chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Back pain, Blood culture, Capillary nail refill test abnormal, Death
Clinical narrative: Information has been received from a published literature article. The patient in this case was a 15-year-old male patient with T-cell precursor acute lymphoblastic leukemia undergoing re-induction chemotherapy. His immunization records from school revealed that the boy had received one varicella vaccination (manufacturer unknown, lot #, dose and route were not reported) when he was 5 years old but none thereafter; he was up-to-date on other vaccines. We defined Day 1, as the day when the patient presented to the Emergency Department for fever and a sharp stabbing back pain. He had blood cultures drawn and received levofloxacin. On Day 2, he presented again with high fever and decreased peripheral perfusion, with prolonged capillary refilling time. Thus, he was admitted to the Pediatric Intensive Care Unit (PICU) and received intravenous antibiotics. Laboratory data on admission showed lymphocytopenia (200 count/mm2). After his general condition was stabilized, the re-induction chemotherapy regimen with vincristine, doxorubicin, asparaginase, and dexamethasone (manufacturer unknown) was resumed. On Day 3, he developed a non-vesiculated acne-like rash, believed to be related to the high dosage of dexamethasone (manufacturer unknown), based on its appearance. On Day 7, the rash started to vesiculate. Vesicular fluid was obtained and Varicella-Zoster Virus (VZV) deoxyribonucleic acid (DNA) was detected with polymerase chain reaction (PCR) analysis. Intravenous acyclovir was started. On Day 9, he developed hepatitis, which subsequently progressed to multi-organ failure and death. DNA analysis of the PCR product from the vesicle indicated that the virus was wild type VZV (5). VZV antibody titers were never obtained. The authors considered the event as vaccination failure and the patient died of disseminated varicella. This is one of 2 reports received from the same literature (other case # 1505USA000527). Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Hepatitis, Intensive care, Lymphocyte count decreased, Lymphopenia, Multi-organ failure
Clinical narrative: Information has been received from a published literature article. The patient in this case was a 15-year-old male patient with T-cell precursor acute lymphoblastic leukemia undergoing re-induction chemotherapy. His immunization records from school revealed that the boy had received one varicella vaccination (manufacturer unknown, lot #, dose and route were not reported) when he was 5 years old but none thereafter; he was up-to-date on other vaccines. We defined Day 1, as the day when the patient presented to the Emergency Department for fever and a sharp stabbing back pain. He had blood cultures drawn and received levofloxacin. On Day 2, he presented again with high fever and decreased peripheral perfusion, with prolonged capillary refilling time. Thus, he was admitted to the Pediatric Intensive Care Unit (PICU) and received intravenous antibiotics. Laboratory data on admission showed lymphocytopenia (200 count/mm2). After his general condition was stabilized, the re-induction chemotherapy regimen with vincristine, doxorubicin, asparaginase, and dexamethasone (manufacturer unknown) was resumed. On Day 3, he developed a non-vesiculated acne-like rash, believed to be related to the high dosage of dexamethasone (manufacturer unknown), based on its appearance. On Day 7, the rash started to vesiculate. Vesicular fluid was obtained and Varicella-Zoster Virus (VZV) deoxyribonucleic acid (DNA) was detected with polymerase chain reaction (PCR) analysis. Intravenous acyclovir was started. On Day 9, he developed hepatitis, which subsequently progressed to multi-organ failure and death. DNA analysis of the PCR product from the vesicle indicated that the virus was wild type VZV (5). VZV antibody titers were never obtained. The authors considered the event as vaccination failure and the patient died of disseminated varicella. This is one of 2 reports received from the same literature (other case # 1505USA000527). Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Polymerase chain reaction positive, Poor peripheral circulation, Pyrexia, Rash, Rash vesicular
Clinical narrative: Information has been received from a published literature article. The patient in this case was a 15-year-old male patient with T-cell precursor acute lymphoblastic leukemia undergoing re-induction chemotherapy. His immunization records from school revealed that the boy had received one varicella vaccination (manufacturer unknown, lot #, dose and route were not reported) when he was 5 years old but none thereafter; he was up-to-date on other vaccines. We defined Day 1, as the day when the patient presented to the Emergency Department for fever and a sharp stabbing back pain. He had blood cultures drawn and received levofloxacin. On Day 2, he presented again with high fever and decreased peripheral perfusion, with prolonged capillary refilling time. Thus, he was admitted to the Pediatric Intensive Care Unit (PICU) and received intravenous antibiotics. Laboratory data on admission showed lymphocytopenia (200 count/mm2). After his general condition was stabilized, the re-induction chemotherapy regimen with vincristine, doxorubicin, asparaginase, and dexamethasone (manufacturer unknown) was resumed. On Day 3, he developed a non-vesiculated acne-like rash, believed to be related to the high dosage of dexamethasone (manufacturer unknown), based on its appearance. On Day 7, the rash started to vesiculate. Vesicular fluid was obtained and Varicella-Zoster Virus (VZV) deoxyribonucleic acid (DNA) was detected with polymerase chain reaction (PCR) analysis. Intravenous acyclovir was started. On Day 9, he developed hepatitis, which subsequently progressed to multi-organ failure and death. DNA analysis of the PCR product from the vesicle indicated that the virus was wild type VZV (5). VZV antibody titers were never obtained. The authors considered the event as vaccination failure and the patient died of disseminated varicella. This is one of 2 reports received from the same literature (other case # 1505USA000527). Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Information has been received from a published literature article. The patient in this case was a 15-year-old male patient with T-cell precursor acute lymphoblastic leukemia undergoing re-induction chemotherapy. His immunization records from school revealed that the boy had received one varicella vaccination (manufacturer unknown, lot #, dose and route were not reported) when he was 5 years old but none thereafter; he was up-to-date on other vaccines. We defined Day 1, as the day when the patient presented to the Emergency Department for fever and a sharp stabbing back pain. He had blood cultures drawn and received levofloxacin. On Day 2, he presented again with high fever and decreased peripheral perfusion, with prolonged capillary refilling time. Thus, he was admitted to the Pediatric Intensive Care Unit (PICU) and received intravenous antibiotics. Laboratory data on admission showed lymphocytopenia (200 count/mm2). After his general condition was stabilized, the re-induction chemotherapy regimen with vincristine, doxorubicin, asparaginase, and dexamethasone (manufacturer unknown) was resumed. On Day 3, he developed a non-vesiculated acne-like rash, believed to be related to the high dosage of dexamethasone (manufacturer unknown), based on its appearance. On Day 7, the rash started to vesiculate. Vesicular fluid was obtained and Varicella-Zoster Virus (VZV) deoxyribonucleic acid (DNA) was detected with polymerase chain reaction (PCR) analysis. Intravenous acyclovir was started. On Day 9, he developed hepatitis, which subsequently progressed to multi-organ failure and death. DNA analysis of the PCR product from the vesicle indicated that the virus was wild type VZV (5). VZV antibody titers were never obtained. The authors considered the event as vaccination failure and the patient died of disseminated varicella. This is one of 2 reports received from the same literature (other case # 1505USA000527). Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Condition aggravated, Epistaxis
Clinical narrative: This is a spontaneous report from a non-clinical study program, from a contactable consumer who reported for herself. An 82-year-old female patient received on 20Jan2015 at 11 am first dose of PREVNAR 13 at 0.5 ml single dose intramuscular in left arm. Vaccination was performed by a pharmacist at pharmacy. No other vaccine was administered on the same date. Relevant medical history included ongoing compromised immune system due to hepatitis C since about 15 years and ongoing nosebleeds. Concomitant medication included Vitamin D, Milk Thistle for hepatitis C, Omega 3/Vitamin E, Kelp, COQ 30, aspirin, Vitamin E. Previously, about 6 years before this report (1999), the patient received an unspecified pneumonia vaccination. On 20Jan2015, the patient felt fine. On 21Jan2015, the patient woke up with chest congestion, pain in all her joints and her hips, knees, fingers, and back of neck hurt. On an unspecified date, she was too weak to walk or do everyday tasks. There was never any head congestion, she received lung decongestants as treatment. She did not think she had the flu because she was not running a fever and had not any upper respiratory disorder. According to the reporter, a physician advised her not to do influenza vaccine because of her compromised immune system due to having Hepatitis C. On 23Jan2015 the patient had 2 nosebleeds, but since she has gotten nosebleeds before, she did not think that nosebleeds were related to PREVNAR 13. The next day (date unspecified) the patient was hospitalized for the events pain in all her joints and hips, knees, fingers, and back of neck hurt/hands, fingers the most. The outcome for all events was recovered. Follow-up (23Apr2015): New information obtained from a contactable consumer includes: new event (too weak to walk or do everyday tasks), additional concomitant drugs, hospitalization, treatment, outcome.
Age: 82.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Gait disturbance, Neck pain, Pain in extremity, Respiratory tract congestion
Clinical narrative: This is a spontaneous report from a non-clinical study program, from a contactable consumer who reported for herself. An 82-year-old female patient received on 20Jan2015 at 11 am first dose of PREVNAR 13 at 0.5 ml single dose intramuscular in left arm. Vaccination was performed by a pharmacist at pharmacy. No other vaccine was administered on the same date. Relevant medical history included ongoing compromised immune system due to hepatitis C since about 15 years and ongoing nosebleeds. Concomitant medication included Vitamin D, Milk Thistle for hepatitis C, Omega 3/Vitamin E, Kelp, COQ 30, aspirin, Vitamin E. Previously, about 6 years before this report (1999), the patient received an unspecified pneumonia vaccination. On 20Jan2015, the patient felt fine. On 21Jan2015, the patient woke up with chest congestion, pain in all her joints and her hips, knees, fingers, and back of neck hurt. On an unspecified date, she was too weak to walk or do everyday tasks. There was never any head congestion, she received lung decongestants as treatment. She did not think she had the flu because she was not running a fever and had not any upper respiratory disorder. According to the reporter, a physician advised her not to do influenza vaccine because of her compromised immune system due to having Hepatitis C. On 23Jan2015 the patient had 2 nosebleeds, but since she has gotten nosebleeds before, she did not think that nosebleeds were related to PREVNAR 13. The next day (date unspecified) the patient was hospitalized for the events pain in all her joints and hips, knees, fingers, and back of neck hurt/hands, fingers the most. The outcome for all events was recovered. Follow-up (23Apr2015): New information obtained from a contactable consumer includes: new event (too weak to walk or do everyday tasks), additional concomitant drugs, hospitalization, treatment, outcome.
Age: 82.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Asthenia, Blood test normal, Chest X-ray normal, Epistaxis
Clinical narrative: This is a spontaneous report from a non-clinical study program, from a contactable consumer who reported for herself. An 82-year-old female patient received on 20Jan2015 at 11 am first dose of PREVNAR 13 at 0.5 ml single dose intramuscular in left arm. Vaccination was performed by a pharmacist at pharmacy. No other vaccine was administered on the same date. Relevant medical history included ongoing compromised immune system due to hepatitis C since about 15 years and ongoing nosebleeds. Concomitant medication included Vitamin D, Milk Thistle for hepatitis C, Omega 3/Vitamin E, Kelp, COQ 30, aspirin, Vitamin E. Previously, about 6 years before this report (1999), the patient received an unspecified pneumonia vaccination. On 20Jan2015, the patient felt fine. On 21Jan2015, the patient woke up with chest congestion, pain in all her joints and her hips, knees, fingers, and back of neck hurt. On an unspecified date, she was too weak to walk or do everyday tasks. There was never any head congestion, she received lung decongestants as treatment. She did not think she had the flu because she was not running a fever and had not any upper respiratory disorder. According to the reporter, a physician advised her not to do influenza vaccine because of her compromised immune system due to having Hepatitis C. On 23Jan2015 the patient had 2 nosebleeds, but since she has gotten nosebleeds before, she did not think that nosebleeds were related to PREVNAR 13. The next day (date unspecified) the patient was hospitalized for the events pain in all her joints and hips, knees, fingers, and back of neck hurt/hands, fingers the most. The outcome for all events was recovered. Follow-up (23Apr2015): New information obtained from a contactable consumer includes: new event (too weak to walk or do everyday tasks), additional concomitant drugs, hospitalization, treatment, outcome.
Age: 82.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Fatigue, Gait disturbance, Lip pain, Liver function test normal, Neck pain
Clinical narrative: This is a spontaneous report from a non-clinical study program, from a contactable consumer who reported for herself. An 82-year-old female patient received on 20Jan2015 at 11 am first dose of PREVNAR 13 at 0.5 ml single dose intramuscular in left arm. Vaccination was performed by a pharmacist at pharmacy. No other vaccine was administered on the same date. Relevant medical history included ongoing compromised immune system due to hepatitis C since about 15 years and ongoing nosebleeds. Concomitant medication included Vitamin D, Milk Thistle for hepatitis C, Omega 3/Vitamin E, Kelp, COQ 30, aspirin, Vitamin E. Previously, about 6 years before this report (1999), the patient received an unspecified pneumonia vaccination. On 20Jan2015, the patient felt fine. On 21Jan2015, the patient woke up with chest congestion, pain in all her joints and her hips, knees, fingers, and back of neck hurt. On an unspecified date, she was too weak to walk or do everyday tasks. There was never any head congestion, she received lung decongestants as treatment. She did not think she had the flu because she was not running a fever and had not any upper respiratory disorder. According to the reporter, a physician advised her not to do influenza vaccine because of her compromised immune system due to having Hepatitis C. On 23Jan2015 the patient had 2 nosebleeds, but since she has gotten nosebleeds before, she did not think that nosebleeds were related to PREVNAR 13. The next day (date unspecified) the patient was hospitalized for the events pain in all her joints and hips, knees, fingers, and back of neck hurt/hands, fingers the most. The outcome for all events was recovered. Follow-up (23Apr2015): New information obtained from a contactable consumer includes: new event (too weak to walk or do everyday tasks), additional concomitant drugs, hospitalization, treatment, outcome.
Age: 82.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Renal function test normal, Respiratory tract congestion, Somnolence, Ultrasound abdomen normal
Clinical narrative: This is a spontaneous report from a non-clinical study program, from a contactable consumer who reported for herself. An 82-year-old female patient received on 20Jan2015 at 11 am first dose of PREVNAR 13 at 0.5 ml single dose intramuscular in left arm. Vaccination was performed by a pharmacist at pharmacy. No other vaccine was administered on the same date. Relevant medical history included ongoing compromised immune system due to hepatitis C since about 15 years and ongoing nosebleeds. Concomitant medication included Vitamin D, Milk Thistle for hepatitis C, Omega 3/Vitamin E, Kelp, COQ 30, aspirin, Vitamin E. Previously, about 6 years before this report (1999), the patient received an unspecified pneumonia vaccination. On 20Jan2015, the patient felt fine. On 21Jan2015, the patient woke up with chest congestion, pain in all her joints and her hips, knees, fingers, and back of neck hurt. On an unspecified date, she was too weak to walk or do everyday tasks. There was never any head congestion, she received lung decongestants as treatment. She did not think she had the flu because she was not running a fever and had not any upper respiratory disorder. According to the reporter, a physician advised her not to do influenza vaccine because of her compromised immune system due to having Hepatitis C. On 23Jan2015 the patient had 2 nosebleeds, but since she has gotten nosebleeds before, she did not think that nosebleeds were related to PREVNAR 13. The next day (date unspecified) the patient was hospitalized for the events pain in all her joints and hips, knees, fingers, and back of neck hurt/hands, fingers the most. The outcome for all events was recovered. Follow-up (23Apr2015): New information obtained from a contactable consumer includes: new event (too weak to walk or do everyday tasks), additional concomitant drugs, hospitalization, treatment, outcome.
Age: 0.1
Sex: F
Vaccine: HEP
Symptoms: Cystogram, Hydronephrosis, Pyrexia, Ultrasound kidney, Urinary tract infection
Clinical narrative: Fever, diagnosed with UTI, treated in emergency department with antibiotics (Rocephin) sent home on Cefdinir, followed up with Renal ultrasound on 12/02/2014 and VCUG on 01/07/2015. Hydronephrodis revealed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Abscess formation on left thigh for 1 day, redness, tender, warm to touch started on BACTRIM and neosporin applied.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Welts breaking out on shoulder.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This spontaneous report as received from the physician's office via medical assistant and via company representative refers to a currently 46 year old female patient. In April 2005, reported as 10 years ago, when the patient was 36 years of age, she was vaccinated with two doses of VARIVAX (Merck) (dose, route,  lot #s not reported). On an unknown date the patient failed to seroconvert. On 25-FEB-2015 the titer test showed IgG immunoglobulin antibody titer was 45, which was negative, there was no antibody titer. The patient sought medical attention by seeing the physician. The outcome of the events was not reported. The causality between the events and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient about 20 years of age. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL, (dose, route of administration, lot number and expiry date were not reported). Immediately after receiving GARDASIL, the patient experienced seizure. The therapy with GARDASIL was discontinued and not reintroduced. On unknown date, the patient recovered. The relatedness between seizure and GARDASIL was not reported. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative refers to an approximately 66 year old patient of unknown gender. No medical history was reported. On 13-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # J015868, exp date 25-FEB-2015) (0.5 ml, intramuscular). No concomitant therapy was reported. It was reported that PNEUMOVAX 23 was administered post expiry. No adverse effects were reported. The outcome of the events was unknown. The events were considered to be not related to PNEUMOVAX 23. No product quality issue was involved. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a 32 year old male patient. In approximately October 2014, 6 months ago the patient received his first dose of M-M-R II. On 30-APR-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (subcutaneous, lot # reported as K025759, expiration date: 08-JUN-2016, 0.5ml), in place of the second dose of M-M-R II. No adverse affect was reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a 15 year old female patient with unspecified illness. There was no pertinent medical history and drug reaction/allergy. On 21-APR-2015, the patient was vaccinated with the second dose of GARDASIL (dose 0.5 ml, intramuscularly, lot # K007264, expiry date: 02-MAR-2017 while the patient was in the office for an "ill visit". Concomitant therapies included CLARITIN, trazodone hydrochloride (manufacturer unknown) and ZOLOFT. After receiving the GARDASIL on 21-APR-2015, a urine pregnancy test was performed twice and it was determined the patient was pregnant. Serum pregnancy test confirmed the pregnancy. Last menstrual period (LMP) was 24-MAR-2015, date of conception: 07-APR-2015 and estimated (EDD): 29-DEC-2015. It was reported that no treatment was given for adverse events. The patient's outcome was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The nurse reported that on unspecified dates the patients received improperly stored RECOMBIVAX HB (Lot# reported as K0177321, 0.5ml/once) intramuscularly. No adverse effects were reported. This is one of two reports received from the same reporter (other linked MARRS # 1505USA000525). Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse regarding an approximately 16 year old patient of unknown gender. There was no information on pertinent medical history and drug reactions or allergies. The registered nurse reported that patient received doses of GARDASIL (product lot#, expiry date not reported) on 28-OCT-2014, 16-MAR-2015 and 29-APR-2015. No adverse effect had been observed or reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. Information concerning medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (lot#, expiration date, dose and route not provided), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. Information concerning medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with doses of ROTATEQ (oral, lot#, expiration date and dose not provided), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. Information concerning medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (lot#, expiration date, dose and route not provided), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. Information concerning medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with doses of GARDASIL (lot#, expiration date, dose and route not provided), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patient of unknown age and gender. The nurse reported that on unspecified dates these patients received improperly stored GARDASIL (Lot# K006960 with expiration date 19-FEB-2017, 0.5ml/once) intramuscularly. No adverse effects were reported. This is one of two reports received from the same reporter (other linked MARRS # 1505USA000532). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unknown number of patients. Between 27-APR-2015 and 30-APR-2015, the patients received improperly stored doses (unspecified in series) of (Oka/Merck) VARIVAX, lot number: K016129, expiry date: 23-SEP-16, (another lot number was reported as L001332, and expiry date: 13-JAN-2017), 0.5ml, subcutaneously. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unknown number of patients. Between 27-APR-2015 and 30-APR-2015, the patients received improperly stored doses (unspecified in series) of ZOSTAVAX lot # K009771, expiry date: 09-OCT-2015, 0.5 ml, subcutaneously. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Information has been received from a male patient of unknown age who was also a retired physician concerning himself. The patient had no pertinent medical history or drug allergies. On 28-MAR-2015 the patient was vaccinated with a single dose of ZOSTAVAX (dose and frequency not reported), subcutaneously in the left arm. There was no concomitant medication. On 29-MAR-2015, the patient developed a vesicular rash on the posterior aspect of the right leg and burning and stinging in the area of the rash. The patient also experienced low-grade fever, headache and significant malaise. The patient did not seek medical attention but self-treated with NAPROSYN. No lab diagnostics studies were performed. At the time of the report, the fever and headache were reported as resolved on unknown dates in 2015. The lesions were crusted, and the patient was recovering from the rest events. Additional information is not expected since the physician is not allowed to be contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a male patient of unknown age who was also a retired physician concerning himself. The patient had no pertinent medical history or drug allergies. On 28-MAR-2015 the patient was vaccinated with a single dose of ZOSTAVAX (dose and frequency not reported), subcutaneously in the left arm. There was no concomitant medication. On 29-MAR-2015, the patient developed a vesicular rash on the posterior aspect of the right leg and burning and stinging in the area of the rash. The patient also experienced low-grade fever, headache and significant malaise. The patient did not seek medical attention but self-treated with NAPROSYN. No lab diagnostics studies were performed. At the time of the report, the fever and headache were reported as resolved on unknown dates in 2015. The lesions were crusted, and the patient was recovering from the rest events. Additional information is not expected since the physician is not allowed to be contacted.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site reaction, Pruritus, Rash, Rash pustular
Clinical narrative: Information has been received from a 52 year old female pharmacist who was also the patient. The patient had no pertinent medical history or drug reactions/allergies. On 24-MAR-2015 the patient was vaccinated with ZOSTAVAX, (lot# reported as 1003218, exp date 30-APR-2016), subcutaneously in the left arm to prevent shingle (dose and frequency were not reported). Concomitant therapy included naproxen which was used as needed. On 24-MAR-2015 (reported as "within 24 hours" of receiving ZOSTAVAX, the patient experienced stiffness in her left arm at the injection site. Between 01-APR-2015 and 04-APR-2015, she developed a rash that appeared as "pimples with whiteheads" that "break open" and "ooze out" on her left back, left ear, left insole of foot, left knee, right side of neck, down right arm and right leg, and 3 pustules on her face. The patient reported that had been very itchy since an unspecified date in April 2015. The patient sought medical attention and was seen by a physician on 23-APR-2015. The physician prescribed the patient ATARAX 50mg three times daily for ten days, prednisone 10mg once daily for 10 days, and CALAMINE LOTION and BENADRYL cream as needed for itching. No lab diagnostis studies were performed. The outcome of the events was reported as not recovered. This case was one of two cases from same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin tightness
Clinical narrative: Information has been received from a 52 year old female pharmacist who was also the patient. The patient had no pertinent medical history or drug reactions/allergies. On 24-MAR-2015 the patient was vaccinated with ZOSTAVAX, (lot# reported as 1003218, exp date 30-APR-2016), subcutaneously in the left arm to prevent shingle (dose and frequency were not reported). Concomitant therapy included naproxen which was used as needed. On 24-MAR-2015 (reported as "within 24 hours" of receiving ZOSTAVAX, the patient experienced stiffness in her left arm at the injection site. Between 01-APR-2015 and 04-APR-2015, she developed a rash that appeared as "pimples with whiteheads" that "break open" and "ooze out" on her left back, left ear, left insole of foot, left knee, right side of neck, down right arm and right leg, and 3 pustules on her face. The patient reported that had been very itchy since an unspecified date in April 2015. The patient sought medical attention and was seen by a physician on 23-APR-2015. The physician prescribed the patient ATARAX 50mg three times daily for ten days, prednisone 10mg once daily for 10 days, and CALAMINE LOTION and BENADRYL cream as needed for itching. No lab diagnostis studies were performed. The outcome of the events was reported as not recovered. This case was one of two cases from same reporter. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Activities of daily living impaired, Fluid retention, Injury, Insomnia, Joint range of motion decreased
Clinical narrative: Symptoms: shoulder pain, loss of range of motion. Signs: thought it was residual pain from vaccine but realized it was an injury after a week of persisting and increasing pain; unable to sleep on left side (injection site); unable to do yoga or exercises involving arms; discomfort placing bag or purse on left shoulder.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal discomfort, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, X-ray
Clinical narrative: Symptoms: shoulder pain, loss of range of motion. Signs: thought it was residual pain from vaccine but realized it was an injury after a week of persisting and increasing pain; unable to sleep on left side (injection site); unable to do yoga or exercises involving arms; discomfort placing bag or purse on left shoulder.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fluid retention, Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Sleep disorder
Clinical narrative: Symptoms: shoulder pain, loss of range of motion. Signs: thought it was residual pain from vaccine but realized it was an injury after a week of persisting and increasing pain; unable to sleep on left side (injection site); unable to do yoga or exercises involving arms; discomfort placing bag or purse on left shoulder.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Weight bearing difficulty
Clinical narrative: Symptoms: shoulder pain, loss of range of motion. Signs: thought it was residual pain from vaccine but realized it was an injury after a week of persisting and increasing pain; unable to sleep on left side (injection site); unable to do yoga or exercises involving arms; discomfort placing bag or purse on left shoulder.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Pyrexia, Skin warm, Swelling
Clinical narrative: Patient experienced swelling, blisters, warmth to touch, fever. Patient said that at home she popped one of the blisters with a needle, that she sterilized. She was then treated for cellulitis. Given cephalexin 500mg 1 capsule twice daily x 7 days.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm swollen, red, and hot, in deltoid area. Arm was also sore to touch. Started on KEFLEX.
Age: 29.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Lymph node pain, Lymphadenopathy, Malaise, Myalgia, Pyrexia
Clinical narrative: General malaise, muscle aches began evening after vaccine administration- 3/28/15. Stayed in bed next 2 days. No relief with NSAIDs able to work from home from home for next 2 days-did report symptoms to clinic. Was seen in clinic 4/3/15- advised to continue INDOCIN (found old Rx at home) stay home. Abrupt resolution of symptoms reported 4/4/15. One exam had found tender, enlarged lymph nodes (R) axilla, groin and fever.
Sex: U
Vaccine: HIBV, HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: A spontaneous report has been received 24APR2015 from a licensed practical nurse, who stated that multiple unspecified patients were administered either GARDASIL (Lot # K007828, exp 02MAR2017), Oral ROTATEQ (Lot K009901, exp 08MAY2016) or PEDVAXHIB (Lot K015462, exp 10JUL2017) that had temperature excursion. No adverse events were reported. No further information was available. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to three patients of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 lot # reported as L003188, expiration date 06-JUL-2016 (dose, strength, frequency were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that upon administration of PNEUMOVAX 23 to the patients, they experienced injection site reaction described as swollen, red and rasied area with blisters. No treatment was received for the events. It was reported that the patients sought medical attention by tellling the pharmacist about the events. The outcome of the events were not reported. The events did not required intervention to prevent serious criteria, did not produce signficant disability or incapacity, did not required hospitalization and were not life threatening for the patients. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information was received from a pharmacist concerning a patient of unknown age and gender, who on 20-APR-2015, was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously for the prevention of shingles. The pharmacist reported that she was informed by an unspecified pharmacist at another store, that this unspecified patient was prescribed Prednisone (manufacturer unknown) 5 mg, twice a day, for an unknown reason after receiving ZOSTAVAX. The pharmacist had no patient or physician identifying information. No further information was provided. Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a healthcare worker and a vender referring to a 46 year old female patient with allergies to pencillin, sulfa and codeine. The patient was vaccinated with her first, second and third dose of RECOMBIVAX HB (first dose: lot# and expiration date were not available, second dose: lot # reported as 1519Z, expiration date: 29-MAR-2013, third dose: lot# 0020AE, expiration date: 10-JUN-2014) (strength, route and dose were unknown) on 12-NOV-2011, 13-DEC-2011 and 12-JUN-2012, respectively. The patient received two doses of pediatric RECOMBIVAX HB to make one adult dose on each of the above three dates. The patient was anxious, and she consulted the physician, on an unspecified date, to request antibody titers for Hepatitis B. On 11-APR-2015, the results of the Hepatitis B titers were negative for Hepatitis B antibodies. The patient had experienced any other adverse effects. The outcome of the adverse events was unknown. The relationship of the adverse events and RECOMBIVAX HB was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative refers to an approximately 65 year old patient of unknown gender. No medical history was reported. On 13-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # J015868, exp date 25-FEB-2015) (.0.5 ml, intramuscular). No concomitant therapy was reported. It was reported that PNEUMOVAX 23 was administered post expiry. No adverse effects were reported. The outcome of the events was unknown. The events were considered to be not related to PNEUMOVAX 23. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The nurse reported improperly stored doses of GARDASIL (lot#, expiration date, dose and route not reported) were administered to an unspecified number of patients (incorrect product storage). No adverse events were reported. This is one of several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown of patients of unknown age and gender. Information concerning medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patient was vaccinated with doses of MMR II (lot#, expiration date, dose and route not provided), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. Information concerning medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patient was vaccinated with doses of VAQTA (lot#, expiration date, dose and route not provided), which had been improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pyrexia
Clinical narrative: Information has been received from a physician referring to a 30 year old female patient with HIV positive. On 20-APR-2015 the patient was vaccinated with PNEUMOVAX 23, 0.5 mL/one time dose, lot # K022886, expiration date: 09-JUN-2016, intramuscularly. Concomitant therapies included NORVIR, sulfamethoxazole, BACTRIM, azithromycin, emtricitabine, TRUVADA and ZOLOFT. The physician reported that following the administration of PNEUMOVAX 23 on 20-APR-2015 the patient experienced chills, and a fever of 101 F on 23-APR-2015. The outcome of the events was unknown. The patient had called the physician's office. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: Information has been received from a physician via Pfizer (Manufacturer Report Number: 2015140640) on 24-APR-2015 referring to a patient of unknown gender in his or her fifties. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, dose and route were unknown). On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, dose and route were unknown). On an unknown date the patient developed allergic reactions to PNEUMOVAX 23. The outcome and causality of the event was unknown. The reporter wanted to known if the patient should be give PREVNAR 13. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Fatigue, Hot flush, Injection site erythema, Injection site pain
Clinical narrative: Pain and redness in arm at injection site that radiates into neck and over collarbone. Hot flashes, chills, nausea. Cannot lift arm. As of 4/29, pain is now in bicep, hurts to straight arm. Overall-tired-haven't eaten since Monday.
Age: 35.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Mobility decreased, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Pain and redness in arm at injection site that radiates into neck and over collarbone. Hot flashes, chills, nausea. Cannot lift arm. As of 4/29, pain is now in bicep, hurts to straight arm. Overall-tired-haven't eaten since Monday.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The nurse reported improperly stored doses of ROTATEQ (orally, lot#, expiration date, dose and frequency not reported), were administered to an unspecified number of patients. No adverse events were reported. This isone of several reports from same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner via pharmacist refers to a 58 year old female patient. The patient's relevant medical history included being healthy. She had no relevant concomitant medications or past drug history. On 25-APR-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (reported lot# J013556), dose: 0.1 mg, intradermally instead of MANTOUX TB SKIN TEST made by Sanofi Pasteur. On 25-APR-2015, the nurse practitioner checked the patient's arm 10 minutes after she received the PNEUMOVAX 23 and she did not see any symptoms. It was unknown if any relevant lab work had been done. As of 25-APR-2015, it was unknown if the patient will receive PNEUMOVAX 23. The nurse was unable to find where the PNEUMOVAX 23 was administered. The outcome of patient's event was not reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician regarding a 63 year old male patient with diabetes mellitus, hyperlipidaemia and hypertension, and with no drug reactions or allergies. On 20-APR-2011, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not provided) for prevention of shingles. Concomitant therapies included LANTUS, APIDRA, omeprazole (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), metoprolol, COZAAR and CRESTOR. oN 26-MAR-2013, on 29-JUL-2014 and on 22-APR-2015, the patient experienced episodes of shingles, after having received ZOSTAVAX. The patient was treated with VALTREX for the adverse event. Laboratory test was not performed. On an unknown date, the patient sought medical attention. The physician accepted the VZVIP packet. At the time of the reportt, the final patient's outcome was recovering. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Chest X-ray normal, Dyspnoea, Full blood count normal, Metabolic function test normal, Urticaria
Clinical narrative: A spontaneous report was received from a physician regarding a 52 year old female patient with a history of appendectomy and allergy to penicillin. The patient received her third dose of RECOMBIVAX (unknown to the physician when the patient received her first two dose of RECOMBIVAX) on 24MAR2015. A "half hour later" the patient developed shortness of breath and hives. The physician reported that the patient went to the emergency room "right away" after developed the symptoms. The physician reported that the patient recovered from the shortness of breath and hives after she received PEPCID, Prednisone, and BENADRYL and an unspecified nebulizer treatment in the emergency room (ER) on 24MAR2015. Laboratory studies done in the ER on 24MAR2015 included comprehensive metabolic panel (CMP), complete blood count (CBC) and chest x-ray. The physician reported all were normal. The physician stated that the patient was not admitted to the hospital. No further information was provided. Additional information has been requested.