chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: I couldn't sleep at night, because I could not lay not my right side it was throbbing and extremely sore, the side of my injection. I could not raise my arms to put my shirt on, wash my hair, even lift a copy of coffee. Taking off my shirts, bras, and tops are a struggle. The moment I use my right arm, there is pain, especially any movements that requires using my rotator cuff muscles. Even moving my arm from my mouse to the key boards cause my upper right arm pain. The symptoms started a the next day, when I woke up, my arm just didn't feel right, it was not the typical soreness you get with a flu shot that last for a few days. At the time I am writing this, it is now almost 2 1/2 weeks. I still cannot lift my right arm without pain. I don't sleep well to begin with, and now I hardly get any rest. I have seen a doctor and he has referred me to an orthopedic doctor, which I will see today.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Poor quality sleep
Clinical narrative: I couldn't sleep at night, because I could not lay not my right side it was throbbing and extremely sore, the side of my injection. I could not raise my arms to put my shirt on, wash my hair, even lift a copy of coffee. Taking off my shirts, bras, and tops are a struggle. The moment I use my right arm, there is pain, especially any movements that requires using my rotator cuff muscles. Even moving my arm from my mouse to the key boards cause my upper right arm pain. The symptoms started a the next day, when I woke up, my arm just didn't feel right, it was not the typical soreness you get with a flu shot that last for a few days. At the time I am writing this, it is now almost 2 1/2 weeks. I still cannot lift my right arm without pain. I don't sleep well to begin with, and now I hardly get any rest. I have seen a doctor and he has referred me to an orthopedic doctor, which I will see today.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: 13 month old child given KINRIX. No adverse reaction noted. HD RN notified. Education to clinical staff on age appropriate vaccine administration.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Injection site cellulitis, Injection site hypersensitivity, Injection site reaction, Injection site swelling
Clinical narrative: Moderate swelling at injection site with associated cellulitis and allergic reaction- angioedema.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Erythema nodosum, Injection site erythema, Skin warm
Clinical narrative: Patient  has 3 red spots on her right arm that are warm to the touch and the size of a 50 cent piece.  She also has redness in the area that her immunization was given. Patient was evaluated and diagnosed with erythema nodosum.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, chills, fatigue, headache, diarrhea.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dyspnoea, Headache, Injection site pain, Nausea
Clinical narrative: About 3:30 she began to feel pain in the injection site, slight itching and nausea. This progressed to diffuse headache, nausea, chills, throat tightening and sensation of shortness of breath. She notified her mom 8 PM and they came to the emergency department. No history of prior allergic reactions or anaphylaxis.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Throat tightness
Clinical narrative: About 3:30 she began to feel pain in the injection site, slight itching and nausea. This progressed to diffuse headache, nausea, chills, throat tightening and sensation of shortness of breath. She notified her mom 8 PM and they came to the emergency department. No history of prior allergic reactions or anaphylaxis.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apnoea, Cyanosis, Electroencephalogram abnormal, Eye movement disorder, Intensive care
Clinical narrative: That night the vaccines were administered, patient with apneic and cyanotic episodes as well as eye deviation. Inital EEG with focal seizures, MRI unchanged from NICU. EEG normalized on KEPPRA. Will repeat EEG in 1 month.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Nuclear magnetic resonance imaging, Partial seizures, pH body fluid
Clinical narrative: That night the vaccines were administered, patient with apneic and cyanotic episodes as well as eye deviation. Inital EEG with focal seizures, MRI unchanged from NICU. EEG normalized on KEPPRA. Will repeat EEG in 1 month.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Pruritus, Rash
Clinical narrative: Rash and itching across upper torso, numbness in R lower lip. Continuing more that 12 hours after onset.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Approximately 20 minutes after administration of the second in a three immunization series for the Hepatitis B vaccine, I experienced severe itching on my front and back upper torso region and neck. I did not notice if there were hives associated with this itching. The itching lasted for approximately 10-15 minutes. It did not occur to me that the Hep B vaccine could be causing the itching. When I went to my employer's Occupational Health Department to inquire if I should get the third vaccine in the series, the Occupational Health nurse suggested that I fill this form out and submit it to you.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Shortness of breath and chest pain-Pt presented to ER.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who referred to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot # reported as 9009773, expiration date 20-SEP-2018 (dose and route of administration were not reported) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 8.6 degrees Fahrenheit for 1 hour 10 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. It has been determined that lot number 9009773 is not valid for PROQUAD; Sender's Comments: US-009507513-1709USA006379:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot # M042497, expiration date on 17-APR-2018 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile water diluent. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 10 minutes and from the second excursion 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 15 minutes. Data logger was involved in recording the excursion details. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA006448:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 23-APR-2016, the patient was vaccinated with a first dose of ZOSTAVAX (exact dose, route of administration, lot number and expiry date were not reported) for prophylaxis and on 25-AUG-2017, he/she was inadvertently administered a second dose of ZOSTAVAX (exact dose, route of administration, lot number and expiry date were not reported) for prophylaxis. The lot # and expiration date for the sterile diluent used to reconstitute the ZOSTAVAX was not provided. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified amount of patients of unknown demographics. The patients' pertinent medical histories and drug reactions or allergies were not reported. From 01-JAN-2017 to 25-SEP-2017, the patients received an improperly stored doses of VAQTA (lot # reported as N032492 with expiration date at 02-MAR-2018; dose, route of administration and anatomical location were not provided), for prophylaxis. There were previous temperature excursions (unknown by reporter). The reporter did not know the ranges of temperature excursions and their time frames. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012746: US-009507513-1709USA012745: US-009507513-1709USA012747: US-009507513-1709USA012744.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified amount of patients of unknown demographics. The patients' pertinent medical histories and drug reactions or allergies were not reported. From 01-JAN-2017 to 25-SEP-117, the patients received an improperly stored doses of PNEUMOVAX 23 (lot # N011491 with expiration date at 04-NOV-2018; dose, route of administration and anatomical location were not reported), for prophylaxis. There were previous temperature excursions (unknown by reporter). The reporter did not know the ranges of temperature excursions and their time frames. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012746: US-009507513-1709USA012745: US-009507513-1709USA012747: US-009507513-1709USA012635: US-009507513-.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified amount of patients of unknown demographics. The patients' pertinent medical histories and drug reactions or allergies were not reported. From 01-JAN-2017 to 25-SEP-117, the patients received an improperly stored doses of RECOMBIVAX HB (lot # M000442 with expiration date at 31-MAR-2018; dose, route of administration and anatomical location were not reported), for prophylaxis. There were previous temperature excursions (unknown by reporter). The reporter did not know the ranges of temperature excursions and their time frames. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012746: US-009507513-1709USA012635: US-009507513-1709USA012747: US-009507513-1709USA012744.
Age: 90.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 90-year-old female patient received PREVNAR 13 (Lot Number: N17827, Expiry date: Nov2017), intramuscular in the left deltoid on 06Dec2016 at single dose for immunisation and AFLURIA (Lot Number: 13849221A, Expiry date: 30Jun2017), via an unspecified route of administration on 06Dec2016 at unspecified dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced ongoing pain in her shoulder almost from 9 months on 06Dec2016. The outcome of the event was not recovered. The pharmacist considered that the event was possibly related to the suspect drugs.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer-sales representative. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash on an unspecified date. Outcome of the event was unknown. No Follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Blood test, Chills, Fatigue, Feeling cold
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 82-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) in early Jun2017 at single dose in arm for immunization. The patient medical history was not reported. Concomitant medication included baby aspirin. On an unspecified date in early Jun2017 (shortly after vaccination) the patient experienced muscle pain, fatigue, weakness, chills and cold and she couldn't sleep. Blood work was done on an unspecified date and no results available. Patient received ADVIL to treat muscle pain; no treatments were given for the other events. Patient not recovered from the events at the time of the report. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine in reporter's country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine has submitted the same report to the regulatory authorities.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 82-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) in early Jun2017 at single dose in arm for immunization. The patient medical history was not reported. Concomitant medication included baby aspirin. On an unspecified date in early Jun2017 (shortly after vaccination) the patient experienced muscle pain, fatigue, weakness, chills and cold and she couldn't sleep. Blood work was done on an unspecified date and no results available. Patient received ADVIL to treat muscle pain; no treatments were given for the other events. Patient not recovered from the events at the time of the report. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine in reporter's country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Injection site reaction, Urticaria
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist via Pfizer sales representative, who reported for her/his daughter. A 18-year-old female patient received the second dose of TRUMENBA on an unspecified date at single dose in arm for immunization. The patient medical history and concomitant medications were not reported. Patient was otherwise healthy and not feeling sick when vaccinated. Previously on an unknown date, she received the first dose of meningococcal group b rlp2086. On an unspecified date, after the administration of the second dose of the vaccine, the patient experienced a large baseball-sized welt at the injection site on her arm and flu-like symptoms for two days. Final outcome of the events was reported as unknown. Patient did not have these reactions with the subsequent third dose of meningococcal group b rlp2086. No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Blood albumin, Nephrotic syndrome, Protein total, Protein urine present, Weight increased
Clinical narrative: Pt developed Nephrotic Syndrome 4 days after administration of vaccine. Patient may have been in early stages of nephrotic syndrome at time of vaccination, as she had gained some weight since previous visit.  However this is unclear.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Arthralgia, Crying, Gait disturbance, Gait inability, Irritability
Clinical narrative: 5 days after receiving her vaccines (9/24)she began to "not walk well."  On the morning of the 25th she refused to walk and seemed to be having left hip pain. There was no history of injury, fever, nor previous illness. I saw her in the afternoon. Initially she was asleep in Mom's arms. Her lower extremities had full range of motion without any discomfort, and no tenderness to palpation. When she was awakened she was a bit fussy, calming as she came fully awake. Again, on exam, she had full range of motion without pain. When placed on her feet, she cried but was able to walk. Per Mom, this was much better than she had been earlier. Her clinical picture was highly suggestive of toxic synovitis or minor trauma. No tests were performed, and I had her come back the next day (9/26). She is totally fine, running around the room, climbing on the chairs, etc. Her lower extremity exam is totally normal. The picture suggests post-vaccine toxic synovitis, as I do not have any other explanation.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Synovitis, Weight bearing difficulty
Clinical narrative: 5 days after receiving her vaccines (9/24)she began to "not walk well."  On the morning of the 25th she refused to walk and seemed to be having left hip pain. There was no history of injury, fever, nor previous illness. I saw her in the afternoon. Initially she was asleep in Mom's arms. Her lower extremities had full range of motion without any discomfort, and no tenderness to palpation. When she was awakened she was a bit fussy, calming as she came fully awake. Again, on exam, she had full range of motion without pain. When placed on her feet, she cried but was able to walk. Per Mom, this was much better than she had been earlier. Her clinical picture was highly suggestive of toxic synovitis or minor trauma. No tests were performed, and I had her come back the next day (9/26). She is totally fine, running around the room, climbing on the chairs, etc. Her lower extremity exam is totally normal. The picture suggests post-vaccine toxic synovitis, as I do not have any other explanation.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever (101 degrees), severe chills, body aches for 3 hours; treated with ibuprofen, 300 mg
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Influenza virus test negative, Pyrexia
Clinical narrative: Patient developed a fever up to 103 the morning following his vaccinations. Physical exam was normal at that time. Influenza test was negative. Fever resolved within 48 hours.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Solid red rash with itching under both arms, starting in the afternoon and still present the next morning.
Age: 0.67
Sex: F
Vaccine: MMR
Symptoms: Anger, Developmental regression, Drug administered to patient of inappropriate age, Dyskinesia, Eczema
Clinical narrative: After my daughter received two shots I was called back in by the doctor's office claiming there was a measles outbreak and wanted all children to come back in for their first measles shot. I told them my child is too young for the shot they said in cases like this we can "bend" the rules. After she received this shot, her pupils were dilated for at least 48 hours. She also was very lethargic. Within the first 24 hours her neck would convulse her head back, so fast, it looked like a tic or seizure. Her injected leg also was very stiff and would not bend. Myself and her great grandmother would bicycle her legs to try to get the muscles from being so rigid. Her body became inflamed with Eczema. I called the doctor's office and told them her head is jerking back and they told me to write it down in a journal and proceeded to tell me there was no measles outbreak. So needless to say we never went back there.  My daughter also regressed in her already developed motor skills. She would pass a toy slowly between her hands as if it was the first time she did. She has since been referred to an Occupational Therapist for her outbursts and meltdowns, obsessive compulsiveness, lack of speech. Her OT said she has all the telltale signs of Autism but cannot give an official diagnosis. After she received the MMR vaccine WAY too early I watched her change physically, mentally, and emotionally into something else.
Age: 0.67
Sex: F
Vaccine: MMR
Symptoms: Inflammation, Injection site movement impairment, Lack of spontaneous speech, Lethargy, Mydriasis
Clinical narrative: After my daughter received two shots I was called back in by the doctor's office claiming there was a measles outbreak and wanted all children to come back in for their first measles shot. I told them my child is too young for the shot they said in cases like this we can "bend" the rules. After she received this shot, her pupils were dilated for at least 48 hours. She also was very lethargic. Within the first 24 hours her neck would convulse her head back, so fast, it looked like a tic or seizure. Her injected leg also was very stiff and would not bend. Myself and her great grandmother would bicycle her legs to try to get the muscles from being so rigid. Her body became inflamed with Eczema. I called the doctor's office and told them her head is jerking back and they told me to write it down in a journal and proceeded to tell me there was no measles outbreak. So needless to say we never went back there.  My daughter also regressed in her already developed motor skills. She would pass a toy slowly between her hands as if it was the first time she did. She has since been referred to an Occupational Therapist for her outbursts and meltdowns, obsessive compulsiveness, lack of speech. Her OT said she has all the telltale signs of Autism but cannot give an official diagnosis. After she received the MMR vaccine WAY too early I watched her change physically, mentally, and emotionally into something else.
Age: 0.67
Sex: F
Vaccine: MMR
Symptoms: Obsessive-compulsive disorder, Seizure, Seizure like phenomena, Tic
Clinical narrative: After my daughter received two shots I was called back in by the doctor's office claiming there was a measles outbreak and wanted all children to come back in for their first measles shot. I told them my child is too young for the shot they said in cases like this we can "bend" the rules. After she received this shot, her pupils were dilated for at least 48 hours. She also was very lethargic. Within the first 24 hours her neck would convulse her head back, so fast, it looked like a tic or seizure. Her injected leg also was very stiff and would not bend. Myself and her great grandmother would bicycle her legs to try to get the muscles from being so rigid. Her body became inflamed with Eczema. I called the doctor's office and told them her head is jerking back and they told me to write it down in a journal and proceeded to tell me there was no measles outbreak. So needless to say we never went back there.  My daughter also regressed in her already developed motor skills. She would pass a toy slowly between her hands as if it was the first time she did. She has since been referred to an Occupational Therapist for her outbursts and meltdowns, obsessive compulsiveness, lack of speech. Her OT said she has all the telltale signs of Autism but cannot give an official diagnosis. After she received the MMR vaccine WAY too early I watched her change physically, mentally, and emotionally into something else.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Raised, heated, red, painful site.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain lower, Abdominal pain upper, Back pain, Chills, Depressed mood
Clinical narrative: Nausea, upper and lower abdominal pain, severe full body myalgia, lethargy, low back pain, malaise/ extreme fatigue, chills, difficulty concentrating, depressed mood.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Disturbance in attention, Fatigue, Lethargy, Malaise, Myalgia
Clinical narrative: Nausea, upper and lower abdominal pain, severe full body myalgia, lethargy, low back pain, malaise/ extreme fatigue, chills, difficulty concentrating, depressed mood.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Nausea, upper and lower abdominal pain, severe full body myalgia, lethargy, low back pain, malaise/ extreme fatigue, chills, difficulty concentrating, depressed mood.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediately after injection, the site started swelling. In a matter of seconds the site swelled to the size of larger than a quarter and was raised. There was no rash, no itching, no trouble breathing, and the patient felt fine. I monitored the patient for about 10 minutes to make sure no further reaction occurred.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient reported to pharmacy with a red arm, described swelling, heat, and tenderness from previous days, but that it seemed to be resolving on its own.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Dizziness, Feeling abnormal, Malaise
Clinical narrative: Patient stated that he felt "ill" and "very off." Stomach upset and lightheadedness.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Pain, Respiratory tract congestion
Clinical narrative: STARTING DAY AFTER VACCINATION AND CONTINUING FOR 4 DAYS THUS FAR - WORSENING FLU-LIKE SYMPTOMS - ACUTE BODILY ACHES AND RESPIRATORY CONGESTION. SINCE THE DURATION AND INCREASING SEVERITY OF THE SYMPTOMS ARE ATYPICAL; HEADING TO EMERGENCY OUTPATIENT CLINIC ASAP.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Mobility decreased
Clinical narrative: DIFFICULTY MOVING RT ARM AND WEAKNESS.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Right leg (redness, warm to touch and itchy), treatment was ice on leg and Benadryl for itchy.
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 29-AUG-2017 via phone call from a healthcare worker and medical assistant who reported that multiple unspecified patients received improperly stored doses of RECOMBIVAX HB (unspecified lot#/expiration date) or VAQTA (unspecified lot#/expiration date) on "either yesterday or today". Temperature was -5C for a time frame of 24 hours. No previous temperature excursion. Call was because of a "data logger". No further information to report as the call was disconnected and an outbound call was made to the office however a voicemail was reached. No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who referred to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # reported as 9009773 with expiration date on 20-SEP-2018 (therapy type, dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 8.6 degrees Fahrenheit for 1 hour and 10 minutes. Data logger was involved in recording the excursion details. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Lot number 9009773 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.; Sender's Comments: US-009507513-1709USA002933:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose 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. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-JUN-2017, the patient was vaccinated with a first dose of ZOSTAVAX, subcutaneous for prophylaxis (dose, site of administration, lot # and expiration date were not reported). On 14-SEP-2017, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX, subcutaneous for prophylaxis (dose, site of administration, lot # and expiration date were not reported). Concomitant therapies included sterile diluent (MRK). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 80-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in approximately 2014 (reported as 2 to 3 years ago), the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported) for prevention of shingles. On an unknown date, after getting ZOSTAVAX, the patient experienced shingles. The patient sought medical attention by seeing a physician and received unspecified treatment for the adverse event. The outcome of shingles was reported as not recovered/not resolved. The relatedness between the adverse event and ZOSTAVAX was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 28-AUG-2017, the patient was vaccinated with improperly stored VARIVAX (exact dose, dose number, route of administration were not reported; lot # M035687 with the expiration date of 10-AUG-2018), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No adverse effects were reported. The administered dose of VARIVAX underwent a temperature excursion between 6 and 14 degrees Fahrenheit for 20 days. There were no previous temperature excursions reported. Digital data logger was involved to capture the temperature excursion. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA012775.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 18-SEP-2017, the patient was vaccinated with properly stored expired dose of GARDASIL 9 (exact dose and dose number were not reported; lot # was reported as L040459, expiration date 06-APR-2017), intramuscularly for prophylaxis. No adverse effects were reported. No Product Quality Complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot# L039095 and expiration date: 08-JAN-2017 (dose and route of administration were not reported) reconstituted with sterile diluent. There were no adverse effects reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 12 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 16-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M036059, expiration date 03-JUN-2019) (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012777: US-009507513-1709USA012776.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 14 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 06-JUL-2017, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M036059, expiration date 03-JUN-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012777: US-009507513-1709USA012776:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 14 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 06-JUL-2017, the patient was vaccinated with the second dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA010537: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA012774: US-009507513-1709USA012777: US-009507513-1709USA012776:
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 9 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 11-JUL-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012777: US-009507513-1709USA012776:
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 18 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 11-JUL-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012730: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012777: US-009507513-1709USA012776: US-009507513-1709USA012774:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 14 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 14-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012777: US-009507513-1709USA012776: US-009507513-1709USA012774:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 11 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 14-JUL-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012777: US-009507513-1709USA012776:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 14 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 17-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012777: US-009507513-1709USA012776: US-009507513-1709USA012774:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 11 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 21-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012776: US-009507513-1709USA012777:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 11 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 24-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012776: US-009507513-1709USA012777: US-009507513-1709USA012774: