chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Feb2021 (lot number: EL9263) as single dose at the age of 23 years old, for COVID-19 immunisation. Medical history included common variable immunodeficiency and covid-19 (prior to vaccination). The patient's concomitant medications were not reported. The patient previously took bactrim and clindamycin and experienced allergies. The patient did not receive any other vaccines 4 weeks prior to COVID vaccination. The patient was not pregnant at the time of vaccination. The patient experienced positive covid-19 test with symptoms on 17Mar2021. The patient underwent COVID-19 PCR test with result of positive on 17Mar2021. The patient has not recovered from the events.
Date vials moved from freezer to refrigerator on 15Jun22 and administered on 16Jul22; doses given after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15Jun22 and administered on 16Jul22) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     Patient had no known allergies to medications, food and other products.  Unknown if Patient had ever been diagnosed with/ tested positive for COVID-19.  Unknown if Patient had acute illnesses at the time of vaccination and up to one month before vaccine. Unknown if Patient had chronic or long standing health conditions. Unknown if Patient took prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination and/ or at the time of the adverse event.     On 16-Jul-2022 at 10:37 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Jul-2022 at 10:37 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15Jun22 and administered on 16Jul22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15Jun22 and administered on 16Jul22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. Date vials moved from freezer to refrigerator 15-Jun-2022. It was reported that patient did not have any adverse event. No treatment details were provided.
PT HAS EXPERIENCED FATIGUE, ELEVATED HIGH BLOOD PRESSURE AND FELT LIKE A LITTLE SHORTNESS OF BREATH ON 7TH DAY AFTER GETTING JANSSEN VACCINE.  PT DOES TAKE MED FOR BLOOD PRESSURE AND TAKES ANXIETY MEDICATION AS WELL.
Facial + neck swelling, numbness + tingling in arm, shoulder, neck, face, lips, hands + fingers.  "Spaciness".  Flush in head + neck.
Breakthrough case admission after 4 vaccines Pfizer 4/20/21 Lot# Ew0150;  Pfizer 5/11/21 Lot# Ew0179;  Pfizer 11/11/21 Lot# 32030BD;  5/10/22 Moderna Lot# 049L21A
Hives present on face-not at injection site.  No redness or induration at injection site.  Eating, drinking and playing fine.  No scratching.  Given orapred, Benadryl and Tylenol.
- Adverse events started that day with dizziness and pain at injection site. -Other adverse events that quickly came about include migraines, dizzy spells, nausea/vomitting, faint spells, blood pooling, extreme fatigue, low blood pressure, and tachycardia (all of which continously got worse). - After two years of trying to find my diagnosis, I was found to have P.O.T.S. in 2021. Treatments included increased salt and water, beta blockers, multiple medications to help with symptoms, IV infusions, herbal medicine, compression stockings, etc. However, none of these treatments stop or prevent the symptoms I face daily. Most of the medications I was put on increased my symptoms or gave me new ones.
Warm, flushed, rash on face and chest feeling of weakness in my legs and light-headed upon standing
There are no adverse reaction, the reason of this report is because the patient was under age(17 years) at the moment of the vaccination.
it swelled in to my right lung so bad; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0198) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not know but had pretty involved situation due to, patient had got one of 2 shots and had been on the phone for 2 hours speaking with doctors and everything and it was on 23Jun2021 and it swelled in to right lung so bad, it last 3 days now, the patient had nothing the problems ever since got that shot and did not know that language barriers may affect what was understanding you are trying to tell because of your accent. The patient had gotten over the world and had got nothing against anybody. Anyhow patient spoke to family doctor. The patient having a bad side effect it went through body. The outcome of event was unknown.  No follow-up attempts are possible. No further information was expected.
recurrence of Ulcerative Colitis symptoms:  abdominal pain.  constipation, diarrhea, blood in stool.     Started with constipation and has now turned to mainly abdominal pain, blood & mucus in stools.
pt recvd vax & area around shot hard & slightly swollen; bumps started to form around needle inject area; could not raise arm, nor sleep confortably & had pain; blisters at inject site; arm red; hot; swollen; swelling to shoulder & elbow;
Temperature of 103F, irritable, eating poorly, sleeping excessively, left thigh is warm and swollen when DTAP/HIB given. Convulsion on 8/11/2000 with fever requiring hospitalization.
Patient was well 5/13/21 vaccinated 05/14/2021 with second Moderna COVID Vaccine and according to son pt rapidly declined with recurrent falls 5/15-seen in er 5/16 and sent home and cont to have worsening profound weakness presenting to the ER again 5/18 and admitted with Sepsis secondary to right lower lobe pneumonia, right 8th, 9th and 10th  rib fractures, syncope/ rhabdomylosis and NSTEMI, profound weakness and new anemia with GIB needing 2 units prbcs. Pt was living independently alone pta with help from his son and was at his baseline up until getting his second vaccine. he was ultimately discharged to nursing home on 5/21/21. he was still too weak to walk or get out of bed at the time of discharge.
muscle pain  nausea/ joint pain involuntery rigors (chills)x48hrs fever
Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 7/18/2023 Discharge Date: 7/28/2023   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1]   Patient is a 87 y.o. female with past medical history significant for hypertension, hyperlipidemia, possible chronic obstructive pulmonary disease presented to the emergency department by family for generalized weakness post recent COVID19 infection.  Patient did not have any major acute issues or findings in workup.  She was seen by PT/OT who recommended SAR; she was discharged to SAR on 7/28.
HIVES   8/15/19-6 PM, Stomach area, left side, took 1 benadryl.  8/16/19-7 AM, Thigh, left side. 8/19/19-8 PM, wrist area, right arm.  8/19/19-9  PM, Palm, left hand, under thumb.  8/21/19 Stomach area, right side-large hive, took 1 benadryl.  8/21/19-Right arm, underside.    NONE as of 8/27/19
17 minuites after vaccine admisistration, pt reported sensation of heat in her face and reported a feeling of something stuck in her throat, nausea, and hives were observed on her chest, no facial swelling ,was observed pt was treated with diphenhydramine 50mg IM aproximatley 1110, pt reproted no relief of symptoms approximately 15 minutes after diphenhydramine administration. epiniphrine (epipen) was administered at 1119 in pt right  thigh. 1220 pt vital signs were stable, clear lung sounds, oxygen greater than 95% on RA, pt reported absence of symptoms, no more feeling of object in throat. pt was discharged
Client came requesting a second dose, however it was noted that the client had not received a first dose. Client received a second dose as a first dose.
I had chest pains. I ended up in the emergency room and diagnosed with tachycardia.
Patient experienced redness in the arm that is about 3 inches in diameter that is warm to touch. She also had a low fever a couple of days after receiving the vaccination. Patient complains of recent itchiness around the redness area. I refer the patient to urgent care/ER , or to speak with her doctor as soon as possible.
This spontaneous report as received from a certified medical assistant on 07-NOV-2014 refers to a patient of unknown age and gender. On 07-NOV-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # 0384AE, expiration date: 02-NOV-2014 strength, dose and route were unknown) injection. No adverse effects were noted. Additional information has been requested.
Significant fatigue, hematoma at site of injection, headache, bilateral arm paresthesia, muscular aches.
Info has been received from an RN concerning her 9 years old daughter who in 1997, at 1 year of age, was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. The RN reported that sometime in 2005, her daughter developed chickenpox characterized by 25 lesions. Unspecified medical attention was sought. Four days after developing chickenpox, the pt recovered. Additional info has been requested.
Pt experienced erythematous, indurated area on left leg, no discharge. Treated with Keflex for 10 days.
at 3:40 PM mom noticed rash on the face, checked further no other rash areas.  Rash under eyes, nose and temple.  Treatment with benadryl and cold wash cloths relieves symptoms.
Tiredness, Chills, Shaking, Muscle Aches, Nausea, Headache. This started around 8:30 p.m. on July 20th. It is now 8:00 p.m. on July 21st. I don't feel well. I am mainly tired.  TYLENOL and Pepto BISMOL.
Breakthrough COVID-19 infection.  I tested positive for COVID-19 on April 27, 2022.  My first symptoms were noticed on April 25th but I tested negative that day.  By the 27th I had more symptoms and tested positive.  Other than that, the only reaction to the vaccine itself seemed to be a sore right arm for a couple of days.
I had the first of two SHINGRIX vaccinations around 4:00 PM on Friday January 4, 2019. I felt nauseous at about 7:00 PM. When I went to bed around 10:00 PM my muscle in my upper arm hurt from the vaccination. It hurt for nearly three days. For the first two nights, I could not sleep on my left side where I had the vaccination because of the pain.
After receiving the Booster COVID Pfizer vaccine client reported her "heart beating fast."  RNs responded. The client ambulated unassisted and sat down in a chair. EMT responded and placed the pulse oximeter on the client's finger. Vitals obtained at 1:15 PM were as follows: BP 140/80, HR 71, and O2 99%. EMT responded with the anti-gravity chair. The client ambulated unassisted and sat down in the anti-gravity chair. RN and Interpreter  responded for additional assistance. The client denied any other s/s of anaphylaxis. RN  noted HR of 65 on the pulse oximeter. The client stated she felt "shaking." RN responded. The client reported feeling hot on her chest. RN visualized 3-5 red discoloration spots on the client's chest. The client denied feeling any itching on her chest. RN offered the client Benadryl. The client reported a history of hives after taking Benadryl. The client reported itchiness in her throat. RN activated EMS at 1:20PM. The client was alert and oriented to person, place, time, and situation. The client stated her throat and chest felt better, but felt like her "mandible was shaking." Repeat vitals obtained at 1:25PM were as follows: BP 135/80, HR 72, and O2 100. The client reported persistent irritation on chest. She stated that her trembling was worse. Repeat vitals obtained at 1:29PM were as follows: HR 71 and O2 99%. The client stated her heart racing was not as strong. The client reported new onset of nausea. The client received 1st dose Janssen Lot#042A21A on 04/01/21. The client denied any symptoms after the dose of Janssen. The client reported a history of hypertension controlled with Metoprolol and Hypothyroid controlled with Levothyroxine. EMS arrived at 1:34 PM and assumed care. The client was transported by  Fire Department. VAERS completed. VAERS confirmation number.
Localized, erythematous, 4cm area on the left deltoic with mild itching, edema. Instructed to use ice/cold packs with Benadryl.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, historical conditions or concomitant therapies were reported. On 29-JUN-2016, the patient was vaccinated with improperly stored M-M-R II (albumin status: rHA, lot # L024265, expiration date 01-JUL-2017, route of administration not provided). The vaccine was stored in an improper temperature of 50.8F for a cumulative period of 38 hours. The temperature excursion was captured by digital data logger. No adverse effects were reported. Additional information has been requested.
24 hours after my most recent vaccination I have the following side effects: dizziness and slight vertigo trouble focusing my vision sleepiness (I slept from 10:30 PM till 6:00 AM, and I slept again from 12 noon to 5:00 today and I still feel sleepy) bad fatigue headache trouble concentrating, like I'm a haze I felt heart palpitations when lying down occasional tingling sensation in both hands and forearms  occasionally have strange taste in mouth  so far I haven't had any treatment, I will if these symptoms persist. I feel the need to report this as an adverse reaction because this is the worst I've felt after getting this vaccination.
Redness, swelling at site, date given 11-04-08. Calls 11-7-8 with report pain at site, warmth, swelling and red approx size of fist X 2 days. Pt. advised her to use ice with heat and TYLENOL PRN, per RN Pt to call in 4 hr before office closes with report.
She has had both doses of the covid 19 vaccine and two boosters, all were Pfizer covid 19 vaccines/first day of covid; She has had both doses of the covid 19 vaccine and two boosters, all were Pfizer covid 19 vaccines/first day of covid; 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 64-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "She has had both doses of the covid 19 vaccine and two boosters, all were Pfizer covid 19 vaccines/first day of covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) positive, notes: I tested positive on the 6th of last week and my doctor started me on the Paxlovid,. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient tested positive on the 6th of last week and her doctor started her on the Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1st vaccination:  Sore arm within 2 hours of vaccination. Severe headache 12 hours after vaccination. Extreme fatigue and body chills 2 days and 4 hours after vaccination.
Migraines have became more frequent and more intense to the point of were she could not function; Developed a welt at the injection site that she describes as COVID arm which was a 3-4inch raised circle underneath the injection site; Pain under lymph nodes; Developed thrombosis on her head, but it went away; A spontaneous report was received from a consumer on 04 Mar 2021 concerning a 45-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed thrombosis on her head, but it went away, migraines have become more frequent and more intense to the point of were she could not function, developed a welt at the injection site that she describes as COVID arm  which was a 3-4inch raised circle underneath the injection site,  lymph nodes pain, which she still has.  The patient's medical history was not reported. Current conditions included migraine. The patinet had allergy to latex and pineapple. No relevant concomitant medications were reported  On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection.  Since 14 Feb 2021, patient's migraines had became more frequent and more intense to the point of were she could not function. She also developed thrombosis on her head, but it went away. The patient also developed a welt at the injection site that she described as COVID arm which was a 3-4 inch raised circle underneath the injection site. She also developed pain under lymph nodes, which she still had.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The event of migraines have became more frequent and more intense to the point of were she could not function and pain under lymph nodes which she still has were unresolved, the event of developed thrombosis on her head but it went away was resolved, while the outcome of the event of developed a welt at the injection site that she describes as COVID arm which was a 3-4inch raised circle underneath the injection site was unknown.   The reporter did not provide an assessment for the events thrombosis on her head, but it went away, migraines have became more frequent and more intense to the point of were she could not function, developed a welt at the injection site that she describes as COVID arm which was a 3-4inch raised circle underneath the injection site, Pain under lymph nodes, which she still has.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I just had a pain in my hands, it was just sore. I went to urgent care and it negative; I went back because my throat was hurting. I tested again and it was positive. I just took TYLENOL, ADVIL and a cough syrup. I did have a little cough. I think I took too much and developed acid reflux. The sore throat continued, then I knew from my doctor it was acid reflux.
fatigue , nausea, vomiting, slow speech, memory problems, sluggish, weakness , swelling of the arm, Sent him to hospital ER
Severe arm pain and bodyaches, headache, fever, ***inflammatory rash on left breast-this was most concerning. Looked like hives.
tinnitus, ringing in ears daily, has not gone away since 2nd vaccine, worsened at night, sometimes interferes with my ability to focus on my work
COVID-19; confusion; weakness; cough; fever; body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), ASTHENIA (weakness) (seriousness criterion hospitalization prolonged), COUGH (cough) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization prolonged) and MYALGIA (body aches) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 14-Mar-2021 due to ASTHENIA, CONFUSIONAL STATE, COUGH, COVID-19, MYALGIA and PYREXIA. At the time of the report, COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 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 relevant concomitant medications were reported.   Treatment information was not provided.  Patient was hospitalized due to worsening condition.  Company Comment: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Syncope 5 minutes after HPV (GARDASIL) vaccine lasted about 1 minute with L arm jerking X 3 sec pale looking referred to ER. BP 100/80, HR 78, RR 18, O2 sat 97%.
Rash for 1 day-scattered, rare (<20) vesicular lesion on red bases, in various stages on chest, belly, legs, arms and 2 on face.
40-year-old female presents for rash s/p receiving her 2nd Moderna vaccine. States she received the vaccine at 12:30 pm. Completed her 15 minute observation period with no reaction. States around 12:55 she started feeling hot and itchy and noticed that she had developed hives to her chest and neck. Denies any swelling of the lips, tongue, throat, or difficulty breathing. She returned to the vaccine clinic where she was brought to the acute care area. VS @ 1300 were BP 122/67 HR 87 R 16 PO 98%. Patient was in no acute distress. Uriticaria was noted to her anterior chest and neck. No swelling of the lips, tongue, or throat were noted. Airway was patent. Lung sounds clear. She was given diphenhydramine 50 mg PO @ 1305 and observed for 30 minutes. Hives improved and almost completely abated. No swelling of the lips, tongue, or throat. Airway patent. No respiratory distress. VS at 1335 BP 110/62 HR 78 R 16 PO 98%. Patient was discharged in stable condition to home with instructions to seek immediate medical attention in the ED should she have any worsening of symptoms. Verbalizes understanding and agrees with POC.
Patient called and states Friday early evening hours she had a terrible headache, fullness in her throat,  ear pain,  muscle pain, gum pain and then Saturday morning woke up with blisters in her mouth.
3 x 4 cm area of hot & red area deltoid area post 11/5/99 DTAP. Pt was given antibiotics per PMD.Dxed w/ unspecified cellulitis.