chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Erythema, Feeling hot, Injection site pain
Clinical narrative: Pt felt nauseous, hot, started getting red, and sat down on floor about 5 minutes after receiving the vaccine. I was alerted and I helped him into the vaccination room to lay down on the floor with his feet propped up. His girlfriend was there to help calm him down. I offered to call 911, he refused. I grabbed a fan for him, and turned it off when he requested. He then began shivering rather uncontrollably and said his left arm (injection site) was hurting and tingling, and at one point, said his right arm was beginning to tingle as well.  We had him breath and relax, he began to return to normal and he and girlfriend discussed how he must be partly having an anxiety/panic attack. He trialed standing up a few times until he felt good enough to leave the room, all in all about 20 minutes. He sat close by for additional 15 minutes of observation, at which point he left stating he felt more like himself.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Nausea, Panic attack, Paraesthesia
Clinical narrative: Pt felt nauseous, hot, started getting red, and sat down on floor about 5 minutes after receiving the vaccine. I was alerted and I helped him into the vaccination room to lay down on the floor with his feet propped up. His girlfriend was there to help calm him down. I offered to call 911, he refused. I grabbed a fan for him, and turned it off when he requested. He then began shivering rather uncontrollably and said his left arm (injection site) was hurting and tingling, and at one point, said his right arm was beginning to tingle as well.  We had him breath and relax, he began to return to normal and he and girlfriend discussed how he must be partly having an anxiety/panic attack. He trialed standing up a few times until he felt good enough to leave the room, all in all about 20 minutes. He sat close by for additional 15 minutes of observation, at which point he left stating he felt more like himself.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: 19 yo otherwise healthy f c/o ongoing mild diffuse ha w/o visual changes, dizziness and nausea w/o vomiting x24hrs s/p J&J vaccine yesterday; Pt denies any cp, sob, rashes, dyspnea, abd pain/cramping, prior hx of vaccine rxn.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Swollen tender red lump near injection site on arm
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Pain
Clinical narrative: PT states he got the j&j vaccine at 0930 today. He states he experienced chills, body aches, head ache and numbness in his hands. PT denies taking any medication.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Electrocardiogram, Fatigue, Hyperhidrosis
Clinical narrative: c/o bodyache, fever, sweathing, H pounding, and difficulty breathing since J&J shot @1130 today. took Tylenol x2 but not helped. last Tylenol @1830.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Palpitations, Pyrexia
Clinical narrative: c/o bodyache, fever, sweathing, H pounding, and difficulty breathing since J&J shot @1130 today. took Tylenol x2 but not helped. last Tylenol @1830.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pyrexia, Vomiting
Clinical narrative: Bodyache, headache, vomiting x2times and fever after  J&J shot 2days ago. Denies abdominal pain, difficult breathing or chest pain.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Sleep disorder
Clinical narrative: Pt received J&J yesterday. Pt c/o having fever/ha/unable to sleep. Pt is walking w/o issue. Pt VSS and NAD.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature abnormal
Clinical narrative: temperature excursion with vaccine administered
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure increased, Blood test, Feeling hot, Haemoglobin
Clinical narrative: Started feeling waves of heat across chest 2 days after vaccine, called advise nurse multiple times during first week and emailed doctor's office. Experienced low back pain on day 3 lasted for three days, day 5 developed tingling feet. Tingling in feet persisted and occasionally in hands the following week  Went to doctors the following week for checkup on 5/6/21  Doctors notes: PARESTHESIA Note: ? Etiology Possibly COVID vaccine related ? Check labs.  Monitor symptoms, follow up if worsening.    ELEVATED BP READING WO HTN DIAGNOSIS Note: check labs Return 2 weeks blood pressure check.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Paraesthesia, Renal function test, Thyroid function test, Vitamin B12
Clinical narrative: Started feeling waves of heat across chest 2 days after vaccine, called advise nurse multiple times during first week and emailed doctor's office. Experienced low back pain on day 3 lasted for three days, day 5 developed tingling feet. Tingling in feet persisted and occasionally in hands the following week  Went to doctors the following week for checkup on 5/6/21  Doctors notes: PARESTHESIA Note: ? Etiology Possibly COVID vaccine related ? Check labs.  Monitor symptoms, follow up if worsening.    ELEVATED BP READING WO HTN DIAGNOSIS Note: check labs Return 2 weeks blood pressure check.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Computerised tomogram, Surgery
Clinical narrative: Appendicitis with hospitalization and surgery.   Vaccine site. 2nd dose administered on 05/12/2021 at 3:00pm
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Swelling
Clinical narrative: Client presented to 2nd dose appointment for Pfizer COVID vaccine and reports she experienced swelling in right inner elbow, forearm, and wrist about 1 week after first dose Pfizer COVID vaccination to right arm. Client reports she followed up with her PCP regarding symptoms.  Client reports she was prescribed a topical steroid of unknown name, but reports she did not use the steroid as the swelling resolved before she was able to pick up the prescription from the pharmacy.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Arthralgia, Arthritis, Rheumatoid arthritis, Rheumatoid factor increased
Clinical narrative: Symptoms: joint pain and inflammation  Diagnosis: Rheumatoid Arthritis (no hereditary history)  Progressive course
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspepsia
Clinical narrative: I had severe stomach problems. I wasn't digesting fibrous foods like vegetables; I would poop them out still formed. I ate just yogurt and smoothies for a few days until the symptoms stopped, which was about 10 days.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Heart rate increased, Pharyngeal swelling, Urticaria
Clinical narrative: swelling in throat <1 min hives <10 min
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: swelling in throat <1 min hives <10 min
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Dissociation, Dizziness, Dysphonia, Hypertension
Clinical narrative: swelling in throat <1 min hives <10 min
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Livedo reticularis, Oropharyngeal pain, Sensation of foreign body, Tachycardia
Clinical narrative: swelling in throat <1 min hives <10 min
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 y F vaccinated with J&J vaccine. Pt reported to check in to be 18 years of age and was given the Janssen Vaccine. Post vaccination it was subsequently found that the patient was 17 years of age. Pt monitored and did not have any adverse reactions during this period.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: temperature excursion with vaccine administered
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: temperature excursion with vaccine administered
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: On Thursday May 13th, 2021, patient arrived  to receive his first Pfizer vaccination. Patient was vaccinated and sent to the observation area.  At 1342, the patient stated," I feel dizzy, like I might pass out," to EMT observer. EMT observer immediately assisted the patient to the gravity chair. The patient's vital signs were taken: BP 110/72, HR 84, RR 15, oxygen saturation at 96% . The patient was alert and oriented to person, place, time, and situation. The patient was given water and stated, " I feel so much better after sitting in this chair." No loss of consciousness or syncope occurred. The patient was given a bottle of water.  Co-lead, assessed the patient, who was alert and oriented to person, place, time, and situation, was in no apparent distress, and was speaking in full sentences. No pallor or diaphoresis was observed.  Vitals were taken at 1347: BP 108/70, HR 63, RR 14, oxygen saturation at 99%. The patient took off his mask to reduce anxiety. Denied any history of fainting. or having any known drug allergies. Vitals were retaken at 1352: BP 120/68, HR 63, RR 14 ,oxygen saturation at 98%. The patient was offered a granola bar but denied it, as he ate around 1230. Patient denied any shortness of breath, blurry vision, lightheadedness, dizziness, itching, nausea, or facial flushing. The patient stated, " I feel totally fine."  Vitals were retaken at 1357, BP 120/70, RR: 14, HR 63, and oxygen saturation at 98%. Notified patient to inform the vaccinator about his reaction when returning for his second Pfizer dose. Vital retaken at 1402, BP 125/ 68, RR 14, HR 63, 98% oxygen saturation. The patient felt comfortable to drive home and left the site at 1405. The patient left the site with an even and steady gait.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash, 'rash' on both ears.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Herpes simplex, Herpes simplex test positive, Inflammation
Clinical narrative: To start, I had chicken pox as a child, 6 years old. On April 24, I had laser hair removal on my vagina - which I?m required to shave. The laser really gets into the skin, leaving it raw and open to infection.  I received my vaccine 5 days later.  I experienced chills, body aches for 2 days after, then the rash on vaginal area became extremely inflamed and red. I went to urgent care, doctor stated it did not look like genital herpes, but a skin infection.  The following morning, it was worst, so I went to medical facility, who swabbed it. Came back as HSV-2. A week later, i had blood work G and M, which showed no signs or Antibodies for HSV- 2.  I read an article that the vaccine is related to shingles activation.  From my understanding: A dermatome is the area of skin supplied by a particular nerve. The varicella zoster virus lies dormant in the cranial and spinal nerves. When the virus is reactivated, it travels along the affected nerves to the area of the skin served by those nerves, where it causes a distinctive, stripe-like rash. Which, was my vaginal area after intense laser.  Im also aware the the herpes zoster can be confused with gential, even in a culture that only test for hsv 1 and 2.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Skin infection
Clinical narrative: To start, I had chicken pox as a child, 6 years old. On April 24, I had laser hair removal on my vagina - which I?m required to shave. The laser really gets into the skin, leaving it raw and open to infection.  I received my vaccine 5 days later.  I experienced chills, body aches for 2 days after, then the rash on vaginal area became extremely inflamed and red. I went to urgent care, doctor stated it did not look like genital herpes, but a skin infection.  The following morning, it was worst, so I went to medical facility, who swabbed it. Came back as HSV-2. A week later, i had blood work G and M, which showed no signs or Antibodies for HSV- 2.  I read an article that the vaccine is related to shingles activation.  From my understanding: A dermatome is the area of skin supplied by a particular nerve. The varicella zoster virus lies dormant in the cranial and spinal nerves. When the virus is reactivated, it travels along the affected nerves to the area of the skin served by those nerves, where it causes a distinctive, stripe-like rash. Which, was my vaginal area after intense laser.  Im also aware the the herpes zoster can be confused with gential, even in a culture that only test for hsv 1 and 2.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Pain
Clinical narrative: Pain and loss of hearing
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Oropharyngeal pain, Pain, Pain in jaw, Pyrexia
Clinical narrative: Fever 103 with shaking, body aches including joints, jaws, and throat.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Fever 103 with shaking, body aches including joints, jaws, and throat.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Condition aggravated, Dry mouth
Clinical narrative: Extremely dry mouth / regularly experiences a dry mouth, but this is more than it typically is.; Extremely dry mouth / regularly experiences a dry mouth, but this is more than it typically is.; loss of taste; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 97-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 07Feb2021 at 14:30 (age at the time of vaccination 97-years-old), as single dose for covid 19 immunisation. The patient medical history included Hypertension, Diabetes. No allergies were reported. The patient concomitant medications included Metformin , Januvia, Enalapril, HCTZ, levothyroxine. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that the patient received her first dose of the COVID vaccine on 07Feb2021. On 15-FEB-2021 13:00 she had experienced a drier than normal mouth since that time; ongoing for the last 18 days and loss of taste. She is scheduled to receive her second dose of the vaccine on 01Mar2021. Her daughter is calling because the dry mouth condition seems to have been exacerbated after her mother received the first dose of the vaccine. she is questioning if this is a possible side effect of the vaccine, and of her mother should receive the scheduled 2nd dose. Her daughter stated that her mother regularly experiences a dry mouth, but this is more than is typically is. The Caller's (Withheld) took her first dose on 07February2021. A week after that, she's still not experiencing any side effects. But now, she is having a really dry mouth. Caller, She, is asking if that is one of the possible side effects of the vaccine Patient did not receive any treatment for the events. The outcome of all events was not resolved.  Follow up #1 (27Feb2021): This is a follow up spontaneous report from a contactable consumer. This 97-year-old female consumer(patient) reported for herself that: New information included: age added, event information added, events onset date and time added  Follow up#2 (27Feb2021): This is a follow up spontaneous report from a Pfizer sponsored program. This consumer (patients daughter) reported for a 97-year-old female patient (reporters mother) includes: Dose administration date was updated.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia, Somnolence, Tremor
Clinical narrative: my body shutdown I had to sleep out of no where after about an hour I started to have uncontrollable shivers/shakes I was over heating but under a blanket to see if that would help with the shaking but it didn't once it did stoped I was knocked out sleeping again until 3am. I took my temp for the first time that night around 3pm also and it was at 100.5°f. I haven't had a fever over 99.9 since elementary school
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered , OUTCOME UNKNOWN
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinusitis
Clinical narrative: sinus; tested positive on 18Feb2021; This is a spontaneous report from a contactable consumer (reported for herself) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (solution for injection, Lot number was not reported) via an unspecified route of administration on 05Feb2021, as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18Feb2021, the patient was tested positive, without fever and no chills, only sinus. She was under quarantine for 10 days; quarantine would be finished by 28Feb2021. Her second dose was scheduled on 01Mar2021. The outcome of the events of tested positive for Covid and sinus was unknown.  No follow-up attempts were possible. No further information was expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Heart rate increased
Clinical narrative: Patient presented to Community Center at her scheduled appointment time to receive her  2nd dose of the COVID Pfizer vaccine. While being processed for 2nd dose vaccination, the client reported she experienced a feeling which she describes as a "a shot of adrenaline" about 5 minutes after administration of first Pfizer COVID vaccine.  RN responded. Client symptoms of elevated heart rate, shortness of breath and dizziness lasted 1-2 minutes and resolved without treatment. Client did not follow up with PCP.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered state of consciousness, Blood pressure increased, Electrocardiogram, Heart rate increased, Impaired work ability
Clinical narrative: On 3/27/2021 had" black out" at around 9:30am drove to another city without any knowledge. Proceeded to home without any knowledge. My children not aware I was in a "black out" situation. I slept for four days on and off without knowledge of this. My children became aware something was wrong when I was acting strangely the times I was awake and that I did not go to work for three days (very unusual for me to miss work) Wednesday 3/31/2021, I finally started coming out of this" black out ", not knowing where I was or who my children were. My cousin came after my children called her and took me to the medical center. My blood pressure was through the roof as was my heart rate. I do not recall what they were. I still was not totally" with it" and left the emergency room without treatment because of E.R. doctor. There is a record of me being there as I was billed for the date 3/31/2021. They did manage to get an EKG.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: On 3/27/2021 had" black out" at around 9:30am drove to another city without any knowledge. Proceeded to home without any knowledge. My children not aware I was in a "black out" situation. I slept for four days on and off without knowledge of this. My children became aware something was wrong when I was acting strangely the times I was awake and that I did not go to work for three days (very unusual for me to miss work) Wednesday 3/31/2021, I finally started coming out of this" black out ", not knowing where I was or who my children were. My cousin came after my children called her and took me to the medical center. My blood pressure was through the roof as was my heart rate. I do not recall what they were. I still was not totally" with it" and left the emergency room without treatment because of E.R. doctor. There is a record of me being there as I was billed for the date 3/31/2021. They did manage to get an EKG.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling
Clinical narrative: treated for swollen in the mouth
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy
Clinical narrative: Severe pain in injection site for several days. Lethargic for 3 days.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: temperature excursion with vaccine administered , OUTCOME UNKNOWN.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Breaking out in a "Chicken Pox" like rash over a large portion of my body. Legs, arms, and torso. Extremely itchy and often painful.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Breaking out in a "Chicken Pox" like rash over a large portion of my body. Legs, arms, and torso. Extremely itchy and often painful.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered , OUT COME UNKNOWN
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: temperature excursion with vaccine administered , OUTCOME UNKOWN
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Nausea
Clinical narrative: On the day of the vaccination, a few minutes later (8 approximately) I felt mild dizziness, then the next day pain in the area of the vaccine (it was given on May 6), on Wednesday, May 12, when I woke up I began to feel very dizzy. Frequent at all times, at the moment today Friday 1:31 am I feel dizzy and nauseated, fatigue.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Temperature excursion with vaccine administered
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Musculoskeletal stiffness, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to touch extending 2 inches down from injection site. Pain on touch and consistent pain. Stiffness extending down left arm. Received both doses in left arm.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Redness, swelling, hot to touch extending 2 inches down from injection site. Pain on touch and consistent pain. Stiffness extending down left arm. Received both doses in left arm.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered , OUTCOME UNKNOWN
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: I had 3-4 days of spotting after my second dose of the Pfizer COVID19 vaccine. I have had an IUD for almost 10 years, with no periods or spotting after the initial few months, so this was surprising. It was light but consistent with stringy matter.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Temperature Excursion with vaccine administered
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Guillain-Barre syndrome, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Patient developed paresthesia/sensory changes and lower back and abdominal pain. Found to have likely Guillain Barre syndrome. No motor involvement and discharged home.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered , OUTCOME UNKNOWN
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Noticed a bump below my collarbone 12 hours after injection. Now believe that it is a swollen lymph node based on what other people have reported and pictures of lymph nodes online.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Temperature excursion on administered vaccine.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Multiple sclerosis relapse
Clinical narrative: Approximately three weeks after first dose, I experienced a Multiple Sclerosis relapse.  Possibly an adverse side-effect.  Diagnosed with MS by Neurology and confirmed by  (second opinion).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Ear infection, Ear pain, Ear swelling, Herpes zoster
Clinical narrative: shingles; had ear infection; red spots on ear; Otitis Media; Ear Ache; ear feeling sore, swollen, stopped up; ear feeling sore, swollen, stopped up; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 10Feb2021 11:30 (lot number: EL9265) at the age of 65 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included Grave's disease. There were no concomitant medications. The patient previously took morphine (lot number and expiry date unknown) and experienced allergy. On 18Feb2021, the patient had earache, ear feeling sore, swollen and stopped up. On 25Feb2021, found red spots on ear. Clinical course: The patient had ear infection two weeks after the dose and was given antibiotics and eardrops. Four days later, the patient had spots and the doctor said it was shingles. Patient was given meds and cream. Patient is scheduled for the second dose on the 03Mar2021 and wanted to know if she can get the vaccine. 10 days after the first shot, her ear began to ache and so she went to doctor on Monday 22Feb2021, and the doctor said it was an ear infection and prescribed antibiotic and drops. Then on 25Feb2021, she had little red spots on ear and went back to the doctors and he thought it was shingles, but she has already had the shingles vaccine. Her earache was on 18Feb2021, she woke up with her ear feeling sore, swollen, stopped up. It is still ongoing but feels better. She made the doctor's appointment for her earache on 22Feb2021 Monday, he diagnosed her with Otitis Media. He prescribed Azithromycin, Z-pak 250mg 5 tablets. Patient confirmed it was generic azithromycin prescribed. The doctor also prescribed ear drops neomycin polymyxin hydrocortisone 3.5mg, 3 times a day. Her red spots appeared on 25Feb2021, it is ongoing, she has scabs now so it has improved. The doctor's appointment for the red spots was on 25Feb2021, she woke up, her husband is the one that puts the drops in her ear and so he was the one that noticed the spots, the doctors diagnosis was shingles or herpes zoster. He prescribed Valacyclovir 1 gram, 1 tablet by mouth 3 times a day for 7 days. He also prescribed a mupirocin ointment. Patient stated that she got her Shingles vaccine 10Nov2016. She is scheduled for her second dose of the COVID vaccine on 03Mar2021. The patient was recovering from earache, ear feeling sore, swollen, stopped up, and red spots on ear. Outcome of the remaining events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Otitis media, Rash macular
Clinical narrative: shingles; had ear infection; red spots on ear; Otitis Media; Ear Ache; ear feeling sore, swollen, stopped up; ear feeling sore, swollen, stopped up; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 10Feb2021 11:30 (lot number: EL9265) at the age of 65 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included Grave's disease. There were no concomitant medications. The patient previously took morphine (lot number and expiry date unknown) and experienced allergy. On 18Feb2021, the patient had earache, ear feeling sore, swollen and stopped up. On 25Feb2021, found red spots on ear. Clinical course: The patient had ear infection two weeks after the dose and was given antibiotics and eardrops. Four days later, the patient had spots and the doctor said it was shingles. Patient was given meds and cream. Patient is scheduled for the second dose on the 03Mar2021 and wanted to know if she can get the vaccine. 10 days after the first shot, her ear began to ache and so she went to doctor on Monday 22Feb2021, and the doctor said it was an ear infection and prescribed antibiotic and drops. Then on 25Feb2021, she had little red spots on ear and went back to the doctors and he thought it was shingles, but she has already had the shingles vaccine. Her earache was on 18Feb2021, she woke up with her ear feeling sore, swollen, stopped up. It is still ongoing but feels better. She made the doctor's appointment for her earache on 22Feb2021 Monday, he diagnosed her with Otitis Media. He prescribed Azithromycin, Z-pak 250mg 5 tablets. Patient confirmed it was generic azithromycin prescribed. The doctor also prescribed ear drops neomycin polymyxin hydrocortisone 3.5mg, 3 times a day. Her red spots appeared on 25Feb2021, it is ongoing, she has scabs now so it has improved. The doctor's appointment for the red spots was on 25Feb2021, she woke up, her husband is the one that puts the drops in her ear and so he was the one that noticed the spots, the doctors diagnosis was shingles or herpes zoster. He prescribed Valacyclovir 1 gram, 1 tablet by mouth 3 times a day for 7 days. He also prescribed a mupirocin ointment. Patient stated that she got her Shingles vaccine 10Nov2016. She is scheduled for her second dose of the COVID vaccine on 03Mar2021. The patient was recovering from earache, ear feeling sore, swollen, stopped up, and red spots on ear. Outcome of the remaining events was unknown.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered , OUTCOME UNKNOWN
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Paraesthesia, Swelling, Swelling face
Clinical narrative: About 30 minutes after getting the first shot of Pfizer vaccines, the left side of my body started to feel like getting swollen.  Left half of my face started feeling swollen and tingling - like when your dental anesthesia was wearing off, and my left arm feeling swollen.  I checked my left hand and my face on the mirror to see if they were really swollen, but they looked normal.  I think it was more of the neurological effect.  I can't remember if my left leg was also impacted.  I think about 30 minutes or so, it started get better so I didn't go to see a doctor.  About an hour after the shot, I think it was pretty much gone.  Now, I may be too self conscious, but I feel like something wrong /weird with the left side of my body/face, but that may be my anxiety tricking me.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with administered vaccine
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular
Clinical narrative: I usually have a very regular menstrual cycle and my period was late by a full week. Also had unusual period side effects.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Temperature excursion on administered vaccine
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Injected limb mobility decreased
Clinical narrative: Injection site is really high my arm. I am experiencing shoulder pain and limited mobility in my arm. Dose was today so will monitor.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administered , OUTCOME UNKNOWN
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Father of the patient lied about the patient's age at time of vaccine administration to make child eligible to receive vaccine (said patient was was 12 years old when really was 10 years old). Spoke with the father regarding the incident on 5/12/21 after discovering the child's real age.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Temperature excursion on administered vaccine
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic shock, Condition aggravated, Tinnitus
Clinical narrative: After 7-10 days after the second Pfizer shot, my existing Tinnitus worsened in my left ear.  The ringing grew louder and I felt a shock if someone yelled or if there was a loud noise.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Headache, Influenza like illness
Clinical narrative: feel muscle aces all over body, bad headace,.wheezing ,trouble breathing. shortness of breath., feel like I have to throw -up, Flu like symtons, weakness, chills, but I do NOT have fever. was vaccinated May 6th 2021, seven days ago
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Wheezing
Clinical narrative: feel muscle aces all over body, bad headace,.wheezing ,trouble breathing. shortness of breath., feel like I have to throw -up, Flu like symtons, weakness, chills, but I do NOT have fever. was vaccinated May 6th 2021, seven days ago
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Muscle spasms, Oropharyngeal spasm, Swelling face
Clinical narrative: Throat and chest spasms; Throat and chest spasms; Lower lip and jaw swelling; Lower lip and jaw swelling; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264), via an unspecified route of administration on 08Feb2021 02:45 PM in the left arm at single dose for COVID-19 immunisation. The patient age at vaccination was 70 Years. Facility where COVID-19 vaccine was administered was at the Hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included 6 Autoimmunes, asthma, diabetes 2, Celiac, depression, anxiety, Extra allele on chromosome for histamine production, Genetic extra histamine production, allergic to many meds, foods and environmental. Concomitant medications included certolizumab pegol (CIMZIA); pramipexole dihydrochloride (MIRAPEX); desvenlafaxine succinate (PRISTIQ); olmesartan medoxomil; All were taken for an unspecified indication, start and stop date were not reported. On 08Feb2021 14:45, the patient experienced throat and chest spasms with delayed lower lip and jaw swelling several hours later even with 50 mg Benadyrl. Swelling receded 36 hrs later. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19, since the vaccination. Therapeutic measures were taken as a result of the events with 50 mg Benadryl repeatedly. Outcome of the events was recovered on an unknown date.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pollakiuria
Clinical narrative: was up all night urinating/starting urinating at midnight; Diarrhea; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 23Feb2021 03:00 (Lot Number: EN6200, expiration date: unknown) as unknown, single dose for covid-19 immunisation. Medical history included irritable bowel syndrome from 2011 to an unknown date, ongoing blood cholesterol abnormal , ongoing blood pressure abnormal. Concomitant medications included valsartan taken at a dose 160 mg, once a day (at night) for blood pressure from an unspecified start date and ongoing; amlodipine besilate taken for blood pressure at 2.5 mg, daily from an unspecified start date and ongoing; atorvastatin taken for blood cholesterol at 20 mg, daily from an unspecified start date and ongoing. The patient had been taking concomitant medicines for a couple of years. The patient was up all night urinating/starting urinating at midnight on 24Feb2021, diarrhea on 24Feb2021. She is concerned if she should get the second shot or not. It just didn't seem right to her. Therapeutic measures were taken as a result of diarrhea. She took Imodium AD for the diarrhea. The diarrhea has improved. The outcome of the events was recovering.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Atypical pneumonia, Blood test, Fatigue, Headache, Heart rate
Clinical narrative: bumps on arms; Atypical Pneumonia; elevated heart rate; Headache; Sleepy; tired; This is a spontaneous report from a contactable consumer (reported on herself). A 70-year-old female patient received first dose of BNT162B2 (solution for injection, Lot number: EN6202 expiry date: unknown) via an unspecified route of administration in left arm on 02Mar2021, as a single dose of COVID-19 immunization. Medical history included COPD, Asthma: She had a cough for two years and had acid reflux which was when they diagnosed her with asthma, Coughing started 1-2 hours after that flu vaccine which she received in 2019, she did not have the NDC number, lot number, or expiration. The caller had not received a flu vaccine since. She was diagnosed with Lichen sclerosus 3 months prior to this report, pneumonia diagnosed 4 years prior to this report, and she believed it was autoimmune. Concomitant medication included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (Trelegy) inhaler dosage text: 1 inhalation a day, 200mcg been taking it a couple of months for asthma and COPD. On 02Mar2021, she had her vaccine in the morning and by the afternoon her heart rate was high at the appointment with her asthma doctor and her heart rate had been elevated ever since. She then noticed bumps on both of her arms when she was getting out of the bath. Her heart rate was still elevated so she went to the Emergency Room a day prior to this report and was diagnosed with atypical pneumonia. She had a headache, she took a Tylenol, and little bumps on both of her arms. The bumps did not itch, but they were still there. Her doctor put her on antibiotics (unspecified). The patient was she was tired and sleepy from the vaccine but did not feel quite so groggy. She did not feel good a week prior to this report, she thought it was something she ate, she was going to reschedule vaccine because of it. She had blood tests (unspecified) done a day prior to this report, in the Emergency Room and they all came out okay, she guessed. She did not have history of previous immunization with the Pfizer vaccine and was not administered additional vaccines on same date of the Pfizer Suspect. She did not have a family medical History relevant to events. The outcome of the events of atypical pneumonia, elevated heart rate, bumps on arms, and headache was not recovered, however the outcome of the events tired and sleepy was unknown.   No further information was available.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Keratosis pilaris, Somnolence
Clinical narrative: bumps on arms; Atypical Pneumonia; elevated heart rate; Headache; Sleepy; tired; This is a spontaneous report from a contactable consumer (reported on herself). A 70-year-old female patient received first dose of BNT162B2 (solution for injection, Lot number: EN6202 expiry date: unknown) via an unspecified route of administration in left arm on 02Mar2021, as a single dose of COVID-19 immunization. Medical history included COPD, Asthma: She had a cough for two years and had acid reflux which was when they diagnosed her with asthma, Coughing started 1-2 hours after that flu vaccine which she received in 2019, she did not have the NDC number, lot number, or expiration. The caller had not received a flu vaccine since. She was diagnosed with Lichen sclerosus 3 months prior to this report, pneumonia diagnosed 4 years prior to this report, and she believed it was autoimmune. Concomitant medication included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (Trelegy) inhaler dosage text: 1 inhalation a day, 200mcg been taking it a couple of months for asthma and COPD. On 02Mar2021, she had her vaccine in the morning and by the afternoon her heart rate was high at the appointment with her asthma doctor and her heart rate had been elevated ever since. She then noticed bumps on both of her arms when she was getting out of the bath. Her heart rate was still elevated so she went to the Emergency Room a day prior to this report and was diagnosed with atypical pneumonia. She had a headache, she took a Tylenol, and little bumps on both of her arms. The bumps did not itch, but they were still there. Her doctor put her on antibiotics (unspecified). The patient was she was tired and sleepy from the vaccine but did not feel quite so groggy. She did not feel good a week prior to this report, she thought it was something she ate, she was going to reschedule vaccine because of it. She had blood tests (unspecified) done a day prior to this report, in the Emergency Room and they all came out okay, she guessed. She did not have history of previous immunization with the Pfizer vaccine and was not administered additional vaccines on same date of the Pfizer Suspect. She did not have a family medical History relevant to events. The outcome of the events of atypical pneumonia, elevated heart rate, bumps on arms, and headache was not recovered, however the outcome of the events tired and sleepy was unknown.   No further information was available.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Tenderness, Urinary tract infection, Vaccination site pain
Clinical narrative: urinary tract infection; the vaccine stung when it went in and the site was tender; shingles / shingles rash; the vaccine stung when it went in and the site was tender; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 23Feb2021 at 12:00 (Batch/Lot number: EL9269) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included pain, eye condition, Prediabetes, immunosuppressive - she is also taking immunosuppressive medication that is lowering her immunity: Mycophenolate since Dec2020. She also had a pain in her lower back on about 19Feb2021. Concomitant medications included prednisone (PREDNISONE) taken for eye condition from Aug2020 and ongoing-her immune system is attacking her retina, started a high dose in Aug2020 and has titrated down since then; mycophenolate mofetil (MYCOPHENOLATE) taken for eye condition and immunosuppressive from Dec2020 and ongoing; metformin (METFORMIN) taken for Prediabetes from an unspecified start date and ongoing and been on it about 6 years; and gabapentin for pain. The patient developed shingles on 03Mar2021. She is on prednisone, mycophenalate, and pain medications. She wants to know if it's ok to get the second dose since she is immunosuppressed. The patient was calling about the Covid-19 vaccine and reported that she got the first dose on 23Feb2021 and about 3.5 days later she got a shingles rash. She wanted to know if it is ok to get the second vaccine or if that is contraindicated. The patient said that she is also taking immunosuppressive medication that is lowering her immunity (Mycophenolate) and she has been on it since Dec2020. The patient said that she was on another immunosuppressive medication before this for a month that she had a reaction to. She said that was when she was switched to Mycophenolate. The doctor had her on an antiviral for shingles rash that she started on 03Mar2021. She clarified that it is Valacyclovir HCL 1 pill 3 times a day for 7 days, and she was given pain medicine called Gabapentin 100mg 1 pill 3 times a day by mouth. Her next dose of the Covid-19 Vaccine was scheduled for 16Mar2021. The patient said that the vaccine stung when it went in and the site was tender. Her arm is still a little tender at the site. She said that it seems since she has the shingles stuff it is a little tender. The patient said that she had a pain in her lower back on about 19Feb2021. She went to the doctor on 01Mar2020 because it was not going away. The doctor thought it was a urinary tract infection and gave her an antibiotic that she stopped on 04Mar2021 after being diagnosed with the shingles. The event shingles / shingles rash required a visit to Physician Office; she did a telehealth visit with her doctor for her shingles rash. The event shingles / shingles rash had not resolved while the outcome of the rest of the events was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: el92103), via an unspecified route of administration, administered in Arm Right on 31Jan2021 14:45 (at the age of 50years) as 1ST DOSE, SINGLE for Covid-19 immunization. Medical history included hypertension high blood pressure and high blood cholesterol increased; both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that within 2 days of vaccine he started having left arm pain. On the 3rd day, he had arm pain with the start of a rash. On the 4th day, he had shooting pain down his arm to his hand, arm pain, and more rash. It is then that he sought out medical care and was diagnosed with shingles. The rash covered his left arm and 5 weeks later he was still suffering from extreme pain. The event onset date was reported as 02Feb2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated for the adverse evet and he was on second round of antiviral's, pain medications. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was not recovered.