chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1. significant right side arm pain from fingers to shoulder blade including under arm (armpit). Lasted 4 days  2. Redness, noticeable right arm swelling near injection site but encompassing entire upper arm 3. Fatigue
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that the vial did not undergo any temperature excursions and on 17-Nov-2021 the vial was placed in refrigerator and patient did not experienced any adverse event.  No concomitant and treatment drug information was provided.
Date/time/when adverse event started: 12/31/20  noticed a white streak noted from R eyelid straight down to the R jaw. Numbness, tingling feeling from R mid cheek moving toward R ear. Swelling of the face at this site as well. Paresthesia feeling, abnormal sensations at this same area of the face. These issues continues even to today. Initially, I experienced a H/A on the R sided above my eye which has not been occurring lately. On 1/8/21 I was seen by the NP at and was dx. with Bell?s Palsy. The NP noticed that when I initially speak my mouth doesn?t move properly, but once I get my words started then my mouth moves properly. My smile is noticed to be abnormal. The NP then sent me to ER for evaluation with the dx. Of Bell?s Palsy and because of another potential medical condition there?s a high risk for a stroke. A CT scan and blood work were obtained. A f/u script for a MRI of the brain has been ordered as well. Discharge paperwork states: Bell?s Palsy. Currently, I am taking a tapering dose of Prednisone and Valtrex as prescribed.
The day after getting the vaccine that patient stated she experienced swelling, redness and rash on her face and neck, but no trouble breathing or swelling of the throat or tongue. She stated it was painful, itchy, and a burning sensation. It lasted about 3 days and gradually got better. The patient today 8/20/22 appears to not have any symptoms and is fully recovered.
Had horrible case of flu; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious case received from a patient.  This case involves a patient of unknown demographic who had flu (influenza), while the patient received influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received an unknown  dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route and administration site unknown) for prophylactic vaccination.  On an unknown date, the patient had flu (influenza) following the administration of influenza vaccine.  No relevant laboratory test was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
I had severe soreness for 2 days; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; This is a spontaneous report from a contactable pharmacist (patient). A 34-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL9264), via an unspecified route of administration at left deltoid on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient reported that she had her vaccine last Thursday (28Jan2021) and believed she had an injection site reaction. She had severe soreness for 2 days and she had a half of the dollar size, coin size of bump and it's been red, swollen and itchy. She did not take anything for the events because she wanted to see how bad it goes. There was no Physician's Office/Emergency Room visit. She was curious if she will get the second dose since she had this first reaction. The outcome of the events was unknown.
Dizzy lasted 30 minutes nausea/ vomiting, felt nauseated for 10 minutes then vomited on 4/24/07.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022 at 5:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Mar-2022 at 5:05 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received vaccine past its 30 day expiry date on 18-Mar-2022 at 5:05:17 PM. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment information was reported.
sore arm; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) and MYALGIA (sore arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced COVID-19 (tested positive for Covid-19). On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, COVID-19 (tested positive for Covid-19) and MYALGIA (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Rebound from Paxlovid; Rebound from Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing); "valley fever", start date: Dec2019 (unspecified if ongoing), notes: valley fever in Dec2019; "known allergies sulfa" (unspecified if ongoing); "known allergies penicilin" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE, start date: 01Sep2020; METHIMAZOLE, start date: 08Feb2021. Past drug history included: Levaquin, reaction(s): "known allergies: levaquin". The following information was reported: VACCINATION FAILURE (medically significant) with onset 23May2022 at 19:00, outcome "recovering", SUSPECTED COVID-19 (medically significant) with onset 23May2022 at 19:00, outcome "recovering" and all described as "Rebound from Paxlovid". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Additional information: Report about covid treatment was Yes. If vaccine received reported as Yes. Other medication in 2weeks reported as Yes. Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 13May2022, Treatment stop date: 18May2022, Indication: Treatment of COVID-19. Adverse event: Rebound from Paxlovid. Known allergies: Sulfa penicillin Levaquin. Other medical history: Graves' disease, valley fever in Dec2019.
"Janseen COVID-19 Vaccine EUA" - experienced following symptoms for 1 day: diarrhea, stomach pain, chills, brain fog/headache, aches throughout my entire body, could barely walk
rash on her arm that spread through her back; This spontaneous report as received from a physician via a company representative refers to a 11-year-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number, expiration date, dose and route of administration were not reported).  On an unspecified date, the patient experienced rash on her arm that spread through her back. It was reported that she returned to the office on an unspecified date with this event. On an unknown date, the patient recovered from the event.   The relatedness between the event and the vaccine was not reported.
uncontrollable crying for 1 to 1 1/2hr p/vax; & sl redness @ inj site that disappeared in about an hr
One day prior to the clinic on 5/18/22, an email was sent with a list of patients that needed boosters. At the start of the clinic on 5/19/22, copies of vaccine cards for these patients were given to staff. All cards were checked by ensure eligibility for boosters. Vaccine administration started at 1pm. At approximately 1:20pm, after 14 vaccines were given, staff alerted facility that the copies of vaccine cards and emailed list were not up-to-date. After consulting with staff, who had an updated list of vaccine records, it was determined that six patients were given a booster shot when not eligible. Consulted with facility team on how to follow-up and proceed with the clinic. Going forward, each patient vaccinated had their records verified on the databases. Emailed list was cross-checked with the updated list given by staff. Even with updated list from facility, errors were found with vaccine records not being up-to-date and inconsistencies. Photos of covid vaccination cards were taken for records and vaccination cards were sorted.  Patient recieved second booster but did not qualify for second booster.
Possibly that same night, but definitely the next day, the lymph nodes under my right arm swelled up, and they were very painful. It was difficult to put my arm down. It last a little over a week, maybe about 10 days. I did talk to my PCP but she told me the same thing had happened to her with the vaccination, and I knew from the first dose that it would go down. I took some Tylenol or Aleve.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 18-APR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered a rash and discomfort around the left chest which traveled anteriorly towards the breastbone and posteriorly over the shoulder blade; then, the patient was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, symptoms had resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX) vaccination, he sustained severe and permanent personal injuries. Further, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).  Reporter considered herpes zoster to be a disabling event.
Pain on lifting left arm, constant pain upper left arm, pain behind left shoulder, pain in shoulder joint, pain in left elbow, tingling in fingers of left hand.
Patient reported that she had fainted in the past with injections.  Immediately after receiving TWINRIX patient became dizzy and passed out.  Patient was non-responsive for 15-30 seconds.  After awakening patient began to vomit and continued to do so for 20 minutes.  No shortness of breath.  At 1815, blood pressure 124/60, pulse 72 regular.  Patient offered ambulance, declined, desired to go home.  Left with husband - walked to car.  On 5/1/08, patient reports she called MD and he told her she had a "severe allergic reaction to injection" and not to get another.  Feeling better.
Since vaccination I was diagnosed with chronic hives and chronic sinusitis. Then my COVID-19 symptoms were lost of taste, temperature changes, fatigue, congestion, runny nose. It began with a hoarseness and headache.
This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the left arm on 07May2021 at 08:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 12Apr2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 20: 00, the patient experienced chills, aches, 101 plus fever and tightness of chest. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, aches, 101 plus fever and tightness of chest was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Aches and pains on ours hands and our legs and sometime we cannot even close our fist; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown, Expiration date was not reported), dose 2 via an unspecified route of administration on 31Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (COMIRNATY) 1st dose on an unknown date for COVID-19 immunisation. Reporter stated, calling to see if there is anybody has had, because he had the Pfizer, his 2nd shot he had it at the end of March this year and his wife had it at the same time. He was just wondering if anybody else called and have this complaint at all. The patient experienced aches and pains on our hands and our legs and sometimes we cannot even close our fist on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) as same reporter/drug/event, different patient.
Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This is a spontaneous report from a Non-contactable Other Health Professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunization.  Medical history reported as none. Known allergies: NO (Allergies to medications, food, or other products: No). The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination: No. The patient experienced Fever, body aches, joint pain, headache, diarrhea, dizzy spells, uncontrollable shakes, chills, all on 06Jan2021 21:00 with outcome of recovering.  Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. No treatment received for the adverse event. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Covid test post vaccination: Nasal Swab on 07Dec2021 with result negative. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
approx 12NOV pt exp painful, swollen neck glands & cont w/stiff neck 7 swollen neck glands;/ ?rt arm sl pain;12NOV no c/o arm pain today; rt leg & knee hurt;ill since OCT97 w/URI & bilat ear infect;
Patient's mother advised to contacted local health department.  Patient received total of 5 shots on 5/20/08.  Mother received call from daycare center on morning of 5/21/08 indicating that patient's left arm was swollen and red.  Mother also stated that patient's arm is warm to touch and hard.  Mother did not notice any swelling while giving patient a bath on the morning of 5/21/08.
Client complained of complained of flushed face, swelling to hands, headache, vision changes and dizziness after receiving Janssen Covid vaccine (lot 1808980 exp 6/20/21). Client was walking out of waiting room and approached the PHN to inform she was not feeling well. Client assisted to closest chair, EMT joined in and started vitals as PHN did assessment. Per client started feeling mild symptoms after 5mins and by 15 mins symptoms had progressed. Client did not alert anyone until her time was done and she began to walk at 1125. Client alert and oriented, flushed face, mild diaphoresis, per client spots in vision, swelling to hands, left hand more, and headache. Client denied shortness of breath, chest pain. History of allergy to penicillin. No other pertinent medical history. Vitals 1125: blood pressure 140/98, pulse 99, oxygen 100%. Client transfered to gravity chair and given water. Client wanted to call husband to come pick her up. 1134: pulse 97, oxygen 98%. Client stated pressure behind eyes. PHN offered client benadryl, flushed face continued, headache, swelling to hands. Client accepted as husband was on his way. Benadryl 50mg PO given at 1137. Vitals 1139: blood pressure 150/90, pulse 95, oxygen 98%. Per client dizzy, felt warm across face, headache, pressure around eyes, swelling on hands and flushed face. Client denied shortness of breath. Client asked if she wanted 911 to be called for further assessment, client denied, she stated she would continue waiting. Vitals 1144:blood pressure 130/90, pulse 97, oxygen 90. Per client headache gone, no flushing, felt tired. 1148 swelling on hands was improving. Vitals 1152: blood pressure 110/80, pulse 89, oxygen 96%. No headache, just pressure on forehead, no flushing, blurry vision improving. Vitals 1157: blood pressure 126/90, pulse 90, oxygen 97%. Per client all symptoms improving. Wanted to sit straight on chair. Client stated felt well enough to go home. Pressure on head was only symptom at this time. Client given ER precautions. Husband was going to driver her home. Last vitals at 1205: blood pressure 120/90, pulse 86, oxygen 97%. Alert and oriented, stood up with no complaints of dizziness. Client walked out of facility with steady gait
Swelling, itching, inflamed and hot to touch at upper arm where shot was given.  Emergency room doctor said it was a local allergic reaction or cellulitis and gave antibiotic for seven days.
Pfizer 1st dose 3/05/21 (lot # EN6198),  Pfizer 2nd dose 3/26/21 (lot # ER8727).    Patient is fully vaccinated with Pfizer COVID vaccine back in March 2021. Patient came to ED for SOB and tested positive for COVID on 7/30/21.
diarrhea real bad; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included constipation (had planned to take a stool softener) and maybe deaf or hard of hearing. The patient's concomitant medications were not reported. Right after the shot on 08Apr2021, patient almost did not make it to the bathroom. She had diarrhea real bad, off and on, that whole day for about 3 hours and was fine after that. Outcome of the event was recovered on 08Apr2021. The reporter considered the event non-serious.  No follow-up attempts are completed. Information about lot/batch number cannot be obtained.
Gall stones, colic leading to gall bladder removal. Potentially had stones before the shot, but increased colic after probably due to unrelated weight loss plan.