chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness in the arm - left; potentially exposed to the virus; headache; A spontaneous report was received from a consumer, concerning a 59-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in the arm - left, headache, potentially exposed to the virus.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (Batch number: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) soreness in the arm - left, headache, potentially exposed to the virus. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), soreness in the arm - left, headache, potentially exposed to the virus was unknown.
Syncope. Fell and hit head, woke up within 30 sec - 1 min. Abrasion to elbow and left forehead. EMT applied antiseptic ointment/bandage. Observed an additional 15-20min. Water, crackers given. Stable and released.
06/09/2021 Pt tested positive for Covid 19 , Asymptomatic, Tested for admission  06/09/2021 Pt admitted  Pt 1st dose recieved on 01/21/2021, 2nd dose Recieved on 02/18/2021 , Lot #, Time of vaccination, Site unknown.
Please note the patient did not receive the vaccination at state Medicine  so the lot # and site of administration information is NOT available.  Unclear if vaccine contributed to patient condition or outcome, but reporting due to timing of events. Patient received her 2nd Pfizer COVID vaccine around 2 pm on 5/19. She felt fatigued and had some localized arm pain in the arm she received her shot. She returned home and took a long nap from 3:30 pm to 11 pm at her daughter's house. She was playing with her grand-daughter and lifting her up when all of a sudden the daughter and her daughter's husband noticed the patient made a grunting/choking noise. She all of a sudden became unresponsive, had fixed pupils and a blank stare and found to be in PEA arrest with acute respiratory failure. Patient was initially admitted 5/20 to  Medical Center and then transferred to state Medicine on 5/21.  Patient passed on 5/31/21.
Severe headache beginning approximately 8 hours after injection. Headache has not gone away as of the date of this report (11/27/2021), 27 days after the injection. Visited urgent care facility on 11/15/2021 for suspected VITT; platelet count and d-dimer levels were within normal range, reducing the likelihood of VITT, but Brain MRI/MRV still recommended to be sure. Could not afford Brain MRI/MRV since insurance has a high deductible and would not pay for it. Visited neurologist and headache specialist on 11/22/2021 and was diagnosed with New Daily Persistent Headache.
Information has been received from a physician concerning a 14 year old female who was vaccinated with a dose of GARDASIL (Lot # unknown). The physician reported that after receiving the dose, the patient fainted. The patient sought unspecified medical attention. Additional information has been requested.
This case was reported by a physician and described the occurrence of vasculitis in a 27 year old male subject who was vaccinated with hepatitis B vaccine for prophylaxis. On unspecified dates in 2002, the subject received hepatitis B vaccine (dose number and lot number not provided). On an unspecified date in 2002, less than one year after vaccination with hepatitis B vaccine, the subject experienced vasculitis or skin eruptions like red blotches on the trunk and arms, and peripheral neuropathy. The subject was seen at a physician's office. The subject was treated with steroid and colchicine. At the time of initial reporting, 6/19/06, the events were ongoing. Comment: Vasculitis was assessed as medically serious (OMIC).
Patient developed intractable vomiting within 72 hours of vaccine administration resulting in dehydration and hypokalemia.  Patient also developed hypertension.  Symptoms lasted approximately 3-1/2 weeks. 10/27/08-records received for DOS 9/6/08-presented to ED with C/O vomiting times 3 days with abdominal pain (LUQ) and persistent nausea. Slight dysuria and frequency. DX: left pyelonephritis with abdominal pain and vomiting.
patient states that right  arm was bruised and sore and unable to lift and very painful.... when viewing clinical services tab under patient profile records state patient received vaccine in left arm
First dose of Moderna covid vaccine on 4/14/21, patient was given another dose of Moderna vaccine on 4/21/21; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna covid vaccine on 4/14/21, patient was given another dose of Moderna vaccine on 4/21/21) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021 at 8:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 12:01 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna covid vaccine on 4/14/21, patient was given another dose of Moderna vaccine on 4/21/21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna covid vaccine on 4/14/21, patient was given another dose of Moderna vaccine on 4/21/21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. It was reported that no immediate side effect was noted  but the patient will be checked again. The healthcare professional has plan of giving the patient his second real dose on 14 May 2021.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26 May 2021 contains no new information.
HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at 15:00 to left arm for prophylactic vaccination. Concomitant medications included methotrexate. On 28-MAR-2021 12:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Onset of red nipple discharge 5/7/2022. Cause of red nipple discharge in estigated by Breast Care Specialiats. Eventually diagnosed with Ductal Cell Carcinoma In Situ (Stage 0 breast cancer) on 1/9/2023.
Had Feeling Similar To Covid Effects; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) at SINGLE DOSE (Took Her 2 Covid Shots) for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. Patient reported caught Covid in Nov2020. Then she took her 2 Covid Shots By Mar2021. On 12Mar2021, she was feeling similar to covid effects and resolved on 29Mar2021.    No follow up attempts are possible; information about lot number/batch number cannot be obtained.
arms and hands is shaking like a tiny spasm; arms and hands is shaking like a tiny spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), TREMOR (non-serious), outcome "unknown" and all described as "arms and hands is shaking like a tiny spasm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RASH AND SWELLING  AT INJECTION SITE; LARGE RAISED RED AREA FROM INJECTION SITE DOWN TO RIGHT ELBOW
Metallic Taste in mouth. Muted sense of taste and smell. 102 Fever. Started when I woke up the next morning at 7:00 AM MDT. The metallic taste lasted 24hour. When I woke up on 4/22/2021 at 7:00AM MDT the metallic taste was gone but the fever of 102 persisted. My sense of taste and smell started to come back. When I woke up on 4/23/2021 at 7:00AM temperature returned to 97.6 and my sense of taste and smell seemed to be normal (hard to quantify taste).
Achiness; Cough; Rapid heartbeat; Chills; Fever 102 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), COUGH (Cough), HEART RATE INCREASED (Rapid heartbeat), CHILLS (Chills) and PYREXIA (Fever 102 F) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Feb-2021, the patient experienced PAIN (Achiness), COUGH (Cough), HEART RATE INCREASED (Rapid heartbeat), CHILLS (Chills) and PYREXIA (Fever 102 F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achiness), COUGH (Cough), HEART RATE INCREASED (Rapid heartbeat), CHILLS (Chills) and PYREXIA (Fever 102 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported.
2-3 days, post vax, lost appetite. Approx. 2 weeks after vaccine overwhelming fatigue, slept for 1 week. Malaise and fatigue persists.
SHINGRIX admin 1030AM; patient experienced hives, red and itchy skin, warmth and redness all over, shaking. S/S developed approximately 2PM.
COVID-19 diagnosis; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 diagnosis), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high since an unknown date.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Jan-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). On 06-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 diagnosis). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 diagnosis), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events included ibuprofen and paracetamol.  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. However, the event SARS-COV-2 test positive is unlikely related to mRNA-1273. Further information is requested.; 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. However, the event SARS-COV-2 test positive is unlikely related to mRNA-1273. Further information is requested.
Extreme, extreme muscle (deltoid) & joint pain to (R) arm 3 weeks s/p influenza injection began 3/28 to present.
Patient describes a tingling in her tongue, this is the same reaction she gets with exposure to her other allergens including: grapes, blueberries, and dust. The patient was given 50mg Benadryl and monitored for 1.5 hours. The patient did not report a gradual lessening of symptoms. Patient will be released with instructions for self monitoring and emergency planning if the symptoms get worse. She has had no history of EPI usage for an allergic reaction. She has gone for the
Pain in entire left arm one week after vaccine and then extreme fatigue and lethargic, nausea, headache, weakness, low energy, feverish, chills, cramping 2 weeks after. I have no energy or will power to do anything i use to do before the vaccine, i am in bed all day if i am not at work and then i also would have to call out of work on some days. I feel sick and lifeless.
she had a tiny bit of sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to eggs" (unspecified if ongoing), notes: Also allergic to eggs. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a tiny bit of sore arm".  Additional information: The patient already took the primary series and two booster shots from Pfizer and scheduled for the fifth shot. The patient has been hearing reports that Pfizer and Moderna are planning on working with boosters that contain flu shots as well. She was suggesting that Pfizer's researchers might consider having the next booster without any egg based in it or other options because she is allergic to eggs, she also did not take her flu shot because of that. She had a tiny bit of sore arm after those four shots from Pfizer other than that she had no problem with the vaccines.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : 202201283736 same patient and event, different dose;202201283735 same patient and event, different dose;202201283734 same patient and event, different dose;
pt reports sharp/shooting pain @site and parallel across the back. specifically reports "as if i've been punched in the sternum". States difficulty in lifting arm
Post vax, the patient developed moderate swelling with erythema and warmth and was severely tender on palpation at the injection site.
Within 48 hours of receiving covid vaccine, patient started experiencing severe headaches, mild nausea, and moderate chills. patient had tried OTC medication to help with symptoms with little to no relief. Same reaction/symptoms happened after 2nd covid dose. Symptoms are still present as of 3/9/2021 and not getting any better.   2nd covid shot was  2/11/2021  LOT:016M20A
I had a reaction at injection site nine days later. Injection site was red, swollen and very firm to the touch. It was about the size of a quarter and was very hot and sore.
swelling in her lymph nodes / swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non-hcp (patient).  A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 16Feb2021 (at the time of vaccination 70-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling in her lymph nodes/ swollen lymph nodes. It was reported that the caller got the first dose of the vaccine on 16Feb2021 and noticed swelling in her lymph nodes after the first dose but got the second dose 3 weeks later and is still having this swelling. She stated she talked to the doctor when it didn't go away for a month and he said give it a week or two. After that he said to send pictures and said give it another month but now it has been 3 months. She stated that everyone else she talked to that experienced this had it resolve in a couple weeks. She stated this is not comfortable. She asked how long is swollen lymph nodes supposed to last. Caller reports that she got her first dose of the Pfizer COVID Shot on 16Feb2021, and either that night or the next morning, the lymph nodes under her left arm were swollen. Caller thought they would just go away and she can't remember if it started on just the left side or on both sides, but anyway, three weeks after that. Caller states that the lymph nodes have not gone down as of now. The outcome of the event was unknown.  Additional information has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021564906 Same reporter/ drug/ event for different patients.
Chills, stomach ache, vomiting, diarrhea, headache, overall weakness.
Patient C/O bilateral ankle, wrist and knee pain. 1/16/2009 MR received from PCP. Pt in for 11yr WCC and vaccines 6/28/07. Well child with normal G&D with Dx: Exercise Induced asthma. Several sick visits for asthma exacerbations and cough and sore throats that year. At 12 yr exam 5/7/08, reports H/As, bilateral wrist, knee, and ankle pain and swelling. PE WNL Impression: Migraine H/A.
Gave TD at 2:30pm. Client was asked to wait 15 min before leaving clinic waiting area. At  2:41 pm RN was asked to waiting area to check on client, Client was sitting, diaphoretic, alert and oriented to PPTS stated felt ok. Bp 90/50 p62 resp WNL no signs of resp distress. Asked client to rest in exam room; stated only had drank water today ok, not eaten any food, Gave sucker, checked FS BS 71. Rechecked BP at 2:55 94/58. No swelling or redness or rash at inj site.
Blood clots in urine; Chills; A spontaneous report was received from a consumer concerning an 83-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clots in urine/haemorrhage urinary tract and chills.  The patient's medical history was not provided. Concomitant product use provided by reporter included baby aspirin.     On 18 Mar 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch number: 030A210) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced blood clots in urine and chills. The event blood clots in urine was medically significant. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events blood clots in urine and chills was resolved on an unspecified date.; Reporter's Comments: Although a temporal association exist, there is not enough information to assess the events of blood clots in urine as the patient's medical history is lacking.  However, chills is consistent with the known safety profile of the vaccine. Further information has been requested.
New onset bilateral hip and shoulder joint pain. Shoulder Joint pain now resolved, hip joint pain still ongoing.
Chills; Tiredness; Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (Chills) and FATIGUE (Tiredness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 31-Jan-2021, the patient experienced CHILLS (Chills) and FATIGUE (Tiredness). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Advil
after one hour legs wouldn't move, trouble speaking, very weak, left side of face. I was in this condition for two days. My legs are still very weak
Forgetting where I parked car; not getting everything I went to the store for. Burning food on stove.; patient took 1st and 2nd dose both on 02Apr2021; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 60-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0150, expiration date not reported), via an unspecified route of administration in left arm on 02Apr2021 10:30 (age at vaccination 60years old) as 1st dose, single dose for covid-19 immunisation. Reportedly, same day patient was administered second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0167, expiration date not reported) via an unspecified route of administration in right arm on 02Apr2021 as 2nd dose, single dose for covid-19 immunisation. The most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Medical history included fibromyalgia, allergies to tannins from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 27May2021 11:30 the patient experienced forgetting where he parked car, not getting everything he went to the store for and burning food on stove. The patient did not receive any treatment for the adverse events. The case was assessed as non-serious as per the reporter. The clinical outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Decreased use of arm and hand. ED visit ? Ulnar palsy. Still having arm weakness 12/1/14. At onset shooting electrical shock like sensation  weakness. Had Extra strength Vaccine for >65yr. Given at a pharmacy.
missed her second dose, passed 42 days window; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed her second dose, passed 42 days window) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her second dose, passed 42 days window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed her second dose, passed 42 days window) outcome was unknown.        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 not provided.  Treatment information not provided.