chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a 73-year-old female patient regarding herself. Current conditions included thimerosal allergy. Approximately on an unknown date in February 2003 (reported as 10 years ago) the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot#, expiration date and route not reported). Upon receiving pneumococcal vaccine polyvalent (23-valent) (manufacturer unknown), approximately on an unknown date in February 2003 she had a severe drug reaction and interaction due to thimerosal and preservatives contained within the vaccine. The patient had flu-like symptoms fever, vomiting and extreme fatigue. She went to physician and was given antibiotics. Patient fully recovered from the events after several weeks. It was unspecified whether lab diagnostic studies were performed. The patient sought medical attention by office visit. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 22-MAR-2011, patient was vaccinated with dose 1, GARDASIL (lot #, expiration date and route not reported). On 29-NOV-2012 the patient was vaccinated with dose 2, GARDASIL (lot #, expiration date and route not reported). On 12-FEB-2013 the patient was vaccinated with dose 3, GARDASIL (lot #, expiration date and route not reported). No adverse effect. No other information provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a fourth dose of GARDASIL (lot number, expiry date, dose and route unspecified). The patient received a fourth dose of GARDASIL because the GARDASIL series was restarted due to a 3 year delay after the first dose. No concomitant medications were reported. On an unknown date, the patient developed neck stiffness after receiving the fourth dose of GARDASIL. On an unknown date, the patient recovered and was not hospitalized. The relatedness for neck stiffness was unknown for GARDASIL. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Erythema, Oedema peripheral, Pyrexia, Skin reaction
Clinical narrative: Left arm red swollen warm to touch, pain in axillary, fever. No treatment.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Left arm red swollen warm to touch, pain in axillary, fever. No treatment.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 08-FEB-2013, the patient was vaccinated with a dose of VARIVAX (merck), (lot number, expiry date and route was not reported) instead of ZOSTAVAX. No adverse event was reported. The nurse felt that the medication error was due to product confusion between VARIVAX (merck) and ZOSTAVAX and provided that the two names were similar, they both and in VAX and they were kept side by side in the freezer and it was easy to get them mixed up. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to a female patient of unknown age. No medical history or concurrent conditions were reported. On 14-FEB-2013 the patient was vaccinated with VARIVAX (merck), 0.5 ml, intramuscular. Lot number was reported as 1700Z with an expiration date of 09-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was administered with an expired dose of VARIVAX (merck) on 14-FEB-2013. No adverse effects were reported. Additional information was not provided. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician concerning two patients of 3 month old (gender unspecified). On 14-FEB-2013, the patients were vaccinated with a dose of VAQTA (lot number, expiry date, dose and route unspecified), 25/0.5 units per milliliter U/ML) instead of RECOMBIVAX HB (reported as RECOMBIVAX (lot number, expiry date, dose and route unspecified). No adverse symptoms were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash pruritic
Clinical narrative: This spontaneous report as received from a company representative via registered nurse, refers to a 70 year old female patient. Concomitant medication and medical history was not provided. On an unspecified date 1 to 2 years ago the patient was vaccinated with live ZOSTAVAX. On an unknown date the patient experienced shingles. It began with spots above her eyes that hurt and itched. Her physician was contacted and antiviral solution was prescribed. The outcome of shingles was mot reported. The relatedness for shingles was not reported for live ZOSTAVAX. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 65 year old male patient with no drug allergies. On 15-FEB-2013 the patient was vaccinated with a dose of 0.65 mL live ZOSTAVAX (Lot# reported as H020844, Exp: 20-FEB-2014) subcutaneous in the right arm. The pharmacist mentioned the patient received live ZOSTAVAX and on 16-FEB-2013 experienced injection site reactions of redness that is 4x5 inches in diameter, warm to the touch, pain at the injection site that was radiating to a good part of the upper arm, painful when area around injection site was touched or scratched (sensitive to the touch). The patient also had a rash on the shoulder of the right arm. The patient sought medical attention by visiting the pharmacist. No treatment was given and no lab diagnostics were performed. At the time of reporting, the patient was not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. Approximately on an unknown date in February 2010 (reported as approximately 2 or 3 years ago), the patient was vaccinated with dose 1 GARDASIL (lot #, expiration date and route not reported). The nurse reported that the patient was in office on 21-FEB-2013 (reported as 'now') to receive dose 2 GARDASIL (lot #, expiration date and route not reported) which would be late. Dose 1 was administered by a different unspecified provider. No symptoms reported. No other details. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Tongue discolouration, Tongue disorder
Clinical narrative: This spontaneous report as received from an individual who worked at a pharmacy but was not a pharmacy technician or a health care professional refers to a female patient of unknown age with no medical history On 12-FEB-2013 the patient was vaccinated with live ZOSTAVAX (lot# was not reported). There was no concomitant medications. The reporter reported that the patient had" white bumps on the back part of tongue that appeared between the time the vaccine was administered and now." The patient called the pharmacy for medical attention. The outcome of the adverse event was reported as not recovered/not resolved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: After receiving injection pt states very sore, then after some time started to swell and became very tender. Is still swollen, red tender measured around arm 43cm left where inj was given right is 36 1/2 cm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Oedema, Pain
Clinical narrative: Large local reaction - redness, edema, pain.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt rec'd PNEUMOVAX on 1-17-13. She developed diffuse redness & swelling on (L) arm at immunization site on 1-19-13. Redness/swelling extended from (L) deltoid down to (L) elbow & lasted x 4 days, according to patient. Patient seen in office on 1-25-13 and sx resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: 10 x 10 cm well demarcated lesion left upper arm with central circular lesion 3 cm diameter warm to touch. Treated with.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt called Sunday am stating that had baseball sized raised red, hot, itchy area where ZOSTAVAX was administered on 2-16-13.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Arm hurt, itching, arm warm, dizzy, weak.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Redness, sore, painful to lift of left arm. PNEUMOVAX given in left deltoid. Patient given prednisone 20 mg 2 tabs x 4day's 1 tab x 4 days. KEFLEX 500 mg TID x 7 days.
Age: 23.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram repolarisation abnormality, Headache, Injection site reaction, Local reaction
Clinical narrative: This study case was received on 13 February 2013 from the investigator in a trial. A 23-year-old male subject, with no relevant past medical history, developed an elevated rapid Troponin result, seven days after he received the following vaccines: a left arm injection of ACAM2000, SP Biologics Co., (lot number, route not reported) and TYPHOID VACCINE, manufacturer unknown, (lot number, route, site and side not reported) on 05 February 2013. Seven days post vaccination, on 12 February 2013, the subject had an elevated rapid Troponin I result reported as not within normal limits (Positive) and an extra tube was drawn for Troponin I laboratory testing. The subject also reported worsening headaches and local site symptoms, but denied all cardiopulmonary symptoms. On 12 February 2013, an electrocardiogram (ECG) was reported as sinus rhythm with sinus arrhythmia, ST elevation probably early repolarization, borderline ECG. According to investigator, ECG appeared normal by preliminary reading. The subject was referred for care due to suspicion for myopericarditis. According the investigator, the elevated rapid Troponin level was mild severity. Concomitant medications were not reported. The subject did not take any medications to treat the adverse event. The subject's outcome was reported as not recovered (not resolved, still present and being treated). According to the investigator, the event of elevated Troponin was considered an other important event and probably related to the trial product. This represents a case of potential myopericarditis per the investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: Medical Records.
Age: 23.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Myopericarditis, Sinus arrhythmia, Troponin I increased
Clinical narrative: This study case was received on 13 February 2013 from the investigator in a trial. A 23-year-old male subject, with no relevant past medical history, developed an elevated rapid Troponin result, seven days after he received the following vaccines: a left arm injection of ACAM2000, SP Biologics Co., (lot number, route not reported) and TYPHOID VACCINE, manufacturer unknown, (lot number, route, site and side not reported) on 05 February 2013. Seven days post vaccination, on 12 February 2013, the subject had an elevated rapid Troponin I result reported as not within normal limits (Positive) and an extra tube was drawn for Troponin I laboratory testing. The subject also reported worsening headaches and local site symptoms, but denied all cardiopulmonary symptoms. On 12 February 2013, an electrocardiogram (ECG) was reported as sinus rhythm with sinus arrhythmia, ST elevation probably early repolarization, borderline ECG. According to investigator, ECG appeared normal by preliminary reading. The subject was referred for care due to suspicion for myopericarditis. According the investigator, the elevated rapid Troponin level was mild severity. Concomitant medications were not reported. The subject did not take any medications to treat the adverse event. The subject's outcome was reported as not recovered (not resolved, still present and being treated). According to the investigator, the event of elevated Troponin was considered an other important event and probably related to the trial product. This represents a case of potential myopericarditis per the investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: Medical Records.
Age: 24.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Pharyngeal oedema, Tachycardia, Urticaria
Clinical narrative: Urticaria, throat swelling and tachycardia requiring treatment with BENADRYL, SOLUMEDROL and epinephrine. Transferred to ER; monitored; discharged to home.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Pt received PNEUMOVAX & flu vaccine in (R) deltoid. Developed redness, swelling and itching later that night.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Dysphagia, Feeling cold, Feeling hot, Nervousness
Clinical narrative: Patient complains of feeling shaky - not feeling herself - getting hot and then chilled. Very dry mouth with trouble swallowing.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Pain, Pruritus, Swelling
Clinical narrative: On 2-18-13 Patient had achiness on left arm with flu like symptoms in the evening on 2-19-13 in the am had redness and swelling 8"x 4" and itchiness. Took CLARITIN 2-19-13 saw MD on 2-20-13.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Paraesthesia
Clinical narrative: Pain (R) shoulder. Paresthesia (L) foot.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TD
Symptoms: Electrocardiogram normal, Headache, Muscle tightness, Troponin increased
Clinical narrative: This study case was received from the investigator on 13 February 2013. A male subject (birth date not reported) had received the ACAM2000 (lot number, route, and site of administration not reported) on 29 January 2013. The subject had also received the following vaccinations on 29 January 2013: anthrax vaccine (manufacturer, lot number, route and site not reported) and tetanus/diphtheria vaccine (manufacturer, lot number, route and site not reported). On 08 February 2013, 10 days post vaccination, the subject with benign past medical history was noted to have lab troponin = 0.26 ng/mL (rapid troponin normal). The subject denied any cardiac symptoms. The subject reported headache and "neck tension" for which he took TYLENOL 325 milligrams orally as needed. On 11 February 2013, the lab troponin was < 0.10 ng/mL. The electrocardiogram from 11 February 2013 was normal. The subject was referred for care but was unable to be reached for further information on care received. The subject's outcome was reported as recovered on 11 February 2013. According to the investigator, the event of elevated troponin was considered probably related to vaccination. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: none.
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal
Clinical narrative: This study case was received from the investigator in the trial on 15 January 2013, and follow-up was received on 13 February 2013. A female subject (birth date not reported, age 20 years old on electrocardiogram) had received on 03 January 2013 ACAM2000 (lot number, and route not reported) in the right arm and an anthrax vaccine (manufacturer, lot number, route and site not reported). The subject had negative past medical history. On 07 January 2013 the subject reported mild ongoing chest pressure and shortness of breath with onset 2 and 5 days post ACAM2000 vaccine, respectively. She was referred to her primary care physician for care. Possible myopericarditis was considered. An ECG completed on 11 January 2013 was normal and it was less suspicious for myopericarditis, but there were no Troponin results and it could not be excluded as a diagnosis. No other adverse events were reported. The subject's outcome was reported as not recovered on 14 February 2013. According to the investigator, the event of possible myopericarditis was considered possibly related to vaccination. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: In day following administration developed redness and pain near site. Treating with cool compress right arm. 10 x 13.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Emp states she started itching on wrists, arms, chest, stomach and back a few hours after receiving her 2nd Hep B vaccine (Received 1st Hep B vaccine 14 yrs ago, does not remember having a rxn). Seen in ED, prescribed BENADRYL, ATARAX & prednisone.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Carditis, Echocardiogram normal, Electrocardiogram abnormal, Nuclear magnetic resonance imaging thoracic normal, Pericarditis
Clinical narrative: This study case was received from the investigator in a trial on 18 February 2013. A 24-year-old male subject had received ACAM2000 on 06 December 2012 and 18 days later he was diagnosed with acute idiopathic pericarditis. At 20 days post vaccination, he was diagnosed with Other, carditis. On 21 December 2012, ECG results were abnormal. On 22 December 2012, troponin I results were abnormal (3.07 ng/mL) and echocardiogram was normal. On 26 December 2012, an MRI of the heart was normal. Lumbar puncture (spinal tap) and MRI of the brain and spinal cord were not performed. The subject previously received an injection of the following vaccines on 27 November 2012: TYPHIM VI (ViCPs), Anthrax 1 (other manufacturer), and Influenza seasonal (manufacturer unknown) (lot numbers, routes and sites of administration not reported). The subject has no significant medical history. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 18 February 2013. A 24-year-old male subject had received ACAM2000 on 06 December 2012 and 18 days later he was diagnosed with acute idiopathic pericarditis. At 20 days post vaccination, he was diagnosed with Other, carditis. On 21 December 2012, ECG results were abnormal. On 22 December 2012, troponin I results were abnormal (3.07 ng/mL) and echocardiogram was normal. On 26 December 2012, an MRI of the heart was normal. Lumbar puncture (spinal tap) and MRI of the brain and spinal cord were not performed. The subject previously received an injection of the following vaccines on 27 November 2012: TYPHIM VI (ViCPs), Anthrax 1 (other manufacturer), and Influenza seasonal (manufacturer unknown) (lot numbers, routes and sites of administration not reported). The subject has no significant medical history. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of live ZOSTAVAX and live (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the live ZOSTAVAX and live (Merck) VARIVAX were stored in the freezer. There were 9 patients who received live ZOSTAVAX. On 07-FEB-2013, one of the them was vaccinated with a dose of live ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported).No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. Pharmacist mentioned a shipment of live ZOSTAVAX and live (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the live ZOSTAVAX and live (Merck) VARIVAX were stored in the freezer. There were 9 patients who received live ZOSTAVAX. On 12-FEB-2013, two of the them were vaccinated with a dose of live ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported).No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Rapid heartbeat, pounding heart beat.
Age: 52.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site rash, Nausea, Oedema peripheral
Clinical narrative: Swollen arm, red rash from my left shoulder to my elbow, fever and chills, hives on my face, nausea.
Age: 52.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Swollen arm, red rash from my left shoulder to my elbow, fever and chills, hives on my face, nausea.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt. was dizzy, passed out.
Sex: F
Vaccine: TD
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: Initial report was received on 12 February 2013 from a health care professional. An elderly female patient had received TENIVAC, lot number U4068AA (route, site and date of administration not reported) and an unspecified amount of time later, experienced muscle weakness and inability to bend arm or lift arm across shoulder. At the time of the report the events had been ongoing for a month. The patient's outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of live ZOSTAVAX and live (Merck) VARIVAX were received with a 4 days shipping tome period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the live ZOSTAVAX and live (Merck) VARIVAX were stored in the freezer. There were 9 patients who received live ZOSTAVAX. On 30-JAN-2013, one of the them was vaccinated with a dose of live ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported).No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of live ZOSTAVAX and live (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the live ZOSTAVAX and live (Merck) VARIVAX were stored in the freezer. There were 9 patients who received live ZOSTAVAX. On 02-FEB-2013, one of the them was vaccinated with live ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported).No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, Mumps antibody test negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 19 year old female patient with no pertinent medical history and no drug reactions or allergies. On an unknown date, as a child, the patient was vaccinated with "lot number reported as 0008AA, expiry date 18-DEC-2012", M-M-R II. No lot numbers, dates, dose or route were available for the vaccine doses received in childhood. In 2013 (reported as recently), the patient had a negative titer for mumps (mumps failure to seroconvert). On 15-FEB-2013, the patient was vaccinated with an expired dose of live M-M-R II (lot number 0008AA, expiry date 18-DEC-2012 not verified), 0.5 ml, subcutaneous. No adverse event was associated with the administration of the expired vaccine. The outcome of recently had a negative titer fir mumps (mumps failure to seroconvert) is unknown. It is unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of live ZOSTAVAX and live (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the live ZOSTAVAX and live (Merck) VARIVAX were stored in the freezer. There were 9 patients who received live ZOSTAVAX and on 25-JAN-2013, one patient a dose of live (Merck) VARIVAX lot # H016715, Expire date: 07-SEP-2014 (route and dose not reported). No concomitant medications were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 75 year old male patient. The patient's medical history included double bypass surgery prior to vaccination and removal of impacted tooth. No allergies were reported. In summer 2007 the patient was vaccinated with a single dose of live ZOSTAVAX, 0.65 ml, subcutaneously (dose # and lot # not reported). No laboratory diagnostic studies were performed. In 2008 the patient had a shingles outbreak. On an unspecified date the patient recovered from shingles outbreak. The patient sought medical attention. No other adverse event information was reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of live ZOSTAVAX and live (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the live ZOSTAVAX and live (Merck) VARIVAX were stored in the freezer. There were 9 patients who received live ZOSTAVAX. On 19-FEB-2013, one of the them was vaccinated with a dose of live ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported).No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of ZOSTAVAX and (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the ZOSTAVAX and (Merck) VARIVAX were stored in the freezer. There were 9 patients who received ZOSTAVAX. On 25-JAN-2013, one of the them was vaccinated with a dose of ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported). No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site anaesthesia, Injection site pain, Injection site reaction, Pain
Clinical narrative: Pain, tingling and numbness in left arm where vaccine was administered; pain has worsened considerably over past three months; difficulty raising and using arm without excrutiating pain.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia, X-ray limb normal
Clinical narrative: Pain, tingling and numbness in left arm where vaccine was administered; pain has worsened considerably over past three months; difficulty raising and using arm without excrutiating pain.
Age: 0.95
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Cough, Lacrimation increased, Lymphocyte percentage increased, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, maximum 104.2.  Patient also had cough, congestion, sneezing, and watery eyes.  The fever lasted 3 days.
Age: 0.95
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Sneezing, Streptococcus test negative, White blood cell count normal
Clinical narrative: Fever, maximum 104.2.  Patient also had cough, congestion, sneezing, and watery eyes.  The fever lasted 3 days.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema mouth, Pruritus, Throat irritation, Urticaria
Clinical narrative: Red hives on forehead, behind both ears, itching to face and neck, "throat clearing," (possible itching in throat but pt denied itching) gave 50mg of Benadryl at 4:15PM. Pt continued to have itching on face and neck progressing to back of neck, redness, hives, and slight swelling around mouth and hives in right armpit continuing down upper right arm. 0.30mg of Epi was given in Right deltiod at 4:36PM. Itching, redness, and hives started to disappear at 4:42PM. By 4:57PM hives, redness, itching, and "throat clearing" all disappeared. Pt discharged from clinic at 5:00PM and was given Claritin 10mg and Prednisone 50mg.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of ZOSTAVAX and (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the ZOSTAVAX and (Merck) VARIVAX were stored in the freezer. There were 9 patients who received ZOSTAVAX. On 11-FEB-2013, one of them was vaccinated with a dose of ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported). No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Cough
Clinical narrative: Initial information has been received from physician via field representative concerning a 2 months old male patient with an unspecified pertinent medical history or drug reactions / allergies. On an unknown date, the patient was vaccinated with ROTATEQ (lot number 0577AE exp date October 2013) (dose, frequency and route were not reported). No other co-suspect medications were reported. No concomitant medications were reported. On 11-FEB-2013 the patient was having persistent coughing. No treatment was reported. No laboratory studies were reported. At the time of report, the patient had not recovered. The patient sought medical attention by telephone contact. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of ZOSTAVAX and VARIVAX (Merck) were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the ZOSTAVAX and VARIVAX (Merck) were stored in the freezer. There were 9 patients who received ZOSTAVAX. On 06-FEB-2013, one of them was vaccinated with ZOSTAVAX lot # H019040, Expire date:17-JAN-2014 (route and dose not reported). No concomitant Medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Initial information has been received from physician via field representative concerning a 2 months old male patient with an unspecified pertinent medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with oral ROTATEQ (lot number 0577AE exp date October 2013 (dose, frequency and route were not reported). No other co-suspect medications were reported. No concomitant medications were reported. On 11-FEB-2013 the patient experienced vomiting. No treatment was reported. No laboratory studies were reported. At the time of report, the patient had not recovered. The patient sought medical attention by telephone contact. This is one of several reports from the same source. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Initial information has been received from physician via field representative concerning a 2 months old male patient with an unspecified pertinent medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with oral ROTATEQ (lot number 0577AE exp date October 2013) (dose, frequency and route were not reported). No other co-suspect medications were reported. No concomitant medications were reported. On 11-FEB-2013 the patient experienced vomiting. No treatment was reported. No laboratory studies were reported. At the time of report, the patient had not recovered. The patient sought medical attention by telephone contact. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received call from mother on 02-19-2013 who stated child had reddened warm area on leg who shot was given, spoke w/father on leg who shot was given, spoke w/father on 02-20-13 who stated rt Leg is still reddened and swollen but swelling is decreased. No answer at home on 02-25-13, spoke with grandmother 02-26-13 (at above number) who stated "child is allergic to vaccine-area size of quarter at present no MD visit site improved per grandmother.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Tenderness
Clinical narrative: Post zoster vaccination high skin sensitivity from right side of spine following to right side of breast.  Could be painful with slightest touch.  No visual skin changes.  Lasted 4 weeks.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Vaccination site swelling
Clinical narrative: Swelling of arm vaccination was given on (from vaccination site down to hand).
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal product of conception, Foetal death, Foetal disorder, Foetal hypokinesia, Maternal exposure during pregnancy
Clinical narrative: On 1/25/13, patient felt decreased fetal movement. By ~1/27 she was no longer feeling the baby move. Seen in clinic with IUFD on 1/30. Pathology showed trisomy 12 consistent with dysmorphic fetus at the time of delivery. Pt continued to believe it was related to TDaP and asked that the event be reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Swelling at injection site with painful rash and itching.  Use of Benadryl cream temporary relief.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Local reaction
Clinical narrative: 4CM LOCAL REACTION TO MENVEO LAST WEEK.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Dizziness, rapid heart rate, weakness, labored breathing and headache.
Age: 39.0
Sex: M
Vaccine: FLUN3, MMR, TDAP
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Lumbar stiffness and pain, sore knees joints, arthritis-like pain in joints below waist and arms, fingers.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Computerised tomogram head abnormal, Crying, Dizziness, Electrocardiogram normal
Clinical narrative: Began feeling tightness of eyes, drowsiness and head swimming. Laid head down on desk and became unresponsive. Could hear co-workers around her, but could not move or speak. Incontrollable sobbing alerted co-workers who tried to obtain response. Taken to ER. Continued intermittent inability to speak or move or grasp. Hands and arms tingled and cold. Legs shaking uncontrollably. Some nausea, but no vomiting. Labs WNL, MRI unremarkable, EKG unremarkable.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Eye disorder, Grip strength decreased, Hypokinesia, Laboratory test normal, Nausea
Clinical narrative: Began feeling tightness of eyes, drowsiness and head swimming. Laid head down on desk and became unresponsive. Could hear co-workers around her, but could not move or speak. Incontrollable sobbing alerted co-workers who tried to obtain response. Taken to ER. Continued intermittent inability to speak or move or grasp. Hands and arms tingled and cold. Legs shaking uncontrollably. Some nausea, but no vomiting. Labs WNL, MRI unremarkable, EKG unremarkable.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Paraesthesia, Peripheral coldness, Somnolence, Tremor
Clinical narrative: Began feeling tightness of eyes, drowsiness and head swimming. Laid head down on desk and became unresponsive. Could hear co-workers around her, but could not move or speak. Incontrollable sobbing alerted co-workers who tried to obtain response. Taken to ER. Continued intermittent inability to speak or move or grasp. Hands and arms tingled and cold. Legs shaking uncontrollably. Some nausea, but no vomiting. Labs WNL, MRI unremarkable, EKG unremarkable.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Unresponsive to stimuli, Urine analysis normal
Clinical narrative: Began feeling tightness of eyes, drowsiness and head swimming. Laid head down on desk and became unresponsive. Could hear co-workers around her, but could not move or speak. Incontrollable sobbing alerted co-workers who tried to obtain response. Taken to ER. Continued intermittent inability to speak or move or grasp. Hands and arms tingled and cold. Legs shaking uncontrollably. Some nausea, but no vomiting. Labs WNL, MRI unremarkable, EKG unremarkable.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema of eyelid, Eye irritation, Eye pain, Eyelid oedema, Eyelid pain
Clinical narrative: Woke up next day with swollen, red and aching eyelids. Eyes were burning and painful.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture normal, Muscular weakness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Tingling in legs, progressed to weakness, hospitalized and treated for Guillain Barre Syndrome at Hospital (treated with IVIG).  Still has intermittent weakness in the lower extremities.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal cord normal, Paraesthesia
Clinical narrative: Tingling in legs, progressed to weakness, hospitalized and treated for Guillain Barre Syndrome at Hospital (treated with IVIG).  Still has intermittent weakness in the lower extremities.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Gait disturbance, Muscular weakness, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain
Clinical narrative: Began to develop hives on arms, then face and trunk. Eventually covered most of body in hives and rash. Over course of the next few days developed weakness in legs with some difficulty walking with pain.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Began to develop hives on arms, then face and trunk. Eventually covered most of body in hives and rash. Over course of the next few days developed weakness in legs with some difficulty walking with pain.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Influenza like illness, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: On the side of the vaccination administration developed pain in arm - from elbow up in to the neck and also right side of chest. Lymph nodes were enalarged and palpable - extremely painful. Remained enlarge for 10 day. Developed aches and flu like symptoms.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: On the side of the vaccination administration developed pain in arm - from elbow up in to the neck and also right side of chest. Lymph nodes were enalarged and palpable - extremely painful. Remained enlarge for 10 day. Developed aches and flu like symptoms.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Erythema, Lethargy, Local reaction, Pyrexia, Rash
Clinical narrative: Local rash, local redness and fever, lethargic.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: On 2-21-13, patient discovered a warm raised, 1-1/2 inch diameter red lump at the injection site without pain. She reported it to the phcy 2-22-13 (unchanged). Pt went to MD on 2-26-13-appears to be healing. No treatment required.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain, Pruritus, Pyrexia
Clinical narrative: Red, swollen, hot, itchy, painful, feverish, sore, extremely tired Monday night and today. Antibiotics: cephalexin, hydroxyzine tablets.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Red, swollen, hot, itchy, painful, feverish, sore, extremely tired Monday night and today. Antibiotics: cephalexin, hydroxyzine tablets.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site ulcer
Clinical narrative: This spontaneous report as received from a health worker refers to a 59 year old female patient with allergy to tetracycline. On 18-FEB-2013, the patient was vaccinated with ZOSTAVAX 1 vial for via intramuscular route instead of subcutaneous route (lot # H019034, expiration date: 17-JAN-2014). In February 2013, the patient developed an ulcer at the injection site after receiving a dose of ZOSTAVAX. The patient sought medical attention in the hospital. On 21-FEB-2013(approximately) the patient was admitted at the hospital. The patient outcome was not provided. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site ulcer
Clinical narrative: This spontaneous report as received from a health worker refers to a 59 year old female patient with allergy to tetracycline. On 18-FEB-2013, the patient was vaccinated with ZOSTAVAX 1 vial for via intramuscular route instead of subcutaneous route (lot # H019034, expiration date: 17-JAN-2014). In February 2013, the patient developed an ulcer at the injection site after receiving a dose of ZOSTAVAX. The patient sought medical attention in the hospital. On 21-FEB-2013(approximately) the patient was admitted at the hospital. The patient outcome was not provided. Additional information has been requested.
Age: 1.13
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Blister, Cough, Pyrexia, Rash, Rash vesicular
Clinical narrative: 1-2 days after MMRV, pt. had vesicular rash on face, trunk and extremities. 3 days after had fever 39-40 C, cough, and congestion. Bacitracin for vesicles that ruptured. Ibuprofen PRN fever.
Age: 1.13
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Respiratory tract congestion, Varicella virus test negative
Clinical narrative: 1-2 days after MMRV, pt. had vesicular rash on face, trunk and extremities. 3 days after had fever 39-40 C, cough, and congestion. Bacitracin for vesicles that ruptured. Ibuprofen PRN fever.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient noted redness, pruritus and pain at injection site (L) deltoid at site of injection. Sought care 2/13 Rx: Ibuprofen, diphenhydramine PO PM 1% hydrocortisone topical cream, f/u prn.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Injected limb mobility decreased, Injection site pain, Rotator cuff syndrome
Clinical narrative: Pain after injection that persisted for weeks & limited mobility that needed Dr.'s visit & Emergency Room. Patient was finally diagnosed with torn rotator cuff & given steroids. Pain is still there.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: At site of injection - red and raised and rash around injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a currently 66 year old female patient with none Pertinent Medical History or Drug Reactions/allergies. On 21-FEB-2013, the patient was vaccinated intramuscularly (IM) with a 0.5 ml once dose of PNEUMOVAX 23 lot # H013847, expire date: 15-MAR-2014. Concomitant therapies included FOSAMAX, AMBIEN, CELEBREX, warfarin and ZOCOR. The Registered Nurse was reporting that a patient developed redness and swelling at the injection site along with nausea (onset date: 21-FEB-2013). Patient's outcome reported as recovering. The patient sought Medical Attention by calling the nurse. No lab tests were performed. No treatment was given. Causality assessment was not reported. Additional information has been requested.