chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right wrist swollen and painful; Right wrist swollen and painful; Immediate itchy rash on lower left arm between wrist and elbow; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number BH9899), via an unspecified route of administration in the left arm on 17Dec2020 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), penicillin allergy, and contact dermatitis to multiple agents. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included: prednisone, leflunomide (ARAVA), hydroxychloroquine sulfate (PLAQUENIL), meloxicam, "and more" (as reported, unspecified), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 17Dec2020 at 10:30, the patient experienced immediate itchy rash on lower left arm between wrist and elbow. On day 2 post vaccine (19Dec2020), her right wrist was swollen and painful. The patient did not receive any treatment for the events. The clinical outcome of immediate itchy rash on lower left arm between wrist and elbow and right wrist swollen and painful was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Soreness at site, redness at site, rash on arm, fever on arm and at site, large lump on and rash on bicep muscle. All symptoms have occurred in 7 days.
death Narrative: 92 yo male seen in clinic on 12/30/2020 for transfusion, hbg 6.9. PMH includes HLD, CKD, myelodysplastic syndrome, DM, prostate cancer, HTN. Pt also received COVID19 Pfizer vaccine the same day. The patient denied any prior severereaction to this vaccine or its components. Post-transfusion, patient had a mechanical fall (per patient he was seated and used the cane to help him stand. However the cane slipped on the floor causing the patient to fall, patient hit his head and injured his right hip, no loss of consciousness at the time). Rapid response team was called and patient was admitted to the ED. Pt was found to have subcapital right femoral neck fracture, scalp contusion, and TBI (per ED provider's note). Ortho evaluated and said patient wasn't a surgical candidate. During his hospitalization, patient tested positive for COVID19 on 1/12/2021, pt was asymptomatic at the time. On 1/13/2021, pt exhibited mild URI symptoms, no respiratory distress. He was started on cetirizine, Montelukast, albuterol, and inhaled steroids to manage his symptoms. Dexamethasone was started on 1/14/2021. Chest Xray was ordered on 1/17/2021, pt's respiratory was slowly getting worse, resting O2 sats were in the high 80s and low 90s with IS. On 1/18/2021, CXR shows patchy bilateral airspace opacities suspious for pneumonia of bacterial or viral etiology. Pt was started on remdesivir 01/18/2021 (5 doses, from 1/18-1/22/2021). Pt required 5-6 LPM of oxygen at rest. Pt was then transferred to the ICU. His oxygen demand continued to increase and his condition worsened. On 2/14/2021, pt started to desat into the 70s on max high flow. Patient/family agree to comfort care. Medical cause of death was listed as "acute hypoxic respiratory failure due to COVID19." Patient expired 1/24/2021.
The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 27-May-2022; Administered vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 27-May-2022) in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     No known allergies reported, Patient was not diagnosed with or tested positive for COVID-19. Patient not had acute illnesses at the time of vaccination and up to one month before. Patient not had Chronic or long standing health conditions.     On 27-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 27-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 27-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Reported that patient was not taking prescriptions, over the counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  Time of administration for first dose reported as 12:00 am.  Reported that administered vaccine after the BUD from 08-Mar-2022 to 01-Jun-2022. The vial was initially stored in refrigerator on 08-Mar-2022. The vial did not undergo the temperature excursion. The patient had not reported symptoms. No additional doses, medications, or treatments had been administered.
This spontaneous report was received from a physician via field employee regarding a male patient over 60 years of age. There was no information reported on medical history and concomitant medications. On an unknown date in 2010, the patient was vaccinated with ZOSTAVAX (Lot number, expiry date, dose, frequency, route not reported). The reporter stated that on an unknown date (reported as recently), the patient had an office visit with shingles rash on their forehead and nose are. There was no product quality complaint involved. The outcome of the event was unkonwn. Additional information has been requested.
Information has been requested from a registered nurse concerning a 13 year old male patient who on an unspecified date was vaccinated with a dose of PROQUAD (Lot # not provided), "back to school dose required by the state", instead of VARIVAX (Merck). It was reported that the patient had not experienced any known symptoms. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt was given a flu shot on 9/19/12. Pt complained that she broke out with a rash along her neck on Saturday night & all over her body by Sunday. BENADRYL & hydrocortisone was used for treatment.
not sleeping as much, but feels weary; sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping a lot) and FATIGUE (not sleeping as much, but feels weary) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009621A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 22-Jan-2021. Concurrent medical conditions included HIV disease. Concomitant products included ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE (TRIUMEQ) for HIV infection.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced HYPERSOMNIA (sleeping a lot). On 30-Apr-2021, the patient experienced FATIGUE (not sleeping as much, but feels weary). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 Tab and IBUPROFEN at a dose of 1 Tab. At the time of the report, HYPERSOMNIA (sleeping a lot) and FATIGUE (not sleeping as much, but feels weary) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
1:10pm c/o itching, hives(chest, back and right arm) warm feeling, throat tightness, BP 129/84 P 98 Sp02 RA 98% 1:15pm Benadryl 25mg po given 1:17pm moved to recliner 1:24pm P 130 Sp02 96% RA 1:25 IV est, 20gauge LAC x 1 attempt RN,  NS1000ml infusing 1:26pm Solumedrol 125mg IV given by RN, and reported Sp02 in 80's and lips "blue" BP 122/82 P85 1:27pm, to hospital with staff. RN, reports by the time they reached hospital her lips were "pink" 1:27 report given to RN in hospital via phone
high dose influenza given inadvertently when should have been the influenza vaccine. patient is not 65 years old.
Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EL3246) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "recovered".  Additional information: The reporter was the patient's mother. Reported that her daughter, after receiving the second dose vaccine, developed a rash that lasted for 6 months. Stated that it was pretty bad. The patient's doctor told her to not get the booster. The patient could not go to work because she has to have the vaccine and booster in. Then, she got COVID and then she could go to work.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300078017 same reporter and patient, different AE;
Day of receiving vaccine (01/26/2022) - Some body aches; fatigue within 1 hour of receiving shot Second Day - Low-grade fever, body aches, joint pain, fatigue, sleepiness, swollen lymph node under left armpit Third Day - Low-grade fever; body aches, joint pain, fatigue, sleepiness, swollen lymph node under left armpit (very sore and sensitive to the touch); Fever broke at night Fourth Day - No more fever or fatigue. Lymph node continues to be swollen and sensitive. Warm compresses help.
Generalized rash, urticaria, employee denied any allergies until reaction occurred she stated she had cortisone the same day as her flu vaccine 2 yrs ago and was told by her MD rash was due to cortisone.
Bells Palsy in right side of his face. Pain in jaw, eye twitching and fatigue.  Went to ER same morning of 6/28/21 and received 10 day dose of Prednisolone.
Moderna vaccine. injection site began to itch on Friday. ( initially arm sore for first day or two and disappeared). By Saturday a rash at the site about 5 inches oval. By Sunday, itching increased and area hot to the touch.
Fever of 101.8 degrees, cold chills, some nausea, and it lasted 15 hours
3/17/21- Sore arm at injection site.  3/18/21-  Nausea (no vomiting) and lack of appetite, arm more sore, very tired.  3/19/21- Very tired, nausea gone but still not very hungry, arm soreness getting better.  3/20/21- Feeling much better. 4/7/21- Took Vitamin C, Magnesium, and drank a lot of water for 2 days prior to getting 2nd shot- only experienced sore arm (which started that evening and lasted 2 days) and was extremely tired- which lasted 4/8/21 and 4/9/21.
High blood pressure day of vaccine Shortness of Breath continues, but better Pain in upper shoulder for a month following
Patient stated she felt like she was going to pass out after vaccine administration. She started to look pale.  I supported her and talked to her.  She passed out for a few moments. I had a fellow team member call 911.   She did shake/tremble a couple times as well. Her mother was present. She came to after a few moments and told us that she was nauseous and dizzy.  I sent someone to get a blanket so we could lay her on the floor. I also took her blood pressure.  Her blood pressure and pulse were low.  As we went to lay her on the floor, paramedics arrived.  She was talking to the paramedics. They lifted her out of the chair onto their bed.  The entire event lasted approx 10-15 minutes. I did not administer any medications - only took blood pressure and pulse.
Pain in the arm and very sore immediately. Swollen, no heat, red at the site the size of wife's hand, felt achy, left leg really hurting, headache and dizzy spells. took Tylenol 500mg every 4 hours. Feeling  some better now.
At 12 noon 4/10/15 she examined back of right arm where ZOSTAVAX administered. Large size (larger than a fist), color deep red, hard, hot to touch area. Since time of vaccine administer reports arm was sore, has not felt herself, and no energy today. Advise warm compress, consult her physician.
Burning, redness, itching, rash arm and abdomen hives. Monitoring, using BENADRYL, ADVIL.
Patient reported right arm pain at time of injection on 6/8/23 that did not improve over time.  He had a follow up appointment on 6/20/23 with the same doctor as seen on 6/8/23 and right arm pain was not documented in the chief complaint or in the note of the doctor. On 7/17/23 he walked in the clinic without a scheduled appointment and reported to the nurse that he had right upper arm pain that had not improved since the injection and asked for evaluation. He was seen by the on site physical therapist that day. The physical therapist documented : "Pt. is a 70 year old male with complaints of intermittent right upper arm pain since June 8, after vaccination.  Felt total body chills after injection that resolved, but left with shoulder pain.  Denies N/T, radiating pain.  Raising arm up, back, lifting objects painful. RHD.  Feels there was a mistake done at time of injection." After evaluation the assessment was "Signs and symptoms consistent with right RC tendon irritation, impingement.  Needs  exercise, body mechanics and posture training for resolution of functional limitations.."
Vaccinated 6-23 and 6-25, Pt with swollen rt arm with arm pain. Swelling got bigger. He then developed tremor, SOB and change in pallor. He reported back to us on 27 Jun and we advised him to go to ED. No diagnosis. Returned again on 2 July, again advised to go to ED. Has not heard from pt since that time.
sore arm; Headache lasted for 4 days; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration on 26Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 26Apr2021, the patient experienced sore arm, headache, and chills. Headache lasted for 4 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, chills was recovered on an unspecified date in 2021. Whereas, that of headache was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Pt recvd immun on 16MAY91 @ 1130 @ 1500 started w/high pitched scream, uncontrollable for about 2hrs, would not even nurse; Has been fine since;
Patient admitted 11/10-12/19; transferred to Specialty Hospital 12/19-12/27 and came to Medical Center on 12/29 as a direct admit.  She tested positive for COVID 12/22/22 and died 12/30/22.
Rash, swelling, redness at injection site. Approximately 2cm by 3cm  ventral to injection location.  Area hot to touch. Skin sensation decreased. Painful to touch.  Itching developed in location approximately 24 hours after abnormality occurred.  Pain on lifting of arm. Achey pain  in muscles of left forearm and elbow.  Acetaminophen and Benadryl decreased symptoms but have not resolved them.
Patient developed intussusception on 9/14/16 and required surgery. Patient received ROTATEQ on 9/7/16.
a rash which started Friday all over my arms, legs, chest, stomach and back.; This is a spontaneous report from contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a rash which started friday all over my arms, legs, chest, stomach and back on an unspecified date. The action taken in response to the events for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2z2 area on left leg, warm to touch. Red and hard area at site. Tylenol for discomfort and have mom report if it doesn't get better within the week.
Came down with shingles / shingles episode is not totally over; rash is receding ut there are still some eruptions; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 3 weeks after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in an unspecified arm.  Three weeks later she came down with shingles.  The patient stated she did not necessary think Shingrix caused the shingles outbreak, she said it was probably just a coincidence. She stated that the pharmacist did not give her any literature therefore she did not have the lot number or expiration date of the vaccine.  The shingles episode was not totally over  She said the rash was receding but there were still some eruptions. Consented to follow up.
Diarrhea; Flu like symptoms; Neck stiffness; Neck pain; Sleepy; Cloggy; Temperature of 99°; Headache; Tired; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain) and SOMNOLENCE (Sleepy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included West Nile viral infection (She already had antibodies).    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain), SOMNOLENCE (Sleepy), VACCINATION COMPLICATION (Cloggy), PYREXIA (Temperature of 99°), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain), SOMNOLENCE (Sleepy), VACCINATION COMPLICATION (Cloggy), PYREXIA (Temperature of 99°), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 °f (High) 99 °F. On an unknown date, West Nile virus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
6 year old WF presented on 02/16/04 with a 2 day history of red vesicles. Started on shoulders and neck. Now all over trunk. No vesicles on extremities. Various stages-including 3 places scabbed over. No history of fever or upper respiratory infection symptoms. Positive malaise. Diagnosed chicken pox.
Received first injection 05/19/21. Experienced common side effects (soreness in arm, swelling and redness near injection site). On 05/24/21, swelling and redness at injection site spread out beyond immediate surrounding of injection site in a circular pattern. As of 05/24/21, the affected patch of skin was red, swollen, hot, and was measuring at a diameter of approximately 3 centimeters. As of 05/27/12, the circular pattern has continued to grow and is measuring at approximately 9.5 centimeters in diameter. The affected area of the skin continues to remain red, swollen, and hot.
Severe reaction; This case was reported by a consumer and described the occurrence of adverse event in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included prevnar 13 with an associated reaction of nonspecific reaction (put the patient in an ICU for 5 days and another 5 days in step down units.).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient had severe reactions to shots and Prevnar 13 put me in an ICU for 5days.  The patient also spent another 5 days in step down units. The patient reacted to GlaxoSmithKline garden variety flu shot every year. The reporter finally changed physician and was told the truth about what was going on. The reporter asked GlaxoSmithKline about getting these shots. The reporter was terrified of getting any shots.
Started my period on day 20 of my cycle. This is very unusual for me. I'm usually on day 32-35. It was also much heavier than normal and lasted longer.
On July 18 I began feeling achy and tired and had a terrible sore throat. Tested on July 19th and tested positive. July 19-24 I had fatigue, tired, and sore throat. Began PAXLOVID on July 25th and began feeling better on July 29th. Fatigue and brain fog lasted 4-6 weeks.
Patient got her 2nd covid19 vaccine on July 2nd. starting from July 7th, after eating methimazole, she feel headache, nausea, want to vomit, but can't spit it out. she is lack of energy. she take methimazole for more than 2 years, never has this symptom before. all abnormal happened 1 week after her 2nd covid19 vaccine. I am worried about her.
Body broke out in cold sweat, followed by extreme hoarseness, difficulty swallowing, constant coughing, runny nose.  Symptoms increased in intensity for 4 days, and then began to subside by day 5.  Symptoms almost gone today but still lingering mildly.