chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe sinus swelling / sinus cavity around the bridge of nose "swole"; severe sinus pain/sinus cavity around the bridge of nose "swole and it caused really bad pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (severe sinus swelling / sinus cavity around the bridge of nose "swole") and SINUS PAIN (severe sinus pain/sinus cavity around the bridge of nose "swole and it caused really bad pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, the patient experienced SINUSITIS (severe sinus swelling / sinus cavity around the bridge of nose "swole") and SINUS PAIN (severe sinus pain/sinus cavity around the bridge of nose "swole and it caused really bad pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and STEROIDS for Adverse event, at an unspecified dose and frequency. At the time of the report, SINUSITIS (severe sinus swelling / sinus cavity around the bridge of nose "swole") and SINUS PAIN (severe sinus pain/sinus cavity around the bridge of nose "swole and it caused really bad pain) had not 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 drug details were reported.
lower back pack that has not gone away - any lower back pain that I have had in the past only lasted 2 days.  This has lasted two weeks without signs of abating.  Shortness of breath during light exertion - walking, climbing stairs, light exercise.  These are similar to when I was recovering from Covid-19.
Information was received from a physician via company representative and referred to a female patient of unspecified age. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant medications was reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 (intramuscularly; dose, lot# and expiration date were not reported). On an unspecified date, the patient developed rash on insertion arm. The patient went to doctor office. No relevant laboratory tests were performed. No treatment was given. The reporter stated the rash was resolved. Causality assessment was not provided.
HCP put her on low  taper dose steroid -mederol to minimize swelling; This is a follow up spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first dose on 21Dec2020, and she will be receiving 2nd dose of vaccine this coming Monday (11Jan2021). She had oral surgery yesterday on 05Jan2021, the surgery was already planned prior to first dose of vaccine. HCP (health professional) put her on low taper dose steroid, mederol to minimize swelling. The patient asked if there was any reason to continue to take her steroid medication and if is it ok to continue to take. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
This case was reported by a physician via call center representative and described the occurrence of lyme disease in a 75-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (refer case US2018GSK177661 for tolrance of 1st dose). On 11th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced lyme disease (serious criteria GSK medically significant), cellulitis (serious criteria GSK medically significant), raised rash and localized erythema. On an unknown date, the outcome of the lyme disease, cellulitis, raised rash and localized erythema were unknown. It was unknown if the reporter considered the lyme disease, cellulitis, raised rash and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however, it could be 74 or 75 years. The patient had developed big red plaque that was 10 to 12 cm in diameter at an inferior location to the injection site which was on the shoulder. The reporter described the area of the red plaque as being in the bicep area. The patient's family care physician was treating for possible lymes disease, but the reporter thought that the reaction might be a general cellulitis or related to the SHINGRIX injection site. The reporter was driving in his car and was not able to provide further details but was fine with follow-up from safety team.
approximately 16-18 hours following administration, mild symptoms of fatigue, chills, and muscle aches. Fever was not assessed.
Pt has a PMH of MI, CAD s/p CABG, and CKD stage 3. He presented to the ED with a complaint of weakness. Pt has developed shortness of breath and coughing. He was found to be COVID positive and admitted with COVID-19 pneumonia.
10 minutes after vaccine administration, child developed hives of the face spreading to the torso. Reaction resolved after 20 minutes without treatment only observation. Follow up four hours later no recurrence of hives or any adverse symptoms noted.
I was shocked that the same day my left eye started twitching and now it has not stopped 2 days later.; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:45 (Lot number: FH8027) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MICROGESTIN. Vaccination history included: Bnt162b2 (dose number: 1, Lot number: EN6199, administration Time:03:00 PM, vaccine location: Left arm), administration date: 08Mar2021, when the patient was 19 years old, for COVID-19 immunization, reaction(s): "my left eye started twitching all day"; Bnt162b2 (dose number: 2, Lot number: ER2613, administration Time:02:00 PM, vaccine location: Left arm), administration date: 29Mar2021, when the patient was 19 years old, for COVID-19 immunization, reaction(s): "my left eye started twitching all day"; Flu shot (Anatomical Location: left arm), administration date: 01Nov2021. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 15:45, outcome "unknown", described as "Booster"; BLEPHAROSPASM (non-serious) with onset 06Dec2021 16:45, outcome "not recovered", described as "I was shocked that the same day my left eye started twitching and now it has not stopped 2 days later.". Therapeutic measures were not taken as a result of blepharospasm.  Additional Information: The patient had no known allergies. The patient stated "the day I got my first dose my left eye started twitching all day every day until one week after my second dose, 4 weeks later". Hospitalization prolonged reported as No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device date was reported 08Dec2021. The case was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
I tested positive on August 31st and I'm still testing positive today. I have had significant lung problems and on the nebulizer 4 times a day and on prednisone. It started with severe flu-like symptoms that moved to my chest. I've missed 2 weeks of work and now back today trying to work.
Information has been received from a nurse referring to a 33 year old female patient. The patient had no relevant medical history or concomitant medications, and her past drug history was unknown. On 17-MAY-2016 the patient was vaccinated with 1 dose of PROQUAD (Merck) (rHA) (dose unknown, subcutaneous in the left arm, lot# M004895, expiration date 26-JUL-2017) accidentally instead of M-M-R II. The nurse reported the patient did not have any adverse events while she was in the office. It was unknown if there was any relevant laboratory data. At the reporting time it was also unknown if the patient would ever get PROQUAD again. Additional information has been requested.
While trying to administer the vaccine, the patient moved his right arm and vaccine was not administered to right arm. Patients mother was advised to hold arm tightly to administer the vaccine on opposite arm, left arm. Vaccine was administered on left arm successfully.
27JAN92 pts t102 by 2AM 28JAN92 t105; pt cried, leg was tender no redness or swelling; mom bathed pt & gave APAP; mom in contact w/MD pts temp up & down; MD felt temp fr pertussis;
7-10 days post vax pt exp 3 1/2 days temp-started w/spots on face & chest, all over body rash p/temp resided;looks like measles;
pt recv vax 18OCT95&exp severe ache for 3 to 6 days;there was a reddened area @ the inj site about the size of a quarter;
No adverse symptoms or signs. Employee administered PENTACEL reconstituted with wrong diluent.
I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain; I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain; I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain; This spontaneous case was reported by a patient and describes the occurrence of VAGINAL DISCHARGE (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain), THERAPEUTIC RESPONSE UNEXPECTED (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) and DYSMENORRHOEA (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Amenorrhea (had not had any period in 2 years).   On 29-Oct-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) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced VAGINAL DISCHARGE (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) and DYSMENORRHOEA (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain). At the time of the report, VAGINAL DISCHARGE (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain), THERAPEUTIC RESPONSE UNEXPECTED (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) and DYSMENORRHOEA (I started a period that I had not had a period in 2 years, black clot coming out with a white stuff/ in lot of pain) outcome was unknown.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-626054 (Patient Link).
my knees are sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (my knees are sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (my knees are sore). At the time of the report, ARTHRALGIA (my knees are sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants included. No Treatment included.
Ongoing Dizziness Ongoing lightheadedness Ongoing face numbness Ongoing face tingling Ongoing fatigue
FLUZONE received 10/04/2011 - developed diffuse rash w/in 4 hours; reports diarrhea (8-10 liquid stools) w/in 8 hours. No fever - resolved.
Discharge Provider: Private DO Primary Care Provider at Discharge: Private DO  Admission Date: 3/8/2023 Discharge Date: 03/9/2023 PRESENTING PROBLEM: Debility [R53.81] Weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 75-year-old male with a past medical history significant for Alzheimer's dementia, seizure, hypertension, hyperlipidemia and diabetes who presented to the emergency department after a fall at home.  In the emergency department, vital signs were stable.  Lab work was obtained which revealed a sodium of 128. He was found to have COVID-19.  Chest x-ray with no acute cardiopulmonary disease.  Patient was admitted to the Internal Medicine Service for generalized weakness.  PT/OT evaluated patient recommended home with home health care.  The following day patient felt well. A 4ww was delivered to the hospital for patient to take home.  He was recommended follow up his primary care physician.  He was discharged home in stable condition
On 3/30/18 (Friday) patient received PNEUMOVAX 23 (NDC 00006-48-3703) in her left arm. She has no history of having adverse reactions to vaccines. She called in today (4/3/18 Tuesday) stating that Friday night after receiving the vaccine she had a some pain in her arm. And woke up saturday morning with a large rash. The rash turned into huge welts, she said approximately the size of baseballs that were warm to touch and covered from the site of the injection down to her elbow. She states she called the emergency room who recommended she use Benadryl and a heating pad to help bring down the welts. She says she did that and is doing much better, that the rash is much better, but she wanted to call and tell us as an FYI. She said she would have called sooner but she was busy this weekend with family over visiting. I told her that it was recommended to see her doctor in the event that the area was infected, but she was sure that the swelling had gone down to a place she was comfortable with. I told her we would report it to VAERS and let her doctor know. She said she has an appointment with her doctor Thursday for a wellness check and would be letting her doctor know when she sees him.
head and body aches; head and body aches; shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced headache, general body pain and shivering. On an unknown date, the outcome of the headache, general body pain and shivering were unknown.   It was unknown if the reporter considered the headache, general body pain and shivering to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced head and body and shivering. The patient asked if contagious to any children who have not had chicken pox or the vaccine.
Patient tested positive for Covid19 after receiving the Pfizer vaccination EUA 05/07/21-05/28/21
Pt vaccinated with DTP/OPV experienced high pitched cry 4 hrs after injection.
BODY ACHES.  LOOSE STOOL.  CHILLS AND EXTREME HOT.  SKIN SENSITIVITY.  HEADACHE.  JOINT PAIN. EYES HURT. DIZZINESS.  INTESTINES FELT INFLAMED. SOMETIMES SYPMTOMS NOT ALL AT THE SAME TIME.
bones started to ache; really sick to the stomach; felt hot and kind of weak and sweaty; not feeling good; nausea; dizziness; felt hot and kind of weak and sweaty; felt hot and kind of weak and sweaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 2, unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 3, unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 4, unknown manufacturer), for covid-19 immunisation. The following information was reported: BONE PAIN (non-serious), outcome "not recovered", described as "bones started to ache"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "really sick to the stomach"; HYPERHIDROSIS (non-serious), ASTHENIA (non-serious), outcome "recovered" and all described as "felt hot and kind of weak and sweaty"; FEELING HOT (non-serious), outcome "unknown", MALAISE (non-serious), outcome "unknown" and all described as "not feeling good"; NAUSEA (non-serious), outcome "recovered"; DIZZINESS (non-serious), outcome "recovered". Additional information: patient was calling about COMIRNATY 2023-2024. She reported that she had a reaction where her bones started to ache, caller got really sick to the stomach, felt hot and kind of weak and sweaty. Patient stated that she was still experiencing bone pain and generally not feeling good. She stated that she wanted to know if there was any lasting issue about this. Patient didn't have anything else but the bone pain and she was hoping that this won't last long. She added that her weakness, nausea, sweating and dizziness only lasted for 5 minutes but the bone pain had been going on since. Patient stated that she exercises everyday and she is not the type to sit down and do not feel like doing anything right now. Caller mentioned that this is her fifth shot and the first time she experienced these side effects after the shot. Patient wants to know how long will the bone pain may last.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Right arm began to swell, redness, and pain at site of Pneumovax 23 injection (left deltoid) with in 4 hours of injection. By next morning skin from left ear to left elbow was red, sensitive to touch,  hot, swollen, and patient had several moments of general fever. Patient self treated acetaminophen 1000mg about every 8 hours along with ice on the affected shoulder. 48 hours later - reduction in reaction symptoms but still notable swelling, some redness and pain.
Swelling to cheeks (worse to left cheek), swelling to right upper arm, erythema to right upper arm.
A lot pain at injection site for 50 hours, difficult to use arm. Fever of 99.5 or above for 3 days (72 hours). Nausea and I vomited once. Chills and non-stop sweating, body aches.
About 15 lesions, papules on trunk, vesicles on back scabbed vesicles on neck. DX varicella TX Acyclovir.
Pt. received 1st dose of Pfizer COVID19 vaccine on 2/10/21, and 2nd dose of Pfizer COVID-19 vaccine on 3/3/2021 and was subsequently admitted to the hospital on 3/11/21 with COVID-19.
I was having heart palpitations and it happened several times at night and in the morning, I went to work and it was continuing. I went to the doctor's Hospital ER - and they ran tests. - No treatment; they couldn't find anything. I do still have a little bit of symptoms -(Palpitations) but nothing like what it was when I first started getting them. I was told to follow up with PC doctor in a month.
Patient seen on 6/24/2023 c/o black, watery stool X3 weeks with csome vomiting after feedings Ordered GI Panel through test. Resutes came back 07/25/2023 positie ROTAVIORUS
Itching on the left side of body. When first receiving the vaccine the first shot my arm swoll up at the injection site took awhile to go away now a month later I have itching on the whole left side of body.
Patient developed fever and erythema and tenderness at injection site. She also noted myalgia and nausea.
PT CALLED PHARMACY ON 8/26 INQUIRING ABOUT UNDERARM SWELLING IN LYMPH NODE AREA OF LEFT ARM. TENDERNESS AND PAIN AT THE SITE. TOLD PT TO CONTACT A PRIMARY CARE DOCTOR TO EXAMINE FOR ADVERSE EFFECT, AND TOLD PT TO SEEK IMMEDIATE ATTENTION IF IT BECOMES MUCH WORSE. PT FOLLOWED UP WITH STUDENT HEALTH CENTER THE NEXT DAY. BY TUESDAY WE CHECKED IN WITH PT AND HE REPORTED THE AREA WAS GETTING BETTER AND SWELLING WAS DECREASING.
redness, swelling and itching above elbow on same arm as injection. Patient took 1 dose of benadryl which seemed to help but condition later progressed. pt saw doctor on morning of 10/23 and was diagnosed with possible infection and prescribed 7 day course of doxycycline.
throat tightness; chills; fever; This is a spontaneous report from a contactable pharmacist (patient) via Pfizer sales representative. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on an unspecified date at single dose for COVID-19 immunisation. Within 5-10 minutes, she noted throat tightness which she successfully treated with diphenhydramine. Within 1-2 hours she noted chills and fever which partially resolved with ibuprofen. Clinical outcome of throat tightness was unknown while for the other events was recovering.  Information on the lot/ batch number has been requested.
Pt received 2nd series of Hep A at 1400, At 1500 pt started to having burning at injection sit right deltoid and positive urticaria, red blotches noted on bilateral upper extremities. no sob no difficulty swallowing. Pt seen by MD who administered Benadryl 50 mg PO at 15:15. Pt observed for 30 minutes after.
Caller states that she received her 1st vaccine on 02/26/2021.  Awoke at 7:30 am today and now with redness, hardness and tender to touch at injection site.  Instructed to apply warm compresses to the injection site and notify PCP if sx worsens.
Generalized itching over entire body which progressively got worse each day.  Head to toe itching with no relief from topical interventions nor antihistimines.  12/1/09 & 12/8/09 Chemistry panel showed liver involvement.  Subsequent liver biopsy on 12/14/09 showed rejection of the liver.  12/17/09 admitted to Hospital to treat rejection of the liver transplant.  12/20/09 discharged from hospital.  12/17/09 changed her antirejection medication (one she had been on for 20 years) to 7 different medications to treat the rejection and the itching issues.
Sore arm at injection site, entire body muscular soreness and stiffness, headache, chills, tiredness.