chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For two weeks following my 2nd dose of the Moderna Covid 19 vaccine on April 22, 2021, I was significantly ill. The symptoms felt quite unique compared to any other illness or side effect that I have ever had, and consisted of: nausea and queasiness, fatigue, loose stool and gas with an odd odor, feeling somewhat achy and headachy, a funny taste in my mouth, feeling warm (but not actually having a fever), feeling like I was about to get the chills (except I did not actually get the chills), and generally feeling ?blah.?  These symptoms persisted without significant improvement for one week (from about April 23, 2021 to April 30, 2021), then gradually improved over the 2nd week (from about May 1, 2021 to May 8, 2021).  Probably even more significant is that I continued having recurring episodes of the exact same symptoms ? and I mean the exact same symptoms ? until at least September 2021. Typically, these episodes started about 36 hours after occasions on which I had exposed myself to a crowd of persons in which neither I nor the other persons were generally wearing a mask, e.g. going to a restaurant, bar, indoor golfing range and so forth. On some of these occasions, I consumed alcohol. In these episodes, the symptom recurrence would usually start about 36 hours and last for a few days and dissipate.  As time went on, it seemed that the symptoms were getting more mild with each recurrence, but there were recurrences that did not fit that pattern, such as in August 2021.  My primary care physician, MD, tested me for Covid and non-vaccine Covid anti-bodies in August 2021, and ran some other blood tests, and all tests were negative.  As recently as November 19, 2021, about 36 hours after I attended an event with a crowd of about 50 people in which masks were generally not worn, I had yet another recurrence of the same symptoms.  This recurrence was however mild.
Patient had the first two doses of GARDASIL 9 and now she is 46 years old; Patient had the first two doses of GARDASIL 9 and now she is 46 years old; This spontaneous report was received from a registered nurse, referring to a 46 year old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On unknown dates (reported as when the patient was 45 years old), the patient received the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, anatomical location, lot #, and expiration date were not reported) for prophylaxis. At the time of the report (stated by the patient as now), the patient was 46 years old (product administered to patient of inappropriate age and circumstance or information capable of leading to medication error).
Parasthesias in right side and then traveled to left side within 30 hours of vaccine being administered. Symptoms lasted for 3+ days. Numbness in the face and lips as well as tingling in all limbs. Went to the ER and subsequently had a MRI completed to prove that I didn't have MS.
Still sick; Very weak; Vomitting; High fever; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ILLNESS (Still sick), ASTHENIA (Very weak), VOMITING (Vomitting) and PYREXIA (High fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomitting) and PYREXIA (High fever). On 14-Jun-2021, the patient experienced ILLNESS (Still sick) and ASTHENIA (Very weak). At the time of the report, DIARRHOEA (Diarrhea), ILLNESS (Still sick), ASTHENIA (Very weak), VOMITING (Vomitting) and PYREXIA (High fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received and contains no new information.
Upon injection there was immediate numbness and burning at the injection site. One hour post injection there was swelling and heat at the site, with the arm remaining numb. Four hours post injections a dark red circle appeared below the injection site, spreading down the arm, towards the elbow, and small hive like red bumps appeared. Over the next 48 hours this ring became larger and larger, reaching a maximum diameter of ~5 inches. After 72 hours the redness started to dissipate but area continues to be raised and swollen, and painful to the touch.
Arm from just above elbow to shoulder became red, swollen, warm and indurated but not painful.
Patient was admitted with some increasing shortness of breath for last 2 days and he was recently tested positive at the dialysis unit, apparently 2 days back was positive for COVID-19 virus.  In the ER, the patient was placed on some oxygen; however, he was not in any acute distress. He denied any chest pain, etc.  No fevers, chills, etc. .  He was initially on oxygen, but did ot require any supplemental oxygen. He has been dialyzed several times and is also getting dialysis today prior to discharge.   The patient empirically was started on initial dose was IV dexamethasone 6 mg and then was placed on oral dexamethasone 6 mg daily, also was started on ceftriaxone and also got a 1 g of azithromycin as well.  The patient is being switched now to Ceftin 125 mg b.i.d. for 5 days at time of discharge.  He has been pretty stable symptomatically and is stable for discharge.
This case was reported by a physician and described the occurrence of fever in a patient who received DTAP, Hep B recombinant and IPV, combined Pediarix for prophylaxis.  On an unspecified date, the patient received injections of Pediarix (Lot # 21881C9) and Hib (PedvaxHIB, Merck).  At an unknown time post-immunization, the patient experienced fever of 102-104 degrees F, irritability, and inconsolable crying.  The patient was seen by the physician.  The events resolved after an unspecified period of time. Comment: The reporter indicated that "at least 25" patients experienced these events following receipt of Pediarix Lot # 21881C9.  However, they are not presently identifiable.
7 days after the vaccination a small red, itchy rash appeared at the injection site.  It?s gradually spreading down and under my left arm.  It?s very red,  itchy,  hard to the touch and blistering.
nausea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills). At the time of the report, NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Treatment information was not provided.  Concomitant medication was not provided.   Reporter did not allow further contact
Moderna first Dose Vaccine give 09/23/2021.  Lot later found to have expired 09/22/2021.   Moderna contacted, all handling details given,  Moderna tested viability of vaccine lot beyond expiration and found it maintained the activity necessary to protect against Covid 19 at the time of administration.  Client found to have no adverse reaction to lot expiration.  ** Patient meets 3 rd dose due to Immune compromised patient
Information has been received from a nurse concerning an around 14 or 15 year old female patient who a few month ago, on an unspecified date was vaccinated with a second dose of GARDASIL (Lot # unknown). The nurse reported that after the patient received the second dose of GARDASIL started experiencing syncope episodes that persisted for a few months. According to the nurse, the patient was still experiencing dizziness and lightheadedness. The outcome of the syncopes is unclear. At the time of the report, the patient had not recovered from dizziness and lightheadedness. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Flu shot given on 11/17/2020 at 3:10 pm  and patient died on 11/18/2020 at approx. 10:30 am at his home.
(R) shoulder - area 11x8 cm red, warm, no Hp. Improving fr. one day of vaccine administration.
her hands started feeling like swollen; she only having muscle swelling; the pain of the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 09Nov2021 (Lot number: FF2587) at the age of 16 years as dose number unknown, singl for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "her hands started feeling like swollen"; MUSCLE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "she only having muscle swelling"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "the pain of the arm". Therapeutic measures were taken as a result of peripheral swelling, muscle swelling, pain in extremity.  Additional details: primary reporter stated, I have a question, I went to the shot yesterday. I was asking for my daughter, everything was fine with me but I was little bit concerned about my daughter when she took her vaccine and she have like she just started telling me that her hands started feeling like swollen so I am kind of concerned about that. Primary Reporter stated that, patient did not received any other vaccine within 4-weeks prior to Covid-19 vaccine. Primary reporter stated, probed was not for the Prior medical history, primary reporter stated, she only having muscle swelling. The only thing she took it was Advil for the pain of the arm she was telling me. That's it."(not appropriately clarified hence not captured in tab). primary reporter stated, when probed for still experiencing the adverse event. it was still there, and the reason I know that it was swollen she putting her rings on that's were tight, the ring are tiny but they are loose."Treatment taken for the adverse event: Primary reporter stated, "Advil"  No follow-up attempts are possible. No further information is expected.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Apr2021 (Lot number: EP6955) at the age of 41 years as dose 2, single and (Lot number: EP6955) as dose 1, single 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 02Jan2022, outcome "unknown" and all described as "Tested positive for Covid". The event "tested positive for covid" and "tested positive for covid" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Myself and My husband both tested positive for Covid. We were both vaccinated the same time with the batch number provided. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200010534 same reporter/drug/event for different patients
"Swelling and soreness" 2 months after flu shot was given per pt. MD exam = No swelling (L) arm; Diffuse tenderness over radial nerve; similar tender opposite arm (left arm).
Erythema, warmth, pruritus around injection site, rapidly spread down arm, treated with triamcinolone and Benadryl 50mg TID without success, seen at physician office on 12/19/14 was given prednisone taper and Avelox 400mg for 7 days.
When I received the vaccine it seemed odd to me first because to me the needle was left in my arm longer than expected. This was my second vaccine and so I was familiar with it.  The first vaccine I had no adverse effects to.   It felt like the needle was left in and then maybe slightly pulled out then another drop injected.  When I got up to leave, I had a medicine type taste in the right corner of my mouth. The vaccine was given in my right arm.  Also I was injected high up on my arm, very close to my shoulder.   That day I was okay, but the following morning I was very thirsty and had no appetite.  I drank two tall glasses of water in the morning and had 1/2 piece of toast.  I also had a fever of 101.8.  I never get fevers!  I'm usually at around 96.8 to 97.   I then had chills during the day, and remained quite thirsty, and was also quite fatigued., with body aches, and a bit nauseated. I tried to eat something at 3 p.m. but still had no appetite so ate very little.   It seemed I craved carbs.  That evening I had French toast as my dinner, ate to slices.  I went to bed early and during the night I was sweating.  The next day (2 days after vaccine) I woke up with a terrible headache, again, I usually never get headaches.  It lasted all day. I took some aspirin, which did help.  I was still quite fatigued also.  By the 3rd day or so I was feeling better, but to this day I have body aches and pains, a bit of dizziness, nausea and fatigue.  My appetite has returned, though I don't eat as much.   I'm wondering if it was possible I was given too much of the vaccine?  I have not contacted my doctor at this point.  Hoping things will improve over time.
This patient is a 33-year-old female presenting to the ED today with finding a lump on the right collarbone.  Patient received second dose of Pfizer vaccine on Monday.  Patient is complaining of numbness and tingling to the right arm with slight chills that started today and slight shortness of breath on exertion. Patient also complains of tightness to the right armpit and slight discomfort to the right side of the neck. Patient denies any other symptoms at this time.
giving the injection the medication leaked over the patient's arm/No AE; giving the injection the medication leaked over the patient's arm/NO AE; giving the injection the medication leaked over the patient's arm, needle was not on secure the needle on tight prior to the injection/NO AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] the injection the medication leaked over the patient's arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines were given this visit.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ241AB, Expiry 18/04/2020 via intramuscular route in the right deltoid.  It was a case of actual medication error due to vaccine underdose and Exposure via skin contact.  It was also the case of syringe leak. The needle was not on secure and she states she had the needle on tight prior to the injection. Does not know exactly where the syringe was leaking and none of the other questions under leaking apply since this was a syringe and not a vial. Caller states since the syringe was leaking she did not examine it too closely to tell where.  At the time of report 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.  Documents held by sender: none.
Light itchy rash around left armpit; mild itchy rash around thighs, groin, hips; light, non-itching rash on chest and arms; fever of almost 103; extreme fatigue; no appetite; headache; some difficulty breathing; disoriented: thought an entire day had passed when only a couple of hours; hard, bright red mound 2" x 3" around injection site; very dark bruise around injection site.
Presents for sudden onset weakness & increased confusion. CXR revealed aytpical pneumonia; no respiratory sx other than unchanged chronic cough. Admit for generalized weakness & COVID. Began running fever and became hypoxic day after admission. Per ID, abx stopped & pt weaned back to RA. Tx: abx, vit c, zin, singulair, dexamethasone, O2 via NC. DC to home w/HH.
He complained breathing problem and sweating and vision problem and twisting muscle  few minutes later after first dose Moderna vaccine. He was sitting on chair and I gave him massaging to relax muscle and then called 911. EMT checked his status and then felt better. He denied to go hospital and then he walked out
Patient had a reaction to first Pfizer vaccine on 5-5-21 was treated and released with prescription for Prednisone. Patient was told by physician to receive her second dose but to pre-medicate with prednisone 50mg and Benadryl 25mg. Pt did as she was advised and received second Pfizer vaccine. She started exhibiting s/s of anaphylaxis within 5 minutes of the vaccine. Treated with 50mg benadryl and 2 epi pen injections of .3mg 5 minutes apart while awaiting EMS. Patient  treated and released later in the day.
He was sore the first night but last night his arm turned bright red. When he came to the pharmacy today there was a bright red area that was warm to the touch. He also reported a low fever.
Developed facial rash with periorbital redness, bilaterally and mild left sided periorbital edema, developed within 24 hours after vaccination. Also developed perineal rash likely from candida.
Roughly 5 minutes after receiving the injection the patient began to feel dizzy, nurses went to check on him and he had a syncopal episode, he was caught by nurses and was assisted to the ground, vitals were checked, monitored for 30 minutes until stable
received his 1st dose last December 2020. He became COVID positive and received passive antibody treatment for COVID last February 2021.; received his 1st dose last December 2020. He became COVID positive and received passive antibody treatment for COVID last February 2021.; patient received his 1st dose last December 2020/He is asking if it will be okay for him to get his 2nd dose today; patient received his 1st dose last December 2020/He is asking if it will be okay for him to get his 2nd dose today; This is a spontaneous report from a Pfizer sponsored program from a contactable pharmacist. An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (at the age of 79 years) via an unspecified route of administration on 30Dec2020 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his 1st dose last Dec2020 and became COVID positive and received passive antibody treatment for COVID last February 2021. The patient was hospitalized from Feb2021 to 04Feb2021. Outcome of the events was unknown. The events were reported as non-serious. He is asking if it will be okay for him to get his 2nd dose today and for how long should he wait before he does get the 2nd dose after getting antibody treatment.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.    There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
6 patients were administered moderna covid-19 booster doses after the vaccine was expired.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients were administered moderna covid-19 booster doses after the vaccine was expired.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients were administered moderna covid-19 booster doses after the vaccine was expired.). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (6 patients were administered moderna covid-19 booster doses after the vaccine was expired.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Hospitalized 12/11/2021; COVID-19 positive 12/11/2021; fully vaccinated  BRIEF OVERVIEW:  Admission Date: 12/11/2021 Discharge Date: Dec 15, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Sepsis Urinary tract infection with hematuria, site unspecified COVID-19   HOSPITAL COURSE:  60 year old male with history of cerebral palsy presented with complaints of sepsis. His infection was suspected due to UTI. He was started on rocephin. His blood cultures showed coagulase negative staph and e.coli. Doctor was consulted and he was continued on rocephin. His repeat blood cultures came back negative. He was switched to oral bactrim and discharge home on 5 more days of bactrim. He was noted to have covid infection. No hypoxia was noted. Monoclonal antibody team discussed with his guardian and they did not want monoclonal antibody infusion.