chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SINUS ISSUES; DRY EYES; DRY MOUTH; PEELING SKIN; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (SINUS ISSUES), DRY EYE (DRY EYES), DRY MOUTH (DRY MOUTH) and SKIN EXFOLIATION (PEELING SKIN) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TUCATINIB (TUKYSA) for Breast neoplasm malignant female.    Concurrent medical conditions included Breast neoplasm malignant female. Concomitant products included APIXABAN (ELIQUIS), BISOPROLOL FUMARATE, EXEMESTANE, ACYCLOVIR [ACICLOVIR], DILTIAZEM HYDROCHLORIDE (DILTIAZEM HCL EXTE-REL), LORAZEPAM (ATIVAN), PROCHLORPERAZINE MALEATE and LACTOBACILLUS NOS (CULTURELLE) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form and TUCATINIB (TUKYSA) (unknown route) dosage form. On an unknown date, the patient experienced SINUS DISORDER (SINUS ISSUES), DRY EYE (DRY EYES), DRY MOUTH (DRY MOUTH) and SKIN EXFOLIATION (PEELING SKIN). At the time of the report, SINUS DISORDER (SINUS ISSUES), DRY EYE (DRY EYES), DRY MOUTH (DRY MOUTH) and SKIN EXFOLIATION (PEELING SKIN) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were reported.
Had them in eye, got both shots/Suspected vaccination failure; Had them in eye; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's relative. The age at vaccination was not reported. The patient had them in eye, the patient got both shots. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
I did not have an adverse reaction to the vaccine. On 12/16/2022 I had a scratchy throat; cough and just felt sick. On 12/17/20222, I continued to have a sore throat, shortness of breath and very weak. I tested positive for COVID-19 on 12/17/2022. I contacted my doctor and was advised to take cough medicine and acetaminophen. As of today, I was doing better but I got a horrible sinus infection of which I'm still experiencing and my throat is still scratchy.
Hospital Course and Significant Findings: Patient was admitted with a right femur fracture.  They underwent named surgery under care of DR.  The patient tolerated the  procedure well.  Please see  operative report. Postop the patient's pain was controlled with multimodal regimen.  They were tolerating oral pain meds, wound had clean, dry dressing on and all instructions were given to them both orally and in written form.   Weight bearing status:  WBAT RLE / DVT prophylaxis: ASA Patient was cleared for discharge as well The patient will follow up in ortho clinic as appointed or sooner should they have any problems or concerns.
Event occurred after final dose. Patient was diagnosed with COVID. Tylenol, Multivitamin, Discharged home
INJECTION SITE STARTED SWELLING SAME DAY ABOUT SIZE OF A NICKEL AND WAS HOT TO TOUCH, TODAY SITE IS SWOLLEN TO SIZE OF  ORANGE AND HOT TO TOUCH.  IS GOING TO ALTERNATE TYLENOL AND IBUPROFEN.  I WILL CALL AND GET UPDATES THRU OUT THIS WEEKEND.
RECEIVED FLUZONE HIGH DOSE AND PNEUMOVAX IN THE SAME ARM  (LEFT DELTOID).  CLIENT EXPERIENCE PAIN, REDNESS, AND SWELLING THAT EVENTUALLY EXTENDED TO HER ELBOW.  WAS SEEN BY PRIVATE DOCTOR AND TREATED WITH Z-PACK.  DOCTOR EXPLAINED TO HER THAT SHE HAD RECEIVED A PNEUMOVAX VACCINE 3 YEARS AGO AND SHOULD HAVE WAITED BEFORE RECEIVING ANOTHER.
PNEUMOVAX administered 12/16/16 AM in office. Patient developed pain and swelling (L) upper arm/shoulder by same evening. Seen in office 12/20/16 - still having pain, limited ROM (L) arm. Still pain/swelling at recheck, 12/28/16.
Iinformation has been received from a 34 year old male pharmacy technician with seasonal allergy referring to himself. There was no pertinent medical history. On 16-SEP-2015, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included ALLEGRA. After reconstituting ZOSTAVAX on 16-SEP-2015, when withdrawing needle from vial, some of the ZOSTAVAX reconstituted solution might have splashed in his left eye (accidental exposure while preparing drug for administration). Caller stated that he did not rinse his left eye after that occurred. The reporter stated he was really not having any problems with his left eye, except a little bit of redness. The reporter stated the redness can possibly be attributed to  his seasonal allergies. There was no treatment given for events. No other symptoms reported. The outcome of eye redness was unknown. Additional information has been requested.
Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old female patient started to received first dose of BNT162B2 (COVID-19, Pfizer, Solution for injection, lot number: EL3247), via an unspecified route of administration at left arm on 29Jan2021 14:00 at single dose for covid-19 immunisation. Medical history included scleroderma. The patient's concomitant medications were not reported. No other vaccine administration reported within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. No Allergies to medications, food, or other products were reported. The patient was not pregnant at the time of vaccination. On 29Jan2021 at 19:00 the patient experienced sore arm. No treatment was received for the event. The patient underwent lab tests and procedures which included sars-cov-2 test: COVID-19 virus test was negative prior to vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Swelling and severe itching at injection site along with pain in arm that all lasted approximately 1.5 weeks. Tachycardia on the day after injection that lasted 2 days.
This spontaneous report as received from a registered nurse refers to a 27 years old female patient. The patient was vaccinated with GARDASIL (lot number, dose, route not reported) on 07-JUL-2012 at the age of 27. No other co-suspects or concomitant medications were reported. Additional information has been requested.
I awoke on Nov. 10, 2009 to a noise in my left ear. It intensified and I got up and went about my usual routing preparing to go to work. I had severe constipation and finally became dizzy and had the dry heaves and complete hearing loss in my left ear. My husband took me to Dr. where they did a hearing test and he prescribed an antibiotic even though he didn't see any infection. When my hearing didn't return in a few days I made an appointment with an ENT. Dr. gave me a hearing test and prescribed prednisone which I was unable to take due to severe adverse reaction. I then went to another ENT, Dr. on 12/21 and he prescribed an antiviral and steroid. He recommended I see another doctor who specializes in this type of sudden hearing loss. I have an appointment with him on 1/7/2010. Also have appointment with an acupuncture doctor on 1/9/2010.
This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (Qualifies now as an immunocompromised patient) and BONE MARROW TRANSPLANT (Bone narrow transplant) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced IMMUNODEFICIENCY (Qualifies now as an immunocompromised patient) (seriousness criterion medically significant) and BONE MARROW TRANSPLANT (Bone narrow transplant) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Qualifies now as an immunocompromised patient) and BONE MARROW TRANSPLANT (Bone narrow transplant) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient received first, second and booster dose of Moderna. On 24-NOV-2021, patient had a bone marrow transplant and was then an immunocompromised patient. No treatment information was provided. Company Comment: This is a Spontaneous case concerning a 76-year-old patient of an unknown gender, with no medical history reported, who experienced Serious unexpected adverse events of Immunodeficiency and Bone marrow transplant (serious criteria Medically Significant). The events occurred approximately 19 days after the administration of the 3rd dose of the mRNA-1273 vaccine. Regarding this case, the patient received a bone narrow transplant and qualifies as an immunocompromised patient. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a Spontaneous case concerning a 76-year-old patient of an unknown gender, with no medical history reported, who experienced Serious unexpected adverse events of Immunodeficiency and Bone marrow transplant (serious criteria Medically Significant). The events occurred approximately 19 days after the administration of the 3rd dose of the mRNA-1273 vaccine. Regarding this case, the patient received a bone narrow transplant and qualifies as an immunocompromised patient. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
No history of knee problems or recent trauma.  Awoke the morning after the injection with severe bilateral knee pain to extent that I could barely walk. I started Ibuprofen 800 mg bid with some improvement over the next day or two. I subsequently regained near normal function with resolution of the right knee pain but with residual intermittent left knee pain associated with tenderness to external pressure over the medial knee. I have been using Voltaren hs with good effect. Symptoms seem to be stabilized but persistent.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was a senior women age 66 and has received the Covid-19 vaccine. Each time receiving the shot have gotten her very sick. Yesterday at 09:30 am she received her second booster shot. She started getting very sick after 10:00 pm. She had a fever of 101.8 all night with headache like she never had before. She wanted to ask why every time Ishe receive the shot and got extremely sick. She don't think she would get another booster. Her friends got the shot with no problem, and asked what made her get so sick.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Spiked a 103.5 fever within one hour, nausea, vomiting, diarrhea, abdominal cramps
Initially dull pain; chronic-progressed to sharp pain. Daily. No relief w/ice, heat, IBU, APAP, Alternating. Not every day but almost everyday. No improvement. Worse. Hurts to lift arm parallel to shoulder.
pt exp grand mal sz approx 24hr p/vax;there was no prior hx of sx activity;
Arm Pain; Joint Aches; Redness of the Face; Ear Swelling; Hot Sensation of the Face; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), ARTHRALGIA (Joint Aches), ERYTHEMA (Redness of the Face), EAR SWELLING (Ear Swelling) and FEELING HOT (Hot Sensation of the Face) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), ARTHRALGIA (Joint Aches), ERYTHEMA (Redness of the Face), EAR SWELLING (Ear Swelling), FEELING HOT (Hot Sensation of the Face) and PAIN (Soreness). On 16-Feb-2021, PAIN IN EXTREMITY (Arm Pain), ARTHRALGIA (Joint Aches), ERYTHEMA (Redness of the Face), EAR SWELLING (Ear Swelling), FEELING HOT (Hot Sensation of the Face) and PAIN (Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, dose number, lot/batch number, expiration date and route were not reported) for shingles prevention. On an unknown date, reported as about a week after the administration, the patient experienced shingles. No product quality complaint (PQC) was involved. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
I couldn't think straight; It went to the front of my head; Headache; Extreme fatigue; My arm hurt for almost 12 hours but this thing went in to my neck; My arm hurts and it was very bad; arm hurt for almost 12 hours but this thing went in to my muscles; This is terrible; Got so sick; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 28Jul2021 (vaccinated at the age of 58-years) as dose 1, single for Covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient reported as "my arm hurts and it was very bad on 28Jul2021, arm hurt for almost 12 hours but this thing went in to my muscles in 2021, i couldn't think straight; it went to the front of my head on an unspecified date, headache and extreme fatigue on 30Jul2021, this is terrible and got so sick in 2021, my arm hurt for almost 12 hours but this thing went in to my neck on 29Jul2021". It was reported by patient that she took the first Pfizer, she didn't want to take it but she went to take it and she would not taking the second one. she got so sick from that shot, her arm hurts but she have no problem she don't care if her arm hurt for almost 12 hours but this thing went in to her neck, her muscles, she couldn't move her neck for about two or three days, came up to her head and she couldn't think straight and it went to the front of her head, she have headache and she was really upset with this. Also extreme fatigue as well. So, her arm hurts, Wednesday night on 28th at night as expected, as she said, her arm hurts and it was very bad but that is okay and then by Thursday, until the next day about 24 hours later, that is when it started with her neck for about 2 or 3 days and Friday, Saturday, Sunday was the headache and fatigue. Still experiencing events: Consumer stated that the neck was better, still getting headache, she do have some fatigue but she went for 2 hours massage as well. Treatment: Consumer stated, "Aspirin just like two Aspirin, two Aspirin and two Ibuprofen, two Ibuprofen, she meant altogether will be 8 (further clarification about the medications was unknown). "Therapeutic measures were taken as a result of arm pain, myalgia, headache and neck pain. No lab work was reported and her family doctor told her that she was at risk with this shot. Consumer stated, "So, they are going to improve it for next 'guinea pig' really she mean was glad because when there was lawsuit she had it documented that she called in, really this was terrible." Outcome of Headache, extreme fatigue was not resolved; neck pain was resolving and for other events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
11/5/09 H1N1 vaccination; 11/6/09 noticed rash, red/itching-throat started swelling, closing up 7 took benadryl & atarax. Became worse over weekend- rash extended from neck to legs-went to her doctor today 11/09/09-was told to continue benadryl, atarax & take 20 mg Prednisone daily x 3 days. If condition worsens go to ER. Will refer to allergist
Patient received 3 doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the series was completed in 2018).   On 10th October 2022, the patient received the 3rd dose of Shingrix. On 10th October 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2022. Reporter's Comments: The reporter stated that a patient who received 3 doses of Shingrix.  Did not consent to follow-up. No other information available. Additional Supportive Information: The patient received 3rd dose of Shingrix which lead to extra dose.
Have Epilepsy  and he has had his seizures under control for over a year. A few days after he received vaccine he started having seizures that came and went for about a month.
Pt was fine after receiving both immunizations. After immunizations were complete, he stood at the counter waiting for me to make copies of the immunization forms for school. While standing at the counter, he passed out and fell to the ground. Another patient in the waiting area said it looked like he was seizing. Seconds later, I was notified he passed out and was on the ground, so I ran to grab my emergency bag and out to the waiting room. He was already talking and saying he was fine. I had pulled out an Epi-Pen in case I needed to administer, and he declined the need for administering it. I asked how he was feeling and he stated he felt fine, but wanted to continue to lay on the floor, just in case. I did grab him some water. 911 was called but the patient declined the need for them to come. Our store manager sat with him in the waiting area for another 15 minutes to make sure he was fine. The patient left on his own, walking, just fine.
I am experiencing sever muscular/skeletal pain in all, I repeat all of my joints. I can't bend over in the mornings. I have a high pain threshold. The pain is affecting my vision.
White blisters on elbows, red bumps on top of arms, both areas are itching
Pt returned for recheck appt. of other problem - showed injection site (L) upper arm - red and swollen.
- Started getting my period every 2 1/2 weeks. Although I am almost 50 I have been very regular, every 29 days, up until injection. I have had 3 periods since April 29, and today is 6/2.    - This may or may not be related, but i have awful muscle pain in my right leg that started 3 days after 2nd dose. It is unrelated to activity or clothing. Does not limit my activities - just a weird, dull ache in the muscle of my right quad.
Pt was in 15 minute waiting area and began to have chest tightness with Shortness of Breath.  911 called, 50mg of Benadryl administered orally.  BP remained very high.  EMS arrived and transported pt to local hospital via ambulance.
Red swelling after the first dose in the upper left  High fever after the second dose from 9:00 pm (approximately 5 hours after vaccination) on 7/5/21 till 12:30 pm on 7/7/21 Chest pains at 12:30 pm on 7/7/21. Went to the ER at 1:30 pm. Diagnosed with a heart attack with heart attack symptoms at 1:40 pm Many tests occurred, some being a Hospital Echo and X-Ray The procedure that occurred is the Cardia Catheterization Procedures  Diagnosed with myocarditis Hospitalized for three days and two nights Medication: Colchicine (colchicine 0.6mg oral capsule)/ 1 cap by mouth/ once daily for one month Ibuprofen (ibuprofen 600mg oral tablet)/ 1 tab by mouth/ three times daily for one month PredniSONE (predniSONE 10mg oral tablet)/40mg PO daily x3 days/30 mg PO daily x3 days/20mg PO daily x3/10mg PO daily x3 days No physical activities or work for one month after discharge 2 months later, chest pains occur sometimes
Pt called reporting right shoulder pain radiating down right arm and right elbow. Patient states injection site feels warm but denies redness, swelling, denies fever. Pt advised to take ALEVE and call if does not get better/worsens.
AE(s) following prior vaccinations: States any vaccines her arm is sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM9810) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing), notes: takes cholesterol medication. The patient took concomitant medications. Vaccination history included: Shingles (States the last one was shingles a couple of years before.), for Immunization; Flu shot (States she had more soreness with her last flu shot.), for Immunization, reaction(s): "soreness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "AE(s) following prior vaccinations: States any vaccines her arm is sore".  Additional information: Patient had no prior vaccinations (within 4 weeks). Stated the last one was shingles a couple of years before. Stated any vaccines her arm is sore, like the flu shot. Reported that at 75 her arms are somewhat muscular and so she assumed that might be why and other people say they get a sore arm and she believes it is more about the needle going in and not the medication. Stated she had more soreness with her last flu shot back in the fall. Patient takes cholesterol medication.