chrisvoncsefalvay/vaers-outcomes huggingface dataset:
C-Section delivery of twins on date. Hospital admission for delivery was within 6 weeks of receiving the COVID vaccine.
Several hours after 10:30am vax, odd sensations in left ear canal/drum, as like needing to equalize pressure. Unaffected by scratching or wiggling. Then it turned in to tinnitus by about 7pm. of moderate intensity, lasting for about 5 hours that night. Was bad enough did not think I'd be able to sleep, but abated while reading in bed, and was gone in morning. No further issues since.
His arm blew up to the size of a baseball, red, itchy, burning. Also spiked fever of 100 (his normal temp is 97.8)
Pt reports 4 days after taking the Pfizer COVID vaccine she developed unrelenting pain and soreness to her left arm followed by general myalgias to her body and weakness. She states she sx have not resolved and has only been taking ASA. Rx Voltaren gel and Tizanidine refill given.
Patient given vaccine. Within 5 minutes husband said she?s having another spasm.  She was being monitored for 15 minutes after the injection.  After the spasm  it appeared to. become a seizure and  passed out for 5 minutes .  Husband said she missed her medicine and needed her carbidopa/levodopa. 911 arrived and administered oxygen and took to the hospital.
Getting breakthrough cases; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Getting breakthrough cases) in a  patient of an unknown age and 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Getting breakthrough cases) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Getting breakthrough cases) outcome was unknown.            Concomitant product use was not provided by the reporter.  Reporter stated some people who have completed the Moderna COVID-19 vaccination series (dose 1 and dose 2) are now getting breakthrough cases.  No treatment information was provided.  This case concerns and unknown person with no history who called to report that several people, presumably who they knew, had received both doses of a COVID-19 vaccine, manufacturer unknown, and had a breakthrough infection. No dates dosing information or other relevant information is reported. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns and unknown person with no history who called to report that several people, persmably who they knew, had received both doses of a COVID-19 vaccine, manufacturer unknown, and had a breakthrough infection. No dates dosing information or other relevant information is reported. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: finger numbness tingling-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: tingling fingers
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient hospitalized 1/29/22-2/4/22 for small bowel obstruction, abdominal pain. Tested positive for COVID 1/29/22. Oxygen saturation 93-98% on room air-no treatment for COVID indicated per MD.
This is a 19 y.o. female status post 1st dose of Moderna vaccination on 04/14/21 at 130PM. Patient was outside under the tent waiting 15 minutes  post vaccination when she fell out of her chair and onto the ground. Upon arrival, patient was lying face down and unresponsive. 10 seconds later patient regained consciousness, but was lethargic, clammy and pale. Patient is nauseous and vomiting. With assistance, patient was transported via wheelchair inside the modular unit in the  parking lot. Reports eating a cookie this morning. Last meal was last night and it was a bowl of spaghetti.  Patient reports having a syncopal episode and seizure 5 months ago after getting a COVID-19 nasal testing. Denies any medical history, no NKDA, no medications, no recent illness. Initial VS at 1400 was 90/56 HR 52, 02 sats 98% on room air. Denies SOB, denies difficulty breathing, denies chest pain, denies HA, denies dizziness.  VS 1408- 90/56 HR: 57 BPM, RR: 12 BPM, O2 Sats: 98% Room Air VS 1425-91/57 HR 50 BPM, RR: 12 BPM 02 Sats 98% Room Air VS 1440- 94/57 HR: 54 BPM, RR: 12 BPM, 02 Sats: 98% RA  Plan: Syncope and collapse- Patient was evaluated for 1 hour. Patient reports that she was feeling much better and was eager to go back to her room. Her pallor improved, she was AOx3 and speaking in clear sentences. , RN was advised to try patient with sips of clear liquids and provide her some crackers and have patient ambulate prior to discharge. When the nurse was repeating her VS and providing the patient the crackers, patient experienced another syncopal episode, but regained consciousness immediately. VS at 1450:  HR 49 BPM, O2 Sats 99%, BP 82/50.  Because patient experienced another syncopal episode, 911 was dispatched for ER evaluation. Patient asked that I speak to her mother, mother updated on patient's condition and that she needs to go the ER for further evaluation. Mother agrees and verbalizes understanding of care. Spoke to  with the local health department and she reports that this case will need to be reported to VAERS. Patient is being transported by stretcher to the hospital. Will follow up with the patient.   Nausea and Vomiting- Patient refusing Zofran IM, prefers PO. Zofran 4 mg SL given once at 1400 for nausea and vomiting. Nausea and Vomiting improved within 20 minutes. No nausea or vomiting upon discharge from the health center.
Headache, Myalgia, Arthralgia, Diarrhea, Fatigue Narrative:  Had body aches, fatigue, arm soreness day after injection. Took Ibuprofen. Felt terrible the next day. Also reported diarrhea.
Initial information received from other company on 07 JANUARY 2013. The initial reporter was a healthcare professional. A patient, whose age, gender, medical history and concomitant medication were not reported, had received a dose of FLUZONE (batch number, dose number, route and anatomical site of vaccination were not reported) on an unspecified date a few years ago. On an unspecified date, after vaccination the patient developed an unspecified reaction. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome of the event was not reported. List of documents held by reported: None.
First 3 days, heart racing, blood pressure issues (not sure exactly) I couldn't go up the stairs, getting off the couch I'd nearly pass out. Chest pain. On both hands my middle finger to my pinky would tremor on and off for weeks. It was constant the first 3 days. I felt like the inside of my body was on over drive and the outside of my body was lethargic. The symptoms have persisted on and off for a month now. Currently, I have a heart monitor on for a week. I had blood work done, most of it came back normal. My bilirubin is always elevated due to Gilbert's syndrome. But my bilirubin count was double what it was in March of 2021
Vaccine administration error. MMR vaccine was administered too early, it was given two weeks after varicella vaccine was administered.
Currently 8 months pregnant, due May 19th 2021.   Adverse effects were: muscle and joint pain as well as fever. Muscle pain started 4/13 around 8/8:30pm and persisted until 4/14 around 10pm. Fever started in the middle of the night on 4/13 into 4/14, peaked at 7 am on 4/14 at 100.8, took Tylenol and fever broke about 2 hours later. Muscle pain intensified around 3pm 4/14 and lasted until about 9pm.
After about a month my Wife started to show signs of weakness and unable to do a lot of the daily routines and appreare to have no energy.  We have been wondering why this was happening and I mentioned that all of this started happening about a month after the short and she agreed.  She has continued to go down hill with little energy and sleeps a lot.  Her voice has weakened.  I decided to make a report for her as this is the only thing that I can think of that would have caused her health decline.  Prior to the shot she was active and could do many routine things during the day.
Patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired vaccine) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired vaccine) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     No treatment information was provided.
Syncopal episode which occurred five minutes after intranasal vaccine was given.  This happened while patient was driving and resulted in an accident with no injuries, but car was totalled.
Patient received MMR vaccine only, as patient was walking out to the check out desk patient whispered to her mother and she fell limp in her mother's arms.  The patient immediately opened her eyes when PHN called out her name, a cool compress was applied to the forehead and the back of the neck, EMS was notified per mother and the EMS was in the clinic within less than 5 minutes.  Ems assessed the patient and recommended she be transported to hospital for evaluation.  The patient did not hit her head or any other part of her body when she fell limp, she was in her mother's arms.  The patient and her mother/EMS left the clinic at exactly 11:30 AM
Second dose outside of 42 day window; Red, bruised like a deep purple rash; Itchy; Hive near the injection site; Red at injection site; Swollen at injection site; Arm has some soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm has some soreness), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Hive near the injection site), VACCINATION SITE RASH (Red, bruised like a deep purple rash) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm has some soreness), VACCINATION SITE URTICARIA (Hive near the injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). On 12-Mar-2021, the patient experienced VACCINATION SITE RASH (Red, bruised like a deep purple rash). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose outside of 42 day window). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm has some soreness), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE URTICARIA (Hive near the injection site), VACCINATION SITE RASH (Red, bruised like a deep purple rash), VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE SWELLING (Swollen at injection site) and PRODUCT DOSE OMISSION ISSUE (Second dose outside of 42 day window) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included blood pressure medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Follow-up information received  contains non-significant information. On 22-Jun-2021: Follow up received on 22-JUN-2021: Event was added.
booster shot instead of third shot; side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) and ACCIDENTAL UNDERDOSE (booster shot instead of third shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Primary immunodeficiency syndrome.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (side effects). On 17-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (booster shot instead of third shot). On 17-Dec-2021, ACCIDENTAL UNDERDOSE (booster shot instead of third shot) had resolved. At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            Patient received the booster shot by mistake, instead of the third full dose. Pharmacist called and Moderna said to give another booster shot as soon as possible. Reporter wanted to know if they can delay it as patient got side effects and Christmas is coming up. No concomitant medication were provided. No treatment information were given.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/07/21 2nd dose01/28/21 Diagnosed covid positive:08/23/21 Symptom onset: Exposure: Symptoms:Asymptomatic.
This spontaneous report was received from a physician, referring to himself, a 66 year-old male patient. The patient did not have any concomitant medications or medical history were not disclosed. Past drug reactions included Parsonage Turner Syndrome developed after the vaccination with an unspecified flu vaccine, on an unspecified date in September 2018. On 21-JAN-2019, the patient received a dose of PNEUMOVAX 23 (route, dose, frequency, lot # and expiration date were unknown) in the left arm, for prophylaxis. He reported that the vaccine was painful when administered (injection site pain) and later that day, he had soreness at the injection site and chills, but no fever. The next day, on 22-JAN-2019, the patient felt that pain traveled to the bicep (pain in extremity), and there was macular redness at injection site (injection site erythema). Afterwards, on 23-JAN-2019, the patient experienced some distal swelling (peripheral swelling) and noticed that the redness spread to size of 4.5 inches by 3 inches (erythema). The patient reported that he received treatment due to these events and sought medical attention with a primary care physician, but it was not specified further. No Lab diagnostics or studies were performed. At the time of this report, the outcome of pain in extremity, chills, injection site erythema, injection site pain, peripheral swelling and erythema was reported as not recovered. Causality assessment between PNEUMOVAX 23 and the aforementioned events was not provided by the reporter.
This case was reported by a healthcare professional and described the occurrence of allergic reaction in a child subject of unspecified gender who was vaccinated with TWINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk), MMR vaccine (non-gsk) and PREVNAR (Wyeth). On 20 June 2011 the subject received unspecified dose of TWINRIX (unknown), varicella virus vaccine (Non-GSK), MMR vaccine (Non-GSK), and a dose of PREVNAR (Wyeth). On 20 June 2011, less than one day after vaccination with MMR vaccine, PREVNAR, TWINRIX and varicella virus vaccine, the subject experienced allergic reaction. The healthcare professional considered the event was clinically significant (or requiring intervention). The child was treated in the emergency room and then released. At the time of reporting the event was improved. No further details were known at the time of reporting. The lot number for TWINRIX was reported as 0125AA from the reporter; however, based on a TWINRIX lot number review, it was decided to enter the batch number as AHABB0125AA?. Expiration was not provided.
I began to fell dizzines when bending , moving head, or laying down early in the week. I began to feel discomfort in my ears on Friday 9/9/2022. I went to the Urgent care because I thought that I had an ear infection. I was diagnosed with Otalgia of right ear, non-recurrent acute serous otitis media of right ear, and BPPV (benign Paroxysmal positional veritgo,) right. I was given the following medication: amoxicilian, meclizine, and predniSone. I was also given exercises to help the displaced crystals in the inner ear to move. I really do not believe that my condition was caused by the vaccine. I believe that I began to experience the dizziness prior to receiving the vaccine.
Pt received 2nd dose of Moderna vaccine #034121A at approximately 0830. At about 0840: Pt reported feeling a mild "itch in the throat, right arm, and back". Pt stated she felt her throat "closing a little" Pt was brought back to the oberservation unit at 0841. Pt took her own diphenhydramine 50 mg at approximately 0842. Lung sounds clear and no stridor indicated. Continue to monitor.   Vitals :0845   Temp: 97.5 BP: 157/91 HR: 65 RR: 18 O2: 99 on RA   0900: Pt stated her symptoms are not getting worse. Pt was able to drink water and carry a normal conversation with this RN. Continue to monitor.   Follow up vitals at 0915:   BP: 153/100 HR: 65 RR: 18 O2: 100 on RA   Lung sounds are clear and no stridor indicated. Pt stated she is not feeling worse. Pt is working on her phone and taking phone calls and able to carry a conversation. No complaints of SOB. Continue to monitor.   Follow up vitals at 0930:   BP: 159/89 HR: 60 RR: 18 O2: 100 on RA   Pt stated symptoms are getting better. Itching is resolving. Throat doesn't feel constricted anymore. Lung sounds clear and no stridor indicated. Continue to monitor.    Follow up vitals: 0945:   BP: 136/95 HR: 55 RR: 18 O2: 100 on RA   Pt feeling much better. No other symptoms reported besides mild itching to the stop of scalp and chin.    Dr. was updated on pt's progress and current status and cleared pt to go home. Pt was educated on precautions to take if worsening symptoms develop. Pt advised not to drive. Pt passed walking test and swallowing test.
BAD ADVERSE REACTION; This spontaneous report received from a consumer via a company representative 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced bad adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad adverse reaction was not reported. This report was non-serious.
Pentacel  Vaccine Lot # UJ571AAA Exp. date 09112011 was give by RN.  He scanned Pentacel vaccine in system, administered vaccine, and attempted to put administration documentation and it would not pull vaccine with lot # and he realized he did not check expiration prior to administration and had administered an expired vaccine. LPN who manages vaccine inventory had Pentacel written on Monthly Expiration Date calendar and also on calendar at desk with other vaccine that was due to expire 09092022. She checks this calendar daily for vaccines that are due to expire and removes them. She removed other vaccine from vaccine refrigerator on 09092022 but failed to remove the Pentacel vaccine on 09092011 that expired 09112022.  She put a check mark by vaccines on Monthly Expiration Date calendar and desk calendar  indicating both had been removed. They immediately came to Nursing Supervisor and notified her of error.
Pt recvd 2nd dose of MMR vax 17SEP90; 18OCT90 lab eval revealed pos preg test; 20OCT90 exp heavy bleeding; Pathology report small tissue sample on 22OCT90 revealed decidual tissue & endometrium; Dx intrauterine preg w/spontaneous abortion;
Physician ordered pneumo vaccine. patient given varicella  Lot # 0994X    Exp: 11 July 2010
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (vaccine administered after 6 days of puncturing the vial) in a 92-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006C21A) for COVID-19 immunization. No medical history reported. On Sep 2, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 2, 2021, patient administered expired product (vaccine administered after 6 days of puncturing the vial). On Sep 2, 2021, administered expired product (vaccine administered after 6 days of puncturing the vial) resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information. This case linked to MOD-2021-337437 (patient link). Most recent follow-up information incorporated. On Sep 28, 2021: Follow-up received contained updated event verbatim.
pt who was reported in excellent health & did not have HTN, high cholesterol, or cardiovascular disease recv vax & was found dead;COD=cardiovascular disease & HTN
One week after the shot I have an itchy rash that developed on my arm at the shot site. I also have several itchy bumps and hives that have developed on my forearms, elbows, palm and back of the hand.
Sustained tachycardia presenting as poor feeding and decreased responsiveness.  10/5/09 Hospital records, DC summary, received DOS 7/2/09 to 7/3/09. Assessment: Viral infection with unknown location, anemia unknown etiology, tachycardia, lethargy, dehydration. Patient became lethargic and had low-grade fever. Fussy. Poor feeding and decreased level of activity. Bandemia. Pallor. Grunting respirations. Labored breathing. Spitting up. Heart rate 200 /min.   ICD-9 Codes: 785.0 Tachycardia NOS, 285.9 Anemia NOS.
Narrative:  Per comment on ADR: maculopapular rash on both arms, about 2-3 weeks after vaccine. Note vaccine given 03/26/21. Patient seen in urgent care on 04/05/21 for shortness of breath. Patient was sent to non-agency hospital with acute on chronic respiratory failure, COPD exacerbation, CHF exacerbation, acute alcohol withdrawal, acute kidney injury. Patient seen per PCP on 04/16/21 where reaction reported; however, unable to locate documentation of rash evaluation.