chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recv vax on 12/3/98; on 12/6/98 pt exp red, swollen, painful, hot vax site; cellulitis; tx=Keflex
Fainted.  15 minutes later had explosive diarrhea.  Felt weak and went to bed.  On 11/16 had little diarrhea and today feels fine.
Hospitalized with COVID-19.  Dyspnea, fever, O2 requirement.
9MAR98 pt recv vax @ approx 2PM started screaming @ 430PM nothing helped crying;even when held cried;went to hosp 9PM;also noted redness, swelling of lt thigh;ER temp 102;not sleep well, dec appetite, leg swollen, inc fluids;
Vertigo; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration on 02Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as N/A. The patient did not have any allergies to food, medications, or other products. Concomitant medication included paracetamol (TYLENOL) for an unknown indication on an unspecified date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 08:00, the patient experienced vertigo and dizziness. The patient had been feeling dizzy since then. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. On an unknown date patient underwent lab test which included PCR test for COVID-19 and tested negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the events vertigo and dizziness were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
lump on the arm; documentation it says arm swelling or injection side swelling is that basically what I am looking at; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 03Jan2022 (Lot number: FK5618, Expiration Date: 31May2022) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Adderall for ADHD; Fluoxetine for ADHD. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, the reporter stated "I guess it is FK5127, oh no sorry that was a first dose".), for Covid-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset Jan2022, outcome "unknown", described as "lump on the arm"; VACCINATION SITE SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "documentation it says arm swelling or injection side swelling is that basically what I am looking at".  Additional Information: The reporter stated, "My daughter just received this shot about 2 days ago and on her arm she has like a probably about a 'saw it our' sized lump on the arm and as I was reading through the documentation it says arm swelling or injection side swelling is that basically what I am looking at (Further clarification unknown). It is like a 'saw it our' size lump. It is her second shot for the COVID she did not have get something like that for the first shot. I just have to know it is second shot she getting a lump. She is 11 years old and just receiving the child dosage". When asked about Height & Weight, the reporter stated "she is probably 160, and she is 5 ft. 6 inches". No prior vaccination (4 weeks prior). No Investigation Assessment reported.  No follow-up attempts are possible. No further information is expected.
Narrative:  Pt reported injection site swelling and pain that lasted ~24 hours s/p vaccination.
Patient was in a lot of pain/ Everything hurt; Leg hurt; Horrible headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Patient was in a lot of pain/ Everything hurt), PAIN IN EXTREMITY (Leg hurt) and HEADACHE (Horrible headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Peanut allergy.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-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 PAIN (Patient was in a lot of pain/ Everything hurt), PAIN IN EXTREMITY (Leg hurt) and HEADACHE (Horrible headache). At the time of the report, PAIN (Patient was in a lot of pain/ Everything hurt), PAIN IN EXTREMITY (Leg hurt) and HEADACHE (Horrible headache) outcome was unknown.            Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. Patient was taking other medication. No treatment medications were reported.   This case was linked to MOD-2022-630443 (Patient Link).
shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.     On an unspecified date in 2015, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a healthcare provider at a medical office for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).        Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a physician for shingles for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering 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 would continue to suffer such losses, and damages in the future.   The outcome of shingles was reported as not recovered.    The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
A non-serious spontaneous report of influenza has been received from a physician concerning a 12-year-old male patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 19-Oct-2010, the patient received FLUMIST. On 15-Feb-2011, the patient tested positive for Flu. On an unknown date, the influenza resolved. The outcome of the event of influenza was resolved. Additional information was received on 08-Jun-2011 and incorporated into the narrative: Outcome of the event. Reporter also confirmed that the patient did not have any other AEs.
Initial misuse report received from a health care professional on 17 January 2014. The cases were received at GPV on 21 March 2014. It was reported that 13-year-old patient had received FLUZONE HD inadvertently. No adverse event was reported. List of documents held by sender: none
Left arm red and tender to touch above elbow and pt. claimed had fever and experienced double vision per other pharmacist on duty when she returned PM of 10/3/14. Tried to call her, left msg for her to call me.
Patient received first dose and shortly c/o feeling lightheaded.   Clinic staff assisted pt to lay on floor mat with feet elevated.  Pt remained alert and able to answer questions.  VS taken, all WNL.  Pt offered fluids.  After 5 minutes, pt was assisted to seated position and reassessed; pt continued to c/o dizziness and was assisted back to laying.  After 5 minutes, pt was assisted to seated position and reassessed; pt no longer c/o dizziness and was assisted to chair.  After 5 minutes, pt was assisted by clinic staff to ambulate to observation area.
and months of intermittent heart arrhythmia and pain; and months of intermittent heart arrhythmia and pain; severe fever; chills; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Batch/Lot number and expiration date unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes 2" (unspecified if ongoing), notes: diabetes 2; "known allergies: NSAIDs" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), administration date: 2021 (also reported as Feb2021), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), administration date: 2021 (also reported as Mar2021), for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant), ANGINA PECTORIS (medically significant) all with onset 06Oct2021, outcome "recovering" and all described as "and months of intermittent heart arrhythmia and pain"; PYREXIA (non-serious) with onset 06Oct2021, outcome "recovering", described as "severe fever"; CHILLS (non-serious) with onset 06Oct2021, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 06Oct2021, outcome "recovering", described as "fatigue". Clinical course: Initial reaction to 3rd dose was severe fever and chills lasting 4-5 days, followed by 3 weeks of major fatigue, and months of intermittent heart arrhythmia and pain. She went to the emergency room for the heart issues. The events were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of arrhythmia, angina pectoris and treatment included propranolol. The patient didn't received other vaccine in four weeks. The patient received other medications in two weeks. There was no  covid prior vaccination or covid tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
FELT SUPER COLD; GOT A FEVER; MINOR HEADACHE; SORE ARM; This spontaneous report received from a patient via a company representative concerned a female 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore arm. On an unspecified date, the subject experienced felt super cold, got a fever, and minor headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt super cold, got a fever, and minor headache, and the outcome of sore arm was not reported. This report was non-serious.
Lab results taken in Nov PRIOR to vaccine:  ALT (SGPT) results 31.  Range 0-32. Lab results taken in  April following the March vaccine:  ALT (SGPT) results 56 .  Range 0-32 Followed up with Alpha-1 Antitrypsin Serum in June.  Result 72.  Range 101-187 Primary care provided referred to pulmonologist/gi physicians for followup. Liver enzymes were normal prior to vaccine.  They have returned to normal but I still have follow up appts with pulmonologist and gastroenterologist.
became extremely congested, unable to breath well, severe h/a, sore throat;throat felt like it was closing;lips swollen, high BP; fast pulse; ER-Epinephrine-DPH-Pred
mom brought pt into clinic requesting RN to check rash; pt noticed rash on 3NOV93 p/wearing new winter clothing that had not been washed (wool type); generalized rash prickly itching, starting on abdo-then to tender areas of arms & legs;
Initial typical shot reaction-- Soreness in arm and stiffness in joints, headache, lightheaded for a couple of days.  The following days and weeks I had extremely sharp, brief pains in my left, lower and mid chest area-- accompanied by stiffness in my lower right leg on either side of my Achilles tendon below my calf. this was followed shortly after by what has been described / diagnosed as "Covid Toes".  My wife took images of my feet, particularly my right foot , which was very painful, purple and swollen.  I thought it was an infection. Went  to the doctor.  My toes were ice cold. Not an infection.  Shortly thereafter, the same pain, discoloration and swelling affected my hands and fingers, most notably on the fingers of my right hand.  These conditions persist to today.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  Patient age was reported as 42  years and 8 months.  Ndc Code was mentioned as 80777-0273-99. It was reported that on 10-Jun-2022 Medical was notified of an audit that was done and was then made aware of vaccines that were administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medication was provided by the reporter.
C/o of strange metal taste in mouth, lightheadedness, pale color, heart racing throat feeling tight pain in Left arm. Treatment 0.3cc epinephrine to Right arm where H1N1 shot was given 911 called sent to Medical Center by paramedics.
Fever, muscle pain, sweating, chills, bowel movements, vomiting, fatigue, loss of appetite.
I have been responding to texts for the last 7 days. After my 7th, yesterday,  I noticed a dried scab on my arm - kinda like a pus scab. Didn't think anything of it. Today there is a large red blotch on my arm and it's itchy.  Also a little tender.. I had been reporting no issues the last several days so I thought this was worth mentioning.
Started to notice a little swelling in September on the collarbone. The swelling doubled in size after the booster shot in Oct.  The right side is twice the size of the left side.  Also have a lump under each arm pit.  The 4 sites are soft and are not painful.  The swelling has not gone down.  I visited my primary care physician. He recommended an ultra sound of the neck and a chest x-ray. Physician examined the lumps under the arms and determined they were not in the lump nodes.
One week after my second vaccine I started having bad pain and itch. A few days later had horrible swollen rash. Went to urgent care and found out I have the shingles.
Within a few minutes of receiving injection, my arm went numb from site of injection to the tips of my fingers.  Experienced severe swelling, inflammation and pain in whole arm.  Fingertips were numb and tingled with the sensation of pins and needles on them. Arm remained inflammed, swollen and in severe pain for two weeks weeks and then decided to see a doctor. Doctor said it should go away fully in two more weeks and that if it did not to come back and see her. It had been the two weeks since I have seen the doctor and full use of my arm is still not fully restored and still feels pain when I try to resume full normal use of it.  Also had some slight dizziness and sensation on tongue after two weeks of shot.
developed pulsatile tinnitus 1 wk after vaccine that I've never had before;  saw an ENT and had ct head, cta neck; saw another ENT and had mra head and neck; am seeing neurophthalmologist this week
A wheal did not forma after the first attempt at the Intradermal administration. An expert in intradermal administration reattempted, and they were successful.
approx 4-6 wks p/vax noted that rt thumb & index finger joints were moderately swollen but extremely painful x approx 2 wks; also devel pain & swelling of lt thumb joint & joints in toes of lt foot painful couldn't walk x 1 day;
metastasized /spread to the liver; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of METASTASES TO LIVER (metastasized /spread to the liver) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Fluzone High-Dose Quadrivalent influenza in 2021. Past adverse reactions to the above products included No adverse event with Fluzone High-Dose Quadrivalent influenza. Concurrent medical conditions included Immunocompromised and Colon cancer stage IV.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced METASTASES TO LIVER (metastasized /spread to the liver) (seriousness criterion medically significant). At the time of the report, METASTASES TO LIVER (metastasized /spread to the liver) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Positron emission tomogram: abnormal (abnormal) the cancer had metastasized and spread to the liver. On an unknown date, Computerised tomogram: inconclusive (Inconclusive) something suspicious was identified in her abdomen.         No concomitant drug details were reported.  Patient received the last chemotherapy treatment on 06-Jul-2021. Company Comment : This spontaneous case concerns a 77 year old female patient  with relevant medical history of Colon Cancer Stage IV, S/P chemotherapy  (on immune compromised state), vaccinated with flu vaccine, who experienced Serious (medically significant), unexpected event of metastases to liver which occurred 3 months , 26 days post vaccination with the 2nd dose of mRNA -1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The current medical condition of Colon CA Stage IV is a confounder for this case . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77 year old female patient  with relevant medical history of Colon Cancer Stage IV, S/P chemotherapy  ( on immune compromised state) , vaccinated with flu vaccine , who experienced Serious ( medically significant ) , unexpected event of metastases to liver which occurred 3 months , 26 days post vaccination with the 2nd dose of mRNA -1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The current medical condition of Colon CA Stage IV is a confounder for this case . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Patient describes symptoms started same day after received vaccine: allergies and itch on both arms and chest, body cramps  on left arm and chest; pain on back of the head; a couple of days after a burning sensation start on right testicle; low back pain; intermittent dizziness; chin splits pain, weakness and intense heart palpitations
Injection site was in the right shoulder of the right arm. The next day a large area of the right underarm/armpt is swollen and painful; pain extends into right side of right breast. Pain also present in back of right shoulder - serratus posterior superior, but no swelling.
8/23 11pm mom noted swelling at injection site L arm. 8/24 swelling extending to elbow, 8/25 swelling extending to wrist, 8/26 swelling extending to fingertips. Did not seek medical attention. Fine, red rash noted in L arm-adv to see physical stat-Rx: given included antibiotics prednisone + Benadryl. 8/28 swelling decreased.
Slight inflammation at injection site; pain and weakness upper left arm; fatigue; tiredness, slight nausea
Patient wants to sleep all the time after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient wants to sleep all the time after the second dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 23-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced SOMNOLENCE (Patient wants to sleep all the time after the second dose). At the time of the report, SOMNOLENCE (Patient wants to sleep all the time after the second dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
I peed some blood clots for 2 days, it was sporadic, not every time I went to the restroom.  My urine turned orange.