chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: <5 min post dose patient noted feeling short of breath, numbness, dizzy, sweaty, shaky and then lost consiousness. I was able to catch her head so she didnt hit a hard surface. Patient was unresponsive for 10 seconds. She started to seize and her eyes rolled to the back of her head. After she regained consciousness she was moved into the pharmacy and laid down. Pt was given a cool towel and water.1st BP (112/70 & HR74), 2nd BP 15min later (110/70 & HR 84). After 45 min pt left with family member
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac murmur, Death, Pneumonia, Weight decreased
Clinical narrative: death Pneumonia heart murmur weight loss
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling jittery, Insomnia
Clinical narrative: is having difficulty sleeping at night due to being jittery; being jittery; he is feeling a lot of fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 29th May 2021, the patient received the 1st dose of Shingrix. On 29th May 2021, less than a day after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced difficulty sleeping and jitteriness. On an unknown date, the outcome of the fatigue, difficulty sleeping and jitteriness were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, difficulty sleeping and jitteriness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had taken first COVID 19 shot two months ago. The patient received first dose of Shingrix three days ago felt lot of fatigue on same day and also had difficulty in sleeping at night due to being jittery. The reporter did not consented to follow up. This case has been linked with case US2021117068 by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117064:same reporter
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Large red rash around injection site. Heating pad and ice used to help but no effect on rash.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Thrombosis
Clinical narrative: I have an extremely heavy period now, I woke up and there was a huge blood clot in my underwear and I literally gushed blood I?ve never seen that in all my 27 years of living and I?m afraid of what the next few days of my period will be like.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: 45 minutes after patient recieved the vaccine , she came back complaining aboout generalized mild to mederate rash and redness specially in the upper extremeties. advised patient that a call to 911 will be required and possible emergency visit. patient approved , i called 911 and while on the phone briefing the operator i was advised not to give the paient any medications or food or drinks and the emt will be on the way now
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Ophthalmic herpes zoster, Pruritus, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Suspected vaccination failure in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included shingles (since February 2020 in head). In October 2020, the patient received the 2nd dose of Shingrix. In August 2020, the patient received the 1st dose of Shingrix. In August 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced off label use. In October 2020, the patient experienced off label use. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), exacerbation of disease and pruritus. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, exacerbation of disease, pruritus, off label use and off label use were unknown. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, exacerbation of disease and pruritus to be related to Shingrix and Shingrix. Additional details were reported as follows: The age at vaccination was not reported however it could be 87 or 88. The patient had active episode of Shingles and vaccinated with Shingrix shot which led to Off label use. Since getting the 2nd shot, the patient stated the shingles as worsened and was affecting her right eye. The patient also had shingles on the left side of her face. The patient had a lot of itching in her eye brow. This case was considered as suspected vaccination  laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Pneumonia
Clinical narrative: death J18.9 - Pneumonia, unspecified organism
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on July 19th, 2018/ has not received the second dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th July 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccinations. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Nausea, Pyrexia
Clinical narrative: HAD PHIZER VACCINE:  HEADACHES,  CHILLS,  HOT FLASHES,  NAUSEA, SLIGHT TEMPERATURE.  STARTED AT 6:00PM DAY OF VACCINE AND TODAY IS FRIDAY THE 4TH AND I STLL HAVE HEADACHE
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypotension, Pyrexia
Clinical narrative: High fever of 103.4 Had heat flashes blood pressure low 90's but was in 120 when doctor took it took Ibprofen took a ice bath next day fever was 100 , then in the next few hours i was fine.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb
Clinical narrative: swelling/of the injected arm/ 'considerable'/ arm swollen up to 20 inches; redness/of the injected arm; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb and erythema of extremities were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The case was reported by family nurse practitioner. The age at vaccination was not reported. The reporter did not have full demographic details to provide. The patient experienced redness and swelling of the injected arm the next day after the dose of Shingrix. The swelling was described as 'considerable' with the arm swollen up to 20 inches. The reporter did not have lot number or expiration date details of Shingrix. No resolution date was provided. The reporter consented to follow up via email.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Cardiac function test normal, Headache, Hypertension, Renal function test normal
Clinical narrative: I got the shot and that afternoon I had a really bad headache , it continued until that sunday and I could get out of bed. My husband asked me to check my blood pressure and it was really high. I saw a PP at work and she put me on med and the dose kept jumping until I was taking it 4 times a day. When I went to the doctor they switch the med for my blood pressure it seems to be helping but every once in a while it dose spike. I have had no change in my diet so the only thing that we can think is that it had something to do with the vaccine. I was recommend to not get the 2nd dose.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Neck pain, Pain, Pain in extremity
Clinical narrative: On Sun., 4/11/21 I awoke with sharp, burning needle-like pain in EVERY joint on my RIGHT SIDE ONLY from my toes all the way to the right side of my neck (including toes, ankle, knee, hip, shoulder, elbow, wrist, ENTIRE right hand). Pain was only on the RIGHT side of my body. Very odd.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Malaise, Paraesthesia, Vomiting
Clinical narrative: It was the patients first COVID-19 Pfizer vaccine dose and he was sitting in the waiting room after his vaccination and came to get me to tell me that he did not feel well. He was sweating and then proceeded to vomit. We had him sit in the other exam room and gave him some water. After that he started saying his arms were tingling and going numb, when that happened I discussed with him calling EMS and instructed the PCT to call EMS. When EMS came the pt said he was feeling better and signed a refusal to go with them to the ER. The pt had a friend who was in the store with him that was going to drive him home. He was able to sit for about 30  minuets when he stated that he was feeling better and was wanting to go home. PCT walked him to the car. He was instructed that if at any time he started having symptoms again that he needed to go to the ER.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of the vaccine on November 15th, 2019 / not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 15th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received had not yet received the second dose of Shingrix, which led to incomplete course of vaccination. No further events were reported. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death, Pneumonia
Clinical narrative: death I46.9 Cardiac Arrest J18.9 - Multifocal pneumonia
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate decreased
Clinical narrative: After my second day of receiving my J&J vaccine, I felt very tired. On the 3rd and 4th day, I went to see my PCP and went for a  routine check up where I was found to have a low heart rate. My heart rate had dropped to 34. I went to the ER due to my low heart rate and not because of the J&J vaccine. Also due to my anorexia condition, I could not sleep, drink fluids and also had diarrhea.  To this day I still have low heart rate.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant ringing in one ear. It has not gone away nor improved.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Chills, Myalgia, Pain
Clinical narrative: I woke up with the chills, every bone hurt, and every muscle aches for 24 hours. I stayed in bed!
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS ADMINISTERED A COVID MODERNA VACCINE 5 DAYS BEFORE THEY TURNED 18
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Nausea, Ocular hyperaemia
Clinical narrative: SUDDEN ELEVATION OF TEMPERATURE= 102, NAUSEA, BLOOD SHOT EYES, GENERALIZED JOINT PAIN. TOOK TYLENOL/ASPIRIN. LESSENED THE EFFECTS.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Death
Clinical narrative: death - Non-ST elevation (NSTEMI) myocardial infarction
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vocal cord paralysis, Vocal cord paresis
Clinical narrative: Vocal paresis / paralysis after J&J COVID Vaccine
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: COIN STICK TO HER ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown expiry date: UNKNOWN) dose was not reported, therapy dates were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced coin stick to her arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of coin stick to her arm was not reported. This report was non-serious..
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dissociation, Nausea
Clinical narrative: She began to feel nauseated and "distant", which she describes as being somewhat separated from her surroundings.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Dumbness and tingling in arm, hand and fingers of arm in which shot was administered.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient was brought to the mass vaccination clinic by their father for their initial dose of Pfizer vaccine on 5/12/21. Father went to the website and rescheduled the boys' second dose appointment due to location convenience. The patient presented on 5/27/21 for a second Pfizer vaccination, dose spacing was only 15 days apart instead of the minimum recommended of 18 days separation between doses. The registered nurse called and spoke with the patient's father, discussed the concern. The patient's father reports child has not experienced any adverse reaction and is aware that VAERS is being completed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pyrexia, Tachypnoea
Clinical narrative: Fever, hypotension, tachypnea
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Lip swelling, Pharyngeal swelling
Clinical narrative: swollen eyes, swollen lips, headache, swollen throat
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash, Rash erythematous, Rash papular
Clinical narrative: Four days after my second injection I developed,  at first on my right wrist to forearm,  a serious of blisters (which appeared to look like shingles) as well as bumps (mosquitoe bite size) on my head,  ring finger, and face.  Within three days thereafter the rash spread to my chest, abdomen,  left ankle, left wrist, and buttocks.  The size of those rashes varied from a few millimeters to over 100 millimeters.  Most were raised, and were discolored red.  Not all were itchy.   By happenstance my annual dermatology visit was scheduled two days after the first reaction.   My dermatologist PA looked at the site and told me she had seen  numerous patients who had reactions to the Moderna vaccine, including two of the staff.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient and brother were brought to the mass vaccination clinic by their father, for his initial dose of Pfizer vaccine on 5/12/21. Father went to the medical website and rescheduled the boys' second dose appointment due to location convenience. The boys presented on 5/27/21 for a second Pfizer vaccination, dose spacing was only 15 days apart instead of the minimum recommended of 18 days separation between doses. RN called and spoke with father, discussed the concern. Father reports neither child has experienced any adverse reaction and is aware that VAERS is being completed.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid ptosis, Headache, Hypertension, Hypoaesthesia
Clinical narrative: Patient presented symptoms of high blood pressure three days after receiving the vaccine (05/31/21). Seven days later, the wife tells the pharmacy that she has a headache in the left back, has a droopy eyelid on the left side and numbness in the left area of ??the face. He was advised to visit his doctor, and his wife indicated that the patient was going to go that same day (04/06/2021).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: With a second Vaccine I took Zyrtec that morning. 1AM I had low grade fever and chills, in a morning woke up feeling okay and  forgot to take zyrtec. the third day after vaccine I develop rash on my neck, my arm was swollen ad I started to feel nauseous.  Nausea lasted for 10 days after the shot. The first few days were the worst I couldn't get up from bed it felt like I would faint if standing.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: With a second Vaccine I took Zyrtec that morning. 1AM I had low grade fever and chills, in a morning woke up feeling okay and  forgot to take zyrtec. the third day after vaccine I develop rash on my neck, my arm was swollen ad I started to feel nauseous.  Nausea lasted for 10 days after the shot. The first few days were the worst I couldn't get up from bed it felt like I would faint if standing.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Dyspnoea, Headache
Clinical narrative: Headache, stomachache, tightness in chest, shortness of breath, onset at ~2:30am, approx. 14.5 hrs after first shot.  Headache lasted approx. 3 hours. At time of this report, the stomachache, chest tightness, and shortness of breath are continuing.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast disorder, Breast tenderness, Drooling, Facial paralysis
Clinical narrative: I woke up at 6 am with numbness in my left arm and hands, I went to work and it kept progressing, I took Claritin, drove home and slept for 2 days, I was totally out of it, I only got up to go to the bathroom or drink something. I was good for 24 hours then I was so fatigued slept 2 more days, I woke on the 18th I was numb, I woke up drooling, my whole left side was numb I had some drooping in my face and my boob. I did a tele med visit that morning , My doctor started me on a prednisone pack, Lymph nodes and my breast for very tender on left side. I went to see neurologist bc symptoms were not getting better and I was extremely fatigued, which is not me, I also have sever hip pain, that I never have had before. The neurologist diagnosed me Sensory deficit disorder on the left side of my body.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Hypoaesthesia, Lymph node pain, Mammogram
Clinical narrative: I woke up at 6 am with numbness in my left arm and hands, I went to work and it kept progressing, I took Claritin, drove home and slept for 2 days, I was totally out of it, I only got up to go to the bathroom or drink something. I was good for 24 hours then I was so fatigued slept 2 more days, I woke on the 18th I was numb, I woke up drooling, my whole left side was numb I had some drooping in my face and my boob. I did a tele med visit that morning , My doctor started me on a prednisone pack, Lymph nodes and my breast for very tender on left side. I went to see neurologist bc symptoms were not getting better and I was extremely fatigued, which is not me, I also have sever hip pain, that I never have had before. The neurologist diagnosed me Sensory deficit disorder on the left side of my body.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: I woke up at 6 am with numbness in my left arm and hands, I went to work and it kept progressing, I took Claritin, drove home and slept for 2 days, I was totally out of it, I only got up to go to the bathroom or drink something. I was good for 24 hours then I was so fatigued slept 2 more days, I woke on the 18th I was numb, I woke up drooling, my whole left side was numb I had some drooping in my face and my boob. I did a tele med visit that morning , My doctor started me on a prednisone pack, Lymph nodes and my breast for very tender on left side. I went to see neurologist bc symptoms were not getting better and I was extremely fatigued, which is not me, I also have sever hip pain, that I never have had before. The neurologist diagnosed me Sensory deficit disorder on the left side of my body.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Rash pruritic
Clinical narrative: Unspecified lot, unspecified route  Patient had MD visit 6/3/21  Complaining of an itchy rash on his back and abdomen, started a few days after getting the second dose of Covid vaccine; Assessment/Plan Skin rash, most probably an allergic reaction to Covid vaccine, start Zyrtec, avoid heat and start prednisone 40 mg for 4 days then 20 mg, follow-up if no improvement
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Muscle contractions involuntary, Paraesthesia
Clinical narrative: Approximately 4 weeks after receiving the second dose of Moderna COVID-19 vaccine, patient experienced tingling and loss of muscle control on one side of his face.  He presented to Emergency department and was diagnosed with Bells Palsy.  The ED was not concerned that he had received the vaccine 4 weeks earlier and dismissed it as a coincidence.     Family and I decided it would be a good idea to report here just in case there is a pattern with other people.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pityriasis rosea, Pruritus, Rash, Swelling
Clinical narrative: Sx began April 29th, started with one site of a Harold patch, raised area with a white center, spread with rings and itchy bumps. Stated both shots were on her left side, and the patches are the frontal trunk of her body. Visited Dr. on May 12th, diagnosed with pityriasis rosea,  ongoing issue.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: AE: patient experienced blurred vision and ringing in the ears Treatment: No medical treatment were given. Patient was observed for 15 minutes. Outcome: Patient was discharged home with the help of mother.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling abnormal, Headache, Malaise
Clinical narrative: At 5:00a.m. I woke up feeling awful, bad headache and feeling like I was hit by a truck.  By 8:30 I was trying to grab my phone by my night stand to call my kids (who were in the house to get me Ibuprofen).  I could barely talk and I asked them to get me water and Ibuprofen.  I started to get a fever of 103.2.  Then I had the chills so bad.   My head still hurt, I had no appetite, I could not stay awake.  I was in bed for 34 hours.  I kept with the Ibuprofen to try to help.  The next day I developed a rash on my check and stomach.   I have never had a rash before, I am guessing this was a fever rash.  I honestly can say that I don't think I have ever been so sick in my life.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Somnolence
Clinical narrative: At 5:00a.m. I woke up feeling awful, bad headache and feeling like I was hit by a truck.  By 8:30 I was trying to grab my phone by my night stand to call my kids (who were in the house to get me Ibuprofen).  I could barely talk and I asked them to get me water and Ibuprofen.  I started to get a fever of 103.2.  Then I had the chills so bad.   My head still hurt, I had no appetite, I could not stay awake.  I was in bed for 34 hours.  I kept with the Ibuprofen to try to help.  The next day I developed a rash on my check and stomach.   I have never had a rash before, I am guessing this was a fever rash.  I honestly can say that I don't think I have ever been so sick in my life.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was brought by her father to a mass vaccination clinic on 5/13/21. At this time, patient was 13 years old. Father requested that patient receive Moderna, volunteer vaccinator gave Moderna vaccine. Patient's mother, brought her to the second dose appointment. Confirmed that father requested Moderna and that is the product that patient received. Discussed error with RN, vaccine coordinator. Plan to complete Moderna series, appointment for second dose rescheduled for next week for appropriate dose spacing. Mother and patient both deny any reaction or ill effects related to receiving Moderna vaccine. Mother is aware that error will be reported to VAERS.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain
Clinical narrative: Headache, dizziness, fatigue, soreness
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Some blurred vision with objects far away about 15-30 minutes after the shit. Then I felt fine for about 12 hours after the shot (1st moderna shot on 1/21/21, 2nd moderna shot on 06/02/21). About 9:00 pm I had soreness in my arm and body aches. By 2 am on 6/3, the body aches were extreme, along with chills, and a low fever 99-100. The headache that followed lasted hours and was terrible. I had not been sick, or felt sick, in more than a year, and experienced only a sore arm with the first shot. The after affects from the second shot were terrible and I am afraid and anxious. I hope I don't die.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Some blurred vision with objects far away about 15-30 minutes after the shit. Then I felt fine for about 12 hours after the shot (1st moderna shot on 1/21/21, 2nd moderna shot on 06/02/21). About 9:00 pm I had soreness in my arm and body aches. By 2 am on 6/3, the body aches were extreme, along with chills, and a low fever 99-100. The headache that followed lasted hours and was terrible. I had not been sick, or felt sick, in more than a year, and experienced only a sore arm with the first shot. The after affects from the second shot were terrible and I am afraid and anxious. I hope I don't die.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: Typical injection site pain and mild swelling in right arm on day of injection.  Also reported pain at site of COVID 19 (Johnson & Johnson) vaccine administered on 3/16/21 in left arm and severe hip pain.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Had vaccine on December 31, 2020.  Itchiness and rash began on January 2, 2021 and lasted the entire month.  Tried using Benadryl, but it didn't stop the itchiness.  Had Virtual Urgent Care visit on January 19, 2021.  Was prescribed famotidine, hydroxyzine, and triamcinolone.  This stopped the itchiness.  The rash disappeared.  I stopped taking the meds after two weeks, but the rash/itchiness returned after two days.  So I resumed the medication until the end of January when the pills ran out.  The rash/itchiness did not reappear.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gingival pain, Haematochezia, Oral pain
Clinical narrative: This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriatic arthritis. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported at 1 total frequency, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1133817 expiry: UNKNOWN) dose was not reported, 1 time every 1 total, therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced bloody stool and diarrhea. On an unspecified date, the subject experienced sore mouth, and sore gums. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable and for adalimumab was not reported. The outcome of the bloody stool, diarrhea, sore mouth and sore gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210601168-COVID-19 VACCINE AD26.COV2.S- Bloody Stool. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: Vaccine Administration Error
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: patient reported heart palpitations beginning approximately 48 hours after vaccine administration which lasted about 24 hours.  Reported HR 138bpm at one point.  Did not seek medical attention.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Pericarditis
Clinical narrative: Onset of pericarditis 6 days after 2nd Pfizer vaccine - with CRP elevation and EKG changes.  Symptomatically resolving after 1 week of treatment with ibuprofen.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PATIENT DID NOT HAVE AN ADVERSE EVENT.  Simply filling out form to document patient had asked for Moderna but was given Janssen in error.  Patient was notified of error. Patient was understanding of error and verbalized that it did not matter much to him which COVID vaccination he received.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Chest pain, Dizziness, Headache
Clinical narrative: FEET HURTING; FEELS SO WEAK; HURTING HEAD; HEART HURTING; CHEST HURTING; FEET SWOLLEN; DIZZY; This spontaneous report received from a patient concerned a female of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included STD (sexually transmitted disease), and non-alcoholic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805021, and expiry: UNKNOWN) dose was not reported, administered frequency one total on 26-MAY-2021 11:48 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 31-MAY-2021 (also stated as 2 days ago) patient reported chest was hurting, heart was hurting, feet swollen, head hurts, and feels weak. On an unspecified date the patient experienced feet hurting. It was also mentioned that the patient was currently still experiencing these side effects (dates unspecified). It was stated that the patient took a heart pill. Patient was unable to identify what kind of heart pill she was taking. On an unspecified date in 2021, the patient experienced dizzy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest hurting, heart hurting, feet swollen, hurting head, and feels so weak, and the outcome of dizzy, and feet hurting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: -covid-19 vaccine ad26.cov2.s -heart hurting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: FEET HURTING; FEELS SO WEAK; HURTING HEAD; HEART HURTING; CHEST HURTING; FEET SWOLLEN; DIZZY; This spontaneous report received from a patient concerned a female of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included STD (sexually transmitted disease), and non-alcoholic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805021, and expiry: UNKNOWN) dose was not reported, administered frequency one total on 26-MAY-2021 11:48 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 31-MAY-2021 (also stated as 2 days ago) patient reported chest was hurting, heart was hurting, feet swollen, head hurts, and feels weak. On an unspecified date the patient experienced feet hurting. It was also mentioned that the patient was currently still experiencing these side effects (dates unspecified). It was stated that the patient took a heart pill. Patient was unable to identify what kind of heart pill she was taking. On an unspecified date in 2021, the patient experienced dizzy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest hurting, heart hurting, feet swollen, hurting head, and feels so weak, and the outcome of dizzy, and feet hurting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: -covid-19 vaccine ad26.cov2.s -heart hurting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Brain compression, Brain oedema, Computerised tomogram abnormal, Endotracheal intubation, Intensive care
Clinical narrative: became unresponsive, intubated in the field with CT images revealing a diffuse SAH, IVH, cerebral edema, brain compression, possible aspiration pneumonia o Admit to NICU s/o Doctor o Consult Doctor for CC o Neuro checks q1h o SBP < 110 o Mannitol 50g IV x1 stat than 3% HTS for NA goal 145-155 o EVD placement ASAP o Amicar 5g stat o COVID PCR negative o Labs/ medications as ordered o SAH protocol o Plan for cerebral angiogram and possible coiling in am with Doctor.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Intraventricular haemorrhage, Laboratory test, SARS-CoV-2 test negative, Subarachnoid haemorrhage, Unresponsive to stimuli
Clinical narrative: became unresponsive, intubated in the field with CT images revealing a diffuse SAH, IVH, cerebral edema, brain compression, possible aspiration pneumonia o Admit to NICU s/o Doctor o Consult Doctor for CC o Neuro checks q1h o SBP < 110 o Mannitol 50g IV x1 stat than 3% HTS for NA goal 145-155 o EVD placement ASAP o Amicar 5g stat o COVID PCR negative o Labs/ medications as ordered o SAH protocol o Plan for cerebral angiogram and possible coiling in am with Doctor.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular drainage
Clinical narrative: became unresponsive, intubated in the field with CT images revealing a diffuse SAH, IVH, cerebral edema, brain compression, possible aspiration pneumonia o Admit to NICU s/o Doctor o Consult Doctor for CC o Neuro checks q1h o SBP < 110 o Mannitol 50g IV x1 stat than 3% HTS for NA goal 145-155 o EVD placement ASAP o Amicar 5g stat o COVID PCR negative o Labs/ medications as ordered o SAH protocol o Plan for cerebral angiogram and possible coiling in am with Doctor.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Bone pain, Headache, Pain, Pyrexia
Clinical narrative: Bone pain and internal organ pain. Severe pain in kidney and ovary areas. When the standard side effects went away (body aches, fever, headache, etc.) the internal organ pain is lingering around 2 days post 2nd covid vaccine shot.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Bone pain and internal organ pain. Severe pain in kidney and ovary areas. When the standard side effects went away (body aches, fever, headache, etc.) the internal organ pain is lingering around 2 days post 2nd covid vaccine shot.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vaccine Administration Error
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Moderna vaccine (approved for 18+) at age 16. No adverse reaction to the vaccine was observed.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chest pain, Pain
Clinical narrative: pinpoint pain mid chest for 1 day, body aches the next day for about 8 hours,   noticed hair loss within 2 days of the shot and still losing hair 2 months later  *note: retired and have had shots for many things over 20 year career--this is the first shot I've had this kind of reaction to.  Thought that was worth mentioning.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, chills, sore throat. Started around 1 am according to son. Parent notified at 0730 and Tylenol given and throat spray used
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Feeling hot, Hyperhidrosis
Clinical narrative: Aches in joints, then extremely cold, followed by extremely hot with severe body sweats starting around 9PM and lasting until 6AM.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain, Peripheral swelling, Vasculitis
Clinical narrative: HAND AND WRIST SWELLING; PAIN IN JOINTS; VASCULITIS; BODY ACHES; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A  and expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced vasculitis. On JUN-2021, the subject experienced pain in joints. On 02-JUN-2021, the subject experienced hand and wrist swelling. Treatment medications (dates unspecified) included: cefalexin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on MAY-2021, and had not recovered from vasculitis, hand and wrist swelling, and pain in joints. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Blood test, Computerised tomogram, Electrocardiogram, Endoscopy
Clinical narrative: HAND AND WRIST SWELLING; PAIN IN JOINTS; VASCULITIS; BODY ACHES; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A  and expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced vasculitis. On JUN-2021, the subject experienced pain in joints. On 02-JUN-2021, the subject experienced hand and wrist swelling. Treatment medications (dates unspecified) included: cefalexin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on MAY-2021, and had not recovered from vasculitis, hand and wrist swelling, and pain in joints. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Henoch-Schonlein purpura
Clinical narrative: HAND AND WRIST SWELLING; PAIN IN JOINTS; VASCULITIS; BODY ACHES; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A  and expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced vasculitis. On JUN-2021, the subject experienced pain in joints. On 02-JUN-2021, the subject experienced hand and wrist swelling. Treatment medications (dates unspecified) included: cefalexin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on MAY-2021, and had not recovered from vasculitis, hand and wrist swelling, and pain in joints. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vaccine Administration Error
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My Brother was found dead at home -  Not sure it's vaccine related - but  he did not have major or urgent health issues .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in right armpit - same side as shot was given.  Lasted about a week.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Heavy menstrual bleeding, Hysteroscopy abnormal, Ultrasound scan vagina, Uterine haemorrhage
Clinical narrative: I had a strong reaction to the second dose (fever over 101 after taking Ibuprophen that lasted 2 days).  Then I had abnormal uterine bleeding that prompted me to contact my doctor who ordered a pelvic ultrasound.  The ultrasound showed what looked like possibly a clot or a cyst in the uterus.  I then had a hysteroscope to further examine it and it was no longer there so it has been a clot that subsequently passed. Since then, my periods have returned to a normal timing pattern, but remain heavier than before.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vaccine Administration Error
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Bumps on elbow, knees, inner thighs. Overall itchiness.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 6/02/2021: 2 hives on my right eyelid. Took benadryl 25 mg  upon arriving home at 17:00 and 1000mg extra strength tylenol. Used warm compress. Took another benadryl 25 mg at 23:30. At that time itching was almost gone and 1 hive was gone the other was smaller. 6/03/2021: No benadryl taken. Warm compress applied twice during day.  6/04/2021: Remaining bleb still there but very small and just slightly itchy. No benadryl taken.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Hyperhidrosis, Scab, Urticaria
Clinical narrative: reaction on upper torso to sweat. Break out in hives from sweating  blister up and scabbing over lasting several days
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Disturbance in attention, Dizziness postural, Headache, Pain
Clinical narrative: Body aches Loss of mental clarity - extreme confusion lasting for the first 5 days Very extreme headaches lasting for 9 days, then recurring on Apr 27 for another 7 days Intolerance to heat or temperatures above 72F lasting 30 days Positional dizziness lasting 30 days
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Temperature intolerance
Clinical narrative: Body aches Loss of mental clarity - extreme confusion lasting for the first 5 days Very extreme headaches lasting for 9 days, then recurring on Apr 27 for another 7 days Intolerance to heat or temperatures above 72F lasting 30 days Positional dizziness lasting 30 days
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Left ear acute Tinnitus.  Right ear moderate.  Never had this before vaccine.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Palpitations, Pyrexia
Clinical narrative: Around 12 hours after my injection I began experiencing fever, chills, and heart palpitations. These symptoms lasted about 24 hours.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: A few hours after receiving my first dose of the vaccine, as I was going to sleep, my heart started beating very fast. It was hard getting to sleep as I could not seem to slow it down with breathing. As of this morning at 6:41am, it still feel as though it is beating abnormally fast.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Pain
Clinical narrative: Eye pain (left), fatigue, headache, body pain.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea, Dysgeusia, Headache
Clinical narrative: I experienced diarrhea and headaches on the third day. I also experienced cold sweats and I also had a bad taste in my mouth approximately 3 days.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Shivers, chills, nausea, joint aches, muscle aches, headache, sweating, muscle spasms, shaking - Lasting overnight. Exhaustion and some aching next day.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Tremor
Clinical narrative: Shivers, chills, nausea, joint aches, muscle aches, headache, sweating, muscle spasms, shaking - Lasting overnight. Exhaustion and some aching next day.