chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: Took vaccine on 23rd September around noon. Symptoms started late in evening of 28th September.  - There was general itching but was most uncomfortable on the scalp, skin under the eyebrows, chin and back.  - Hands were slightly swollen and red. There were some red areas on the inside of the left arm. - Slight dizziness; no nausea or headache.  Symptoms persisted on 29th September: - Could see redness on the skin of the face where I had scratched. Ears were itchy: not the inside of the ear canal but the outside part of both ears. - Hives (small red dots concentrated in one area under the skin) were visible on the inside of both arms and around armpits. More concentrated at the wrist.  Self-medication started on 29th: - Took a Claritine tablet (10mg loratadine) at 1:40 pm.  - Symptoms started going away with 2 hours. By 4:00 pm there were no symptoms.  30th September: - Woke up at 2:30 am with itching in hands. They were swollen and red.  - Took another Claritine tablet. - Had hives on inside of arms and tops of feet in the morning with general redness on entire arms but symptoms went away after cold shower.   Today is Oct 3rd: there have not been any symptoms since last recording. Will continue to take 1 Claritine tablet every 24 hours for another week.  All the described symptoms are similar to the reaction I get from Pseudoephedrine (in cold medicine) except that the itching is not this intense and is localized to the hands and feet. I had also expected the skin on my palms and soles of feet to peel, which usually happens at the end of the reaction to pseudoephedrine but this did not happen with the Janssen vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Urticaria
Clinical narrative: Took vaccine on 23rd September around noon. Symptoms started late in evening of 28th September.  - There was general itching but was most uncomfortable on the scalp, skin under the eyebrows, chin and back.  - Hands were slightly swollen and red. There were some red areas on the inside of the left arm. - Slight dizziness; no nausea or headache.  Symptoms persisted on 29th September: - Could see redness on the skin of the face where I had scratched. Ears were itchy: not the inside of the ear canal but the outside part of both ears. - Hives (small red dots concentrated in one area under the skin) were visible on the inside of both arms and around armpits. More concentrated at the wrist.  Self-medication started on 29th: - Took a Claritine tablet (10mg loratadine) at 1:40 pm.  - Symptoms started going away with 2 hours. By 4:00 pm there were no symptoms.  30th September: - Woke up at 2:30 am with itching in hands. They were swollen and red.  - Took another Claritine tablet. - Had hives on inside of arms and tops of feet in the morning with general redness on entire arms but symptoms went away after cold shower.   Today is Oct 3rd: there have not been any symptoms since last recording. Will continue to take 1 Claritine tablet every 24 hours for another week.  All the described symptoms are similar to the reaction I get from Pseudoephedrine (in cold medicine) except that the itching is not this intense and is localized to the hands and feet. I had also expected the skin on my palms and soles of feet to peel, which usually happens at the end of the reaction to pseudoephedrine but this did not happen with the Janssen vaccine.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Had period a week ago. My period ended 7 days prior to this event. Today I have started another heavy period.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Heart rate abnormal, Tachycardia
Clinical narrative: Bradycardia and tachycardia - heart rate dropped to 40 BPM and upon standing heart rate rose to over 130 BPM.  Symptoms started the night after the injection and continued for 3 days. Tachycardia was managed by increased salt, water, and electrolytes as well as lifestyle changes such as taking more time between resting/standing. However, I still periodically have a heart rate between 40-50 BPM while resting.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever 101.5 Chills Body aches Headache
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Laboratory test normal, Pain
Clinical narrative: Roaming pain through out bod. goes from one to the other . Up to thumbs, fingers, tops of feet, backs of hands, back down to all toes. Got sever neck and upper back pain with no toe or finger pain.  It was severe. The my thumbs hurt for a minute and the back pain went form an intense pain level of 8 down to a 3 in seconds.  The pain was intense all day from 7 am to 3 pm. 4 Advil every 4 hours didn't help at all. Neither did the ice pack.  The pain just roams around to different parts of the body.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Nausea, Pain in extremity
Clinical narrative: Sore arms (Fluzone in RT ARM) immediately after injection, followed the next morning by bad headache, nausea with vomiting and dizziness for two days.  Her temperature was never more than  .4 degrees above normal.  Could not keep toast or tea and water down until the second afternoon after the injections.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sore arms (Fluzone in RT ARM) immediately after injection, followed the next morning by bad headache, nausea with vomiting and dizziness for two days.  Her temperature was never more than  .4 degrees above normal.  Could not keep toast or tea and water down until the second afternoon after the injections.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Eye pain
Clinical narrative: Stomach pain, Loose stools, Neck pain, Wrist and arm pain, Extreme fatigue, Bad headache, Eye pain, Chills.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neck pain, Pain in extremity
Clinical narrative: Stomach pain, Loose stools, Neck pain, Wrist and arm pain, Extreme fatigue, Bad headache, Eye pain, Chills.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: Pain in both biceps & pectoral muscles mainly at night. Severe enough to cause awakening from sleep. This level of pain lasted about 5 days. Still get some pain in biceps on excersion.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Upper left arm was sore from the time of 1st shot, with pain when I moved the arm toward back. Resolved with no medical intervention about October 1, 2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral disorder
Clinical narrative: Mouth lesion on interior of lip appeared 12-24 hours post shot, very swollen bottom lip and painful
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Somnolence
Clinical narrative: Patient got vaccine at 10 am, by 2pm she started to develop drowsiness, fever and pain (105F). She described she sleep more than 72 hours in 4 days. Pain is severe. Her arm is swollen as big as the size of a softball.  She called the nurse line and they told her to apply heat to arm-not working. Patient call pharmacy on 10/2/21, I recommend cold compression for the swelling, help a little bit. Patient did not have pain at this time. I advice patient to see doctor if symptoms not resolve or get worse.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular, Migraine, Muscle spasms
Clinical narrative: Headaches, migraines, cramping, irregular menstrual bleeding
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Vaccine was put below muscle toward the side of right arm , within a few minutes of vaccine I felt  a lot of arm / shoulder pain  , by the next day I had increased pain , swelling and numbness radiating from right side of my neck , arm and shoulder down to my hand . Still to date pain and swelling .
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Vaccine was put below muscle toward the side of right arm , within a few minutes of vaccine I felt  a lot of arm / shoulder pain  , by the next day I had increased pain , swelling and numbness radiating from right side of my neck , arm and shoulder down to my hand . Still to date pain and swelling .
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain
Clinical narrative: Annual Flu Vaccine, unaware of type, brand, or lot number - Painful lymph node in armpit on left side, same side as injection site.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Condition aggravated, Feeling hot, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Within 12 -15 hours I was feeling the same tingling hot feeling in my brain, top of my head, side of my face  that I felt when I had the stroke in April. I am starting to think that this vaccine led to my stroke.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under both armpits
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Painful itchy raised Rash on bend of right arm 1x1 inch in size. Smaller in size on the fore left arm. Still present after 10 days
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Amblyopia, Angiogram normal, Blood thyroid stimulating hormone increased, Diplopia, Endocrine ophthalmopathy
Clinical narrative: Intermittent double vision side to side starting in mid June with right eye wandering out, Previously right eye would deviate only when tired. Vision worsened in July 2021 with much more pronounced strabismus and double vision prompting visit to ophthalmologist, Doctor., on 7/23/2021. Exotropia noted to be acute, severe, and very atypical; sent to the emergency room the same day for an MRI/MRA of brain, which ruled out acute third nerve palsy. Past medical history of Graves' disease more than 25 years ago noted. Condition has worsened and thyroid eye disease (TED) was diagnosed on 9/13/21 with elevated thyrotropin receptor antibodies. I have now been referred to a TED clinic for management.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging head normal, Strabismus
Clinical narrative: Intermittent double vision side to side starting in mid June with right eye wandering out, Previously right eye would deviate only when tired. Vision worsened in July 2021 with much more pronounced strabismus and double vision prompting visit to ophthalmologist, Doctor., on 7/23/2021. Exotropia noted to be acute, severe, and very atypical; sent to the emergency room the same day for an MRI/MRA of brain, which ruled out acute third nerve palsy. Past medical history of Graves' disease more than 25 years ago noted. Condition has worsened and thyroid eye disease (TED) was diagnosed on 9/13/21 with elevated thyrotropin receptor antibodies. I have now been referred to a TED clinic for management.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity
Clinical narrative: Extreme injection site pain, days after vaccine, radiating to shoulder and down forearm
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Arthralgia, Back pain, Chills, Feeling cold
Clinical narrative: Fever (102), unable to control body temperature (always cold), migrain, intense joint pain, periodic stabbing pain in right lower abdomen and right lower back. Obtained second dose of vaccine at 0900, 30 Sep 21. Pain and chills started at 0230, 1 Oct 21. Checked into ER at 1300, 1 Oct 21.  Released from at 2030, 1 Oct 21 after testing, Toradol, Zofran, and 100ml IV Tylonal.  2 Oct 21, abdominal pain continued. After the first dose I experienced 72 hours of fever, chills, migrain, vomiting, and body aches. This was the same as when I had covid.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: Fever (102), unable to control body temperature (always cold), migrain, intense joint pain, periodic stabbing pain in right lower abdomen and right lower back. Obtained second dose of vaccine at 0900, 30 Sep 21. Pain and chills started at 0230, 1 Oct 21. Checked into ER at 1300, 1 Oct 21.  Released from at 2030, 1 Oct 21 after testing, Toradol, Zofran, and 100ml IV Tylonal.  2 Oct 21, abdominal pain continued. After the first dose I experienced 72 hours of fever, chills, migrain, vomiting, and body aches. This was the same as when I had covid.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node in groin; tender and painful to the touch ; seemingly just one, no other lymph nodes apparently affected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Urticaria
Clinical narrative: I started  getting hives couple of days after the vaccine. I?ve never experienced hives before in my life. I?ve never had allergic reaction to anything. The hives are coming back almost every week. I had to leave work a couple of days ago because of them. I?m worried that this has become a chronic condition and vaccine might have triggered something
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Palpitations
Clinical narrative: Bad Headache, very bad body aches, nausea, heart palpitations
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed an active case of shingles on my right side back and trunk. Symptoms continued to increase. I was diagnosed by a doctor's appointment on September 29, 2021 and prescribed an antiviral acylovir 800 mg tablet 5 times a day for 7 days.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: I have experienced severe arm pain, fever, dizziness, fatigue, and muscle pains all over my body.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I have hives all over my back, chest stomach, neck, behind ears, lower abdomen, underarms, shoulder, and itchy ears
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Heavy menstrual bleeding, Menstruation irregular, Smear cervix normal, Thrombosis
Clinical narrative: About 2 weeks (maybe less) after the vaccine I began to have some very light vaginal bleeding, spotting,  and some clots. It lasted about 10 days. I then went over 5 months without a menstrual cycle. When I did start what I believed to be my period, it was more spotting and light clotting.  A couple months later I began spotting again, this lasted for about 4-5 days. Then the bleeding became much heavier and many more clots (which is unusual for me). I have been bleeding heavier & clotting consistently for  4 more days and counting.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan normal, Ultrasound scan vagina, Vaginal haemorrhage
Clinical narrative: About 2 weeks (maybe less) after the vaccine I began to have some very light vaginal bleeding, spotting,  and some clots. It lasted about 10 days. I then went over 5 months without a menstrual cycle. When I did start what I believed to be my period, it was more spotting and light clotting.  A couple months later I began spotting again, this lasted for about 4-5 days. Then the bleeding became much heavier and many more clots (which is unusual for me). I have been bleeding heavier & clotting consistently for  4 more days and counting.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Constipation, Dysuria, Headache
Clinical narrative: 103.4 fever x2d, nausea x3d, headache x2d, constipation x3d, difficulty urinating x3d, increased anxiety x4d Congestion/cold 5 days after vaccine
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pyrexia, Respiratory tract congestion
Clinical narrative: 103.4 fever x2d, nausea x3d, headache x2d, constipation x3d, difficulty urinating x3d, increased anxiety x4d Congestion/cold 5 days after vaccine
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain, Periarthritis, Sleep disorder
Clinical narrative: Left shoulder pain and limited range of motion. Pain severe, affecting sleep. Worsening since vaccination. Symptoms ongoing. Now have adhesive capsulitis.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Cardiac monitoring, Discomfort, Extrasystoles, Heart rate irregular
Clinical narrative: On April 23, about 26 days after the second shot I experience general discomfort.  I took my blood pressure and it was elevated and my heart beat was irregular.  I called my doctor, but due to  a busy schedule he could not see me until May 6.   At the time of my Doctor visit I felt OK and my heart beat was normal.  He suggested a follow up with a Zio patch monitor.  Because of busy schedules and other delays I could not get the monitor until until August 30. I wore the monitor for two weeks.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Loss of consciousness, Musculoskeletal discomfort, Photophobia
Clinical narrative: About 10 min into driving home I blacked out and went unconscious. I woke up in the median of the HWY with my car in the ditch. After gathering myself I got back on the road. The remainder of the morning until after lunch I had cold chills, sensitivity to sunlight for my eyes, ringing in my ears, and burning sensations through my neck.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Road traffic accident, Tinnitus
Clinical narrative: About 10 min into driving home I blacked out and went unconscious. I woke up in the median of the HWY with my car in the ditch. After gathering myself I got back on the road. The remainder of the morning until after lunch I had cold chills, sensitivity to sunlight for my eyes, ringing in my ears, and burning sensations through my neck.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives over entire body
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: dizziness, pale face, sweating, inability to open her eyes due to dizziness
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site nodule
Clinical narrative: during 2nd dose pt asked if normal to still have a lump where 1st dose was given -not burning, tingling - no ROM loss but a knot where shot went. I asked her to show where it's three in below the deltoid in a triangle on distal lower than deltoid
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropod bite, Back pain, Dizziness, Dysstasia, Magnetic resonance imaging
Clinical narrative: Uncontrollable bladder.  On 8/4/21 when getting out of bed my bladder immediately emptied and I ended in a puddle on the floor.  This continued throughout the next two days, subsiding on Saturday but resurfacing on Sunday and a slight amount of blood was evident on the pad but not in the urine.  I went to urgent care, on 8/7 tested for UTI but no culture found.  I was also experiencing severe back pain.  I visited my primary care office on 8/9 and was referred to spine physician and radiologist and MRI and additional x-rays.  Additionally it was suggested that I see an urologist to examine the reason for the uncontrollable bladder which I did 9/28 but no diagnosis was provided. I am sending this because recently I was told by a friend that the same set of circumstances that happened to me also happened to her mother.  In her case she was told that the incontinence was caused by two medications she was taking. In my case the diagnosis was not definite but a guess of kidney stones was a possibility.  The problem has resolved by itself but it took a couple of months to get back to normal.  I do not have an incontinence problem on a normal basis. This was more than incontinence - the bladder completely let go like a flood. Also, in April, approximately two months after vaccine I was doing some yard work.  I moved a timber that had some black ants on it and much to my surprise I was bitten.  I wasn't initially concerned when I saw the ants because they were black and I'm familiar with fire ants.  In any event, within minutes I became dizzy, blurred vision, unable to stand so I sat down which I think kept me from passing out completely and then I had to crawl up my steps to get into the house.  After resting for a short time I was back to normal again and out working in the yard in the afternoon.  Again, I'm telling you this story because just a week ago or so my daughter told me that the same thing happened to a man at a retail store she was at.  He has been standing in line with his shoes off on the grass (waiting for store to open) and got bitten by some ants.  He started called for help and demonstrated all the same things that I had but he actually passed out and had to be taken by ambulance.  Mayabe nothing but both kind of strange and then stranger that even one other person had the exact same experience.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal fracture, Splenic artery aneurysm, Urinary incontinence, Urine analysis normal, Vaginal haemorrhage
Clinical narrative: Uncontrollable bladder.  On 8/4/21 when getting out of bed my bladder immediately emptied and I ended in a puddle on the floor.  This continued throughout the next two days, subsiding on Saturday but resurfacing on Sunday and a slight amount of blood was evident on the pad but not in the urine.  I went to urgent care, on 8/7 tested for UTI but no culture found.  I was also experiencing severe back pain.  I visited my primary care office on 8/9 and was referred to spine physician and radiologist and MRI and additional x-rays.  Additionally it was suggested that I see an urologist to examine the reason for the uncontrollable bladder which I did 9/28 but no diagnosis was provided. I am sending this because recently I was told by a friend that the same set of circumstances that happened to me also happened to her mother.  In her case she was told that the incontinence was caused by two medications she was taking. In my case the diagnosis was not definite but a guess of kidney stones was a possibility.  The problem has resolved by itself but it took a couple of months to get back to normal.  I do not have an incontinence problem on a normal basis. This was more than incontinence - the bladder completely let go like a flood. Also, in April, approximately two months after vaccine I was doing some yard work.  I moved a timber that had some black ants on it and much to my surprise I was bitten.  I wasn't initially concerned when I saw the ants because they were black and I'm familiar with fire ants.  In any event, within minutes I became dizzy, blurred vision, unable to stand so I sat down which I think kept me from passing out completely and then I had to crawl up my steps to get into the house.  After resting for a short time I was back to normal again and out working in the yard in the afternoon.  Again, I'm telling you this story because just a week ago or so my daughter told me that the same thing happened to a man at a retail store she was at.  He has been standing in line with his shoes off on the grass (waiting for store to open) and got bitten by some ants.  He started called for help and demonstrated all the same things that I had but he actually passed out and had to be taken by ambulance.  Mayabe nothing but both kind of strange and then stranger that even one other person had the exact same experience.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, X-ray
Clinical narrative: Uncontrollable bladder.  On 8/4/21 when getting out of bed my bladder immediately emptied and I ended in a puddle on the floor.  This continued throughout the next two days, subsiding on Saturday but resurfacing on Sunday and a slight amount of blood was evident on the pad but not in the urine.  I went to urgent care, on 8/7 tested for UTI but no culture found.  I was also experiencing severe back pain.  I visited my primary care office on 8/9 and was referred to spine physician and radiologist and MRI and additional x-rays.  Additionally it was suggested that I see an urologist to examine the reason for the uncontrollable bladder which I did 9/28 but no diagnosis was provided. I am sending this because recently I was told by a friend that the same set of circumstances that happened to me also happened to her mother.  In her case she was told that the incontinence was caused by two medications she was taking. In my case the diagnosis was not definite but a guess of kidney stones was a possibility.  The problem has resolved by itself but it took a couple of months to get back to normal.  I do not have an incontinence problem on a normal basis. This was more than incontinence - the bladder completely let go like a flood. Also, in April, approximately two months after vaccine I was doing some yard work.  I moved a timber that had some black ants on it and much to my surprise I was bitten.  I wasn't initially concerned when I saw the ants because they were black and I'm familiar with fire ants.  In any event, within minutes I became dizzy, blurred vision, unable to stand so I sat down which I think kept me from passing out completely and then I had to crawl up my steps to get into the house.  After resting for a short time I was back to normal again and out working in the yard in the afternoon.  Again, I'm telling you this story because just a week ago or so my daughter told me that the same thing happened to a man at a retail store she was at.  He has been standing in line with his shoes off on the grass (waiting for store to open) and got bitten by some ants.  He started called for help and demonstrated all the same things that I had but he actually passed out and had to be taken by ambulance.  Mayabe nothing but both kind of strange and then stranger that even one other person had the exact same experience.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored administered MMR II, VAQTA and ROTATEQ; This spontaneous report was received from a registered nurse referring to unknown number of patient with unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. Concomitant medication included sterile diluent (STERILE DILUENT) (lot# reported as T018895).   On unknown dates, the patients were vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA)(M-M-R II) (lot # T001214, expiration date 12-JAN-2022, therapy type: rha, 1 dose, dose number and route of administration were not reported), or hepatitis a vaccine, inactivated(VAQTA) (lot#T023914, expiration date 31-MAR-2022,1 dose, dose number and route of administration were not reported), or rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally (lot# reported as 1741416, expiration date 21-MAR-2022, 1 dose, dose number was not reported) for prophylaxis.   The vaccines were stored improperly in the temperature of 9 degree Celsius for the time frame of 12 minutes. There was no previous temperature excursion. Digital Data Logger was involved. No adverse event was reported.  Follow up information was received on 20-SEP-2021 from the registered nurse, concerning an approximately 4-month-old female patient. On 20-JUL-2021 or 21-JUL-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose, dose and dose number not reported). Lot # 1707486, with expiration date 20-MAR-2022. It was reported that the digital data logger showed that a temperature excursion occurred on 20-JUL-2021 to 21-JUL-2021 for a total of 19 hours with a low temperature of 1.5 C. The office temperature monitoring device never registered a temperature below 2 C. There were 4 doses of rotavirus administered during this time to patients. The reporter believed that the sensor of the digital data logger was trapped under a cold pack under the refrigerator, which was the reason for the low reading, since the office data logger sensor was in the correct place and never registered temperature excursions.   This report was considered non-valid due to lack of patient identifiers. Upon receipt of follow up information it was determined to be a valid case.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2108USA000827: US-009507513-2109USA007601: US-009507513-2109USA007600: US-009507513-2109USA007602:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored administered MMR II, VAQTA and ROTATEQ; No additional AE reported; This spontaneous report was received from a registered nurse referring to unknown number of patient with unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. Concomitant medication included sterile diluent (STERILE DILUENT) (lot# reported as T018895).   On unknown dates, the patients were vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA)(M-M-R II) (lot # T001214, expiration date 12-JAN-2022, therapy type: rha, 1 dose, dose number and route of administration were not reported), or hepatitis a vaccine, inactivated(VAQTA) (lot#T023914, expiration date 31-MAR-2022,1 dose, dose number and route of administration were not reported), or rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally (lot# reported as 1741416, expiration date 21-MAR-2022, 1 dose, dose number was not reported) for prophylaxis.   The vaccines were stored improperly in the temperature of 9 degree Celsius for the time frame of 12 minutes. There was no previous temperature excursion. Digital Data Logger was involved. No adverse event was reported.  Follow up information was received on 20-SEP-2021 from the registered nurse, concerning an approximately 4-month-old male patient. On 20-JUL-2021 or 21-JUL-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose, dose and dose number not reported). Lot # 1707486, with expiration date 20-MAR-2022. It was reported that the digital data logger showed that a temperature excursion occurred on 20-JUL-2021 to 21-JUL-2021 for a total of 19 hours with a low temperature of 1.5 C. The office temperature monitoring device never registered a temperature below 2 C. There were 4 doses of rotavirus administered during this time to patients. The reporter believed that the sensor of the digital data logger was trapped under a cold pack under the refrigerator, which was the reason for the low reading, since the office data logger sensor was in the correct place and never registered temperature excursions.   This report was considered non-valid due to lack of patient identifiers. Upon receipt of follow up information it was determined to be a valid case.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2108USA000827: US-009507513-2109USA007601: US-009507513-2109USA007600: US-009507513-2109USA007603:
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored administered MMR II, VAQTA and ROTATEQ; No additional AE reported; This spontaneous report was received from a registered nurse referring to unknown number of patient with unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. Concomitant medication included sterile diluent (STERILE DILUENT) (lot# reported as T018895).   On unknown dates, the patients were vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA)(M-M-R II) (lot # T001214, expiration date 12-JAN-2022, therapy type: rha, 1 dose, dose number and route of administration were not reported), or hepatitis a vaccine, inactivated(VAQTA) (lot#T023914, expiration date 31-MAR-2022,1 dose, dose number and route of administration were not reported), or rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally (lot# reported as 1741416, expiration date 21-MAR-2022, 1 dose, dose number was not reported) for prophylaxis.   The vaccines were stored improperly in the temperature of 9 degree Celsius for the time frame of 12 minutes. There was no previous temperature excursion. Digital Data Logger was involved. No adverse event was reported.  Follow up information was received on 20-SEP-2021 from the registered nurse, concerning an approximately 6-month-old female patient. On 20-JUL-2021 or 21-JUL-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose, dose and dose number not reported). Lot # 1707486, with expiration date 20-MAR-2022. It was reported that the digital data logger showed that a temperature excursion occurred on 20-JUL-2021 to 21-JUL-2021 for a total of 19 hours with a low temperature of 1.5 C. The office temperature monitoring device never registered a temperature below 2 C. There were 4 doses of rotavirus administered during this time to patients. The reporter believed that the sensor of the digital data logger was trapped under a cold pack under the refrigerator, which was the reason for the low reading, since the office data logger sensor was in the correct place and never registered temperature excursions.   This report was considered non-valid due to lack of patient identifiers. Upon receipt of follow up information it was determined to be a valid case.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2108USA000827: US-009507513-2109USA007600: US-009507513-2109USA007602: US-009507513-2109USA007603:
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored administered MMR II, VAQTA and ROTATEQ; This non-valid spontaneous report was received from a registered nurse referring to unknown number of patient with unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. Concomitant medication included sterile diluent (STERILE DILUENT) (lot# reported as T018895).   On unknown dates, the patients were vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA)(M-M-R II) (lot # T001214, expiration date 12-JAN-2022, therapy type: rha, 1 dose, dose number and route of administration were not reported), or hepatitis a vaccine, inactivated(VAQTA) (lot#T023914, expiration date 31-MAR-2022,1 dose, dose number and route of administration were not reported), or rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally (lot# reported as 1741416, expiration date 21-MAR-2022, 1 dose, dose number was not reported) for prophylaxis.   The vaccines were stored improperly in the temperature of 9 degree Celsius for the time frame of 12 minutes. There was no previous temperature excursion. Digital Data Logger was involved. No adverse event was reported.  Follow up information was received on 20-SEP-2021 from the registered nurse, concerning an approximately 7-month-old male patient. On 20-JUL-2021 or 21-JUL-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose, dose and dose number not reported). Lot # 1707486, with expiration date 20-MAR-2022. It was reported that the digital data logger showed that a temperature excursion occurred on 20-JUL-2021 to 21-JUL-2021 for a total of 19 hours with a low temperature of 1.5 C. The office temperature monitoring device never registered a temperature below 2 C. There were 4 doses of rotavirus administered during this time to patients. The reporter believed that the sensor of the digital data logger was trapped under a cold pack under the refrigerator, which was the reason for the low reading, since the office data logger sensor was in the correct place and never registered temperature excursions.   This report was considered non-valid due to lack of patient identifiers. Upon receipt of follow up information it was determined to be a valid case.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2108USA000827:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Otitis externa
Clinical narrative: March 19 - Ear Ache started March 21 -  Went to urgent care for ear ache  Neomycin Polymyxin Sulfate and Hydrocortisone prescribed,  The ear ache was  a symptom  of the Bell's Palsy due to the inflamed nerve which we did not realize at the time. March 22 - Bell's Palsy Appeared - went to Urgent Care then to Emergency Room July 21 -  Stitches in corner of eye to protect Cornea -  Plastic Surgeon    August 12 -  Eye surgery to correct droopy eye - Plastic Surgeon  (more eye surgery will be required) Bell's Palsy Assessment -  House Brackman - V - Severe Dysfunction  More eye surgery is required in a few months I go to speech therapy weekly
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Central nervous system inflammation, Ear pain, Eye operation, Eyelid function disorder
Clinical narrative: March 19 - Ear Ache started March 21 -  Went to urgent care for ear ache  Neomycin Polymyxin Sulfate and Hydrocortisone prescribed,  The ear ache was  a symptom  of the Bell's Palsy due to the inflamed nerve which we did not realize at the time. March 22 - Bell's Palsy Appeared - went to Urgent Care then to Emergency Room July 21 -  Stitches in corner of eye to protect Cornea -  Plastic Surgeon    August 12 -  Eye surgery to correct droopy eye - Plastic Surgeon  (more eye surgery will be required) Bell's Palsy Assessment -  House Brackman - V - Severe Dysfunction  More eye surgery is required in a few months I go to speech therapy weekly
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelids protective suture
Clinical narrative: March 19 - Ear Ache started March 21 -  Went to urgent care for ear ache  Neomycin Polymyxin Sulfate and Hydrocortisone prescribed,  The ear ache was  a symptom  of the Bell's Palsy due to the inflamed nerve which we did not realize at the time. March 22 - Bell's Palsy Appeared - went to Urgent Care then to Emergency Room July 21 -  Stitches in corner of eye to protect Cornea -  Plastic Surgeon    August 12 -  Eye surgery to correct droopy eye - Plastic Surgeon  (more eye surgery will be required) Bell's Palsy Assessment -  House Brackman - V - Severe Dysfunction  More eye surgery is required in a few months I go to speech therapy weekly
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Muscle spasms
Clinical narrative: I received my 2nd shot of the covid vaccine Pfizer April 15th I was fine that day that night I experienced major cramps and numbness throughout my left and right arm and upper back the next morning I could not lift my hands or arms above my head it's arms above my head this continued to exist as the day went forward Although numbness moved into the fingertips of my right hand And has continued to be that way. I reported it to my doctor and have had an MRI to determine what's going on.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Mobility decreased, Muscle spasms
Clinical narrative: I received my 2nd shot of the covid vaccine Pfizer April 15th I was fine that day that night I experienced major cramps and numbness throughout my left and right arm and upper back the next morning I could not lift my hands or arms above my head it's arms above my head this continued to exist as the day went forward Although numbness moved into the fingertips of my right hand And has continued to be that way. I reported it to my doctor and have had an MRI to determine what's going on.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Confusional state, Fatigue, Feeling abnormal
Clinical narrative: Speech was off, brain fog, extreme yawning, slurred speech. Multiple doctor's visits confirm stroke. Speech came back but post stroke now additionallly taking taking crestor and low dose aspirin, had a psoriasis large patch on inner lower thigh, swollen ankles and feet and foot pain, heart tests from when she had the stroke looked ok.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Blood test, Cerebrovascular accident, Dysarthria, Echocardiogram
Clinical narrative: Speech was off, brain fog, extreme yawning, slurred speech. Multiple doctor's visits confirm stroke. Speech came back but post stroke now additionallly taking taking crestor and low dose aspirin, had a psoriasis large patch on inner lower thigh, swollen ankles and feet and foot pain, heart tests from when she had the stroke looked ok.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Joint swelling, Pain in extremity, Peripheral swelling, Psoriasis
Clinical narrative: Speech was off, brain fog, extreme yawning, slurred speech. Multiple doctor's visits confirm stroke. Speech came back but post stroke now additionallly taking taking crestor and low dose aspirin, had a psoriasis large patch on inner lower thigh, swollen ankles and feet and foot pain, heart tests from when she had the stroke looked ok.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler, Yawning
Clinical narrative: Speech was off, brain fog, extreme yawning, slurred speech. Multiple doctor's visits confirm stroke. Speech came back but post stroke now additionallly taking taking crestor and low dose aspirin, had a psoriasis large patch on inner lower thigh, swollen ankles and feet and foot pain, heart tests from when she had the stroke looked ok.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aplasia, Aspiration bone marrow abnormal, Biopsy bone marrow abnormal, Haemoglobin decreased, Pancytopenia
Clinical narrative: Patient developed severe aplastic anemia 2 weeks post vaccination. She currently is still in hospital.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, White blood cell count decreased
Clinical narrative: Patient developed severe aplastic anemia 2 weeks post vaccination. She currently is still in hospital.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aplastic anaemia, Eosinophil count decreased, Eosinophil percentage, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Patient developed severe aplastic anemia 2 weeks post vaccination. She currently is still in hospital.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphocyte count, Lymphocyte percentage increased, Mean cell haemoglobin concentration decreased, Mean cell volume normal, Mean platelet volume increased
Clinical narrative: Patient developed severe aplastic anemia 2 weeks post vaccination. She currently is still in hospital.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Monocyte count decreased, Monocyte percentage decreased, Platelet count decreased, Red blood cell count decreased, Red blood cell nucleated morphology
Clinical narrative: Patient developed severe aplastic anemia 2 weeks post vaccination. She currently is still in hospital.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red cell distribution width increased, White blood cell count decreased
Clinical narrative: Patient developed severe aplastic anemia 2 weeks post vaccination. She currently is still in hospital.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aplasia, Asthenia, Biopsy bone marrow abnormal, Diarrhoea, Full blood count abnormal
Clinical narrative: Patient developed severe aplastic anemia 2 weeks post vaccination. She currently is still in hospital.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haematemesis, Haematocrit decreased, Haemoglobin decreased, Intensive care, Pancytopenia
Clinical narrative: Patient developed severe aplastic anemia 2 weeks post vaccination. She currently is still in hospital.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell count decreased, Transfusion, Upper gastrointestinal haemorrhage, White blood cell count decreased
Clinical narrative: Patient developed severe aplastic anemia 2 weeks post vaccination. She currently is still in hospital.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Computerised tomogram abdomen, Laboratory test, Ultrasound abdomen
Clinical narrative: Please obtain records from specialty Hospital and another Medical Center Patient received the booster shot of COVID vaccine 8/30/21 because specialty Clinic recommended it because he was a high-risk patient. 5 days later 9/4/21 he had severe abdominal pain that he went to a Medical Center Emergency Department for severe abdominal pain and was discharged to go to a specialty Hospital for treatment of possible ischemic colitis.  His symptoms got better and he was discharged 9/7/21 but returned to a Medical Center on 9/9/21 with the same symptoms. He was admitted to the hospital and decompensated over the next few days and was transferred to a specialty Clinic on 9/13/21. At the specialty Clinic they realized the heparin drip wasn't working because his antithrombin level was too low so he was changed to Angiomax because he had new thrombus to his Aorta and iliac arteries and the chronic clots to his mesenteric, splenic and portal veins got worse. He decompensated further until he had a perforated bowel and DIED on 10/2/21.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, Antithrombin III decreased, Aortic thrombosis, Death
Clinical narrative: Please obtain records from specialty Hospital and another Medical Center Patient received the booster shot of COVID vaccine 8/30/21 because specialty Clinic recommended it because he was a high-risk patient. 5 days later 9/4/21 he had severe abdominal pain that he went to a Medical Center Emergency Department for severe abdominal pain and was discharged to go to a specialty Hospital for treatment of possible ischemic colitis.  His symptoms got better and he was discharged 9/7/21 but returned to a Medical Center on 9/9/21 with the same symptoms. He was admitted to the hospital and decompensated over the next few days and was transferred to a specialty Clinic on 9/13/21. At the specialty Clinic they realized the heparin drip wasn't working because his antithrombin level was too low so he was changed to Angiomax because he had new thrombus to his Aorta and iliac arteries and the chronic clots to his mesenteric, splenic and portal veins got worse. He decompensated further until he had a perforated bowel and DIED on 10/2/21.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Intestinal perforation, Mesenteric artery thrombosis, Peripheral artery thrombosis, Portal vein thrombosis
Clinical narrative: Please obtain records from specialty Hospital and another Medical Center Patient received the booster shot of COVID vaccine 8/30/21 because specialty Clinic recommended it because he was a high-risk patient. 5 days later 9/4/21 he had severe abdominal pain that he went to a Medical Center Emergency Department for severe abdominal pain and was discharged to go to a specialty Hospital for treatment of possible ischemic colitis.  His symptoms got better and he was discharged 9/7/21 but returned to a Medical Center on 9/9/21 with the same symptoms. He was admitted to the hospital and decompensated over the next few days and was transferred to a specialty Clinic on 9/13/21. At the specialty Clinic they realized the heparin drip wasn't working because his antithrombin level was too low so he was changed to Angiomax because he had new thrombus to his Aorta and iliac arteries and the chronic clots to his mesenteric, splenic and portal veins got worse. He decompensated further until he had a perforated bowel and DIED on 10/2/21.