chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a co-worker of the pharmacist of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified) (dose, route location unspecified). The reporter stated that on an unspecified date, a co-worker of the pharmacist developed shingles after receiving the (ZOSTAVAX) and "lost a few weeks of work" due to the shingles. She also reported that the pharmacist informed that this case was already reported to the Food and Drug Administration (FDA). At the time of report, the outcome of the event was not provided. Upon internal review, event was considered as disability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Local swelling, Rotator cuff syndrome
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. About five years ago, in approximately November 2008 the patient was vaccinated with first 0.5 ml dose of PNEUMOVAX23 (route and lot number unspecified). On 28-OCT-2013, the patient was received the second 0.5 ml dose of PNEUMOVAX23 (lot number unspecified) in the deltoid region in the arm. The pharmacist stated that immediately after the dose was administered, on 28-OCT-2013, the patients arm was swollen and immobilized. The patient was seen in an unspecified walk in clinic and was diagnosed with rotator cuff tendonitis. The patient was to follow up with an orthopedist, but it was unknown if she had. The patient's arm was no longer immobilized, but the shoulder was swollen and had decreased function. The patient reported no injury or previous problems with her rotator cuff. No treatment was given for the events. At the time of the report, the patient was recovering from the events. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Healthcare Worker refers to a 17 year old female patient. On 15-OCT-2013 the patient received a urine pregnancy test which was negative for pregnancy. After the test, the patient received vaccinated with GARDASIL (lot # J002641, intramuscular, exp 10-DEC-2013) that day. There was none concomitant medication and none medical history. The patient had none drug reactions. On an unspecified date "about 2 weeks later", the patient had another urine pregnancy test which was positive for pregnancy. The EDD was 18-JUN-2014. Initial exposure to GARDASIL was at 5 week(s). The pregnancy outcome was outcome pending. The patient went to see the nurse practitioner. No known adverse effects. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 01-NOV-2013, the patient received an expired dose of MMR II (lot # 671103/1025AA, expiry: 30-JUN-2013). No adverse effect reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Chills, Echocardiogram, Electrocardiogram change, Pyrexia
Clinical narrative: This study case was received from the investigator in a trial on 06 November 2013. A 19 year-old male subject with a past medical history of chest pain was found to have unspecified disease of pericardium 13 days after the subject had received the following vaccines on 07 August 2013: an injection of ACAM2000 (lot number and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 20 August 2013, Troponin I result was abnormal with highest record value of 00.38. On 16 August 2013, the subject had an abnormal ECG and on 21 August 2013, had a normal echocardiogram. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: This study case was received from the investigator in a trial on 06 November 2013. A 19 year-old male subject with a past medical history of chest pain was found to have unspecified disease of pericardium 13 days after the subject had received the following vaccines on 07 August 2013: an injection of ACAM2000 (lot number and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 20 August 2013, Troponin I result was abnormal with highest record value of 00.38. On 16 August 2013, the subject had an abnormal ECG and on 21 August 2013, had a normal echocardiogram. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Chills, Echocardiogram, Pyrexia, Troponin increased
Clinical narrative: This study case was received from the investigator in a trial on 06 November 2013. A 19 year-old male subject with a past medical history of chest pain was found to have unspecified disease of pericardium 13 days after the subject had received the following vaccines on 07 August 2013: an injection of ACAM2000 (lot number and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 20 August 2013, Troponin I result was abnormal with highest record value of 00.38. On 16 August 2013, the subject had an abnormal ECG and on 21 August 2013, had a normal echocardiogram. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 06 November 2013. A 19 year-old male subject with a past medical history of chest pain was found to have unspecified disease of pericardium 13 days after the subject had received the following vaccines on 07 August 2013: an injection of ACAM2000 (lot number and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 20 August 2013, Troponin I result was abnormal with highest record value of 00.38. On 16 August 2013, the subject had an abnormal ECG and on 21 August 2013, had a normal echocardiogram. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: DTAP, PPV, VARZOS, PPV, TDAP, VARZOS
Symptoms: Muscle strain, Pain, Rash
Clinical narrative: Bright red painful rash on right side of body from frontal pelvic area around to middle of lower back.
Age: 66.0
Sex: M
Vaccine: DTAP, PPV, VARZOS, PPV, TDAP, VARZOS
Symptoms: Pain, Rash
Clinical narrative: Bright red painful rash on right side of body from frontal pelvic area around to middle of lower back.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Balance disorder, Dysstasia
Clinical narrative: Imbalance. Sensation of falling forward when standing.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Balance disorder
Clinical narrative: Imbalance. Sensation of falling forward when standing.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Balance disorder, Nuclear magnetic resonance imaging brain
Clinical narrative: Imbalance. Sensation of falling forward when standing.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site bruising, Injection site haematoma
Clinical narrative: Patient reported to pharmacy on 10/28/13 with hematoma, large bruising on upper arm where injection was given.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient got vaccine on 7-18-13, patient still experiencing arm soreness; he states pain is also in shoulder now.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient got vaccine on 7-18-13, patient still experiencing arm soreness; he states pain is also in shoulder now.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Bronchospasm, Respiratory distress
Clinical narrative: Bronchospasm, respiratory distress.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Abasia, Activities of daily living impaired, Axonal neuropathy, Back pain, Cough
Clinical narrative: This literature report (initial receipt 05-Nov-2013) concerns a 6 year old male patient. The patient had no previous medical history. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, the patient experienced symptoms of cough and fever for ten days post influenza vaccination. The patient was noted to be limping and collapsed to the floor with complaints of headache, back pain, and lower extremity weakness. The patient was admitted to a local hospital and underwent lumbar puncture. He was diagnosed with Guillain-Barre Syndrome (GBS). He underwent five days of intravenous immunoglobulin therapy, but was still noted to have impaired motor function, left greater than right, with intact sensation in bilateral lower extremities. The patient was admitted to acute inpatient rehab three weeks after diagnosis secondary to his inability to ambulate. While in rehab, the patient underwent electromyography testing which was consistent with severe axonal motor neuropathy. Acute Motor Axonal Neuropathy (AMAN), a pure motor variant of GBS was diagnosed. The patient was admitted at wheelchair mobility level. At the time of discharge, 12 weeks after admission to acute inpatient rehab, he was able to ambulate a distance of 15 feet using a posterior walker utilizing bilateral hip-knee-ankle-foot-orthoses requiring moderate level of assistance. He was able to transfer with supervision and performed activities of daily living with minimal assist. Outcome was not reported. Reporter's comment: The author stated that the AMAN GBS had a possible onset ten days after influenza vaccination.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Headache, Immunoglobulin therapy
Clinical narrative: This literature report (initial receipt 05-Nov-2013) concerns a 6 year old male patient. The patient had no previous medical history. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, the patient experienced symptoms of cough and fever for ten days post influenza vaccination. The patient was noted to be limping and collapsed to the floor with complaints of headache, back pain, and lower extremity weakness. The patient was admitted to a local hospital and underwent lumbar puncture. He was diagnosed with Guillain-Barre Syndrome (GBS). He underwent five days of intravenous immunoglobulin therapy, but was still noted to have impaired motor function, left greater than right, with intact sensation in bilateral lower extremities. The patient was admitted to acute inpatient rehab three weeks after diagnosis secondary to his inability to ambulate. While in rehab, the patient underwent electromyography testing which was consistent with severe axonal motor neuropathy. Acute Motor Axonal Neuropathy (AMAN), a pure motor variant of GBS was diagnosed. The patient was admitted at wheelchair mobility level. At the time of discharge, 12 weeks after admission to acute inpatient rehab, he was able to ambulate a distance of 15 feet using a posterior walker utilizing bilateral hip-knee-ankle-foot-orthoses requiring moderate level of assistance. He was able to transfer with supervision and performed activities of daily living with minimal assist. Outcome was not reported. Reporter's comment: The author stated that the AMAN GBS had a possible onset ten days after influenza vaccination.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Lumbar puncture, Motor dysfunction, Muscular weakness, Pyrexia, Syncope
Clinical narrative: This literature report (initial receipt 05-Nov-2013) concerns a 6 year old male patient. The patient had no previous medical history. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, the patient experienced symptoms of cough and fever for ten days post influenza vaccination. The patient was noted to be limping and collapsed to the floor with complaints of headache, back pain, and lower extremity weakness. The patient was admitted to a local hospital and underwent lumbar puncture. He was diagnosed with Guillain-Barre Syndrome (GBS). He underwent five days of intravenous immunoglobulin therapy, but was still noted to have impaired motor function, left greater than right, with intact sensation in bilateral lower extremities. The patient was admitted to acute inpatient rehab three weeks after diagnosis secondary to his inability to ambulate. While in rehab, the patient underwent electromyography testing which was consistent with severe axonal motor neuropathy. Acute Motor Axonal Neuropathy (AMAN), a pure motor variant of GBS was diagnosed. The patient was admitted at wheelchair mobility level. At the time of discharge, 12 weeks after admission to acute inpatient rehab, he was able to ambulate a distance of 15 feet using a posterior walker utilizing bilateral hip-knee-ankle-foot-orthoses requiring moderate level of assistance. He was able to transfer with supervision and performed activities of daily living with minimal assist. Outcome was not reported. Reporter's comment: The author stated that the AMAN GBS had a possible onset ten days after influenza vaccination.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: This literature report (initial receipt 05-Nov-2013) concerns a 6 year old male patient. The patient had no previous medical history. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, the patient experienced symptoms of cough and fever for ten days post influenza vaccination. The patient was noted to be limping and collapsed to the floor with complaints of headache, back pain, and lower extremity weakness. The patient was admitted to a local hospital and underwent lumbar puncture. He was diagnosed with Guillain-Barre Syndrome (GBS). He underwent five days of intravenous immunoglobulin therapy, but was still noted to have impaired motor function, left greater than right, with intact sensation in bilateral lower extremities. The patient was admitted to acute inpatient rehab three weeks after diagnosis secondary to his inability to ambulate. While in rehab, the patient underwent electromyography testing which was consistent with severe axonal motor neuropathy. Acute Motor Axonal Neuropathy (AMAN), a pure motor variant of GBS was diagnosed. The patient was admitted at wheelchair mobility level. At the time of discharge, 12 weeks after admission to acute inpatient rehab, he was able to ambulate a distance of 15 feet using a posterior walker utilizing bilateral hip-knee-ankle-foot-orthoses requiring moderate level of assistance. He was able to transfer with supervision and performed activities of daily living with minimal assist. Outcome was not reported. Reporter's comment: The author stated that the AMAN GBS had a possible onset ten days after influenza vaccination.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Myelitis
Clinical narrative: This medically confirmed report (initial receipt 07-Nov-2013) concerns a 60-year-old male patient. On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient developed myelitis. Outcome was not reported.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This consumer report (initial receipt 07-Nov-2013) concerns a 59 year old female patient. On an unspecified date in 2013, about 3 weeks prior to reporting the patient received the influenza virus vaccine (manufacturer and batch number not specified). On the same day, the patient received ZOSTAVAX (batch number not reported) at a standard dose via sub Q (subcutaneous) injection. Three to four days after vaccination, the patient developed a shingles outbreak on her forehead and in her hair. The patient sought medical attention by calling the physician. The patient received an unspecified treatment for the condition. Outcome was reported as recovering.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Feeling hot, Insomnia, Pain, Palpitations
Clinical narrative: Received shot at 4 pm. Around 9 pm felt hot and had aches throughout body. I was uncomfortable to the pt. I could not sleep. In the middle of night heart started palpitating fast. Symptoms lasted until about 10 am next day.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling/redness. Treatment started 11/16/13: Diphenhydramine 1-2 mg/kg body weight. Swelling has already decreased.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous report as received from a physician refers to a 24 year old female. The patient had no pertinent medical history and drug reactions/allergies. On 08-OCT-2013 the patient was vaccinated with a dose of GARDASIL (lot# 671463/1359AA, expiry date: 23-JUN-2014) (expiry date; 14-JUN-2014 as reported) (dose, location unspecified) intramuscular. No concomitant medication was reported. On 04-NOV-2013, a urine pregnancy test was performed that was positive for pregnancy. The last menstruation period (LMP) was on 14-SEP-2013. The patient's Expected Delivery Date (EDD) was 21-JUN-2014. No known adverse effects. The patient had sought medical attention via went to see the physician. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dry skin, Dyspnoea, Feeling hot, Pain in extremity
Clinical narrative: Rt. arm sore (heavy sensation under arm) breathing difficulty for 2 hr. Coughing all night, then rash on face and dry bumpy skin, then mild rash more on Rt side than left. Slight heat sensations. No soreness in joints.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash, Sensation of heaviness
Clinical narrative: Rt. arm sore (heavy sensation under arm) breathing difficulty for 2 hr. Coughing all night, then rash on face and dry bumpy skin, then mild rash more on Rt side than left. Slight heat sensations. No soreness in joints.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Rt. arm sore (heavy sensation under arm) breathing difficulty for 2 hr. Coughing all night, then rash on face and dry bumpy skin, then mild rash more on Rt side than left. Slight heat sensations. No soreness in joints.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dry skin, Dyspnoea, Feeling hot, Pain in extremity
Clinical narrative: Sore throat.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash, Sensation of heaviness
Clinical narrative: Sore throat.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from an office manager (healthcare worker) refers to a 66 year old female patient with diabetes and hypertension and with none drug reactions/allergies. On 05-NOV-2013 the patient was vaccinated intramuscularly with a dose of PNEUMOVAX23, in the right deltoid, dose not reported, lot # reported as J005071 and expiry date 19-JAN-2015. Concomitant therapies included Amlodipine, Aspirin (manufacturer unknown), Hydrochlorothiazide, DIOVAN HCT, fish oil, FLONASE, Metformin, Omeprazole (manufacturer unknown), Simvastatin (manufacturer unknown), VAGIFEM, vitamin B complex, ascorbic acid, vitamin D (unspecified), vitamin E and calcium. In November 2013 the patient experienced redness, pain and swelling at the injections site after vaccination with PNEUMOVAX23. The patient's outcome was unknown. The patient was treated with BENADRYL ZYRTEC, and Cephalexin. There were none lab diagnostic studies performed. The patient sought medical attention in office. The relatedness between adverse events and PNEUMOVAX23 was unknown Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 21-OCT-2013 at 17:30 the patient was administered with a MMR II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours ate temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13.26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13.56 to 16.08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-213 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 17-OCT-2013 at 13:00 the patient was administered with M-M-R II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date M-M-R II was exposed approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. No information regarding the patient's medical history was provided. On 09-NOV-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml injection, subcutaneously. No concomitant medication was reported. On an unknown date in November 2013 the patient experienced cellulitis at injection site, and injection site swelling and redness. The patient was treated at an emergency room and received "BACTRIM and pain medication". The pharmacist also mentioned that the patient developed fever blisters after receiving FLUVIRIN (not dates specified). The outcome of cellulitis at injection site, injection site was swelling and injection site redness was reported as recovering/resolving. No causality assessment was provided. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. No information regarding the patient's medical history was provided. On 09-NOV-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml injection, subcutaneously. No concomitant medication was reported. On an unknown date in November 2013 the patient experienced cellulitis at injection site, and injection site swelling and redness. The patient was treated at an emergency room and received "BACTRIM and pain medication". The pharmacist also mentioned that the patient developed fever blisters after receiving FLUVIRIN (not dates specified). The outcome of cellulitis at injection site, injection site was swelling and injection site redness was reported as recovering/resolving. No causality assessment was provided. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Gave subcutaneous PNEUMOVAX shot, next day pt developed cellulitis. Was told she had to go to hospital.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Gave subcutaneous PNEUMOVAX shot, next day pt developed cellulitis. Was told she had to go to hospital.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 48 year old male patient. The patient's medical history included stroke. The reporter informed that the patient thought that he was vaccinated with PNEUMOVAX dose 1, on an unknown date in 2012 (lot, expiry date and dose unknown). On 18-OCT-2013, the patient was vaccinated with PNEUMOVAX23 dose 2 (0.5 milliliters), via intramuscular route in left arm for vaccination. Lot number was reported as J010332 and expiry date 14-JAN-2015 (reported as unspecified). Concomitant therapies included hydrocodone (manufacturer unknown), acetaminophen(manufacturer unknown), insulin(manufacturer unknown), LYRICA, ZOLOFT and LIPITOR. On an unknown date in October 2013 the patient developed redness and swelling of the arm that continued for 10 days post vaccination. The outcome of redness and swelling of the arm for 10 days post vaccination was reported as already resolved at the time of report. The patient had contacted doctor office to seek medical attention. No treatment was provided for the events. Lab diagnostic studies performed were none. There was no intervention to prevent seriousness. No treatment was provided for the events. Lab diagnostic studies performed were none. There was no intervention to prevent seriousness criteria. The reporter informed that they did not have any documentation of the patient vaccination in 2012. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Body temperature increased, Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 16-OCT-2013 at 11:00 the patient was administered with M-M-R II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the M-M-R II was exposed approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13.26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 15-OCT-2013 at 09:15 the patient was administered with M-M-R II (lot number H018184, expiry date 05-OCT-2014) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date M-M-R II was exposed approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13.26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an immunization program refers an patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (route, site, dose, strength not reported, lot # H021861, exp. date: 09-OCT-2015). This is one of several reports received from the same source (linked MARRS#: 1311USA000056, 1310USA015119, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014891, 1310USA014870, 1310USA015113, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014881, 1311USA000059, 1310USA014866, 1310USA014868, 1310USA014883, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA004931, 1311USA000042, 1311USA000065, 1310USA014888, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000739, 1311USA000075, 1310USA014895.  Additional information is not expected.
Sex: U
Vaccine: UNK
Symptoms: Accidental exposure to product, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to herself, her age was not reported. On an unknown date, the patient was preparing LIQUID PEDVAXHIB. On an unknown date, the registered nurse experienced while withdrawing a dose out of PEDVAX HIB vial, she noticed excessive pressure as needle entered the rubber stop and content sprayed out all over and some of it got onto nurse's hand and no adverse effect. A PQC has been reported. The outcome of she was withdrawing a dose out of PEDVAX HIB vial, she noticed excessive pressure as needle entered the rubber stop and content sprayed out all over and some of it got onto nurse's hand and no adverse effect is unknown. The reporter considered that she was withdrawing a dose out of PEDVAX HIB vial, she noticed excessive pressure as needle entered the rubber stop and content sprayed out all over and some of it got onto nurse's hand and no adverse effect to be not related to LIQUID PEDVAXHIB. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Antibody test positive, Asthenia, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: This spontaneous report as received from an about 38 year old male consumer with no pertinent medical history refers to himself. The patient had drug reactions/allergies to RONDEC and penicillin. The reported stated that he had first dose of the hepatitis A vaccine, inactivated (manufacturer unknown) (lot# J005680) injection (dose, strength, route and site of administration not reported) on an unspecified date in approximately August 2013, reported as about 2 months ago and a second dose of hepatitis A vaccine, inactivated (manufacturer unknown) (lot#reported as: J005680) injection(dose, strength, route and site of administration not reported). was on 28-OCT-2013. Both doses were administered for employment requirements. It was reported that on unspecified date, in 2013, an unspecified test performed after the first dose of hepatitis A vaccine, inactivated (manufacturer unknown) showed a good level of immunity but the patient elected to get a second dose because of being informed by an unspecified technician that it would not hurt and that it would be for longer-lasting immunity. The reporter stated that, immediately following the first dose of hepatitis A vaccine, inactivated (manufacturer unknown), an unspecified technician told him to wait about 5 minutes and because he felt fine he was released from the clinic. The reporter stated that he felt "a little weird" while travelling back to his work location, but he recovered from the feeling within about an hour of its onset (onset and stop date for the event approximately in August 2013). After receiving the second shot on 28-OCT-2013, the patient felt lousy and experienced dizziness, a foggy head, chest tightness, shortness of breath, and racing heartbeat. When he reported those reactions to his work supervisor, he was sent to be evaluated at the Emergency Room (ER). At the ER, the patient's vitals were taken and, afterward, the patient was sent home from work for the rest of the day. The patient reported that, since receiving the second dose of hepatitis A vaccine, inactivated (manufacturer unknown) on 28-OCT-2013, he had missed work from being sick at home. The patient reported that he himself had been staying mostly in bed with no energy, head pressure, and dizziness. adverse events. The patient did not recovered from the adverse events. The relatedness between hepatitis A vaccine, inactivated (manufacturer unspecified) and the events was not reported. This report is linked to the report:# 1310USA014976, which refers to coworker who was vaccinated with the hepatitis A vaccine, inactivated (manufacturer unknown) with the same lot# and experienced similar adverse events. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Feeling abnormal, Headache, Malaise, Palpitations
Clinical narrative: This spontaneous report as received from an about 38 year old male consumer with no pertinent medical history refers to himself. The patient had drug reactions/allergies to RONDEC and penicillin. The reported stated that he had first dose of the hepatitis A vaccine, inactivated (manufacturer unknown) (lot# J005680) injection (dose, strength, route and site of administration not reported) on an unspecified date in approximately August 2013, reported as about 2 months ago and a second dose of hepatitis A vaccine, inactivated (manufacturer unknown) (lot#reported as: J005680) injection(dose, strength, route and site of administration not reported). was on 28-OCT-2013. Both doses were administered for employment requirements. It was reported that on unspecified date, in 2013, an unspecified test performed after the first dose of hepatitis A vaccine, inactivated (manufacturer unknown) showed a good level of immunity but the patient elected to get a second dose because of being informed by an unspecified technician that it would not hurt and that it would be for longer-lasting immunity. The reporter stated that, immediately following the first dose of hepatitis A vaccine, inactivated (manufacturer unknown), an unspecified technician told him to wait about 5 minutes and because he felt fine he was released from the clinic. The reporter stated that he felt "a little weird" while travelling back to his work location, but he recovered from the feeling within about an hour of its onset (onset and stop date for the event approximately in August 2013). After receiving the second shot on 28-OCT-2013, the patient felt lousy and experienced dizziness, a foggy head, chest tightness, shortness of breath, and racing heartbeat. When he reported those reactions to his work supervisor, he was sent to be evaluated at the Emergency Room (ER). At the ER, the patient's vitals were taken and, afterward, the patient was sent home from work for the rest of the day. The patient reported that, since receiving the second dose of hepatitis A vaccine, inactivated (manufacturer unknown) on 28-OCT-2013, he had missed work from being sick at home. The patient reported that he himself had been staying mostly in bed with no energy, head pressure, and dizziness. adverse events. The patient did not recovered from the adverse events. The relatedness between hepatitis A vaccine, inactivated (manufacturer unspecified) and the events was not reported. This report is linked to the report:# 1310USA014976, which refers to coworker who was vaccinated with the hepatitis A vaccine, inactivated (manufacturer unknown) with the same lot# and experienced similar adverse events. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blister, Dermatitis contact, Fall, Feeling abnormal
Clinical narrative: This spontaneous report as received from a patient via Market Research refers to himself or herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route not reported0. The patient felt on 26-OCT-2013 injuring by left shoulder and arm. The patient went to the doctor and at that time did not have a rash on the patient's arm, just pain in the shoulder joint and upper arm area. The patient was given pain medications and told that the patient had pulled muscles. On 31-OCT-2013 ("five days later"), the patient developed a red rash, then fluid filled pus pockets beginning at my shoulder going down to the hand and into fingers. The patient went to doctor on 02-NOV-2013 ("Sunday") and was told that it was contact dermatitis and if it was the shingles it was to late to begin viral medications. The patient was given prednisone shot and pills to take. On 05-NOV-2013 morning ("Tuesday morning") the patient woke up with severe shoulder joint pain, more blisters, and swollen arm, the patient went to the regular doctor was told the patient had full blown shingles and the doctor wanted the patient to stop the prednisone and wrote prescription for a viral medication to begin taking immediately and stronger pain medications. The patient was at home resting and felt terrible. The doctor was hoping that the viral medications will help. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Joint injury, Limb injury, Local swelling, Muscle strain
Clinical narrative: This spontaneous report as received from a patient via Market Research refers to himself or herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route not reported0. The patient felt on 26-OCT-2013 injuring by left shoulder and arm. The patient went to the doctor and at that time did not have a rash on the patient's arm, just pain in the shoulder joint and upper arm area. The patient was given pain medications and told that the patient had pulled muscles. On 31-OCT-2013 ("five days later"), the patient developed a red rash, then fluid filled pus pockets beginning at my shoulder going down to the hand and into fingers. The patient went to doctor on 02-NOV-2013 ("Sunday") and was told that it was contact dermatitis and if it was the shingles it was to late to begin viral medications. The patient was given prednisone shot and pills to take. On 05-NOV-2013 morning ("Tuesday morning") the patient woke up with severe shoulder joint pain, more blisters, and swollen arm, the patient went to the regular doctor was told the patient had full blown shingles and the doctor wanted the patient to stop the prednisone and wrote prescription for a viral medication to begin taking immediately and stronger pain medications. The patient was at home resting and felt terrible. The doctor was hoping that the viral medications will help. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Rash erythematous, Rash pustular
Clinical narrative: This spontaneous report as received from a patient via Market Research refers to himself or herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route not reported0. The patient felt on 26-OCT-2013 injuring by left shoulder and arm. The patient went to the doctor and at that time did not have a rash on the patient's arm, just pain in the shoulder joint and upper arm area. The patient was given pain medications and told that the patient had pulled muscles. On 31-OCT-2013 ("five days later"), the patient developed a red rash, then fluid filled pus pockets beginning at my shoulder going down to the hand and into fingers. The patient went to doctor on 02-NOV-2013 ("Sunday") and was told that it was contact dermatitis and if it was the shingles it was to late to begin viral medications. The patient was given prednisone shot and pills to take. On 05-NOV-2013 morning ("Tuesday morning") the patient woke up with severe shoulder joint pain, more blisters, and swollen arm, the patient went to the regular doctor was told the patient had full blown shingles and the doctor wanted the patient to stop the prednisone and wrote prescription for a viral medication to begin taking immediately and stronger pain medications. The patient was at home resting and felt terrible. The doctor was hoping that the viral medications will help. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 13-NOV-2013, the patient was vaccinated with PNEUMOVAX23 (0.5 ml) with lot # 0217AE and expiry date 22-AUG-2013, via intramuscular route. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 23-OCT-2013 at 12:00 the patient was administered with a M-M-R II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date M-M-R II was exposed approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17: 14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 22-OCT-2013 at 11:30 the patient was administered with a MMR II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the MMR II was exposed approximately for 9.5 hours at temperature of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:25 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. On 05-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX dose, route and lot # not reported. On 06-NOV-2013, the following day, the patient presented with hives on his face. The outcome of adverse event was unknown. The pharmacist advised the patient to seek care from his unspecified primary healthcare provider. The relatedness between adverse event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient. No medical history provided. On 28-OCT-2013 the patient was vaccinated with improperly stored VARIVAX lot # 671848/1797AA (expiration date: 15-NOV-2013), 0.5 ml once. No concomitant medications were provided. The VARIVAX had been stored in a freezer that had not maintained temperature since August 2013 and has had multiple excursions since then up to -10C maximum. No adverse events were reported. No outcome was reported. Additional information has been requested.