chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on stomach and little red spot on L leg 6 inches down from knee on anterior side, it looked like a cigarette burn and started itching. Other rash on stomach was itching also, but it was regular rash and red. Leg rash started weeping and developed a circle around it. Tried to clean it up and started bleeding and looked like an ulcer. Went to the doctor and treated as a fungus, but it did not respond. Did a biopsy and showed that it was an allergic reaction to something. I was not exposed to anything else other than receiving the vaccine. Treatment is a steroid cream, it has taken the redness away, and I have a follow up in the future with dermatologist. Using triamcinolone acetonide cream USP 0.5% for the rash. Itchiness is doing better. Not fully recovered, but still recovering, and improving.
Date of First shot: 14Aug2021, Date of Second shot: 28Aug2021; spO2 was at 73 percent; Pretty severe asthma attacks; Had a very hard time breathing; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FC3183; Expiration date was not reported) on the left deltoid on 28Aug2021 as dose 2, single, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included an unspecified antidepressant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: FD8448; Expiration date was not reported) on 14Aug2021 (at the age of 28 years old) for COVID-19 immunization, and had And had difficult time breathing, big rash on the back and chest, back was itching and there were like at least a 100 small red bumps covering the entire back migrating towards the spinal area. On 28Aug2021, the patient had received the second dose of vaccination, when the first dose of vaccination was received on 14Aug2021. On an unspecified date in 2021, after the second dose of vaccination, the patient's oxygen saturation (SpO2) was at 73 percent; patient had pretty severe asthma attacks; and had a very hard time breathing. It took the patient "like 15 days" for the breathing to return to normal; breathing was being so compromised. The event, oxygen saturation at 73 percent, was assessed as serious (medically significant). The patient had received albuterol as treatment for the reported events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
little soreness at the injection site/slight pain at injection site; they have vials set already prepared to administered was like a walking setting and they had a couple they are ready to go; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, solution for injection, Batch/Lot Number: FC3180) intramuscular, administered in right arm on 11Aug2021 (at the age of 51-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical his-tory included hypothyroidism. The concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism. On 11Aug2021, probably later in the evening the patient had a little soreness at the injection site. Patient reported slight pain at injection site. The patient reported that "I got my vaccine yesterday I know they had vials set already prepared to administered was like a walking setting and they had a couple they were ready to go, So I didn't know if there was something to make you guys aware of or not." Patient did not received any treatment of event. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected. Batch/lot number available for BNT162B2.
Male patient received vaccine in the morning, then around lunch time started feeling symptoms of headache, runny nose and ringing in ears. He then got shortness of breath, which got exacerbated so Pharmacy called ambulance and because patient became hypertensive , it was recommended he go to the E.R. Patient is currently at the E.R. at time of this report
Warm, raised, hard red injection site reaction approx. 3 inches in diameter.  Persisting at least 48 hours post injection. No other bodily symptoms.
This spontaneous report was received from a physician refers to an unknown number of an unknown patients of an unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients was vaccinated with an improperly stored doses of ROTATEQ, lot# K019370 (expiry date: 16-JUL-2016) were administered to an unknown number of an unknown patients (dosage not reported). The storage temperature was 32 Fahrenheit for 24 hours. No previous excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
female patient received two doses of IMOVAX RABIES  vaccine on 03-Jul-2021 and next 08-Jul-2021, no AE; Initial information received on 20-Jul-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who received two doses of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] (Inappropriate schedule of vaccine administered).  Past vaccination included initial encounter with Imovax Rabies was in 2011 with a suspected bat exposure that turned out to be an insect; that on the initial she received the immunoglobin and the Imovax vaccine, also she was given Imovax Rabies three shots; that in 2018, she had an exposure and had to receive two to three Imovax shots and she had a suspected encounter with an animal, that prior to this exposure she had one in 2019 when a bat flew out and left scratches on the arm.  Medical history included Animal scratch on 19-JUL-2021 (flying animal left scratches on her face and on her legs; that she is not sure if she needs another series due to having previous exposure Imovax vaccines; that she has had several rounds of post rabies exposure doses of Imovax).  Medical treatment, concomitant medication and family history were not provided.  On 03-Jul-2021 and 08-Jul-2021, the patient received a 1 ml doses of suspect RABIES (HDC) VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site (Inappropriate schedule of product administration) for post exposure immunization.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was reported that "a consumer that has recently received post exposure doses of Imovax is wanting to know does she have to get the post exposure series again since she was possibly exposed to rabies on 19Jul2021".  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 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.  There will be no information available on the batch number for this case.
Developed body aches, fever, neck pain, heart palpitations, & dizziness 2 days after receiving H1N1 injectable vaccine. Seen in physician's office 5 days after vaccine (3 days after hospital discharge). Felt better but HA & neck pain remained. 11/18 and 12/2/2009 MR for 11/2-11/3/2009, patient with c/o's body aches, fever,neck stiffness, heart palpitations, dizziness, bitemporal H/A's and photophobia. Tx: IVF, Tylenol Dx Viral syndrome
P/ shots, pt felt puny, coughed during the night. Next night could not breathe. Eyes were shaking. Called paramedics->hosp stayed 4 days. Throat had swelled. T went up to 103 in the hosp.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 12Mar2022 at 13:00 as dose 2, single (Lot number: 1823), in left arm, on 02Apr2022 at 13:00 as dose 3 (booster), single (Lot number: 1900), in left leg and on 15May2022 at 16:00 as dose 4 (booster), single (Lot number: FW8703) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). Concomitant medication(s)/Other medication in 2weeks included: FLONASE [MOMETASONE FUROATE], start date: 01Jul2022, stop date: 25Jul2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jul2022, stop date: 25Jul2022. Past drug history included: Demerol, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. After 3 days on medicine had terrible nausea had to fight not to throw up. symptoms running nose soar throat cough got better  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 27-APR-2017, the patient was vaccinated with an expired dose of M-M-R II injection, lot # L007217, expiration date on 03-MAR-2017 (dose route and site of administration were not reported). No adverse events were reported. Additional information has been requested.
Narrative: Patient received J&J vaccine on 3/25/21 administered by PC staff. On 4/28/21 the patient self reported to an OSH for severe COVID-19 symptoms -- he tested positive at that time. Patient had ~5 day stay in outside hospital and is now home recovering
Redness, warmth around injection site size of tennis ball. No treatment necessary, just Advil prn and ice to right shoulder
Soreness in shoulders, arms, hands progressed to pelvic area & by 12/4/12 had difficulty getting out of bed. Felt better with exercise & normal activity. Spoke with MD 12/14 & saw MD 1/4, 1/11, 1/18 when he began Methylprednisolone orally. Cardiologist also called him about lab results.
I was fine for the first 8 hours after the injection. Then I noticed feeling achy, especially in the shoulder where I got the vaccine and in the left side of my neck. Within a couple of hours, my skin began to hurt terribly when I moved. It was like torture to move for the next 18 hours or so. But I couldn?t wake up for long, so that was a blessing. I couldn?t fully wake up, my head was swimming every time I did wake up. I couldn?t think. I wasn?t hungry and wouldn?t have been able to feed myself if I needed to. This started maybe 20 hours after the injection and lasted for about 24 hours. If I were to have to get another booster, I?d need a baby sitter to look after me. But I will not choose to get another booster if there is any choice at all. I also measured a low grade fever. Not sure exactly when. It was higher than 100 but less than 101. Once the reaction was over, I was fine. I later reported all this to my doctor.
Palpitations, dizziness, shortness of breath ( wheezing), flushing, nausea Palpitations started when left arm raised, followed by flushing, shortness of breath and nausea.  Dizziness and flushing lasted over one hour
Patient went to Urgent Care for rash on her abdomen and face that started on 12/12/20.  Patient had started taking Benadryl
Three days post vaccine pt developed varicella rash which progressed to number of lesions, > 300. Had fever 102 x 2 days.
Rectal bleeding appeared one day after first dose and disappeared 2 weeks after second dose.  Treatment for hemorrhoids including cream and increased fiber and water intake started 04/01/2021
Her niece who received a dose and is pregnant; This is a spontaneous report from a contactable consumer or other non hcp.  This consumer or other non hcp reported information for both mother and fetus/baby. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as an unknown dose, single for covid-19 immunization. The patient medical history and concomitant was not reported. On an unspecified date, it was reported that, Caller states she was scared for her niece who received a dose and is pregnant.  The reporter stated that she has heard about babies being stillborn and a breastfeeding mother whose child died one day after. She stated that she spoke to someone at a medical team. infection better have immunity than vaccination.  People who have had a previous infection do not need to be vaccinated. Not susceptible to malaria.  She knows genetically speaking some people are susceptible.  The spike protein could prevent women from developing a placenta. She was scared to death to get this thing and develop a blood clot. If there is anything Pfizer can say one hundred percent safe. Feel the more honest. People are going to become more violent. When daughter diagnosed with cancer stage 4 tumor in her stomach. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
popular rash all over left arm 1 day after vaccination, some itchiness, No lymphadenopathy in Axilla
Information has been received from a registered nurse referring to a patient of unknown gender between the 6 years and 12 years old, who was involved in a patient support program. Information concerning medical history and concurrent condition was not reported. On 26-MAY-2015, the single dose vial of PROQUAD (Merck) underwent temperature excursions on 5.3 degrees Celsius for 2 hours and 8 minutes. On 30-JUN-2015 the patient was vaccinated with the improperly stored PROQUAD (Merck) (dose, strength and route were not reported, lot # K014798, expiry date: 12-MAR-2016). The patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. This case is one of several cases received from the same source. Additional information has been requested.
10 days after the vaccine there is a large red circle surrounding the area where I got it. It is mildly itchy.
Fever, erythema (5cm), pain at injection site 100.9 degrees chills, nausea.
Information has been received from a health professional concerning a 25 year old female with no medical history and no drug allergies, who on 22-OCT-2007 was vaccinated IM in the right deltoid with a first dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  On 20-DEC-2007 the patient was vaccinated with a second dose of GARDASIL.  The patient received dose one and two without any complaints.  On 26-APR-2008 the patient was vaccinated with a third dose of GARDASIL (Lot# 654272/0073X).  On 26-APR-2008 the patient developed bumps all over her face and on the arms.  The bumps were not itchy or red.  The patient called the office.  No laboratory diagnostics were performed.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX, 0.5 ml once, subcutaneous, lot number L006386, expiration date 25-FEB-2017). There was no concomitant medication reported. No adverse events were reported after (Oka/Merck) VARIVAX was administered. This is one of several reports from the same source. Additional information has been requested.
Fatigue  Chills Body aches (shoulders, back, hips, knees) Fever Swollen lymph node in left armpit
About 48hrs after getting the vaccine I started experiencing numbness in my right knee. It radiated down my right side. My right knee is numb 24/7. Occasionally my arm goes numb.
This is a spontaneous report from a contactable physician. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's concomitant medications were not reported. The physician reported that the patient had a severe injection site reaction very large on an unspecified date. Additionally the physician mentioned that it was actually more than that, which was just the first of many reactions the patient had. The outcome of the event was unknown. Information on the lot number has been requested.
Body aches; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Administered expired vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown when the vial was stored in the refrigerator. Vial did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received contains non-significant information.
He reported that the vial label is confusing; No adverse event; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and NO ADVERSE EVENT (No adverse event). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (He reported that the vial label is confusing). At the time of the report, INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT LABEL CONFUSION (He reported that the vial label is confusing).    No concomitant medication was reported.  Reporter had a Dark Blue Cap and a label with purple border. On the vial label it stated, Booster dose only. Reporter stated that the vial label was confusing, so 5 adult Patients received Monovalent booster instead of Bivalent booster of Moderna COVID-19 vaccine.  No treatment information was provided.
Blood pressure 155/107  Lightheaded, tongue tingling, hand/arm numbness  Pressure on chest, dizziness and confusion, slow words. Uncoordinated hands and legs
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.  The vial was initially stored in the refrigerator on 01 Dec 2021. The vial did not undergone any temperature excursion. HCP states that some patients had reported flu-like symptoms after receiving the vaccination but she did not have details on that.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Case changed to valid. Added patient details and dose details.