chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Raised, firm, swollen, red, hot area surrounding injection site, approximately 3" in diameter by 3/14/2019; gradually subsided but with peeling of overlying skin (such as with a mild sunburn) over the next week
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Skin exfoliation
Clinical narrative: Raised, firm, swollen, red, hot area surrounding injection site, approximately 3" in diameter by 3/14/2019; gradually subsided but with peeling of overlying skin (such as with a mild sunburn) over the next week
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: headache, stomach ache, nausea, vomiting, left lower leg muscle pain, injection site soreness first day; flu-like symptoms lasting 2-3 days; treated with ibuprofen
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: headache, stomach ache, nausea, vomiting, left lower leg muscle pain, injection site soreness first day; flu-like symptoms lasting 2-3 days; treated with ibuprofen
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Back pain, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Right after injection, both sites became red and warm and sore (5/31), gave tylenol, (6/2) severe muscle aches and back pain. Symptoms resolve by June 6, the site of shingles shot (R deltoid) still warm
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Myalgia
Clinical narrative: Right after injection, both sites became red and warm and sore (5/31), gave tylenol, (6/2) severe muscle aches and back pain. Symptoms resolve by June 6, the site of shingles shot (R deltoid) still warm
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Patient had localized reaction of left arm with erythema, edema, warmth, and tenderness of  anterior  and lateral side of upper left arm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient had swelling on left (injection site) arm. it was swollen and red
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Decreased appetite, Hypersomnia, Lethargy, Mobility decreased, Pain in extremity
Clinical narrative: Arm extremely sore (could not move) ran slight fever, very lethargic,  Slept for about 2 days after shot.  No appetite Then a rash developed across chest and back that lasted for approximately 5 days
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Rash
Clinical narrative: Arm extremely sore (could not move) ran slight fever, very lethargic,  Slept for about 2 days after shot.  No appetite Then a rash developed across chest and back that lasted for approximately 5 days
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Foreign body sensation in eyes, Urinary incontinence
Clinical narrative: Loss of bladder control and extreme shivers.....over in 24 hours.  Left eye very uncomfortable for 3-4 weeks.  Felt as if something was in my eye (behind) Sight not effected but am hesitant to receive 2nd dosage.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: patient's wife called 3 days after vaccine to report patinet's arm was warm to the touch and painful. Counseled to seek medical evaluation and possible treatment. Son is an MD and started patient on antibiotics for possible cellulitis. Called patient 2 days after reported event- states his arm is much better and he is feeling just fine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Right arm is extremely sore with area of swelling and redness around injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Dehydration, Flushing, Heart rate increased
Clinical narrative: Severe weakness in legs, sore calves, balance, rapid heart rate, shallow breathing,  fever, feeling, flushed, feeling  dehydrated , shivering
Sex: U
Vaccine: VARZOS
Symptoms: Hypopnoea, Laboratory test, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Severe weakness in legs, sore calves, balance, rapid heart rate, shallow breathing,  fever, feeling, flushed, feeling  dehydrated , shivering
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site induration, Injection site nodule
Clinical narrative: Immediately following the injection, the injection site started swelling , bleeding, and looked as it was bruised. I asked the patient to wait the 15 minutes for me to supervise her. She states that has no throat closing, shortness of breathe, hives, or rash. The bleeding stopped, but the injection site still was bruised and raised. I advised the patient to use a cold compression to help aleiviate any inflammation or swelling. I called the patient back after two hours of leaving  the pharmacy, she states that the swelling has gone down some but there still appears to be a "knot" at the injection site. She states that it is not as hard as it was previously. I advised her to continue with cold compressions and if it did not  improve please come back to us or follow up with primary care doctor. I also stated that I would call and check on her this week.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Immediately following the injection, the injection site started swelling , bleeding, and looked as it was bruised. I asked the patient to wait the 15 minutes for me to supervise her. She states that has no throat closing, shortness of breathe, hives, or rash. The bleeding stopped, but the injection site still was bruised and raised. I advised the patient to use a cold compression to help aleiviate any inflammation or swelling. I called the patient back after two hours of leaving  the pharmacy, she states that the swelling has gone down some but there still appears to be a "knot" at the injection site. She states that it is not as hard as it was previously. I advised her to continue with cold compressions and if it did not  improve please come back to us or follow up with primary care doctor. I also stated that I would call and check on her this week.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Asthenia, Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: The patient received vaccination in both thighs (parent does not know which shots were in which legs). The next morning the sites were red and inflamed. Over the course of the day and night the sites become larger, hard and hot to the touch. The second day (6/9/2019) the mother brought the child in to the Urgent Care to be evaluated for the reaction. The child was not excessively fussy or irritable. Slightly less energetic and playful but still herself. The thighs both had noticeable large swollen red marks on them with hard indurations in the center of them above and below the skin.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site warmth
Clinical narrative: The patient received vaccination in both thighs (parent does not know which shots were in which legs). The next morning the sites were red and inflamed. Over the course of the day and night the sites become larger, hard and hot to the touch. The second day (6/9/2019) the mother brought the child in to the Urgent Care to be evaluated for the reaction. The child was not excessively fussy or irritable. Slightly less energetic and playful but still herself. The thighs both had noticeable large swollen red marks on them with hard indurations in the center of them above and below the skin.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Redness,swelling, pain,fever.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site pain
Clinical narrative: My husband and I both experienced shills, fever, nausea, loss of appetite, headaches, multiple trips to urinate, redness and soreness at site of injection the entire nite and day following our injections on 6/8/19.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pollakiuria, Pyrexia
Clinical narrative: My husband and I both experienced shills, fever, nausea, loss of appetite, headaches, multiple trips to urinate, redness and soreness at site of injection the entire nite and day following our injections on 6/8/19.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Patient had redness and bruise at injection, said it was hot to the touch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Pain in extremity
Clinical narrative: Received vaccination at 12:20pm on 6/8/19, patient experienced arm aching pain around 8pm 6/8/19 in which she stated on 6/9/19 that she took two tablets of Tylenol 500mg then again every 4 hours. Patient called RPh at 10:12am on 6/9/19 once pharmacy opened to report aching pain in arm and minor difficulty swallowing food. She did not have a fever, or rash, or trouble breathing. RPh recommended seeking medical care first. Patient refused stating she rather try a medication to help her first. Therefore, RPh recommended Benadryl and continue every 4 to 6 hours as needed. RPh pager her primary doctor at 10:20pm, however no call back to the pharmacy. RPh checked on patient by calling her at 10:51am 6/9/19, patient stated she was feeling a lot better and reufsed going to the ER and stated she will take her second dose of Benadryl in 4 hours. RPh called patient again at 2:23pm in which pt stated she was able to swallow and eat solid food properly and felt completely better. RPh stated to follow up with her doctor in the morning.
Age: 58.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Hypotension, Loss of consciousness, Syncope
Clinical narrative: AFTER RECEIVING VACCINE, PATIENT FAINTED IN LOBBY AREA. PATIENT WAS UNCONSCIOUS, BLOOD PRESSURE WAS LOW.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Patient experienced myalgia,headache, and fever for 2 days after receiving vaccine. The adverse events did improve on their own. Patient did not need medical attention. Patient took tylenol for their headache.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Patient reported to pharmacy on 6/9/19 with a 4-4.5 inch swollen red spot on her right arm that was firm to the touch, but otherwise well.  She was told to take 25 mg of benadryl during the day and 50 mg at night for two days and use an ice pack intermittently.  She called back later that same day to report that the swelling had gone down some and that the skin was a lighter shade of red, but still swollen.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Influenza like illness, Injection site erythema
Clinical narrative: 6/7/19 7am: diarrhea, Fever of 100 F. , Flu-like (achy, headache, chills). Upper left arm at injection site very red and sore 6/7/19  11am  diarrhea, Fever of 101 F. Continue with Flu-like symptoms.  Upper half of left arm is red, swollen and very sore. 6/7/19  Continue rest of day and evening with fever 100 to 101 F , Flu-like symptoms and swollen red upper arm.  6/8/19  Temp down to 99F. Arm continues as before with swelling, redness.  6/9/19  No fever. Arm redness,. soreness and swelling diminshes.  1.5" strip of redness remains around middle of arm.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: 6/7/19 7am: diarrhea, Fever of 100 F. , Flu-like (achy, headache, chills). Upper left arm at injection site very red and sore 6/7/19  11am  diarrhea, Fever of 101 F. Continue with Flu-like symptoms.  Upper half of left arm is red, swollen and very sore. 6/7/19  Continue rest of day and evening with fever 100 to 101 F , Flu-like symptoms and swollen red upper arm.  6/8/19  Temp down to 99F. Arm continues as before with swelling, redness.  6/9/19  No fever. Arm redness,. soreness and swelling diminshes.  1.5" strip of redness remains around middle of arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Disorientation, Dizziness, Dysstasia
Clinical narrative: Shaking, shivering. Feeling very cold, not related to shaking. Intense headache, extreme pressure at temples. Dizziness. Feeling faint.  Extreme nausea. Disorientation.  Intensified as day progressed. Unable to stand. Stomach pain. I called my doctor who advised me to go immediately to the emergency room.  I was unable to afford this.  Went to sleep, had my husband check on me. Symptoms lasted for approximately  4 days, less intensity as time went on. I also lost time at work because of this.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Head discomfort, Headache, Impaired work ability, Nausea
Clinical narrative: Shaking, shivering. Feeling very cold, not related to shaking. Intense headache, extreme pressure at temples. Dizziness. Feeling faint.  Extreme nausea. Disorientation.  Intensified as day progressed. Unable to stand. Stomach pain. I called my doctor who advised me to go immediately to the emergency room.  I was unable to afford this.  Went to sleep, had my husband check on me. Symptoms lasted for approximately  4 days, less intensity as time went on. I also lost time at work because of this.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Shaking, shivering. Feeling very cold, not related to shaking. Intense headache, extreme pressure at temples. Dizziness. Feeling faint.  Extreme nausea. Disorientation.  Intensified as day progressed. Unable to stand. Stomach pain. I called my doctor who advised me to go immediately to the emergency room.  I was unable to afford this.  Went to sleep, had my husband check on me. Symptoms lasted for approximately  4 days, less intensity as time went on. I also lost time at work because of this.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Influenza like illness, Pyrexia, Urticaria
Clinical narrative: Patient developed hives over the body and a fever of 102.  He experienced tiredness and flu-like symptoms.   PAtient went to the doctor and recieved prednisone and zantac to treat. he lso took benadryl.   He wasreportedly doing better today  (6-9-2019)
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever and myalgia
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abnormal sensation in eye, Heart rate increased, Influenza like illness, Insomnia, Myalgia
Clinical narrative: It began with flu-like aches and pains. I had difficulty sleeping and I recall becoming aware of rapid pulse. My watch showed a pulse of 99 during the early morning hours. Headache in the morning. Watch showed a peak resting pulse of over 140. Prior shingles vaccine was administered = 10/17/17 Zostavax. Reaction I observed was consistent with non-emergency reactions described on drug & government websites, as I recall. Reaction to this Shingrix vaccination on 5/20/19 - this was the first shot. (Should I take the second shot?) The flu-like symptoms included low-grade fever of 100. Aches and pains were severe; arms, legs, body and my eyeballs. The rapid pulse was frightening.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: It began with flu-like aches and pains. I had difficulty sleeping and I recall becoming aware of rapid pulse. My watch showed a pulse of 99 during the early morning hours. Headache in the morning. Watch showed a peak resting pulse of over 140. Prior shingles vaccine was administered = 10/17/17 Zostavax. Reaction I observed was consistent with non-emergency reactions described on drug & government websites, as I recall. Reaction to this Shingrix vaccination on 5/20/19 - this was the first shot. (Should I take the second shot?) The flu-like symptoms included low-grade fever of 100. Aches and pains were severe; arms, legs, body and my eyeballs. The rapid pulse was frightening.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Headache, Heart rate increased, Influenza like illness, Insomnia
Clinical narrative: It began with flu-like aches and pains. I had difficulty sleeping and I recall becoming aware of rapid pulse. My watch showed a pulse of 99 during the early morning hours. Headache in the morning. Watch showed a peak resting pulse of over 140. Prior shingles vaccine was administered = 10/17/17 Zostavax. Reaction I observed was consistent with non-emergency reactions described on drug & government websites, as I recall. Reaction to this Shingrix vaccination on 5/20/19 - this was the first shot. (Should I take the second shot?) The flu-like symptoms included low-grade fever of 100. Aches and pains were severe; arms, legs, body and my eyeballs. The rapid pulse was frightening.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: It began with flu-like aches and pains. I had difficulty sleeping and I recall becoming aware of rapid pulse. My watch showed a pulse of 99 during the early morning hours. Headache in the morning. Watch showed a peak resting pulse of over 140. Prior shingles vaccine was administered = 10/17/17 Zostavax. Reaction I observed was consistent with non-emergency reactions described on drug & government websites, as I recall. Reaction to this Shingrix vaccination on 5/20/19 - this was the first shot. (Should I take the second shot?) The flu-like symptoms included low-grade fever of 100. Aches and pains were severe; arms, legs, body and my eyeballs. The rapid pulse was frightening.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Facial pain, Fatigue, Headache
Clinical narrative: chills, severe muscle aches, severe shivering, severe facial pain, headache, stomach pain, fatigue. treatment over 36 hours: ibuprofen, tylenol, cyclobenzaprine, tramodol, hot showers, massage, relaxation breathing. symptoms took 3-4 days to subside.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: chills, severe muscle aches, severe shivering, severe facial pain, headache, stomach pain, fatigue. treatment over 36 hours: ibuprofen, tylenol, cyclobenzaprine, tramodol, hot showers, massage, relaxation breathing. symptoms took 3-4 days to subside.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Myalgia, Peripheral swelling
Clinical narrative: Swollen arm, swelling and redness at injection size, headache, muscle ache
Sex: F
Vaccine: MMR, UNK
Symptoms: Polymerase chain reaction positive, Pyrexia, Rash
Clinical narrative: PCR testing which was positive for strain found in MMR II; had fever; rash; This spontaneous report was received from the employee from the office and refers to two 1-year-old female patients. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(dose, frequency, route of administration, lot# and expiry date were not specified) for prophylaxis. Other suspect therapies included sterile diluent (Merck Sharp & Dohme). On unknown dates (also reported as "two of the patients were female and one of the patients was male", "4, 6 and 12 days respectively, after measles, mumps, and rubella (wistar ra 27-3; virus vaccine, live (M-M-R II) was administered"), the patients experienced fever and rash. Additionally, on unknown dates, the patients had polymerase chain reaction (PCR) testing which was positive for strain found in measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA002031:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Maternal exposure before pregnancy
Clinical narrative: received an unspecified HPV vaccine and became pregnant; received an unspecified HPV vaccine; This spontaneous prospective pregnancy report was received from a consumer referring to her friend, a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.     On an unknown date, the patient was vaccinated with an HPV vaccine (unspecified if hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) or hpv rl1 6 11 16 18 vlp vaccine (yeast)) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).    On an unknown date after vaccination, the patient became pregnant. The last menstrual period (LMP), estimated date of conception and estimated date of delivery (EDD) were not known and could not be calculated. The pregnancy outcome was pending and the fetal outcome was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was administered one dose of improperly stored Proquad; No adverse effects were reported; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's relevant medical history, previous allergies or drug reactions, concomitant medications and concurrent conditions were not disclosed.  On 30-JAN-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, frequency, anatomical injection site and route of administration were not disclosed) for prophylaxis; lot # R015740 and expiration date  reported as 03-DEC-2019, but upon internal validation established as 02-DEC-2019.  It was reported that this vaccine had been on a temperature excursion and was stored at 21 °F during 19 hours; and it was also noted that there had been a previous temperature excursion of 96 hours at a temperature of 14 °F (6 °F - 14 °F).  At the time of this report, there were no adverse events reported. Digital data logger was involved.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 09-NOV-2018, the patient was vaccinated with the first dose of GARDASIL 9 and on 31-MAY-2019, the patient received the second dose GARDASIL 9; No adverse effects reported; This spontaneous report was received from a pharmacist, referring to a 23-year-old female patient. The patient's medical history, current conditions, concomitant medications and drug/allergies were not reported.  On 09-NOV-2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular for prophylaxis (lot# N015089, expiration date on 20-OCT-2019) (strength, anatomical location, dose and route of administration were not reported).  On 31-MAY-2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular for prophylaxis (lot# N015089, expiration date on 20-OCT-2019) (strength, anatomical location, dose and route of administration were not reported) (inappropriate schedule of vaccine administered). There was no additional information provided.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no adverse effects; two patients, received improperly stored PROQUAD; This spontaneous report as received from a medical assistant and refers to a patient of unknown age.  The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.      On 28-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), for prophylaxis lot number R030800 and expirtation date 22-APR-2019 (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit. Total frame from 15-MAY-2019 to 31-MAY-2019 (16 days, 384 hours).  No previous temperature excursion. It was not recorded by a data logger.; Sender's Comments:  US-009507513- 1906USA000953:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A patient received a dose of Varivax following a temperature excursion; No adverse effects were reported in the patient; This spontaneous report was received from a healthcare provider and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019236, expiration date 04-JUL-2020, subcutaneously (dose and frequency were not reported) for prophylaxis.     The improperly stored vaccine was exposed to a temperature between 15 Fahrenheit degrees (F) and 46 F (-9 Celsius degrees and 8 Celsius degrees) with an average of 23 F; during 3 hours.  The call was because of a data logger. There were no previous temperature excursions. No product quality complaint (PQC) was involved.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A dose of VAQTA was given "too soon" / first dose of VAQTA was received when patient "was 12 months old and second dose was given when patient was only 17 months old"; No adverse effects reported; This spontaneous report was received from a licensed practical nurse referring to a 17 months old patient of unknown gender. The patient's concurrent conditions, past medical history, concomitant medications, and drug reactions or allergies were not reported.  On an unknown date, when the patient was 12 months old, he/she was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) vial 50, intramuscular (dose, anatomical location, lot # and expiration date were not reported), for prophylaxis.  Subsequently, on an unknown date, when the patient was 17 months old, the patient received the second dose of hepatitis a vaccine, inactivated (VAQTA). It was reported that the dose was given "too soon". No adverse effects reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; Inadvertent administration third dose beyond 32 weeks; Information has been received from a medical assistant referring to a 9 week old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided.      On 15-OCT-2018 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose 1, strength, dose, batch/lot number and expiration date were not provided) orally for prophylaxis. On 05-FEB-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose 2, strength, dose, batch/lot number and expiration date were not provided) orally for prophylaxis. On 03-JUN-2019 when the patient was 9 months 18 days, the patient was inadvertently received third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number R027154 and expiration date 27-JUN-2020; strength and dose were not provided) orally for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Therapeutic response unexpected
Clinical narrative: An unspecified patient who was administered a dose of Gardasil 9 on an unspecified date had pre-existing warts in an unspecified location that resolved on an unspecified date following administration of gardasil 9.; This spontaneous report was received from a physician referring  to a male patient of unknown age.  Patient's concurrent conditions, medical history, concomitant medications, drug allergies or reactions were not reported.     On an unspecified date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, administration route, dose number, lot number and expiration date was nor provided) for prophylaxis.       On an unspecified date (reported as following administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) ),  the patient recovered from a pre-existing warts on an unspecified location.  The event outcome was unknown.  And the reported did not assessed the causal relatedness between the event and vaccination with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) .   This is one of several reports from the same reported .; Sender's Comments:  US-009507513-1906USA001693:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 10-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 14-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 16-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 16-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 21-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 22-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 24-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 29-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 30-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Diagnosed with Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the routine health maintenance and for the prevention of shingles. On an unspecified date after the vaccination, the patient suffered a painful rash on his arm. As a result of these symptoms, the patient presented to a medical provider and was diagnosed with Herpes Zoster. Thereafter, the patient has continued to suffer the effects of Herpes Zoster. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Patients were vaccinated with improperly stored vaccines; no adverse symptom; This non-valid spontaneous report was received from a medical assistant concerning an unspecified number of patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012416, expiration date 28-OCT-2019) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# N031003, expiration date 03-NOV-2019) (strengths, doses, frequencies and anatomical sites were unknown) all for prophylaxis, which had a temperature excursion on the range of 15°F to 46°F (21.6°F) for 12.5 hours. The temperature excursion was detected by a data logger and no adverse symptoms were reported.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient were each administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse referring to two unspecified patients of unknown ages and unknown genders. Information of concurrent condition, medical history and concomitant therapy were not provided.    On 24-OCT-2018, patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot#R017635 with expiration date 20-JUN-2020 (strength, dose and route were not reported) for prophylaxis and sterile diluent (STERILE DILUENT). The varicella virus vaccine live (oka/merck)(VARIVAX) vaccines experienced temperature excursion and were stored at 6 to 14 Fahrenheit degrees (9.1 Fahrenheit degrees ) for 50 minutes (Product storage error). There was no previous temperature excursion. No adverse events were reported in any patients. A data logger was involved. The outcome of the event was not reported.  Follow-up information was received from the reporting nurse on 05-JUN-2019.  The nurse reported the patient's demographics and were updated in the case.  It was also reported that on 24-OCT-2018, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis, lot # R011802, expiration date 21-OCT-2019 (strength, dose, frequency, route of administration and anatomical site of injection were not reported).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA002234: US-009507513-1810USA011328:
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Nausea
Clinical narrative: The nurse states that she received a dose of MMR II on an unknown recent date and developed nausea and recent date and developed nausea and diarrhea for 3 days after receiving the dose.; The nurse states that she received a dose of MMR II on an unknown recent date and developed nausea and recent date and developed nausea and diarrhea for 3 days after receiving the dose.; This spontaneous report was received from a nurse via company representative referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies, lab diagnostics/studies performed and concomitant therapies were unknown by the reporter.  On an unknown date in 2019 (reported as "recent date"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneous injection for immunisation (number of doses,  dose, frequency, anatomical location were not provide and lot number and expiration date were unknown by the reporter)  On an unknown date (reported as "3 days after received the dose"),  the patient developed nausea and diarrhea (diarrhoea).  The outcome of the events nausea and diarrhoea was reported as fully recovered, without treatment.     The relatedness assessment between the suspect therapy measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the events nausea and diarrhea was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pain in extremity, Wrong product administered
Clinical narrative: her arm is little sore; by mistake was givena dose of GARDASIL 9 instead if Tdap; 29 weeks pregnant/by mistake was given a dose of GARDASIL 9 instead if Tdap; 29 weeks pregnant/by mistake was given a dose of GARDASIL 9 instead if Tdap.; This spontaneous prospective pregnancy report was received from a consumer referring on herself a 30-year-old female patient. Her concurrent condition included high cholesterol; her medical history included abnormal Papanicolaou test; her drug reactions or allergies included morphine. Concomitant therapies included progesterone and prenatal vitamins. The patient's last menstrual period (LMP) was calculated at 14-NOV-2018 and the Estimated Date of Delivery (EDD) at 21-AUG-2019. The pregnancy outcome was pending.  For the past 3 or 4 years the patient's Papanicolaou test has been normal. It was reported that on an unknown date, a colposcopy was performed for the abnormal Papanicolaou tests.  On 04-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 dosage form, in the upper arm (formulation, dose, route of administration, lot # and expiration date were not reported) instead of tetanus, diphtheria and pertussis (Tdap) vaccine (wrong product administered) (foetal exposure during pregnancy) (exposure during pregnancy); also, her arm was a little sore (pain in extremity). It was reported that the patient  spoke to physician's office.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administration and pain in extremity occurrence was not provided by the reporter.
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: developed a lump at the site of GARDASIL 9 injection; This spontaneous report was received from a pharmacist via company representative concerning to a male patient of unknown age.  The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On approximately 15-MAY-2019 (reported as " about 3 weeks ago"), the patient was vaccinated with a dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prevent Human papillomavirus  (HPV).     On an unknown date in 2019 (reported as "on an unknown date after this"), the patient developed a lump at the site of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (injection site mass). No treatment was given for the adverse event. It was reported that the patient went to see the pharmacist.   At the time of the report, the outcome of injection site mass was reported as not recovered.   The relationship between adverse event and suspect therapy were not provided.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 19-week-old male patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 12-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ((dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 25-week-old male patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 15-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ((dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning an 8-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 11-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger. ; Sender's Comments:  US-009507513-1903USA013366: