ER visit if got worse.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Injection site pain, Musculoskeletal pain
Clinical narrative: Patient's daughter described patient to have bad shoulder pain, pain at injection site, dizziness, and patient fell. Told patient's daughter to contact physician.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient noticed rash (skin) on left lower arm.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Vaccination complication
Clinical narrative: Arm swelled (claimed pneumo shot) and went to Urgent Care with a severe reaction and was given steroids and pain medication.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swollen right arm from shoulder to elbow.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Localized soreness, redness, warm to touch. IBU 400 mg bid x 1 day.
Age: 59.0
Sex: U
Vaccine: FLU3
Symptoms: Decreased appetite, Diarrhoea, Feeling hot, Hypokinesia, Nausea
Clinical narrative: Could not move. Diarrhea & nausea. Could not drink or eat, felt very hot 2 days after flu shot.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: 9/16 felt achy (body aches) left arm has redness (below injection site). 9/18 redness has subsided in one area and moved downward and around upper arm. Now on inside portion of arm.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Coordination abnormal, Injection site pain, Muscular weakness
Clinical narrative: Soreness at injection site (Left arm), muscle weakness and poor coordination.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Patient had a fever after 1 day. Submitted to ER and hospital said patient has a Staph infection due to flu shot.
Sex: F
Vaccine: IPV, UNK
Symptoms: Convulsion
Clinical narrative: Initial report received on 28 July 2010 from another manufacturer, Merck, under service request 1-3630816675. The reporter was a pharmacist. An infant patient, whose medical history was not reported, received an unspecified Pertussis vaccine (manufacturer and lot number not reported) on an unspecified date over 15 years ago. The patient was reported to have had a severe reaction to the pertussis vaccine. No other information was available. Follow-up information received from a pharmacist on 07 September 2010. Due to the following information, this case was upgraded to serious. The patient's date of birth was provided as 08 January 1988. The patient is a female. It was unknown if the patient had any concurrent illnesses at the time of receiving the Pertussis vaccine, and an additional polio vaccine (trade name, manufacturer name, lot number, route and site of administration  were unknown) over 15 years ago. It was reported the patient experienced a seizure after administration of the vaccines and recovered (date not reported). Time and course of the seizure were unknown. No other information was provided. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain, Anti-insulin antibody increased, Anti-islet cell antibody, Asthenia, Autoantibody positive
Clinical narrative: Service member (SM) was in his usual state of excellent health prior to May 2010. SM received Typhoid and Meningococcal vaccine on 9 Feb 2010, and had received an inactivated H1N1 flu vaccine in Jan 2010. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. He completed a physical exam in Feb 2010 and reported feeling well. However, his fasting serum glucose level on 9 Feb 2010 was 211. Sometime in mid-April 2010, SM noted increased thirst and urination and weakness. Between Feb 2010 and time of diagnosis in May 2010, SM lost 25 pounds (BMI 21.62). Also, by the time of diagnosis, SM complained of abdominal pain and constipation, but denied nausea and/or vomiting. When he sought evaluation on 3 May 2010, his serum glucose level was 258, his HgbA1c was 11.8 and his urine was positive for glucose and ketones. He He was hospitalized for 5 days for hydration, electrolyte replacement, and insulin titration, as well as diabetes self management training. He was discharged on once daily Lantus with additional supplementation for hyperglycemia using Novolog. Since that time, SM has been followed through local military health care providers, as well as by civilian Endocrinologist. SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. he does not recall a history of recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (23.92) prior to diagnosis. SM has no family history of diabetes. DX: Type 1 Diabetes Mellitus.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood 25-hydroxycholecalciferol, Blood cholesterol normal, Blood glucose increased, Constipation, Electrolyte substitution therapy
Clinical narrative: Service member (SM) was in his usual state of excellent health prior to May 2010. SM received Typhoid and Meningococcal vaccine on 9 Feb 2010, and had received an inactivated H1N1 flu vaccine in Jan 2010. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. He completed a physical exam in Feb 2010 and reported feeling well. However, his fasting serum glucose level on 9 Feb 2010 was 211. Sometime in mid-April 2010, SM noted increased thirst and urination and weakness. Between Feb 2010 and time of diagnosis in May 2010, SM lost 25 pounds (BMI 21.62). Also, by the time of diagnosis, SM complained of abdominal pain and constipation, but denied nausea and/or vomiting. When he sought evaluation on 3 May 2010, his serum glucose level was 258, his HgbA1c was 11.8 and his urine was positive for glucose and ketones. He He was hospitalized for 5 days for hydration, electrolyte replacement, and insulin titration, as well as diabetes self management training. He was discharged on once daily Lantus with additional supplementation for hyperglycemia using Novolog. Since that time, SM has been followed through local military health care providers, as well as by civilian Endocrinologist. SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. he does not recall a history of recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (23.92) prior to diagnosis. SM has no family history of diabetes. DX: Type 1 Diabetes Mellitus.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Glucose urine present, Glycosylated haemoglobin, High density lipoprotein increased, Hyperglycaemia, Insulin C-peptide decreased
Clinical narrative: Service member (SM) was in his usual state of excellent health prior to May 2010. SM received Typhoid and Meningococcal vaccine on 9 Feb 2010, and had received an inactivated H1N1 flu vaccine in Jan 2010. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. He completed a physical exam in Feb 2010 and reported feeling well. However, his fasting serum glucose level on 9 Feb 2010 was 211. Sometime in mid-April 2010, SM noted increased thirst and urination and weakness. Between Feb 2010 and time of diagnosis in May 2010, SM lost 25 pounds (BMI 21.62). Also, by the time of diagnosis, SM complained of abdominal pain and constipation, but denied nausea and/or vomiting. When he sought evaluation on 3 May 2010, his serum glucose level was 258, his HgbA1c was 11.8 and his urine was positive for glucose and ketones. He He was hospitalized for 5 days for hydration, electrolyte replacement, and insulin titration, as well as diabetes self management training. He was discharged on once daily Lantus with additional supplementation for hyperglycemia using Novolog. Since that time, SM has been followed through local military health care providers, as well as by civilian Endocrinologist. SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. he does not recall a history of recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (23.92) prior to diagnosis. SM has no family history of diabetes. DX: Type 1 Diabetes Mellitus.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Laboratory test normal, Low density lipoprotein increased, Pollakiuria, Thirst, Type 1 diabetes mellitus
Clinical narrative: Service member (SM) was in his usual state of excellent health prior to May 2010. SM received Typhoid and Meningococcal vaccine on 9 Feb 2010, and had received an inactivated H1N1 flu vaccine in Jan 2010. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. He completed a physical exam in Feb 2010 and reported feeling well. However, his fasting serum glucose level on 9 Feb 2010 was 211. Sometime in mid-April 2010, SM noted increased thirst and urination and weakness. Between Feb 2010 and time of diagnosis in May 2010, SM lost 25 pounds (BMI 21.62). Also, by the time of diagnosis, SM complained of abdominal pain and constipation, but denied nausea and/or vomiting. When he sought evaluation on 3 May 2010, his serum glucose level was 258, his HgbA1c was 11.8 and his urine was positive for glucose and ketones. He He was hospitalized for 5 days for hydration, electrolyte replacement, and insulin titration, as well as diabetes self management training. He was discharged on once daily Lantus with additional supplementation for hyperglycemia using Novolog. Since that time, SM has been followed through local military health care providers, as well as by civilian Endocrinologist. SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. he does not recall a history of recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (23.92) prior to diagnosis. SM has no family history of diabetes. DX: Type 1 Diabetes Mellitus.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Urine ketone body present, Weight decreased
Clinical narrative: Service member (SM) was in his usual state of excellent health prior to May 2010. SM received Typhoid and Meningococcal vaccine on 9 Feb 2010, and had received an inactivated H1N1 flu vaccine in Jan 2010. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. He completed a physical exam in Feb 2010 and reported feeling well. However, his fasting serum glucose level on 9 Feb 2010 was 211. Sometime in mid-April 2010, SM noted increased thirst and urination and weakness. Between Feb 2010 and time of diagnosis in May 2010, SM lost 25 pounds (BMI 21.62). Also, by the time of diagnosis, SM complained of abdominal pain and constipation, but denied nausea and/or vomiting. When he sought evaluation on 3 May 2010, his serum glucose level was 258, his HgbA1c was 11.8 and his urine was positive for glucose and ketones. He He was hospitalized for 5 days for hydration, electrolyte replacement, and insulin titration, as well as diabetes self management training. He was discharged on once daily Lantus with additional supplementation for hyperglycemia using Novolog. Since that time, SM has been followed through local military health care providers, as well as by civilian Endocrinologist. SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. he does not recall a history of recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (23.92) prior to diagnosis. SM has no family history of diabetes. DX: Type 1 Diabetes Mellitus.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Convulsion, Dyskinesia, Feeling abnormal, Loss of consciousness
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female patient who on 09-SEP-2010 was vaccinated IM with a first dose of GARDASIL (Lot# 666163/0664Z) (Expiration date: 18-SEP-2012). The patient did not receive any concomitant vaccinations. The medical assistant reported that on 09-SEP-2010, about 10 minutes after the patient received the GARDASIL, she had blood drawn. About 5 minutes after she had her blood drawn she passed out and had loss of consciousness. She had a seizure and was "moving her body all around". The patient had lost of consciousness and had a seizure for a few seconds. The patient regained consciousness and completely recovered within a few minutes. The patient stated that when she fainted it felt like she was in a car accident, she saw lots of lights. The Emergency medical technician was notified and came to the physician's office. The patient blood pressure was normal. The patient was not taken to the hospital. The patient left the office with her mother and went home. Upon internal review, patient's seizure was determined to be an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Photophobia, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female patient who on 09-SEP-2010 was vaccinated IM with a first dose of GARDASIL (Lot# 666163/0664Z) (Expiration date: 18-SEP-2012). The patient did not receive any concomitant vaccinations. The medical assistant reported that on 09-SEP-2010, about 10 minutes after the patient received the GARDASIL, she had blood drawn. About 5 minutes after she had her blood drawn she passed out and had loss of consciousness. She had a seizure and was "moving her body all around". The patient had lost of consciousness and had a seizure for a few seconds. The patient regained consciousness and completely recovered within a few minutes. The patient stated that when she fainted it felt like she was in a car accident, she saw lots of lights. The Emergency medical technician was notified and came to the physician's office. The patient blood pressure was normal. The patient was not taken to the hospital. The patient left the office with her mother and went home. Upon internal review, patient's seizure was determined to be an other important medical event. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction : redness all along upper arm, hot to touch, muscle soreness radiating under arm to shoulder, pain, temp of 99.2 degrees.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia
Clinical narrative: Injection site reaction : redness all along upper arm, hot to touch, muscle soreness radiating under arm to shoulder, pain, temp of 99.2 degrees.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dyskinesia, Gaze palsy, Grand mal convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female patient with no family history of seizure disorder and no past medical history of seizure disorder who on 09-SEP-2010 was vaccinated with the first dose of GARDASIL (Lot # 666118/1539Y). The patient did not receive any concomitant vaccinations at the time of GARDASIL was administered. The nurse reported that the patient left the office with her mother after the GARDASIL vaccination had been administered. Within 15 minutes after the GARDASIL vaccination had been administered the patient had a "seizure-like episode" (also reported as a grand mal seizure) while being driven home by her mother. The patient's mother stated that her daughter's eyes rolled to the back of her head and patient began to flail her extremities. The patient was taken back to the physician's office and was seen in the Urgent Care Center which is contained in the physician's facility. The patient did not remember having the "seizure-like episode". The patient was not hospitalized. On 10-SEP-2010, the patient's mother stated that she kept her daughter home from school on Friday and planned to send her to school on Monday, 13-SEP-2010. The patient's mother stated that her daughter had recovered. The patient had been referred to a Pediatric Neurologist. The GARDASIL series had been discontinued. Upon internal review, seizure-like episode was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site swelling, Urticaria
Clinical narrative: Broke out in hives on head/back & arms. Face turned red. Injection site swollen/hard & red for 5 days following.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dizziness
Clinical narrative: Pt received the Zoster vaccine at appx 3:10p 9.17.10. He remained in clinic for observation. Appx 15-20 minutes post vaccination he reported experiencing chest pain and dizziness. He was placed on an exam table. VS assessed. EMS activated. He was transported to ER.
Age: 1.03
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Otitis media, Pyrexia
Clinical narrative: Fevers up to 105.0 reported by parent. Also had otitis media infection prior, then after vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Chest pain, Dyspnoea, Flushing, Urticaria
Clinical narrative: Flushing, hives, chest pain, shortness of breath few minutes after administration of immunizations.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (L) arm had red circle on deltoid approx. 2 1/2 in. in diameter & patient just started to feel warmth within the red circle, no pain. Advised to take BENADRYL & apply warm compresses.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever > 102 x 48 hrs.
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray, Cough, Pneumonia, Rales, Wheezing
Clinical narrative: Initial case received on 10 September 2010 from a healthcare professional. A "2 and 1/2" year old (2 years 11 months per date of birth) male patient received a right thigh intramuscular injection of FLUZONE SV 2010-2011 (lot number UH181AC) on 03 September 2010. The patient developed a persistent cough a few days after the vaccination. At an office visit on 09 September 2010, he was diagnosed with pneumonia with wheezing and bilateral rales. He was afebrile at that time. A chest x-ray was performed (date and results not reported). The patient had no illness at the time of the vaccination. He had no vaccinations within four weeks and no adverse events following prior vaccinations. He had no pre-existing medical conditions, allergies and no concomitant medications. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Nausea, Throat tightness, Tremor
Clinical narrative: Initial and follow-up reports were received from a nurse on 13 September 2010 and 15 September 2010, respectively. A 71-year-old female patient had received an intramuscular left deltoid injection of FLUZONE High-Dose (lot number U3600AA) on 10 September 2010 as part of her well visit. When the patient returned home, an 8 mile ride from the office, she felt like her throat was closing off, but her airway was not obstructed. She could not catch her breath and was nauseated and shaky and vomited one time. The patient did not want to go to the hospital and self-mediated with BENADRYL. Fifteen minutes after taking the BENADRYL, the patient felt better and all her symptoms resolved within one hour. It was noted the patient had medical conditions of asthma that was being treated with albuterol and QVAR and hypertension that was treated with an unspecified medication. The patient receives yearly flu vaccines. It was reported the patient has a history of local reactions to prior vaccines (reactions and vaccines not identified), and was not pre-medicated prior to receiving the FLUZONE HD; and did not stay at the office for observation after the vaccination. Per the reporter, the events was considered to be an anaphylactic reaction, but did not know if she would call it severe or not, but if the patient had been in the office when it happened she would have given EPI. The reporter has since followed up with the patient and reported that the patient had not experienced any other symptoms and has not needed any other follow-up or care. Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial and follow-up reports were received from a nurse on 13 September 2010 and 15 September 2010, respectively. A 71-year-old female patient had received an intramuscular left deltoid injection of FLUZONE High-Dose (lot number U3600AA) on 10 September 2010 as part of her well visit. When the patient returned home, an 8 mile ride from the office, she felt like her throat was closing off, but her airway was not obstructed. She could not catch her breath and was nauseated and shaky and vomited one time. The patient did not want to go to the hospital and self-mediated with BENADRYL. Fifteen minutes after taking the BENADRYL, the patient felt better and all her symptoms resolved within one hour. It was noted the patient had medical conditions of asthma that was being treated with albuterol and QVAR and hypertension that was treated with an unspecified medication. The patient receives yearly flu vaccines. It was reported the patient has a history of local reactions to prior vaccines (reactions and vaccines not identified), and was not pre-medicated prior to receiving the FLUZONE HD; and did not stay at the office for observation after the vaccination. Per the reporter, the events was considered to be an anaphylactic reaction, but did not know if she would call it severe or not, but if the patient had been in the office when it happened she would have given EPI. The reporter has since followed up with the patient and reported that the patient had not experienced any other symptoms and has not needed any other follow-up or care. Documents held by sender: None.
Age: 81.0
Sex: M
Vaccine: PNC10
Symptoms: Dizziness, Erythema, Malaise, Pain, Swelling
Clinical narrative: TERRIBLE SWELLING & SORENESS, REDNESS, DIZZINESS, MALAISE, GENERAL ILL FEELING
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Pyrexia, Tachycardia, Vomiting
Clinical narrative: Patient presented one hour after receiving 2010 influenza vaccine with sudden onset of fever (102F), tachycardia, vomiting.  Patient treated with epinephrine and Benadryl, and corticosteroids.  Resolution of S/S within 20 minutes.
Age: 62.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Diarrhoea, Fatigue, Nausea
Clinical narrative: Started with extreme fatigue on 9/16, worse than I have had before. Went to bed as soon as I got home from work and slept all night. Woke up on 9/17 with nausea and diarrhea. Today, I still have some nausea and diarrhea.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Blood bilirubin normal, Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: Shortness of breath, chest pain at 1600, progressively worsening with SpO2 of 87% on room air noted at 1830. Pt responded well when placed on 10L O2 via non-rebreather, sx decreased, gradually resolving.  1 Gm IV Paracetamol (acetaminophen) and 20mg IV Omeprazole administered. Pt admitted overnight for observation. Discharged the next morning with Ventolin inhaler.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Fibrin D dimer normal, Granulocytes abnormal, Oxygen saturation decreased, Prothrombin time prolonged
Clinical narrative: Shortness of breath, chest pain at 1600, progressively worsening with SpO2 of 87% on room air noted at 1830. Pt responded well when placed on 10L O2 via non-rebreather, sx decreased, gradually resolving.  1 Gm IV Paracetamol (acetaminophen) and 20mg IV Omeprazole administered. Pt admitted overnight for observation. Discharged the next morning with Ventolin inhaler.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Cellulitis, Injected limb mobility decreased, Injection site anaesthesia, Injection site induration
Clinical narrative: 9/15/2010. numbness and tingling of Left arm (where Vaccination was administered), achy and dull pain with minimal- to no relief with ibuprofen. Very limited movement of left arm possible.  Very hard, tender at injection site and entire left shoulder. 9/16/2010. Significant swelling of lymph nodes in Left neck, Left shouder, left axilla, Left clavicle. Signifcant pain in left shouder and arm that went to primary care doctor at 4pm.  Primary care doctor had never seen swelling to this extent from a DTaP vaccination before and urged me to return to ED at hospital where administered. 9/16/2010. Went to ED at hospital.  Dx'd me with cellulitis and gave me Levaquin and 600mg of ibuprofen.  9/18/2010. Swelling has subsided minimally and pain and achy is still present on scale 5/10.  Day 3 on Levaquin.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Lymphadenopathy, Musculoskeletal pain, Pain
Clinical narrative: 9/15/2010. numbness and tingling of Left arm (where Vaccination was administered), achy and dull pain with minimal- to no relief with ibuprofen. Very limited movement of left arm possible.  Very hard, tender at injection site and entire left shoulder. 9/16/2010. Significant swelling of lymph nodes in Left neck, Left shouder, left axilla, Left clavicle. Signifcant pain in left shouder and arm that went to primary care doctor at 4pm.  Primary care doctor had never seen swelling to this extent from a DTaP vaccination before and urged me to return to ED at hospital where administered. 9/16/2010. Went to ED at hospital.  Dx'd me with cellulitis and gave me Levaquin and 600mg of ibuprofen.  9/18/2010. Swelling has subsided minimally and pain and achy is still present on scale 5/10.  Day 3 on Levaquin.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia, Tenderness, Vaccination site pain
Clinical narrative: 9/15/2010. numbness and tingling of Left arm (where Vaccination was administered), achy and dull pain with minimal- to no relief with ibuprofen. Very limited movement of left arm possible.  Very hard, tender at injection site and entire left shoulder. 9/16/2010. Significant swelling of lymph nodes in Left neck, Left shouder, left axilla, Left clavicle. Signifcant pain in left shouder and arm that went to primary care doctor at 4pm.  Primary care doctor had never seen swelling to this extent from a DTaP vaccination before and urged me to return to ED at hospital where administered. 9/16/2010. Went to ED at hospital.  Dx'd me with cellulitis and gave me Levaquin and 600mg of ibuprofen.  9/18/2010. Swelling has subsided minimally and pain and achy is still present on scale 5/10.  Day 3 on Levaquin.
Age: 2.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Body temperature increased, Consciousness fluctuating, Convulsion, Crying, Drooling
Clinical narrative: Patient woke up at 3:30 AM on 9/17/2010 with a fever warm to the touch.  I gave her a dose of Tylenol at that time and then again at approximately 8:00 AM the same morning.  She fell asleep around 11:15 AM and when I went to check on her around 11:59 AM she was jerking with a seizure and foaming/drooling at the mouth.  I picked her up and tried to wake her.  She did stop jerking, but was unresponsive and just staring into space.  I called her doctor's office to report the situation and they had me take her temperature which exceeded 103 and they said to keep taking her temperature, but that she needed to have some Tylenol.  The nurse instructed me to give her some Tylenol, but patient's body was completely tense and unresponsive, her arms were turning purple and she had goose bumps.  The nurse instructed me to hang up and dial 911 and go to the nearest hospital.  A first responder arrived approximately 6 minutes later and was able to get patient to make eye contact with him. She seemed to slip in and out of consciousness until we were about half way to the hospital approximately 15 minutes later.  She finally cried and then at the hospital began talking.  The hospital staff administered Ibuprofen at 1:00 PM and Tylenol at 1:30 PM.  Her fever continued to go down and we were released from the hospital around 2:39 PM.
Age: 2.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Dyskinesia, Foaming at mouth, Piloerection, Pyrexia, Skin discolouration
Clinical narrative: Patient woke up at 3:30 AM on 9/17/2010 with a fever warm to the touch.  I gave her a dose of Tylenol at that time and then again at approximately 8:00 AM the same morning.  She fell asleep around 11:15 AM and when I went to check on her around 11:59 AM she was jerking with a seizure and foaming/drooling at the mouth.  I picked her up and tried to wake her.  She did stop jerking, but was unresponsive and just staring into space.  I called her doctor's office to report the situation and they had me take her temperature which exceeded 103 and they said to keep taking her temperature, but that she needed to have some Tylenol.  The nurse instructed me to give her some Tylenol, but patient's body was completely tense and unresponsive, her arms were turning purple and she had goose bumps.  The nurse instructed me to hang up and dial 911 and go to the nearest hospital.  A first responder arrived approximately 6 minutes later and was able to get patient to make eye contact with him. She seemed to slip in and out of consciousness until we were about half way to the hospital approximately 15 minutes later.  She finally cried and then at the hospital began talking.  The hospital staff administered Ibuprofen at 1:00 PM and Tylenol at 1:30 PM.  Her fever continued to go down and we were released from the hospital around 2:39 PM.
Age: 2.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Skin warm, Staring, Tension, Unresponsive to stimuli
Clinical narrative: Patient woke up at 3:30 AM on 9/17/2010 with a fever warm to the touch.  I gave her a dose of Tylenol at that time and then again at approximately 8:00 AM the same morning.  She fell asleep around 11:15 AM and when I went to check on her around 11:59 AM she was jerking with a seizure and foaming/drooling at the mouth.  I picked her up and tried to wake her.  She did stop jerking, but was unresponsive and just staring into space.  I called her doctor's office to report the situation and they had me take her temperature which exceeded 103 and they said to keep taking her temperature, but that she needed to have some Tylenol.  The nurse instructed me to give her some Tylenol, but patient's body was completely tense and unresponsive, her arms were turning purple and she had goose bumps.  The nurse instructed me to hang up and dial 911 and go to the nearest hospital.  A first responder arrived approximately 6 minutes later and was able to get patient to make eye contact with him. She seemed to slip in and out of consciousness until we were about half way to the hospital approximately 15 minutes later.  She finally cried and then at the hospital began talking.  The hospital staff administered Ibuprofen at 1:00 PM and Tylenol at 1:30 PM.  Her fever continued to go down and we were released from the hospital around 2:39 PM.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Increased upper airway secretion, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site of vaccination is red bumpy, swollen, warm and itchy.  Notice throat congestion and notice tired after short walk, itchy all over arms, back of neck, called Dr.'s office and told to take Benadryl and see if that helps, if not go to hospital to get help.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Site of vaccination is red bumpy, swollen, warm and itchy.  Notice throat congestion and notice tired after short walk, itchy all over arms, back of neck, called Dr.'s office and told to take Benadryl and see if that helps, if not go to hospital to get help.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Body temperature increased, Erythema, Irritability, Pyrexia, Screaming
Clinical narrative: Child became very fussy near bedtime at 8:00 PM and then began screaming uncontrollably for 2 hours.  He had no other symptoms or outward signs of illness at the time.  In the morning at approx 8:00 AM he had a fever of 102, rosy cheeks and still very fussy. Called nurse in AM and instructed me that fever wasn't high enough to worry and crying was just because shots hurt.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Malaise, Nausea
Clinical narrative: 5-10 minutes post-shot patient began to complain of feeling nauseated, sweating profusely and general malaise. Patient was given water and Benadryl 50mg per direction of his grandfather who is a physician as he was called. The patient felt better after 15 minutes and left with family members.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fear, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Severe nausea, fever, chills. Patient fainted while dry heaving in bathroom. Large amount of swelling at injection site. Patient was scared, but recovered by next morning.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Retching, Syncope
Clinical narrative: Severe nausea, fever, chills. Patient fainted while dry heaving in bathroom. Large amount of swelling at injection site. Patient was scared, but recovered by next morning.
Age: 19.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 09/18/2010 - Donor reported today that he developed swelling and redness to the area, and hurting more. Sx developed on 09/16/10 approximately 09:00 PM and is a little worse every day. Upon examination of his right arm, the deltoid has a firm nodule palpated that was approximately one inch width, skin w/tinted - more pinkish-reddish area 1 3/4" x 2 1/16" perimeter. Skin was warmer to touch the area w/comparison to his left arm. Had a small pinkish/red pin point area that resemble a pimple - donor questioned if this was the area of his injection and stated, "no". Skin w/o any open areas, no red streaks, or pustule. Denied any other s/s. Denied previous reactions or sensitivity to previous Tetanus injections that he received in 02/2010, 09/2009, and ? 2005 d/t injury.
Age: 19.0
Sex: M
Vaccine: TTOX
Symptoms: No reaction on previous exposure to drug, Papule
Clinical narrative: 09/18/2010 - Donor reported today that he developed swelling and redness to the area, and hurting more. Sx developed on 09/16/10 approximately 09:00 PM and is a little worse every day. Upon examination of his right arm, the deltoid has a firm nodule palpated that was approximately one inch width, skin w/tinted - more pinkish-reddish area 1 3/4" x 2 1/16" perimeter. Skin was warmer to touch the area w/comparison to his left arm. Had a small pinkish/red pin point area that resemble a pimple - donor questioned if this was the area of his injection and stated, "no". Skin w/o any open areas, no red streaks, or pustule. Denied any other s/s. Denied previous reactions or sensitivity to previous Tetanus injections that he received in 02/2010, 09/2009, and ? 2005 d/t injury.
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: Developed a rash on right side of waist extending to milddle of lower back.
Age: 58.0
Sex: M
Vaccine: FLUX, TTOX
Symptoms: Chills, Erythema, Headache, Injection site pain, Injection site swelling
Clinical narrative: Headache; redness; Chill; Nausea; Body aches; severe arm soreness and swollen arm where the injection was given.
Age: 58.0
Sex: M
Vaccine: FLUX, TTOX
Symptoms: Nausea, Pain
Clinical narrative: Headache; redness; Chill; Nausea; Body aches; severe arm soreness and swollen arm where the injection was given.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Eye pruritus, Headache, Irritability, Ocular hyperaemia
Clinical narrative: Itchy red eyes, sores in mouth, aches in joints, irritablity, headaches. Noticed these symptoms starting around about 06:30 pm with headache, red itchy eyes, irritablity.  Later in the evening I experienced the mouth sores and aches in my joints at about 10:00pm. I still have sores in my mouth and headaches that come and go as of today, 9/18/2010.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Stomatitis
Clinical narrative: Itchy red eyes, sores in mouth, aches in joints, irritablity, headaches. Noticed these symptoms starting around about 06:30 pm with headache, red itchy eyes, irritablity.  Later in the evening I experienced the mouth sores and aches in my joints at about 10:00pm. I still have sores in my mouth and headaches that come and go as of today, 9/18/2010.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Dysstasia, Ear pain, Feeling abnormal, Gait disturbance
Clinical narrative: My ear and head hurt so bad it was like they were going to explode. Felt dizzy and whole body hurt. Was not able to stand up straight and walking was difficult. I took Tylenol for the fever that ranged into 102.6 for a couple days. My body hurt so bad I used my Vicodin to try and ease the pain but it didn't work to well. I will never get another flu shot if it is a 3in1 again. I wanted to die to get rid of that pain. This is my 4th day and I still ache bad and my head doesn't feel normal, foggy headache.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: My ear and head hurt so bad it was like they were going to explode. Felt dizzy and whole body hurt. Was not able to stand up straight and walking was difficult. I took Tylenol for the fever that ranged into 102.6 for a couple days. My body hurt so bad I used my Vicodin to try and ease the pain but it didn't work to well. I will never get another flu shot if it is a 3in1 again. I wanted to die to get rid of that pain. This is my 4th day and I still ache bad and my head doesn't feel normal, foggy headache.