chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed local site reaction (swelling, warmth, itchiness, erythema) and itchiness and faint rash that appeared off and on on face and chest. Has history of getting rash when stressed, but usually only on chest. Rash is not vesicular in nature.
Pt recv vax on unspecified day; post vax pt exp warm/ itchy/ rash/ lump at vax site
extreme fatigue that went away after  48 hours   I now have a hearing problem that I did not have prior to the vacceine , I am not sure if it is a eustacean tube disorder but everything sounds muffled and it is like when you need to get your ear to pop but it wont. This has been going on for 5 days now and I plan to see a doctor to see if anything can be done, I am hoping that this is not a permanant issue. I have read of other people having hearing loss from the vacceines from all 3 manufacturers
A female nurse (LD), age unspecified, experienced drug exposure to the eye during administration of RabAvert to her patient. Her past medical history and concomitant medications were unspecified. During administration of RabAvert to her patient on 09/08/2004, the needle popped off from the syringe and some RabAvert solution went into her eye. She immediately flushed her infected eye with water. No burning, stinging, or other irritations noted and she was completely fine on that same day.
PAIN IN THE JOINTS; CHILLS; This spontaneous report received from a patient concerned a male 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: unknown) dose was not reported, administered on 17-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-MAR-2021, the subject experienced pain in the joints. On 18-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the joints, and chills. This report was non-serious.
This report has not been verified by a physician or other healthcare professional.  Medical history, concurrent medications were not specified. The pt reported that he received 3 injections of Lymerix. the 1st injection was given in 1999, and the last one was given in 2000, exact dates of of IZ's not reported. In July or August of 2001, the vaccinee reportedly he began to experience burning pain in the joints of his left hand. He then experienced the burning joint pain in his left elbow, right toe, and right knee. The vaccinee reported that he has not sought medical attention for the burning joint pain persisted as of 11/14/2001. the adverse event of burning pain in the joints does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per 06/28/2000 letter.
Patient received COVID vaccine dose 2 by Pfizer on Saturday. They report significant arm pain (middle finger up to shoulder - burning / aching) and fever (101.2 to 102F per patient), but also trouble breathing which required a trip to the ER. Also pain in the left side of the head, body aches, confusion, and extreme fatigue. Per patient - lungs were burning within 45 minutes of the shot. She works at Hospital  and visited the ER there.
After receiving the vaccine the patient became flush and faint.  He was labored breathing and then proceeded to throw up.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022).    Concomitant product use was not provided by the reporter.  Patient received half dose.  Number of vials: 35 vials.  On 04-Jun-2022 the vial was initially stored in the refrigerator. The vial did not underwent any temperature excursions.  Treatment information was not provided.
fever, chills, muscle aches/pains, headache, extreme fatigue, sweating, diarrhea  fever resolved with ibuprofen x1; symptoms lasted until morning 2/3 around 5:30am when I woke up agaon
fever at above 102 degrees F; Chills; lethargy; This is a spontaneous report from a contactable consumer. This consumer reported for a 13-year-old male patient that:  A 13-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0167), intramuscular, administered in Arm Left on 05Jun2021 12:00PM (At the age of 13 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously  received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0167), intramuscular, administered in Arm Left on 15May2021 05:00PM (At the age of 13 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient did not receive other medications within 2 weeks of vaccination. On 06Jun2021 09:00AM, the patient experienced fever at above 102 degrees, chills and lethargy. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected
Patient received a booster dose of the Pfizer PEDIATRIC vaccine, when should have received the ADULT dosage; No adverse events occured as a result
3 patients received a dose that was exposed to low temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 4NX5J, expiry date 9th June 2023) for prophylaxis.   On 4th April 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.       Additional Information: GSK Receipt Date: 5th April 2022 Reporter's Comments: The pharmacist reported the patient received a dose of Shingrix that was exposed to low temperature excursion of 31.5 degree F. The reporter did not consent to follow-up. Additional Supportive Information: As the Shingrix was exposed to low temperature excursion, which led to incorrect storage of drug. The case has been linked with the case US2022060314 and US2022060315 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022060314:same reporter US-GLAXOSMITHKLINE-US2022060315:same reporter
Following the second dose of the vaccine, I developed a rash made up of blisters (mainly on my arms, but some also all over my body), severe weakness, fatigue, fast breathing and shortness of breath, and severe feelings of abnormal heart rhythm and palpitations. Over time, the feelings of abnormal heart rhythm and palpitations became less severe, however, the weakness and fatigue remained, with the rash made up of blisters relapsing.
Large hive size of softball on injection site. It was hot and tender to the touch with bruising. Had chills and aches 12 hours after injection. Fatigued the day after injection.
patient developed wheezing 10 minutes after receiving the vaccine, patient has history of asthma which she states is well controlled
vaccine triggered reactivation of dormant chickenpox virus with a terrible shingles outbreak around my eye. Very painful and is still ongoing.  Pain, burning, ongoing blisters which have not yet resolved.
Injection site swelling with pain and reduced range of motion due to pain.  Swelling spread across entire top of the arm and shoulder
I started to have burning and pain on my right side in two different places.  It blistered up 3 inches by 3 inches wide. Under right arm, and the mid back. I called my daughter in law who is a Nurse Practitioner. I didn't do anything for treatment, it took about two weeks for it to run it's course.
Costochondritis; Feeling Unwell; Rib Inflamation; This spontaneous case was reported by a physician and describes the occurrence of INFLAMMATION (Rib Inflamation), COSTOCHONDRITIS (Costochondritis) and MALAISE (Feeling Unwell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included RINVOQ from 04-May-2021 to 06-May-2021 for Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced INFLAMMATION (Rib Inflamation). On an unknown date, the patient experienced COSTOCHONDRITIS (Costochondritis) and MALAISE (Feeling Unwell). At the time of the report, INFLAMMATION (Rib Inflamation), COSTOCHONDRITIS (Costochondritis) and MALAISE (Feeling Unwell) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.
pain & swelling @ inj site w/in a few hours of receiving vax;swelling extended into lt axilla & lt proximal forearm by 6/3/99 AM;induration 21 x 14cm;6/4/99 sore still, swelling & redness improved greatly;
About a week after I received the second Moderna injection, I noticed that my rheumatoid arthritis was noticeably worse. I went to see my internist, and he prescribed me Lufyllin and a two-week supply of low-dose prednisone. The Lufyllin gave me severe diarrhea and dehydration, so I stopped taking it after a few days. However, the prednisone was helpful, as it reduced the swelling. To this day, I still experience severe pain in my feet, ankles, hands, and wrists. I have had RA for many years and had managed it very well, but it was only around 2/23/2021 that it worsened considerably. I don't take any pain medication, and I try to avoid it.
This case was reported by a pharmacist via sale rep and described the occurrence of injection site pain in a female patient who received FLULAVAL QUADRIVALENT (batch number K5T45, expiry date 31st May 2018). On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain and runny nose. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the runny nose was recovering/resolving. It was unknown if the reporter considered the injection site pain and runny nose to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain at injection site which lasted up to 3 days. No medical treatment was needed. The patient's symptoms were subsided. The FLULAVAL QUADRIVALENT multi dose vial was the only vaccine given. No additional information was provided. The reporter requested to contact the nurse for further follow ups. It was reported that only one patient experienced runny nose out of the 5 patients, however, it was unknown that which patient had experienced it. This case was one of the 5 cases, reported by the same reporter.
my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rate went up, not extremely high but and EMT said it felt "racy".; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: RL3249) at left arm on 21Jan2021 12:15 AM at single dose for COVID-19 immunization. Medical history included asthma, allergies to sulfa, dairy, egg, peanuts. Patient is not pregnant. Other medications in two weeks included low dose naltrexone and salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) and Herbals. No other vaccine in four weeks. Patient previously took erythromycin and epinephrine and had allergy to them. Within 5 minutes (21Jan2021 12:15 AM), her system felt ramped up. Her heart rate went up, not extremely high but and EMT said it felt "racy". She was told that her voice sounded worked up. she had slightly shallow breathing. It lasted about 30 minutes then began to subside. The next day she felt it somewhat. she was totally normal after 12 hours. She had a sensitivity to epinephrine and the Pfizer dose reaction reminded her of a milder version of the epinephrine reaction. No Covid prior vaccination, no covid tested post vaccination. No treatment received for the events; patient was recovered from the events in 22Jan2021.
Since the patient received the third vaccination, she has been experiencing occasional skipped heart sensations., which developed into worsening palpitations associated with stabbing and aching chest pain.  Patient is treated with aspirin 325mg, ketololac 15 mg, and metoprolol 25 mg.  Patient recommended for outpatient stress test and follow up with cardiologist.
Injection site reaction. 4 inch diameter swelling/redness, painful to touch 48 hours post injection.
This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 04-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number and route were not reported) lot # J011212, expiration date 29-AUG-2014. Co-suspect concomitant therapies were not reported. The pharmacist reported that patient received expired dose of ZOSTAVAX on 04-SEP-2014. No adverse effect was reported. Additional information has been requested.
She had 102 temperature for next three days, accompanied by severe headache, extreme nausea (still a bit nauseous today), face red and swollen, jaw hurt, stomach pains-she couldn't eat.
Admitted to hospital. Pt experienced apnea the night of receiving immunizations.4/4/06 Medical records received from hospital which revealed patient & his twin were born preemies on 1/25/06 & were not d/c from hospital until 3/20/06.  Patient's mother was smoker who had incompetent cervix & PPROM.  Mom had yeast infection 2 wks prior to delivery.  Patient was Breech presentation delivery.  At birth had RDS, anemia & sepsis.  D/C dx: preemie w/extremely low birth weight, RDS, chronic lung disease, anemia, apnea.  Readmitted to hospital 3/28/06, 2 days after vax w/apnea, anemia & feeding difficulties.  D/C to home 4/1/06 w/apnea & home nursing/ss
Papulo-vesicular rash over face, front, back, fingers with erythematous base.
Tinnitus began approximately a day later but not sure on the exact date.  Still present.  Believe it is in both ears, although difficult to tell.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to three temperature excursions (dates unspecified): the first lasting for 192 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius), the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the third lasting for 24 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
I developed left arm soreness (at the injection site) 12 hours after getting the shot. I also developed a temperature up to 100.7 associated with chills. I took Tylenol 1000 mg and fever subsided for 4 hours but fever and chills came back and now temp was 101.1 which was relieved by Aleve (took 2 of the 375 mg tabs). I had low-grade fevers up to 100-101 for 24 hours, associated with myalgia but no more chills for the whole Christmas Day. All symptoms resolved except for left arm soreness within 24 hours. Left arm is still sore even after 72 hours.
Breakthrough case admission after 2 vaccines Pfizer 5/8/21 lot# Ew0164;  pfizer 5/29/21 lot# Ew0172
hives on the arm; the arm swelled; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on the arm) and PERIPHERAL SWELLING (the arm swelled) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives on the arm) and PERIPHERAL SWELLING (the arm swelled). At the time of the report, URTICARIA (hives on the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-086957, MOD21-087003, MOD21-087005, MOD21-087006, US-MODERNATX, INC.-MOD-2021-107093 (Linked Report).; Sender's Comments:  MOD21-086957: MOD21-087003: MOD21-087005: MOD21-087006: US-MODERNATX, INC.-MOD-2021-107093:
Patient was given a booster dose of the pfizer COVID19 vaccine on 9/30/21. The vaccine was taken out of ultra cold on 8/30/2021 brought to us on 9/1/2021. It was missed that the vaccine must be moved to the refrigerator storage after 2 weeks for an additional 30 days. The vaccine was in the freezer for 1 month.
On April 23rd, I noticed a sore on my left ear that evening. It was very tender. It finally occurred to me on the 27th. That's when I went to the dr's office because I thought I might have shingles. The dr started me on valtrex for a week. I was told because I work in a cancer center that I could not be at work with shingles. They thought that I might be contagious and I had to work from home for four days before they cleared me to come back to work.
d/c summary: "Patient was floridly psychotic at start of her stay, hallucinating, speaking of herself in 3rd person, disoriented, agitated, bizzare speech with a morbid theme.  Because of some reported buccal sxs (yawning like mouth movements), and the morbid thinking with hallucinations anti NMDA encephalitis was entertained.  Additional w/u included neg urine drug screen, head CT, T4/TSH, syphilis, HIV, ceruloplasmin, Anti DNAse B and strep PCR throat, serum lactate. An LP was traumatic but tested neg for HSV and Enterovirus.  Acyclovir was started and stopped.   An MRI of brain was normal but no contrast used.   She was treated empirically with IVIG even before MRI and Pulse Solumedrol started 1gm/day x 5 days. We repeated LP to send for autoimmune encephalitis panel at clinic 8/5 as a more sensitive test.  This sample was not traumatic and had 10 WBC.   IGM and IGG for WNV were neg on this sample.  15 ml CSF was obtained with plenty of extra available for further testing if needed.  Clinic contacted Dr, and recommended some other testing (see pending).  She felt it unlikely by sx that this represented an infectious cause. She required doses of Ativan early in her course. Her sx improved dramatically by the 3rd day of Solumedrol and we no longer needed Ativan. She had only subtle sx by 8/8 with some odd ideations/recollections of events but by that time was eating, cooperative, socially engaging w/o any evidence of hallucinations or morbid thinking or speaking of herself in 3rd person. Treating per the Protocol until the Enc 2 panel comes back negative.  After pulse solumedrol completed she started Prednisone 60mg/day until further instructions from peds neuro as outpatient.  IVIG would be tentatively scheduled for 8/18.  Rituximab is on hold and would only be given if testing positive for anti NMDAR encephalitis. Psych consulted prior to discharge, considered psych meds but felt that due to lack of prodromal symptoms this would more likely represent acute medical encephalitis rather than a psychiatric diagnosis-- >prefer to not start psych meds yet and instead have close follow-up in psych clinic in parallel with peds neuro clinic follow-up.   On day of discharge pt much improved, behavior appropriate, walking around the room oriented with pleasant affect, brushing her hair after showering.  "
Pink and itchy area over vaccination site with minimal tenderness per pt. Pt stated, she went to her provider.