chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Ageusia, Body temperature increased, Chills, Decreased appetite, Dizziness
Clinical narrative: fever, loss of appetite, irritability, feeling tired, headache, chills....temerature 98 to 102.4 over four days...loss of taste, night sweats, 2/28 had dizzy and vision changes.  symtoms severe to cause loss of work for the week
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Impaired work ability, Influenza A virus test negative, Influenza B virus test
Clinical narrative: fever, loss of appetite, irritability, feeling tired, headache, chills....temerature 98 to 102.4 over four days...loss of taste, night sweats, 2/28 had dizzy and vision changes.  symtoms severe to cause loss of work for the week
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Irritability, Night sweats, Pyrexia, SARS-CoV-2 test negative, Visual impairment
Clinical narrative: fever, loss of appetite, irritability, feeling tired, headache, chills....temerature 98 to 102.4 over four days...loss of taste, night sweats, 2/28 had dizzy and vision changes.  symtoms severe to cause loss of work for the week
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Malaise, Mobility decreased, Pain
Clinical narrative: I received my 2nd booster shot on 04/18/2022 and my COVID symptoms started on 05/10/2022 some time in the evening scratchy throat, 05/11/2022 I woke up at 01:30 PM felt fever and achy all over my body. Wednesday and Thursday I stayed in bed all day. I did a home COVID test on the Wednesday 11th and it was negative. 05/10/2022 my wife was positive. But I was negative. The guest that came in my apartment was COVID positive, so were all positive. I messaged my doctor and she sent medications for me and my wife. PAXLOID for 5 days starting on the 05/13/2022. My wife tested positive on 05/12/2022.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I received my 2nd booster shot on 04/18/2022 and my COVID symptoms started on 05/10/2022 some time in the evening scratchy throat, 05/11/2022 I woke up at 01:30 PM felt fever and achy all over my body. Wednesday and Thursday I stayed in bed all day. I did a home COVID test on the Wednesday 11th and it was negative. 05/10/2022 my wife was positive. But I was negative. The guest that came in my apartment was COVID positive, so were all positive. I messaged my doctor and she sent medications for me and my wife. PAXLOID for 5 days starting on the 05/13/2022. My wife tested positive on 05/12/2022.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Paraesthesia, Swelling
Clinical narrative: Patient experienced pain/tingling in their forearm in the same arm injected, at the time of injection. Inejction was administered in deltoid. After 5-10 minutes, bruising developed on the forearm. After another 10-15 minutes, the bruising had grown to 1/4" x 1" approximate area. A cold pack was given to the patient which reduced the pain and swelling.   The injury was examined by a Physician's Assistant next door. Patient was sent home with directions to continue to ice and monitor.   Patient reported that the immunization was more painful than previous immunizations. No reactions developed at the site of injection.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Asthenia, COVID-19, Decreased appetite, Dysphonia
Clinical narrative: My husband who also was double boosted had been out of the state. He came home and developed symptoms 2-3 days before I did. My symptoms began with a sore throat first. I had a slightly hoarse voice. I felt kind of warm, but my temperature was 97.2. I felt warm and had a slightly runny nose. But that day my COVID test was negative. Sunday the 15 was negative. Tuesday the 17 was still negative. The sore throat on the 17th was pretty much all day. It was a bit intermittent. Wednesday May 18, the sore throat would not go away. I had nasal congestion; I was sneezing. My voice was hoarse, and I had no appetite. I was also unusually thirsty. Couldn't get enough to drink. On that day, first thing in the morning with the sore throat. I was still afebrile. My temp was 98.4. I waited to see how the day would go. Felt lousy all day. Symptoms did not go away, just did not feel well. By 2PM, nothing felt better, and I took my temperature. I did a COVID test on May 18 at 2PM and it was positive. My temperature was 99.9 at 2:20PM. At that point, I got on the phone with my doctor for telemedicine. She prescribed molnupiravir, the antiviral 200mg. Take 4 capsules twice a day for 5 days. I began that the evening of May 18. The last dose was yesterday morning May 23, 2022. Took it twice a day all those days in between. May 19, no more sore throat. Temp was 98.1. Afebrile. A little bit of a runny nose, not really congestion, Sunday-Today I'm symptom free. We did some have malaise. No energy and no ambition to do much on Saturday. But everything Sunday on has been better. I was feeling absolutely normal on Sunday. I did another test and that remained positive May 22, 2022. Finished the antiviral.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: My husband who also was double boosted had been out of the state. He came home and developed symptoms 2-3 days before I did. My symptoms began with a sore throat first. I had a slightly hoarse voice. I felt kind of warm, but my temperature was 97.2. I felt warm and had a slightly runny nose. But that day my COVID test was negative. Sunday the 15 was negative. Tuesday the 17 was still negative. The sore throat on the 17th was pretty much all day. It was a bit intermittent. Wednesday May 18, the sore throat would not go away. I had nasal congestion; I was sneezing. My voice was hoarse, and I had no appetite. I was also unusually thirsty. Couldn't get enough to drink. On that day, first thing in the morning with the sore throat. I was still afebrile. My temp was 98.4. I waited to see how the day would go. Felt lousy all day. Symptoms did not go away, just did not feel well. By 2PM, nothing felt better, and I took my temperature. I did a COVID test on May 18 at 2PM and it was positive. My temperature was 99.9 at 2:20PM. At that point, I got on the phone with my doctor for telemedicine. She prescribed molnupiravir, the antiviral 200mg. Take 4 capsules twice a day for 5 days. I began that the evening of May 18. The last dose was yesterday morning May 23, 2022. Took it twice a day all those days in between. May 19, no more sore throat. Temp was 98.1. Afebrile. A little bit of a runny nose, not really congestion, Sunday-Today I'm symptom free. We did some have malaise. No energy and no ambition to do much on Saturday. But everything Sunday on has been better. I was feeling absolutely normal on Sunday. I did another test and that remained positive May 22, 2022. Finished the antiviral.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sneezing, Thirst
Clinical narrative: My husband who also was double boosted had been out of the state. He came home and developed symptoms 2-3 days before I did. My symptoms began with a sore throat first. I had a slightly hoarse voice. I felt kind of warm, but my temperature was 97.2. I felt warm and had a slightly runny nose. But that day my COVID test was negative. Sunday the 15 was negative. Tuesday the 17 was still negative. The sore throat on the 17th was pretty much all day. It was a bit intermittent. Wednesday May 18, the sore throat would not go away. I had nasal congestion; I was sneezing. My voice was hoarse, and I had no appetite. I was also unusually thirsty. Couldn't get enough to drink. On that day, first thing in the morning with the sore throat. I was still afebrile. My temp was 98.4. I waited to see how the day would go. Felt lousy all day. Symptoms did not go away, just did not feel well. By 2PM, nothing felt better, and I took my temperature. I did a COVID test on May 18 at 2PM and it was positive. My temperature was 99.9 at 2:20PM. At that point, I got on the phone with my doctor for telemedicine. She prescribed molnupiravir, the antiviral 200mg. Take 4 capsules twice a day for 5 days. I began that the evening of May 18. The last dose was yesterday morning May 23, 2022. Took it twice a day all those days in between. May 19, no more sore throat. Temp was 98.1. Afebrile. A little bit of a runny nose, not really congestion, Sunday-Today I'm symptom free. We did some have malaise. No energy and no ambition to do much on Saturday. But everything Sunday on has been better. I was feeling absolutely normal on Sunday. I did another test and that remained positive May 22, 2022. Finished the antiviral.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyond use date.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE EXPIRED 04/02/2022
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: VACCINE EXPIRED 04/02/2022
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered outside of beyond use date-not supported by vaccine manufacturer
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vomiting
Clinical narrative: Patient vomited after breakfast.  She was given ginger tea and bed rest. The vomiting stopped about 30 minutes and she stayed in bed for about 4 hours.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after beyond use date.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Pt given full dose moderna (0.5ml) supposed to be given half dose (0.25ml)
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered outside the beyond use date- not supported by vaccine manufacturer
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Blood test abnormal, Full blood count abnormal, Laboratory test abnormal
Clinical narrative: Soon after receiving the first COVID  booster, I was diagnosed with Anemia.  I don't know if my Anemia was related to the booster, but I want to report it in case others have experienced a similar diagnosis.  I have been taking an Iron supplement since the diagnosis, and the Anemia is now under control.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered outside of beyond use date- not supported by vaccine manufacturer
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Delivery, Exposure during pregnancy, SARS-CoV-2 test positive
Clinical narrative: When I received my Moderna booster shot, I was 14 weeks pregnant with my son. My son was born 5/13/2022, and he weighed in at 8 lbs., 5 oz. I was originally planning to give birth at home, but since I tested positive for COVID on 5/12/2022, I had to give birth at the hospital. At the time of my son's birth, I was 39 weeks pregnant. It was an uncomplicated vaginal delivery, and my original due date had been 5/18/2022. My son tested negative for COVID at the hospital on 5/14/2022. However, he tested positive on 5/18/2022 when a rapid test was done at home. He was asymptomatic.
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine tolerated well after 15 min of wait time. vaccine was expired05/15/2022 but with in she same month of administration. Patient was notified of incident at the time of visit by providers she will also see her specialist.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: urticaria
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Vaccine administered was for age group 5-11 patient and patient should have received dosage for 12-17 y.o.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient who was vaccinated earlier in the day was on staff's list to offer patient vaccination. Patient accepted and received another dose of Moderna booster shot. provider notified and pt was monitored for any side effects.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy
Clinical narrative: axillary lymphadenopathy
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after beyond use date.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE EXPIRED 04/02/2022
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: VACCINE EXPIRED 04/02/2022
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered to patient after beyond use date.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Laboratory test abnormal, Tinnitus
Clinical narrative: after about a week my ears started ringing, I immediately thought it might be fro the booster, gave it time to hopefully clear up it did not it kept getting louder,   as time went on I started researching to find answers. after 3 months with no reseloution
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after beyond use date.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: When I received the injection, it burned quite a bit and then briefly went away. Then about 10 minutes after I received the injection, the burning returned and lasted for over an hour. I also developed a sharp needle stabbing pain in the left foot as I was driving home about 40 minutes after that and it lasted about 30-40 minutes as well. I have never felt that foot pin stabbing pain before in my life nor did that happen after the first 2 injections in the initial series. After it went away, it did not return (either the arm burning or sharp foot pain).
Age: 50.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: COVID-19, Exposure to SARS-CoV-2, Fatigue, Malaise, Nausea
Clinical narrative: COVID BREAKTHROUGH CASE. I felt unwell on Thursday May 19th and I tested and I was negative. My husband was diagnosed on May 16 so I kept testing to ensure I was still negative. Fever the night before, Congestion, Sore throat, Very tired/rundown, Some nausea. These symptoms weren't 100% constant they would come and go from time to time. My first positive test was May 21st. I went to urgent care and tested positive.
Age: 50.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH CASE. I felt unwell on Thursday May 19th and I tested and I was negative. My husband was diagnosed on May 16 so I kept testing to ensure I was still negative. Fever the night before, Congestion, Sore throat, Very tired/rundown, Some nausea. These symptoms weren't 100% constant they would come and go from time to time. My first positive test was May 21st. I went to urgent care and tested positive.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in shoulder since injection. has not resolved
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weakness
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vaccine breakthrough infection
Clinical narrative: BREAK-THROUGH case fever over 101. I also had headache and body aches
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Within seconds of vaccination, patient passed out/had syncopal episode. Patient was in a sitting position when event occurred. Applied cool compresses and laid him down. Evaluated by provider.  No other treatment needed. Patient back to normal within a few seconds. Monitored for 30 minutes. Per mother, this has happened to patient prior, with most injections.  Did not happen with first COVID vaccine, but per mom, patient was lying down during the injection.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Biopsy peripheral nerve, Electromyogram, Neuropathy peripheral
Clinical narrative: Neuropathy, ongoing
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Pain, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA in left shoulder after 3rd dose of Pfizer vaccine.  Pain increased the second week and became constant afterwards.  Also experienced Shingles outbreak in same shoulder along C6 dermatome 2 weeks after 3rd dose of Pfizer vaccine.  Prescribed Acyclovir 800 MG 5 times a day for 7 days.  SIRVA treatment calls for MRI, PT, Orthopedist appointments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site dryness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Two days after the vaccine shot the area where it was injected was very swollen and red and very hot to the touch.  I used ice and Benadryl cream per my physician since it had a bit of an itch to it.   It improved over the next week, however, my skin became brown in color and seemed dry.  By the 8th day, the brown area started to peel.  It is like I have a bad sunburn in that one area.  The skin under the skin that peeled off is very pink and delicate and I am scared of infection or a sunbrun.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Skin exfoliation
Clinical narrative: Two days after the vaccine shot the area where it was injected was very swollen and red and very hot to the touch.  I used ice and Benadryl cream per my physician since it had a bit of an itch to it.   It improved over the next week, however, my skin became brown in color and seemed dry.  By the 8th day, the brown area started to peel.  It is like I have a bad sunburn in that one area.  The skin under the skin that peeled off is very pink and delicate and I am scared of infection or a sunbrun.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE EXPIRED 4/2/2022
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: VACCINE EXPIRED 4/2/2022
Age: 72.0
Sex: F
Vaccine: TD
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Patient experienced SIRVA after receiving a dose of Tenivac which was later confirmed/diagnosed by a provider.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: Tested positive with Covid and was given Paxlovid on May 19. Had runny nose and developed a fever and chills. Started taking Paxlovid, it relieved the symptoms in 1 day. 2nd day was only extremely tired and felt a lot better, continued the medication until all taken.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive with Covid and was given Paxlovid on May 19. Had runny nose and developed a fever and chills. Started taking Paxlovid, it relieved the symptoms in 1 day. 2nd day was only extremely tired and felt a lot better, continued the medication until all taken.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthenopia, Decreased appetite, Fatigue, SARS-CoV-2 antibody test negative
Clinical narrative: Slept day and night 5 days after vaccination.  Extreme fatigue & weakness still. No appetite for 3 weeks, lost 5 pounds. Eyes very tired - blurry vision.  No arm pain.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vision blurred, Weight decreased
Clinical narrative: Slept day and night 5 days after vaccination.  Extreme fatigue & weakness still. No appetite for 3 weeks, lost 5 pounds. Eyes very tired - blurry vision.  No arm pain.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4, MMR
Symptoms: Headache, Influenza A virus test positive, Myalgia, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: HEADACHE, SYNCOPE, SORE THROAT, AND MUSCLE ACHES.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4, MMR
Symptoms: Streptococcus test positive, Syncope
Clinical narrative: HEADACHE, SYNCOPE, SORE THROAT, AND MUSCLE ACHES.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Micrographic skin surgery, Oropharyngeal pain
Clinical narrative: Breakthrough Case: I started to have a cough and a sore throat. I thought it was allergies. The next morning I had much more coughing which was continuous and painful. 05/09/2022 I decided to go to see my doctor and test for COVID-19 because I need to go out of town and my test came back positive. I was started on PAXLOVID. I started to feel better over the next few days. I did still have a cough and I was experiencing a funny taste in my mouth. A week later I tested for COVID-19 again and it came back negative. After about 3-4 days the symptoms returned. The cough had subsided. I did have a MOHS surgery which went well. I did experience fatigue and the cough came back more. On 05/21/2022 I took another COVID-19 test and it came back positive. I talked to my doctor and was told I could take cough medicine.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Taste disorder, Vaccine breakthrough infection
Clinical narrative: Breakthrough Case: I started to have a cough and a sore throat. I thought it was allergies. The next morning I had much more coughing which was continuous and painful. 05/09/2022 I decided to go to see my doctor and test for COVID-19 because I need to go out of town and my test came back positive. I was started on PAXLOVID. I started to feel better over the next few days. I did still have a cough and I was experiencing a funny taste in my mouth. A week later I tested for COVID-19 again and it came back negative. After about 3-4 days the symptoms returned. The cough had subsided. I did have a MOHS surgery which went well. I did experience fatigue and the cough came back more. On 05/21/2022 I took another COVID-19 test and it came back positive. I talked to my doctor and was told I could take cough medicine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was 14 when given a Moderna vaccine. The recommendation is 18 and older. Patient did not have any reaction to the vaccine
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: pt got a 2nd booster (4th dose), two days after administration she got red blotchiness and itchniess on her leg.  She is managing symptoms with zyrtec and topical corticosteroids.  she will follow up with physician if it gets worse.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Patient developed a rash 10 days after the HPV vaccine.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT RECEIVED VACCINE THAT'S EXPIRED - NO ADVERSE EFFECTS REPORTED
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: On May 17, 2022 I had a headache and I thought that it was allergies as it I do take Zyrtec. On May 19, 2022 I took a home COVID-19 test that came back positive and called my doctor he prescribed my Paxlovid. On May 22, 2022 I went to the pharmacy and took another test. For me it felt more like a sinus cold and I was really, really tired.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a Moderna Vaccine by mistake. Patient was 17 years old
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE THAT'S EXPIRED
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Scratch, Syringe issue, Vaccination error
Clinical narrative: When completing vaccine administration, needle scratched the child's skin and cut them due to child moving. Scratch is approximately 20-25mm in length but intermittent.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Blood test normal, Deafness unilateral, Dyspnoea, Ear discomfort
Clinical narrative: Adverse events:  three-day headache, palpitations and shortness of breath requiring visit to urgent care one week after vax.  Administered check for thrombocytopenai/blood test and came back negative.  Main problem:  tinnitus.  Onset four or five hours after shot in left arm.  Significant ear pain in left ear (sharp/stabbing).   Lasted several minutes/intermittent for about an hour.  This symptom segued into a feeling like hearing underwater in both left and a few hours later, my right ear.  A feeling of fullness and intermittent water-in-the-ear.  I did not connect either to the vaccine.  The next day or so these symptoms resolved, but I was left with a high pitched ringing sound in my left ear which lasted several minutes and continued intermittently for minutes at a time over the next days and weeks.  Over the next few months, the ringing increased in occurrence and began in the right ear a few weeks later as well.  A year later, I have permanent ringing in my right ear (low level constant sound) and intermittent ringing in left.  Right ear will increase in pitch and is significantly distracting, including causing sleep deprivation.  Because of COVID, I couldn't get in to get a hearing test and received one on 5/16/2022, audiometry, comprehensive, tympanometry testing.  I have mild hearing loss in my right ear and a sustained, constant mid-level hum/ringing.  Waiting for further medical help with the condition.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Hypoacusis, Laboratory test, Palpitations
Clinical narrative: Adverse events:  three-day headache, palpitations and shortness of breath requiring visit to urgent care one week after vax.  Administered check for thrombocytopenai/blood test and came back negative.  Main problem:  tinnitus.  Onset four or five hours after shot in left arm.  Significant ear pain in left ear (sharp/stabbing).   Lasted several minutes/intermittent for about an hour.  This symptom segued into a feeling like hearing underwater in both left and a few hours later, my right ear.  A feeling of fullness and intermittent water-in-the-ear.  I did not connect either to the vaccine.  The next day or so these symptoms resolved, but I was left with a high pitched ringing sound in my left ear which lasted several minutes and continued intermittently for minutes at a time over the next days and weeks.  Over the next few months, the ringing increased in occurrence and began in the right ear a few weeks later as well.  A year later, I have permanent ringing in my right ear (low level constant sound) and intermittent ringing in left.  Right ear will increase in pitch and is significantly distracting, including causing sleep deprivation.  Because of COVID, I couldn't get in to get a hearing test and received one on 5/16/2022, audiometry, comprehensive, tympanometry testing.  I have mild hearing loss in my right ear and a sustained, constant mid-level hum/ringing.  Waiting for further medical help with the condition.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep deficit, Tinnitus, Tympanometry
Clinical narrative: Adverse events:  three-day headache, palpitations and shortness of breath requiring visit to urgent care one week after vax.  Administered check for thrombocytopenai/blood test and came back negative.  Main problem:  tinnitus.  Onset four or five hours after shot in left arm.  Significant ear pain in left ear (sharp/stabbing).   Lasted several minutes/intermittent for about an hour.  This symptom segued into a feeling like hearing underwater in both left and a few hours later, my right ear.  A feeling of fullness and intermittent water-in-the-ear.  I did not connect either to the vaccine.  The next day or so these symptoms resolved, but I was left with a high pitched ringing sound in my left ear which lasted several minutes and continued intermittently for minutes at a time over the next days and weeks.  Over the next few months, the ringing increased in occurrence and began in the right ear a few weeks later as well.  A year later, I have permanent ringing in my right ear (low level constant sound) and intermittent ringing in left.  Right ear will increase in pitch and is significantly distracting, including causing sleep deprivation.  Because of COVID, I couldn't get in to get a hearing test and received one on 5/16/2022, audiometry, comprehensive, tympanometry testing.  I have mild hearing loss in my right ear and a sustained, constant mid-level hum/ringing.  Waiting for further medical help with the condition.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Pruritus, Rash, Rash papular
Clinical narrative: Developed redness & induration around the injection site a few hours after vaccine administration.  Then the following days developed hives on neck, face,  and itchy, papular eruption on anterior torso,  groin, inner thighs.  Notified clinic on 5/ 24 when there was more progression of the rash. cetirizine and diphenhydramine  given orally.  Triamcinolone 0.1% topical
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed redness & induration around the injection site a few hours after vaccine administration.  Then the following days developed hives on neck, face,  and itchy, papular eruption on anterior torso,  groin, inner thighs.  Notified clinic on 5/ 24 when there was more progression of the rash. cetirizine and diphenhydramine  given orally.  Triamcinolone 0.1% topical
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/03/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/03/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: PATIENT CALLED COMPLAINED OF SORENESS IN RIGHT ARM.  SHE COMPLAINED THAT IS MORE SORE WITH MOVEMENT.  PATIENT THINKS THAT A NERVE WAS POSSIBLY HIT
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/03/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Haematoma
Clinical narrative: SMALL HEMATOMA DEVELOPED AFTER INJECTION
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/05/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/06/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy colon abnormal, Blood test, Colitis ulcerative, Colonoscopy, Diarrhoea haemorrhagic
Clinical narrative: 3 weeks after 2nd dose of vaccine, he was hospitalized for bloody diarrhea.  5 days later was diagnosed with Ulcerative colitis.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endoscopy, Gastrointestinal pathogen panel, Haemoglobin decreased, Stool analysis, Transfusion
Clinical narrative: 3 weeks after 2nd dose of vaccine, he was hospitalized for bloody diarrhea.  5 days later was diagnosed with Ulcerative colitis.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient was given the vaccine on the 21st day and not the 28th day.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pruritus
Clinical narrative: Patient presented to the pharmacy to get her first COVID 19 vaccine. After pharmacy technician administered the vaccine the patient waited for 15 minutes outside the pharmacy. After the 15 minutes we asked her how she was feeling and she said that she felt her tongue was a little numb and she felt a little itchy. Pharmacist asked her to sit down for observation for another 15 minutes to make sure symptoms did not progress and the patient waited another 15 minutes, the pharmacy provided patient with a bottle of water. Patient said she was feeling better after the 30 minutes she seemed physically fine. No signs of hives or difficulty breathing or anything related to anaphylaxis. Patient went home after feeling better.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Hearing aid therapy, Hyperacusis, Hypoacusis, Sleep disorder
Clinical narrative: Tinnitus, Moderate to Severe: affecting sleep, ability to hear voices of family and coworkers, other sounds were loud and abrasive. Treatment: Hearing Aids with a tinnitus program, ongoing Outcome: After 9 months of treatment, the tinnitus is decreased, but not gone.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, Moderate to Severe: affecting sleep, ability to hear voices of family and coworkers, other sounds were loud and abrasive. Treatment: Hearing Aids with a tinnitus program, ongoing Outcome: After 9 months of treatment, the tinnitus is decreased, but not gone.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram head normal, Headache, Immediate post-injection reaction
Clinical narrative: Had severe headache immediately after booster, then a series of severe headaches lasting for over a week a few weeks later.  Suddenly developed ongoing pain in knees, beginning about a month after the booster.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the stability guidelines from Pfizer and the CDC.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lymph node pain, Lymphadenopathy, Mammogram abnormal, Positron emission tomogram abnormal
Clinical narrative: Ever since my second Pfizer Covid Vaccine on 1/7/21, my lymph nodes under my arms, sides and above my left breast have been enlarged and sore.  When I had my 1st booster in November 2021, The soreness and swelling that was doing a little better started up again.   My last 2 mammograms showed the enlargements of the lymph nodes.  This past March after my mammogram, I was referred for an ultrasound which resulted in being referred to oncology whereby they ordered a PET Scan which showed the uptick of the nodes.  All tests could not determine the reason for the enlarged nodes so need to repeat the Ultrasound in Nov 2022.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound breast abnormal
Clinical narrative: Ever since my second Pfizer Covid Vaccine on 1/7/21, my lymph nodes under my arms, sides and above my left breast have been enlarged and sore.  When I had my 1st booster in November 2021, The soreness and swelling that was doing a little better started up again.   My last 2 mammograms showed the enlargements of the lymph nodes.  This past March after my mammogram, I was referred for an ultrasound which resulted in being referred to oncology whereby they ordered a PET Scan which showed the uptick of the nodes.  All tests could not determine the reason for the enlarged nodes so need to repeat the Ultrasound in Nov 2022.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID a month after getting my 4th dose of Pfizer.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt scheduled for 2nd Booster (4th in series) Moderna given instead of Pfizer
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Throat tightness
Clinical narrative: airway restriction, light headed, naseaus
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Cognitive disorder, Feeling abnormal, Laboratory test, Respiratory rate
Clinical narrative: LONG TIME COGNITIVE PROBLEMS; LOTS OF COMPLICATIONS SINCE VACCINATED; DIFFICULTY BAGGING GROCERIES/NOT HIMSELF; This spontaneous report received from a patient via a company representative concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included: suspected covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced long time cognitive problems, lots of complications since vaccinated, and difficulty bagging groceries/not himself. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the long time cognitive problems, lots of complications since vaccinated and difficulty bagging groceries/not himself was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: LONG TIME COGNITIVE PROBLEMS; LOTS OF COMPLICATIONS SINCE VACCINATED; DIFFICULTY BAGGING GROCERIES/NOT HIMSELF; This spontaneous report received from a patient via a company representative concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included: suspected covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced long time cognitive problems, lots of complications since vaccinated, and difficulty bagging groceries/not himself. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the long time cognitive problems, lots of complications since vaccinated and difficulty bagging groceries/not himself was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Cognitive disorder, Mobility decreased
Clinical narrative: LONG TIME COGNITIVE PROBLEMS; LOTS OF COMPLICATIONS SINCE VACCINATED; DIFFICULTY BAGGING GROCERIES/NOT HIMSELF; This spontaneous report received from a patient via a company representative concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included: suspected covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced long time cognitive problems, lots of complications since vaccinated, and difficulty bagging groceries/not himself. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the long time cognitive problems, lots of complications since vaccinated and difficulty bagging groceries/not himself was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Dyspnoea, Echocardiogram normal, Fibrin D dimer, Gene mutation identification test
Clinical narrative: Increased shortness of breath and subsequent hospitalization with pulmonary embolism.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Increased shortness of breath and subsequent hospitalization with pulmonary embolism.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Stiff leg syndrome
Clinical narrative: Stiffness and severe pain in my legs; Stiffness and severe pain in my legs; Problems getting up from a sitting position because of my legs being so weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 at 14:30 as dose 3 (booster), single (Lot number: EW0182) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Iodine dyes" (unspecified if ongoing), notes: known allergies: Iodine dyes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL9263, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 11Feb2021, when the patient was 80-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left, Vaccine Administration Time: 11:45 AM), administration date: 21Jan2021, when the patient was 80-year-old, for Covid-19 Immunization. The following information was reported: STIFF LEG SYNDROME (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "Stiffness and severe pain in my legs"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Problems getting up from a sitting position because of my legs being so weak". Therapeutic measures were taken as a result of stiff leg syndrome, pain in extremity, muscular weakness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Only had problems with the booster. Reported Event was Stiffness and severe pain in my legs. Problems getting up from a sitting position because of my legs being so weak. Treatment received for the adverse event: shot in spine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.