chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a pharmacist refers to a 21 year old female patient with cold sores and no drug allergies or reactions. On 12-APR-2013, the patient was vaccinated with a first dose of GARDASIL (lot # 1073AA, exp date 11-OCT-2015). 0.5 ml, intramuscular; on 31-MAY-2013 was vaccinated with a second dose of GARDASIL (lot # H018755, exp date 21-MAR-2015), 0.5 ml, intramuscular and on 18-OCT-2013 was vaccinated with a third dose of GARDASIL, 0.5 ml, intramuscular lot # reported as J007850 exp date 07-APR-2016. Concomitant therapies included VALTREX. The pharmacist stated that patient tested positive for HPV on a "pap smear" on a recent, unspecified date in 2013. The outcome of patient tested positive for HPV on a "pap smear" was reported as not recovered/not resolved. No other adverse effects had been observed or reported. The pharmacist stated that the physician is going to repeat the "pap smear" in 6 months on an unspecified date, and the physician would be agreeable to follow-up. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with the first dose and the second dose of GARDASIL, INJ 120 Y, (lot #, expiration date, dose and route unspecified) on 02-NOV-2012 and in January 2013 respectively. The patient would like to receive the third dose on 08-NOV-2013 (at the reporting time). No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. On 08-NOV-2013 the patient who was 34 weeks in her pregnancy was vaccinated with the first dose of GARDASIL (dosage detail, lot number unspecified). The patient last menstrual period (LMP) was on approximately 15-MAR-2013 and Estimated Date of Delivery (EDD) was on approximately 20-DEC-2013. The patient exposure to GARDASIL during third trimester. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 15-JUL-2011 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular. The physician reported that the patient was administered the second dose of GARDASIL (0.5 ml, intramuscular) on 25-JUN-2013 and the third dose (0.5 ml, intramuscular) was administered on 21-AUG-2013. No adverse effects reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Dyspnoea, Headache, Palpitations, Rash
Clinical narrative: Case number PHHY2013US110736 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 497025) on 04 Oct 2013, with the follow-up received from Quality Assurance Department (reference number: 257006) on 13 Nov 2013: This report refers to a 27-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12131 and expiry date: Aug 2015) in to the left arm on 07 Jul 2013. On the same day, she experienced rash and hives on the left arm and left posterior thigh within hours of receiving vaccine. Further on she also experienced intermittent dizziness, moderate to severe headache, blurry vision, shortness of breath and palpitations. Following these events, the patient had to visit the Emergency Room (ER). Final outcome of the events was reported as condition unchanged as of 17 Jul 2013. No further information about causality and seriousness was reported. Based on the investigation performed, QA department stated that, the concerned MENVEO vaccine (batch number: M12131) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 257006) on 13 Nov 2013. Updated batch review report.
Age: 27.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Urticaria, Vision blurred
Clinical narrative: Case number PHHY2013US110736 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 497025) on 04 Oct 2013, with the follow-up received from Quality Assurance Department (reference number: 257006) on 13 Nov 2013: This report refers to a 27-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12131 and expiry date: Aug 2015) in to the left arm on 07 Jul 2013. On the same day, she experienced rash and hives on the left arm and left posterior thigh within hours of receiving vaccine. Further on she also experienced intermittent dizziness, moderate to severe headache, blurry vision, shortness of breath and palpitations. Following these events, the patient had to visit the Emergency Room (ER). Final outcome of the events was reported as condition unchanged as of 17 Jul 2013. No further information about causality and seriousness was reported. Based on the investigation performed, QA department stated that, the concerned MENVEO vaccine (batch number: M12131) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 257006) on 13 Nov 2013. Updated batch review report.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Urticaria, Wheezing
Clinical narrative: 1025 am Pt never had flu shot before; here, with mom given T-free flu vaccine. Told to wait, within 5 min. she had localized hives on (L) arm and upper chest and stating she was wheezing per mom. Chest checked clear BP 120/70 P 84. Continued to monitor, stated she is okay, went back to work 1055. Ten minutes later c/o of SOB again. Epipen given and was monitored by PA.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Chest pain, Cough, Dysphagia, Dyspnoea
Clinical narrative: Initial report was received on 08 November 2013 from a healthcare professional, who was also the patient. A 31-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH920AC, on 11 October 2013. Within minutes, the patient felt funny and about one hour later she began experiencing welt on arm that was itchy, unable to swallow and difficulty in breathing. She was transported to the emergency room and admitted to the hospital. The patient had a history of cardiac arrhythmia and dysautonomia and at the time of vaccination was on prednisone. The patient has had previous flu vaccines without preservatives. She continues to have "health issues" as a result of high doses of SOLUMEDROL and medications she had been administered for reaction following vaccination. The patient also has allergies to nuts, spices and numerous antibiotics. Outcome was not recovered. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fear, Feeling abnormal, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Initial report was received on 08 November 2013 from a healthcare professional, who was also the patient. A 31-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH920AC, on 11 October 2013. Within minutes, the patient felt funny and about one hour later she began experiencing welt on arm that was itchy, unable to swallow and difficulty in breathing. She was transported to the emergency room and admitted to the hospital. The patient had a history of cardiac arrhythmia and dysautonomia and at the time of vaccination was on prednisone. The patient has had previous flu vaccines without preservatives. She continues to have "health issues" as a result of high doses of SOLUMEDROL and medications she had been administered for reaction following vaccination. The patient also has allergies to nuts, spices and numerous antibiotics. Outcome was not recovered. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Panic reaction, Tachycardia, Urticaria, Wheezing
Clinical narrative: Initial report was received on 08 November 2013 from a healthcare professional, who was also the patient. A 31-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH920AC, on 11 October 2013. Within minutes, the patient felt funny and about one hour later she began experiencing welt on arm that was itchy, unable to swallow and difficulty in breathing. She was transported to the emergency room and admitted to the hospital. The patient had a history of cardiac arrhythmia and dysautonomia and at the time of vaccination was on prednisone. The patient has had previous flu vaccines without preservatives. She continues to have "health issues" as a result of high doses of SOLUMEDROL and medications she had been administered for reaction following vaccination. The patient also has allergies to nuts, spices and numerous antibiotics. Outcome was not recovered. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Feeling abnormal, Laboratory test, Pruritus
Clinical narrative: Initial report was received on 08 November 2013 from a healthcare professional, who was also the patient. A 31-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH920AC, on 11 October 2013. Within minutes, the patient felt funny and about one hour later she began experiencing welt on arm that was itchy, unable to swallow and difficulty in breathing. She was transported to the emergency room and admitted to the hospital. The patient had a history of cardiac arrhythmia and dysautonomia and at the time of vaccination was on prednisone. The patient has had previous flu vaccines without preservatives. She continues to have "health issues" as a result of high doses of SOLUMEDROL and medications she had been administered for reaction following vaccination. The patient also has allergies to nuts, spices and numerous antibiotics. Outcome was not recovered. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: Initial report was received on 08 November 2013 from a healthcare professional, who was also the patient. A 31-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH920AC, on 11 October 2013. Within minutes, the patient felt funny and about one hour later she began experiencing welt on arm that was itchy, unable to swallow and difficulty in breathing. She was transported to the emergency room and admitted to the hospital. The patient had a history of cardiac arrhythmia and dysautonomia and at the time of vaccination was on prednisone. The patient has had previous flu vaccines without preservatives. She continues to have "health issues" as a result of high doses of SOLUMEDROL and medications she had been administered for reaction following vaccination. The patient also has allergies to nuts, spices and numerous antibiotics. Outcome was not recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Pt given Tdap at app 9:25 AM on 11/08/13. Grandmother stated pt started having "lowgrade fever, slight swelling and redness at injection site, and vomiting at about 1:30 pm. GM called and spoke to HD nurse at 3:30.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Infectious mononucleosis, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Pt given Tdap at app 9:25 AM on 11/08/13. Grandmother stated pt started having "lowgrade fever, slight swelling and redness at injection site, and vomiting at about 1:30 pm. GM called and spoke to HD nurse at 3:30.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Axillary pain, Chills, Flushing, Immediate post-injection reaction, Lymphadenitis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 46 year old female patient with drug reaction or allergy to sulfa. The patient had no pertinent medical history. On 11-NOV-2013, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular, into the patient's left arm, lot # reported as J010654, expiration date 17-OCT-2014. Other suspect therapies included FLUZONE, also administered on 11-NOV-2013 into the patient's left arm. On 13-NOV-2013, the patient presented to the office with a 102 degree F fever, rigors, malaise, feeling terrible and was tearful. In addition, there was erythema, the size of a coin around the PNEUMOVAX23 injection site. The patient was started on DURICEF. On 13-NOV-2013, the patient again presented to the office and while the fever had abated, there was now swelling at the PNEUMOVAX23 injection site. A magnetic resonance imaging (MRI) was performed and possible fasciitis was diagnosed. The patient was hospitalized that same day and continued to be so on 14-NOV-2013. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Malaise, Nuclear magnetic resonance imaging, Pyrexia, Tenderness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 46 year old female patient with drug reaction or allergy to sulfa. The patient had no pertinent medical history. On 11-NOV-2013, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular, into the patient's left arm, lot # reported as J010654, expiration date 17-OCT-2014. Other suspect therapies included FLUZONE, also administered on 11-NOV-2013 into the patient's left arm. On 13-NOV-2013, the patient presented to the office with a 102 degree F fever, rigors, malaise, feeling terrible and was tearful. In addition, there was erythema, the size of a coin around the PNEUMOVAX23 injection site. The patient was started on DURICEF. On 13-NOV-2013, the patient again presented to the office and while the fever had abated, there was now swelling at the PNEUMOVAX23 injection site. A magnetic resonance imaging (MRI) was performed and possible fasciitis was diagnosed. The patient was hospitalized that same day and continued to be so on 14-NOV-2013. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Feeling abnormal, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 46 year old female patient with drug reaction or allergy to sulfa. The patient had no pertinent medical history. On 11-NOV-2013, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular, into the patient's left arm, lot # reported as J010654, expiration date 17-OCT-2014. Other suspect therapies included FLUZONE, also administered on 11-NOV-2013 into the patient's left arm. On 13-NOV-2013, the patient presented to the office with a 102 degree F fever, rigors, malaise, feeling terrible and was tearful. In addition, there was erythema, the size of a coin around the PNEUMOVAX23 injection site. The patient was started on DURICEF. On 13-NOV-2013, the patient again presented to the office and while the fever had abated, there was now swelling at the PNEUMOVAX23 injection site. A magnetic resonance imaging (MRI) was performed and possible fasciitis was diagnosed. The patient was hospitalized that same day and continued to be so on 14-NOV-2013. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Malaise, Nuclear magnetic resonance imaging abnormal, Pyrexia, Tearfulness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 46 year old female patient with drug reaction or allergy to sulfa. The patient had no pertinent medical history. On 11-NOV-2013, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular, into the patient's left arm, lot # reported as J010654, expiration date 17-OCT-2014. Other suspect therapies included FLUZONE, also administered on 11-NOV-2013 into the patient's left arm. On 13-NOV-2013, the patient presented to the office with a 102 degree F fever, rigors, malaise, feeling terrible and was tearful. In addition, there was erythema, the size of a coin around the PNEUMOVAX23 injection site. The patient was started on DURICEF. On 13-NOV-2013, the patient again presented to the office and while the fever had abated, there was now swelling at the PNEUMOVAX23 injection site. A magnetic resonance imaging (MRI) was performed and possible fasciitis was diagnosed. The patient was hospitalized that same day and continued to be so on 14-NOV-2013. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Electroencephalogram, Hypoaesthesia, Infection, Muscle spasms
Clinical narrative: Went to ER due to numbness in left arm and hand. Neuropathy of half of hand up to elbow with elbow and hand pain, with spasms.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Neuropathy peripheral, Pain in extremity, X-ray limb
Clinical narrative: Went to ER due to numbness in left arm and hand. Neuropathy of half of hand up to elbow with elbow and hand pain, with spasms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy bone marrow abnormal, Full blood count abnormal, Idiopathic thrombocytopenic purpura, Megakaryocytes normal, Petechiae
Clinical narrative: This spontaneous report as received from a physician refers to a 61 year old female patient. On 15-SEP-2013 the patient was vaccinated with ZOSTAVAX, (lot number, expiry date and route was not reported). Approximately on 15-SEP-2013, the patient developed wide spread petechiae. The patient had a complete blood count on 31-OCT-2013 and was diagnosed with thrombocytopenia. The patient then had a bone marrow biopsy on 01-NOV-2013 which revealed idiopathic thrombocytopenic purpura with no megakaryocytes. The patient sought medical attention (office visit). The patient has been treated with multiple platelet transfusions. The outcome of the reported events were not recovered. All the reported events were considered to be significant disability, life threatening and medically significant. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Platelet transfusion, Thrombocytopenia
Clinical narrative: This spontaneous report as received from a physician refers to a 61 year old female patient. On 15-SEP-2013 the patient was vaccinated with ZOSTAVAX, (lot number, expiry date and route was not reported). Approximately on 15-SEP-2013, the patient developed wide spread petechiae. The patient had a complete blood count on 31-OCT-2013 and was diagnosed with thrombocytopenia. The patient then had a bone marrow biopsy on 01-NOV-2013 which revealed idiopathic thrombocytopenic purpura with no megakaryocytes. The patient sought medical attention (office visit). The patient has been treated with multiple platelet transfusions. The outcome of the reported events were not recovered. All the reported events were considered to be significant disability, life threatening and medically significant. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Condition aggravated, Fibromyalgia, Neck pain, Pain
Clinical narrative: Patient with fibromyalgia experienced a flare-up of her symptoms 48 hours post-immunization. Described as neck and all-body pain -> took approximately 2 weeks to resolve.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Injection site erythema, Neck pain, Pain in extremity
Clinical narrative: Patient had FLUVIRIN and ZOSTAVAX shots same day on same arm. She complained of her toes hurting really bad, lower back and neck hurting. She had a quarter size red area where ZOSTAVAX was administered. Patient's symptoms all resolved within 4 days.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Limb discomfort, Sensory disturbance
Clinical narrative: Arm felt tense and jumping up that lasted 5 mins in the beginning after the shot pulsating feeling.
Age: 21.0
Sex: M
Vaccine: FLUN4, HEP, YF
Symptoms: Cough, Dyspnoea, Erythema, Urticaria
Clinical narrative: Approx 45 minutes after receiving vaccines; c/o (+) cough; difficulty breathing; noted: redness to facial area; (+) hives on both inner upper arms. Patient in exam room; at 1:48 Epi 0.3mg given; BENADRYL 50mg/1mL given at 1:59; Epi 0.3 mg x 2 given in clinic emergency room, followed by SOLUMEDROL 125 mg IM - albuterol treatment via nebulizer, O2 at 2L. ZANTAC to take at home.
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 24-OCT-2013 at 09:15 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 to 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: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: I felt at time of injection at the injection site and surrounding area burning sensation that lasted approximately 30 minutes or so, approximately 2-3 inches around the injection site swelled, became hard, warm to the touch and red, worsened and became more red as the day went on and became hot to the touch and lasted until 11/16/13 when it was more pink than red and still swollen but less than it had been.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: I felt at time of injection at the injection site and surrounding area burning sensation that lasted approximately 30 minutes or so, approximately 2-3 inches around the injection site swelled, became hard, warm to the touch and red, worsened and became more red as the day went on and became hot to the touch and lasted until 11/16/13 when it was more pink than red and still swollen but less than it had been.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Rash started as small circle around injection site and progressively got bigger and started down the patients leg.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Influenza, Mobility decreased
Clinical narrative: Felt like I had the flu, couldnt get out of bed, exhausted.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Lightheaded and dizziness lasted a few minutes. Sat down until the symptoms went away.
Age: 1.03
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 24-OCT-2013 at 12:00 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 to 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.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 PFU of lot # j006155 (expiry date 30-AUG-2014). No concomitant medications were reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. AT the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX was administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX may have been stored improperly since May 2013 and that the temperature of the ZOSTAVAX has ranged between 15F and 20F for an unspecified amount of hours. At the time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacists reported that ZOSTAVAX has been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effects. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a doctor of pharmacist refers to a female patient of unknown age who on 13-NOV-2013 was vaccinated with an expired dose of ZOSTAVAX (lot # 669746/0356AA, exp 09-JUN-2012) (dose and route not provided). No known adverse effects. 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 28-OCT-2013 at 08:45 the patient was administered with M-M-R II (lot number J002867, expiry date 08-MAR-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 to 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.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, dose, frequency, route and indication not reported). The representative received a voicemail from the nurse stating that the patient who received GARDASIL was now pregnant. The LMP(Last Menstrual Period) and EDD(Estimated Date of Delivery) was not known. No other information was left on the voicemail. The outcome of the event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Blood test, Presyncope, Syncope
Clinical narrative: Near syncopal episode with vaccine and blood draw. At 0900 after vaccines administered and lab being drawn, pt had fainting spell x 30 sec. Pt placed in supine position, vitals taken, pt assessed AAO x 3. Held for 15-20 minutes.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a 76 year old female patient (also the reporter) with high blood pressure, diabetes and endocarditis. The patient's medical history included prior cases of pneumonia. On 13-NOV-2013 the patient was vaccinated with PNEUMOVAX23 (dose, lot and expiry date unknown), Metformin (manufacturer unknown) aspirin (manufacturer unknown), Coreg, Lipitor, Iron (unspecified) (iron supplements, manufacturer unknown and Doxycycline (manufacturer unknown). On 13-NOV-2013, 1 day after onset of therapy the patient developed soreness and pain in the shoulder and arm, and the patient stated she could not sleep. The outcome of events was reported as resolving. As treatment for the events, the patient took TYLENOL (unspecified manufacturer, dose, frequency). The patient had contacted the pharmacist by phone to seek medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: This spontaneous report as received from Novartis (MFR # PUS2103US109430) refers to a 65 year old female patient. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23. Reporter stated that originally patient thought she got influenza vaccine. However, they later discovered that she only got the PNEUMOVAX23 shot. Arm was really numb and couldn't lift it. Influenza vaccine was not administered. The outcome of events was unknown. The original reporter was an officer manager. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot and expiry date was unknown). The pharmacist also mentioned that at an unspecified time in the past, she had heard that a patient at their pharmacy had developed an injections site rash after receiving ZOSTAVAX, and this rash resolved on its own. This is report 2 of 2 from same reporter. 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 30-OCT-2013 at 14:45 the patient was administered with M-M-R II (lot number J002867, expiry date 08-MAR-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 to 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: 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 04-NOV-2013 at 13:00 the patient was administered with M-M-R II (lot number J002867, expiry date 08-MAR-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 to 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: 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 04-NOV-2013 at 15:45 the patient was administered with M-M-R II (lot number J002867, expiry date 08-MAR-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 to 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.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX in the arm in a different pharmacy. On an unknown date in November 2013 the patient experienced rash on her arm at the injections site and came to the reporter's pharmacy to seek medical attention. The outcome of event was reported as not resolved. This is report 1 of 2 from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age with herpes outbreak. On an unknown date the patient was vaccinated with ZOSTAVAX. Concomitant therapies included Acyclovir. The patient was taking acyclovir intermittently for herpes outbreak and received a dose of ZOSTAVAX on unspecified date. Patient has not taken acyclovir for quite some time but exact date when patient last took acyclovir was unspecified. No adverse effects reported. No additional information provided. This is report 2 of 2 from same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Skin swelling, Skin warm
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route unknown, lot # J006242 and expiry date 03-AUG-2014). On an unknown date the patient had a reaction that considered of red hot swollen skin the day after the vaccination. The outcome of events was unknown. 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 04-NOV-2013 at 16:30 the patient was administered with MMR II (lot number J002867, expiry date 08-MAR-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 to 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: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a Physician's Assistant refers to a 22 year old female patient. On 20-MAR-2012, the patient was vaccinated with GARDASIL dose 1. On 14-NOV-2013 (reported also as today), 605 days after dose 1, the patient was in office to receive her second dose. No further information available. Dosage information, lot and expiry date were unknown for both doses. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot, expiry date were unknown). The patient was administered ZOSTAVAX at a pharmacy and had informed the reporter that the needle was leaking. The reporter could not confirm if the needle was leaking at the site of administration and whether patient may not have received a full dose of ZOSTAVAX as recommended in the prescribing information. No adverse events were reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from a consumer (patients mother) via an unspecified person from an Immunization Coalition and company representative refers to a female patient of unknown age. No information regarding the patients medical history was provided. On an unknown date the patient was vaccinated with GARDASIL injection. Dose and route of administration were not provided. No concomitant medication was reported. In the email from the Immunization Coalition was stated that an unspecified mother claimed that her daughter died in 2008 as a result of GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender who on 13-NOV-2013 was inadvertently vaccinated with an expired dose of ZOSTAVAX (dose, route and lot # number not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender who in May 2013 was vaccinated with a first dose of GARDASIL, IM (dose, route and lot number not provided), in July 2013 was vaccinated with a second dose of GARDASIL, IM (dose, route and lot number not provided) and in September was vaccinated with a third dose of GARDASIL, IM (dose, route and lot number not provided). No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection
Clinical narrative: Infection at the site requiring antibiotics.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Convulsion, Nausea
Clinical narrative: This spontaneous report as received from an unspecified person from an Immunization Coalition via a company representative refers to a young female patient of unknown age. No information regarding the patient's medical history was provided. On an unknown date the patient was vaccinated with GARDASIL injection. Dose and route of administration were not provided. No concomitant medication was reported. On an unknown date the patient experienced seizures, nausea and abdominal pain. No treatment information was provided. The outcome of seizures, nausea and abdominal pain is unknown. No causality assessment was provided. Upon internal review the event seizures was considered medically significant based on the list of always serious events. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and frequency were not reported). Concomitant therapy was not reported. The physician was asked by a patient's mother if GARDASIL caused weight gain. No treatment was given for the adverse event. The outcome of weight gain was reported as not recovered. The reporter considered weight gain to be not related to GARDASIL. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, X-ray limb
Clinical narrative: Prolonged pain at injection site. Subsequent L shoulder bursitis.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an 18 year old patient (gender not specified). No information regarding the patient medical history was provided. On 06-MAR-2012 the patient was vaccinated with GARDASIL injection dose 1. Route not specified. On 08-MAY-2012 the patient received the second dose and on 18-NOV-2013 the patient was in the office to receive the third dose. No concomitant medication was reported. No adverse effect was reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Blood glucose normal, Chest X-ray normal, Dizziness, Dyspnoea
Clinical narrative: 2 weeks after immunization blacked out during volleyball game and went to ER. Ongoing symptoms of dizziness, passing out, trouble breathing, nausea and headaches. Missing school and working with doctors to relieve symptoms. After 90 days, still having reactions.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram normal, Full blood count normal, Headache, Loss of consciousness, Nausea
Clinical narrative: 2 weeks after immunization blacked out during volleyball game and went to ER. Ongoing symptoms of dizziness, passing out, trouble breathing, nausea and headaches. Missing school and working with doctors to relieve symptoms. After 90 days, still having reactions.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine analysis normal
Clinical narrative: 2 weeks after immunization blacked out during volleyball game and went to ER. Ongoing symptoms of dizziness, passing out, trouble breathing, nausea and headaches. Missing school and working with doctors to relieve symptoms. After 90 days, still having reactions.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspnoea, Migraine, Nausea, Syncope
Clinical narrative: 2 weeks after immunization blacked out during volleyball game and went to ER. Ongoing symptoms of dizziness, passing out, trouble breathing, nausea and headaches. Missing school and working with doctors to relieve symptoms. After 90 days, still having reactions.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Tenderness
Clinical narrative: (L) arm tenderness and redness. Denies discharge. Improved with ice packs and time.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Reported 11-2-13 arm red, swollen, warm to touch from shoulder to elbow. Called family doctor prescribed cephalexin 500mg tid x 10 days and BENADRYL 25 mg every 6 hours. Itched originally not real painful.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness at the injection site soreness, swelling, itching.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Culture wound negative, Eschar, Injection site erythema, Injection site reaction
Clinical narrative: Pt. received vaccine 10-29-13. Pt was seen on 11/4/13 with injection site reaction. Pt complained arm was red and swollen for a few days after injection and then a wound appeared. It was tender red with large white center was give Dig cellulitis. P has been seen several times by multiple doctors as well as ER visit. Has been dig 11/13/13 with Eschar tissue.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Wound
Clinical narrative: Pt. received vaccine 10-29-13. Pt was seen on 11/4/13 with injection site reaction. Pt complained arm was red and swollen for a few days after injection and then a wound appeared. It was tender red with large white center was give Dig cellulitis. P has been seen several times by multiple doctors as well as ER visit. Has been dig 11/13/13 with Eschar tissue.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt. hospitalized on 11/12 for Guillain Barre Syndrome.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Swelling
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research program refers to a 14 year old female daughter's friend. In 2011, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not reported). No concomitant medications were reported. In 2011, the patient experienced "distorted skin" reaction at injection site and stated puffy for a couple months after 2nd shot of GARDASIL. The outcome of the events was reported as recovered (probably resolved before 3rd shot). It was noted that the reporter was unsure if the adverse event re-appear after restarting GARDASIL. MRK 30809-V503 HCC Qualitative Research. Additional information has been requested.