chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Cellulitis, Discomfort, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received a 62 year old female nurse reporting on herself. The patient had allergy to penicillin. Concomitant medication included lansoprazole(PREVACID) and levothyroxine sodium (manufacturer unknown). On 14-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N009167 and expiration date 02-FEB-2018 , subcutaneously for immunization; in combination with sterile diluent(DILUENT MRK). The patient stated that she ended up having cellulitis around injection site. She reported that right after vaccination, she felt little sore and noticed redness around injection site with no other symptoms. However, by following day on 15-JUN-2017, redness started spreading and area was swollen, painful and hot to touch and top layer of the affected area started forming blisters. By Friday, on 16-JUN-2017, the area was almost size of a tangerine (about 6 inches in length, 5 inches in diameter) under her skin. The patient went to see her physician and was diagnosed with acute cellulitis. Consequently, amoxicillin, clavulanate potassium(AUGMENTIN) 500 mg twice daily was prescribed. No laboratory diagnostic studies were performed. At the time of reporting cellulitis was almost resolved and "now" just a nickel size of hardened area was still present. The Nurse also reported that she got little soreness and redness after receiving flu vaccine (manufacturer unspecified). The causality between the events and ZOSTAVAX and sterile diluent(DILUENT MRK) was not provided. Upon internal review cellulitis was considered as medically significant event. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site mass, Rash, Skin warm, Vaccination complication
Clinical narrative: This spontaneous report as received a 62 year old female nurse reporting on herself. The patient had allergy to penicillin. Concomitant medication included lansoprazole(PREVACID) and levothyroxine sodium (manufacturer unknown). On 14-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N009167 and expiration date 02-FEB-2018 , subcutaneously for immunization; in combination with sterile diluent(DILUENT MRK). The patient stated that she ended up having cellulitis around injection site. She reported that right after vaccination, she felt little sore and noticed redness around injection site with no other symptoms. However, by following day on 15-JUN-2017, redness started spreading and area was swollen, painful and hot to touch and top layer of the affected area started forming blisters. By Friday, on 16-JUN-2017, the area was almost size of a tangerine (about 6 inches in length, 5 inches in diameter) under her skin. The patient went to see her physician and was diagnosed with acute cellulitis. Consequently, amoxicillin, clavulanate potassium(AUGMENTIN) 500 mg twice daily was prescribed. No laboratory diagnostic studies were performed. At the time of reporting cellulitis was almost resolved and "now" just a nickel size of hardened area was still present. The Nurse also reported that she got little soreness and redness after receiving flu vaccine (manufacturer unspecified). The causality between the events and ZOSTAVAX and sterile diluent(DILUENT MRK) was not provided. Upon internal review cellulitis was considered as medically significant event. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received a 62 year old female nurse reporting on herself. The patient had allergy to penicillin. Concomitant medication included lansoprazole(PREVACID) and levothyroxine sodium (manufacturer unknown). On 14-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N009167 and expiration date 02-FEB-2018 , subcutaneously for immunization; in combination with sterile diluent(DILUENT MRK). The patient stated that she ended up having cellulitis around injection site. She reported that right after vaccination, she felt little sore and noticed redness around injection site with no other symptoms. However, by following day on 15-JUN-2017, redness started spreading and area was swollen, painful and hot to touch and top layer of the affected area started forming blisters. By Friday, on 16-JUN-2017, the area was almost size of a tangerine (about 6 inches in length, 5 inches in diameter) under her skin. The patient went to see her physician and was diagnosed with acute cellulitis. Consequently, amoxicillin, clavulanate potassium(AUGMENTIN) 500 mg twice daily was prescribed. No laboratory diagnostic studies were performed. At the time of reporting cellulitis was almost resolved and "now" just a nickel size of hardened area was still present. The Nurse also reported that she got little soreness and redness after receiving flu vaccine (manufacturer unspecified). The causality between the events and ZOSTAVAX and sterile diluent(DILUENT MRK) was not provided. Upon internal review cellulitis was considered as medically significant event. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site vesicles, Injection site warmth, Pain
Clinical narrative: This spontaneous report as received a 62 year old female nurse reporting on herself. The patient had allergy to penicillin. Concomitant medication included lansoprazole(PREVACID) and levothyroxine sodium (manufacturer unknown). On 14-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N009167 and expiration date 02-FEB-2018 , subcutaneously for immunization; in combination with sterile diluent(DILUENT MRK). The patient stated that she ended up having cellulitis around injection site. She reported that right after vaccination, she felt little sore and noticed redness around injection site with no other symptoms. However, by following day on 15-JUN-2017, redness started spreading and area was swollen, painful and hot to touch and top layer of the affected area started forming blisters. By Friday, on 16-JUN-2017, the area was almost size of a tangerine (about 6 inches in length, 5 inches in diameter) under her skin. The patient went to see her physician and was diagnosed with acute cellulitis. Consequently, amoxicillin, clavulanate potassium(AUGMENTIN) 500 mg twice daily was prescribed. No laboratory diagnostic studies were performed. At the time of reporting cellulitis was almost resolved and "now" just a nickel size of hardened area was still present. The Nurse also reported that she got little soreness and redness after receiving flu vaccine (manufacturer unspecified). The causality between the events and ZOSTAVAX and sterile diluent(DILUENT MRK) was not provided. Upon internal review cellulitis was considered as medically significant event. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Cellulitis
Clinical narrative: This spontaneous report as received a 62 year old female nurse reporting on herself. The patient had allergy to penicillin. Concomitant medication included lansoprazole(PREVACID) and levothyroxine sodium (manufacturer unknown). On 14-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N009167 and expiration date 02-FEB-2018 , subcutaneously for immunization; in combination with sterile diluent(DILUENT MRK). The patient stated that she ended up having cellulitis around injection site. She reported that right after vaccination, she felt little sore and noticed redness around injection site with no other symptoms. However, by following day on 15-JUN-2017, redness started spreading and area was swollen, painful and hot to touch and top layer of the affected area started forming blisters. By Friday, on 16-JUN-2017, the area was almost size of a tangerine (about 6 inches in length, 5 inches in diameter) under her skin. The patient went to see her physician and was diagnosed with acute cellulitis. Consequently, amoxicillin, clavulanate potassium(AUGMENTIN) 500 mg twice daily was prescribed. No laboratory diagnostic studies were performed. At the time of reporting cellulitis was almost resolved and "now" just a nickel size of hardened area was still present. The Nurse also reported that she got little soreness and redness after receiving flu vaccine (manufacturer unspecified). The causality between the events and ZOSTAVAX and sterile diluent(DILUENT MRK) was not provided. Upon internal review cellulitis was considered as medically significant event. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Bacterial test negative, CSF glucose normal, CSF lymphocyte count abnormal
Clinical narrative: Pt developed symptoms lethargy & fever, went to urgent care(no findings). 6/24 Parent noticed pt's gait to be unsteady, and speech was slurred, went to ER, Dx with atypical febrile seizure & presumed UTI d/t WBC in her urine.  Subsequent urine & C+S neg. sent home on Omnicef. 6/26/17 Presented to office afebrile, sleepy but normal speech pattern and gait was slightly unsteady.  CBC done in office showed an elevated WBC of 20.4 w/ 82% polys, was given 750 mg of Rocephin IM and told to F/U in 24hrs.  Pt went home where she became increasingly lethargic, speech began to slur, and gait became unsteady. Went to ER at Winthrop Univ. Hospital and was admitted with dx of ADEM vs Encephalitis , started on IVIG & Steroid, pt improved and was d/c on 7.3/17
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: CSF monocyte count decreased, CSF neutrophil count increased, CSF protein normal, CSF red blood cell count positive, CSF white blood cell count increased
Clinical narrative: Pt developed symptoms lethargy & fever, went to urgent care(no findings). 6/24 Parent noticed pt's gait to be unsteady, and speech was slurred, went to ER, Dx with atypical febrile seizure & presumed UTI d/t WBC in her urine.  Subsequent urine & C+S neg. sent home on Omnicef. 6/26/17 Presented to office afebrile, sleepy but normal speech pattern and gait was slightly unsteady.  CBC done in office showed an elevated WBC of 20.4 w/ 82% polys, was given 750 mg of Rocephin IM and told to F/U in 24hrs.  Pt went home where she became increasingly lethargic, speech began to slur, and gait became unsteady. Went to ER at Winthrop Univ. Hospital and was admitted with dx of ADEM vs Encephalitis , started on IVIG & Steroid, pt improved and was d/c on 7.3/17
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Computerised tomogram head normal, Culture urine negative, Electroencephalogram abnormal, Encephalitis viral, Enterovirus test negative
Clinical narrative: Pt developed symptoms lethargy & fever, went to urgent care(no findings). 6/24 Parent noticed pt's gait to be unsteady, and speech was slurred, went to ER, Dx with atypical febrile seizure & presumed UTI d/t WBC in her urine.  Subsequent urine & C+S neg. sent home on Omnicef. 6/26/17 Presented to office afebrile, sleepy but normal speech pattern and gait was slightly unsteady.  CBC done in office showed an elevated WBC of 20.4 w/ 82% polys, was given 750 mg of Rocephin IM and told to F/U in 24hrs.  Pt went home where she became increasingly lethargic, speech began to slur, and gait became unsteady. Went to ER at Winthrop Univ. Hospital and was admitted with dx of ADEM vs Encephalitis , started on IVIG & Steroid, pt improved and was d/c on 7.3/17
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Facial paralysis, Fatigue, Gait disturbance, Herpes simplex test negative, Immunoglobulin therapy
Clinical narrative: Pt developed symptoms lethargy & fever, went to urgent care(no findings). 6/24 Parent noticed pt's gait to be unsteady, and speech was slurred, went to ER, Dx with atypical febrile seizure & presumed UTI d/t WBC in her urine.  Subsequent urine & C+S neg. sent home on Omnicef. 6/26/17 Presented to office afebrile, sleepy but normal speech pattern and gait was slightly unsteady.  CBC done in office showed an elevated WBC of 20.4 w/ 82% polys, was given 750 mg of Rocephin IM and told to F/U in 24hrs.  Pt went home where she became increasingly lethargic, speech began to slur, and gait became unsteady. Went to ER at Winthrop Univ. Hospital and was admitted with dx of ADEM vs Encephalitis , started on IVIG & Steroid, pt improved and was d/c on 7.3/17
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Intensive care, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction, Pyrexia, Scan with contrast abnormal
Clinical narrative: Pt developed symptoms lethargy & fever, went to urgent care(no findings). 6/24 Parent noticed pt's gait to be unsteady, and speech was slurred, went to ER, Dx with atypical febrile seizure & presumed UTI d/t WBC in her urine.  Subsequent urine & C+S neg. sent home on Omnicef. 6/26/17 Presented to office afebrile, sleepy but normal speech pattern and gait was slightly unsteady.  CBC done in office showed an elevated WBC of 20.4 w/ 82% polys, was given 750 mg of Rocephin IM and told to F/U in 24hrs.  Pt went home where she became increasingly lethargic, speech began to slur, and gait became unsteady. Went to ER at Winthrop Univ. Hospital and was admitted with dx of ADEM vs Encephalitis , started on IVIG & Steroid, pt improved and was d/c on 7.3/17
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Shift to the left, Speech disorder, Urinary tract infection, White blood cell count increased
Clinical narrative: Pt developed symptoms lethargy & fever, went to urgent care(no findings). 6/24 Parent noticed pt's gait to be unsteady, and speech was slurred, went to ER, Dx with atypical febrile seizure & presumed UTI d/t WBC in her urine.  Subsequent urine & C+S neg. sent home on Omnicef. 6/26/17 Presented to office afebrile, sleepy but normal speech pattern and gait was slightly unsteady.  CBC done in office showed an elevated WBC of 20.4 w/ 82% polys, was given 750 mg of Rocephin IM and told to F/U in 24hrs.  Pt went home where she became increasingly lethargic, speech began to slur, and gait became unsteady. Went to ER at Winthrop Univ. Hospital and was admitted with dx of ADEM vs Encephalitis , started on IVIG & Steroid, pt improved and was d/c on 7.3/17
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Acute disseminated encephalomyelitis, CSF white blood cell count increased, Culture urine negative, Dysarthria, Encephalitis
Clinical narrative: Pt developed symptoms lethargy & fever, went to urgent care(no findings). 6/24 Parent noticed pt's gait to be unsteady, and speech was slurred, went to ER, Dx with atypical febrile seizure & presumed UTI d/t WBC in her urine.  Subsequent urine & C+S neg. sent home on Omnicef. 6/26/17 Presented to office afebrile, sleepy but normal speech pattern and gait was slightly unsteady.  CBC done in office showed an elevated WBC of 20.4 w/ 82% polys, was given 750 mg of Rocephin IM and told to F/U in 24hrs.  Pt went home where she became increasingly lethargic, speech began to slur, and gait became unsteady. Went to ER at Winthrop Univ. Hospital and was admitted with dx of ADEM vs Encephalitis , started on IVIG & Steroid, pt improved and was d/c on 7.3/17
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Febrile convulsion, Gait disturbance, Immunoglobulin therapy, Lethargy, Neutrophil percentage increased
Clinical narrative: Pt developed symptoms lethargy & fever, went to urgent care(no findings). 6/24 Parent noticed pt's gait to be unsteady, and speech was slurred, went to ER, Dx with atypical febrile seizure & presumed UTI d/t WBC in her urine.  Subsequent urine & C+S neg. sent home on Omnicef. 6/26/17 Presented to office afebrile, sleepy but normal speech pattern and gait was slightly unsteady.  CBC done in office showed an elevated WBC of 20.4 w/ 82% polys, was given 750 mg of Rocephin IM and told to F/U in 24hrs.  Pt went home where she became increasingly lethargic, speech began to slur, and gait became unsteady. Went to ER at Winthrop Univ. Hospital and was admitted with dx of ADEM vs Encephalitis , started on IVIG & Steroid, pt improved and was d/c on 7.3/17
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Somnolence, White blood cell count increased, White blood cells urine positive
Clinical narrative: Pt developed symptoms lethargy & fever, went to urgent care(no findings). 6/24 Parent noticed pt's gait to be unsteady, and speech was slurred, went to ER, Dx with atypical febrile seizure & presumed UTI d/t WBC in her urine.  Subsequent urine & C+S neg. sent home on Omnicef. 6/26/17 Presented to office afebrile, sleepy but normal speech pattern and gait was slightly unsteady.  CBC done in office showed an elevated WBC of 20.4 w/ 82% polys, was given 750 mg of Rocephin IM and told to F/U in 24hrs.  Pt went home where she became increasingly lethargic, speech began to slur, and gait became unsteady. Went to ER at Winthrop Univ. Hospital and was admitted with dx of ADEM vs Encephalitis , started on IVIG & Steroid, pt improved and was d/c on 7.3/17
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Eye movement disorder, Eyelid ptosis
Clinical narrative: Drooping left eye. Gaze off-center.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Mobility decreased, Muscle fatigue, Myalgia
Clinical narrative: Pt came in after weekend complain of joint and muscle pain after anthrax vaccine on 7/7/2017. Pt stated he was unable to move or hardly function over the weekend. The pt said the muscle fatigue is gone it just joint pain in both arms and knees. Pt had no redness, swelling, or tightness at injection area.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Within 18 hours patient had intense pain, induration and erythema on wide area surrounding injection site. On exam 7/7/17 left deltoid was warm, tender, 10cm dia area of blanching erythema with mild induration, full range of motion, normal distal sensation and perfusion, normal grip strength.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pallor
Clinical narrative: Within 18 hours patient had intense pain, induration and erythema on wide area surrounding injection site. On exam 7/7/17 left deltoid was warm, tender, 10cm dia area of blanching erythema with mild induration, full range of motion, normal distal sensation and perfusion, normal grip strength.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Note from M.D. - This 13 year old male is accompanied by his father with complaint of hives reaction over torso after receiving two injections yesterday at the Health Department. Patient has marked itching over chest and back. The raised rash was first noted upon waking this morning. No other complaints. Rash likely linked to immunizations received yesterday.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 2 month old patient of unknown gender. On an unknown date in 2009, the patient was vaccinated with ROTATEQ, orally (dose, lot # and expiration date were not provided). On an unknown date, the patient experienced diarrhoea and vomiting. The outcome of diarrhoea and vomiting was reported as recovered/resolved. The relatedness between the adverse events and ROTATEQ was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 30-MAY-2017, the patient was vaccinated with one single dose of PROQUAD injection, lot # M026879 with expiry date on 27-NOV-2017, subcutaneously for prophylaxis. Concomitant therapies included properly stored STERILE DILUENT used to reconstitute the dose of PROQUAD. Administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit for 8 hours. There was also a previous temperature excursion reported, with 19 degrees Fahrenheit for 12 hours. Data logger was involved in recording the excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 06-JUN-2017 the patient was vaccinated with VARIVAX lot # L020001 for prophylaxis. Concomitant therapies included sterile diluent lot # M014698. On 06-JUN-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to VARIVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 07-JUN-2017, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally, lot # M039061 with expiration date of 28-APR-2018 (dose was not reported). The vaccine experienced temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Digital data logger was involved in recording the excursion. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza, Injection site rash, Pain, Rash vesicular
Clinical narrative: This spontaneous report was received from a 60 year old female patient, who was also a registered nurse and was reporting on herself. The patient did not have any pertinent medical history, drug reactions or allergies and did not take any concomitant medications. On 04-JUN-2017, the patient was vaccinated with ZOSTAVAX injection, 19400 plaque-forming units(PFU), subcutaneously (dose, lot # and expiration date were not reported). The ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown). On 06-JUN-2017, the patient developed a rash at the injection site, which worsened. The rash looked like shingles, and did not feel good. On the same date, the patient also experienced flu symptoms, congestion and little body aches. The patient sought medical attention by calling a physician's office on 07-JUN-2017. No treatment was given for the adverse events and no laboratory diagnostic studies were performed. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information is not expected as no permission to contact the physician was given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a 60 year old female patient, who was also a registered nurse and was reporting on herself. The patient did not have any pertinent medical history, drug reactions or allergies and did not take any concomitant medications. On 04-JUN-2017, the patient was vaccinated with ZOSTAVAX injection, 19400 plaque-forming units(PFU), subcutaneously (dose, lot # and expiration date were not reported). The ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown). On 06-JUN-2017, the patient developed a rash at the injection site, which worsened. The rash looked like shingles, and did not feel good. On the same date, the patient also experienced flu symptoms, congestion and little body aches. The patient sought medical attention by calling a physician's office on 07-JUN-2017. No treatment was given for the adverse events and no laboratory diagnostic studies were performed. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information is not expected as no permission to contact the physician was given.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with ZOSTAVAX, lot # M037655 with expiry date on 29-NOV-2017 (dose and route of administration were not reported) for prophylaxis. Administered doses of vaccines experienced an excursion of unknown temperature for 48 hours. The previous temperature excursion of 10 degrees Fahrenheit for 19 hours was also reported (it was unknown if the vaccines which experienced previous excursion were administered to the patients). Data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000400: US-009507513-1707USA000401.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who referred to an unspecified number of patients of unknown demographics. No information regarding the patient's pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot# L037559 and expiration date: 29-SEP-2017; dose, route of administration and anatomical location were not reported) as prophylaxis. The vaccines were stored at 21 degrees Fahrenheit (F) for 1 hour with a previous temperature excursion of 8 degrees Celsius (C) for 1 hour. The temperature excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003439.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who referred to an unspecified number of patients of unknown demographics. No information regarding the patient's pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot# M035694 and expiration date: 07-NOV-2017; dose, route of administration and anatomical location were not reported) as prophylaxis. The vaccines were stored at 21 degrees Fahrenheit (F) for 1 hour with a previous temperature excursion of 8 degrees Celsius (C) for 1 hour. The temperature excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003438.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. No information on the patients' pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with PROQUAD, lot # M043310 with expiry date on 22-APR-2018, lot # M044575 with expiry date on 04-MAY-2018, lot # M043306 with expiry date on 24-APR-2018, lot # N004631 with expiry date on 07-AUG-2018 (albumin status: recombinant human albumin), lot # M042499 with expiry date on 17-APR-2018 and lot # M049122 with expiry date on 13-JUN-2018 (albumin status: recombinant human albumin) (dose and route of administration were not reported) for prophylaxis. The doses of vaccine were reconstituted with properly stored MERCK STERILE DILUENT. Administered doses of vaccine experienced a temperature excursion between 15 and 46 degrees Fahrenheit for 1 hours 28 minutes. There was no previous temperature excursion reported. Data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000413.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 16-MAY-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L040419 for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000409: US-009507513-1707USA000411: US-009507513-1707USA000412: US-009507513-1707USA000407: US-009507513-1707USA000410: US-009507513-1707USA000408.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information on the patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported. On 07-JUN-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # L019989 with expiry date on 01-JUN-2017; dose and route of administration were not reported) for prophylaxis. This was supported as per stability memo. No adverse effects were reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a 53-year-old female patient who was reporting on herself. The patient did not have any pertinent medical history and known drug reactions or allergies. She declined to provide information concerning concomitant medications. On 06-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot number and expiration date were not reported), for prevention of shingles. On the evening of 07-JUN-2017, she noticed that her arm was red at the injection site, had a hard lump and was tender to the touch. The patient did not receive treatment for the events. There was no lab diagnostic tests performed. At the time of this report, she did not report these events to her health provider. No product quality complaint (PQC) was involved. The outcome of the events and the relatedness between the events and ZOSTAVAX were not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on the patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported. On 06-JUN-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB injection, lot # M045653 with expiry date on 03-JUL-2019 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 12.6 degrees Celsius for 1 hour 45 minutes. There were no previous temperature excursions reported. Data logger was involved in recording the excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, who referred to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient received two pediatric doses of VAQTA 25U/0.5 ml, 1ml (lot # M039202 and expiration date: 11-MAR-2018; indication defaulted to prophylaxis; route of administration not reported) to equal one adult dose. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Drug dose omission, Product expiration date issue, Product supply issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II for prophylaxis. On an unknown date the patient experienced drug dose omission, product supply issue, product expiration date issue and circumstance or information capable of leading to medication error. The outcome of drug dose omission, product supply issue, product expiration date issue and circumstance or information capable of leading to medication error is unknown. The reporter considered drug dose omission, product supply issue, product expiration date issue and circumstance or information capable of leading to medication error to be not related to M-M-R II. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 45 year old female patient. The patient's medical history, drug reactions or allergies, and concurrent conditions were not reported. On 07-JUN-2017, the patient was inadvertently vaccinated with a single dose of PROQUAD injection, by subcutaneous route, lot number M041082, expiration date: 04-APR-2018  for prophylaxis. This vaccine was reconstitued with diluent MRK (lot # and expiration date were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality compalint was involved.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-JUN-2017, the patient was inadvertently vaccinated with an expired dose of VAQTA injection, lot number M034893, expiration date: 26-MAY-2017 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported and not product quality complaint (PQC) was involved. It was unknown if the patient sought medical attention.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant medications was provided. On unknown dates since 06-MAR-2017, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot # M040141, expiration date: 27-MAR-2018, albumin status: recombinant human albumin (rHA); lot # M036158, expiration date: 12-FEB-2018, albumin status: rHA; lot # M014301, expiration date: 22-SEP-2017; albumin status: rHA; exact doses and route of administration were not reported). Vaccines were reconstituted with well-stored MERCK STERILE DILUENT. The reporter stated that the administered doses of PROQUAD were stored at temperature between 15 to 46 degrees Fahrenheit (F) for 9 hours on unknown dates. Data logger was used to detect temperature excursions. There were no previous excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA015652.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, referring to a currently 56 male patient, with shellfish allergy. The patient's medical history and concomitant therapies were not reported. On 31-MAY-2017, the patient was vaccinated with ZOSTAVAX injection under the skin (subcutaneous), for shingles. The patient visited an Immediate Care location on 03-JUN-2017 because he developed hives all over his body on an unspecified date. It was unknown what treatment the patient received. On 04-JUN-2017, the patient went to the Emergency Room at an unspecified hospital where the patient was administered unspecified oral medications. The outcome of urticaria was reported as recovering/resolving (the patient "was better"). The causality between urticaria and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Drug administered at inappropriate site
Clinical narrative: This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. She was not pregnant at the time of reporting. On 02-MAY-2017, the patient received a dose of properly stored VARIVAX, administered subcutaneously in the abdomen (which was not one of the area of administration listed in the prescribing information) for prophylaxis. The Lot # was M028551, with an expiration date of 07-JUN-2018. On 02-MAY-2017, the reporter stated that the patient tolerated the vaccination well but then stated that the patient was lightheaded. Subsequently, the vital signs were taken and were normal. The outcome of the event of lightheadedness was not reported. The causal relationship of the event and the VARIVAX vaccine was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist reporting on a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 08-JUN-2017, the patient was scheduled to receive a dose of M-M-R II. However, the patient was administered inadvertently an unspecified dose of VARIVAX lot # M003440, expiration date 20-JAN-2018 (route of administration was not reported) which was reconstitued with diluent MRK (lot # L005461, expiration date 28-OCT-2017). No adverse effects reported. It was unknown if the patient sought medical attention. No product quality complaint was involved.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a nurse, referring to a 52 year old male patient with no pertinent medical history and no drug reactions or allergies. The patient's concomitant therapies were not provided. On an unknown date, when the patient "was a child" was vaccinated with a dose of M-M-R II injection (dose, route, lot # and expiration date were not provided) for prophylaxis. On 02-MAY-2017, the patient had unspecified laboratory test for his job and it showed that he was immune to mumps and rubella but was "equivocal for rubeola" (Rubella antibody negative). The patient did not seek medical attention. The causal relationship between M-M-R II and rubella antibody negative was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions allergies or concomitant therapies  were provided. From 10-MAR-2017 to 09-JUN-2017, the patients were vaccinated with unspecified improperly stored doses of VAQTA for prophylaxis (lot # M033611 with an expiration date of 02-MAR-2018) (dose, route and anatomical location were not reported). The administered doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit  to 35 degrees Fahrenheit for 72 hours, no data logger was involved and no previous temperature excursions were reported. There was no adverse reactions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA000421.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 19 year old patient of unknown gender. No pertinent medical history, drug reactions or allergies were reported. On 09-JUN-2017, the patient was vaccinated with a pediatric dose of VAQTA for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse  effects were reported.
Age: 21.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 21-year-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On 08-APR-2017, the patient received the first dose of GARDASIL 9 (lot number, expiration date, and dose regimen details were not provided) for prophylaxis. On 10-MAY-2017, the patient received the second dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a 74 years old female patient. The patient's concurrent conditions, allergies, medical history and concomitant therapies were unknown. On 07-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (site, lot number and expiration date were not provided) for prevention from shingles. On 10-JUN-2017, the patient called the pharmacist to report a knot at injection site where the ZOSTAVAX had been administered. It was reported that the patient did not seek for medical attention and that no treatment was given for this adverse event. No intervention to prevent serious criteria was made. No death, disability, hospitalization, overdose nor life threatening were reported. The outcome of the event was unknown by the time of reporting. The pharmacist did not supply the demographics for the patient or the patient's physician. The causal relationship of the knot at injection site with the ZOSTAVAX was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of two different lot # of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 and/or lot # M037770, expiration date 01-JUN-2019 (strength, dose and route of administration were not provided) for prophylaxis. The patients' concomitant therapies were not reported. On an unspecified date, the vaccines were exposed to a temperature excursion between 47° Fahrenheit (F) and 77°F during a time frame of 8 hours and 20 minutes, which had a data logger involved. There was not previous temperature excursion. Adverse effects were not reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA006922.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. Since 14-FEB-2017 to 13-JUN-2017, the patients were vaccinated with an unspecified number of improperly stored ZOSTAVAX injection (dose was no reported, lot # and expiration date were unknown by the reporter) diluted with sterile diluent (lot # and expiration date were unknown by the reporter). Administered doses of vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. The sterile diluent had no excursion. There were no adverse effects reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-MAY-2016, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included PREVNAR 13. On an unknown date, the patient experienced local injection site reaction. The patient told pharmacist that she was not sure if reaction was due to ZOSTAVAX or PREVNAR 13. The outcome of injection site reaction was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, who referred to an unknown number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 16-SEP-2016 and 27-FEB-2017, the patients were administered improperly stored doses of VAQTA (lot# M022924 an expiration date: 24-JAN-2018; dose, route of administration and anatomical location were not reported) as prophylaxis. The doses of vaccine were stored at 47.7 degrees Fahernheit (F) for 8 hours. All temperature excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. It was also reported that several improperly stored doses of VAQTA with the above mentioned lot# and expiration date were not administered to patients. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA006147: US-009507513-1706USA006148: US-009507513-1706USA006149: US-009507513-1706USA006150: US-009507513-1706USA006151: US-009507513-1706USA004143: