chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After dose 1 on 02/24/2021 in right arm had typical side effects:  sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer.  Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face.  After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included:  sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days. Following dose 2 fatigue continued, then seemed to resolve for a few days after ~7-10 days. Severe fatigue returned ~3/29 and continued.  Also began experiencing intermittent facial twitching on left side:  cheek, cheekbone, eyelid, facial area immediately adjacent to left ear. Twitching and fatigue continued.  Awakened at 6 a.m. on Mon. 4-5-21 by loud roaring sound (tinnitus) in left ear, was dizzy & lightheaded upon standing, & found that I was completely deaf in my left ear.  I have never had tinnitus in my life nor have I had ear problems or facial twitching before. Saw doctors because sudden hearing loss is a medical emergency.  Primary care found no ear wax or visible problems on ear drum on either side.  Then referred to ENT practice.  Audiology testing confirmed no ear wax or ear canal blockage, no fluid in left ear. Test showed: "severe to profound Mixed loss AS. Type A normal typanograms noted bilaterally." Dr. indicated likely inflammation of auditory nerve in left inner ear of unknown cause; called it sudden acute sensorineural hearing loss.  Prescribed high dose prednisone for 21 days plus MRI of head and left ear canal.  Still experiencing continuing complete left ear hearing loss, dizziness, feeling light headed, and continuous unrelenting tinnitus in left ear, and fatigue. The only change in my health status has been getting the Pfizer covid-19 vaccines. Doctor said I should report this as adverse vaccine reaction.  Will have MRI on 4-21-2021 at which time there may be more information. If not resolved by oral prednisone they may try injections into ear canal.  Hearing loss and tinnitus could be permanent (50-50 chance.) Return visit with MD on 4-21-21.
Pt experienced redness, irritation, swelling and itching at the site of injection. After 7 days the site still appears swollen and pt indicates it still itches.
Bad taste in mouth after the covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "Bad taste in mouth after the covid vaccine".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
PATIENT EXHIBITS RANGE OF MOTION LOSS AND IS UDNERGOING PHYSICAL THERAPY. PRIMARY DOCTOR SUGGESTS BURSA. PATIENT IS SCHEDULED FOR MRI FOR FURTHER TREATMENT AND DIAGNOSIS.
With 2nd Dose of MMR as my titers were low I developed hive at the injection site, in bilat arms and on my back
Onset 09/25/08 - swollen injection site, warm to touch, HA, dizzy, feeling bad, size of palm of hand, itchy, tightness in chest for 45 minutes.  Hydrocortisone 1%, Tylenol ice pack.
Upper Abdominal Cramping and Mild Nausea beginning about 10 minutes after injection and lasting for 35 minutes.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 05-JAN-2016 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K009771, expiration date 09-OCT-2015, dose, dose# and route unknown). No adverse effect reported. Additional information has been requested.
Tornado hit in the county resulting in a temperature excursion.  Verification via manufacturer performed; however, wording not understood that vial was considered activated since vial had been punctured and a dose removed.  Office was contacted by consultant that medication was considered activated since the vial was opened prior to the excursion and should not be used. Re-verification with the manufacturer performed. At that time, it was noted dose was considered invalid and patient would need revaccinated. Parent contacted and aware.
A lot of fluid under arm, on chest and down rib cage.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; Extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest.; 3rd day after injection, significant swelling in the arm pit,  lymph nodes and chest.; 3rd day after injection, significant swelling in the arm pit,  lymph nodes and chest.; A lot of fluid under arm, on chest and down rib cage.; dose received: 3; dose received: 3; This is a spontaneous report from a contactable consumer (patient).  A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 04Oct2021 17:30 (Batch/Lot number was not reported) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation. Medical history was none; no known allergies. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 08:00 AM (Batch/Lot number was not reported) age at vaccination of 57-years-old, as single dose, for covid-19 immunisation. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 08:00 AM (Batch/Lot number was not reported) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation.  There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Oct2021 (3rd day after injection), patient experienced significant swelling in the arm pit, lymph nodes and chest; a lot of fluid under arm, on chest and down rib cage; extremely uncomfortable arm pain radiating to shoulder blade, shoulder and chest. No treatments were given for the events. Facility type vaccine: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was considered recovered with lasting effects on an unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
5cm x 3cm of erythema and induration at vaccination site starting approx. 36 hrs after injection given.
PT C/O RACING HEART AT 12:22. PT LATER STATED SHE FEELS BETTER
A week later after vaccine, I had fatigue and about three days of headache. I have a lot of auto-immune diseases but this was worse fatigue than I normally feel but the fatigue was just about the same time. My husband got sick and so I went and got tested with him for COVID. Received an IV treatment for COVID - I don't know what the name of it was. I received that at UMC. My son works for UMC and he made sure that I got the IV treatment - my doctor was aware of it.
Vaccine administered post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event; Vaccine administered post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-Healthcare professional (hcp).  This case involves a 52 years old and unknown gender patient to whom vaccine administered post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event for vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (dose, formulation, strength, expiry date: unknown) lot UJ899AA via unknown route in unknown administration site for immunization post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event (poor quality product administered) (product storage error).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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 the 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.
After the booster shot, very bad back pains started the second day after and are still present, but are not as bad as when they started. It effected my life greatly. Then, on Jan. 2nd, chest pains and shortness of breath began. I thought maybe I slept wrong or something but the next few days it worsened to the point of needing to go to the doctor immediately. I took a Covid test prior to going in, it was negative. I then went to Urgent Care to find some answers and get help. The doctors and nurses were great and saw me right away. All of my vitals were normal - good but still puzzling. Then the doctor assessed me. I had no cough or sickness, no injury, I hadn't been exercising vigorously, no indigestion. I am too young for a heart attack. The doctor ruled out is was Costochondritis. The cartilage is irritated and inflamed between the ribs causing painful breathing and pressure. I was given a 5 day prescription of Prednisone, 20 mg twice a day. If it doesn't subside, then we will do x-rays to see if there is a blood clot. I asked the doctor if it could be a side effect of the booster shot since I just had it 12 days prior, they said they didn't think it was that. I don't believe that. Very strange this is happening. The only thing different is I had the shot.
Skin Rash injection site red and itchy. Pain to injection arm. Facial flushing Narrative: reports that injection site is red and itchy. Facial flushing present.
Information has been received from a legal firm regarding a case in litigation concerning a minor male child who was administered vaccines containing thimerosal and has suffered devastating injuries caused by mercury toxicity via IM injection of mercury. As a result of cumulative exposure to mercury contained in the vaccinations and the pt was caused to suffer mercury poisoning and has experienced devastating injuries, complications and sequelae and the aggravation of other conditions. The pt was neurologically devastated by the accumulation of mercury in his body, having been exposed via IM vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior; and the loss of language skill, motor skills and affect. He has suffered severe, devastating, permanent, neurological injuries and will sustain in the future a mental intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments. Other immunizations included: HIBTITER containing thimerosal and PENTAVAC containing thimerosal on 8/2/94, 10/8/94, 2/22/95, and 4/5/96. A dose of HIBTITER containing thimerosal was also given on 8/2/94. Upon internal review, the pt's intellectual, developmental, neurological incapacity, devastating injuries/complications, losing milestones of neurological development, mercury toxicity, and neurological injuries, impairments, delayed development were considered to be other important medical events (OMIC). No further info is available.
Fever Chills Sneezing Running nose Headache Fever 102 Giving Motrin every 4 hours
Dose administered after a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 031A21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Had temperature excursion of about 20 doses of moderna,it got down to 32 degree Fahrenheit and went unto 34degree Fahrenheit and then to 37 degree Fahrenheit over the course of an hour.The doses were put in a portable transport unit and left at 32°F, the transport unit was not prepared for enough time to maintain the temperature. No concomitant medication  were reported. No Treatment information was provided.
ACUTE CORONARY SYNDROME, UNSPECIFIED HYPOTENSION 3/2/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Extreme joint pain, headache, nausea, exhaustion for 48 hours. As of today 1/24/20 im still experiencing tightness in my chest and some difficulty breathing, breathing heavily.
Fever of 101.8, chills, fatigue - duration approximately 24 hours.
12/27/2022 I was rehabbing from another health event. I was limping on my left leg. I had a CT and x-ray which showed I had sciatica in my left leg. I had a test for DVT, which was normal. I went through physical therapy and am continuing physical therapy. I am almost recovered.
inj site pain; severe tiredness and fatigue Narrative:  Day 2 - sore arm; Day 5 through 8 - severe tiredness and Fatigue.
I am a healthy woman, 49 years of age and active. In October of 2021, 3 months after 2nd vaccination, I started experiencing muscle weakness in my legs. It continued to get worse where I could not walk from our bedroom to kitchen without having to sit down. If I pushed myself to continue on I would collapse. I needed to use a cane. Out of nowhere in January 2022 this went away and I am back to normal. Not sure if this was from vaccine but thought I should report it in case others experienced the same thing.
This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (dose, frequency, route of administration and indication were not reported; lot # L023387 with expiration date: 22-JUN-2017). Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested. RECOMBIVAX HB and VAQTA.
headache started on saturday (day 2) and continued until day 8 (friday), fever (day 6-9) wednesday to saturday, paresthesia on body that started day 9 (saturday)
MMR vaccine administered on 12/28/05.  On the next day patient developed maculopapular rash over the body, very mild itching.
Pt started getting daily headaches lasting 5 mins multiple times per day in different parts of her head.  Some can be severe enough that they wake her from her sleep.
Increased fever, 103.4, twelve hours after vaccine, nausea and vomiting one time, swollen lymph nodes underarm that received the vaccine, weakness, chills, body aches.
patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up information included patient's age group updated.
Information has been received from a registered nurse concerning a 2 year old female who in June 2001, was vaccinated with a dose of varicella virus vaccine live. On 23APR2003 it was reported that the patient "now" has "chicken pox". Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the registered nurse which indicated that one year post vaccination with varicella virus vaccine live the patient had a chickenpox like rash which turned out to not be chickenpox. The patient subsequently recovered. The reporter also noted that this was not a vaccine adverse experience. No further information is expected.
Patient received vaccine and had immediate adverse reaction. His eyes rolled to the back of his head and he had complete loss of consciousness that lasted around 2-3 minutes. Assessed patient for heart rate (there) and breathing (unsure if lost breath at first, could not determine with mask on, and when I pulled off it took me a few moments to get his mouth open to hear breathing occur). Elevated legs. Patient lost color and became sweaty and cold in his hands. His wife was in the room with me. I had 911 called, and they arrived within 10 minutes of incident. Patient awoke and was responsive around the 3 m it took me a few moments to get his mouth open to hear breathing occur). Elevated legs. Patient lost color and became sweaty and cold in his hands. His wife was in the room with me. I had 911 called, and they arrived within 10 minutes of incident. Patient awoke and was responsive around the 3 minute mark, and he slowly came to, not remembering incident. Had him wait around 45 minutes to ensure okay before he declined transfer to emergency care and left with his wife.  inute mark, and he slowly came to, not remembering incident. Had him wait around 45 minutes to ensure okay before he declined transfer to emergency care and left with his wife.
received on Nov 8th 2021 a dose expired on Nov 6th 2021; Patient was 17 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received on Nov 8th 2021 a dose expired on Nov 6th 2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 17 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received on Nov 8th 2021 a dose expired on Nov 6th 2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 17 years old). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received on Nov 8th 2021 a dose expired on Nov 6th 2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 17 years old) 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 drugs were reported
I had meningitis.  Bad headaches went to the hospital was there for 5 days. I was out of work for two and a half weeks.