chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Only a few hours later, I had flu-like symptoms of total body aches, headache, lethargy and chills.  Injection site also was red and harder than normal.  Upper arm felt sore as well. The next morning the chills were gone but other symptoms persisted until bedtime that night.  The following morning I felt somewhat better and in 4 days I felt more like myself again.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Pain
Clinical narrative: Only a few hours later, I had flu-like symptoms of total body aches, headache, lethargy and chills.  Injection site also was red and harder than normal.  Upper arm felt sore as well. The next morning the chills were gone but other symptoms persisted until bedtime that night.  The following morning I felt somewhat better and in 4 days I felt more like myself again.
Age: 59.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Flushing, Headache
Clinical narrative: Patient to office with c/o allergic reaction to Shingles shot received on 2.26.2020.  Patient states that symptoms started that night - same day vaccination was given, with flushing across chest, shivering, joint pain, fever, and HA that lasted ~5 hours. Patient felt she needed to go to ER, but did not go and scheduled appointment to office this AM 2.27.2020. Patient states that symptoms improved over night with Motrin and now is very tired at this time.
Age: 59.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Hypersensitivity, Pyrexia
Clinical narrative: Patient to office with c/o allergic reaction to Shingles shot received on 2.26.2020.  Patient states that symptoms started that night - same day vaccination was given, with flushing across chest, shivering, joint pain, fever, and HA that lasted ~5 hours. Patient felt she needed to go to ER, but did not go and scheduled appointment to office this AM 2.27.2020. Patient states that symptoms improved over night with Motrin and now is very tired at this time.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Vomiting
Clinical narrative: Patient awake at 0400 following the injection, experienced nausea and then vomited once. She quickly recovered after the bout of emesis.
Age: 1.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Quadracel given by mistake, not indicated for age of patient
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ocular discomfort, Ocular hyperaemia, Rash
Clinical narrative: Patient noticed small blisters around her left eye, on upper eyelid and under lower eyelid, along with redness in the eye and slight feeling of pressure in the eye which accompanied these symptoms. There is slight discomfort but no pain. She also noted some small bumps on her chin around the same time that she is not sure if they are related or if they are pimples. This began ten days after her 2nd dose of Shingrix. She saw the dermatologist today and the differential diagnosis at the moment is shingles. She began treatment with valacyclovir today.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reports extreme soreness/pain at injection site, unable to lift arm, redness of cheeks. Using ibuprofen and heat at injection site. Advised to seek medical attention if she feels necessary.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain upper, Chills, Cough, Headache, Pain in extremity
Clinical narrative: BIB mother for concern for vaccine reaction Mom states that 3 days ago patient had vaccines That night patient had right arm pain, cough, and a tactile fever with chills on monday and tuesday Mom states symptoms lasted all night Patient also had headache and stomach ache Last fever was yesterday Patient states pain is improving Denies vomiting, nausea, shortness of breath, other swelling
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pyrexia
Clinical narrative: BIB mother for concern for vaccine reaction Mom states that 3 days ago patient had vaccines That night patient had right arm pain, cough, and a tactile fever with chills on monday and tuesday Mom states symptoms lasted all night Patient also had headache and stomach ache Last fever was yesterday Patient states pain is improving Denies vomiting, nausea, shortness of breath, other swelling
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dry mouth, Dysphagia, Headache, Heart rate increased
Clinical narrative: Went to bed on 2/26/2020 but could not go to sleep, even after taking sleep aid. Around 1:00am on 2/27/2020 heart began pounding in my head, rapid heart rate. Still not sleeping. Around 4PM I got out of bed and measured my heart rate at 100bpm. Around 5pm my wife measured my heart rate at 100bpm. My resting heart rate is 55-60. When I got up at 1am I began shaking quite hard with the chills. I took 400mg of ibuprofen. Shaking stopped 5-10 min after getting back into bed. I noticed that I had body aches and my injection site shoulder was sore. At 1am I noticed it was taking a little extra effort to swallow. At 4am my tongue felt enlarged, but my wife indicated it did not look enlarged to her. My mouth was very try and due to the dryness it was more dificult to speak. At 5pm I phoned my insurance carrier's Ask-A-Nurse number. The nurse asked me lots of questions and in the end felt I was not in immediate risk but should go to my PCP within 4 hours. Temperature was 99.2 By 6 or 7am by heart rate had dropped down to 80-85. I was able to schedule an appointment on 2/27/2020 with my PCP at 11am. BP and oxygen was normal. Heart rate was 88.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Pain, Speech disorder, Tremor
Clinical narrative: Went to bed on 2/26/2020 but could not go to sleep, even after taking sleep aid. Around 1:00am on 2/27/2020 heart began pounding in my head, rapid heart rate. Still not sleeping. Around 4PM I got out of bed and measured my heart rate at 100bpm. Around 5pm my wife measured my heart rate at 100bpm. My resting heart rate is 55-60. When I got up at 1am I began shaking quite hard with the chills. I took 400mg of ibuprofen. Shaking stopped 5-10 min after getting back into bed. I noticed that I had body aches and my injection site shoulder was sore. At 1am I noticed it was taking a little extra effort to swallow. At 4am my tongue felt enlarged, but my wife indicated it did not look enlarged to her. My mouth was very try and due to the dryness it was more dificult to speak. At 5pm I phoned my insurance carrier's Ask-A-Nurse number. The nurse asked me lots of questions and in the end felt I was not in immediate risk but should go to my PCP within 4 hours. Temperature was 99.2 By 6 or 7am by heart rate had dropped down to 80-85. I was able to schedule an appointment on 2/27/2020 with my PCP at 11am. BP and oxygen was normal. Heart rate was 88.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: patient states she had significant pain in her arm at the injection site for over 3 weeks.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: ON 2/27/2020 1 DAY AFTER THE IMZ THE PT REPORTED EXTREME MALAISE ALLDAY, PAIN, SWELLING, AND HOT TO TOUCH AT THE INJECTION SITE. PATIENT WAS ADVISED TO TAKE IBUPROFEN AND USE A COLD COMPRESSION ON ARM
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: moderate pain in arm at location of injection, by 2nd day was very mild only headache appeared several hours after injection, lasted all the next day, took Ibuprofen, headache gone by 2nd day fever appeared evening of the injection, lasted all the next day, gone by 2nd day body aches, most noticeable in the knees, lower back and shoulders, lasted all the next day, took Ibuprofen, aches gone by the 2nd day
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pyrexia
Clinical narrative: Patient experienced neck stiffness, neck pain, and fever
Age: 64.0
Sex: M
Vaccine: YF
Symptoms: Blood culture, CSF culture, CSF test, Confusional state, Diplopia
Clinical narrative: Fever, headache, diplopia and confusion
Age: 64.0
Sex: M
Vaccine: YF
Symptoms: Headache, Lumbar puncture, Magnetic resonance imaging brain, Pyrexia
Clinical narrative: Fever, headache, diplopia and confusion
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: PAINFUL ARM WITH NO SWELLING OR REDNESS MORE THAN A MONTH AFTER ADMINISTRATION
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Full blood count normal, Irritable bowel syndrome, Stool analysis normal
Clinical narrative: Within a few days of getting the vaccine, I developed Irritable Bowel Syndrome, which I had never had before.  It was controllable only by Imodium.  After about two months of constant IBS, it  has become a sometimes occurence.  Although I have mostly recovered, the recovery is not complete.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Streptococcus test negative, Urticaria
Clinical narrative: -Patient develop hives all over body the next day after receiving vaccines. Patient was seen by Urgent Care on 2/8/2020. Patient was prescribed Prednisolone 15 mg oral solution, Zyrtec 5mg, take 2.5 ml daily up to 1 week, Children Tylenol 32 mg, 5ml every 6 hours for fever. -patient was seen again on 2/23/2020 at urgent care for hives all over body. He was prescribed Decadron 0.6 mg one dose. Zyrtec 5mg/5ml oral solution, sig: 2.5 ml daily until hives gone(up to 1 week). -2/27/2020 Patient came in for f/u from urgent care. Mom reports, that if she gives him the Zyrtec, the rash will disappear almost immediately. Referral placed to Pediatric/Allergy/Immunology
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Rash, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Red, swollen, itchy rash, very painful. Could not lift arm. Took ~36 hours before sxs subsided. Took Aspiring to help with sxs, helped somewhat.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin lesion
Clinical narrative: 1st symptom was red spot at site for 4 days with frequent bowel movement resolved after 4 days. 2nd symptoms was lesions on roof of mouth that started 4 days after 1 or 2 and continued until time of report. PATIENT hAs follow-up appt. on 3/9/20 to assess the unresolved oral lesions on roof of mouth.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reported muscle pain at the site of injection without any redness or swelling. The muscle pain is interfering with the mobility of the right arm in motions that reach out and up. Patient missed work and called md office the day after vaccination.  Patient has since seen prescriber.  Patient reported 2/28/20 that there has been no changes in those symptoms.
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Erythema, Full blood count, Influenza virus test, Rash, Swelling
Clinical narrative: stiff arm; she lost sensation of the arm; swelling of the right arm; severe reaction; back pain; difficulty moving neck and arm; severe fever; cellulitis; PNEUMOVAX 23 to prevent future compilations of asthma; This spontaneous report refers to a 19 year old female patient who reported on herself with nuts allergy. It was reported that patient had no pertinent medical history nor concomitant therapies.  On 12-FEB-2020, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S026366, expiration date reported as 21-DEC-2021, but upon internal review established as 17-SEP-2020 (route of administration and exact dose were not reported) to prevent future compilations of asthma.  In the early morning of 13-FEB-2020, the patient started to have a severe reaction. In the early morning of 13-FEB-2020 she had a severe fever. Other symptoms such as swelling of the right arm, back pain and difficulty moving neck and arm followed. On the same day the patient visited Emergency room. The patient was released from the Emergency room on 13-FEB-2020 after receiving ibuprofen. On 14-FEB-2020, the swelling on the patient got worse, her arm became stiff, and she lost sensation of the arm. On 14-FEB-2020, she visited Emergency room again. There she was administered KEFLEX. She did not respond to the cephalexin (KEFLEX) and was then admitted to the Hospital. At hospital, the patient was treated with clindamycin. On 14-FEB-2020, pt had laboratory tests performed: complete blood count (CBC) twice, x-ray, sonogram twice (no results were provided). The patient was discharged from Hospital on 17-FEB-2020. The patient was instructed to continue unspecified antibiotics for 10 days after discharge. The patient was diagnosed with cellulitis on unspecified date. The patient was requesting a reimbursement of hospital bills.  Cellulitis had not resolved yet. The outcome of the events was reported as not recovered. The reporter considered all events except cellulitis to be related to the suspect therapy. The causality assessment for cellulitis was not provided.   Upon internal review, the event of cellulitis was considered to be medically significant.
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Ultrasound scan, X-ray
Clinical narrative: stiff arm; she lost sensation of the arm; swelling of the right arm; severe reaction; back pain; difficulty moving neck and arm; severe fever; cellulitis; PNEUMOVAX 23 to prevent future compilations of asthma; This spontaneous report refers to a 19 year old female patient who reported on herself with nuts allergy. It was reported that patient had no pertinent medical history nor concomitant therapies.  On 12-FEB-2020, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S026366, expiration date reported as 21-DEC-2021, but upon internal review established as 17-SEP-2020 (route of administration and exact dose were not reported) to prevent future compilations of asthma.  In the early morning of 13-FEB-2020, the patient started to have a severe reaction. In the early morning of 13-FEB-2020 she had a severe fever. Other symptoms such as swelling of the right arm, back pain and difficulty moving neck and arm followed. On the same day the patient visited Emergency room. The patient was released from the Emergency room on 13-FEB-2020 after receiving ibuprofen. On 14-FEB-2020, the swelling on the patient got worse, her arm became stiff, and she lost sensation of the arm. On 14-FEB-2020, she visited Emergency room again. There she was administered KEFLEX. She did not respond to the cephalexin (KEFLEX) and was then admitted to the Hospital. At hospital, the patient was treated with clindamycin. On 14-FEB-2020, pt had laboratory tests performed: complete blood count (CBC) twice, x-ray, sonogram twice (no results were provided). The patient was discharged from Hospital on 17-FEB-2020. The patient was instructed to continue unspecified antibiotics for 10 days after discharge. The patient was diagnosed with cellulitis on unspecified date. The patient was requesting a reimbursement of hospital bills.  Cellulitis had not resolved yet. The outcome of the events was reported as not recovered. The reporter considered all events except cellulitis to be related to the suspect therapy. The causality assessment for cellulitis was not provided.   Upon internal review, the event of cellulitis was considered to be medically significant.
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Back pain, Cellulitis, Full blood count, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: stiff arm; she lost sensation of the arm; swelling of the right arm; severe reaction; back pain; difficulty moving neck and arm; severe fever; cellulitis; PNEUMOVAX 23 to prevent future compilations of asthma; This spontaneous report refers to a 19 year old female patient who reported on herself with nuts allergy. It was reported that patient had no pertinent medical history nor concomitant therapies.  On 12-FEB-2020, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S026366, expiration date reported as 21-DEC-2021, but upon internal review established as 17-SEP-2020 (route of administration and exact dose were not reported) to prevent future compilations of asthma.  In the early morning of 13-FEB-2020, the patient started to have a severe reaction. In the early morning of 13-FEB-2020 she had a severe fever. Other symptoms such as swelling of the right arm, back pain and difficulty moving neck and arm followed. On the same day the patient visited Emergency room. The patient was released from the Emergency room on 13-FEB-2020 after receiving ibuprofen. On 14-FEB-2020, the swelling on the patient got worse, her arm became stiff, and she lost sensation of the arm. On 14-FEB-2020, she visited Emergency room again. There she was administered KEFLEX. She did not respond to the cephalexin (KEFLEX) and was then admitted to the Hospital. At hospital, the patient was treated with clindamycin. On 14-FEB-2020, pt had laboratory tests performed: complete blood count (CBC) twice, x-ray, sonogram twice (no results were provided). The patient was discharged from Hospital on 17-FEB-2020. The patient was instructed to continue unspecified antibiotics for 10 days after discharge. The patient was diagnosed with cellulitis on unspecified date. The patient was requesting a reimbursement of hospital bills.  Cellulitis had not resolved yet. The outcome of the events was reported as not recovered. The reporter considered all events except cellulitis to be related to the suspect therapy. The causality assessment for cellulitis was not provided.   Upon internal review, the event of cellulitis was considered to be medically significant.
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Peripheral swelling, Pyrexia, Sensory loss, Ultrasound scan, X-ray
Clinical narrative: stiff arm; she lost sensation of the arm; swelling of the right arm; severe reaction; back pain; difficulty moving neck and arm; severe fever; cellulitis; PNEUMOVAX 23 to prevent future compilations of asthma; This spontaneous report refers to a 19 year old female patient who reported on herself with nuts allergy. It was reported that patient had no pertinent medical history nor concomitant therapies.  On 12-FEB-2020, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S026366, expiration date reported as 21-DEC-2021, but upon internal review established as 17-SEP-2020 (route of administration and exact dose were not reported) to prevent future compilations of asthma.  In the early morning of 13-FEB-2020, the patient started to have a severe reaction. In the early morning of 13-FEB-2020 she had a severe fever. Other symptoms such as swelling of the right arm, back pain and difficulty moving neck and arm followed. On the same day the patient visited Emergency room. The patient was released from the Emergency room on 13-FEB-2020 after receiving ibuprofen. On 14-FEB-2020, the swelling on the patient got worse, her arm became stiff, and she lost sensation of the arm. On 14-FEB-2020, she visited Emergency room again. There she was administered KEFLEX. She did not respond to the cephalexin (KEFLEX) and was then admitted to the Hospital. At hospital, the patient was treated with clindamycin. On 14-FEB-2020, pt had laboratory tests performed: complete blood count (CBC) twice, x-ray, sonogram twice (no results were provided). The patient was discharged from Hospital on 17-FEB-2020. The patient was instructed to continue unspecified antibiotics for 10 days after discharge. The patient was diagnosed with cellulitis on unspecified date. The patient was requesting a reimbursement of hospital bills.  Cellulitis had not resolved yet. The outcome of the events was reported as not recovered. The reporter considered all events except cellulitis to be related to the suspect therapy. The causality assessment for cellulitis was not provided.   Upon internal review, the event of cellulitis was considered to be medically significant.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood calcium increased, Blood magnesium normal, Blood potassium normal, Chest X-ray normal, Electrocardiogram ST segment abnormal
Clinical narrative: SVT - I woke up with a very rapid heartbeat, over 130.  Waited for it to subside but it didn't.  My husband drove me to Hospital ER, about 20 minutes away, where my heart rate had lowered to 125 while waiting and then to the 90s in the exam room.   I had not been to an emergency room in over 20 years.  After test results came back and several hours of observation I was instructed to set up a follow up appt with a cardiologist, which I did
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram T wave abnormal, Full blood count normal, Heart rate increased, International normalised ratio normal, Metabolic function test
Clinical narrative: SVT - I woke up with a very rapid heartbeat, over 130.  Waited for it to subside but it didn't.  My husband drove me to Hospital ER, about 20 minutes away, where my heart rate had lowered to 125 while waiting and then to the 90s in the exam room.   I had not been to an emergency room in over 20 years.  After test results came back and several hours of observation I was instructed to set up a follow up appt with a cardiologist, which I did
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Prothrombin time prolonged, Supraventricular tachycardia, Troponin I increased
Clinical narrative: SVT - I woke up with a very rapid heartbeat, over 130.  Waited for it to subside but it didn't.  My husband drove me to Hospital ER, about 20 minutes away, where my heart rate had lowered to 125 while waiting and then to the 90s in the exam room.   I had not been to an emergency room in over 20 years.  After test results came back and several hours of observation I was instructed to set up a follow up appt with a cardiologist, which I did
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; patient was administered an improperly stored dose of PEDVAX HIB; This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 03-FEB-2020, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # S008730, expiration date 23-JAN-2020, (exact dose, dose number and route of administration were not provided) for prophylaxis.  The temperature excursion was above 9 degrees Celsius (C) (13.1 C) for 1 hour 30 minutes. There were no previous excursions reported. The digital data logger was involved. There was no adverse event reported.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Decreased appetite, Dehydration, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: rash, fever, decreased appetite, lethargic, and cough and vomiting/the patient was diagnosed with dehydration and viral illness; the patient was diagnosed with dehydration; The patient was also suspected of having Kawasaki disease but was not confirmed with a diagnosis; Information has been received from a registered nurse referring to a 13 months old male patient. The patient's had no pertinent medical history and concomitant medication. The patient was allergic to egg white, milk, almonds and soy.   On 07-FEB-2020, the patient received both 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose and frequency were unknown; subcutaneous, lot # S015092 and expiration date 15-MAY-2021) and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and frequency were unknown; subcutaneous, lot # S021323 and expiration date 09-JUL-2021) for prophylaxis.    The patient developed rash on 11-FEB-2020 and fever on 12-FEB-2020. On 12-FEB-2020, the rash spread onto entire body and on 13-FEB-2020 rash started to fade. On 13-FEB-2020, the patient also experienced decreased appetite, was lethargic and developed cough. On 14-FEB-2020, the patient went to an emergency room and was admitted into hospital. In the hospital, the patient was diagnosed with dehydration and viral illness. Respiratory panel result was negative. On 17-FEB-2020, the patient was discharged. The patient was also referred to cardiologist after discharged from hospital. The cardiologist tested the patient with an electrocardiogram and echocardiogram but results were all normal. The patient was also suspected of having Kawasaki disease but was not confirmed with a diagnosis. The outcome of all the events was recovering. The causality between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX) and the events were not provided.  The event of viral illness was considered as significant disability or incapacity by the nurse since patient was lethargic and vomiting. Upon internal review, Kawasaki disease was considered as medical significant.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Kawasaki's disease, Laboratory test normal, Lethargy, Pyrexia, Rash
Clinical narrative: rash, fever, decreased appetite, lethargic, and cough and vomiting/the patient was diagnosed with dehydration and viral illness; the patient was diagnosed with dehydration; The patient was also suspected of having Kawasaki disease but was not confirmed with a diagnosis; Information has been received from a registered nurse referring to a 13 months old male patient. The patient's had no pertinent medical history and concomitant medication. The patient was allergic to egg white, milk, almonds and soy.   On 07-FEB-2020, the patient received both 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose and frequency were unknown; subcutaneous, lot # S015092 and expiration date 15-MAY-2021) and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and frequency were unknown; subcutaneous, lot # S021323 and expiration date 09-JUL-2021) for prophylaxis.    The patient developed rash on 11-FEB-2020 and fever on 12-FEB-2020. On 12-FEB-2020, the rash spread onto entire body and on 13-FEB-2020 rash started to fade. On 13-FEB-2020, the patient also experienced decreased appetite, was lethargic and developed cough. On 14-FEB-2020, the patient went to an emergency room and was admitted into hospital. In the hospital, the patient was diagnosed with dehydration and viral illness. Respiratory panel result was negative. On 17-FEB-2020, the patient was discharged. The patient was also referred to cardiologist after discharged from hospital. The cardiologist tested the patient with an electrocardiogram and echocardiogram but results were all normal. The patient was also suspected of having Kawasaki disease but was not confirmed with a diagnosis. The outcome of all the events was recovering. The causality between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX) and the events were not provided.  The event of viral illness was considered as significant disability or incapacity by the nurse since patient was lethargic and vomiting. Upon internal review, Kawasaki disease was considered as medical significant.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Respiratory viral panel, Viral infection, Vomiting
Clinical narrative: rash, fever, decreased appetite, lethargic, and cough and vomiting/the patient was diagnosed with dehydration and viral illness; the patient was diagnosed with dehydration; The patient was also suspected of having Kawasaki disease but was not confirmed with a diagnosis; Information has been received from a registered nurse referring to a 13 months old male patient. The patient's had no pertinent medical history and concomitant medication. The patient was allergic to egg white, milk, almonds and soy.   On 07-FEB-2020, the patient received both 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose and frequency were unknown; subcutaneous, lot # S015092 and expiration date 15-MAY-2021) and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and frequency were unknown; subcutaneous, lot # S021323 and expiration date 09-JUL-2021) for prophylaxis.    The patient developed rash on 11-FEB-2020 and fever on 12-FEB-2020. On 12-FEB-2020, the rash spread onto entire body and on 13-FEB-2020 rash started to fade. On 13-FEB-2020, the patient also experienced decreased appetite, was lethargic and developed cough. On 14-FEB-2020, the patient went to an emergency room and was admitted into hospital. In the hospital, the patient was diagnosed with dehydration and viral illness. Respiratory panel result was negative. On 17-FEB-2020, the patient was discharged. The patient was also referred to cardiologist after discharged from hospital. The cardiologist tested the patient with an electrocardiogram and echocardiogram but results were all normal. The patient was also suspected of having Kawasaki disease but was not confirmed with a diagnosis. The outcome of all the events was recovering. The causality between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX) and the events were not provided.  The event of viral illness was considered as significant disability or incapacity by the nurse since patient was lethargic and vomiting. Upon internal review, Kawasaki disease was considered as medical significant.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Depressed level of consciousness, Dizziness, Human papilloma virus test positive, Incomplete course of vaccination
Clinical narrative: tested high risk positive for a (unknown) strand of HPV a couple of weeks ago/ tested possitive for HPV; when my daughter received the first two doses of GARDASIL she almost passed out, had to lie down, she was seeing light and she looked gray; therapy start date: August 2013/ therapy end date: August 2014.; when my daughter received the first two doses of GARDASIL she almost passed out, had to lie down, she was seeing light and she looked gray; This spontaneous report was received from the patient's mother, referring to a currently 23-year-old female patient. The patient had none concomitant medications, pertinent medical history, concurrent conditions, or drug reactions or allergies.  On an unknown day in August 2013 and August 2014, the patient was vaccinated with the first two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) as prophylaxis, route of administration was reported as "shot" (anatomical location was not reported; lot number and expiration date were unknown by the reporter) (inappropriate schedule of product administration).  When the patient received the first two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), she almost passed out, had to lie down,  she was seeing light and she looked gray (dizziness). The patient chose not to get the third dose because she almost passed out.  On an unspecified date (also reported as "a couple of weeks ago"), the patient was performed a colposcopy. The patient tested high risk positive for an unknown strand of human papillomavirus (HPV) (also reported as "tested positive for HPV") (human papilloma virus test positive).  The patient sougth medical attention in the doctor's office. It was reported that the patient did not received treatment for the events.  The outcome of the human papilloma virus test positive was reported as not recovered. The outcome of both episodes of dizziness was not reported.   The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the aforementioned events was not provided.
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: tested high risk positive for a (unknown) strand of HPV a couple of weeks ago/ tested possitive for HPV; when my daughter received the first two doses of GARDASIL she almost passed out, had to lie down, she was seeing light and she looked gray; therapy start date: August 2013/ therapy end date: August 2014.; when my daughter received the first two doses of GARDASIL she almost passed out, had to lie down, she was seeing light and she looked gray; This spontaneous report was received from the patient's mother, referring to a currently 23-year-old female patient. The patient had none concomitant medications, pertinent medical history, concurrent conditions, or drug reactions or allergies.  On an unknown day in August 2013 and August 2014, the patient was vaccinated with the first two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) as prophylaxis, route of administration was reported as "shot" (anatomical location was not reported; lot number and expiration date were unknown by the reporter) (inappropriate schedule of product administration).  When the patient received the first two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), she almost passed out, had to lie down,  she was seeing light and she looked gray (dizziness). The patient chose not to get the third dose because she almost passed out.  On an unspecified date (also reported as "a couple of weeks ago"), the patient was performed a colposcopy. The patient tested high risk positive for an unknown strand of human papillomavirus (HPV) (also reported as "tested positive for HPV") (human papilloma virus test positive).  The patient sougth medical attention in the doctor's office. It was reported that the patient did not received treatment for the events.  The outcome of the human papilloma virus test positive was reported as not recovered. The outcome of both episodes of dizziness was not reported.   The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the aforementioned events was not provided.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: the patient was administered lhe first dose of GARDASIL 9 on 12-FEB-2020 and fainted while in the office; Information has been received from a nurse via filed representative, referring to a 14 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-FEB-2020, the patient was administered the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength and dose detail were not reported) (lot # R029507, expiration date 10-JUL-2021) intramuscularly for prophylaxis.  On the same date after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient fainted while in the office. The patient was given treatment with crackers and water. The outcome of faint was recovered and the patient was able to go home shortly after fainting. The causality assessment was not provided.  Upon internal review, faint was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; a patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a Medical Assistant who referred to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies, were not provided.   On 19-FEB-2020, the patient was inadvertently administered with  an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose orally for prophylaxis (strength not reported)(lot number S014947 had been verified to be valid lot numbers; expiration date 10-DEC-2020). The  temperature  excursion was at below 36 degrees Fahrenheit (34 F), for a time frame of 27 minutes, and  no had previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.; Sender's Comments:  US-009507513-2002USA010005: US-009507513-2002USA009991:
Age: 2.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse symptoms reported; an unspecified 2 year old patient inadvertently received a dose of GARDASIL 9; This spontaneous report was received form a nurse, regarding a 2-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 25-FEB-2020 , the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis (product administered to patient of inappropriate age). No adverse symptoms were reported.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 18 year old patient received an adult dose of VAQTA; This spontaneous report was received from an office manager, via a company representative, referring to an 18-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not reported.  On 24-FEB-2020, the 18-year-old patient was vaccinated with an adult dose of hepatitis A vaccine, inactivated (VAQTA) 50 units per milliliter (U/ml) as prophylaxis (product administered to patient of inappropriate age) (lot number S007265, has been verified to be a valid lot number, expiration date not reported, but upon internal validation, it was established as 07-JUL-2020) (frequency of vaccination scheme, route and anatomical location of vaccination were not reported).  No additional information was provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; vaccine administered to patient of inappropiate age; This spontaneous report was received from a pharmacist via company representative refers to an unspecified patient who was over 50 years of age with unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Approximately on an unknown date in January 2020 (reported as "may be a month ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, strength, route, vaccination site, # lot, expiry date unspecified) (product administered to patient of inappropriate age). No additional adverse effect was reported. Product quality complaint (PQC) was not involved.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA010791:
Sex: F
Vaccine: HPV9
Symptoms: Paralysis
Clinical narrative: was paralyzed from the neck down; Information has been received from a health business professional (HBP) via a merck employee referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown.  On an unknown date, the patient got hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, lot # and expiration date were unknown) for prophylaxis.  On an unknown date, the patient was paralyzed from the neck down. The outcome of the event was unknown. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, paralyzed from the neck down was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; vaccine administered to patient of inappropiate age; This spontaneous report was received from a pharmacist via company representative refers to an unspecified patient who was over 50 years of age with unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Approximately on an unknown date in January 2020 (reported as "may be a month ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, strength, route, vaccination site, # lot, expiry date unspecified) (product administered to patient of inappropriate age). No additional adverse effect was reported. Product quality complaint (PQC) was not involved.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA010092:
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Haematochezia
Clinical narrative: blood in their stools; This case was reported by a physician via call center representative and described the occurrence of blood in stool in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Concurrent medical conditions included breast feeding.   On 17th February 2020, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 19th February 2020, 2 days after receiving Rotarix lyophilized formulation, the patient experienced blood in stool (serious criteria GSK medically significant). On an unknown date, the outcome of the blood in stool was unknown.   It was unknown if the reporter considered the blood in stool to be related to Rotarix lyophilized formulation.  Additional details were provided as follows: The patient received the  dose of the Rotarix vaccine and two days after receiving the vaccine, the patient had blood in their stools without any other additional symptoms.  The patient was exclusively breastfed. The follow up consent was granted.
Age: 79.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient developed redness and significant swelling at the site of reaction followed by swelling that spread down the arm to the hand and lasted for 2 to 3 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Joint stiffness, Pain, Pyrexia
Clinical narrative: Fever, soreness, weakness, headache, joint stiffness
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Malaise, Neck pain
Clinical narrative: Pt states she received tetanus shot at OV 2/22/20 and since early Sunday, 2/23, she has had pain at the site in left shoulder, into left neck and jaw, headache, fever of 100, 100.5 Sun, Mon, even with Tylenol and Advil. States temp 99.5-100 Tuesday. States she still has mild chills at times and malaise. States left jaw pain has decreased, and overall she feels better, feels like she has "turned the corner."
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Pyrexia
Clinical narrative: Pt states she received tetanus shot at OV 2/22/20 and since early Sunday, 2/23, she has had pain at the site in left shoulder, into left neck and jaw, headache, fever of 100, 100.5 Sun, Mon, even with Tylenol and Advil. States temp 99.5-100 Tuesday. States she still has mild chills at times and malaise. States left jaw pain has decreased, and overall she feels better, feels like she has "turned the corner."
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Aggression, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram pelvis, Condition aggravated
Clinical narrative: Per office note 1/13/20: Patient has a history of sensory processing disorder.  She was previously followed by occupational therapy but was discharge in January of 2019. Her mother reports her sensory issues have been exacerbated since November of 2019 and worsened significantly in the past week.     Last Wednesday she went to school.  When she got home she had a meltdown.  Every day since that day she has had meltdowns with more severity.  She will throw things, hitting mom, screaming.  Mom used to try to ignore the behavior or walk away--3 hour meltdown Thursday which prompted ER visit. Mom has since tried staying with her instead of ignoring the behavior and the meltdowns don't last as long.  The meltdown ends with her going back to normal behavior.  She does not appear tired and doesn't go to sleep.  At the first ER visit she was given benadryl.  At the second ER visit she was started on risperdone.  Her mother really doesn't want her on regular medication until she has further medical and psychiatric evaluation.    Examples of things that have set her off the past few days: clothes--won't wear regular clothes because of things itching or they have germs.   She has been scrubbing her hands and feet with water to the point they are rough and dry/cracked. She won't go in her room due to fear of germs. She even went to grandmother's house due to fear of germs in her own home (no sick contacts at home). Food issues: has always been picky but has been more restrictive recently.  She will not say why she will no longer eat certain things. She has not had much to eat in the past 5 days.  Urine output has also been less--one day in the past 5 she only had uop x 2 in 24 hours.  Drinking a little better past few days.  After this visit, symptoms progressed such that she had severe phobia of germs.  she would not get dressed, would only sit in certain rooms of the house, and had food refusal.  the patient underwent laboratory evaluation and imaging and was referred to OT and psychiatry
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Culture throat, Food refusal, Full blood count, Hypophagia, Metabolic function test
Clinical narrative: Per office note 1/13/20: Patient has a history of sensory processing disorder.  She was previously followed by occupational therapy but was discharge in January of 2019. Her mother reports her sensory issues have been exacerbated since November of 2019 and worsened significantly in the past week.     Last Wednesday she went to school.  When she got home she had a meltdown.  Every day since that day she has had meltdowns with more severity.  She will throw things, hitting mom, screaming.  Mom used to try to ignore the behavior or walk away--3 hour meltdown Thursday which prompted ER visit. Mom has since tried staying with her instead of ignoring the behavior and the meltdowns don't last as long.  The meltdown ends with her going back to normal behavior.  She does not appear tired and doesn't go to sleep.  At the first ER visit she was given benadryl.  At the second ER visit she was started on risperdone.  Her mother really doesn't want her on regular medication until she has further medical and psychiatric evaluation.    Examples of things that have set her off the past few days: clothes--won't wear regular clothes because of things itching or they have germs.   She has been scrubbing her hands and feet with water to the point they are rough and dry/cracked. She won't go in her room due to fear of germs. She even went to grandmother's house due to fear of germs in her own home (no sick contacts at home). Food issues: has always been picky but has been more restrictive recently.  She will not say why she will no longer eat certain things. She has not had much to eat in the past 5 days.  Urine output has also been less--one day in the past 5 she only had uop x 2 in 24 hours.  Drinking a little better past few days.  After this visit, symptoms progressed such that she had severe phobia of germs.  she would not get dressed, would only sit in certain rooms of the house, and had food refusal.  the patient underwent laboratory evaluation and imaging and was referred to OT and psychiatry