chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 5th April 2019 11:00, the patient received the 1st dose of SHINGRIX. In April 2019, 1 day 5 hrs after receiving SHINGRIX, the patient experienced stomach pain. In April 2019, the outcome of the stomach pain was recovered/resolved. It was unknown if the reporter considered the stomach pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 6th April 2019 at 4:00 pm, the patient started to experience severe stomach pain which lasted 4 hours and resolved. On 8th April 2019 night at 9:00 pm, the same pain presented again and lasted until 5:00 am at the day reporting. The reporter consented to follow up.
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of an adult patients who received SHINGRIX for prophylaxis. Co-suspect products included FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patients received SHINGRIX (intramuscular) and FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, 2 days after receiving SHINGRIX and FLULAVAL QUADRIVALENT 2018-2019 season, the patients experienced influenza-like symptoms, chills, headache, feeling bad and sickness. On an unknown date, the outcome of the influenza-like symptoms, chills, headache, feeling bad and sickness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, headache, feeling bad and sickness to be related to SHINGRIX and FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The reporter reported that when some patients receive FLULAVAL and SHINGRIX in different arms while at the pharmacy, they come back and say they got sick 2 to 3 days after. The patients experienced flu like symptoms including headache, chills and feel bad for a day or 2. The reporter reported that physicians had also experienced these symptoms when they got vaccinated with both the vaccines. Some patients who received SHINGRIX at the Medicine Doctor (MD) office then came to the pharmacy that same day to get FLULAVAL and vice versa where these symptoms has happened to them as well. Some patients were opting not to get the second dose of SHINGRIX as a result. This had been ongoing for a couple of months. The reporter cannot quantify and had no further patient or product details. The reporter stated that this was just a general question regarding co-administration. The reporter did not consent to follow-up. This case has been linked with case US2019GSK066451, reported by same reporter.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Foetal cardiac disorder, Prenatal screening test, Ultrasound antenatal screen abnormal, Urinary tract infection
Clinical narrative: This is a serious study case, initially received on 03-Apr-2019, concerning a 25-year-old, adult female pregnant subject with weight 106 lbs, height 62 inches and body mass index (BMI) was 19.4, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject's obstetrical history had no previous pregnancies. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's concomitant medication included Vitafol one for healthy pregnancy. The subject's last menstrual period (LMP) date was 18-Aug-2018. The pregnancy type was singleton, with no pregnancy complications. On 06-Oct-2018, at 7 weeks of gestational week, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252232, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication (explicitly coded as vaccine exposure during pregnancy). On 20-Oct-2018, the subject underwent cystic fibrosis mutation analysis which showed no major congenital malformations. On 10-Nov-2018, the subject underwent non-invasive prenatal testing which showed no major congenital malformations. On the same day, the subject also underwent first trimester screening which showed no major congenital malformations. On an unspecified date, the subject experienced urinary tract infection. The subject was treated with Macrobid (dose: 100 mg, twice daily via oral route from 05-Jan-2019 to 12-Jan-2019 and from 02-Feb-2019 to 09-Feb-2019) for urinary tract infection. On 15-Feb-2019, 4 months and 9 days after vaccination, the subject underwent fetal echocardiography which showed minimal tricuspid regurgitation and pulmonary insufficiency. The outcome of the event urinary tract infection was not reported. The subject's estimated date of delivery was reported as 25-May-2019.; Reporter's Comments: A 25-year-old pregnant subject experienced urinary tract infection, on an unspecified day after administration of study vaccine at 07 weeks of gestation (coded to Exposure during pregnancy). Considering the inactivated nature of the suspect vaccine and infectious aetiology of the reported event (suspected bacterial), increased risk of urinary tract infection in pregnancy, the causal role of study vaccine was assessed as not related. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pt arm swelled and was hot to touch, still persisted 2 days later.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Major headache, uncontrollable shaking, fever, upset stomach started around 4:30 AM and could not get out of bed for more than 12 hours. Started feeling better about 5:00 PM on 3/28/2019 (about 24 hours after vaccination). Arm was sore for about 3 days.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Chills, Feeling abnormal, Headache
Clinical narrative: I received the vaccine at 3 pm and started to feel pain on my back around midnight. It felt like my skin hurt--a symptom I get when I have a fever. After sleeping for 2 hrs I awoke with severe burning in my legs, body aches all over, more severe pain in my back, and I was shivering to the point that my teeth were chattering. I took 3 extra strength acetaminophen. I was unable to sleep the rest of the night, but laid in bed anyway because I felt too awful to get up. Later in the night I developed a headache. When I got out of bed, around noon, the body aches and teeth chattering were gone, but my back still hurts, I have a headache, and a fever of 100. My usual temperature is around 97. It is never as high as 98.6. I would have to guess that during the night my fever was well over 101. I am shocked that there was no verbal warning given to me at any time regarding the potential side effects other than a sore arm! I feel that everyone who gets this vaccine should be warned to have no other commitments or plans for the next several days as they may feel like they have the flu--fever and all.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain of skin, Pyrexia
Clinical narrative: I received the vaccine at 3 pm and started to feel pain on my back around midnight. It felt like my skin hurt--a symptom I get when I have a fever. After sleeping for 2 hrs I awoke with severe burning in my legs, body aches all over, more severe pain in my back, and I was shivering to the point that my teeth were chattering. I took 3 extra strength acetaminophen. I was unable to sleep the rest of the night, but laid in bed anyway because I felt too awful to get up. Later in the night I developed a headache. When I got out of bed, around noon, the body aches and teeth chattering were gone, but my back still hurts, I have a headache, and a fever of 100. My usual temperature is around 97. It is never as high as 98.6. I would have to guess that during the night my fever was well over 101. I am shocked that there was no verbal warning given to me at any time regarding the potential side effects other than a sore arm! I feel that everyone who gets this vaccine should be warned to have no other commitments or plans for the next several days as they may feel like they have the flu--fever and all.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Screaming
Clinical narrative: Persistent screaming spells that began ~3 1/2 hours after vaccines, treated with acetaminophen. Episodes lasted for approximately 48 hours. Baby was seen in office, with comprehensive exam, and no cause was found for fussiness/screaming/irritability. He had had no fever, no apparent local reaction to injections, no other signs or symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Neuralgia, Vaccination site pain
Clinical narrative: Neuralgia, Chills, Pain at site of vaccination, sweating, headache.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever (102 degrees F) reported by wife.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain of skin, Pyrexia
Clinical narrative: Aches all over, my clothes rubbing on my skin hurt,   shivering and fever.  These same symptoms happened when I received the 1 dose in December 2018.  The symptoms started at approximately the same time after the injection with the first and second shot, 17 hours.  This adverse symptoms were worse than when I had the flu a few years ago.  At one time during the night I thought "let me die and this will be over".  My husband  had the same symptoms with his 2nd dose, though his started 6 hours after mine.  He commented while we were laying in bed "we don't have to do this again, do we?"  I don't think I would be able to make myself get another dose if it was required.  I realize these symptoms are better than getting Shingles, but boy they were bad.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: no reaction has been reported but this nurse gave 2 doses of diluent and forgot to mix with powder
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: patient came in with painful arm and redness from  mid upper arm to elbow. Area was swollen near elbow and warm to touch. No complaints fever or chills
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction. Vaccine was expired by 5 days at the time of vaccination. Our office has contacted the manufacture GSK in regards to possible adverse reactions and need for re-vaccination. Documentation provided from GSK states the vaccine is stable and potent for up to 30 days after expiration date on box, although not recommended to give an expired vaccine, the patient would not need to be re-vaccinated and can continue on the recommended vaccine schedule for Menveo. Patient is not having any adverse reactions.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient desribes an itchy rash with red bumps beginning the morning of 4/10/2019. Patient's dermatologist started her on valacyclovir and an antihistamine 4/12/19. Currently adverse event is still unresolved.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Cold sweat, Dizziness, Dysstasia, Feeling abnormal
Clinical narrative: A 13 year old male is brought to the office today by his father for well child examination. Father states that he has concerns regarding enuresis. Father explains that the child has nighttime loss of bladder control every night. Father states that the child restricts fluid intake in the evening and micturition occurs before sleep. In addition, the patient denies any burning, change in frequency or change in odor of urine. Father states that there is maternal family history of nocturnal enuresis. Father further explains that the child's bed time is 9:30PM on weekdays and between 2-3 AM on weekends. Patient lives with his father and high school aged brother. Mother has separated from family 2 years ago. Father works at a truck company where most of his time is spent away from the home, out of the state of origin. Patient is currently in 7th grade. Patient explains that school is going well and grades are described as good. Patient states that he participates in football and basketball activities at school. Patient explains that his mood is good. Denies any feelings of depression. During the course of the office visit, patient received a needle injection for influenza vaccination in his upper left arm. After injection, patient subsequently explained that he felt dizzy, anxious and generally 'not ok'. At this time clinicians present in the exam room observed the patient's face become flushed with color. In addition, patient lost muscle tone. Vital signs were assessed: Temperature: 98.3 degrees Fahrenheit Blood pressure: 144/84 Pulse: 64. Subsequently, patient's lips were then observed to become pale for a few minutes. Extremities became cold and moist. During this period of time, the patient was able to state his name, location and identify family members in the exam room. Patient was kept under observation in exam room for 15 minutes. Vital signs reassessed: Blood pressure 132/74 Pulse: 65. Patient was observed to lose muscle tone in his upper right arm and lower left leg. Patient was unable to stand or ambulated without assistance. Patient was then sent to the emergency department. ?
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Gait disturbance, Hypotonia, Pallor
Clinical narrative: A 13 year old male is brought to the office today by his father for well child examination. Father states that he has concerns regarding enuresis. Father explains that the child has nighttime loss of bladder control every night. Father states that the child restricts fluid intake in the evening and micturition occurs before sleep. In addition, the patient denies any burning, change in frequency or change in odor of urine. Father states that there is maternal family history of nocturnal enuresis. Father further explains that the child's bed time is 9:30PM on weekdays and between 2-3 AM on weekends. Patient lives with his father and high school aged brother. Mother has separated from family 2 years ago. Father works at a truck company where most of his time is spent away from the home, out of the state of origin. Patient is currently in 7th grade. Patient explains that school is going well and grades are described as good. Patient states that he participates in football and basketball activities at school. Patient explains that his mood is good. Denies any feelings of depression. During the course of the office visit, patient received a needle injection for influenza vaccination in his upper left arm. After injection, patient subsequently explained that he felt dizzy, anxious and generally 'not ok'. At this time clinicians present in the exam room observed the patient's face become flushed with color. In addition, patient lost muscle tone. Vital signs were assessed: Temperature: 98.3 degrees Fahrenheit Blood pressure: 144/84 Pulse: 64. Subsequently, patient's lips were then observed to become pale for a few minutes. Extremities became cold and moist. During this period of time, the patient was able to state his name, location and identify family members in the exam room. Patient was kept under observation in exam room for 15 minutes. Vital signs reassessed: Blood pressure 132/74 Pulse: 65. Patient was observed to lose muscle tone in his upper right arm and lower left leg. Patient was unable to stand or ambulated without assistance. Patient was then sent to the emergency department. ?
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Excessive cerumen production, Headache, Hypoacusis, Pain
Clinical narrative: Patient called on 4/2/2019 to report an adverse event that she thinks is related to her second SHINGRIX shot. Patient felt achy, arm hurt, and ear felt full of wax build up the next day after the shot. She called her MD, and he advised her to use DYMISTA. When patient called me, she was still having ear pressure and head hurts. She came in that afternoon to pick up a prednisone prescription that was sent in to her that same day (4/2). I told her we would follow up with her in a week to assess how patient is feeling. I also told patient I would report her symptoms to CDC for reference. On 4/8/2019, I called patient and left voice mail to follow up with her. Patient called back and indicated she is now on antiviral, steroid injection and fluid tablets. She was going to have an MRI and CT scan the same week. She still experiencing ringing in the ears. She feels better but not back to normal hearing.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Patient called on 4/2/2019 to report an adverse event that she thinks is related to her second SHINGRIX shot. Patient felt achy, arm hurt, and ear felt full of wax build up the next day after the shot. She called her MD, and he advised her to use DYMISTA. When patient called me, she was still having ear pressure and head hurts. She came in that afternoon to pick up a prednisone prescription that was sent in to her that same day (4/2). I told her we would follow up with her in a week to assess how patient is feeling. I also told patient I would report her symptoms to CDC for reference. On 4/8/2019, I called patient and left voice mail to follow up with her. Patient called back and indicated she is now on antiviral, steroid injection and fluid tablets. She was going to have an MRI and CT scan the same week. She still experiencing ringing in the ears. She feels better but not back to normal hearing.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Fibrin D dimer normal, Muscle spasms, Muscular weakness, Pain
Clinical narrative: SEVERE neck/upper back muscle spasm C7-T2 radiating through to throat and Lt clavicle, neck weakness. Physical Therapy x2, complete bed rest x3 days, drugs: FLEXERIL and NORCO, heating pad helped. Today is the end of day 3 and I can get out of bed with some pain and sit in chair - big improvement..  Not fully recovered but I hope by the first of the week I can return to work.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal X-ray normal
Clinical narrative: SEVERE neck/upper back muscle spasm C7-T2 radiating through to throat and Lt clavicle, neck weakness. Physical Therapy x2, complete bed rest x3 days, drugs: FLEXERIL and NORCO, heating pad helped. Today is the end of day 3 and I can get out of bed with some pain and sit in chair - big improvement..  Not fully recovered but I hope by the first of the week I can return to work.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Lethargy, Pyrexia, Rash erythematous, Rash generalised, Vaccination complication
Clinical narrative: Patient started acting very lathargic on Monday, April 8th 6 days after the vaccine.  He had a fever and was throwing up.  The morning of Wednesday, April 10th 8 days after the vaccine patient woke up covered in red spots.  I called the office and was told it was a reaction to the Varicella vaccine and all I could do was treat the symptoms.  I was not offered an appointment for him to be seen.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient started acting very lathargic on Monday, April 8th 6 days after the vaccine.  He had a fever and was throwing up.  The morning of Wednesday, April 10th 8 days after the vaccine patient woke up covered in red spots.  I called the office and was told it was a reaction to the Varicella vaccine and all I could do was treat the symptoms.  I was not offered an appointment for him to be seen.
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Headache, Injection site warmth, Rash
Clinical narrative: Student has warmth at site, fatigue and bilateral rash to skin on distal orbits.  First dose had given student fatigue and headache. Student concerned about a building reaction to series.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Fatigue, Injection site discolouration, Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included antihistamine for an unknown indication and LAMISIL unknown for an unknown indication. Previously administered products included ZOSTAVAX. Concurrent medical conditions included shingles (mild shingles outbreak). On 2nd March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient started antihistamine at an unknown dose and frequency and LAMISIL at an unknown dose and frequency. On an unknown date, less than a year after receiving SHINGRIX and not applicable after starting LAMISIL, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site rash, injection site discoloration, eruption facial, fatigue and drowsiness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site warmth and injection site rash were recovering/resolving and the outcome of the injection site discoloration, fatigue and drowsiness were unknown and the outcome of the eruption facial was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, injection site rash, injection site discoloration, eruption facial, fatigue and drowsiness to be related to SHINGRIX. It was unknown if the reporter considered the fatigue and drowsiness to be related to LAMISIL. Additional details were provided as follows: The caller was a patient. The caller reported that she experienced local reaction at injection site that was raised, pink in color, warm to the touch that started out size of a 50 cent piece and grew to size of palm of her hand. The caller reported that also developed tiny bumps and itchiness around the perimeter of the area. The caller reported that the reaction has improved, still has discoloration at the area but no other issues. The caller reported that she developed two outbreaks on her face of tiny bumps that resolved and she has experienced fatigue and drowsiness since getting the shot. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Local reaction, Rash, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included antihistamine for an unknown indication and LAMISIL unknown for an unknown indication. Previously administered products included ZOSTAVAX. Concurrent medical conditions included shingles (mild shingles outbreak). On 2nd March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient started antihistamine at an unknown dose and frequency and LAMISIL at an unknown dose and frequency. On an unknown date, less than a year after receiving SHINGRIX and not applicable after starting LAMISIL, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site rash, injection site discoloration, eruption facial, fatigue and drowsiness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site warmth and injection site rash were recovering/resolving and the outcome of the injection site discoloration, fatigue and drowsiness were unknown and the outcome of the eruption facial was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, injection site rash, injection site discoloration, eruption facial, fatigue and drowsiness to be related to SHINGRIX. It was unknown if the reporter considered the fatigue and drowsiness to be related to LAMISIL. Additional details were provided as follows: The caller was a patient. The caller reported that she experienced local reaction at injection site that was raised, pink in color, warm to the touch that started out size of a 50 cent piece and grew to size of palm of her hand. The caller reported that also developed tiny bumps and itchiness around the perimeter of the area. The caller reported that the reaction has improved, still has discoloration at the area but no other issues. The caller reported that she developed two outbreaks on her face of tiny bumps that resolved and she has experienced fatigue and drowsiness since getting the shot. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: patient developed a large redness in upper arm measuring 50 mm by 40 mm She denies pain ,fever or chills
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Pyrexia, Skin warm
Clinical narrative: Little blisters all over body chest, back and arms within the week of SHINGRIX. Patient also reported hot skin and itching and was feeling feverish.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Electromyogram normal, Fibromyalgia, Injection site pain, Laboratory test normal
Clinical narrative: Within 24 hours of flu vaccine I experienced the following symptoms: tingling/prickly pain running down from knees to shins bilaterally, as well as in arms/elbow (felt like electricity running through body). Progressed from that day over a 6 week period and including pain in bilateral hands/fingers and feet/toes as well as bilateral shoulders and hips. Included bouts of muscle weakness that migrated from one body part to another. (could barely hold my baby at times). Also beginning within 24 hours of flu shot: bouts of high pitched tinnitus that would come and go for only a few seconds to minutes at a time. Unfortunately about a week in after the shot, my left ear had a much louder attack on tinnitus that once it came on, has never stopped. My left ear has been loudly ringing 24 hours a day nonstop until this present day even a year later.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Local reaction, Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Within 24 hours of flu vaccine I experienced the following symptoms: tingling/prickly pain running down from knees to shins bilaterally, as well as in arms/elbow (felt like electricity running through body). Progressed from that day over a 6 week period and including pain in bilateral hands/fingers and feet/toes as well as bilateral shoulders and hips. Included bouts of muscle weakness that migrated from one body part to another. (could barely hold my baby at times). Also beginning within 24 hours of flu shot: bouts of high pitched tinnitus that would come and go for only a few seconds to minutes at a time. Unfortunately about a week in after the shot, my left ear had a much louder attack on tinnitus that once it came on, has never stopped. My left ear has been loudly ringing 24 hours a day nonstop until this present day even a year later.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Paraesthesia, Thyroid function test normal, Tinnitus
Clinical narrative: Within 24 hours of flu vaccine I experienced the following symptoms: tingling/prickly pain running down from knees to shins bilaterally, as well as in arms/elbow (felt like electricity running through body). Progressed from that day over a 6 week period and including pain in bilateral hands/fingers and feet/toes as well as bilateral shoulders and hips. Included bouts of muscle weakness that migrated from one body part to another. (could barely hold my baby at times). Also beginning within 24 hours of flu shot: bouts of high pitched tinnitus that would come and go for only a few seconds to minutes at a time. Unfortunately about a week in after the shot, my left ear had a much louder attack on tinnitus that once it came on, has never stopped. My left ear has been loudly ringing 24 hours a day nonstop until this present day even a year later.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Ultrasound scan normal, X-ray limb, X-ray normal
Clinical narrative: Within 24 hours of flu vaccine I experienced the following symptoms: tingling/prickly pain running down from knees to shins bilaterally, as well as in arms/elbow (felt like electricity running through body). Progressed from that day over a 6 week period and including pain in bilateral hands/fingers and feet/toes as well as bilateral shoulders and hips. Included bouts of muscle weakness that migrated from one body part to another. (could barely hold my baby at times). Also beginning within 24 hours of flu shot: bouts of high pitched tinnitus that would come and go for only a few seconds to minutes at a time. Unfortunately about a week in after the shot, my left ear had a much louder attack on tinnitus that once it came on, has never stopped. My left ear has been loudly ringing 24 hours a day nonstop until this present day even a year later.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Blood culture, Chest X-ray, Condition aggravated, Constipation
Clinical narrative: Had very many apnea spells directly after shot all day at least 1 sometimes 2 per hour, she had not had any in weeks. (Attending Physician had already spoke to us about going home within in the week, before vaccines. Delayed 2 mths. Of EXTRA time in NICU stay) The night of the shots at  approximately 2:03 am she flat lined and was perceived dead on monitor, complete flat-line. The hospital alarms went off about 20 doctors and nurses rushed into the room and had to give her oxygen and  recessitate her. The following week she could not eat or do anything on her own, she regressed back to tube feeds,  also effected her Digestive tract & doesn't go to the bathroom for days at a time when normally she went 5-6 times a day. The right leg she got the shot in shakes uncontrollably a lot too when it never once did that before.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Culture urine, Echocardiogram, Feeding disorder, Feeding tube user, Gastrointestinal disorder
Clinical narrative: Had very many apnea spells directly after shot all day at least 1 sometimes 2 per hour, she had not had any in weeks. (Attending Physician had already spoke to us about going home within in the week, before vaccines. Delayed 2 mths. Of EXTRA time in NICU stay) The night of the shots at  approximately 2:03 am she flat lined and was perceived dead on monitor, complete flat-line. The hospital alarms went off about 20 doctors and nurses rushed into the room and had to give her oxygen and  recessitate her. The following week she could not eat or do anything on her own, she regressed back to tube feeds,  also effected her Digestive tract & doesn't go to the bathroom for days at a time when normally she went 5-6 times a day. The right leg she got the shot in shakes uncontrollably a lot too when it never once did that before.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Intensive care, Resuscitation, Tremor
Clinical narrative: Had very many apnea spells directly after shot all day at least 1 sometimes 2 per hour, she had not had any in weeks. (Attending Physician had already spoke to us about going home within in the week, before vaccines. Delayed 2 mths. Of EXTRA time in NICU stay) The night of the shots at  approximately 2:03 am she flat lined and was perceived dead on monitor, complete flat-line. The hospital alarms went off about 20 doctors and nurses rushed into the room and had to give her oxygen and  recessitate her. The following week she could not eat or do anything on her own, she regressed back to tube feeds,  also effected her Digestive tract & doesn't go to the bathroom for days at a time when normally she went 5-6 times a day. The right leg she got the shot in shakes uncontrollably a lot too when it never once did that before.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: 5.5 weeks of very sore joints, slowly went away with time.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling and redness at the injection site, and swelling of the lymph nodes on the left side near her collar bone.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy, Myalgia
Clinical narrative: Muscle ache, headache, chills, lethargy
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Fatigue, Loss of consciousness, Muscle rigidity, Tongue biting
Clinical narrative: After HPV vaccine pt lied supine for a few min, drank some water (He had an episode of dizziness after last injection of HPV). He left the clinic with dad and as they were driving within 5 min he turned to Dad and said he was going to pass out, he got rigid, starting shaking and bit his tongue, unresponsive for aprox 15sec to a min. He came to and felt cold and clammy. He was able to get out of the car and walked into the house. Dad brought him some juice, he is sitting in the chair, and feels tired.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: After HPV vaccine pt lied supine for a few min, drank some water (He had an episode of dizziness after last injection of HPV). He left the clinic with dad and as they were driving within 5 min he turned to Dad and said he was going to pass out, he got rigid, starting shaking and bit his tongue, unresponsive for aprox 15sec to a min. He came to and felt cold and clammy. He was able to get out of the car and walked into the house. Dad brought him some juice, he is sitting in the chair, and feels tired.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Mobility decreased, Nodule, Tenderness
Clinical narrative: Pt felt very run down the day after vaccination, said she could barely lift her limbs. She has redness at the injection site, but the evening after vaccination, she developed a fluid filled knot at the base of her neck above her shoulder. She states that it's sore to the touch, but does not bother her otherwise.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Headache, Mobility decreased, Myalgia
Clinical narrative: Pt reported fever, chills, muscle and bone aches, an incredibly sore arm to the point she could not lift it, nausea and headache for about 24 hours. As of this morning, she is starting to feel better. She took ibuprofen with some relief.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pt reported fever, chills, muscle and bone aches, an incredibly sore arm to the point she could not lift it, nausea and headache for about 24 hours. As of this morning, she is starting to feel better. She took ibuprofen with some relief.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Inadequate aseptic technique in use of product, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called stating she had an adverse reaction to her SHINGRIX vaccination. She was given the vaccination on 4/8/19. She described the reaction at the injection site as being a swollen, big red circle that was hot to the touch. She went to urgent care on 4/10/19 and was diagnosed with cellulitis. Patient also stated that she did not believe that she had her arm cleaned with an alcohol swab and let dry before receiving her immunization.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Dysphagia, Epstein-Barr virus antibody positive, Epstein-Barr virus infection, Epstein-Barr virus test positive
Clinical narrative: 6/14/2017-6/17/2017:  Swollen, puffy neck and jaw; headache; significant jaw and eye pain; sore throat; fever 100-101 degrees. 6/19/2017-6/22/2017:  Measels rash of red, itchy bumps on torso; on day 2 his rash spread to his face, arms, hands and groin. 7/17/2018-8/14/2018:  Hospital admission for Epstein Barr Virus that turned to mono; severe sore throat with inability to swallow or eat, serious headache for two weeks. 9/15/2018-11/2/2018: Erythema nodosum with severe bruise-like lumps on legs from EBV; significant sore throat, and joint pain in his elbows  and knees. Another rash developed after a few weeks similar to the  chicken pox rash.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Erythema nodosum, Eye pain, Feeding disorder, Headache, Infectious mononucleosis
Clinical narrative: 6/14/2017-6/17/2017:  Swollen, puffy neck and jaw; headache; significant jaw and eye pain; sore throat; fever 100-101 degrees. 6/19/2017-6/22/2017:  Measels rash of red, itchy bumps on torso; on day 2 his rash spread to his face, arms, hands and groin. 7/17/2018-8/14/2018:  Hospital admission for Epstein Barr Virus that turned to mono; severe sore throat with inability to swallow or eat, serious headache for two weeks. 9/15/2018-11/2/2018: Erythema nodosum with severe bruise-like lumps on legs from EBV; significant sore throat, and joint pain in his elbows  and knees. Another rash developed after a few weeks similar to the  chicken pox rash.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Limb mass, Measles post vaccine, Morbillivirus test positive, Oropharyngeal pain, Pain in jaw
Clinical narrative: 6/14/2017-6/17/2017:  Swollen, puffy neck and jaw; headache; significant jaw and eye pain; sore throat; fever 100-101 degrees. 6/19/2017-6/22/2017:  Measels rash of red, itchy bumps on torso; on day 2 his rash spread to his face, arms, hands and groin. 7/17/2018-8/14/2018:  Hospital admission for Epstein Barr Virus that turned to mono; severe sore throat with inability to swallow or eat, serious headache for two weeks. 9/15/2018-11/2/2018: Erythema nodosum with severe bruise-like lumps on legs from EBV; significant sore throat, and joint pain in his elbows  and knees. Another rash developed after a few weeks similar to the  chicken pox rash.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: 6/14/2017-6/17/2017:  Swollen, puffy neck and jaw; headache; significant jaw and eye pain; sore throat; fever 100-101 degrees. 6/19/2017-6/22/2017:  Measels rash of red, itchy bumps on torso; on day 2 his rash spread to his face, arms, hands and groin. 7/17/2018-8/14/2018:  Hospital admission for Epstein Barr Virus that turned to mono; severe sore throat with inability to swallow or eat, serious headache for two weeks. 9/15/2018-11/2/2018: Erythema nodosum with severe bruise-like lumps on legs from EBV; significant sore throat, and joint pain in his elbows  and knees. Another rash developed after a few weeks similar to the  chicken pox rash.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody positive, Streptococcus test negative, Swelling, Swelling face
Clinical narrative: 6/14/2017-6/17/2017:  Swollen, puffy neck and jaw; headache; significant jaw and eye pain; sore throat; fever 100-101 degrees. 6/19/2017-6/22/2017:  Measels rash of red, itchy bumps on torso; on day 2 his rash spread to his face, arms, hands and groin. 7/17/2018-8/14/2018:  Hospital admission for Epstein Barr Virus that turned to mono; severe sore throat with inability to swallow or eat, serious headache for two weeks. 9/15/2018-11/2/2018: Erythema nodosum with severe bruise-like lumps on legs from EBV; significant sore throat, and joint pain in his elbows  and knees. Another rash developed after a few weeks similar to the  chicken pox rash.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arthralgia, Hypersensitivity, Loss of personal independence in daily activities, Neck pain, Rash
Clinical narrative: At 6:30 AM on 4/10/19 she woke up with significant facial swelling, hives on her face, neck, arms, and chest, and a rash on her face, arms, chest and neck. She was given 1, 25 mg BENADRYL that had no effect on the hives/swelling/rash. She was taken to the ER (no urgent care or her Pediatrician's office were open). She arrived at the ER by 9:15 AM. She was treated by an ER doctor who said that most likely she was having an allergic reaction to a preservative in one of the vaccines. She was prescribed PEPCID and Prednisone for 5 days, and over the counter BENADRYL every 8 hours. 4/10/19 and 4/11/19 the swelling had gone down, but hives and the rashes were still very evident even with rounds of BENADRYL. She complained of joint pain in her knees, ankles, neck, and elbows. The rash became more widespread although the hives would come and go. She did not go to school on these two days. An appointment with an allergy specialist was made for 4/23/19 with the head of the food allergy doctor. On 4/12/19 we followed up with the Pediatrician (recommended by ER doctor) who examined the rashes and witnessed another round of hives after BENADRYL had worn off. She contacted Allergy to get more information and possibly a second opinion on course of action as her symptoms were not improving and the Pediatrician was worried that the steroids wouldn't work (5 days with the same dosage) I was advised to up the BENADRYL to every 4-6 hours and apply hydrocortisone cream to the rashes. Allergy upped the appointment from 4/23/19 to 4/15/19. As of 4/12/19 at 7:45 the rash is still covering her upper torso, face, and both arms. She will finish her Prednisone on 4/13/19 and PEPCID on 4/13/19.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash generalised, Swelling face, Urticaria
Clinical narrative: At 6:30 AM on 4/10/19 she woke up with significant facial swelling, hives on her face, neck, arms, and chest, and a rash on her face, arms, chest and neck. She was given 1, 25 mg BENADRYL that had no effect on the hives/swelling/rash. She was taken to the ER (no urgent care or her Pediatrician's office were open). She arrived at the ER by 9:15 AM. She was treated by an ER doctor who said that most likely she was having an allergic reaction to a preservative in one of the vaccines. She was prescribed PEPCID and Prednisone for 5 days, and over the counter BENADRYL every 8 hours. 4/10/19 and 4/11/19 the swelling had gone down, but hives and the rashes were still very evident even with rounds of BENADRYL. She complained of joint pain in her knees, ankles, neck, and elbows. The rash became more widespread although the hives would come and go. She did not go to school on these two days. An appointment with an allergy specialist was made for 4/23/19 with the head of the food allergy doctor. On 4/12/19 we followed up with the Pediatrician (recommended by ER doctor) who examined the rashes and witnessed another round of hives after BENADRYL had worn off. She contacted Allergy to get more information and possibly a second opinion on course of action as her symptoms were not improving and the Pediatrician was worried that the steroids wouldn't work (5 days with the same dosage) I was advised to up the BENADRYL to every 4-6 hours and apply hydrocortisone cream to the rashes. Allergy upped the appointment from 4/23/19 to 4/15/19. As of 4/12/19 at 7:45 the rash is still covering her upper torso, face, and both arms. She will finish her Prednisone on 4/13/19 and PEPCID on 4/13/19.
Age: 60.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had the left arm swollen and red around area that was administered, I recommend the patient visit the physician and also I called the physician to let know about it. Patient never went to her office. **Last Sunday April 7, 2019 patient came to the pharmacy and show me the arm. Patient had left arm swollen and red around the area were SHINGRIX was administered. ***I recommended to patient to visit her physician and I also call the physician to let know about the case. Two days later Wednesday April 10. 2019 I called the physician again and told me that she also called the patient but she never went to the office, I tried to communicate with patient a few times and she never answer.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Migraine
Clinical narrative: Pt began having a migraine on the morning of 04/10/19 which lasted all day. Starting on 04/11/19 a large swelling appeared at the injection site. Patient applied a warm compress and the swelling subsided a few hours later.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Exposure during pregnancy, Trismus
Clinical narrative: Lock jaw  starting night of vaccine First pregnancy, EDC 6/29/19, currently pregnant
Age: 3.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Dyskinesia, Dysphemia, Frustration tolerance decreased
Clinical narrative: My son has a severe stutter since the vaccine.  When he tries to speak he will get a head movement similar to a tick where he moves his head to the side and draws the word out with his head movement while his eyes are closed.  It is progressively getting worse and he is noticing it and getting extremely frustrated.  After seeing our pediatrician, she encourages us to report this.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Headache
Clinical narrative: Chills, temperature and headache.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia, Syncope
Clinical narrative: 3-11-19 shaking, headache and nausea. 3-12-19 fever, vomiting, and syncope. 3-13-19 fever. 3-14-19 sore arm.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: 3-11-19 shaking, headache and nausea. 3-12-19 fever, vomiting, and syncope. 3-13-19 fever. 3-14-19 sore arm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Tenderness
Clinical narrative: Left arm tender to touch and sore from shortly after time of injection until present. Flu-like symptoms starting from approximately 1:00 PM 4/9/19 (day of injection), extending until bedtime same day and each day following until 4/11/19, partially relieved by ibuprofen.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site joint pain, Injection site pain, Injection site reaction, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Large welt on arm at injection site, pain and weakness in injected arm, joint pain and stiffness in injected arm. Pain and stiffness in shoulder and neck on affected side.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Neck pain, Pain in extremity, Urticaria
Clinical narrative: Large welt on arm at injection site, pain and weakness in injected arm, joint pain and stiffness in injected arm. Pain and stiffness in shoulder and neck on affected side.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Fever of 101.3. Minor chills. Achy arm and joints all over. Achy back. Achy jaw. Headache. Very tired. Ibuprofen seems to help a bit. Sleeping is best.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: Fever of 101.3. Minor chills. Achy arm and joints all over. Achy back. Achy jaw. Headache. Very tired. Ibuprofen seems to help a bit. Sleeping is best.