chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen face in side of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 05Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization. The following information was reported: SWELLING FACE (medically significant) with onset 05Dec2021, outcome "recovered", described as "Swollen face in side of injection". The event "swollen face in side of injection" was evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling face. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was Bendryl. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pain in lower left abdomen, side, and back extending from mid/lower abdomen to left hip by groin.  Constant throbbing and shoots of intense pain at random intervals. Nausea led to vomiting. The vomiting then led to entirely vomiting yellow bile. Drinking water resulted in vomiting 10-15 minutes later. Unable to keep water down, leading to dehydration. The pain first appeared after 8 am on 10/03/2021. Nausea then followed and a short time later vomiting. Between 8 am-12pm, I vomited approximately 5-6 times. Then I went to one of my local Urgent care centers. At about 2:20 pm I started to receive IV fluids, anti-nausea,  and pain medications. This helped the pain and nausea subside somewhat for a while. The pain on the left side did not entirely dissipate. I was then sent home with OTC Acetaminophen and Advil, and prescription anti-nausea medication. The pain has since started to return along with the nausea.
Severe all over muscle and joint ache, fatigue, dry cough, chills, dizziness and weakness.  Began around 7 or 8 am February 5 and continued all day and evening.  I slept most of the day.  Around 11:30 that night I woke up feeling quite a bit better.  I slept all night.  The next morning, Saturday,  the aches had gone away and I was alot better.  The cough, however, continued.  The cough continued through Sunday.  Monday the cough happened only a few times and I felt energetic and completely back to normal.
Patient given adult dose 0.3mL (grey top) instead of pediatric dose 0.2mL (orange top).
This report was received on 3/6/01, from a healthcare professional concerning a 7 month old female pt who received her 3rd dose of Prevnar, along with IPV and Infanrix on 3/1/01. The reporter is not aware of any concomitant medication and medical history was not provided. On 3/1/01, 3 hours, post vax, the pt experienced fever as high as 103.2F (rectally), irritability, decreased appetite and increased sleep. At the time of this report, events continue. Additional information was received on 4/27/01, from the reporting healthcare professional, indicating that the pt was admitted to a hospital for 3 days for sepsis work-up. The pt developed a rash on day 5 of the fever. The fever abated, 1 day following the appearance of the rash. Blood, urine and spinal fluid cultures were obtained with negative results. The child was discharged from the hospital after 2 days of IV antibiotics. A follow-up appointment with the child's physician on 3/13/01, revealed a healthy child without sequela.
I had the predicted fever 99.9 and chills and headache and sore throat the next day after injection.  Recovered as expected after 24 hours, then the day after was very tired and the day after that.  My question is, could the symptoms have triggered a chronic fatigue episode? I?m still very tired so that I can?t exercise to rehabilitate my left rotator cuff.
This spontaneous report as received from a pharmacist via company representative. The pharmacist inquired "Can a patient get cold sores after getting ZOSTAVAX (lot # unspecified) vaccine?" The company representative was not sure if a patient was involved. The outcome of cold sores was unknown. Additional information has been requested.
complaints of itching starting with upper extremities, then to chest, back and legs. Followed by a feeling of throat congestion.
if it was okay to receive the second dose of the vaccine if the first one was administered on 29March2021 on the right arm; Some discomfort with ringing in his ears; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Some discomfort with ringing in his ears), MYALGIA (Arm was sore) and PRODUCT DOSE OMISSION ISSUE (if it was okay to receive the second dose of the vaccine if the first one was administered on 29March2021 on the right arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included ESTRADIOL and PROGESTERONE for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced TINNITUS (Some discomfort with ringing in his ears) and MYALGIA (Arm was sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (if it was okay to receive the second dose of the vaccine if the first one was administered on 29March2021 on the right arm). At the time of the report, TINNITUS (Some discomfort with ringing in his ears) had not resolved, MYALGIA (Arm was sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (if it was okay to receive the second dose of the vaccine if the first one was administered on 29March2021 on the right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Steroids.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up received includes non significant information. email has been updated
On day 11 post 2nd vaccination, developed chills, severe headache, fever as high as 100.2. Able to reduce fever with ice packs but fever returned after 8 hours.  Had fever from 2/12/21 to 2/18/21.  Headache persisted and did not resolve until 2/22/21.  Poor appetite and ackward taste in mouth.  On 2/16/21, had Rapid Antigen Covid test, results NEGATIVE.  Thought symptoms may have been sinus infection, but usual remedies not effective.  Headache was like nothing ever experienced before.  Symptoms felt very different.  Had Covid test on 1/25/21 prior to 2nd vaccination, NEGATIVE.  Self isolated after vaccination and worked from home so low risk of exposure.  Was not tested for influenza.
Large arm rash. Warm to touch, itchy, raised. 6 inches long 4.5 inches wide.
AFIB reaction; diarrhea; A spontaneous report was received from a consumer concerning a 70-year-old male patient, who experienced AFib/ MedDRA PT: atrial fibrillation and diarrhea/ MedDRA PT: diarrhoea.  The patient's medical history included atrial fibrillation (AFib). No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of Covid-19 infection.   The patient stated that about a day and a half later following vaccination, he started experiencing AFib and diarrhea. He also reported that on the day of his vaccine, he took an echocardiogram and his heart was doing well. Patient was originally diagnosed with AFib in 2011. The patient stated that he is doing better today.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The events, atrial fibrillation and diarrhea, were considered recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event,s a causal relationship cannot be excluded. Patient's medical history of atrial fibrillation is considered a confounder for the event of atrial fibrillation.
Patient presented with a 3 by 3 inch round red induration at the injection site. It was not arm to the touch or painful. Patient reported that it itched slightly. Recommended benadryl and cold compress/ice.
Initially about 1-2 hrs. after my arm was sore and felt like a bruise. Within the first 24 hrs. about 9hrs. later I felt like I had the flu with chills and fatigue and I canceled my dinner plans for that evening. Stayed in bed starting about 4pm and slept thru the night Atm was still extremely sore and ached to lift or move. It was in my upper left arm and I am right handed. By Friday 1/24/2020 my arm had a pink rash located from the injection site down to my elbow and just in the outside of my arm. My Sunday morning the rash had disappeared.
After 15 minutes of receiving the vaccine the right side of my face experienced numbness and tingling which lasted a couple of hours. No treatment was required that day.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 120 hours. The lowest recorded temperature was 34 F. No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Information was received from a nurse concerning a sixth grade student who on 07 SEP 1995 was vaccinated with a dose of Varicella.  On 17 DEC 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the student.  No product quality complaint was involved.  Additional information was requested.
after 2nd dose I was sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Lot number: EN6201, Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "I had covid" (unspecified if ongoing); "very sick" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (21Jan2021, 13:00, 1st dose:, Route of administration: intramuscular, Batch/Lot number: EL8982), reaction(s): "COVID-19 Immunization". The following information was reported: MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "after 2nd dose I was sick". Therapeutic measures were not taken as a result of malaise.  Additional information: Patient had covid by 2 weeks before vaccination patient was very sick for 6 weeks. No prior vaccination (within 4 weeks). After first shot patient was sick for 7days with same as when the patient had covid. After second shot patient was sick for 3 and half days not quite as bad as first shot. He spoke to his family doctor after first shot they said he should have been advised to wait 90 days after recovering from covid before he had first shot.  No follow-up attempts are possible. No further information is expected.
Sharp pain in my upper back / neck / shoulder area. Radiates from the left side. Pain started at an 8 on a 1-10 scale. Has slowly gotten better (at a 5 pain scale today 2/25).
Minor patient received vaccine at the age of 11 years; mother will be notified and will ask her to bring patient once patient has turned 12 years of age (per CDC guidelines).
Difficulty breathing, fast heart beat or dizziness, lower abdominal pain, lower back pain.
3 patients who received Johnson and Johnson for their first dose came in to receive the Moderna booster and were given a full dose of 0.5mL; INTERCHANGE OF VACCINE; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (3 patients who received Johnson and Johnson for their first dose came in to receive the Moderna booster and were given a full dose of 0.5mL) and INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (3 patients who received Johnson and Johnson for their first dose came in to receive the Moderna booster and were given a full dose of 0.5mL) and INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE). At the time of the report, ACCIDENTAL OVERDOSE (3 patients who received Johnson and Johnson for their first dose came in to receive the Moderna booster and were given a full dose of 0.5mL) and INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided
Given PPV-23 vaccine sub-q on 11-2-07. Called health dept this morning and wife said arm got a very large hot red swollen area at injection site and their doctor said go to ER where they diagnosed him with an allergic reaction to PPV23 & ordered benadryl 50mg q 4 hours. Vastly improved now. Never had a fever. Left arm amputated thus flu & PPV in same arm both an same day.
Pt received Gardasil vaccine 2nd within 10 minutes complained of dizziness, heaviness in her head 2nd then had syncope episode. Pt came to with one minute. Lying down had a blood pressure of 100/62 and remained dizzy for next 1/2 hour. Pt recovered within 45 minutes.
Pt c/o "head feels like its going to explode." Vomiting and difficulty breathing. Seen in ER - Benadryl and Steroids given and pt discharged.
All of my symptoms occurred later in the evening: Very cold (lasted 1 night) nausea (lasted 2 days) light headed (lasted 1 night) tingling sensation in hands, feet, legs, and arms (this is still happening as of today)
Shot 1-18. Normal pain and redness at injection site. Went away. Redness, swelling and severe itching at injection site today 1-27.  Woke me up from sleep(itching). Took Zytrec. Is this normal? What does it mean?
administered expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient administered expired dose of Bexsero, which led to expired vaccine used. The nurse declined to provide any additional details. The reporter consented to follow up with safety team.
I had burning pain radiating down my right butt cheek, hip and leg that started on 01/04/2021.  A rash errupted on 01/09/2021 that stayed on my hip. I was prescribed Valtrex on 01/10/2021 for one week that haulted the progression of the rash.
3 days after I received my 2nd dose of Moderna Vaccine at the same facility (Which I received on 4/16/2021), I've had a series of what could be panic attacks.  1 on 4/19/21, 1 on 4/30/21, then another on 5/8/21, which then continues to stay with me on a milder intensity, but is lasting still today.   In my previous 4 years of working, I've only missed a less than a 1 handful of days of work due to health conditions, but suddenly after receiving my 2nd dose of Moderna vaccine, I've had a myriad of what I initially thought were heart attacks where I was unable to drive to work (had to pull over twice on the road due to serious risk of being in an accident / having unprovoked panic attacks the morning of  4/19/21 and 5/8/21).  Had extreme SOB and could seriously considered calling 911 on all 3 of my first episodes.  Went to Urgent Care on 5/10/21, and have had several phone visits with my primary care physician since then and was placed on medical leave until 5/22/21, although I still am experience some side effects even today.
Pt came to lab for COVID Vaccine pfizer for ages 5 to 12 and was given 0.2ml of vaccine BEFORE being diluted. MA was not aware until after patient had left. She reported to supervisor who called CDC to get guidance and then called parents of patients and gave CDC advice on local reaction. Dad said that patient was doing fine and he would keep an eye on her and Call the CDC himself.
Left upper arm - hard to touch, warm to touch, deep red color for 1 and 1/4 inch diameter at site of injection, then pink about size of softball. Painful.
Felt dizzy, shakey, arm pain and heaviness in the arm shot was given, nausea, difficulty thinking. States she just didn't feel well.
No additional AE; Nurse reporting that a dose of PNEMOVAX23 with a labeled expiry of 1/28/2023 was inadvertently administered to a patient on 2/14/2023; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender.   No medical history, concurrent conditions nor concomitant medications were reported.  On 14-FEB-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 mL, lot # U026796, expiration date 28-JAN-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used), inadvertent administration of vaccine beyond expiry date. It was reported no known temperature excursion involved. No additional information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported at the time of reporting.
swelling; infection; fractured left foot; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  This 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fractured left foot (medically significant) on 11Apr2021 with outcome of recovering, swelling on an unspecified date with outcome of recovering, infection on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the events included 500mg prior to second shot. She asked can she get the second dose on 29Apr2021 since she has an injury for fractured leg, swelling and infection. Is taking Naproxen for it. The patient stated that the swelling has gone down. Has been Naproxen taking it for 14 days and tomorrow will be the 15 day. Stated that she will go to the doctor and is not sure if she will get another prescription for it. Stated that the pills are for pain, swelling and potential infection. Clarified that it is for her fractured left foot. Stated that it is a closed fracture.  No follow-up attempts are needed. No further information is expected.
Missing my period; Menstrual cycle is three weeks late; This is a spontaneous report from a contactable Consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: ER8736, expiry date: 02Jul2021) via unspecified route of administration on 01May2021 as DOSE 1, SINGLE in left arm for COVID-19 immunisation (at the age of 43 years). The patient's medical history and concomitant medication was not reported. The patient reported that she met a Gynecologist because I was missing my period, so when I went in I did a urine test but he also did an ultrasound so in conclusion, I was not pregnant on both tests but my menstrual cycle has been three weeks late that's why I went in and I am on top of it's a Copper-T called Paragard it's a birth control. So I am having it for 12 years and I am never really missed the period until I took the Pfizer which is two weeks ago and I wanted you to see, like Is it common with  other women that are they calling in seeing that there periods are irregular because I want to report mine that is three weeks late and I am not pregnant and I am 43 years old and I don't take any drug and I do not take any prescription drug and this is like the first of its kind for me, I usually have regular period because of the Copper-T there is like a hormones in it or any drug. So this was the only thing that I did different. I do exercise. I am fit. No high blood pressure. No low blood pressure. I just wanted to report that if there is anybody like me that are calling in?. When paraphrased the concern: Consumer further stated, "My last menstrual cycle was on 31Mar2021 and it's already 18 so in conclusion I am 3 weeks late on my menstrual cycle and the only thing I did different was taking the Pfizer shot so this Saturday would be my second shot for the COVID-19 the Pfizer shot but I am not gonna take it now because I still haven't had my period yet at all and I am wondering and my doctor. He told me to come back in two months. So you know it's kind of strange. When Probed for the date of the first COVID-19 Shot: Consumer Stated, 01May21. When Probed for the date of the second COVID-19 Shot: Consumer Stated, 22May2021 coming up this week. Well I am freaking to take it because I have not got my period yet and I am thinking that it was the Pfizer that has only changed in first as drug and as eating wise and exercise nothing is changed, Well I actually thought I was pregnant I was 43 years old, so I went in right away because I don't what was happening and I want to know if any other women has been experiencing I guess missing their cycle?. The outcome of events was unknown.  Follow-up attempts are completed. No further information was expected.