chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Malaise
Clinical narrative: This spontaneous report was received from an 81 year old female patient refers to herself. The patient's pertinent medical history included similar reactions to unspecified steroid medications. Current conditions included unspecified side effects caused by other unspecified medications. On 16-JAN-2014 at 10:30, the patient was vaccinated with ZOSTAVAX injection. Concomitant medications included other unspecified medications that have been taken on a regular basis. The patient explained that after receiving ZOSTAVAX within 5 minutes she became dizzy, felt lightheaded, and had malaise. She felt terrific before receiving the vaccine. Patient stated that the reaction had resolved by 4-5PM the same day. No treatment was given. No laboratory tests were performed. Patient sought medical attention. After being vaccinated the patient contacted her physician who instructed her to lie down for about 1 hour, and therefore she sat in the grocery store for about 1 hour and then drove home, ate, and read until 4-5 PM when she felt that the symptoms had passed. NDC provided: 00006-4963-41. The outcome of lightheaded, malaise and dizzy was reported as recovered/resolved on 16-JAN-2014. Causality assessment was not provided. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: FLU3, HEP, HEPA, FLUX, HEP, HEPA
Symptoms: Hepatitis A antibody positive
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's medical history included asthma with no drug reactions or allergies. The patient was on no concomitant medications. The patient previously had no antibodies to Hepatitis A. On 19-NOV-2013 the patient was vaccinated with VAQTA 25/0.5 U/ML. On 04-DEC-2013, the patient was vaccinated with VAQTA, RECOMBIVAX HB and an unspecified flu shot. The patient later requested testing for sexually transmitted diseases. The physician stated a test for IGM Hepatitis A antibodies were erroneously drawn and the results came back positive. The patient was reported of seeking medical attention. The outcome of IgM Hepatitis A antibodies positive was reported as not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 23 year old female patient. On an unknown date "a couple of years ago", the patient was vaccinated with the first dose of GARDASIL. Lot # and administration route were unknown. On 22-JAN-2014, the patient wished to receive her second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: FLU3
Symptoms: Nausea, Pain, Tremor
Clinical narrative: Received shot 12-18-13. Next day had massive shaking, body aches, nausea, pain etc.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose decreased, Dehydration, Dizziness, Dyspnoea, Gaze palsy
Clinical narrative: Less than five minutes after receiving medication, the patient complained of lightheadedness. He sat down and his eyes rolled into the back of his head, he had labored breathing (not wheezing). His body stiffened. His skin turned ashen The symptoms lasted less than 2 minutes. Ambulance was called. We did not treat him. The medics released him, but his mom took him to the ER where he was treated for low blood sugar and dehydration.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: Less than five minutes after receiving medication, the patient complained of lightheadedness. He sat down and his eyes rolled into the back of his head, he had labored breathing (not wheezing). His body stiffened. His skin turned ashen The symptoms lasted less than 2 minutes. Ambulance was called. We did not treat him. The medics released him, but his mom took him to the ER where he was treated for low blood sugar and dehydration.
Sex: U
Vaccine: FLU3
Symptoms: Injection site inflammation
Clinical narrative: Round 2"-2" localized inflamed area left forearm. No other symptoms.
Sex: U
Vaccine: FLU3
Symptoms: Injection site inflammation
Clinical narrative: Oval 2" by 3 1/2 inch localized inflamed area on left forearm. No other symptoms.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Injection was placed at top of left arm in shoulder, not in muscle, and immediately caused severe pain. Could not lift or move left arm without assistance with right arm. Now, three months later, am still in severe pain and do not have full use of arm. Have started pt to try to get some use of arm back. Can anything be done about this?
Age: 58.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: Patient had vaccine on 12/23/13. She called and reported R arm pain on 12/24/13. We advised Tylenol or Motrin for pain, warm compresses and to call or return if not improving. On 12/26/13 she was hypotensive and referred to an ER.
Age: 58.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypotension, Pain in extremity
Clinical narrative: Patient had vaccine on 12/23/13. She called and reported R arm pain on 12/24/13. We advised Tylenol or Motrin for pain, warm compresses and to call or return if not improving. On 12/26/13 she was hypotensive and referred to an ER.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site reaction, Rash vesicular
Clinical narrative: Pain and blistering at the injection site.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: Pain and blistering at the injection site.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Congenital anomaly, Death, Intestinal malrotation, Intestinal obstruction
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 9 week old male patient. No medical history was provided. On 17-DEC-2013 the patient was vaccinated with the first dose of ROTATEQ (lot number, expiration date were not reported) (suspension 2 ml, orally, indication: 'routine'). Seven days later, on 24-DEC-2013 the patient was hospitalized in medical clinic. The patient was diagnosed with a bowel obstruction and congenital malrotations on an unspecified date approximately in December 2013. The patient died on an unspecified date. The outcome of bowel obstruction and congenital malrotation was not reported. No cause of death reported. The relatedness between the events of bowel obstruction and congenital malrotation and ROTATEQ was not reported. The events of bowel obstruction and congenital malrotation were considered to be life threatening and disabling. Upon internal review the event of congenital malrotation was considered to be congenital anomaly. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Antibody test normal, Blood test abnormal, Candida test positive, Clostridium test positive, Conjunctivitis
Clinical narrative: This literature marketed report as received from a physician refers to a 12 years old male patient. Patient's past medical history was remarkable for DiGeorge syndrome, repaired Tetralogy of Fallot and juvenile idiopathic arthritis diagnosed at 15 months of age, which had been controlled for the past 5 years with weekly injections of the tumor necrosis factor inhibitor etanercept. On an unknown date ten days earlier, the patient was inadvertently vaccinated with MMR (Manufacturer unknown) and VARIVAX (Merck) (Manufacturer unknown), during a well-child visit. With the exception of live virus vaccines, he was otherwise up-to-date with his immunizations. On an unknown date, the patient was admitted to hospital with a 2-day history of tactile fevers, sore throat, rash and conjunctivitis. After he developed the tactile fevers his mother held further doses of etanercept, and he was directly admitted to the hospital. On admission, he was afebrile and appeared well. His examination was remarkable for mild conjunctivitis, palatal petechiae with posterior pharyngeal erythema and a blanching morbilliform rash that was present behind the ears, on the face, neck, back, chest and limbs. Mild post auricular cervical lymphadenopathy was present. There were no Koplik spots or vesicular lesions. Due to the possibility of an atypical varicella rash in a patient on a biologic immunomodulatory medication, intravenous acyclovir was initiated. Both urine and skin samples were positive in triplicate for measles virus by reverse transcription polymerase chain reaction with 100% matched identity. He had recently undergone immune evaluation with a lymphocyte count of 1100 x 109 cells/L, of which the lymphocyte subsets were normal. The lymphocyte mitogen and antigen studies included low normal responses to Candida and phytohemagglutinin and normal responses to tetanus, concanavalin A and pokeweed mitogen. Antibody titers to prior inactivated vaccines were normal. The outcome of tactile fever was unknown. The author stated that although excretion of measles virus in his urine enabled detection and sequencing of the virus as a measles vaccine strain, the diagnosis of vaccine-associated disease was determined from the skin scrapings. Measles virus is present in the skin rash during illness; however, to our knowledge, this is the first reported measles vaccine case in which the vaccine strain was detected and genotyped from the skin rash. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administration error, Lymphadenopathy, Lymphocyte count decreased, Measles antibody, Morbillivirus test positive
Clinical narrative: This literature marketed report as received from a physician refers to a 12 years old male patient. Patient's past medical history was remarkable for DiGeorge syndrome, repaired Tetralogy of Fallot and juvenile idiopathic arthritis diagnosed at 15 months of age, which had been controlled for the past 5 years with weekly injections of the tumor necrosis factor inhibitor etanercept. On an unknown date ten days earlier, the patient was inadvertently vaccinated with MMR (Manufacturer unknown) and VARIVAX (Merck) (Manufacturer unknown), during a well-child visit. With the exception of live virus vaccines, he was otherwise up-to-date with his immunizations. On an unknown date, the patient was admitted to hospital with a 2-day history of tactile fevers, sore throat, rash and conjunctivitis. After he developed the tactile fevers his mother held further doses of etanercept, and he was directly admitted to the hospital. On admission, he was afebrile and appeared well. His examination was remarkable for mild conjunctivitis, palatal petechiae with posterior pharyngeal erythema and a blanching morbilliform rash that was present behind the ears, on the face, neck, back, chest and limbs. Mild post auricular cervical lymphadenopathy was present. There were no Koplik spots or vesicular lesions. Due to the possibility of an atypical varicella rash in a patient on a biologic immunomodulatory medication, intravenous acyclovir was initiated. Both urine and skin samples were positive in triplicate for measles virus by reverse transcription polymerase chain reaction with 100% matched identity. He had recently undergone immune evaluation with a lymphocyte count of 1100 x 109 cells/L, of which the lymphocyte subsets were normal. The lymphocyte mitogen and antigen studies included low normal responses to Candida and phytohemagglutinin and normal responses to tetanus, concanavalin A and pokeweed mitogen. Antibody titers to prior inactivated vaccines were normal. The outcome of tactile fever was unknown. The author stated that although excretion of measles virus in his urine enabled detection and sequencing of the virus as a measles vaccine strain, the diagnosis of vaccine-associated disease was determined from the skin scrapings. Measles virus is present in the skin rash during illness; however, to our knowledge, this is the first reported measles vaccine case in which the vaccine strain was detected and genotyped from the skin rash. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Mouth haemorrhage, Oropharyngeal pain, Pallor, Pharyngeal erythema, Polymerase chain reaction
Clinical narrative: This literature marketed report as received from a physician refers to a 12 years old male patient. Patient's past medical history was remarkable for DiGeorge syndrome, repaired Tetralogy of Fallot and juvenile idiopathic arthritis diagnosed at 15 months of age, which had been controlled for the past 5 years with weekly injections of the tumor necrosis factor inhibitor etanercept. On an unknown date ten days earlier, the patient was inadvertently vaccinated with MMR (Manufacturer unknown) and VARIVAX (Merck) (Manufacturer unknown), during a well-child visit. With the exception of live virus vaccines, he was otherwise up-to-date with his immunizations. On an unknown date, the patient was admitted to hospital with a 2-day history of tactile fevers, sore throat, rash and conjunctivitis. After he developed the tactile fevers his mother held further doses of etanercept, and he was directly admitted to the hospital. On admission, he was afebrile and appeared well. His examination was remarkable for mild conjunctivitis, palatal petechiae with posterior pharyngeal erythema and a blanching morbilliform rash that was present behind the ears, on the face, neck, back, chest and limbs. Mild post auricular cervical lymphadenopathy was present. There were no Koplik spots or vesicular lesions. Due to the possibility of an atypical varicella rash in a patient on a biologic immunomodulatory medication, intravenous acyclovir was initiated. Both urine and skin samples were positive in triplicate for measles virus by reverse transcription polymerase chain reaction with 100% matched identity. He had recently undergone immune evaluation with a lymphocyte count of 1100 x 109 cells/L, of which the lymphocyte subsets were normal. The lymphocyte mitogen and antigen studies included low normal responses to Candida and phytohemagglutinin and normal responses to tetanus, concanavalin A and pokeweed mitogen. Antibody titers to prior inactivated vaccines were normal. The outcome of tactile fever was unknown. The author stated that although excretion of measles virus in his urine enabled detection and sequencing of the virus as a measles vaccine strain, the diagnosis of vaccine-associated disease was determined from the skin scrapings. Measles virus is present in the skin rash during illness; however, to our knowledge, this is the first reported measles vaccine case in which the vaccine strain was detected and genotyped from the skin rash. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash morbilliform
Clinical narrative: This literature marketed report as received from a physician refers to a 12 years old male patient. Patient's past medical history was remarkable for DiGeorge syndrome, repaired Tetralogy of Fallot and juvenile idiopathic arthritis diagnosed at 15 months of age, which had been controlled for the past 5 years with weekly injections of the tumor necrosis factor inhibitor etanercept. On an unknown date ten days earlier, the patient was inadvertently vaccinated with MMR (Manufacturer unknown) and VARIVAX (Merck) (Manufacturer unknown), during a well-child visit. With the exception of live virus vaccines, he was otherwise up-to-date with his immunizations. On an unknown date, the patient was admitted to hospital with a 2-day history of tactile fevers, sore throat, rash and conjunctivitis. After he developed the tactile fevers his mother held further doses of etanercept, and he was directly admitted to the hospital. On admission, he was afebrile and appeared well. His examination was remarkable for mild conjunctivitis, palatal petechiae with posterior pharyngeal erythema and a blanching morbilliform rash that was present behind the ears, on the face, neck, back, chest and limbs. Mild post auricular cervical lymphadenopathy was present. There were no Koplik spots or vesicular lesions. Due to the possibility of an atypical varicella rash in a patient on a biologic immunomodulatory medication, intravenous acyclovir was initiated. Both urine and skin samples were positive in triplicate for measles virus by reverse transcription polymerase chain reaction with 100% matched identity. He had recently undergone immune evaluation with a lymphocyte count of 1100 x 109 cells/L, of which the lymphocyte subsets were normal. The lymphocyte mitogen and antigen studies included low normal responses to Candida and phytohemagglutinin and normal responses to tetanus, concanavalin A and pokeweed mitogen. Antibody titers to prior inactivated vaccines were normal. The outcome of tactile fever was unknown. The author stated that although excretion of measles virus in his urine enabled detection and sequencing of the virus as a measles vaccine strain, the diagnosis of vaccine-associated disease was determined from the skin scrapings. Measles virus is present in the skin rash during illness; however, to our knowledge, this is the first reported measles vaccine case in which the vaccine strain was detected and genotyped from the skin rash. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Blood test normal, Computerised tomogram, Electromyogram, Gait disturbance
Clinical narrative: Numbness to hands, feet, mouth.  Severe weakness in legs, elevated blood pressure, trouble walking. EMG test was done to confirm GBS.  Plasmapheresis treatments done with PCAD in place.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Muscular weakness, Plasmapheresis
Clinical narrative: Numbness to hands, feet, mouth.  Severe weakness in legs, elevated blood pressure, trouble walking. EMG test was done to confirm GBS.  Plasmapheresis treatments done with PCAD in place.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood lactic acid, Blood potassium normal
Clinical narrative: Sharp pains in the left upper arm where vaccine was administered that spread gradually to lower arm, hand, and neck. Patient had tenderness of the arm and limited active range of motion. Patient developed chills, but was afebrile. She was admitted on 1/24/14 to ICU, and administered morphine 4 mg/mL 3 mg IVP q4hr PRN pain and acetaminophen 1,000 mg PO q6 hr PRN pain and chills. Patient's arm improved significantly and she was discharged 1/25/14.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Blood sodium normal, Blood urea increased, Carbon dioxide normal, Chills, Haematocrit normal
Clinical narrative: Sharp pains in the left upper arm where vaccine was administered that spread gradually to lower arm, hand, and neck. Patient had tenderness of the arm and limited active range of motion. Patient developed chills, but was afebrile. She was admitted on 1/24/14 to ICU, and administered morphine 4 mg/mL 3 mg IVP q4hr PRN pain and acetaminophen 1,000 mg PO q6 hr PRN pain and chills. Patient's arm improved significantly and she was discharged 1/25/14.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Haemoglobin normal, Injection site pain, Intensive care, Joint range of motion decreased, Neck pain
Clinical narrative: Sharp pains in the left upper arm where vaccine was administered that spread gradually to lower arm, hand, and neck. Patient had tenderness of the arm and limited active range of motion. Patient developed chills, but was afebrile. She was admitted on 1/24/14 to ICU, and administered morphine 4 mg/mL 3 mg IVP q4hr PRN pain and acetaminophen 1,000 mg PO q6 hr PRN pain and chills. Patient's arm improved significantly and she was discharged 1/25/14.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Platelet count normal, Tenderness, Troponin normal, White blood cell count increased
Clinical narrative: Sharp pains in the left upper arm where vaccine was administered that spread gradually to lower arm, hand, and neck. Patient had tenderness of the arm and limited active range of motion. Patient developed chills, but was afebrile. She was admitted on 1/24/14 to ICU, and administered morphine 4 mg/mL 3 mg IVP q4hr PRN pain and acetaminophen 1,000 mg PO q6 hr PRN pain and chills. Patient's arm improved significantly and she was discharged 1/25/14.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Erysipelas, Injection site cellulitis, Injection site reaction
Clinical narrative: Patient demonstrates mild cellulitis versus erysipelas of the left anterior thigh secondary to an injection.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cheilitis, Dizziness, Headache, Injection site discolouration, Injection site induration
Clinical narrative: This spontaneous report as received from a consumer refers to an approximate 54 year old female patient with systemic lupus erythematosus and sulfa drug allergy. On 10-JAN-2014, the patient was vaccinated with PNEUMOVAX23 lot # J009827, expiry date 10-AUG-2014 in the left arm. Concomitant therapies included SYNTHROID, FLUZONE (taken on 10-JAN-2014; (manufactured by Sanofi Pasteur)) and FETZIMA. On 11-JAN-2014, the patient had fever of 102 degree; lips and throat are itchy, headaches, injection site lumpy (She now has two lumps at the injection site on the left arm), hard, purple colored, sensitive to the touch of clothing, itchy, warm, and swollen and patient was dizzy. Last night she stated that the itchiness at the injection site was intense. The outcome of the events was reported as not recovered. Causality assessment was assessed as related to PNEUMOVAX23 as patient reported that the side effects, she was experiencing from PNEUMOVAX23 shot. Patient sought medical attention by seeing the physician. Product quality issue was not involved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to an approximate 54 year old female patient with systemic lupus erythematosus and sulfa drug allergy. On 10-JAN-2014, the patient was vaccinated with PNEUMOVAX23 lot # J009827, expiry date 10-AUG-2014 in the left arm. Concomitant therapies included SYNTHROID, FLUZONE (taken on 10-JAN-2014; (manufactured by Sanofi Pasteur)) and FETZIMA. On 11-JAN-2014, the patient had fever of 102 degree; lips and throat are itchy, headaches, injection site lumpy (She now has two lumps at the injection site on the left arm), hard, purple colored, sensitive to the touch of clothing, itchy, warm, and swollen and patient was dizzy. Last night she stated that the itchiness at the injection site was intense. The outcome of the events was reported as not recovered. Causality assessment was assessed as related to PNEUMOVAX23 as patient reported that the side effects, she was experiencing from PNEUMOVAX23 shot. Patient sought medical attention by seeing the physician. Product quality issue was not involved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Throat irritation
Clinical narrative: This spontaneous report as received from a consumer refers to an approximate 54 year old female patient with systemic lupus erythematosus and sulfa drug allergy. On 10-JAN-2014, the patient was vaccinated with PNEUMOVAX23 lot # J009827, expiry date 10-AUG-2014 in the left arm. Concomitant therapies included SYNTHROID, FLUZONE (taken on 10-JAN-2014; (manufactured by Sanofi Pasteur)) and FETZIMA. On 11-JAN-2014, the patient had fever of 102 degree; lips and throat are itchy, headaches, injection site lumpy (She now has two lumps at the injection site on the left arm), hard, purple colored, sensitive to the touch of clothing, itchy, warm, and swollen and patient was dizzy. Last night she stated that the itchiness at the injection site was intense. The outcome of the events was reported as not recovered. Causality assessment was assessed as related to PNEUMOVAX23 as patient reported that the side effects, she was experiencing from PNEUMOVAX23 shot. Patient sought medical attention by seeing the physician. Product quality issue was not involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who is also a patient via company representative. No relevant medical history was reported. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route and lot number was not reported). On an unknown date, the nurse reported that she had about 10 hepatitis b vaccinations. The nurse could not rule out RECOMBIVAX. It was unspecified as to why she had so many doses. The patient did not confirm that she had negative titers. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-MAR-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 0975AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to an about 80 year old male patient. About a week ago, approximately on 08-JAN-2014 the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose and route unknown). The pharmacist reported that the patient developed a varicella like rash on his stomach about 3 days after vaccination with ZOSTAVAX, approximately on 11-JAN-2014. The patient contacted pharmacist. The outcome of varicella like rash on his stomach was reported as not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 17 year old female patient. On 05-NOV-2013 the patient was vaccinated with VARIVAX (Merck) by her unspecified general health care provider. No concomitant medications, pertinent medical history or drug allergies. The patient was subsequently determined to be pregnant. The date of last menstrual period was 08-SEP-2013 and estimated date of delivery was 15-JUN-2014. Initial exposure to VARIVAX (Merck) was at 8 week(s). The pregnancy outcome was pending. The patient had her first obstetrical evaluation with the nurse practitioner on 22-JAN-2014. On 22-JAN-2014, the patient had a positive pregnancy urine test, an ultrasound revealed a pregnancy of 19 weeks 3 days gestation. No problems reported. No treatment was provided. The patient sought medical attention by making an office visit. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 74 year old male patient. The patient had no known drug reactions/allergies. On 09-JAN-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expire date, route, strength dose and indication not reported). Concomitant therapies included COUMADIN. The healthcare worker reported that the patient called the pharmacy today (on 15-JAN-2014) with "questions regarding ZOSTAVAX" and "in passing stated that he has a rash". The healthcare worker could not provide details of the rash and she did not know if the rash was related to the ZOSTAVAX administration. The healthcare worker did not know the location of the rash and also stated that "he may have had the rash prior to the administration of ZOSTAVAX." At the time of reporting, the outcome of the rash was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-DEC-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 0975AA, expiry date unknown), (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reproted that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 08-OCT-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-JAN-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0975AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. 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 pharmacist refers to a patient of unknown age and gender (no demographic information was provided). No information regarding the patient's medical history was provided. On 23-JAN-2014 the patient was vaccinated with ZOSTAVAX, with valid lot # J000492, which had been expired (expiration date 19-JAN-2014). No concomitant medication was reported. No adverse effects were reported. No outcome was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 21-JUN-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-AUG-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 0435AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 10-AUG-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 0435AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 29-NOV-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-DEC-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 31-JAN-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Intercepted medication error, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient. On date of this report (24-JAN-2014) the patient was 72 years old. No information regarding the patient's medical history was provided. It was reported that on an unspecified date the patient may have received the first dose of PNEUMOVAX23 injection. Route was not reported. No concomitant medication was reported. On 24-JAN-2014 the patient came to the pharmacy for her second injection. No vaccine was administered. No adverse effects were reported. No outcome was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-FEB-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Fungal infection, Haematuria, Hyperglycaemia, Hyponatraemia, Influenza
Clinical narrative: 11/1/13 - Hyperglycemia, renal function worse, UTI, fungal infection, hyponatremia 11/11/13 hematuria; 1/03/14 pneumonia sepsis, respiratory distress; influenza a positive.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Pneumococcal sepsis, Polymerase chain reaction, Renal impairment, Respiratory distress
Clinical narrative: 11/1/13 - Hyperglycemia, renal function worse, UTI, fungal infection, hyponatremia 11/11/13 hematuria; 1/03/14 pneumonia sepsis, respiratory distress; influenza a positive.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Urinary tract infection
Clinical narrative: 11/1/13 - Hyperglycemia, renal function worse, UTI, fungal infection, hyponatremia 11/11/13 hematuria; 1/03/14 pneumonia sepsis, respiratory distress; influenza a positive.
Age: 18.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Dehydration, Fatigue, Pyrexia
Clinical narrative: Rc'd FLUMIST 12-12-13. Developed fever, cough severe dehydration, fatigue 12-18-13 required admission to ER for rehydration.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Guillain-Barre syndrome, Hypoaesthesia, Pain in extremity
Clinical narrative: Pain in legs, half of face numb. Could not walk. Spread to my stomach and back and hands numb. Dr said I had Guillain Barre. Started treatment and that stopped it from moving to my lungs. This condition was from getting the flu shot. No illness prior.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-FEB-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-FEB-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old male patient. Patient's medical history was not provided. On 02-AUG-2012, the patient was vaccinated with VAQTA injection 50/1.0 U/ML, dose 1, 0.5 ml, intramuscular. On 10-DEC-2013, the patient was vaccinated with VAQTA dose 2, 0.5 ml, intramuscular. Patient's concomitant medications were not reported. On 10-DEC-2013, the patient was administered a second dose of pediatric dose instead of the indicated adult dose. No adverse effects reported. No further information provided. The outcome of patient was administered a second dose of pediatric dose instead of the indicated adult dose and no adverse event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 15-NOV-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report refers to a 58 year old female patient. The patient's medical history included shingles. Physician called and stated that she had administered ZOSTAVAX to an unspecified 58 year old female patient that had a prior history of shingles, on November 2013 on an unspecified day. The patient developed a case of shingles on December 2013 on an unspecified day. The patient was recovered from the case of shingles on an unspecified date. Patient stated that she had quite a bit of pain in addition to the herpetic rash. The patient sought medical attention. The rash was only in a small concentrated area on an unspecified part of the patient's body. Patient also stated that the rash lasted a much shorter duration than in the past, prior to receiving ZOSTAVAX. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a patient's mother refers to her approximately 14 year old daughter with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with the first and the second dose of GARDASIL (lot # not reported) (dosage and route not reported) on 21-AUG-2012 and in December 2013. No concomitant medication. The reporter reported that her daughter had been losing hair since shortly after the first GARDASIL vaccination in December 2012. She had a second GARDASIL vaccination in December 2013 and even more hair was coming out. The hair loss was not from a specific location in her scalp. It was from all over, and it was coming out by the roots. It looked thin. No treatment was given for the events. No lab diagnostics studies were performed. The patient sought medical attention via doctor visit. The outcome was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-APR-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 0975AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 24-JUL-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Labelled drug-drug interaction medication error, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 PFU. Lot number, dose, route and frequency were not provided). On an unknown date the patient was taking VALREX when he received ZOSTAVAX. No adverse effect was reported. The action taken regarding ZOSTAVAX was unknown. The outcome of patient was taking VALTREX when he received ZOSTAVAX was unknown. The reporter causality was unknown. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a male patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB dose 3 (dose, frequency, route and therapy type not provided). No concomitant medications were reported. On an unknown date the patient's titres showed less than 3. Patient sought medical attention (office visit). Patient was not hospitalized. There was no significant disability and there was no medical or surgical intervention required. No product quality complaint was involved. The outcome of the event was unknown. The report is lined to 1401USA011517 (same reporter link). Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a female patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB dose 3 (dose, frequency, route and therapy type not provided). No concomitant medications were reported. On an unknown date the patient's titer showed less than 3. Patient sought medical attention (office visit). Patient was not hospitalized. There was no significant disability and there was no medical or surgical intervention required. No product quality complaint was involved. the outcome of the event was unknown. The case is related to 1401USA011778 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 30-JUL-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 1909AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of many reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Rash
Clinical narrative: Rash and cellulitis.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 04-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0975AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.