chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain; nausea; dizziness; aches; fever; This is a spontaneous report from a contactable nurse. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in right arm on 20Jan2021 17:30 (at the age of 45-year-old, Non-pregnant) (Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included migraine, essential tremor, fibromyalgia, arthritis and allergic to Sulfa. Patient has not covid-19. Concomitant medications included methylphenidate hydrochloride (CONCERTA), Propranolol, Tizanidine and Trazodone all for unknown indication. The patient experienced arm pain, nausea, dizziness, aches and fever on 21Jan2021 13:00. Since the vaccination, the patient not been tested for COVID-19. No treatment for events.Outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Developed rash on extremities 2 days after getting flu shot. Rash present today (10/21/) started BENADRYL P.O. To medical aid on unit 10/22 for rash/swelling, Took steroid dose pack and improved.
Initial report was received on 29 August and 31 August 2011 from a consumer, who is also the patient. A female patient, who was 69 years of age at the time of the report and had a history of diabetes, unspecified allergies, nose bleeds since childhood, and allergies to "myacine" and sulfa drugs, had received a INFLUENZA VACCINE (manufacturer unknown, lot number, route, site and exact date of administration not reported) during the first or second week of November 2010 and approximately three months later, she developed intermittent itching at the injection site and was diagnosed with ITP. The intermittent itching occurs once in a while and persists and corrective treatment consists moisturizing cream applied to the affected area. The patient also experienced cold symptoms and a mini-flu described as sore throat, ears were sore, headache and upset stomach (onsets not reported) lasting four to five days which resolved. According to the reporter, somewhere between 27 February 2011 and 01 March 2011 she was diagnosed with ITP. She was hospitalized for four days beginning the morning of 01 March 2011 and her platelet count was 6,000 at that time. She received unspecified treatments to increase platelets described as "some type of cancer drug that started something like Restin". While hospitalized, platelets increased t0 25,000 to 40,000 and the patient was discharged. Four days later, the patient was hospitalized again due to a decrease in platelets to 12,000. Internal bleeding was suspected but was negative. After hospital discharge, she received infusions (not specified) for four weeks which were unsuccessful. The patient has also experienced nose bleeds due to her allergies on occasion which last anywhere from 30 seconds to eight minutes. Concomitant medications include Lantus and an unspecified blood pressure medication. The patient had also been taking GLYBURIDE which was not working; her blood sugar ran 210 220. She switched to LANTUS in April 2011 which reduced her blood sugar nearly 100 points; now running 120-130. According to the reporter, it seemed with her blood sugar under control her ITP was not as bad. The patient has been seen by a hematologist/oncologist and her platelet count was 40,000 - 50,000 at the time of the report. According to the reporter, the outcome for the event of ITP and itching at the injection site were not recovered. The reporter for this case is the same as for case numbers 2011-08150 and 2011-08182.
To H.D. 12-23-08 for vaccines to travel Jan 9 or 10th, 2009 awoke with severe pain in "every" joint. Took aspirin, pain gradually decreased. Felt much better by 1/16/09, although finger and toe joints remain stiff, "uncomfortable" as today. Swelling in knee and behind knees and "some swelling in wrist".
Tightness in throat, wheezing, injected sclera, watery eyes, injection site swelling. Consulted with medical professional. Took Benadryl 50mg and Ibuprofen 600mg complete resolution of throat/chest symptoms at 12 hours and resolution of eye symptoms at 24 hours.
Patient was administered the Pfizer vaccine and was asked to wait around the pharmacy for 15 minutes post vaccination. After 5 minutes, patient started feeling dizzy and started to faint. He was accompanied by his parents, father tried waking patient up a few times but he was unresponsive to wake and started to tilt his head backwards and falling over. We called the paramedics and administered the epipen. Father did notify us that patient is fine and was discharged from the ER on the same day.
expired Daptacel was administered; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that expired Daptacel was administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included IPV and MMR vaccine.  On 19-Apr-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: 65169AA and expiry date: 16-Mar-2019) via intramuscular route in the right thigh.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  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.
2 and half days after, started feeling tingly and very ill. Realized my heart was skipping very fast. Because I have had this before, I wasn't concerned. But about 5-6 days after, felt tingly outside of my little fingers, toes numb, outside of left leg numb up to knee, face from jaw to forehead was numb. Then called clinic. Doctor thought I may have had a stroke. Did not lose motion.
tachycardia, fever chills    chest rash   nausea  diarrhea    extreme fatigue     loss of appetite
pt c/o pain in arm on 26MAR AM;on 27MAR AM lt arm from shoulder to elbow, red, swollen & warm to touch;seen by PA on 27MAR & put on augmentin & ice packs & started DPH;
Severe pain in my head. Blood pressure went up high. blurred vision. Continues today.
Once injected in arm, my neck began to itch, then over the course of the next day red raised bumps started showing up across my chest, at injection site, left upper arm and across top of back. I called pharmacy on Saturday to see what to do. They advised Benadryl. Over the past couple of days I have developed itchy bumps on my toes and palms of hands I believe to be Dyshidrtic Eczema.
received an accidental 2nd dose on 30Aug2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA824A, expiry date 31-JAN-2024) for prophylaxis.   Concomitant products included MENVEO.   On 30-AUG-2023, the patient received the 2nd dose of Menveo. On 30-AUG-2023, an unknown time after receiving Menveo and an unknown time after receiving MENVEO, the patient experienced extra dose administered (Verbatim: received an accidental 2nd dose on 30Aug2023).  The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date 30 Aug 2023 A medical assistant reported that a patient received Menveo on 18Aug2022 and received an accidental 2nd dose on 30Aug2023, which led to extra dose administered.  No symptoms reported. The reporter consented to follow up via mail.
Paralysis of the hands, dizzy, numbness in legs and arms, shortness of breath, unable to speak. Sick to the stomach. Went in waves for a few hours
lt arm w/red rash around inject site warm & tender to touch; t99.8;
I got my second dose on 4/29/2021, and then on 5/1/2021, I started to have itching red rash over my whole body.  I then took one table of cetirizine10 mg OTC tablet and  the rash improved significantly over next two days.  I also had several episodes of watery diarrhea over that weekend (5/1/2021-5/2/2021).  No other adverse reactions.   I didn't have any rash or diarrhea after my first dose on 4/8/2021. (except some  arm soreness)
Deltoid, shoulder in R arm became painful, swollen, warm to touch, erythema from shoulder to elbow. Limited ROM. Pt. stated Dr in ER told him he could not determine if it was local reaction to Tdap or an infection. RX for CLEOCIN, MOTRIN & LORTAB. S/s resolved by 4/14/10.
Seriousness criteria other medically significant (OMIC). A 30 year old female pt received an initial dose of Adacel, lot number C2559AA, administered in the left deltoid, and a dose of influenza vaccine, lot number not reported, administered in the right deltoid on 11/3/06. The needle sizes and gauges were not known. 24 hours later, the pt experienced severe body aches, systemic anorexia, lethargy, and a temp of 101 degs F. Her left deltoid was swollen at the site of injection to golf ball size and was red and painful. the pt also experienced a headache, for which she took Motrin as needed. It was not reported whether the pt required any medical intervention. The pt reported that her body aches subsided by 11/6/06. At the time of this report on 11/7/06, the local site swelling, pain and lethargy continued and the pt had not recovered.
This spontaneous report as received from a nurse refers to an unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored M-M-R II (dose, route, lot number and expiration date not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever; Joint pain in arms and legs; arm is very sore and swollen on the top (injection site); arm is very sore and swollen on the top (injection site); Supraclavicular swelling, a lymph node is swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (Joint pain in arms and legs), VACCINATION SITE PAIN (arm is very sore and swollen on the top (injection site)), VACCINATION SITE SWELLING (arm is very sore and swollen on the top (injection site)) and LYMPHADENOPATHY (Supraclavicular swelling, a lymph node is swollen) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Viral infection NOS in March 2020. Concurrent medical conditions included Viral myocarditis (Cardiomyopathy) in June 2020 and Sleep disorder. Concomitant products included HYDROXYCHLOROQUINE, VITAMIN D NOS, FAMOTIDINE, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), FISH OIL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced PYREXIA (Fever), ARTHRALGIA (Joint pain in arms and legs), VACCINATION SITE PAIN (arm is very sore and swollen on the top (injection site)), VACCINATION SITE SWELLING (arm is very sore and swollen on the top (injection site)) and LYMPHADENOPATHY (Supraclavicular swelling, a lymph node is swollen). The patient was treated with HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Tendinitis, at an unspecified dose and frequency and SULFASALAZINE ongoing from March 2021 for Tendinitis, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), ARTHRALGIA (Joint pain in arms and legs), VACCINATION SITE PAIN (arm is very sore and swollen on the top (injection site)), VACCINATION SITE SWELLING (arm is very sore and swollen on the top (injection site)) and LYMPHADENOPATHY (Supraclavicular swelling, a lymph node is swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients concomitant medications include Medication for sleep disorder.  Lot number for 3rd dose of the vaccine reported as 0 (4 or 7) (5 or S) C21A.  The patient used ice.   This case was linked to MOD-2021-331260, MOD-2021-331212 (Patient Link).
Angina, Chest pain, Arrhythmia, Palpitations, Dizziness, Shortness of breath, Headache
0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Paramedics arrived, Hx of panic attacks that precipitate ED visit, not on any meds.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date in March 2014, the patient was vaccinated with the first dose of ZOSTAVAX, vial, 0.65 ml, subcutaneous (lot # and expired date were not reported) at the pharmacy. Concomitant therapy was not reported. The patient inadvertently received a second dose of ZOSTAVAX at her (the patient's) physician's office today on 03-SEP-2014. No adverse effect reported. Additional information has been requested.
This was my second dose of the Pfizer-BioNTech COVID-19 vaccine. The first injection on 9/22/21, I only had severe arm pain lasting about two days. After this second vaccine, I began feeling feverish on 10/14, and my arm started to hurt, but not as much as the first time around. I woke up on Saturday morning, 10/16/21, with pain on the upper right side of my body where I got the vaccine, it felt like the vaccine pain and soreness had literally gone through my arm and reached my armpit and below my armpit. I later looked in the mirror and saw that my armpit, near my right breast, was very swollen that felt like I had swollen lymph nodes, but was and is too swollen to discern if any are in my armpit. I later discovered a very hard swollen lymph node on the right side of my right breast. It's hard and sensitive. I haven?t visited the doctors office yet as apparently getting swollen lymph nodes in your armpits is normal, but this is in the breast area, so I want to report it as a side effect. I am a healthy adult with no breast cancer in my family, and no history of any such thing, so it is very obvious this arose from vaccine.
Severe arm pain, swelling at injection site, redness, warm to touch.  Feverish, chills, headache, diarrhea, severe body aches, joint pain.
Woke up morning after receiving the second shot with a low grade fever, dizziness, muscle aches, and fatigue. Self-treated with Tylenol, extra water, and rest. As of noon on 2/12/21 fever is 100.1 and rising.
complaints of heart palpitations, hot flashes, feeling "fuzzy in her head" - 1 1/2 hr after FLUARIX injection. BP 152/96, P-102 - 10:20 AM. 10:37 AM BP 132/80, P-82. Foggy feeling still present other symptoms gone. 11 AM BP 132/80, P-80, 11:15 AM BP 110/80, P-76
pt recvd vax & 3 days later exp gen pruritus;next day exp hives on abd, lower back & legs, arthralgia & swelling of joints;tx oral pred;
On 3/4 patient received 1st dose of COVID vaccination. She states that she drove home afterward and decided to sit and watch TV. She immediately began noticing that the words on her TV screen were not legible - her vision had become blurry. This blurriness was accompanied by severe eye pain and pain in the temples of her head. When shutting eyes and keeping them closed for a few hours, the blurriness would subside. However she continues to experience this blurriness 'on and off' to date. Also experienced some mild headaches but they have subsided as of two days ago. Hasn't taken anything to alleviate the symptoms. Patient is extremely concerned that she may permanently lose vision and refuses to get 2nd dose.
felt lightheaded and slightly dizzy; felt like he was floating; Blood Pressure was 188/84, rapid high level rise in his blood pressure.; Tired; hard pain in arm where injection was given and pain also covers his entire bicep on left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Mar2021 10:30 (Lot number: EN6199, Expiration Date: Jun2021) at the age of 70 years as 0.3 ml, dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Has had high blood pressure for 30-40 years. The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 08Mar2021, outcome "recovered" (08Mar2021), described as "felt lightheaded and slightly dizzy"; FEELING ABNORMAL (non-serious) with onset 08Mar2021, outcome "recovered" (08Mar2021), described as "felt like he was floating"; BLOOD PRESSURE INCREASED (non-serious) with onset 08Mar2021, outcome "recovered" (08Mar2021), described as "Blood Pressure was 188/84, rapid high level rise in his blood pressure."; FATIGUE (non-serious) with onset 08Mar2021, outcome "recovered" (08Mar2021), described as "Tired"; VACCINATION SITE PAIN (non-serious) with onset 08Mar2021, outcome "recovering", described as "hard pain in arm where injection was given and pain also covers his entire bicep on left arm". The patient underwent the following laboratory tests and procedures: blood pressure increased: (08Mar2021) 188/84.  Additional Information: The information "Then shortly, a minute or so, after that he felt a rush to his body and he had to sit down" has been subsumed under the event of "Dizziness" (felt lightheaded and slightly dizzy). The patient stated that the nurse gave him some water and took his blood pressure. He has high blood pressure but has it under control and taking medication for years and it is usually 130/whatever is his normal. They took him outside in the breezeway and got fresh air and he felt ok but had to sit. The patient also stated that yesterday afternoon he had pain in his arm where injection was given, he understands this may be normal, but it was a a hard pain and still suffering from it now.The pain is larger than just at the injection site, he states that it covers his entire bicep on the left arm. This started four hours later after getting the vaccine. He reported he knows he is completely recovered from the high blood pressure reading because he checked it at his house with a blood pressure machine and it came back to normal, what is normal for him. Patient stated as treatment that he lounged around the house and didn't do anything all day.He checked it over a period of 3-4 hours. Prior Vaccinations (within 4 weeks): None; AE(s) following prior vaccinations: None.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and frequency was not reported). On an unknown date, post vaccination, the patient experienced headache. The patient sought medical attention and went to pharmacy. The patient took the treatment with unspecified over the counter medication. The outcome of the event headache was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information is not expected.
Pt admitted through ED 1 wk after rcvg. "1 yr. old" vaxs (MMR,DTP,VZV). 2 days PTA, mom reports fever of 103F. 1 day PTA, pt. seen at clinic for fever and < po intake, Dx:Virus. On date of adm., temp 105.6, shaking & sweaty. ED notes rash
Temporal therometer to right thigh injection site was 101.2 and forehead temporal was 102.6 at 1300. Mom circles the red spots around his right thigh injection site at 1230 and the redness has spread significantly since then. Mom called advice nurse who reassured them the fever was normal but asked that his leg get checked. The pt is slightly fussy, not as happy as he usually is. Pt presents with concern for vaccine reaction/fever. I believe that this redness on his thigh is a normal vaccine reaction and i believe his fever (although tested temporally which can be inaccurate) is also a normal vaccine reaction.
1APR92 PM pt recvd 1 dose of Engerix-B & 3ARP92 devel fever, hives, face swollen & body aching resolved w/o treatment;
Patient was given the second COVID 19 vaccine.  Patient reported no problems/concerns with the first vaccine, as well as no allergies to any medications.  Patient was given a 15 minute wait time after the injection.  Patient was talking with staff about an upcoming flight  and had some questions about COVID testing. At around the 26 minute mark patient reported some dizziness to the nurse.  Vital signs were assessed and BP was 122/82, HR-64, 02- 97% RA.  Patient was asked to wait a few addition minutes to reassess her vitals.  Around 4 minutes later patient stood up and BP was assessed once again standing 132/84.  Patient then stated she felt better and left.
This report is NOT to report any adverse interaction with the 5th vaccine booster shot (or any other), but a BREAKTHROUGH case of COVID. My stmptoms were quite severe. No fever or repratory issues, body aches, and intense cold symptomsfatigue, congenstion, coughing, sore throat. After my Paxlovid dose, I recovered for a day or two, then rebounded back to the same as before, with severe symptoms. Over all, I tested POSITIVE for nearly three weeks and severe symptoms continued for that entire duration. Even stilla full month later, I fatigue readily.
Cellulitis (R) arm. Changed to CIPRO, 500 mg, BID x 10 days, secondary to PCN allergy.
improperly stored vaccine administered after temperature excursion; Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 10-SEP-2021, temperature excursion occurred for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457 has been verified to be valid, expiration date 23-FEB-2022) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026961 has been verified to be valid, expiration date 02-APR-2023). On 22-SEP-2021, the patient was vaccinated with both rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral; dose details were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (route and dose details were not provided) for prophylaxis (incorrect product storage).   The storage temperature of both vaccines was 48.7 degrees Fahrenheit for a time frame of 10 minutes. There was no previous temperature excursion. No product quality complaint was reported.