chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Upper respiratory tract infection, Urinary tract infection, Vomiting
Clinical narrative: Information has been received from a consumer via internet concerning her 18 year old daughter with a history of infectious mononucleosis who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (Lot 653937/0637F), her second dose on 15-FEB-2007 (Lot 655618/0186U) and her final vaccination on 02-JUL-2007 (Lot 657737/0522U). It was reported that the patient was a healthy, athletic girl until she had mononucleosis at the age of 15 in May of 2006. By December 2006, she had almost recovered and her pediatrician recommended GARDASIL. The patient's illnesses have covered a three year period and she had still not recovered. The patient was diagnosed with Posterial Orthostatic Tachycardia Syndrome (POTS) in April 2009. Her symptoms during this period of time have included: Immediately Urinary tract infections - 5; Upper respiratory tract infection, strep throat 3 times, progressing to joint pain, muscle pain, muscle weakness, fatigue, irregular but very painful periods, memory loss, moodiness, anger, occasional slurred speech, 2 bumps growing under the skin on her face, insomnia, panic attacks, runny nose all the time (had not allergies previously), body temperature issues, gastrointestinal issues and night sweats. Her days were all the same, she woke up and was in pain all day long - joint, neck, shins, knees and her body was sensitive to touch. She could not take a shower and lift her arm over her head, walking upstairs caused her heart to race and she could not get to sleep without medication. Her sleeping pattern had been completely altered and she could sleep two days in a row. If she was not vomiting or having diarrhea with a stomach upset, then she was constipated. Her concentration levels were poor and could not sit down and read a book, which she always used to enjoy. She was constantly exhausted and this was just not she used to be. Up until 05-MAY-2006, the patient was a healthy, active 15 year old teenager getting A's and B's in school and playing volleyball in national tournaments. She had to give up volleyball because of her chronic illness and in February 2009 had to medically withdraw from college due to medical disability. Posterial orthostatic tachycardia syndrome (POTS) was considered to be disabling. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Cataplexy, Fatigue, Hot flush, Narcolepsy, Sleep study
Clinical narrative: Initial report received from a health care professional via Health Authority on 30 Nov 2010: This patient with medical history of allergy to sulfa drugs and attention deficit hyperactive disorder was vaccinated with FLUVIRIN vaccine (batch number unknown) on an unknown date. She began to feel fatigue, hot flashes followed by narcolepsy and cataplexy shortly after FLUVIRIN. The outcome of the events was not reported. The patient believed that the events were due to FLUVIRIN shot.
Age: 26.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Cataplexy, Fatigue, Hot flush, Narcolepsy
Clinical narrative: Initial report received from a health care professional via Health Authority on 30 Nov 2010: This patient with medical history of allergy to sulfa drugs and attention deficit hyperactive disorder was vaccinated with FLUVIRIN vaccine (batch number unknown) on an unknown date. She began to feel fatigue, hot flashes followed by narcolepsy and cataplexy shortly after FLUVIRIN. The outcome of the events was not reported. The patient believed that the events were due to FLUVIRIN shot.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: PAIN IN SHOULDER THAT RADIATES DOWN ARM. PAIN IS CONSTANT. STEROID TREATMENT REDUCED PAIN, BUT ONCE TREATMENT DONE, PAIN HAS RETURNED.
Age: 28.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Sore Throat, Headache, Fever, Body Aches & Pains, Dizziness, Nausea.  Treated symptoms with OTC Flu medications.  Symptoms lasted for 2 days.
Age: 28.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Sore Throat, Headache, Fever, Body Aches & Pains, Dizziness, Nausea.  Treated symptoms with OTC Flu medications.  Symptoms lasted for 2 days.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Palpitations, Pyrexia
Clinical narrative: Palpitations and fever. Some dizziness beforehand.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Developed redness, edema, tenderness.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Drug exposure during pregnancy, Dyspnoea, Nasal congestion
Clinical narrative: Patient called pharmacy about 2 hours after receiving vaccination. She complained of SOB, chest tightness, and stuffy nose. Patient instructed to immediately contact physician. Patient is pregnant.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Pruritus, Rash, Vaccination site rash
Clinical narrative: Rash on left arm around vaccine site. Raised bumps and itching. Developed 10 days after injection.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Vision blurred
Clinical narrative: Dizziness 5 minutes after the shot. Blurred vision, symptoms last for 3-4 minutes.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Night sweats, Oropharyngeal pain, Tremor
Clinical narrative: Within 6 hrs - violent shakes, night sweats (linen soaked), sore throat, cough did not go to ER. probably should have - called provider - said side effects to be expected.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Itching along length of arm that was injected shortly after receiving shot. Lasted few hrs. w/o treatment. No other reactions.
Age: 1.51
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Abasia, Gait disturbance, X-ray normal
Clinical narrative: Limp following Hep A & Influenza vaccines, given 11-16-2010 & almost completely resolved by 12-6-2010. Initially, patient did not walk for 1-2 days, then walked with a limp. By 11-24, he limped when starting to walk, then walked normally, but limped when running. 12-6 - Limp seen once in 3 days. Hip, leg, exam nl.
Age: 1.05
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: On 11-30-2010 was noted pt received influenza #1- 11-2-10 and influenza #2- 11-12-10 mother aware.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nausea, Pruritus, Tremor, Vision blurred
Clinical narrative: Pt called after 45 min: vomiting, sweaty feet, sweats, "extreme" nauea, shaking. Itching, blurry vision.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Pt called after 45 min: vomiting, sweaty feet, sweats, "extreme" nauea, shaking. Itching, blurry vision.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore arm reported by pt. has received a TORADOL shot approximately 2 week later.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Computerised tomogram normal, Headache
Clinical narrative: Per pt: Noted slight headache at 10pm went to bed, but woke up at 2:10am with sharp stabbing pain in head - occurring at least 5 - 10 mins apart. Pain levels "12". Went to ER at 3:30am, B/P (174/108). Rec'd Tx for HR and increased B/P (IV fluids when B/P decreased). CT scan done with neg. findings. D/C from ER with insts to F/u with PCP and referral to Neurology, No Na diet, Rx: TRAMADOL and rest. Today (11-12-10: pt report with above report and no complaints.
Age: 35.0
Sex: M
Vaccine: ANTH, HEP, PPV
Symptoms: Amnesia, Arthralgia, Computerised tomogram, Erectile dysfunction, Nervousness
Clinical narrative: Joint pain, condition, memory loss, nervous condition, skin condition and sexual dysfunction (ED).
Age: 35.0
Sex: M
Vaccine: ANTH, HEP, PPV
Symptoms: Sexual dysfunction, Skin disorder
Clinical narrative: Joint pain, condition, memory loss, nervous condition, skin condition and sexual dysfunction (ED).
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Localized redness, itching, 8 cm in size - presumed allergic reaction.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Vomiting
Clinical narrative: Severe vomiting x 2 days, foster mother was advised to push fluids including PEDIALYTE and if dehydration occurred to go to ER, fussiness was also noted.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Dizziness, Myalgia
Clinical narrative: Moderate low back pain, back myalgias, lightheaded lumbar arthralgias, no CMS defic, DTRs (+) 2x4 ext. ABC's (+) w/o defic, NAD.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Pt broke out in hives 10-15 min after shots were administered. They moved all over his entire body. He was given BENADRYL & parents were counseled about what to watch for. I attempted to call them the next day & check on child but could not get an answer.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Body temperature increased, Cough, Diarrhoea
Clinical narrative: Per mom, pt. required ER visit with temp of 103 degrees the night of immunizations and could not get it down to 100 degrees the following day. In addition pt. developed a cough & diarrhea. Parent instructed to alternate TYLENOL and Ibuprofen for fever and Pedialyte for diarrhea. Prescriptions for these were called to pharmacy. Parents instructed to return to ER over weekend if sx worsen.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Insomnia, Mental impairment, Oedema peripheral, Pain
Clinical narrative: Information has been received from a physician concerning an 84 year old male with and lumbar spinal stenosis and a history of neuropathy and foot drop who on 11-AUG-2010 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number not provided). On approximately 25-AUG-2010 (reported as "about 2 to 3 weeks later") the patient developed a hyperpigmented, maculo-papular rash on one leg. The patient reported stinging pain that run along the veins in the leg, as well as itching and swelling. The patient was referred to a dermatologist who did not think the rash was "varicella" related. Patient reported mental anguish, inability to sleep and requested tranquilizers for anxiety over the rash. Patient was started on a course of KENALOG spray and was taking 2 TYLENOL tablets one to two times daily for pain. At time of the report, the patient was recovering. Hyperpigmented, maculo-papular rash on one leg, stinging pain that run along the veins in the leg as well as itching and swelling, mental anguish, inability to sleep and were considered to be disabling by the physician. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash maculo-papular, Skin hyperpigmentation
Clinical narrative: Information has been received from a physician concerning an 84 year old male with and lumbar spinal stenosis and a history of neuropathy and foot drop who on 11-AUG-2010 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number not provided). On approximately 25-AUG-2010 (reported as "about 2 to 3 weeks later") the patient developed a hyperpigmented, maculo-papular rash on one leg. The patient reported stinging pain that run along the veins in the leg, as well as itching and swelling. The patient was referred to a dermatologist who did not think the rash was "varicella" related. Patient reported mental anguish, inability to sleep and requested tranquilizers for anxiety over the rash. Patient was started on a course of KENALOG spray and was taking 2 TYLENOL tablets one to two times daily for pain. At time of the report, the patient was recovering. Hyperpigmented, maculo-papular rash on one leg, stinging pain that run along the veins in the leg as well as itching and swelling, mental anguish, inability to sleep and were considered to be disabling by the physician. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Basophil count decreased, Basophil percentage decreased, Blood albumin decreased
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old female patient, with penicillin allergy and asthma, who on 05-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665401/1320Y, expire date 20-MAY-2011, route not reported), 0.5 ml in her left arm. Concomitant therapy included unspecified "asthma medications". On Sunday 07-NOV-2010, the patient was admitted to a hospital with a diagnosis of cellulitis. A diagnosis of cellulitis was considered to be immediately life-threatening and disabling by the certified medical assistant. At the time of the report, the patient was recovering. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the certified medical assistant and medical records. It was reported that on 05-NOV-2010 at 11:45 the 66 year old female patient with penicillin allergy, asthma, dyslipidemia and Gastrooesophageal reflux disease (GERD) was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y, exp 20-MAY-2011) IM into her left arm. There was no illness at time of vaccination. In the morning of 06-NOV-2010 (previously reported as 07-NOV-2010) the patient experienced redness in injection site. She became febrile and the redness increased. She had fever and elevated WBC. On 06-NOV-2010 the patient presented to the emergency room (ER) complaining of severe left arm pain and redness as well as fever at home. The erythema and swelling had extended beyond the original area and the patient was therefore admitted. CT performed on 07-NOV-2010 revealed soft tissue swelling laterally along the deltoid fascia and skin changes distally. No discrete drainable collection identified. She was started empirically on vancomycin and clindamycin. She was seen by doctor from infectious disease and doctor from pulmonary. Her symptoms were felt to be most likely as a result of a reaction to the injection itself, but cellulitis could not be ruled out. The patient was eventually changed to BACTRIM and her symptoms improved and she was cleared for discharge home on 09-NOV-2010 on the following medications: omeprazole 40 mg daily, ADVAIR 100/50 BID, montelukast sodium 10 mg daily, simvastatin 5 mg three times a week, fish oil 1 tablet daily, multivitamin daily, hormone replacement therapy and BACTRIM DS 1 tablet PO BID for 4 more days. The patient was to follow a regular diet. She was to follow up with her primary care physician as an outpatient. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood alkaline phosphatase normal, Blood calcium decreased, Blood creatine phosphokinase normal, Blood glucose normal, Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old female patient, with penicillin allergy and asthma, who on 05-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665401/1320Y, expire date 20-MAY-2011, route not reported), 0.5 ml in her left arm. Concomitant therapy included unspecified "asthma medications". On Sunday 07-NOV-2010, the patient was admitted to a hospital with a diagnosis of cellulitis. A diagnosis of cellulitis was considered to be immediately life-threatening and disabling by the certified medical assistant. At the time of the report, the patient was recovering. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the certified medical assistant and medical records. It was reported that on 05-NOV-2010 at 11:45 the 66 year old female patient with penicillin allergy, asthma, dyslipidemia and Gastrooesophageal reflux disease (GERD) was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y, exp 20-MAY-2011) IM into her left arm. There was no illness at time of vaccination. In the morning of 06-NOV-2010 (previously reported as 07-NOV-2010) the patient experienced redness in injection site. She became febrile and the redness increased. She had fever and elevated WBC. On 06-NOV-2010 the patient presented to the emergency room (ER) complaining of severe left arm pain and redness as well as fever at home. The erythema and swelling had extended beyond the original area and the patient was therefore admitted. CT performed on 07-NOV-2010 revealed soft tissue swelling laterally along the deltoid fascia and skin changes distally. No discrete drainable collection identified. She was started empirically on vancomycin and clindamycin. She was seen by doctor from infectious disease and doctor from pulmonary. Her symptoms were felt to be most likely as a result of a reaction to the injection itself, but cellulitis could not be ruled out. The patient was eventually changed to BACTRIM and her symptoms improved and she was cleared for discharge home on 09-NOV-2010 on the following medications: omeprazole 40 mg daily, ADVAIR 100/50 BID, montelukast sodium 10 mg daily, simvastatin 5 mg three times a week, fish oil 1 tablet daily, multivitamin daily, hormone replacement therapy and BACTRIM DS 1 tablet PO BID for 4 more days. The patient was to follow a regular diet. She was to follow up with her primary care physician as an outpatient. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram abnormal, Eosinophil percentage decreased, Erythema, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old female patient, with penicillin allergy and asthma, who on 05-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665401/1320Y, expire date 20-MAY-2011, route not reported), 0.5 ml in her left arm. Concomitant therapy included unspecified "asthma medications". On Sunday 07-NOV-2010, the patient was admitted to a hospital with a diagnosis of cellulitis. A diagnosis of cellulitis was considered to be immediately life-threatening and disabling by the certified medical assistant. At the time of the report, the patient was recovering. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the certified medical assistant and medical records. It was reported that on 05-NOV-2010 at 11:45 the 66 year old female patient with penicillin allergy, asthma, dyslipidemia and Gastrooesophageal reflux disease (GERD) was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y, exp 20-MAY-2011) IM into her left arm. There was no illness at time of vaccination. In the morning of 06-NOV-2010 (previously reported as 07-NOV-2010) the patient experienced redness in injection site. She became febrile and the redness increased. She had fever and elevated WBC. On 06-NOV-2010 the patient presented to the emergency room (ER) complaining of severe left arm pain and redness as well as fever at home. The erythema and swelling had extended beyond the original area and the patient was therefore admitted. CT performed on 07-NOV-2010 revealed soft tissue swelling laterally along the deltoid fascia and skin changes distally. No discrete drainable collection identified. She was started empirically on vancomycin and clindamycin. She was seen by doctor from infectious disease and doctor from pulmonary. Her symptoms were felt to be most likely as a result of a reaction to the injection itself, but cellulitis could not be ruled out. The patient was eventually changed to BACTRIM and her symptoms improved and she was cleared for discharge home on 09-NOV-2010 on the following medications: omeprazole 40 mg daily, ADVAIR 100/50 BID, montelukast sodium 10 mg daily, simvastatin 5 mg three times a week, fish oil 1 tablet daily, multivitamin daily, hormone replacement therapy and BACTRIM DS 1 tablet PO BID for 4 more days. The patient was to follow a regular diet. She was to follow up with her primary care physician as an outpatient. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Lymphocyte percentage decreased, Mean cell haemoglobin, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old female patient, with penicillin allergy and asthma, who on 05-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665401/1320Y, expire date 20-MAY-2011, route not reported), 0.5 ml in her left arm. Concomitant therapy included unspecified "asthma medications". On Sunday 07-NOV-2010, the patient was admitted to a hospital with a diagnosis of cellulitis. A diagnosis of cellulitis was considered to be immediately life-threatening and disabling by the certified medical assistant. At the time of the report, the patient was recovering. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the certified medical assistant and medical records. It was reported that on 05-NOV-2010 at 11:45 the 66 year old female patient with penicillin allergy, asthma, dyslipidemia and Gastrooesophageal reflux disease (GERD) was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y, exp 20-MAY-2011) IM into her left arm. There was no illness at time of vaccination. In the morning of 06-NOV-2010 (previously reported as 07-NOV-2010) the patient experienced redness in injection site. She became febrile and the redness increased. She had fever and elevated WBC. On 06-NOV-2010 the patient presented to the emergency room (ER) complaining of severe left arm pain and redness as well as fever at home. The erythema and swelling had extended beyond the original area and the patient was therefore admitted. CT performed on 07-NOV-2010 revealed soft tissue swelling laterally along the deltoid fascia and skin changes distally. No discrete drainable collection identified. She was started empirically on vancomycin and clindamycin. She was seen by doctor from infectious disease and doctor from pulmonary. Her symptoms were felt to be most likely as a result of a reaction to the injection itself, but cellulitis could not be ruled out. The patient was eventually changed to BACTRIM and her symptoms improved and she was cleared for discharge home on 09-NOV-2010 on the following medications: omeprazole 40 mg daily, ADVAIR 100/50 BID, montelukast sodium 10 mg daily, simvastatin 5 mg three times a week, fish oil 1 tablet daily, multivitamin daily, hormone replacement therapy and BACTRIM DS 1 tablet PO BID for 4 more days. The patient was to follow a regular diet. She was to follow up with her primary care physician as an outpatient. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mean cell volume normal, Mean platelet volume increased, Monocyte percentage increased, Neutrophil percentage increased, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old female patient, with penicillin allergy and asthma, who on 05-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665401/1320Y, expire date 20-MAY-2011, route not reported), 0.5 ml in her left arm. Concomitant therapy included unspecified "asthma medications". On Sunday 07-NOV-2010, the patient was admitted to a hospital with a diagnosis of cellulitis. A diagnosis of cellulitis was considered to be immediately life-threatening and disabling by the certified medical assistant. At the time of the report, the patient was recovering. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the certified medical assistant and medical records. It was reported that on 05-NOV-2010 at 11:45 the 66 year old female patient with penicillin allergy, asthma, dyslipidemia and Gastrooesophageal reflux disease (GERD) was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y, exp 20-MAY-2011) IM into her left arm. There was no illness at time of vaccination. In the morning of 06-NOV-2010 (previously reported as 07-NOV-2010) the patient experienced redness in injection site. She became febrile and the redness increased. She had fever and elevated WBC. On 06-NOV-2010 the patient presented to the emergency room (ER) complaining of severe left arm pain and redness as well as fever at home. The erythema and swelling had extended beyond the original area and the patient was therefore admitted. CT performed on 07-NOV-2010 revealed soft tissue swelling laterally along the deltoid fascia and skin changes distally. No discrete drainable collection identified. She was started empirically on vancomycin and clindamycin. She was seen by doctor from infectious disease and doctor from pulmonary. Her symptoms were felt to be most likely as a result of a reaction to the injection itself, but cellulitis could not be ruled out. The patient was eventually changed to BACTRIM and her symptoms improved and she was cleared for discharge home on 09-NOV-2010 on the following medications: omeprazole 40 mg daily, ADVAIR 100/50 BID, montelukast sodium 10 mg daily, simvastatin 5 mg three times a week, fish oil 1 tablet daily, multivitamin daily, hormone replacement therapy and BACTRIM DS 1 tablet PO BID for 4 more days. The patient was to follow a regular diet. She was to follow up with her primary care physician as an outpatient. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Platelet count normal, Protein total decreased, Pyrexia, Red blood cell count decreased, Red cell distribution width normal
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old female patient, with penicillin allergy and asthma, who on 05-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665401/1320Y, expire date 20-MAY-2011, route not reported), 0.5 ml in her left arm. Concomitant therapy included unspecified "asthma medications". On Sunday 07-NOV-2010, the patient was admitted to a hospital with a diagnosis of cellulitis. A diagnosis of cellulitis was considered to be immediately life-threatening and disabling by the certified medical assistant. At the time of the report, the patient was recovering. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the certified medical assistant and medical records. It was reported that on 05-NOV-2010 at 11:45 the 66 year old female patient with penicillin allergy, asthma, dyslipidemia and Gastrooesophageal reflux disease (GERD) was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y, exp 20-MAY-2011) IM into her left arm. There was no illness at time of vaccination. In the morning of 06-NOV-2010 (previously reported as 07-NOV-2010) the patient experienced redness in injection site. She became febrile and the redness increased. She had fever and elevated WBC. On 06-NOV-2010 the patient presented to the emergency room (ER) complaining of severe left arm pain and redness as well as fever at home. The erythema and swelling had extended beyond the original area and the patient was therefore admitted. CT performed on 07-NOV-2010 revealed soft tissue swelling laterally along the deltoid fascia and skin changes distally. No discrete drainable collection identified. She was started empirically on vancomycin and clindamycin. She was seen by doctor from infectious disease and doctor from pulmonary. Her symptoms were felt to be most likely as a result of a reaction to the injection itself, but cellulitis could not be ruled out. The patient was eventually changed to BACTRIM and her symptoms improved and she was cleared for discharge home on 09-NOV-2010 on the following medications: omeprazole 40 mg daily, ADVAIR 100/50 BID, montelukast sodium 10 mg daily, simvastatin 5 mg three times a week, fish oil 1 tablet daily, multivitamin daily, hormone replacement therapy and BACTRIM DS 1 tablet PO BID for 4 more days. The patient was to follow a regular diet. She was to follow up with her primary care physician as an outpatient. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin disorder, Swelling, White blood cell count increased
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old female patient, with penicillin allergy and asthma, who on 05-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665401/1320Y, expire date 20-MAY-2011, route not reported), 0.5 ml in her left arm. Concomitant therapy included unspecified "asthma medications". On Sunday 07-NOV-2010, the patient was admitted to a hospital with a diagnosis of cellulitis. A diagnosis of cellulitis was considered to be immediately life-threatening and disabling by the certified medical assistant. At the time of the report, the patient was recovering. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the certified medical assistant and medical records. It was reported that on 05-NOV-2010 at 11:45 the 66 year old female patient with penicillin allergy, asthma, dyslipidemia and Gastrooesophageal reflux disease (GERD) was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y, exp 20-MAY-2011) IM into her left arm. There was no illness at time of vaccination. In the morning of 06-NOV-2010 (previously reported as 07-NOV-2010) the patient experienced redness in injection site. She became febrile and the redness increased. She had fever and elevated WBC. On 06-NOV-2010 the patient presented to the emergency room (ER) complaining of severe left arm pain and redness as well as fever at home. The erythema and swelling had extended beyond the original area and the patient was therefore admitted. CT performed on 07-NOV-2010 revealed soft tissue swelling laterally along the deltoid fascia and skin changes distally. No discrete drainable collection identified. She was started empirically on vancomycin and clindamycin. She was seen by doctor from infectious disease and doctor from pulmonary. Her symptoms were felt to be most likely as a result of a reaction to the injection itself, but cellulitis could not be ruled out. The patient was eventually changed to BACTRIM and her symptoms improved and she was cleared for discharge home on 09-NOV-2010 on the following medications: omeprazole 40 mg daily, ADVAIR 100/50 BID, montelukast sodium 10 mg daily, simvastatin 5 mg three times a week, fish oil 1 tablet daily, multivitamin daily, hormone replacement therapy and BACTRIM DS 1 tablet PO BID for 4 more days. The patient was to follow a regular diet. She was to follow up with her primary care physician as an outpatient. No further information is available.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Arm (upper-left) became swollen & red 12/8/10 early AM - Given IBU x 1 dose & went to school - swelling went down to mid-forearm after nap - came to Health Dept examined by center mgr & RN - advised ice - IBU - observe - ER of worsens.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Body temperature, Chills, Injection site pain, Injection site swelling
Clinical narrative: Temp with mild shivering entire night. Swelling and pain in (R) arm she had received flu and PNEUMOVAX.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Endotracheal intubation, Guillain-Barre syndrome, Intensive care
Clinical narrative: Received flu vaccine 11/24/10. Developed progressive weakness/achiness, could not walk. Admitted to hospital. 12/2 - Neuro consult and critical care consult. Intubated 12/5. Remains intubated 12/10. Suspected Guillain-Barre.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Received flu vaccine 11/24/10. Developed progressive weakness/achiness, could not walk. Admitted to hospital. 12/2 - Neuro consult and critical care consult. Intubated 12/5. Remains intubated 12/10. Suspected Guillain-Barre.
Age: 1.3
Sex: F
Vaccine: PNC13
Symptoms: Blood culture, Pneumonia streptococcal, Streptococcus test positive
Clinical narrative: (+) Strep pneumonia.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Feeling cold, Pallor, Tremor
Clinical narrative: Pt witness to fall to floor, caught by MA and mom, this nurse noted pt to have seizure like jerking and shaking. Pt also was very pale and cold. Lasted approx 1 min and it happened within 60 seconds of vaccine administered. Pt sent out via EMS.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUN3, TYP
Symptoms: Arthralgia, Gastrointestinal disorder, Injection site pain, Myalgia, Rectal haemorrhage
Clinical narrative: Incredibly sore around the injection site the morning after which, has continued to present.  Generally achy around joints and muscles.  Two days ago, I started having rectal bleeding, and GI problems.  I have never had such GI issues before.  This report must be kept confidential.  I can't have this reported to my military chain.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Gastrooesophageal reflux disease, Muscle spasms, Pruritus generalised, Urticaria
Clinical narrative: Started having hives behind right ear, progressed to trunk area. By 12/7/10, had itchiness all over. Went to ED and got prednisone and Benadryl. On 12/8/10 had cramping and increased acid reflux. Was admitted to the hospital for questionable anaphylactic sensations. Vaccine injection site not red/symptomatic.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count increased
Clinical narrative: Started having hives behind right ear, progressed to trunk area. By 12/7/10, had itchiness all over. Went to ED and got prednisone and Benadryl. On 12/8/10 had cramping and increased acid reflux. Was admitted to the hospital for questionable anaphylactic sensations. Vaccine injection site not red/symptomatic.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Swelling face, Throat tightness
Clinical narrative: c/o throat feeling tight and later in the early afternoon had some eye and facial swelling. Took Benadryl po.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV1
Symptoms: Blood test normal, Pyrexia
Clinical narrative: Fever to 102.0; Mother gave antipyretics twice during the night. At clinic visit at 2:00pm fever was 105.3 rectally. Fever management, Pedialyte, blood work.
Age: 0.19
Sex: F
Vaccine: 6VAX-F, PNC13, RVX
Symptoms: Hypersomnia, Irritability
Clinical narrative: irritable, increased sleep
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Pt received the pneumonia vaccine on 10/29/10 between 10 AM-12 noon. He noted the area on his (R) arm becoming sore around 3:30 and it became progressively more painful that night. On 11/30 his arm was swollen, red, hot & painful. He went to the Emergency room & started Cephalexin 500mg which resulted in full recovery.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site swelling, Metabolic function test
Clinical narrative: Left deltoid was sore and painful then redden and swollen on 12/09/2010 in the morning. Patient applied cold compress at that time.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: At some point after vaccine patient developed generalized pruritis which is still ongoing.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Localized erythema extending to elbow with localized pain and muscle edema/induration. Has improved daily and now just slightly tender at injection site. Some backache and joint pain 24 hours after injection.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Localized erythema extending to elbow with localized pain and muscle edema/induration. Has improved daily and now just slightly tender at injection site. Some backache and joint pain 24 hours after injection.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 36 hours after vaccine, full body hives, intense itching, erythema Placed on 5 day dose of steroids Hives lasted 1 week, resolved
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness around injection site of the right arm and tenderness in this area.  Redness 2 days later measures 23cm x 23cm in size.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Immediate post-injection reaction, Inflammation, Injection site pain, Lymphadenopathy
Clinical narrative: "Immediate, severe pain" to Left shoulder, scapula, & upper extremity referred pain on 10/13/10 after receiving flu shot, "aching, pins/needles" upper extremity pain approximating radial nerve distribution. Eval for tx. on 10/25/10, rx'd Ibuprofen, heat, PT eval/tx, poor progress 11/30/10 severe pain abduction/flexion and weakness; Prednisone rx 12/8/10
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia
Clinical narrative: "Immediate, severe pain" to Left shoulder, scapula, & upper extremity referred pain on 10/13/10 after receiving flu shot, "aching, pins/needles" upper extremity pain approximating radial nerve distribution. Eval for tx. on 10/25/10, rx'd Ibuprofen, heat, PT eval/tx, poor progress 11/30/10 severe pain abduction/flexion and weakness; Prednisone rx 12/8/10
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Eye swelling, Urticaria
Clinical narrative: Swollen eye and hives
Age: 0.62
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Acne, Rash macular, Scar
Clinical narrative: Pimples all over arms, legs. Splotches on face. Happened 4 days after first and second dose of Pentacel and Rotavirus. Lasts about six weeks, then clears. Some left scars.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia test negative, Chills, Fatigue, Full blood count normal, Hyperhidrosis
Clinical narrative: Developed shaking and chills, sweating, fatigue. He had received the Typhim vaccine on 11/9/2010.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Immunology test, Laboratory test normal, Lymphocyte count decreased, Tremor
Clinical narrative: Developed shaking and chills, sweating, fatigue. He had received the Typhim vaccine on 11/9/2010.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Disorientation, Pyrexia
Clinical narrative: Fever, chills, coughing, and disorientation that lasted for 6 hours
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Fall, Irritability, Loss of consciousness, Nausea
Clinical narrative: Patient received SP/TIV at approximately 4:15PM on 11/18/2010 during a nurse visit. The child was upset, crying and walking around exam room after the TIV was administered and passed out for a few seconds, approximatly 5 minutes after the vaccine was administered.   She returned to consciousness within a few seconds with no postictal period. Mom promptly picked her up and placed her on the exam table.  She complained of nausea; then vomited and lost urinary control. No tremors noted.    No c/o headache, no injury from fall.  She was taken to see PA.  Exam was negative except for a right otitis media.  Mom was given a prescription for a 10 day course of Amoxicillin for patient and instructed to return to the office in 2 weeks for a recheck.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: Patient received SP/TIV at approximately 4:15PM on 11/18/2010 during a nurse visit. The child was upset, crying and walking around exam room after the TIV was administered and passed out for a few seconds, approximatly 5 minutes after the vaccine was administered.   She returned to consciousness within a few seconds with no postictal period. Mom promptly picked her up and placed her on the exam table.  She complained of nausea; then vomited and lost urinary control. No tremors noted.    No c/o headache, no injury from fall.  She was taken to see PA.  Exam was negative except for a right otitis media.  Mom was given a prescription for a 10 day course of Amoxicillin for patient and instructed to return to the office in 2 weeks for a recheck.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Bone pain, Chills
Clinical narrative: weak, tired, stomach ache, chills, nausea, dizziness, feverish, headache, joint/bone aches
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: weak, tired, stomach ache, chills, nausea, dizziness, feverish, headache, joint/bone aches
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Dermatitis bullous, Leukocytoclastic vasculitis, Purpura
Clinical narrative: Palpable bullous purpuric lesions which spread to cover bilateral lower extremities, face, head, arms, lower back and groin found to be leukocytoclastic vasculitis with further specification pending.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site discharge, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: LOCAL REACTION: REDNESS, HEAT, SWELLING, YELLOW DRAINAGE L DELT. SYSTEMIC: C/O FATIGUE, MUSCLE SORENESS TO CHEST AND ARMS
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Local reaction, Myalgia
Clinical narrative: LOCAL REACTION: REDNESS, HEAT, SWELLING, YELLOW DRAINAGE L DELT. SYSTEMIC: C/O FATIGUE, MUSCLE SORENESS TO CHEST AND ARMS
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: redness, itching, swelling, warmth at the injection site on the L thigh
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Henoch-Schonlein purpura
Clinical narrative: Diagnosed with Henoch Schonlein Purpura.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Injection site haematoma, Malaise
Clinical narrative: redness of upper arm and bruising at site of injection right deltoid, and feeling of being ill and short of breath
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Pt. walked in with c/o redness, swelling to the left arm.  She does have an 8 cm tender edematous circle on the left arm and mild erythema.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea stools X 15 by 12/02/2010 at 3:00 PM
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain, Urticaria
Clinical narrative: Large red welt and smaller welts on my upper arm - the same arm I got the shot in. Welts were hot and very painful. I ended up with cellulitus in my arm and had to get antibiotics for it.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Decreased appetite, Fatigue, Myalgia, Pyrexia
Clinical narrative: Severe bilateral hip pain/first day/treated with ibuprofen/followed by general muscle aches for one week/day 8 supressed appetite with febrile reaction/vertigo & fatigue for 2 more weeks
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Severe bilateral hip pain/first day/treated with ibuprofen/followed by general muscle aches for one week/day 8 supressed appetite with febrile reaction/vertigo & fatigue for 2 more weeks
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site haemorrhage
Clinical narrative: 2-3 inch diameter ecchymosis (dark purple) at injection site of left deltoid, no pain, just discoloration, shown to pharmacist on 12/10/10
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Rash started to appear on right side of torso.  No itch.  Red in appearance.  Slow spread.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Myalgia, Pyrexia, Swelling
Clinical narrative: swelling, fever, malaise, muscle aches
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: hive around site of injection 5 inches x 5 inches
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dysstasia, Nausea
Clinical narrative: Dizziness, wanting to throw up, couldn't stand felt like I was going to fall over.  These symptoms would not go away.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Severe muscle pain, muscle weakness, and muscle spasm; dizziness; nausea; weakness.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Severe muscle pain, muscle weakness, and muscle spasm; dizziness; nausea; weakness.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Erythema - 9x12 area.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Nausea, Pruritus, Swelling
Clinical narrative: Swelling, redness, itchy, headache, nausea the night after vaccination.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Lymphocyte count increased, Oedema peripheral, Pain in extremity
Clinical narrative: Swelling, redness, itchy, headache, nausea the night after vaccination.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling, redness, itchy, headache, nausea the night after vaccination.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling (7 cm diameter) (It's been 2 days).
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Abasia, Erythema, Mass
Clinical narrative: There was a small lump and a little of redness mom state that pt couldn't walk. Called the next day in the morning and mom said pt was doing ok now.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Had vaccination on 12/7, called clinic 12/9 for tenderness and redness to (R) leg. Assessment: Erythematous, indurated, tender area on (R) thigh - measures 7.5 cm with surrounding outer circle of erythema measuring 10 cm. No fluctuance or streaking. Antibiotics x 10 days. BENADRYL x 2 doses.