chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arrhythmia; afib; cryptogenic stroke; tachycardia; feeling tired; having tiny sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmia), ATRIAL FIBRILLATION (afib) and CEREBROVASCULAR ACCIDENT (cryptogenic stroke) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029LZOA) 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 L-THYROXINE [LEVOTHYROXINE], NALTREXONE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (arrhythmia) (seriousness criterion medically significant), ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (cryptogenic stroke) (seriousness criterion medically significant), TACHYCARDIA (tachycardia), FATIGUE (feeling tired) and VACCINATION SITE PAIN (having tiny sore arm). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARRHYTHMIA (arrhythmia), ATRIAL FIBRILLATION (afib), CEREBROVASCULAR ACCIDENT (cryptogenic stroke), TACHYCARDIA (tachycardia), FATIGUE (feeling tired) and VACCINATION SITE PAIN (having tiny sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: normal (normal) CAT scan showed no bleeding. In 2021, Echocardiogram: normal (normal) Echo fine. In 2021, Magnetic resonance imaging: abnormal (abnormal) MRI showed the cardiovascular event such that there was an interruption, but there was no structural issue..         Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-281138 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
September 18, 2007 received third dose of Gardasil.  September 20, 2007 started with temp, headache, nausea.  September 21, 2007 developed vaginal and labial sores. Had to be seen at Urgent Care clinic on 9/22 due to painful sores. Rx given.  Sores went away.  Sores reappeared approx. one month later again and resolved again.No sores at this date of report.
Breakthrough Case of Covid 05/08/2022. I began around 05/08/2022 I had a sore throat and a bad cough. I took a Rapid test on 05/11/2022 came back positive. Doctor prescribed Paxlovid. I think right now we are on the tired side, but that is about it. We were coughing so bad it was hurting. Still a little on the tired side, coughing has gone way down and the sore throat is just about gone.
At around 7pm on 03/16/08, mother noted baby was febrile with temp. 101 and hives-like rash erupted at around right thigh, where he had PCV vaccination, and also eruption at groin, head anterior and posterior trunk. Was brought to ER, where he was given Benadryl IM shot. Rash subsided in 1/2 hour and has not recurred. Baby has been afebrile since.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 18-year-old male patient who received BEXSERO. Concomitant products included BEXSERO. On 15th March 2018, the patient received the 2nd dose of BEXSERO. In March 2018, less than a month after receiving BEXSERO, the patient experienced chills. On 16th March 2018, the patient experienced influenza-like symptoms and fever. On 26th March 2018, the patient experienced low blood pressure and vomiting. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, low blood pressure and vomiting were recovered/resolved. The reporter considered the influenza-like symptoms, fever, chills, low blood pressure and vomiting to be related to BEXSERO. Additional information was received as follows: On 29th January 2018, the patient received 1st dose of BEXSERO and experienced adverse events (refer case US2018GSK056258). On 16th March 2018, 1 day after receiving 2nd dose of BEXSERO, the patient experienced influenza-like symptoms and fever. On 26th March 2018, 11 days after receiving 2nd dose of BEXSERO, the patient experienced low blood pressure and vomiting. The patient went to the hospital on 16th March 2018, he did not stay overnight, but stayed at the infirmary for 24 hours. Adverse events took a week to recovered. This case has been linked to the case US2018GSK056258, reported by same reporter for the same patient. This case has been linked to the case US2018051278 and US2018GSK057910 (brother's case), reported for the patient from same family.
8cm diameter area of edema & erythema (L) deltoid at site of influenza IM injection previous day.
This female inadvertently received a subcutaneous injection of flu vax on 10/1/99. Later that day, she presented with injection site reaction characterized by swelling, redness, and tenderness. She recovered.
Knot under skin increasing. Blisters. Center dark. Itching painful to touch.
This spontaneous report as received from a registered nurse refers to a 20 years old female patient with penicillin allergy and exposed to kids with chicken pox growing up. The patient was vaccinated with the first and second dose of VARIVAX (merck) (lot# unspecified) 0.5ml subcutaneously in January 2011 and March 2011. No other co-suspects were reported. No concomitant medications were reported. On 03-DEC-2012 the patient tested "negative to varicella titer at an IBGG titer of 83.4". No treatment information was reported. The outcome of the event was unknown. The patient called physician's office once she received her results. Additional information has been requested.
Later that evening I began to have a fever and flu-like body aches, mainly pulsating through my hands and feet. After the aches went away 48 hrs later, I have still experienced piercing pain in my hand, mainly through my index finger. It feels like it should look very swollen, but it doesn?t. I can?t grip things like dishes or the steering wheel without pain or sometimes at all. I?ve never had arthritis but I would guess this is what severe arthritis feels like.
Patient has red mark at injection site, hot to the touch , reports soreness and burning at injection site
Came to clinic with concern "face doesn't look right".  Denied pain, feeling of numbness or dizziness.   Smile noticed on right side of mouth none on left side. Extended tongue leans slightly to the left. Slight inequality when soft pallet observed.
Extreme confusion, words were unintelligible Dry heaves Could barely walk Doing odd things...trying to drink out  of tissue box Sucking on blanket  table & walker Could not understand directions Slept then awake every 20 min No fever
Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: ER8732, expiration date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history was not reported. There was no other medications in four weeks. It was also reported that there was allergy medicine in two weeks, which was considered concomitant medication. Patient had blood in stool on 01Apr2021 with outcome of not recovered. Patient reported the event as non-serious. Patient had no COVID-19 prior vaccination. Patient performed COVID-19 tested post vaccination by nasal swab with unknown results.  Information on the lot/batch number was available. Additional information has been requested.
Soon after receiving the first dose, patient started having frequent migraines.; Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Soon after receiving the first dose, patient started having frequent migraines.) and HEADACHE (Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, 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 experienced MIGRAINE (Soon after receiving the first dose, patient started having frequent migraines.) and HEADACHE (Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.). The patient was treated with GABAPENTIN for Migraine, at a dose of Daily and RIZATRIPTAN for Headache, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Soon after receiving the first dose, patient started having frequent migraines.) and HEADACHE (Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. . Patient stated that they started trying different treatments. Patient spent a couple of years adjusting things with the neurologist. Caller stated something about the vaccine changed his typical headache pattern. Now he took daily prescription medicines to manage the migraines. At first he thought it was something temporal but now it looked like it´s going to be something permanent and he will have to take those medicines for the rest of his life. He was seeing the neurologist on an annual basis to monitor the situation. They were able to manage the migraines with the medication.  .   This case was linked to MOD-2023-724597 (Patient Link).
Patient was hospitalized for dysphasia after receiving 2nd dose of Pfizer COVID-19 vaccine.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), second dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was hospitalized for dysphasia after receiving 2nd dose of Pfizer covid-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SEVERE CHILLS HIGH PULSE 106 LOW OXYGEN 92% 103 FEVER
The lymph node in the left side of neck swelled up and stayed swollen for about 6 weeks.
light flu like symptoms; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (light flu like symptoms) and FATIGUE (fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine. Concurrent medical conditions included Lymphoma (treated in the past. She is currently in remission and is not going through any treatments) and Shingles (Patient put on Valcyclovir.) since May 2021. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALCYVIR) for Shingles, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D NOS for an unknown indication. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (light flu like symptoms) and FATIGUE (fatigue). On 13-Aug-2021, INFLUENZA LIKE ILLNESS (light flu like symptoms) and FATIGUE (fatigue) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment drugs were reported. This case was linked to MOD-2021-418874 (Patient Link).
Upper lip swelled up quickly and lasted 8 hours.  After second dose 2 days after by lip and eyes swelled up, I had chest pain and went to Er.
I think that the work you do to bring the flu shot to the office is a great benefit and I do appreciate it as much as I do the heart test. I have to tell you though that I couldn't possibly risk another 2 weeks of pain like I received from this last shot. Youch! It's very surprising to me and I have to believe that it's more a case of misplaced shot than a new mix of vaccine. I'm just guessing really, but my shot was near the top of my shoulder and my pain is sort of in the shoulder itself-not the muscle. Please don't interpret this as a complain in any way 9 I do complain about it as I explain to her why she's raking the leaves and splitting the wood (not really)). I continue to appreciate the effort and concern that you and the company put forth regarding out health. I just wanted to share my experience with you in the even that you continue your dialog with the nurse.
The usual sore arm; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (The usual sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced MYALGIA (The usual sore arm). On 30-Jan-2021, MYALGIA (The usual sore arm) had 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.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-303204, MOD-2021-303300 (Patient Link).
Missed the appointment of the second dose/ 42 days period had passed; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the appointment of the second dose/ 42 days period had passed) and PERIPHERAL SWELLING (Swollen arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, TOPIRAMATE (TOPAMAX) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the appointment of the second dose/ 42 days period had passed). 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). On 07-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed the appointment of the second dose/ 42 days period had passed) had resolved. On 09-Mar-2021, PERIPHERAL SWELLING (Swollen arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Claritin, Motrin. No treatment medications were taken by the patient.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pfizer shot made her tired; she had a sore arm; after her 1st primary dose she slept 13 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, 0.3ml single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high diagnosed most of her life; "High cholesterol" (unspecified if ongoing), notes: High cholesterol diagnosed most of her life. Her liver produces too much but it is pretty even; "thyroid" (unspecified if ongoing), notes: thyroid. The patient's family history included: "heart issues" (unspecified if ongoing), notes: Family member had 5/6 children that had heart surgery and mother had 2 heart attack and 13 bypasses. Concomitant medication(s) included: LISINOPRIL HCTZ taken for hypertension. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Pfizer shot made her tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a sore arm"; HYPERSOMNIA (non-serious), outcome "unknown", described as "after her 1st primary dose she slept 13 hours".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Terrible fever, body aches and chills for hours overnight, recurring randomly and less severely over the following 3 days
Information has been received from a physician concerning a 2 month old female who was vaccinated PO with the first dose of Rotateq. The physician reported that the patient's face turned red and she developed projectile vomiting. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 3/14/2007.  Information has been received from a physician and medical assistant concerning a 57-day-old female with no medical history who on 14-FEB-2007, at 1030, was vaccinated PO with the first dose of ROTATEQ (Lot #654795/1374F).  There was no illness at the time of vaccination.  On 14-FEB-2007, at 1030, the patient's face turned red and she developed projectile vomiting which contained large amounts of formula (patient was fed prior to vaccination) after the first drops of vaccine were administered.  The patient was burped and was given a few more drops of the vaccine.  In seconds, the patient turned red in the face and vomited even more.  Unspecified medical attention was sought.  No laboratory/diagnostic tests were performed.  The remainder of the vaccine was not given and the patient was administered four vaccines for her two month visit.  The patient subsequently recovered.  Additional information is not expected.
FEVER FROM 10/7/21-10/10/21, NAUSEA AND VOMITING FROM 10/8/21-10/11/21, ACHES AND CHILLS FROM 10/7/21-10/11/21, CHEST AND ABDOMINAL PAIN FROM 10/8/21-10/12/21. TREATED WITH TYLENOL AND PEDIALYTE.
Immediately after receiving dose #2 developed a warm sensation from her arm that traveled to her chest. HR 140bpm after receiving vaccine, BP also reported elevated but value not available. Also developed rash over chest. Was sent to ER for observation, given Benadryl, then discharged with epi pen.
mild headache for 3 days after Dose 2; Initial fatigue; diaphoresis; bilateral axillary pain; This is a spontaneous report from a contactable physician. A 37-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL1283, Expiry date: Unknown) via intramuscular route of administration on 08Jan2021 12:00 in left arm as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. There were no other vaccines within 4 weeks. No COVID prior vaccination. There were no known allergies. Covid tested post vaccination. On 18Dec2020 12:00 PM, the patient administered first dose of bnt162b2 intramuscularly in left arm (lot number: EK5730) for COVID-19 immunisation. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced initial fatigue, mild headache for 3 days after dose 2, as commonly described. Starting about 7-10 days after dose 2, diaphoresis, fatigue, bilateral axillary pain continued for 10 days, and recurring now in late Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient took antipyretics as treatment. The patient underwent lab tests and procedures on an unknown date in Feb2021 which included sars-cov-2 antibody test: negative, viral test: negative. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Patient started experiencing chills at 10 pm.  Proceeded to go to work the next morning and complained of dizziness, cold sweats, and nausea.  Patient stated feeling better after vomiting 'green bile.'  Patient was taken to the emergency room and was given IV fluids.