chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid positive with symptoms; Covid positive with symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26May2021 (Lot number: EW0168) at the age of 23 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8736, Location of injection: Arm Left), administration date: 05May2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 03Jan2022, outcome "recovering" and all described as "Covid positive with symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Nov2021) negative, notes: PCR Nasal Swab; (03Jan2022) positive, notes: At home antigen test, Nasal Swab; (03Jan2022) positive, notes: At home antigen test, Nasal Swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure.  Additional information: The patient had not received any other vaccine within 4 weeks. Patient had no known allergies, Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient woke up at 2am, symptoms included: muscle aches, headache, upset stomach, profuse vomiting, chills, body aches and dizziness.  Has not taken any medicine or called the vaccine administrator.    Symptoms similar as the last time received vaccines. Currently, dizziness is gone but headache still is there.
I received the Moderna COVID shot for my 1st injection. Now I received the Pfizer COVID shot for my 2nd injection. Two days after my 2nd injection I have developed swelling and redness and painful reaction in my left arm. Left arm is also very warm to the touch. The CDC website says Moderna should be used for 2nd injection if used for 1st injection.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 vaccine had two temperature excursions; one of 24 hours and the other one of 32 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius) and the highest recorded temperature was 48 F (8.888888889 Celsius). The vaccine status was reported was "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Patient received second dose of Pfizer COVID 19 vaccine 15 days after the first. No reported unexpected side effects the night of or day after vaccination received. Only reported side effect of mild arm soreness.
Hemorrhagic stroke from ruptured M1 MCA aneurysm resulting in emergent coiling followed by Craniectomy/hematoma evacuation.  This followed by two weeks in intensive care. Now outpatient therapy (pt/ot/speech etc).
Underage administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 22-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   In JUN-2023, the patient received Kinrix. In JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JUN-2023 The reporter could not provide the patient's date of birth or gender.  The reporter noted that the dose of Kinrix was administered 5-6 days ago from the day of reporting.  The reporter did not have lot number or expiration date for product.  No additional information was available. The reporter consented to follow up. The reporter reported that a 22 month old patient was given a dose of Kinrix, which led to inappropriate age at vaccine administration.
Pt was given H1N1 FLUMIST on 11/15/2009 during a mass clinic.  Nurse was not aware of pregnancy.  Pt. instructed to see OB/GYN ASAP.  Pt. approximately 6 wks gestation.
Pt received first dose of Pfizer at 0856 to left deltoid and felt immediately lightheaded and had syncopal episode. Pt was able to regain consciousness 5-10 seconds after syncopal episodes but still complaint about feeling lightheaded. Pt felt warm to touch and had was pale. An ice pack was applied to back of neck, vital signs were checked immediately. Pt was asked if he has anything to eat prior to vaccine and he stated he did not have anything to eat. Ice water and granola bar was offered. Around 0858 pt stated he started to feel better, 0859 vital signs indicated the following BP 111/45, HR 47, SpO2 97% RA. Pt denied going to treatment room for further observation or laying down on gurney. Pt kept insisting he felt a lot better and "none of that was necessary". Pt's skin color came back to normal state and stopped feeling lightheaded after eating and drinking a cup of water. Vital Signs were taken again as the following: BP 104/57, HR 62, SpO2 98% RA. Pt felt safe to go home with significant other. Pt doing well, speaking in full sentences, laughing, alert and oriented x 4.
Warm to the touch at the site of injection; Itchiness at the site of injection; Redness at the site of injection; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) had not resolved.        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 concomitant medications were provided by the reporter.  Treatment was not taken.
Swelling of left leg for 3 weeks, went down to a bump, and by 4 weeks gone.
I have been in bed now for 2 days; chills, aching bones, fatigue, I feel like I have the flu., also my face has swelled and my lips are twice their size ( top lip) ..I can?t move my arm; very painful..... This  has never happened with the flu vaccines I have had in the past.
I began experiencing symptoms of COVID-19 on 4/14/22 with fatigue, then I woke up the next morning with fever, chills, headache, cough, congestion, minor abdominal pain, constipation. The fever lasted for 2 and a half days, but my symptoms are resolving as of today 4/20/22.
vaccine is to be administered with a dosage of one part liquid and 1 part powder but infant was only administered the liquid with no adverse event; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involved a 2 months old (unknown gender) patient who had DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with a dosage of one part liquid and 1 part powder but infant was only administered the liquid (Product preparation issue).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was actual an medication error due to inappropriate reconstitution technique.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.  It was reported "The vaccine is to be administered with a dosage of one part liquid and 1 part powder. The infant was only administered the liquid. Patient wanted to know the best way to proceed in regards to assuring that the infant receives the proper dosage. I placed them on hold while contacting medical facility for medical advice. . I made contact. I briefed them on the situation and told them that I would send a copy of the Safety Data Sheet (SDS) by email. I conferenced them in with the caller before leaving the line for privacy".  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 the 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.
Pt was very dizzy and had trouble walking. She was admitted to the hospital and Dr's could not find cause and it resolved itself. Dr's did not feel it was related to vaccine but pt insists it is.  1/5/2010 Discharge summary, hospital records received. Service dates 10/1/09 to 10/4/09. Assessment: Possible TIA of the posterior circulation with acute onset of ataxia and nausea. Patient presented with acute onset of ataxia, discoordination, and nausea. Spinning sensation. Difficulty walking. Activities of daily life impaired. White matter changes both cerebral hemispheres. Mitral and pulmonic insufficiency. Atherosclerosis of the aorta. Cervical fusion screw dislodgement.
I received the J&J Covid vaccine on Saturday, 10/23/21.  During the evening of Monday, 10/25/21, 2 days after my injection, I started to have some side effects (hot flashes; nausea; light headed; weakness; tired and oddly I experienced injection site soreness that evening for the first time (I had thought that injection tenderness would have started the same day as the injection, not 2 days later)) that lasted until Wednesday, 10/27/21.  I assumed that these side effect were common and nothing of concern.  My adverse issues started when I awoke on Saturday, 10/30/21, and my vision was blurry. This lasted for a couple of hours.  On Tuesday, 11/2/21, the front of both my thighs (although my right was much worse than my left) was very sore (this lasted for several days). The next day, Wednesday, 11/3/21, a bruise started to form on my right thigh, just above the knee, which darkened over the next couple of days and thereafter began to fade and go away.
On eighth day. Injection site became red and started to itch. The next day big circle about the size of a baseball had formed. It is hot to the touch and severely itches.
This spontaneous report was received from a non medical healthcare worker refers to three unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date in March 2015, the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # K009759 and expiration date 09-JUL-2016) (dose and route were not reported). No adverse events were reported. This is one of the two reports from the same source. Additional information has been requested.
7/14/2021: symptoms onset. temp 110.4F,abdominal cramps, cough, diarrhea 7/17/2021 hospitalized 7/28/2021 died
chills, fever, vomiting, muscle spasms, extreme fatigue, for three days; fatigue lasting 7 days
origionaly 12 hours post injection my arm was soar - but normal for an injection - lasting til 36 hours post  Then 14 days post injection I had headache, nausea and my arm felt like it was on fire. I looked and it was raised red and hot to touch about a 15x15 cm area around injection site Went
Broke out in sweats and sweating through his shirt, jacket and hat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Broke out in sweats and sweating through his shirt, jacket and hat) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLONIDINE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HYPERHIDROSIS (Broke out in sweats and sweating through his shirt, jacket and hat). At the time of the report, HYPERHIDROSIS (Broke out in sweats and sweating through his shirt, jacket and hat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was taken by the patient for the event.
Patient was vaccinated on the 28th of September. He started to not feel well a day later and stayed home from work. He developed increasing CP and on the 6th of October it worsened he went to the Urgent Care and was found to be in Atrial fibrillation Atria Flutter with a 2:1 rate,he also had a fever of 103.  He was transferred to the hospital and converted into sinus. He developed increasing CP and was started on Prednisone and also Colchicine for Endocarditis. He was also started on Lisinopril for hypertension. Also of note is that he had a COVID test was done which was also initially positive, than negative, but PCR testing was positive while hosptalized.
Moderna Covid-19 Vaccine EUA.  Started 12 hours after receiving 2nd vaccine with fever, chills, aching back and severe headache.  Fever started at 100.2, went up to 101.2, and down to 99.9 by noon today.  Other symptoms persist as of 1:45 pm PT.  I am not able to take over the counter pain relievers because I had acute hepatitis in late October.  No cause was determined and I tested negative to all the various versions.  All my liver function tests returned to normal within 2 weeks or so.
Headache, Myalgia, Fever & NauseaVomiting Narrative: Fever, Headache, Vomiting, Nausea, Diarrhea, Body Aches, Fatigue
Patient reported about 30 minutes after the shot administration an allergic reaction including redness on trunk chest and back itching and hives developed, also redness at injection site. He took a 50mg benadryl and contacted the pharmacy and his physician to make them both aware. He will follow up with subsequent symptoms and or resolution.
Sore arm (1 hour after and on; 1:00pm) Chills (10pm and on) Nausea Headache
Swelling, redness, hives localized to immunization site, pain radiating to back reaction progressed later on 6/4/ to fever, vomiting and chest pain prompting hospital admission.
Severe migrane, full body ache, tenderness around injection site, pain at injection site, unable to move arm due to pain, cramping, PMS symptions without mensturation.
The shot was given too high and at an improper angle and pierced the joint capsule and was injected into it.  the pain was intense  and immediate. it worsened over the next few hours and I am unable to raise my arm and continue to have limited Range of motion and severe pain, especially at night.
Injection site mass. A medical assistant reported that a patient received an injection of Prevnar and subsequently developed a lump at the injection site. No further information was available at the date of this report. Manufacturer's comment: The reporter indicated that 6-7 pt experienced this event' however they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sore arm within 12 hours, followed by sore muscles in left armpit and left upper side the next 2 days (as if the soreness migrated from left deltoid to armpit to upper side); Sore arm within 12 hours, followed by sore muscles in left armpit and left upper side the next 2 days (as if the soreness migrated from left deltoid to armpit to upper side); This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:45 as dose 4 (booster), single (Lot number: GH9694) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if COVID prior vaccination: Yes" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EL3247), for COVID-19 Immunization; Bnt162b2 (Dose: 2, Lot: EL3247), for COVID-19 Immunization; Bnt162b2 (Dose: 3, Lot: FF8839), for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset 23Sep2022 at 05:00, outcome "recovering" and all described as "Sore arm within 12 hours, followed by sore muscles in left armpit and left upper side the next 2 days (as if the soreness migrated from left deltoid to armpit to upper side)". Therapeutic measures were not taken as a result of pain in extremity, myalgia.  Additional information: Dose received More than 3. Patient did not had other vaccine in four weeks. Patient did not had other medications in two weeks. Patient had not tested COVID post vaccination. No Known allergies. Other medical history was none. The case reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Information has been received from a 32 year old female consumer with no past medical history or known allergies. On 10/16/00 and 12/12/00, the pt was vaccinated with a 1st and 2nd dose of varicella virus vaccine live 0.5ml, respectively. There was no concomitant medication. The consumer reported that she conceived on 1/26/01 and discovered that she was pregnant on 2/28/00. Based on the date of conception, the calculated date of LMP was 1/12/01. It was reported that the pt had no diagnostic tests during pregnancy and there were no infections/illnesses during pregnancy. The pt did not take any prescription drugs during pregnancy. Follow-up from the physician indicated that the pt had a spontaneous abortion, 6 weeks from her LMP. No further information is available.
I'm happy to say I got the second dose and had no side effects other than a sore arm.; This is a spontaneous report received from a contactable Nurse (patient).   A female patient of unspecified age received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date was unspecified) on unspecified date as single dose for COVID-19 immunisation. Medical history included being immunosuppressed. Historical vaccine included first dose of BNT162B2. Concomitant medication was not reported.  The patient reported 'I'm happy to say I got the second dose and had no side effects other than a sore arm' on unspecified date. A week after getting the first shot, my daughter got Covid. My son and husband were positive shortly after her. I did get some very mild symptoms, but throughout the weeks of quarantine, I've tested about every 4 days and consistently have been negative.  Lab data included Covid test which was negative on unspecified date ('but throughout the weeks of quarantine, I've tested about every 4 days and consistently have been negative').  Outcome of event sore arm was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Tested positive for Covid a week later; Tested positive for Covid a week later; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 04Jan2021 08:45, and 1st dose on an unspecified date via an unspecified route of administration; both at single doses for COVID-19 immunization. There were no medical history and concomitant medications. The patient has no known allergies. On 12Jan2021, the patient tested positive for COVID a week later from 2nd dose. Outcome of the events was reported as recovering. No treatment was given for the events. The patient underwent lab tests and procedures which included Nasal Swab: positive on 13Jan2021. The patient was not diagnosed with COVID prior vaccination.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for Covid a week later".
Client reported to EMT feeling "itchiness on her hands" after 30 mins in observation. EMT contacted RN  and PHN  for assistance. Upon arrival at 1350 client sitting upright in anti-gravity chair. Client alert and oriented x4. Client reported having rash a few hours after first Pfizer Covid vaccine and self medicated at home. Client reported with her own medication and cream symptoms resolved that time. Per client, today's symptoms "feel just like last time." Client denied shortness of breath or feeling throat close. Vitals at 1355: blood pressure 135/70, pulse 63, oxygen sat 97%. Client reported history of hypertension, unable to recall medication, and allergy to aspirin. PHN asked client to remove mask and assess for swelling, no swelling noted on face, neck, or tongue. Client stated only itchiness to both hands right now. PHN  observed redness on hands, unable to tell if rash as client had been scratching. No other redness noted. PHN offered client Benadryl at 1356 and explained possible side effects. Client declined, stated she drove herself, and she would take her own medication at home. PHN discussed with client importance of following up with medical provider, when to seek medical help, and ER precautions. Client left against medical advise at 1358 with steady gait.
4/09/11: localized redness and swelling about the size of your palm day after administration, hot to touch, no treatment provided  4/10/11: localized redness and swelling doubled in size, hot to touch, no treatment provided   4/11/11: redness and swelling above and below elbow, hot to touch, no fever, Keflex prescribed for 10 days