chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with low grade fever of 100.4 at 7pm on day of injection (4/24).  Low grade fever continued until Monday. Soreness at injection site continues 4 days after injection, but improving. Swollen, tender lymph glands in armpit on right side noticed upon waking on 4/26.   (Injection was in right arm.). Swollen glands continue today (4/28) but improving.
The person does not meet the age criteria per FDA.  When been vaccinated by the POD clinic, the age was not caught until data entry. Person was accidently vaccinated.
Soreness at the injection arm; Knot above her clavicle that is very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection arm) and LYMPHADENOPATHY (Knot above her clavicle that is very painful) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection arm) and LYMPHADENOPATHY (Knot above her clavicle that is very painful). The patient was treated with IBUPROFEN for Pain, at a dose of 600 mg. At the time of the report, VACCINATION SITE PAIN (Soreness at the injection arm) and LYMPHADENOPATHY (Knot above her clavicle that is very painful) had not resolved.            No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow-up received on 06-Apr-2021 included no new information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
11:40am Physician was called to examine pt who was having difficulty breathing. Apprx 1-2 minutes after varicella vaccine. Child had wheezing with B/L retractions. Decrease air entry. Pt O2 SAT decrease to 87%. 5L O2 given via face mask. O2 SAT 99% -100%. 911/EMS called. 11:45am 0.15mg Epincephrine 1:1000 admin. SQ x 1. Pt improved rapidly. 11:50 am Good Air Entry O2 SAT 100%. 11:55am Deltoid swelling. Benadryl 25mg 1m admin. O2 99-100% room air. Pt vomitting Phigm. 11:58am EMS arrived. Pt transferred to ER.
Lt arm pain occured several hours after flu vaccine injection. Difficulty moving arm. TX: Voltaren gel 1% QID, physical therapy, aleve once daily. reduced work shifts. Next f/u appointment is scheduled 12-4-2020.
Pt was vaccinated on 2/20/02 at approx. 10:15. At approx. 21:30, the pt had a seizure lasting about 90 seconds. Her body stiffened and eyes rolled back. She did not have a fever. On Saturday night (early Sunday morning) she had 2 more seizures and was taken to the ER and hospitalized.
Probably immediately, I was lightheaded and woozy. As soon as she put it in my arm I could taste it and I felt like I was going to vomit. She kept me there for 45 minutes to keep an eye on me. As a disclaimer, I am a vegan and very earthy, I do not take any drugs or anything like that. When I was driving home the lightheadedness got so bad that I had to pull over and sat for 15-20 minutes. I called my brother and he told me to get something to eat. I just had some steamed vegetables. I came home, ate and drank a lot of water to try and get the wooziness to pass. I did not have an unusual amount, no more than I would usually drink. Then after the last bottle of water I had, I started getting more queasy and started to feel dizzy. I then vomited all over my self from head to toe. That lasted for two or three hours and then after that I was dry heaving. That happened on Friday, on Saturday I was too afraid to eat anything I only had toast and a smoothie. On Sunday I was just so woozy and lightheaded and exhausted. I didn't feel chills or anything though. My brother brought me soup on Sunday and I did have some broth. I also started drinking a little bit more water. The water didn't taste good though - it tasted like the vaccine so I did not want to have it. I did not workout at all for that week, I was just so tired. I felt like I could sleep for a month and just not get up. I normally workout five days a week. I got an IV with fluids for hydration and a glutathione push on 7/2/2021. On the following Saturday 7/3/2021, I was still lightheaded. Now, I still am extremely tired and there are days that focusing takes more energy than it typically does. My mouth feels like I have cotton balls in it, the nausea and the lightheadedness is still present, but the tiredness is the worst. I normally run everyday but I cannot even do that at all, walking is hard enough. I just had another IV today 7/14/2021. When this started happening, I did contact my DR but I am unable to get in yet, I need to schedule for a full blood panel and see the DR.
soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 12Mar2021 at 13:50 (Batch/Lot Number: EL3247) (at the age of 55-years-old) as 1st dose, single dose for COVID-19 immunisation. Patient's medical history was reported as none. Concomitant medication included ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER) taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 at 01:50 (approximately 12 hours later), patient experienced soreness at the injection site, which was partially relieved with a 400 mg dose of Advil (two 200mg liqui-gels). Some residual soreness continued as of this report. No other symptoms were noted. Outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
2nd Covid dose given at 1000hrs on 16Jun2021. On 17Jun2021, 1700hrs reported to Hospital ER with c/o substernal chest tightness/pressure, +SOB. Was discharged from ER stable and referred to Primary care provider listed above. On 18Jun2021, pt had recurring chest pain/tightness symptoms and returned to ER. Pt was noted to have positive Troponins with symptoms and was transferred by EMS to Hospital. He was admitted to the Cardiology service where subsequently he received a Cardiac Catherization and a Cardiac MRI. Pt was admitted for 2 days; discharged on 20Jun2021 with Dx: Myocarditis. Pt to follow up with Cardiology.
FEVER JOINT PAIN HEADACHE BACK PAIN ARM PAIN NAUSEA, same as when I actually had covid back in Nov
DEEP VEIN THROMBOSIS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total administered on JUL-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On unspecified date in JUL-2022, the patient experienced deep vein thrombosis(DVT) diagnosed in Emergency Room (ER) (ultrasound). Acute DVT in ER in NOV-2022, several more indicated, ultrasound. Patient woke up on 11-NOV-2022 with a swollen foot, looks like that to date, won't go away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000288257.; Sender's Comments: V0: 20230673585- deep vein thrombosis. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
temperature reached was 32.2F for a total excursion time of 39 hours with no reported adverse event; patient to receive MENQUADFI post-excursion with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 11 years old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post-excursion whose temperature reached 32.2f for a total excursion time of 39 hours with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular3-component, tetanus vaccine toxoid (Boostrix) for Prophylactic vaccination.  On 17-Feb-2023, the patient received 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (frequency, once (1x), strength - standard, expiry date  - 28-Feb-2025,  lot U7576AB) via intramuscular route in right deltoid for prophylactic vaccination.  On 17-FEB-2023 meningococcal A-C-Y-W135 (T CONJ) vaccine temperature reached 32.2f for a total excursion time of 39 hours with no reported adverse event (product storage error) and patient receive dmenquadfi post-excursion with no reported adverse event (poor quality product administered) (latency: 1 day)   Reportedly, the temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop. The products involved are MENQUADFI, PENTACEL, and FLUZONE QIV NP.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA065072:01504785 US-SA-2023SA064145:01504843 US-SA-2023SA065058:01504849
Headache, Myalgia, Fever, UrticariaPruritus, NauseaVomiting, chills Narrative:  onset of flu like s/s with 18 hours of injection #2
The daughter heard a pop; a lot of bleeding after the needle came out; now 2 hours later her arm is numb; The daughter heard a pop; a lot of bleeding after the needle came out; now 2 hours later her arm is numb; Her left arm is warm and numb; This is a spontaneous report from the contactable consumers (including patient's mother) from a Pfizer-sponsored program. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04May2021 (Batch/Lot Number: EW0171) as 2nd dose, single for covid-19 immunisation. Medical history included mitral valve prolapse. Concomitant medication included metoprolol. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Apr2021 for covid-19 immunisation. The patient received the second dose of the Pfizer COVID-19 vaccine today (04May2021). She received the vaccine in her upper left arm, when they put the needle, she heard a pop. A lot of blood was floating down her arm when they took out the needle. Her left arm is warm and numb. The reporter wanted to know if this will get better and if the vaccine would be effective. It was reported that the nurse had put the shot in left arm and the patient heard a pop and a lot of bleeding after the needle came out and now 2 hours later, her arm is numb. When they pulled the needle in, she heard a pop and when they pulled the needle out, that's when the blood came out and it ran down her arm and now her arm is numb. It's warm to touch but she's feeling that it's numb. They are not sure if she put the shot into the blood vessel or if she went through the blood vessel and they are not sure if it will be affective and if this numbness will dissipate and go away. The patient gets a checkup every year and everything was fine. The outcome of the event was unknown.
diagnosed with psoriasis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 90-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she only has one kidney" (unspecified if ongoing), notes: she only has one kidney; "had cancer" (unspecified if ongoing), notes: had cancer 20 years ago.; "had a hard time hearing" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer.), for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "diagnosed with psoriasis". Additional information: Caller was looking for something to calm down the rash. After the patient received her most recent Pfizer booster shot, she experienced a rash all over her body and was diagnosed with psoriasis. Caller wanted to know what to do to treat her condition. She had rashes from the palm of her hands and head and was covered all over her body. Caller cannot take medication as she only has one kidney and had cancer 20 years ago. She had a hard time hearing and requested to speak loud and clear.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Heart palpitations, c/o nausea and dizziness. Employee taken to hospital ER. Epi given and prescription for Benadryl
shingles; Little rash/Mild recation on my neck/Itchy; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles and itchy rash. On an unknown date, the outcome of the shingles and itchy rash were unknown.   It was unknown if the reporter considered the shingles and itchy rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just received dose of Shingles vaccine and 2 weeks later experienced mild reaction of shingles on his/her neck that was little rash with Itchy. The patient stated that It was rough, had a few simple side effects but it was better than getting Shingles. The patient also stated that he/she was fine and would wait to get his/her 2nd shot but definitely would do it. Additional supportive information: The follow-up would not possible, as no contact, details were available.
45 minutes after receiving injection, my face, from my nose, across my cheeks, and downward, went numb. This feeling lasted 24 hours. 72 hours later bottom lip still numb.
12 y.o. child. Father called in AM on 9/16/16 et stated his dtr. wasn't feeling will after Td vaccine. He stated she was "running a fever and her bones hurt" went to observe child. Site of vaccine admin not red or swollen. Mom states temp high was 100.5. Child stated she is "sore all over". She states she has had chills and stuffy nose. Denies sore throat or cough. No other children sick at the time of visit. 9/19/16-spoke with father et he stated child is feeling better.
Patient called to follow up on what may be an adverse effect of the vaccine, according to him and his doctors. After both vaccines patient did not complain any adverse effects. It was on Sunday 4/11/2021 that he suffered from a stroke. At work he was walking around and began to feel his left side of his body and face go numb. This lasted for 4-5 hours. He went to Hospital after a few hours and the ER did many imaging tests to which no abnormal results were revealed. Patient has no damage from stroke, paralysis of face is gone. His current treatment is baby aspirin and he will follow-up with neurology. Patient has not complains as of right now but did make it a point to want to document his experience. Pt has no medical hx, is not a smoker, and lives a healthy lifestyle. Patient was encouraged to call if any new follow-up information occurs.
pain on and around injection site. pain and discomfort with swelling in right arm pit. causes numbness if fingertips from time to time.
Neck pain; Left arm knot at injection site; Left arm knot at injection site, knot also red; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), VACCINATION SITE MASS (Left arm knot at injection site), VACCINATION SITE ERYTHEMA (Left arm knot at injection site, knot also red) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Feb-2022, the patient experienced NECK PAIN (Neck pain), VACCINATION SITE MASS (Left arm knot at injection site), VACCINATION SITE ERYTHEMA (Left arm knot at injection site, knot also red) and HEADACHE (Headache). At the time of the report, NECK PAIN (Neck pain), VACCINATION SITE MASS (Left arm knot at injection site), VACCINATION SITE ERYTHEMA (Left arm knot at injection site, knot also red) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had no allergies. The patient had experienced these adverse reactions for the first time and did not experience these adverse reactions with other vaccines.  No treatment medications were reported.   No concomitant medications were reported.
ITP WINRO SD infusion 50 ugm/kg 18AUG96 & 19AUG96 only;
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 8th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2018 after vaccination, the patient experienced soreness, redness and swelling in the form of a big lump on the injection site. The patient also felt nauseous and feverish. The reporter had given consent for follow up. These events were all same as experienced by her boyfriend (case US2018204717), but were less severe.
COVID-19 vaccine EUA. My shot was on Thursday morning. Sunday morning I woke up and the instant I moved the world swirled around me. I have never experienced that sensation before. Every time I changed position or moved my head the swirling happened for five days. The swirling lessened daily afterwards for about 3 more days. I messaged my Dr. But didn't go to see anyone.
Information was received on 16-APR-2019 from a lawyer regarding a case in litigation concerning a female patient (age and history not provided). In or around 12-AUG-2015 the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster). Five days after the vaccination the patient suffered a rash under her breast and increased around to her back and was diagnosed with herpes zoster. As a direct and proximate result of ZOSTAVAX the patients symptoms resulted in physical limitations nor present prior to use of the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of ZOSTAVAX the patient sustained severe and permanent personal injuries, serious progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result the patient has suffered and incurred damages including medical expenses, the loss of accumulation, and other economic and non economic damages. Outcome of herpes zoster was not recovered. Herpes zoster was considered to be disabling.   Additional information has been requested.
On April 6, 2023, I started having a cold, cough that had a little congestion, no fever, my ear felt a little congested. Four days later, I started noticing I was getting that rotten taste and smell that you get when you get an infection, I had sinus pressure that made my head hurt, some bloody discharge when I blew my nose and some that came out of my ear. I called to have a telehealth visit with my doctor, we discussed my symptoms, I was prescribed an antibiotic and prednisone. I am currently taking the medications, the infection in clearing up.
Patient received the Hep A vaccine at her 11AM appt on 7-20-12. She stated to her parents just before 12N: "I feel like I'm going to pass out." Father sat her down; mother stated she was not hot, clammy, and weak. She had an empty stomach. She did not loss conscious. She recovered within 5 minutes and at some food per her mother.
Patient had shot at around 1:35 pm and she began to fall asleep.  She was responsive when talked to and coherent but kept falling asleep and said it was hard for her to stay awake and complains of dizziness.  She was carried to an exam room to monitor and stayed for 30 minutes post injection.  All vitals normal.  Patient revealed that she had just picked up her new pain med and took a dose (her first dose) prior to coming in for her shot.  After 30 minutes of monitoring she was escorted to car by wheelchair. No meds given.  She was alert and oriented x 3. Husband in attendance as well.
RASH on left arm, spread over different areas on my body. arms, legs, back.
Pain at the site of application for one week; severe headaches for three days; dizziness on the day; aquicardia for three days; muscle weakness; excessive sleepiness and chills in the first three days; slight tremors in the hands for two days (sometimes come back still); difficulty sleeping (still persists). Twelve days later I got a strong flu with cough and fever.