chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Initially, redness and itching at injection site (half-dollar size) reported 10/29 (2 days after 10/27/15 injection). Patient refused biopsy offered by Merck. PCP treated patient w/valacyclovir and acyclovir. Injection site still discolored 11/25/15 and patient has seen PCP 4 or 5x since vaccine. Complains of joint pain and "internal shingles".
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Pt stated that she got a low grade fever the night that she received the vaccine, but the swelling and redness didn't start until the morning after. She has been taking TYLENOL and put ice on the redness and swelling area. Now fever is gone, but she still has a lot of redness and a little swelling. Advise pt to check with MD.
Age: 51.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever more than 103 F, neck stiffness, headaches - fever lasted 3 days, stiffness for a week.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2015US019399, is an initial spontaneous report received from a healthcare professional received on 28 Sep 2015. This report refers to an adult male patient of unknown age. Past medical history and concomitant medication were not reported. He was vaccinated Men A lyophilized conjugate component of MENVEO (batch number: A15018 and expiry date: Jan 2016) reconstituted with a diluent from a Zalsrravex instead of Men-CYW-135 liquid conjugate component on an unknown date. No adverse event was reported following this administration error (wrong solution used in drug reconstitution).
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from male patient (who is a physician) of an unknown age referring on himself. The concurrent condition and medical history were not provided. On an unspecified date in 2011 (reported as: approximately four years ago), the patient was vaccinated with an improperly stored dose of ZOSTAVAX (route, dose and lot number were not provided). Concomitant therapies were not provided. No adverse events were reported. No product quality issue as involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 71 year old female patient. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported). On 18-NOV-2015, the patient experienced soreness in the arm and that she cannot raise her arm after receiving PNEUMOVAX 23. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 23-NOV-2015 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K004281, expiration date 22-MAR-2015; strength, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an unspecified number of improperly stored doses of MMR II (rHA, lot # K024824 with expiration 02-DEC-2016; lot# L007578 with expiration 05-MAR-2017; dose, frequency and route were not reported) (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report from a health professional refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date in July 2015, the patient was vaccinated with improperly stored, expired RECOMBIVAX HB (lot # H011741, expiry date 01-FEB-2015) dose, route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint was not filed. This is one of the two cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to two unspecified patients of unknown demographics. The pertinent medical history of patients and their concurrent conditions were not reported. On an unknown date in JUL-2015 the patients were vaccinated with improperly stored GARDASIL (lot # K007264, expiry date: 02-MAR-2017) dose, route unknown. Concomitant medications were not reported. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant refers to an unspecified patients of unknown age and gender. Since 21-OCT-2015, the patients were vaccinated with doses of ROTATEQ (lot # K011952 and expiration date 17-JUN-2016) (dose and route were not reported) which were exposed to temperatures outside of the recommended range. No adverse experience were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability
Clinical narrative: This spontaneous report as received from an office manager refers to a 4 month old male patient with gastroesophageal reflux disease (GERD) and no known drug allergies. On 31-AUG-2015, the patient received his first dose of ROTATEQ lot # L000425, expiry date 21-JUN-2016 and had "no issues" afterward. On 02-NOV-2015, he was vaccinated with the second dose of ROTATEQ, lot # L013188, expiry date 02-NOV-2016 (route of administration was not provided). Other suspect therapies included PENTACEL (dose, lot #, expiry date, route were not specified) and PREVNAR 13 (dose, lot #, expiry date, route were not specified) given on the same day. Concomitant therapies included ZANTAC "as needed" for gastroesophageal reflux disease. "A couple of hours" after receiving the second dose of ROTATEQ, the patient had extreme fussiness and was screaming "like a limb had been cut off", there was no fever. The reporter stated that the infant was given TYLENOL as treatment on the same day. On approximately 03-NOV-2015 (reported as "about" 24 hours"), the patient was completely recovered. The causality assessment for the events was not provided. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Screaming
Clinical narrative: This spontaneous report as received from an office manager refers to a 4 month old male patient with gastroesophageal reflux disease (GERD) and no known drug allergies. On 31-AUG-2015, the patient received his first dose of ROTATEQ lot # L000425, expiry date 21-JUN-2016 and had "no issues" afterward. On 02-NOV-2015, he was vaccinated with the second dose of ROTATEQ, lot # L013188, expiry date 02-NOV-2016 (route of administration was not provided). Other suspect therapies included PENTACEL (dose, lot #, expiry date, route were not specified) and PREVNAR 13 (dose, lot #, expiry date, route were not specified) given on the same day. Concomitant therapies included ZANTAC "as needed" for gastroesophageal reflux disease. "A couple of hours" after receiving the second dose of ROTATEQ, the patient had extreme fussiness and was screaming "like a limb had been cut off", there was no fever. The reporter stated that the infant was given TYLENOL as treatment on the same day. On approximately 03-NOV-2015 (reported as "about" 24 hours"), the patient was completely recovered. The causality assessment for the events was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Headache, Injection site pain, Mobility decreased
Clinical narrative: Pain at injection site, sudden ringing in ears, tunnel vision, light headed/fogginess, moving in slow motion, headache, dizziness, fainting.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tinnitus, Tunnel vision
Clinical narrative: Pain at injection site, sudden ringing in ears, tunnel vision, light headed/fogginess, moving in slow motion, headache, dizziness, fainting.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema
Clinical narrative: Red, burning, itching of upper arm, spreading and continuing at present time 6:45 AM, 11/26/2015.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Muscle tightness, Muscular weakness, Neck pain, Pain
Clinical narrative: Right shoulder vaccination site has been continuously sore since injection 3 weeks ago. Pain and muscle tension migrated across RIGHT neck to LEFT neck, then RIGHT neck, then RIGHT forearm, then RIGHT bicep over ten days. Right arm is mildly weak now. Any muscle movement of right shoulder causes right shoulder moderate pain now.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Right shoulder vaccination site has been continuously sore since injection 3 weeks ago. Pain and muscle tension migrated across RIGHT neck to LEFT neck, then RIGHT neck, then RIGHT forearm, then RIGHT bicep over ten days. Right arm is mildly weak now. Any muscle movement of right shoulder causes right shoulder moderate pain now.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Dizziness, Nausea
Clinical narrative: As Tdap vaccine was being administered, I got horrible chills, nausea, dizziness, weakness.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram, Balance disorder, Blood test, Contusion, Electromyogram
Clinical narrative: Flu like symptom for 3-4 days, fever, sore, throat, body aches, nausea, headache, eye pressure. Back of arm and lower arm was bruised and sore for approx 7-10 days. All resolved except for eye pressure, headache, and unbalanced, muscle weakness. This continues, neurologist consulted.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Influenza like illness, Muscular weakness, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Flu like symptom for 3-4 days, fever, sore, throat, body aches, nausea, headache, eye pressure. Back of arm and lower arm was bruised and sore for approx 7-10 days. All resolved except for eye pressure, headache, and unbalanced, muscle weakness. This continues, neurologist consulted.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular discomfort, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Flu like symptom for 3-4 days, fever, sore, throat, body aches, nausea, headache, eye pressure. Back of arm and lower arm was bruised and sore for approx 7-10 days. All resolved except for eye pressure, headache, and unbalanced, muscle weakness. This continues, neurologist consulted.
Sex: F
Vaccine: FLUN3, HPV9, FLUN4, HPV4, FLUN3, HPV9
Symptoms: Activities of daily living impaired, Adverse event, Death
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. Patient's concurrent condition, medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with an injection of GARDASIL 9 (lot #, expiry date and dose number was not specified) intramuscularly and FLUMIST. The patient went back to the physician's office the same day of vaccination for an unspecified reason. The next day, she did not participate in gym class at her school for an unspecified reason and died at an unknown time. Medical attention was not sought. The cause of death was unknown. There was no information as to if autopsy was performed or not. Causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUN3, HPV9, FLUN4, HPV4, FLUN3, HPV9
Symptoms: Activities of daily living impaired, Death
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. Patient's concurrent condition, medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with an injection of GARDASIL 9 (lot #, expiry date and dose number was not specified) intramuscularly and FLUMIST. The patient went back to the physician's office the same day of vaccination for an unspecified reason. The next day, she did not participate in gym class at her school for an unspecified reason and died at an unknown time. Medical attention was not sought. The cause of death was unknown. There was no information as to if autopsy was performed or not. Causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUN3, HPV9, FLUN4, HPV4, FLUN3, HPV9
Symptoms: Death
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. Patient's concurrent condition, medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with an injection of GARDASIL 9 (lot #, expiry date and dose number was not specified) intramuscularly and FLUMIST. The patient went back to the physician's office the same day of vaccination for an unspecified reason. The next day, she did not participate in gym class at her school for an unspecified reason and died at an unknown time. Medical attention was not sought. The cause of death was unknown. There was no information as to if autopsy was performed or not. Causality assessment was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient with no drug reactions or allergies. The patient's pertinent medical history included asplenia. On 09-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L028281, expiration date: 28-OCT-2016, dose 0.65 ml, subcutaneously. There was no concomitant medication. On 10-NOV-2015, the patient was not feeling well and went to see her physician who diagnosed her with internal shingles. The physician informed the patient that she ended up with internal shingles because of her preexisting disease - asplenia. The physician prescribed acyclovir 800 mg as a treatment for the patient. The outcome of the events was reported as recovered on an unknown date in November 2015. The relatedness between the events and ZOSTAVAX was not reported. The event of internal shingles was considered to be life threatening by the reporter because the doctor told the patient that if it was left untreated it could have gone to her brain. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Hepatic enzyme, Herpes zoster, Laboratory test normal
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 74 year old male patient with no known allergies. The patient's concurrent conditions included hypertension and possible high cholesterol. On 07-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX vial, subcutaneous injection, 0.65 ml on the left arm (lot L028280, expiration date 28-OCT-2016). Concomitant medications were not reported. The pharmacist reported that the patient had shingles on an unspecified date in November 2015. The reporter stated that post vaccination, the patient developed rash and pain radiating from his left arm down to the left side of his chest under his left nipple so the patient went to the hospital with what he thought was a heart attack.  He was kept overnight and treated with 2 heparin injections in the abdomen. Aortic atherosclerotic plaques test performed and result was normal for patient's age. Liver enzymes test was also performed but results were not provided.  Heart attack was ruled out. After one night, the patient was released from the hospital on an unspecified date in November 2015. The pharmacist questioned if the patient could be treated with an antiviral medication. Outcome of shingles was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest discomfort, Discomfort, Dizziness, Erythema, Rash
Clinical narrative: This spontaneous report as received from a registered nurse from the physician's office, refers to a 16 year old female patient. Concurrent conditions and medical history were not documented. On 18-NOV-2015, the patient was vaccinated with a dose of GARDASIL (lot # K010215, expiration date 05-MAY-2017) intramuscular in the left arm. Concomitant therapies included second booster of MENACTRA in the right arm (Lot number, expiration date) the same date. When the reporting nurse was asked if the events were life threatening, the nurse stated that with that in two to five minutes became lightheaded. The patient experienced erythema reported as "face and neck turned beet red" and an unspecified rash appeared on her neck. The patient also complained of chest discomfort. The nurse reported the physician administered an unspecified dose of BENADRYL as well as an unspecified steroid. The rash cleared, but the patient was still uncomfortable, feeling as if she was going to faint. The nurse reported the physician's office called 911 for an ambulance. The patient was taken to the Hospital and was treated with additional unspecified doses of BENADRYL and unspecified steroids in the emergency room. She was treated and released from the emergency room. The patient was not hospitalized. Intervention to prevent serious criteria was not required. The outcome of erythema, dizziness, chest discomfort and rash was reported as recovering. The reporter did not assess the relatedness of GARDASIL to erythema, dizziness, chest discomfort and rash. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Muscle spasms, Muscle tightness
Clinical narrative: Employee flu, vaccine give left upper arm. Hurt a little as fluid injected, but seemed normal injection, achy as usual following day. With 1-2 days it continued to be nagging, but was having spasms/tightness. After a couple of weeks spread to tightness in shoulder and neck, incorporated left shoulder blade. I first thought it would go away. Taking TYLENOL 2-3 x day since beginning, recently tried muscle relaxants; routine visit with chiropractor suggest PT and see PCP for continued spasms/tightening-> saw PCP starting PT scan and PCP said I should call Employee Health.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Back pain, Hyperhidrosis, Thirst
Clinical narrative: At 2:35 PM pt had lower back pain and increased thirst for 10-15 min following IM FLUZONE HD. After event pt was anxious and had friend take him to ER. He was observed and released. At 9PM pt woke up diaphoretic went to ER was observed and released.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to a 4 year old patient of unknown gender. There was no medical history or drug reaction/allergies reported. On 19-AUG-2015 the patient was vaccinated with one dose of (Merck) VARIVAX (dose and route were not reported; lot # K005426 with expiration date 15-APR-2016), which was stored in a freezer which had a max temperature excursion of 35.2 (unit unknown) on 16-FEB-2015 (incorrect product storage). The reporter did not know how long this was at this temperature, nor can she be certain if she pressed the right buttons on the fridge to obtain the readings as she did not be trained. The reporter stated that the freezer temperature was 1 Fahrenheit at 8 am and 3 Fahrenheit at 5 pm. The maximum temperature on that day was 10.9 Fahrenheit (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 74 year old male patient. No concurrent condition or medical history was reported. On 20-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (dose and route of administration was not provided) which had been exposed to temperatures outside of the recommended range (incorrect product storage). No concomitant therapy was reported. No adverse effects was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-NOV-2015, the patient was inadvertently vaccinated with one expired dose of MMR II (lot # J014875, expiration date 21-NOV-2015, dose and route unknown). No adverse effects reported. No PQC was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) referring to a patient of unknown age. No relevant medical history or concurrent conditions were reported. On 23-NOV-2015 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K005402, expiration date 07-NOV-2015; dose and route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a patient's neighbor referring to the patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, dose#, route and lot# not reported). On an unknown date, after the vaccination, the patient contracted shingles. The outcome of the event was unknown. Additional information is not expected since there was no contact details provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No pertinent or historical conditions were reported. On 24-NOV-2015, the patient was inadvertently administered an expired dose of (Merck) VARIVAX (lot # J014407, 13-NOV-2015, strength, dose and route unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to 20 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored (Merck) VARIVAX lot # L020003. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unspecified age and gender. The patients medical and concurrent condition were not reported. On an unspecified date, the unspecified number of patients were administered with improperly stored doses of LIQUID PEDVAXHIB (lot K011077, expiry date: 30-MAR-2017; lot K015462, expiry date: 10-JUL-2017; lot K019701, expiry date: 17-JUL-2017; lot L002866, expiry date: 10-NOV-2017; lot L012838, expiry date: 10-MAR-2018). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unspecified age and gender. On an unspecified date, the unspecified number of patients were administered with improperly stored doses of GARDASIL 9 (lot L013429, exp 21-JUL-2017). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Received vaccine "ADACEL" on 11/15/15. Patient called the pharmacy on 11/25/15 stating she was aware that the vaccine would cause pain at the injection site, but has been 10 days and is sill in pain and experiencing numb/tingling sensation.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Pt called pharmacy 3 days after receiving the vaccine complaining about a fever, headache and nausea also said his arm was swollen from the site to his elbow. Called pt next day to follow up, said he was doing better.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to approximately 20 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # K016311 expiry date: 26-MAY-2016 and lot# L008034 expiry date: 08-MAY-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unspecified age and gender. The patients medical and concurrent conditions were not reported. On an unspecified date, the unspecified number of patients were administered improperly stored doses of GARDASIL (lot K007828, expiry date: 02-MAR-2017; lot K009482, expiry date: 06-MAR-2017; lot K011562, expiry date: 08-AUG-2017). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL injection (lot # K011562, expiration date 08-PAR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Injection site cellulitis, Injection site haematoma
Clinical narrative: Information has been received from a nurse via a field representative referring to 2 unspecified patients. On unknown dates the patients were vaccinated with doses of PROQUAD (Merck) (dose, route and application site were not reported). It was not specified whether this was the first or second dose of PROQUAD (Merck). The nurse reported that the patients presented with injection site reactions ten days after receiving PROQUAD (Merck) injections. The patients had cellulitis and hematoma at the injection site. The nurse had started to collect information with the lot numbers, but found no pattern with the adverse reactions. The lot number information was not provided as of the date of this report. No medical attention was sought. No treatment was given. The outcome of events was unknown. The causality was not reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 55 year old female patient referring to herself. The patient had breast cancer approximately 14.5 years ago and she had no drug reactions/allergies. On 18-NOV-2015 the patient was vaccinated with ZOSTAVAX (lot # L012039 with expiration date July 2016, 0.65 ml) in her left arm. No concomitant medications were provided. On 19-NOV-2015, the patient experienced shingles. The shingles was located on her right side around her waist. The patient visited office to seek medical attention. No lab diagnostics studies were performed. Her physician prescribed an unspecified cream, prednisone and acyclovir for the treatment of the event. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to a 4 year old patient of unknown gender. There was no medical history or concurrent condition reported. On 30-JUL-2015 the patient was vaccinated with one dose of (Merck) VARIVAX (dose and frequency were not reported; lot # K005426 with expiration date 15-APR-2016), which was stored in a freezer which had a max temperature excursion of 35.2 (unit unknown) on 16-FEB-2015 (incorrect product storage). The reporter did not know how long this was at this temperature, nor can she be certain if she pressed the right buttons on the fridge to obtain the readings as she did not be trained. The reporter stated that the freezer temperature was 0 Fahrenheit at 8 am and 1 Fahrenheit at 5 pm. The min/max temperature on that day was 0.8/12.2 Fahrenheit (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to a 4 year old patient of unknown gender. There was no medical history or concurrent condition reported. On 23-JUL-2015 the patient was vaccinated with one dose of (Merck) VARIVAX (dose and frequency were not reported; lot # K005426 with expiration date 15-APR-2016), which was stored in a freezer which had a max temperature excursion of 35.2 (unit unknown) on 16-FEB-2015 (incorrect product storage). The reporter did not known how long this was at this temperature not can she be certain if she pressed the right buttons on the fridge to obtain the readings as she did not be trained. The reporter stated that the freezer temperature was 0 Fahrenheit at 8 am and 3 Fahrenheit at 5 pm. The min/max temperature on that day was 2.4/11.8 Fahrenheit (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Information has been received from a currently 62 year old female patient with allergy to penicillin referring to herself. The patient got hives and rashes easily. On an unknown date in 2012 (reported as "about 3 years ago"), the patient was vaccinated with ZOSTAVAX vial, 0.65 ml one shot (route was not provided). The patient had no concomitant medication. On an unknown date in 2015 (reported as "a few months ago"), the patient developed a mild itchy rash with no blisters on her body and she thought she maybe had a mild case of shingles because three were "bands" of the rash that appeared on her stomach. The patient saw the physician to seek medical attention. No lab diagnostic studies were performed. The patient was received steroid cream for the treatment of the event. At the time of the report, the patient did not recover from the event. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician referring to a 15 year old female patient. On 23-NOV-2015 the patient was inadvertently received a dose of GARDASIL 9 (dose, strength and route unknown, once, lot#: K026247, expiration date: January 2017) instead of GARDASIL. No adverse effects were reported. Additional information has been received.
Age: 54.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from an unspecified reporter as part of a marketing research program refers to a 54 year old patient. On 06-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and lot # not reported) intramuscularly. On 06-NOV-2015, the patient experienced burning sensation at injection site. On the same date, the patient recovered. This is one of several reports received from the same reporter. Additional information is not expected as there is no contact information.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from an unspecified reporter as part of a marketing research program refers to a 54 year old patient. On 04-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) intramuscularly. On 04-NOV-2015, the patient experienced burning sensation and stinging at injection site. On the same date, the patient recovered. This is one of several reports received from the same reporter. Additional information is not expected as there is no contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age and gender. On 25-NOV-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K000326 exp date 27-FEB-2015) (dose and route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to 8 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 03-NOV-2015, the patients were vaccinated with doses of MMR II, lot # L009212 with expiration date 17-MAR-2017, (dose and route of administration were not provided); which had been exposed to a cumulative of 10.9 C for 9 hours and 21 minutes. On the same date, an excursion of 8.6 C for 1 hour and 7 minutes occurred, with a cumulative of 10 hours and 28 minutes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 04-NOV-2015, the patient was vaccinated with a dose of MMR II, lot # reported as L019989 with expiration date 01-JUN-2017, (dose and route of administration were not provided); with a cumulative of 10 hours and 28 minutes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, since 08-OCT-2015, the patients were vaccinated with doses of GARDASIL, lot # K010215 with expiration date 05-MAY-2017, (dose and route of administration were not provided); which were exposed to temperatures outside of the recommended range. The reporter was not aware of any adverse experiences. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to 7 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 29-OCT-2015, the patients were vaccinated with doses of MMR II, lot # L009212 with expiration date 17-MAR-2017, (dose and route of administration were not provided); which had been exposed to a cumulative of 10.9 C for 7 hours and 28 minutes. On the same date, an excursion of 8.9 C for 1 hour and 9 minutes, brought the cumulative to 8 hours and 37 minutes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to 2 unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 27-OCT-2015, the patients were vaccinated with doses of MMR II, lot # L015281 with expiration date 30-APR-2017, (dose and route of administration were not provided); which were exposed to an additional 8.7 C for 1 hour and 22 minutes for cumulative of 10.9 C for 7 hours and 28 minutes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 26-OCT-2015, the patient was vaccinated with a dose of M-M-R II, lot # L015281 with expiration date 30-APR-2017, (dose and route of administration were not provided); which was exposed to 10.9 C for 6 hours and 6 minutes. No adverse effects had been reported. This is one of the several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to 2 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 28-OCT-2015, the patients were vaccinated with doses of MMR II, lot # L015281 with expiration date 30-APR-2017, (dose and route of administration were not provided); which had been exposed to a cumulative of 10.9 C for 7 hours and 28 minutes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 02-NOV-2015, the patient was vaccinated with a dose of MMR II, lot # L009212 with expiration date 17-MAR-2017, (dose and route of administration were not provided); which had been exposed to a cumulative to 8 hours and 37 minutes. On the same date, an excursion of 9.6 C for 44 minutes, brought the cumulative to 9 hours and 21 minutes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
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. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, since 08-OCT-2015, the patients were vaccinated with doses of PNEUMOVAX 23, lot # L001311 with expiration date 06-JUL-2016, (dose and route of administration were not provided); which were exposed to temperatures outside of the recommended range. The reporter was not aware of any adverse experiences. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to 5 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 22-OCT-2015, the patients were vaccinated with doses of MMR II, lot # L015281 with expiration date 30-APR-2017, (dose and route of administration were not provided); which were exposed to 10.9 C for 2 hours and 48 minutes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from the grandmother of the 4 year old male patient who, on 11-NOV-2015, was vaccinated with GARDASIL 9 injection (dose, route, frequency and Lot # were unspecified) (drug administered to a patient of inappropriate age). The patient's concurrent conditions and medical history were not reported. Concomitant therapy was not reported. Additional information is not expected since no contact details were provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with PEDVAXHIB lot # J006418, expiration date 06-MAR-2016 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as improperly stored PEDVAXHIB was administered to unspecified patients. There was no adverse event. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with ROTATEQ lot # K015831, expiration date 18-APR-2016 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as improperly stored ROTATEQ was administered to unspecified patients. There was no adverse event. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with MMR II lot # L012479, expiration date 10-APR-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as improperly stored MMR II was administered to unspecified patients. There was no adverse event. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with GARDASIL lot # K008931, expiration date 04-MAR-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as improperly stored GARDASIL was administered to unspecified patients. There was no adverse event. It was unknown if the patients sought medical attention. At th time of the report, the patients' status was unknown. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. The reporter stated that on 16-NOV-2015, the patient was inadvertently administered an expired dose of VAQTA lot number L001627, expiration date 11-NOV-2015 (dose and route not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On an unknown date in July 2015, the patient was vaccinated with first dose of ZOSTAVAX vial of 19400 PFU (lot/batch#, dose and route were unknown). On an unknown date in 2015 (also reported as recently), the patient received second dose of ZOSTAVAX in error. The reporting pharmacist was not aware of any adverse events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent condition, medical history and concomitant therapy provided. On 09-NOV-2015, the patient was administered with an expired dose of PNEUMOVAX 23 first dose, intramuscularly, lot # K005402, expiration date: 07-NOV-2015 (exact dose was not reported). There were no adverse effects reported. Additional information has been requested.