chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dull ache; Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 22Feb2021 (Batch/Lot Number: EL9267) as SINGLE DOSE for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced headache on 22Feb2021, dull ache on an unspecified date. The reporter stated that she got her first dose yesterday, 22Feb2021. She says her adverse effect was that at 03:00PM or 03:30PM she was fine, then she took a nap and at 06:00PM she woke up with a big headache that she got to go away with an ice pack and a pill, then that night she had a dull headache. She says she didn't take another pill until the next morning, the headache is still here, it is a dull ache, it is not as worse as last night, it is annoying more than anything. Documented as provided. Caller says she took TYLENOL last night about 06:00PM then took another one this morning at 09:00AM. She says that the TYLENOL is 500mg, Extra Strength. UPC: Caller says this is not on the bottle, maybe it was on an outer box that was discarded a long time ago. LOT: SLA002, EXP: Jul2024. The events was considered as a non-serious. Therapeutic measures were taken as a result of headache and, dull ache. The outcome of the events was reported as unknown.
Patient received 1st dose Covid -19 vaccine Pfizer Lot # ER8730 Patient returned 04/29/2021 for 2nd dose and for unknown reason received 2nd dose Johnson and Johnson Lot # 1808609
Immediate reaction,  took over care,  flushed and itchy progressed to facial swelling and difficult of breathing and was given EPI IM  and Benadryl IV, transported Hospital.
Administered around 10am.  By 4pm, starting to feel lethargic, exhausted, achy.  All of these were the feelings of being "sick" but not fully sick.  By 6pm, I had a 102.2 fever which lasted through the night (approx 4am).  I took 2 Tylenol a total of 3 times throughout the night and drank water.  In addition to the fever, I experienced body aches and was drenched in sweat.  By 6:45 am, I had broken the fever and showered.  I worked throughout the day but felt very foggy in my head and just tired.  I did not have another fever but did sweat through the night again on Wednesday evening.  I had a dull headache on Thursday which eventually went away with OTC meds.  Again exhausted on Thursday evening.  By Friday, I was finally feeling a bit more normal.
Patient was given .5ml instead of .25 ml, Patient was called and denies any problems since vaccination and a letter was sent to him also informing of dosage given
PHONE MESSAGE- UNABLE TO REACH FOR FURTHER INFO X2.  STATES NO REACTION UNTIL 1/4/2021- BILATERAL "THROBBING" LEGS - NO RELIEF WITH OTC NSAIDS
Approximately 15 min after flu vax. felt like a bee sting with sharp pain down arm, up to neck, then intermittent. No numbness/tingling.
got the flu every time I had the shot; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.  This case involves a patient (unknown demographics) who experienced flu (influenza), after the patient received vaccine INFLUENZA VACCINE (shot).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) the patient got the flu (influenza) every time the patient had the INFLUENZA VACCINE (shot).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Pulmonary embolus, shortness of breath, chest pain, D-Dimer
Went from hypothyroidism to hyperthyroidism; Fast heartbeat/Like water around the heart/Like a tunnel; Lost a lot of weight; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (Went from hypothyroidism to hyperthyroidism), PALPITATIONS (Fast heartbeat/Like water around the heart/Like a tunnel), WEIGHT DECREASED (Lost a lot of weight) and FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Polio in 1951 and Back surgery. Concurrent medical conditions included Hashimoto's disease (30 years ago) since 1991 and Hypothyroidism. Concomitant products included WARFARIN for Clot blood, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PALPITATIONS (Fast heartbeat/Like water around the heart/Like a tunnel) and FATIGUE (Fatigue). 15-Mar-2021, the patient experienced WEIGHT DECREASED (Lost a lot of weight). In July 2021, the patient experienced HYPERTHYROIDISM (Went from hypothyroidism to hyperthyroidism). In April 2021, PALPITATIONS (Fast heartbeat/Like water around the heart/Like a tunnel), WEIGHT DECREASED (Lost a lot of weight) and FATIGUE (Fatigue) had resolved. At the time of the report, HYPERTHYROIDISM (Went from hypothyroidism to hyperthyroidism) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: 160/100 (High) High and 159/58 (High) High. On 15-Mar-2021, Heart rate irregular: abnormal (abnormal) abnormal. On an unknown date, Blood pressure measurement: 120/70 (normal) Normal. On an unknown date, Renal function test: normal (normal) normal.   The patient had a heart monitor for a month. 6 weeks later, everything went back to normal without medication.  Patient had her annual check on July and doctor told to lower the dose of Synthroid down to 88 mcg from 100 mcg.  Patient was scheduled to receive the booster dose next Sunday on 14 Nov 2021.  No treatment information was provided.
High fever  for 12 hours, sore arm and armpit. Pain all over the body and some headache. Feel nausea and very weak.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Visual Changes/Disturbances-Severe
Extreme fatigue, and confusion, paired with a sinus pressure headache, and mild fever (100F)
This spontaneous report as received from a consumer refers to a 3 week old male patient concerning her son. The patient's current condition, drug allergic reactions and medical history were unkonwn. On 25-NOV-1997 the patient was vaccinated with first dose of RECOMBIVAX HB 5 microgram/0.5 ml (dose, route, lot number and expiry date unknown). On 17-DEC-1997, the patient was vaccinated with second dose of Hepatitis B vaccine which was less than 1 month after the first dose and third dose was vaccinated on 20-AUG-1998. No adverse event was reported. The outcome of event was unknown. No further information was provided. Additional information has been requested.
5/30/08, Headache, sore throat, fever, emesis, fatigue, bilirubinuria, lasted 5 days.
Slight redness, stinging, and warmth to touch. Itching. Evaluated by EMS-Cleared
The RN assigned to work this clinic administered 1mL of the Moderna vaccine as opposed to 0.5mL. Office attempted to reach this patient, via phone, to notify the patient and inquire about symptoms. Patient phone number listed is not correct and somewhat illegible. I made several attempts to contact by trying alternate numbers. Unable to contact patient via email as email address is illegible and returned as undeliverable.
Inflammation of the Heart, inflammation of the Kidneys, Bells Palsy, fatigue, joint pain, headaches, coughing, body cramps, diarrhea, nausea, vomiting, inability to wake or stay awake, blackouts, vision impairment.
Adverse side effect - left side of face/eye swelled.  This subsided the 3/18/2021 - I stayed home from work 1 day.  I had the general side effects of fever, joint and body ache and headache.  I did have COVID-19 on November 8, 2020.  As of 3/19/2021, I am back to work and feeling normal.
Arm is Swelling, hot to touch. Arthritis flare affecting entire arm from wrist to shoulder, some neck stiffness.
41-year-old male who presents to the ED today with a complaint of weakness in his bilateral arms and legs.  He states he fell slightly weak yesterday but this morning when he woke up around 6 AM he was not able to get out of bed because he was so weak.  He states he feels like he has no muscle strength in his arms and legs.  He denies any fever.  He denies any cough or shortness of breath.  He denies any chest pain or abdominal pain.  He denies any nausea, vomiting or diarrhea.  He denies any numbness in his extremities.  He denies any neck or back pain.  He did receive the first Covid vaccination on December 17.
At approximately 9:00 PM (roughly 11.5 hours after vaccination)  I became extremely light headed with slurred speech. I experienced tunnel vision and dizziness. My face turned white, and my lips were a blue color. I sat down immediately, which improved my condition temporarily.   But, within 2 minutes I began experiencing tunnel vision and dizziness again while sitting upright. I laid down on my back and elevated my legs.  My vision returned and but I remained dizzy and pale. I experienced some numbness and tingling in my extremities.  My wife attached a fingertip pulse oximeter to my finger at this time (we did not have a tool to check blood pressure on hand). My blood %SpO2 read between  95 and 98% and pulse ranged from 95 to 101 bpm.  I did NOT experience: difficulty breathing, swelling of the airway, nor itching.   Since I was not having difficulty breathing, and my symptoms seemed to indicate low blood pressure or potentially low blood sugar I decided to wait it out and see if my symptoms worsened.    While laying on the floor, I consumed a glass of milk and a few oreo cookies, hoping to counter hypoglycemia (if that's what was going on).  After approximately 15 minutes my condition began to improve - I could sit up slightly with only mild dizziness and color began returning to my face. After approximately 30 minutes, I was able to stand and walk to my couch and lay down. After around an hour, I was feeling almost back to normal with only a slight dizziness and tiredness remaining.  12 hours after the adverse event (24 hours post vaccination) I feel okay, slightly lightheaded but generally fine. I intend to call a doctor and discuss if any further tests are necessary.
13 DAYS AFTER MY FIRST VACCINE I STARTED TO EXPERIRNCE DIZZINESS - BALNACE ISSUES, DIFFICULTY WALKING WITHOUT HOLDING ON TO SOMETHING. THESE SYMPTOMS ARE STILL GOING ON. SOME DAYS THE SYMPTOMS ARE SO SEVERE THAT THEY ARE ALMOST DEBILITATING.
Vomiting  Loss of consciousness  Fever of 102 unrelieved by Tylenol
Developed redness increased warmth, swelling, tenderness, and firmness of (L) thigh after vaccinations The largest area of redness 7-8 cm across. When seen urgent care 6-20-12, also body fever, sore throat enlarged tender cervical lymph node. Started on sulfa-trimeth 6-20-12, amoxicillin added 6-22-12 much improved by 6-25-12 assessment -> cellulitis vs vaccine reaction.
given a Fluzone HD immunization instead of Fluzone Quadrivalent/no ae; given a Fluzone HD immunization instead of Fluzone Quadrivalent to 17 month old child/no ae; given a Fluzone HD immunization instead of Fluzone Quadrivalent to 17 month old child/no ae; Initial information received on 19-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 month old male patient who was given 0.5mL of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ306AA, Expiration date: 20-JUN-2024) via unknown route at the Left Vastus Lateralis for prophylactic vaccination instead of vaccine  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 28-JAN-2020 (wrong product administered, Product administered to patient of inappropriate age and overdose).  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error case due to wrong product administered, Inappropriate age at vaccine administration and overdose.  The patient had no adverse effect at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
she developed a sinus infection; Within hours the typical symptoms of headache, body aches happened; Within hours the typical symptoms of headache, body aches happened; It has now turned into a Upper respiratory infection; This is a spontaneous report from a contactable consumer. A 14-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09Jun2021 16:00 at age of 14-year-old (Lot Number: EW0178) as DOSE 2, SINGLE for covid-19 immunization. Medical history was none. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No concomitant medications were received. The patient previously received dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 16:00 at age of 14-year-old (Lot Number: ER8736) as DOSE 1, SINGLE for covid-19 immunization. The patient experienced she developed a sinus infection on 13Jun2021 with outcome of not recovered, within hours the typical symptoms of headache, body aches happened in Jun2021 with outcome of not recovered, it has now turned into a upper respiratory infection in 2021 with outcome of not recovered, the vaccine made her sick in 2021 with outcome of not recovered. Additional information included: Within hours the typical symptoms of headache, body aches happened. What is most important is exactly 4-5 days later, she developed a sinus infection and 3 weeks later and 2 antibiotics later, she is still sick. It has now turned into a Upper respiratory infection and had to spend a high amount of money on a CT scan of her lungs because she continues to get worse not better. Our Dr. is confident this is related to the vaccine. She was a perfectly healthy 14 yr. old girl and been sick ever since she got the vaccine. It is not a coincidence. The vaccine made her sick and we deserve answers. The reporter believe in vaccines and wanted to do the right thing to get the numbers down. Had the reporter known this would have been her body's response, reporter never would have had her get vaccinated. The patient underwent lab tests and procedures which included CT scan for her lungs: unknown results on unknown date. Therapeutic measures were taken as a result of all the events and the treatment included antibiotics. The events result in Doctor or other healthcare professional office/clinic visit.
Caused neurological issue related MS to flare. Numb arms and hands no previous issue in 9 years.
Upon the regulatory authority reviewing their weekly notifiable conditions death report, they came across a report of decedent where the death certificate COD literal text is indicated to be: ACUTE MOTOR NEURON DISEASE SERUM REACTION TO VIRAL VACCINE   Here is some additional decedent details:   DOD: 08/30/2021  We speculate that the COD literal text is in reference to COVID-19 vaccinations since those were the most recent two vaccinations that this person had received based on data.  Here are the COVID-19 vaccine dose dates:  3/16/2021 (Pfizer) 4/06/2021 (Pfizer)
Pain and swelling of injection site followed by swollen lymph nodes on left-side (including side of neck, underarm, outside of breast area and collarbone area).
30 mins after vaccination Felt rapid heart rate, tingling in lips, initial BP 100/60
PATIENT WAS MISTAKENLY ADMINISTERED 0.25ML OF MODERNA INSTEAD OF FIRST DOSE OF PFIZER VACCINE.
Case number PHEH2016US026711, is an initial spontaneous report received from a pharmacist on 12 Oct 2016. This report refers to an adult female patient. Past medical history and concomitant medications were not reported. She was vaccinated with single dose of FLUVIRIN (batch number: not reported) (patient was supposed to received 0.5 ml), intramuscularly on 12 Oct 2016. On 12 Oct 2016, patient was given a partial dose of FLUVIRIN. She jerked and lost some of the dose. Pharmacist stated that, they are planning on revaccination of the patient. No adverse event was reported following this medication error. Case was assessed as non-serious by the pharmacist.
Weakness in face; metallic taste in mouth; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Feb2021 15:45 (Batch/Lot Number: EN6200) as SINGLE DOSE, for covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. The patient medical history, no allergies and concomitant medications were not reported. Patient has been tested for COVID, post vaccination. It was reported that, on 22Feb2021 at 16:15, patient experienced weakness in face (muscular weakness) and metallic taste in mouth (taste disorder). The patient underwent lab tests and procedures which included COVID-19 Nasal Swab test unknown on 23Feb2021. The outcome for the events was recovering.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 10-FEB-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at pyharmacy, for the long term prevention of shingles and zoster related conditions. Subsequently, the patient was treated by a healthcare professional at the patient place, since she experienced shingles on unspecified date. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not provided and the causality of the events was related.
Headache, nausea, increased HR and RR, vomiting, fever, chills, night sweats
Patient developed an 8 x 5 cm area of redness, heat and swelling. Patient was seen by urgent care physician on 6/3/01 and treated with antibiotics. She was seen by PCP 6/5/01 at which time the area was still very red, swollen and warm to the touch.
felt mild fatigue and flu like symptoms the next morning, then experienced very intense abdominal cramming, diarrhea, felt light headed, fainted in bathroom, hit head on bathtub, husband called ambulance was given IV Fluids, was transported to Hospital ER, waited over 3 hours, Saw a PA was asked if wanted to stay to get testing done ER was very busy and pt was not having any pain at that time pt stated did not want to stay in ER so I left.
Within first 5 minutes of receiving the injection I had a hot flash which continued for approx.  1.5- 2 hours.  Also within 20-25 minutes of the injection I started having a rapid heart rate and extreme heart burn for an hour and forty-five minutes if not longer,  until it subsided.
PT. ADMINISTERED PFIZER COVID VACCINE 8 DAYS EARLY. DR. NOTIFIED AND STATED "NOT CONCERNED", THAT BOOSTER TIME REDUCED FROM 5 TO 3 MOS. PT. INFORMED AND ADVISED TO CALL DR. WITH ANY QUESTIONS
I could not report March 15 when this occurred because Vaers HHS did not have the Janssen listed as an option to report against at that time. Unusual for me hour long nosebleed resulting in use of a half of box of tissues. It occurred at 3am so doing anything other than homecare didnt seem necessary. After getting this vaccine I felt a brain fog for approx 15 days especially after being awake for about 8 hours, unusual for me as well. The nosebleed was of most concern and with the recent pause I saw on todays news about blood clotting issues. I felt it was important I report my experience on day 8 of vaccine and days 2 thru 15 of vaccine. I would not go back in time and take this vaccine based on my side effects.
Severe and persistent uterine bleeding for 6 weeks, requiring a blood transfusion.
Information has been received from a licensed practical nurse referring to unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose and route not reported, lot # L019996, expiration date 02-DEC-2016). Temperature was 8.6 F. Time frame was 9.5 hours. There was no previous temperature excursion. No adverse effect reported. This is one of two reports from the same reporter. Additional information has been requested.