chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness on Injection site after first vaccine; Sorenson Injection site after first vaccine; Tired at night after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on Injection site after first vaccine), VACCINATION SITE PAIN (Sorenson Injection site after first vaccine) and FATIGUE (Tired at night after first vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder (Autoimmune conditions) and Gastrointestinal surgery (Few years ago had to give her CPR post GI operation and her sternum was hurt.). Concomitant products included OMALIZUMAB (XOLAIR) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on Injection site after first vaccine), VACCINATION SITE PAIN (Sorenson Injection site after first vaccine) and FATIGUE (Tired at night after first vaccine). On 06-Mar-2021, VACCINATION SITE ERYTHEMA (Redness on Injection site after first vaccine), VACCINATION SITE PAIN (Sorenson Injection site after first vaccine) and FATIGUE (Tired at night after first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was mentioned as patient took Xolair for biologics. No treatment medication was given.  Company comment: This case concerns a 54-year-old female subject with medical history of autoimmune disorder and gastrointestinal surgery who experienced the events of vaccination site erythema, vaccination site pain, and fatigue. The events occurred approximately 1 day after the first dose of Spikevax. Rechallenge was positive (fatigue) after the second dose. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2021-320235 (Patient Link).; Sender's Comments: This case concerns a 54-year-old female subject with medical history of autoimmune disorder and gastrointestinal surgery who experienced the events of vaccination site erythema, vaccination site pain, and fatigue. The events occurred approximately 1 day after the first dose of Spikevax. Rechallenge was positive (fatigue) after the second dose. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.
Patient received 1st dose of Pfizer vaccine on 26 February and then moved. No Pfizer available in our medical network. Patient counseled on mixing mRNA vaccines. Patient received 1 dose of Moderna on 26 March. Considered complete series.
A non-serious report of nose bleed has been received from a nurse concerning a three-year-old male subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  No relevant medical history or concomitant medications have been reported for this patient.  The subject received a dose of FLUMIST on 09-Oct-2008.  On 09-Oct-2008, the patient experienced nose bleed after administration of FLUMIST into the the second nostril.  Per the reporter, the patient was moving about during the administration.  The outcome for this event was not reported.
Swelling of foot, chest tightness and pain, stiff neck. Forgetfulness, other joint pain.
Patient was supposed to receive the second dose of Moderna and Pfizer was given  at 5:45pm on Sep 14. The patient did not have any sign or symptoms of adverse effects.
I had a very large pain lump develop in my left breast.  I had a mammograms on April 14th and an ultrasound.  By the time I got the mammogram the lump began to be less painful and smaller.  They diagnosed it as a cyst.  It eventually went away.  I was told that it could happen again.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 46.04 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  The vial was initially stored in the fridge on 30-Mar-2021, moved to the clinic on 03-Apr-2021 and proposed beyond use date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 31-Mar-2021, at 08:00 A.M., the temperature recorded was 32 degree Fahrenheit and at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit that has been reached by the vial.  On 03-Apr-2021, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Chills, nausea, muscle and joint pain, extreme fatigue, headache, 6 inch streak down arm that was also 2 inches wide
I had body aches, chills, cough, and a lot congestive in my throat and chest.  I had stuff nose as well.  These lasted for about 5 days and I still have a cough and headaches.  On the Dec 27th I went and got tested for Covid-19, positive results.
Location of shot (left upper arm) begin to swell to approximately 2 inches. The knot was hard and warm to the touch. The 2nd day I started having body aches, chills and ran a fever of 101.2. I took (2) 200 mg of Ibuprofen. Fever and body aches and chills subsided until 3rd day. The knot was larger and red. I went back to the doctor.
sick; Initial information was received on 30-Nov-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had sick (illness) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I used to get the flu shot, always got sick. Stoped getting it, haven't had a cold or flu in 5 years."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, outcome of the event was unknown.  There will be no information available on the batch number for this case.
Little warm; Really itchy; Sizable rash on upper arm; A spontaneous report  was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Vaccination site rash, vaccination site pruritic,  and vaccination site warmth warm.  The patient's medical history included mild reaction with tetanus shot. No relevant concomitant medications were reported.  The patient received the first of two planned doses of mRNA-1273 (Batch number: unknown) on 03 Feb 2021. On 03 Mar 2021, approximately prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: unknown) in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, after receiving second dose, the patient experienced the event, sizable rash on upper arm, about 5 inches wide and 7 to 8 inches long outside of upper arm, really itchy and little warm. Treatment details included diphenhydramine.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of event, vaccination site rash, vaccination site pruritis, and vaccination site warmth was unknown.; Reporter'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.
About 2 weeks after the 1st vaccination I got a very large, red, almost perfect circle, rash at the site and it got bigger around my arm. Didn't itch or hurt.  Went away within one week..
Body aches and fatigue day of vaccination.  30 hours post vaccine experienced severe body aches, chills, fever of 102.5 (axillary -unresponsive to acetaminophen).  These persisted for 24 hours.  Redness, swelling and pain at injection site continued for 72 hours.  I did not contact my oncologist as I have a monthly appointment prior to my next vaccination. Submitting this because of my MDS as informational.
pt with a history of a positive COVID test on 7/21/2021; pt presents to ED via EMS in cardiac arrest; EMS states ACLS performed 30-40 mins, pt was intubated; pt never achieved ROSC and died in the ED; per death certificate pt had a contributing factor of cause of death as a  "history of COVID -19"
Fatigue; Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills ) and FATIGUE (Fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) 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) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills ). On 01-Mar-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills ) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The patient was administered a Moderna vaccine with published expiry date of 10/15/2021.  He was monitored for 15min after injection. No complications noted.  He left the office with his wife and said they were going to lunch.
2nd shot, 12 hrs after body aches; 24 hrs after fevers high 102.5; rigors; felt I was burning up; This is a spontaneous report from a contactable other healthcare professional reporting for herself (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) intramuscularly at Left arm on 05Jan2021 12:00 at SINGLE DOSE for COVID-19 immunization. Facility type vaccine was Hospital. Medical history included allergies to Sulfa, mild ragweed. Concomitant medication included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC ALLERGY), estradiol (VIVELLE DOT). The patient received the first dose of BNT162B2 vaccine (Lot number EK5730) via intramuscular route of administration in the right arm on 15Dec2020 at 12:30 at single dose for COVID-19 immunization. On 15Dec2020 at 12:30, the patient experienced warm feeling throughout body and heart race which lasted 10 seconds. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination she had not been tested for COVID-19. Adverse events reported as "2nd shot, 12 hrs after body aches, 24 hrs after fevers high 102.5, rigors and felt was burning up". Adverse event start date was reported as 06Jan2021 06:00AM. No treatment received for the events. Outcome of the events was recovered in Jan2021.  Information about Batch/Lot number has been requested.
Patient was found passed out on the floor of her room after family called the facility as she was not answering her phone.  She was taken to the Emergency Room and admitted to the hospital.
12cm X 7cm rectangular erythema of (L) deltoid area with induration and warmth.
Client received Tdap, IPV, Hep B, MCV4, Flumist and HPV4. After HPV4 was administered (which was the last vaccine that was administered, client had syncope episode, client responded within 15secs. Lowered client to floor, elevated legs, juice given. After 10 mins. client stated she was feeling better, asissted her to chair where she finished juice. 3:00pm client had another syncope episode, lowered her to floor and administered O2, client orinated but slow to respond. 911 called, Paramedics transferred client to the hospital.
progressive renal failure; autoimmune diseases; asthma; distress; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 Immunization; Bnt162b2 (dose 2, single), for COVID-19 Immunization.  The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "progressive renal failure"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune diseases"; ASTHMA (non-serious), outcome "unknown"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "distress". The patient underwent the following laboratory tests and procedures: Blood test: autoimmune diseases, notes: Based on routine bloodwork I was found to suffer from autoimmune diseases.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer covid vaccine stored in regular freezer for longer than 2 weeks and patient received.
Patient developed bilateral flaccid paralysis both lower extremities on 8/7/15 and subsequently admitted to hospital with transfer to another hospital ICU on subsequent day.
Jan 12, 2022 Pfizer Booster administered Jan 12, 2022 hot flash after being administered Pfizer and reported to nurses who observed me for additional time (30minutes) and checked my vital signs - all in normal limits no fever. Jan 12-28 fatigue; managing PTSD symptoms stemming from racial sexual trauma from years ago and attempting to manage case Jan 27, 2022 stressful meeting with work director supervisor in which my integrity was questioned when I reported being sick with COVID first week of January, 2022; did not get two or three weeks off away from work like other demographics. I had to be at work the next week. March 18 Provider instructed me to go to ER, admitted for hospital blood transfusion  Jan 2022 detected SAR CoV 2 symptomatic sick Jan 2022 work discriminated against required additional reporting not typical for me to have to call the director when I've talk to those I report to; integrity called into question Jan 2022 went into work after a week; I would learn weeks later males and other demographics were allowed two and some three weeks off Jan 27 2022, meeting with director brought up the week I was sick and my integrity was questioned Jan 28, 2022 went to provider to ask for sick call slip - 24 hours off work Jan 28, 2022, large vaginal clots in toilet first time ever March 18, 2022 provider office called instructed me to have someone drive me to ER for critical low feritin, hemoglobin, hematocrit, iron; admitted to hospital for blood transfusion (first time in my life I required blood transfusion) March 19, 2022 April 2022 : two more infusion sessions (first time in life) May 2022, more large vaginal clots requested quarters - provider gave me 3 days off work Hospital has inaccurate had inaccurate errors in my medical records that I requested to be corrected to include:  1. Ultrasound order reason is incorrect: I DID NOT present to the ER with vaginal bleeding and SOB. I was not vaginally bleeding 2. ER disposition was admitted to the hospital in patient and I was not discharged 3. I do not have a chronic history of vaginal large clots 4. Clarification: I WAS NOT pregnant and DID NOT have a miscarriage or other
At 12:30pm 2/3/2021 Resident experienced Respiratory distress, tachypnea, tachycardia HR 155, RR 38, O2 sats 48%. BP 164/149; frothy sputum from nose and mouth, lungs with coarse crackles, Temp 99. Resident required EMS transport to hospital, and was admitted.
3/15/2014: patient experienced itchiness, hardening, and redness around vaccination site (approx. 2 in diameter) 3/16/2014: AM- redness, inflammation, and itchiness spread from vaccination site to surrounding tissue (approx 4 in diameter). PM- redness, inflammation, hardening continues to spread to 6 in diameter. 3/17/14- AM symptoms spread to entire upper left arm. Tissue is hardened and swollen and emitting heat. Very uncomfortable for patient and tender to touch. Vaccination site is bruised. Member noted a similar but smaller reaction during previous vaccination April 2010.
11 Doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  It was reported that vaccine was put out of the freezer on 01 Dec 2021and placed in the refrigerator, so it was not supposed to be used beyond 31-Dec-2021 but 11 doses were administered on 05-Jan-2022. Vial did not underwent any temperature excursions.
FEVER, ERYTHEMA AND PAIN AT SITE OF INJECTION, SEEMS LIKE CELLULITIS AND VOMITING
Anaphylactic Reaction.  Treatment with Epinephrine, Benadryl, Solumedrol, Albuterol and Atrobent
Extreme arm pain began 4/7, Shingle rash outbreak on 4/9, diagnosed with Shinges on 4/11.  Prescribed Valtrex for 7 days
Tested positive on 11/4.  Dizzy, confused, pale , mild cough
Redness, swelling increased over 2 day period . Warm and hard to touch and itching. Mom placed ice on the area. No medication given
No adverse event reported but patient received both doses of Moderna COVID-19 vaccine at the age of 17 rather than 18 as FDA approved.
15 MINUTES AFTER, PT STARTED FEELING DIZZY.  PT WENT HOME AND TOOK MECLIZINE.  SHE WAS WEAK, ACHY AND HAD LOW GRADE FEVER, FELT FLU-LIKE SYMPTOMS FOR 7 DAYS.  SHE HAD SEVERE DIARRHEA ON THE 7TH DAY AND IT SEEMED TO GET BETTER AFTER THAT.  PT WAS DRINKING A LOT OF FLUIDS AT THE TIME.
Patient states she got a headache 30 minutes after taking the vaccine. Checked on patient 4 hours later, still complaining of a headache.
Severe Dizziness 4 hours after getting my second dose. Went to ER that same day
Vaccine given 1/2/20. On 1/4/20 AM Mother reports that L arm was red, swollen with a lump. Was taken to After hours Clinic. Mother states she was told he had an infection and was put on abx. Mother called our clinic on 1/8/20. Staff attempted to return call and left message. Message passed to another staff member and Mother was reached. States today, 1/9 , the reaction/infection is "almost gone".
itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-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 PRURITUS (itchiness). At the time of the report, PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications
Fatigue; A visibly swollen lymph node in her neck; This is a spontaneous report from a contactable healthcare professional (the patient). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: KK9231, expiration date not reported), via an unspecified route of administration (reported left arm), on 13Jan2021 at 09:45 at a single dose for COVID-19 immunization. Medical history included psoriasis from an unknown date. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 23Dec2020 on her left arm (lot number: EJ1685). After receiving the second dose of the vaccine on 13Jan2021 at 20:15, the patient experienced fatigue and a visibly swollen lymph node in her neck. The patient was recovering from the events. There was no treatment given for the events.