chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt very sick; This spontaneous case was reported by a consumer and describes the occurrence of   in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant drugs includes : blood pressure medicine, very low dosage  Treatment medications were not provided by reporter.
COVID-19 vaccine series administered with Pfizer for prime dose and Moderna for booster dose
Nausea and vomiting. After vomiting nausea was gone and I was able to go to sleep. Nausea did not return.
Within 15-minutes of vaccination, the patient reported dizziness. EMS monitored the patient's condition on-site.
40 mins post vaccine while on train patient stiffened, eyes rolled upward and increased saliva. Then some jerky / trembling movements mouth twisted. No urination. No defecation. Lasted 15 secs. Went home then to ED, left without being seen. Back to normal in 30 min.
injection @ 2130--urticaria bilat hands, elbows et knees approx. 0015 (08/23/09).  Macular rash bilat upper extremites with edema present approx. 0100.   TX:  50 mg Benadryl upon arriving at home approx. 0040; 50 mg Benadryl approx 0415.
Hives to face, neck, chest, arms, and legs; bilaterial.  Urticarial and red. No wheezing or shortness of breath.  Was told to go to the ER.
Body aches; temperature - 102; nausea; fatigue; Exhaustion and weakness. I had those symptoms for three to four days. The fatigue lasted several days. No treatment except Tylenol - which helped bring the fever down. This vaccine - nothing major with injection site.   Correction: The first dose of the vaccine was injected in my right arm and not in my left arm. This vaccine was injected in my left arm (second dose.)
Diffuse erythematous pruritic papular rash with joint swelling of knees and ankles.
Initial report received from a healthcare professional on 15 January 2014. This case is a part of 2 cases (same reporter and vaccine FLUZONE QIV) and is linked to case number 2013SA106863. This case belongs to a female patient. A female patient (date of birth and age at the time of event was not reported) whose medical history and concomitant medication were not reported, had received an intramuscular dose of FLUZONE QIV vaccine (lot number: U4766AA, expiry date: 30 June 2014, dose number and anatomical site of administration were not reported) on 13 September of an unspecified year. On an unspecified date of last week, the patients experienced hurting arm for over a week with some bruising at the injection site. Laboratory investigation and corrective treatments were not reported. At the time of this report, the patients had not recovered from events. Documents held by sender: none.
12/07/2021 I got my booster. I started experiencing adverse event in middle of the night chills, fever, fatigue, headache, in the morning I felt body aches. I tried to relax. the next day felt crummy. my fever was gone. I still had the other symptoms. My heart rate was 90 beats per minutes. My normal resting beat is mid 50 beats per minutes. I noticed the first day of the vaccine my lymph node was swollen under my arm pit. I took ibuprofen 2 times a day. I took plenty of rest and drank a lot of fluids. The booster had the worst reaction on my body than the other two. The heart rate fatigue, and swollen lymph node lasted about a week. My heart day went 10 beats per minutes each day to get back to normal.
Flu like symptoms began Saturday evening. Sunday morning he woke up and his wife heard him hit the bathroom floor. He passed out for 60-90 seconds. She called ambulance and he was taken to Medical Center. His doctor there decided he had a syncopal episode which caused a concussion. He reported still having vertigo and nystagmus Monday and Tuesday morning. He went back to work for the first time on Wednesday.
Vaccine given 2/3/15, broke out in rash on 2/4/15 in the PM. Was taken to Dr's office and was given a DECADRON injection. Rash not at injection site - not papular/macular.
First dose: breaking out with rash; itching was incredible; rash got so bad she had scabs all over; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Mar2021 (Batch/Lot Number: EN6204) as 1st dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and mini stroke. Concomitant medications included blood pressure medicine and a blood thinner. Past drug included unspecified steroids in the past, flu vaccine, pneumonia vaccine, and her shingles vaccine and never had any reaction. On an unspecified date, 2 weeks later, the patient experienced first dose: breaking out with rash, itching was incredible, and rash got so bad she had scabs all over. The patient was going through this from last 6 weeks. She has had this rash for 6 weeks. Her husband was rubbing lotion on her back and he told her she needed to go to the doctor. Her rash was causing itching so bad she had scabs everywhere. She got an appointment with her primary care doctor maybe on 12Apr2021 or 13Apr2021. She thought she might have seen her primary care twice that week. She shared her concern with her primary care doctor that this rash might be because of the Covid 19 vaccine. Her doctor told her she didn't think it was caused by the Covid 19 vaccine. Her primary care doctor put her on steroids and the rash wasn't improving so she was sent to the dermatologist and was put on another round of steroids. Being on the steroids for so long made her crazy. She's taken steroids in the past but this time she was on steroids for almost a month. The first bout of steroids wasn't enough to get rid of the rash. She received second dose on 16Apr2021 (after her doctor suggested to take it) and the second vaccine accelerated the rash and made the rash even worse. She has seen her doctors, took prednisone twice and 4 different kind of creams for the rash and it was coming back again. She wanted to know how long it can last. She was on the steroids for so long she was losing her mind. She was prescribed 4 or 5 different creams. If someone could have felt her skin, she can't say it felt like leather, she can't even describe the way her skin felt. The patient had no additional vaccines administered on the same day of Pfizer vaccine. Prior Vaccinations (within 4 weeks) was none and no events following prior vaccinations. The event rash required a visit to the physician office. Outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered pharmacist concerning a 75 year old female patient who on 23-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot # 659326/1824U). On 09-DEC-2008 the patient was diagnosed with shingles. The patient developed 4-5 lesions in the right axillary area. No treatment was prescribed. As of 17-DEC-2008 the patient was recovering. Additional information has been requested.
Itching was in the arms, head, legs, everywhere; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching was in the arms, head, legs, everywhere) and HYPERSENSITIVITY (Allergic reaction) 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 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching was in the arms, head, legs, everywhere) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with HYDROCORTISONE, OXYTETRACYCLINE (HYDROCYCLIN) for Adverse event, at a dose of 25 mg four times per day. At the time of the report, PRURITUS (Itching was in the arms, head, legs, everywhere) and HYPERSENSITIVITY (Allergic reaction) had resolved.            No relevant concomitant medications were reported.  Patient is immunocompromised and wants to get third dose   This case was linked to MOD-2021-322221 (Patient Link).
Six days later, I began having severe and intense muscle aching on the back side of my head, TMJ along my right upper jaw, aches in both my wrists, aches along my upper calfs, and hip pain (left side).  This pain has been ongoing and unrelenting since March 1st.  Pain is worst at night from approximately 2 hours after bedtime and all through night.  Lying down appears to make it worse.  During night, I'm unable to turn my head left or right without intense pain.  I have never suffered pain like this in the past nor have I had any injuries.
He had the onset of chest pain after dinner 8/6. He took ibuprofen and went to bed. No associated dyspnea, dizziness, diaphoresis or nausea. He woke up at 3am and the pain was gone. The pain recurred later in the morning and he presented to the ED. EKG with subtle ST elevation/J point elevation in the inferior and anterior leads. Mild pain in the ED. First troponin 2931. Underwent LHC showing clean coronaries. Started on DAPT with ASA and plavix. Troponins up trending to 5500.   Underwent ECHO showing Takotsubo cardiomyopathy with LVEF 40-45%. Started on colchicine 0.6 mg and ibuprofen 600 mg TID.  In settign of low EF, started on toprol 25 mg and losartan 25 mg.  Will undergo cardiac MRI today.
Began with muscle twitches and tremors, brain fog and exhaustion immediately following vaccination.  Drop in heart rate observed between doses 1-2. Cardiac symptoms developed over time, including rapid swings in heart rate, sudden onset hypotension, and severe episodes of full body tremors presenting alongside full body tremors,  pre-syncope and tinnitus. Sudden onset of new arrthymias, specifically runs of non-sustained ventricular tachycardia (NSVT). Symptoms similar to dysautonomia but does not meet full clinical criteria. Patient had no prior medical history and diagnostic testing has found no common cause, even as symptoms persisted. Patient sought medical care, did not initially suspect vaccine understanding it to be safe and effective. Patient received booster shot in December 2021 and began to suspect vaccine involvement when symptoms worsened after booster. The more time that passes since the last dose, patient is gradually improving but still struggles with arrythmias and tachycardia.
Sharp pain shooting through arm; The arm is also swollen; She started breaking out in the arm in which she received the vaccine, the arm was all red with itching; She started breaking out in the arm in which she received the vaccine, the arm was all red with itching; She started breaking out in the arm in which she received the vaccine, the arm was all red with itching; Fatigue; Chills; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sharp pain shooting through arm), SWELLING (The arm is also swollen), VACCINATION SITE PRURITUS (She started breaking out in the arm in which she received the vaccine, the arm was all red with itching), FATIGUE (Fatigue) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Blood disorder.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Soreness). On 30-Apr-2021, the patient experienced PAIN (Sharp pain shooting through arm), SWELLING (The arm is also swollen), VACCINATION SITE PRURITUS (She started breaking out in the arm in which she received the vaccine, the arm was all red with itching), VACCINATION SITE RASH (She started breaking out in the arm in which she received the vaccine, the arm was all red with itching) and VACCINATION SITE ERYTHEMA (She started breaking out in the arm in which she received the vaccine, the arm was all red with itching). At the time of the report, PAIN (Sharp pain shooting through arm), SWELLING (The arm is also swollen), VACCINATION SITE PRURITUS (She started breaking out in the arm in which she received the vaccine, the arm was all red with itching), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Soreness), VACCINATION SITE RASH (She started breaking out in the arm in which she received the vaccine, the arm was all red with itching) and VACCINATION SITE ERYTHEMA (She started breaking out in the arm in which she received the vaccine, the arm was all red with itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included anti-itch cream on arm.
First symptoms were various lumps on my face and neck, which have not dissipated. The first were by my lips and on my chin, followed by my neck and jawline. As of 2:30 am on 5-8-21, I have a severe sore throat which has not been eased by my usual methods of taking Advil cold & sinus and gargling with hot salt water. As I am reporting the severe sore throat at 3:47 am on 5-8-21, I do not know yet if I will be required to see a doctor. I consulted with my doctor about the skin effects, but she said that there was nothing that could be done for them.
5 inch round red area on upper arm, not noticed until 2/19/2021. The redness is increasing
patient was administered with expired Flublok vaccine, with no reported AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professionals via Media Information (under reference number 00814737).  This case was linked to 2021SA345761, 2021SA346022,2021SA345646,2021SA345109 (same reporter).  This case involves a female patient of an unknown age who was administered with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to patient.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Total, once, dosage form: PFS (prefilled syringe), lot QFAA2017 and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Stated that they gave 15 patients expired Flublok vaccine, and wants to know what to do.There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."   At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   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.
Pfizer BioNTech COVID Vaccine EUA -- Nurse gave undiluted 0.3ml dose of vaccine out of vial without diluting it
Stiffness, soreness, unable to put pressure on leg and unable to walk.  Even unable to sit on toilet seat without experiencing pain.  Fever of 101.3-101.9, administered Advil for pain and fever, pain and fever relieved temporarily but returned within 4 hours.  Soreness and stiffness remain.
Very swollen arm. From elbow to shoulder and extremely painful.  Arm has bumps (Knotty), very tender and swelling is expanding over last couple of days- Can no longer tell that I   have an elbow.
This case was reported by a nurse and described the occurrence of headache in a 27-year-old female patient who received Influenza vaccine. In 2013, the patient received the 1st dose of Influenza vaccine. In 2013, less than a year after receiving influenza vaccine, the patient experienced headache (serious criteria disability), numbness in fingers (serious criteria disability) and unable to work (serious criteria GSK medically significant). On an unknown date, the outcome of the headache, numbness in fingers and unable to work were recovered/resolved. It was not reported if the reporter considered the headache, numbness in fingers and unable to work to be related to Influenza vaccine. Additional information received: Nurse reports that a patient stated that she received her first flu shot in the fall of 2013, and she had severe headaches for two weeks and numbness in fingers. The headache and numbness resolved after a couple weeks. Nurse states that the patient consulted with the CDC, and that the vaccine she was administered contained monosodium glutamate (MSG) which caused her symptoms. She states that the patient was disabled because she had to miss work due to the symptoms.
heart arrhythmia; flu like symptoms; body aches; headache; This case was reported by a consumer via call center representative and described the occurrence of cardiac arrhythmia in a 62-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included heart disorder and animal bite (Possum bite).   On 11th December 2019, the patient received the 1st dose of RabAvert. On 12th December 2019, 1 days after receiving RabAvert, the patient experienced cardiac arrhythmia (serious criteria GSK medically significant), influenza-like symptoms, general body pain and headache. On 14th December 2019, the outcome of the cardiac arrhythmia, influenza-like symptoms, general body pain and headache were recovered/resolved.   It was unknown if the reporter considered the cardiac arrhythmia, influenza-like symptoms, general body pain and headache to be related to RabAvert.  Additional details were provided as follows: The patient received Rabavert vaccination for post- exposure prophylaxis. The patient experienced flu like symptoms described as body aches and headaches and heart arrhythmia.   The patient's events were resolved in the morning of 14th December 2019. The reporter consented to follow up. For tolerance of 2nd dose refer linked case US2020009056, reported by same reporter.
her legs turned blue for a few days; This is a spontaneous report from a contactable Nurse or other health professional. This nurse reported for herself that a 40 year-old female patient received bnt162b2 (COMIRNATY formulation; solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date (at the age of 40 -year-old) dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On an unknown date, the patient's legs turned blue for few days and then returned to normal color. No other side effects observed. Event took place after use of product. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tested positive for IgG/IgM; Possible Covid-19; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (Tested positive for IgG/IgM) and COVID-19 (Possible Covid-19) in a female patient of an unknown age 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 SARS-COV-2 ANTIBODY TEST POSITIVE (Tested positive for IgG/IgM) and COVID-19 (Possible Covid-19). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (Tested positive for IgG/IgM) and COVID-19 (Possible Covid-19) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
arm itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itching) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (arm itching). At the time of the report, PRURITUS (arm itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 and contains no new information
Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4/15/21 and 5/6/21. Patient presented to ED on 5/9/21 with complaints of acute onset substernal chest pain that woke him from sleep. Patient also endorses left arm pain, diaphoresis and nausea. No significant past medical history or family history of heart disease. ECG demonstrated inferior ST elevations. Patient was taken to cath lab and found to have no angiographic evidence of CAD. Patient discharged on aspirin 81 mg QD, Clopidogrel 75 mg QD, Metoprolol 12.5 mg BID, Rosuvastatin 5 mg QD.
Cold sweating last night Body aches, Headache Shortness of Breathe very shakey
pt recvd vax 3MAR95 in MD ofc 10MAR95; seen in ER for swollen lt thigh dx cellulitis given IM Rocephin then recheck in ofc on 11MAR95 lt leg much improved; given Ceclor x 5 days;
This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient's medical history included allergies to iodine, KEFLEX, penicillin, sulfa. The patient was vaccinated with ZOSTAVAX on 05-DC-2012. No other co-suspects were reported. Concomitant medications included estrogens, PREMARIN, propranolol hydrochloride and NORVASC. On 06-DEC-2012 the patient experienced injection site vesicles, 2 days after onset of therapy. Patient developed a "large, blistery area about the size of a potato" around the injection site. No treatment information was reported. The outcome of injection site vesicles was reported as not recovered/not resolved. The relatedness for injection site vesicles is unknown for ZOSTAVAX. No further information provided. VZVID packet faxed. Additional information has been requested.
1 hour after shot - swelling, fever, rash later - muscle sore, tingle right side of face/ear ear became stopped up - some blurr vision. Today - rash/swelling better > saw her provider given TAC, FLAGYL, cefuroxime.