chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Hypovolaemia, Mechanical ventilation, Paraesthesia, Plasmapheresis, Renal salt-wasting syndrome
Clinical narrative: Case number PHHY2014US046564 is an initial literature report received on 15 Apr 2014. In this article the author presented a case of severe rapid renal salt-wasting in patient with presumed influenza vaccine induced Guillain-Barre Syndrome. The report refers to a 56 year old female patient. She was vaccinated with an influenza vaccine (manufacturer and batch number: not reported). On an unknown date after vaccination, she presented with two weeks of vomiting, progressive weakness and tingling that began in bilateral lower followed by upper extremities. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre syndrome. She was hospitalized and within two days of admission, her condition rapidly deteriorated requiring mechanical ventilation. On an unknown date by day three, her serum sodium level decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium level ranged 3.2 to 3.7 mEq/L, uric acid was 1.5 mg/dL. She was presumed "hypo-to euvolemic" based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. The liquid input and output over 26 hours was 1.2 L 5% dextrose, half normal saline and urine volume was 2.2 L, urine sodium was 235 mEq/L, urine potassium was 41 mEq/L. Net volume was 1.0 L, net sodium potassium was 526 mEq. On an unknown date, brain natriuretic peptide level was 964 pg/mL, plasma renin activity was 2.2 ng/mL/h and serum aldosterone was 12 ng/dL. She was given 3% saline at a rate of 80 to 100 mL/hour with poor response until fludrocortisone 0.1 mg daily was added for three days. On an unknown date, urine sodium level promptly reduced to less than 10 mEq/L. Plasmapheresis was initiated with neurological and serum sodium improvement (6 to 8 mEq/day). Renal salt-wasting had been hypothesized to be due to GBS autonomic dysfunction, resultant sympathoadrenal dysregulation and inappropriate BNP secretion. In conclusion author stated that it was vital to recognize this rare GBS associated renal salt-wasting complication and differentiate the entity from SIADH due to differences in treatment plans.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Renin normal, Urine output, Urine potassium normal, Urine sodium increased, Vomiting
Clinical narrative: Case number PHHY2014US046564 is an initial literature report received on 15 Apr 2014. In this article the author presented a case of severe rapid renal salt-wasting in patient with presumed influenza vaccine induced Guillain-Barre Syndrome. The report refers to a 56 year old female patient. She was vaccinated with an influenza vaccine (manufacturer and batch number: not reported). On an unknown date after vaccination, she presented with two weeks of vomiting, progressive weakness and tingling that began in bilateral lower followed by upper extremities. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre syndrome. She was hospitalized and within two days of admission, her condition rapidly deteriorated requiring mechanical ventilation. On an unknown date by day three, her serum sodium level decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium level ranged 3.2 to 3.7 mEq/L, uric acid was 1.5 mg/dL. She was presumed "hypo-to euvolemic" based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. The liquid input and output over 26 hours was 1.2 L 5% dextrose, half normal saline and urine volume was 2.2 L, urine sodium was 235 mEq/L, urine potassium was 41 mEq/L. Net volume was 1.0 L, net sodium potassium was 526 mEq. On an unknown date, brain natriuretic peptide level was 964 pg/mL, plasma renin activity was 2.2 ng/mL/h and serum aldosterone was 12 ng/dL. She was given 3% saline at a rate of 80 to 100 mL/hour with poor response until fludrocortisone 0.1 mg daily was added for three days. On an unknown date, urine sodium level promptly reduced to less than 10 mEq/L. Plasmapheresis was initiated with neurological and serum sodium improvement (6 to 8 mEq/day). Renal salt-wasting had been hypothesized to be due to GBS autonomic dysfunction, resultant sympathoadrenal dysregulation and inappropriate BNP secretion. In conclusion author stated that it was vital to recognize this rare GBS associated renal salt-wasting complication and differentiate the entity from SIADH due to differences in treatment plans.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Chest X-ray abnormal, Influenza, Influenza like illness, Pneumonia
Clinical narrative: Case number PHEH2014US007574 is an initial spontaneous report received from a consumer on 15 Apr 2014. This report refers to a 69-year-old female patient. Her medical history and concomitant medications were not reported. On an unknown date in Nov 2013, she was vaccinated with a flu shot (manufacturer and batch number: not reported, hence conservatively coded to seasonal influenza vaccine). On an unspecified date in Feb 2014, after the vaccination, she experienced flu like symptoms. Following the event she was admitted in the hospital, where she underwent X-Ray. X-Ray confirmed pneumonia and then bronchitis. She was discharged from the hospital after three days. However after being discharged from the hospital, she did not feel better and was again hospitalized on an unspecified date. She was then diagnosed with flu despite the vaccination and stayed in the hospital for five days. She had completely recovered from the events on an unknown date in Mar 2014. The causality of the events was not reported.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination failure
Clinical narrative: Case number PHEH2014US007574 is an initial spontaneous report received from a consumer on 15 Apr 2014. This report refers to a 69-year-old female patient. Her medical history and concomitant medications were not reported. On an unknown date in Nov 2013, she was vaccinated with a flu shot (manufacturer and batch number: not reported, hence conservatively coded to seasonal influenza vaccine). On an unspecified date in Feb 2014, after the vaccination, she experienced flu like symptoms. Following the event she was admitted in the hospital, where she underwent X-Ray. X-Ray confirmed pneumonia and then bronchitis. She was discharged from the hospital after three days. However after being discharged from the hospital, she did not feel better and was again hospitalized on an unspecified date. She was then diagnosed with flu despite the vaccination and stayed in the hospital for five days. She had completely recovered from the events on an unknown date in Mar 2014. The causality of the events was not reported.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The physician assistant mentioned that a patient received the first dose of GARDASIL (dose, route and site of administration were not reported) on approximately 2010 (reported as 4 years ago), the second dose of GARDASIL (dose, route and site of administration were not reported) on approximately 2011 (reported as 3 years ago) and the third dose of GARDASIL (dose, route and site of administration were not reported) on 04-MAR-2014. The physician assistant having the specific dates for the 1st and 2nd dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a female patient in his 50's who on an unknown date the patient was vaccination with ZOSTAVAX, (dose and route not provided) as accidental. The patient's medical history includes no history of chicken pox and needed to be vaccinated because she will be volunteering at the children's museum. The patient's relevant concomitant medications and past drug history were unknown. On an unknown date, the patient went to the doctor's office to receive a VARIVAX (Merck) injection, she was accidentally given a ZOSTAVAX, by the medical assistant. The physician is not reporting any side effects from accidental administration of the wrong vaccine. It is unknown if there is any relevant laboratory data. As of 06-APR-2014 it was unknown if the patient would ever receive a ZOSTAVAX again and the physician was not reporting any side effects from accidental administration of the ZOSTAVAX rather than the VARIVAX (Merck). No lot numbers or expiration dates were reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Convulsion, Hyperhidrosis, Pupil fixed, Syncope, Unresponsive to stimuli
Clinical narrative: Patient immediately became unresponsive after administering HPV vaccine. Leaned forward into his mother when I brought his head up eye were fixed w/ pupils dilated. Laid back on to exam table. Went to get PAC. Patient began having a convulsion. When PAC and I returned to exam room patient was alert and oriented. Mom stated he blinked his eyes and then he was fine. Entire syncope episode lasted less than a minute. Mom reported that patient gets nervous about vaccines and hadn't had breakfast yet. No medical or family history of seizures. Patient did become diaphoretic. Had him lay down for a few minutes, was given water to drink. Slowly had him sit up and then stand to obtain orthostatic blood pressures. Patient remained in office for at least 15 minutes to be observed, before being released. P - 54 B/P 100/62; P - 62 B/P 104/70; P - 65 B/P 98/70
Sex: U
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unspecified demographics. Patients concurrent condition included asthma. On 11-APR-2014, the patient was vaccinated with ZOSTAVAX, dose 0.65 ml, subcutaneous. Concomitant therapy was unspecified. Approximately in April 2014, the patient experienced exacerbation of asthma. The patient sought medical attention (unspecified). The physician has prescribed him Prednisone 40 milligram (mg) for five days. It was reported that the patient has not begun prednisone treatment. No product quality complaint was involved. The outcome of exacerbation of asthma was reported as recovering. The reporters causality assessment for the event exacerbation of asthma with the therapy of ZOSTAVAX was not reported. No further information was provided. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 year old female patient. Patient's medical history, drug reactions/allergies were reported as none. On 16-APR-2014, the patient was vaccinated with ZOSTAVAX vial strength 19,400 plaque forming units (PFU) (lot number J011828, expiry date 26-DEC-2014), dose and frequency unspecified subcutaneous, at back of arm. Concomitant therapies included estradiol. On 17-APR-2014, the patient developed one giant blister at the injection site as well as other small vesicles that were filled with fluid surrounding the giant blister. The reporter mentioned that this patient received ZOSTAVAX subcutaneously in the back of the arm and stated this was where subcutaneous injections were supposed to be given. The patient sought medical attention contacted pharmacist. The patient was treated with VALTREX and prednisone. No lab diagnostics studies were performed. No product quality complaint was involved. VZVIP packet has been faxed. The outcome of one giant blister at the injection site and other small vesicles that were filled with fluid surrounding the giant blister was reported as not recovered. The reporters causality assessment for the events one giant blister at the injection site and other small vesicles that were filled with fluid surrounding the giant blister with the therapy of ZOSTAVAX was not reported. No further information was provided. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Hypersensitivity, Infection, Pain, Swelling
Clinical narrative: Pt. had swelling, pain, slight infection but ER MD thinks it's more of an allergic rxn.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. On 18-APR-2014, the patient was vaccinated with a properly stored expired dose of ZOSTAVAX (lot # H011426, expiration date 12-SEP-2013) (route not reported). No adverse events were reported. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: During 04/15/14 4 mo WCE O.V. Parent reported that after 02-11-14 2mo imm., pt. slept x3 hours after, then cried x4-5 hours. Parents gave TYLENOL dose and mom nursed pt. Pt. went to sleep after and no more problems on waking. No call to PCP.
Age: 49.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Brachial plexopathy, Hypoaesthesia, Pain, Swelling face
Clinical narrative: L arm pain with radiation to neck, back, arm, hand, numbness to fingers on (L) hand, face swelling. Pt referred to neuro, dx with brachial plexopathy.
Age: 49.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test, Burning sensation, Electromyogram, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: L arm pain with radiation to neck, back, arm, hand, numbness to fingers on (L) hand, face swelling. Pt referred to neuro, dx with brachial plexopathy.
Age: 49.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Radiculitis brachial
Clinical narrative: L arm pain with radiation to neck, back, arm, hand, numbness to fingers on (L) hand, face swelling. Pt referred to neuro, dx with brachial plexopathy.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 61 year old patient. Medical history and concurrent conditions were not reported. On 22-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 66 year old patient. Medical history and concurrent conditions were not reported. On 16-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J009689; expiration date: 29-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm-4 pm) the temperature recorded was 50F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4pm) the temperature recorded was 49.1 F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm- 6 pm) the temperature recorded was 51.8 F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am- 10 pm) the temperature recorded was 64.4 F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a Licensed Vocational nurse refers to a 4 year old male patient with no pertinent medical history or drug allergies or allergies. To weeks ago, on 01-APR-2014, the patient was vaccinated with VARIVAX (Merck) second dose, 0.5 ml, subcutaneous in the right leg. There was no concomitant medication. Two days ago, on 13-APR-2014, 13 days after onset of therapy, the patient experienced a broke out with lesions in both legs. The reporter stated that approximately 20 lesions. The patient came into reporter's office for medical attention. The outcome of the broke out with lesions was reported as not recovered/not resolved. None treatment was given to the event and none laboratories were performed. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 71 year old patient. Medical history and concurrent conditions were not reported. On 14-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J009689; expiration date: 29-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2013, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2013, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 67 year old patient. Medical history and concurrent conditions were not reported. On 13-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J009689; expiration date: 29-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health worker referred to unspecified number of patients of unknown ages and genders. The healthcare worker stated an unspecified number of patients were vaccinated with GARDASIL (lot# 672232/1495AA, exp date 22-AUG-2014), injection, (dose, frequency, route and indication unspecified) between April 2013 and December 2013 with doses that reached 29F for 7 days. Healthcare worker stated no patient records or details available. No adverse effects reported. Additional information has been requested.
Age: 57.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 57 year old patient. Medical history and concurrent conditions were not reported. On 23-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16 MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 61 year old patient. Medical history and concurrent conditions were not reported. On 17-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16 MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 38.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 38 year old patient. Medical history and concurrent conditions were not reported. On 17-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours ((12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 03-MAY-2012, the patient was vaccinated with the first dose of GARDASIL (route and lot # not reported), on 18-FEB-2014, the patient was vaccinated with the second dose of GARDASIL (route and lot # not reported) and on 14-APR-2014, the patient received the third dose of GARDASIL (route and lot # not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. Another nurse in her office stated the vial of PNEUMOVAX 23 (lot # not reported) "exploded" upon trying to withdraw dose three on 14-APR-2014 from a multi-dose vial. A PQC was filed. Because of this problem, the patient missed a dose. No AE symptoms were reported. Additional information has been requested.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 74 year old patient. Medical history and concurrent conditions were not reported. On 16-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16 MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 18-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J000433 exp: 10-APR-2014 (dose and route not provided). On 18-APR-2014, the patient received an expired dose of ZOSTAVAX. The outcome of the patient received an expired dose of ZOSTAVAX was unknown. Additional information has been requested.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 78 year old patient. Medical history and concurrent conditions were not reported. On 13-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J009689; expiration date: 29-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Bursa injury, Injected limb mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Vaccination site pain
Clinical narrative: Initial case received from a consumer, who is also the patient, on 15 April 2014. A 68-year-old female patient, with a history of Crohn's disease and allergies to sulfa and morphine, received an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U4759AA) on 21 October 2013. At the time of vaccination, she experienced pain at the vaccination site. Approximately one week later, on 28 October 2013, her left arm pain became worse, described as "variable from a 6 to 9 with 1 being the lowest on the scale". The patient stated that the pain radiated down to her wrist, and that she had limited range of motion (ROM) in her left arm. She underwent an MRI, which showed that the "bursa is affected". The patient had been seen by her primary physician and a shoulder specialist on three occasions, and had undergone therapy. According to the patient, she was now looking at possible shoulder surgery. At the time of the report, the events were ongoing. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Chills, Decreased appetite, Dizziness, Influenza virus test negative, Nausea
Clinical narrative: Pt had immuns 3/17/14 in PM. By evening started having dizziness, body aches, chills, nausea, no appetite. Went to ER that evening (3/17/14). Strep and influenza negative. Pt came in for ER follow up with Dr. on 3/19/14.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pain, Streptococcus test negative
Clinical narrative: Pt had immuns 3/17/14 in PM. By evening started having dizziness, body aches, chills, nausea, no appetite. Went to ER that evening (3/17/14). Strep and influenza negative. Pt came in for ER follow up with Dr. on 3/19/14.
Age: 25.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Underdose
Clinical narrative: Pediatric HepA dose given to adult. Patient and doctor notified.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Underdose
Clinical narrative: Pediatric dose of HepA was given to adult. Pt and Dr. notified.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a medical assistant via company representative who reported an anonymous female patient (unspecified age) experienced unspecified adverse reactions on an unspecified date after receiving all three shots of GARDASIL (start dates of administration were not reported). It was unspecified if the patient received treatment, sought medical treatment and/or had any laboratory diagnostic tests performed for the adverse reactions to GARDASIL. The outcome of the adverse reactions to GARDASIL and action taken were not provided. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Underdose
Clinical narrative: Pediatric Hep A dose given to adult. Patient and doctor notified.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dyspnoea, Erythema, Influenza, Mouth haemorrhage
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 80 year old male patient. On 10-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J007858, Exp date: 14-JUN-2014), 0.65 ml once, subcutaneously in the left deltoid for shingles prevention by another pharmacist. The pharmacist reported that on 12-JAN-2014, patient developed a rash a "few days after vaccination". Pharmacist stated patient visited unspecified physician about the rash the patient developed; physician diagnosed rash as shingles. Pharmacist stated patient was ordered VALTREX after shingles diagnosis. Pharmacist stated she learned about this incident "third hand" but pulled up some pharmacy records while on phone. Pharmacist stated patient was not yet fully recovered as patient was recently prescribed NEURONTIN. The patient had not recovered from the event. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Pain, Rash macular, Skin discolouration, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 80 year old male patient. On 10-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J007858, Exp date: 14-JUN-2014), 0.65 ml once, subcutaneously in the left deltoid for shingles prevention by another pharmacist. The pharmacist reported that on 12-JAN-2014, patient developed a rash a "few days after vaccination". Pharmacist stated patient visited unspecified physician about the rash the patient developed; physician diagnosed rash as shingles. Pharmacist stated patient was ordered VALTREX after shingles diagnosis. Pharmacist stated she learned about this incident "third hand" but pulled up some pharmacy records while on phone. Pharmacist stated patient was not yet fully recovered as patient was recently prescribed NEURONTIN. The patient had not recovered from the event. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 80 year old male patient. On 10-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J007858, Exp date: 14-JUN-2014), 0.65 ml once, subcutaneously in the left deltoid for shingles prevention by another pharmacist. The pharmacist reported that on 12-JAN-2014, patient developed a rash a "few days after vaccination". Pharmacist stated patient visited unspecified physician about the rash the patient developed; physician diagnosed rash as shingles. Pharmacist stated patient was ordered VALTREX after shingles diagnosis. Pharmacist stated she learned about this incident "third hand" but pulled up some pharmacy records while on phone. Pharmacist stated patient was not yet fully recovered as patient was recently prescribed NEURONTIN. The patient had not recovered from the event. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 80 year old male patient. On 10-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J007858, Exp date: 14-JUN-2014), 0.65 ml once, subcutaneously in the left deltoid for shingles prevention by another pharmacist. The pharmacist reported that on 12-JAN-2014, patient developed a rash a "few days after vaccination". Pharmacist stated patient visited unspecified physician about the rash the patient developed; physician diagnosed rash as shingles. Pharmacist stated patient was ordered VALTREX after shingles diagnosis. Pharmacist stated she learned about this incident "third hand" but pulled up some pharmacy records while on phone. Pharmacist stated patient was not yet fully recovered as patient was recently prescribed NEURONTIN. The patient had not recovered from the event. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old patient. On 29-MAR-2014 the patient was vaccinated with ZOSTAVAX lot # J013451, expiry date 24-JAN-2015 (dose, frequency unknown) subcutaneously by the reporting pharmacist when plunger of syringe malfunctioned causing less than full dose of ZOSTAVAX to be administered to patient. No adverse effects reported for patient. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old patient. On 29-MAR-2014 the patient was vaccinated with ZOSTAVAX lot # J013451, expiry date 24-JAN-2015 (dose, frequency unknown) subcutaneously by the reporting pharmacist when plunger of syringe malfunctioned causing less than full dose of ZOSTAVAX to be administered to patient. No adverse effects reported for patient. This is one of several reports from the same source. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: C-reactive protein, C-reactive protein increased, Chest X-ray normal, Dyspnoea, Monocyte count increased
Clinical narrative: This is a follow-up to a previously submitted VAERS report 527631-1. 22 y/o male who on 23 MAR 2014 received his primary smallpox vaccine (left arm), along with AVA (1) and typhoid vaccines (right arm). He reports normal site progression of his smallpox site and no local site reactions at his other vaccination sites. On 3 APR, around 2100, patient noted the onset of constant, sharp chest pain along his left sternal border. Initially the pain was rated at an intensity level of 2/10, using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). Within 2 hours, the chest pain intensified to a level 10/10 and was accompanied by shortness of breath and his heart was "beating hard". He denies nausea, vomiting, diaphoresis, and pedal edema. He noted the pain increased with deep breaths and when lying flat. He was most comfortable sitting straight up or standing. The pain did not radiate. Patient sought evaluation late evening of 3 APR at his local ER. He was told that he had an abnormal ECG and lab work, so he was transferred and admitted to another hospital. While admitted, he had an echocardiogram and coronary angiography, which patient reports were both normal. Patient does not recall when his chest pain resolved, but it was sometime after his cardiac cath. He has not experienced any recurrence of chest pain since his discharge on 6 APR. He was discharged on colchicine 0.4 mg twice daily and Metoprolol 25 mg daily and on an activity restriction x 3-6 months - "No strenuous activity". At time of discharge, patient was asymptomatic. Patient was seen as an outpatient at Cardiologist on 22 APR. He denies having lab work, echocardiogram, or an exercise stress test completed, but says he is to return for Cardiology appointment in JUN, which will include another echocardiogram. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for a family history of CAD. (Father had an MI in his 40s). Denies history of previous adverse events following immunizations. PMH: Negative. No history of eczema, allergies, or asthma. No history of chronic illnesses. No prior hospitalizations. No surgeries. Family Hx: Mother - 51 years old, history of breast cancer with treatment a few years ago. Father - 53 years old, history of CAD, with MI in his 40s. HTN. 1/2 Sister - age 27, in good health. No family hx of drownings, seizures, unexplained MVAs, and sudden death. Social Hx: Single. Tobacco - None. Alcohol - drinks 12-pack during the weekend. Exercise - Not sedentary. Performed routine group PT prior to recent hospitalization. Allergies: Denies allergies to medications, food, latex, and insect stings. ROS: Review of 13 systems. All systems negative, with the exceptions described in HPI.