chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  78-year-old M with PMHx of dHF (EF 56%), CAD s/p PCI x2 in 2005 x3 2015, left neck Ca s/p radiation (1962), tracheostomy (1972), and PEG tube placement, IDDM, HTN, chronic occlusion of carotid arteries in home hospice care died at home on 12/11/2021. Pt had received covid vaccines on 3/4/21 & 4/1/21. Pt's death is not related to covid vaccines.
Severe Dizziness/Vertigo started evening 02Apr2021 Unable to perform normal daily activities  No treatment at this time  Still ongoing  Nausea with the dizziness/Vertigo  Still ongoing    Injection site soreness  beginning on 01Apr2021 Still ongoing
Numbness on top of young and my lips. I had confusion, anxiety headache, lungs were feeling extremely hot, nauseous, increase heart rate and elevate blood pressure extreme confusion . I was rushed inside the Er. I received a Ct scan, ,lab work, and a EKG I received IV ,fluids,Ativan,, Diphenhydramine, famotidine and Prednisone.
10 minutes After receiving Covid19 moderna vaccination while sitting in the designated post vaccination area pt became weak. According to eye witness statement she started to tilt forward and fell on the floor landing on her right shoulder. She did not witness her head connect to the floor. after 3 seconds she regained conscious and started shaking and vomiting. Medical attention was provided immediately, patient was stabilized and blood pressure checked. after vomiting pt state she immediately felt better. she was provided water and monitored for additional 30 min. she refused EMS or any additional medical treatment. Then event was also documented by store management.
Erythema and induration at site. Size is approximately 10x10cm. Stop amoxil and begin augmentin ES600 3.7ml BID x 5 days then restart Amoxil prophalaxis.
Patient experiencing fever and swollen in injection site area.  Patient is taking tylenol to help with symptoms.
Pain swelling induration at injection site diagnosed as cellultiis. Negative blood cultures temp 100 deg-101.8 deg F. Clinically toxic. Treated with IV Kefzol. Discharged on Augmentin. The discharge summary states chills, anorexia, nausea, and pain.
Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.
The pt developed tenderness and redness on a 2cm area around the site of the vaccinia vaccination with lymphangitis distally; treated with Levaquin 500mg a day X 5 days.
scattered vesicles on erythematous base-typical of mild varicella;no systemic sx/h/a, feverishness, myalgia;
Breakthrough case admission after 3 vaccines Moderna 3/9/21 Lot# 010A21A;  Moderna 4/6/21 Lot# 017B21A;  Moderna 1/9/22 Lot# 068H21A
TINNITUS/RINGING IN BOTH EARS FOR 3 MONTHS; This spontaneous report received from a patient concerned a male 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 not reported, batch number: unknown and expiry: Unknown) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced tinnitus/ringing in both ears for 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus/ringing in both ears for 3 months. This report was non-serious.
nose was bleeding, mouth, blood in urine & stool 2 days prior to being seen by MD in clinic, filled out request slips to be seen; sent to ER 18MAR94;
Information has been received from a pharmacist, concerning a 67 year old male patient who was vaccinated with a dose of VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) by mistake because one technician said to another one that the patient needed the shingles vaccine and when the other technician saw the packaging he said that the vaccine shown was the one for the shingles not realizing that he was looking at the wrong vaccine.  The pharmacist reported that then the vaccine was sent to the patients primary care office to be administered to the patient.  At the clinic the nurse administering the vaccine did not do a final check and gave then the wrong vaccine to the patient.  The pharmacist stated it was not product confusion.  No adverse reaction were reported.  The pharmacist also reported the patient's wife received the wrong vaccine (refer to 0809USA00001).  Additional information has been requested.
I felt extremely exhausted for exactly 2 weeks. I had random migraines from left side and then to the right side back and forth. I felt having a foggy brain, unable to focus, I had heart racing at times when sitting at home at rest, the worst side effect was feeling anxiety and heart racing, this happened 2 times and it was pretty bad. I never had history of headaches or any anxiety before.  Reduced sleep was another side effect, usually I sleep 9 hours, during the 2 weeks it was reduced to 6-7 hours.
had her shot of Covid vaccine last (22Dec2020) 7 days and was tested positive on Dec2020; had her shot of Covid vaccine last (22Dec2020) 7 days and was tested positive on Dec2020; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. It was reported that the patient had her shot of Covid vaccine last (22Dec2020) 7 days and was tested positive on Dec2020. She wanted to know if this was normal to get false positive results after getting the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Presented to hospital c/o SOB, diarrhea, nausea.  Patient denies any fever, chills, headache, photophobia or blurry vision.  He denies chest pain.  Developed acute hypoxemic respiratory failure.
On 10-9-2021, I noticed fatigue, muscle aches all over, fever up to 102.0, sweating and left arm soreness to the point that I was having problems lifting it I stayed in bed for 3 days. On day 4,  i noticed swelling to my ankles and hands but I started feeling a little better and was able to get out of the bed and move to a different room. I did not call or go to the doctor.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Patient came on 5-10 to get revaccinated with another Pfizer 0.3ml dose.
That evening, when I received the vaccination, I had tingling behind my teeth and like a small throbbing behind my teeth. Small headache that lasted 40 minutes. Pain in my ears and a muffling sensation. The next day, which was Tuesday, I felt ok when I woke up but was somewhat stiff with body stiffness throughout the day though. That went on all day and into the night. I stayed home Wednesday from work. Early Thursday morning, right leg pain and throbbing in right groin area and that hurt pretty bad. I took Ibuprofen for that. When I woke up Thursday morning, I had chest pressure and that lasted through out the day. I went to Urgent-Care, ER yesterday. I still feel the tightness in my chest. The doctor prescribed some medication for inflammation - Naproxen. He said possibly I have inflammation on the lining of my lungs so he is treating me for that. When I went in to the hospital, I had blood pressure reading of 144/99 and that's high for me.
Initial information received on 13-Feb-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a four-month old male patient who was vaccinated with a dose of PENTACEL lot U1966AA (liquid vial: Lot: U6138AA, exp date: 7/7/2020, lyophilized Powder: U1966AA, exp date: 7/7/2020 Package: U1966AAA, exp 7/7/2020) via unknown route in the left thigh on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to Inappropriate reconstitution technique. It was reported that patient had the diluent via (Dtap IPV) but not lyophilized powder (HIB). It was reported that the patient had no reports of any side effects. 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 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. List of documents held by sender: none.
MOM CALLED AND STATED THAT CHILD HAD A FEVER OF 102.5, RASH ON TORSO, DIARRHEA AND VOMITING WITH LAST IMMS ON 6/9/15. ALSO STATES THAT HAD THE SAME REACTION THE PREVIOUS TIME BEFORE WHEN IMMS WERE ADMINISTERED ON 5/12/15. S/SX OCCURRED 4-5 DAYS AFTER SHOTS AND MOM FELT CHILD WAS REALLY SICK. NOTIFIED PEDS DOCTOR.
Patient had felt different since the vaccine.  Tired and occasional nausea.  He died suddenly March 30th, 2022 from a heart attack.  He had never had blood pressure issues or heart problems.
This case was reported by a pharmacist via call center representative and described the occurrence of thyroid disorder in a 62-year-old male patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 2nd February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced thyroid disorder. The patient was treated with iodine (131 i) (Radioactive Iodine). On an unknown date, the outcome of the thyroid disorder was unknown. It was unknown if the reporter considered the thyroid disorder to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received radioactive Iodine 1 to 2 months before the date of reporting for a thyroid condition after receiving the SHINGRIX vaccine. The pharmacist considered it as unknown specifics of the condition and if possibly related to receiving the vaccine. No additional Information was provided.
pt woke up morning of 14MAY99 c/o rt arm hurting;applied cool compresses;parents took child to ER late evening p/noting rt deltoid red & warm to touch;area of redness approx 2 inches;to clinic 17MAY99 2PM;rt deltoid red & feverish inj site;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 25-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
dizzy spells; Could barely walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Verbatim: stent placed" (unspecified if ongoing), notes: Cardiologist placed a stent four years ago. He has had no problems. He works out three times a week. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL9266, Expiration Date: 31May2021,  Anatomical Location: Left arm), administration date: 14Feb2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 26Mar2021, outcome "recovering", described as "dizzy spells"; GAIT DISTURBANCE (non-serious) with onset 26Mar2021, outcome "recovering", described as "Could barely walk". The events "dizzy spells" and "could barely walk" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had received the second dose of the Pfizer covid19 Vaccine on 07Mar2021 and experienced no problems afterwards. About 3 weeks after, however, patient was started getting dizzy. It started when patient went down the stairs and subsided until about 3 hours while he was driving, after turning on a red light. Patient was so dizzy that he got out of the car and could barely walk and got his wife to drive. Patient stated, he was fine but there was still a trace of the symptom and it was less severe than it was. He was also on a HF Monitor and will follow up with his doctor. He is a healthy man who does not get sick usually and he was asking if there have been reports of this with the vaccine. Patient did not take his first card with him when he got the second one so he has two cards. He was not sure which lot# EL9266 and EN6205 was his first dose and which was his second dose. Patient would think the one with the earlier expiration date would have been what he got first, but he wants to say it was not. On the card it says first dose Pfizer EL9266. Patient went to the emergency room on 26Mar2021, for dizziness and and his cardiologist but everything was normal. Patient family history was not reported. Patient did not had any AE wit Prior vaccination. The patient had not received prior vaccinations within 4 weeks of getting his first COVID vaccine.  Follow-up attempts are completed. No further information is expected.
I had a fever, congestion, cough, night sweats, headache, ear pain, and fatigue. I congestion was heavy enough that I couldn't breath and I still have a bad cough. This lasted for 7-8 days.
Developed urticaria and angioedema about 3 weeks post smallpox administration.  Still persists.
Swollen lymph nodes on my collar bone; it is painful, it hurts; This is a spontaneous report received from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0187) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient had no medical history and was not taking any other products. On an unspecified date, after receiving vaccination, patient experienced swollen lymph nodes on collar bone, it was painful, and it hurts. Reporter seriousness for Swollen lymph nodes on my collar bone and it is painful, it hurts was unspecified. Consumer asked, "I just need to know if this was normal. Yeah, because it was painful, it hurts."  Consumer was unwilling to share further information. Hence further probing could not be done. Thus, limited information available.
Pt adm 1st dose of vax dialysis formulation 16NOV90; On 20NOV90- lab eval revealed Hep B surface antigen positive & anti-HBs antigen negative; Repeat lab eval 01DEC90 revealed Hep B surface antigen negative & anti-HBs antigen negative;
PFIZER COVID-19 EUA: Fully vaccinated patient presented with loss of taste and smell
Pt called office this afternoon to alert nurse that he woke up this morning with vomiting and sweats. Denies any fever, states he does feel weak, fatigued and did have chills last night. Also states he started with left sided chest pain last night that has continued to be on and off. Advised pt that because of the chest pain he is having it is advised he go to the ER for further evaluation. Pt in agreement and is self transporting to local ER.
patient had a rash and itchiness around site of injection. Patient is allergic to egg but gotten flu vaccine before and for the last 5 years with no reactions.  Patient said symptoms got worse on Friday (10/7) and Saturday (10/8) and that she almost went to the ER. She took some Benadryl for the itchiness and also topical Benadryl for the rash.
Tested positive for Covid after receiving first Covid-19 vaccine; Tested positive for Covid after receiving first Covid-19 vaccine/low grade fever; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982, Expiration date: 20May2021), via an unspecified route of administration, administered in Arm Right on 23Jan2021 14:00 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had got the vaccine, then 16 days later got symptoms of Covid, then on the 17th day, tested positive for Covid and this was after the first dose of the vaccine. He had a low grade fever on 10Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Feb2021. The outcome of the events was unknown.
This spontaneous report was received from an office manager and refers to a 12 month old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 02-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004506: US-009507513-1704USA004505: US-009507513-1704USA004495: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Pt is afraid of needles and has anxiety and no breakfast.  Pt was vaccinated at MAR area and provided with juice & water.  Pt was asymptomatic and stable and released home with mother
Participant states she Woke up not feeling well in the morning she felt like she had been hit by a truck. She had a headache and body pain then noticed about 3 hours later she needed to take her temp and had realized she had a fever of over 105 degrees. She called her doctors office and spoke to Pulmonologist he stated he believed it was a reaction to the shot, He advised her to take Tylenol drink lots of water and monitor symptoms. If not better to go to ER. She monitored symptoms  and took Tylenol while drinking fluids and each day her temp went down. By Saturday temp was 103, by Sunday temp was 101 and by Monday she was back to normal.
Redness, swelling (2 1/2"), itching, black and blue patch above injection with red blood spots, has lasted 5 days and still has not gone away.
passed out; Anxiety; right now she has trouble breathing; nauseous; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C2LA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), ANXIETY (Anxiety), DYSPNOEA (right now she has trouble breathing) and NAUSEA (nauseous). On 03-May-2021, LOSS OF CONSCIOUSNESS (passed out) and NAUSEA (nauseous) had resolved. At the time of the report, ANXIETY (Anxiety) and DYSPNOEA (right now she has trouble breathing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events at was reported as medic was about to give oxygen. The patient did not know if it was her oxygen or heart rate that was low but she became conscious.  Patient is worry about taking second dose. She asked if something bad will happen if she stopped at first dose.
Pt received dose #1 of the Moderna COVID19 vaccine, while sitting in observation she reported feeling itching in her fingers and burning in her arm. Pt has history of anaphylaxis to iron infusions which she has been receiving since she was a child. Pt was evaluated by Trinity EMS. Pt signed refusal for transport to the hospital. Pt was given ED precautions and advised to contact her PCP to discuss her symptoms. Pt verbalized understanding.
Chills, fever, headache, body aches, soreness, and irregular menstrual cycle including blood clots and severe pain.
Localized reaction (L) upper arm after Tdap, MCV4 warm to touch, not hard, 4" area.