chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood trailing; lump in the middle of the breast; tenderness/pain in the injection arm; lump in the injection arm; Contusion of breast; bruise in breast got very purple; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXTRAVASATION (blood trailing), CONTUSION (Contusion of breast), SKIN DISCOLOURATION (bruise in breast got very purple), BREAST MASS (lump in the middle of the breast) and VACCINATION SITE PAIN (tenderness/pain in the injection arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced SKIN DISCOLOURATION (bruise in breast got very purple). On 19-Sep-2021, the patient experienced CONTUSION (Contusion of breast). On an unknown date, the patient experienced INJECTION SITE EXTRAVASATION (blood trailing), BREAST MASS (lump in the middle of the breast), VACCINATION SITE PAIN (tenderness/pain in the injection arm) and VACCINATION SITE MASS (lump in the injection arm). At the time of the report, INJECTION SITE EXTRAVASATION (blood trailing), VACCINATION SITE PAIN (tenderness/pain in the injection arm) and VACCINATION SITE MASS (lump in the injection arm) outcome was unknown and CONTUSION (Contusion of breast), SKIN DISCOLOURATION (bruise in breast got very purple) and BREAST MASS (lump in the middle of the breast) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Immediately after vaccination had sensation of tongue swelling.  No rash, no nausea/vomiting, no lightheadedness.  On exam patient was in no acute distress, well appearing, clear voice, no rash, clear oropharynx with no appreciable tongue swelling.  Patient reports symptoms resolved spontaneously with no intervention while talking with providers.  Patient drinking her own water/gatorade.  Patient taking her own benadryl and husband in car who is a physician driving patient home.  Discussed indications for calling 911 if needed.  Given health provider line number.  VSS: HR 90s, O2sat 97-98%, BP 129/66.
After the 2nd dose vaccine, I  had nausea, vomiting and diarrhea.  A few days later, I developed a rash on both my arms.  The rash looked like little raised bumps and was itchy.  I applied some Benadryl cream on it and it hasn't improved.  About a week after my vaccination, I had flu like symptoms- shortness of breath, cough, low grade fever,  body aches and joint pain.  I went to the ER (Hospital) and was given  oxygen, breathing treatments and was diagnosed with pneumonia.  I was given a prescription of Z-pak azithromycin and discharged to follow up with my PCP.
PATIENT REPORTS PRONOUNCED TIREDNESS AND LOSS OF APPETITE FOR SEVERAL DAYS. PATIENT ALSO REPORTED ARM PAIN AND REDNESS ON LEFT ARM, THE SIDE WHERE THE SHINGRIX VACCINE WAS GIVEN.
Patient received first dose of Pfizer vaccine in left arm at 1128 06/29/2021. Patient stated he was very nervous to get his vaccine when he arrived. Patient was sitting in observation when he stood up to alert someone he was dizzy. Patient started to lose consciousness while a nurse was able to catch him and lower him to the ground safely. The patient's legs were elevated and patient regained consciousness. Blood pressure taken at 1130 and was 105/55 with a HR between 46/52 BPM. The second BP was taken after the patient sat up. At that time, he was 124/64. The patient verbalized that he hadn't eaten anything that day, so staff got him apple juice and crackers which he started to eat/drink immediately. The third blood pressure was 146/68. At this time, the patient verbalized he felt safe to sit in a chair. All blood pressures taken on left arm. Patient denies any dizziness at this time. Additional vitals BP 128/81, HR 57 -- > 126/77, 59 prior to D/C.  Pt stable and released from the vaccination site.
Local redness minor swelling (MMR site). Local redness moderate welting (Varicella site)
within 2 hours of the vaccine, she had excruciating pain in her arm. she went to her doctor that day. her doctor felt that the pharmacist injected the vaccine too high and she was experiencing S.I.R.V.A. If she doesn't fully recover in 2 weeks she will need to be referred to an orthopedic surgeon. The pharmacist emphatically denies that the injection was done incorrectly and feels it was just an adverse reaction to the vaccine.
pt recvd 1st dose of Hep B vax on 29JAN92 & w/in 15 mins of receiving inject pt exp a funny feeling all over & numbness of tongue; exp necessitated a visit to MD; w/in 45 mins sx subsided;
A few minutes after injection the patient reported feeling nauseous.  Had patient sit back down where he then passed out.  Checked for pulse and breathing asked patient if he could respond to me.  Within 15 second patient was able to respond to me.  After about a minute patient color came back and was able to open eyes and look at me.  Patient then complained of not be able to feel his hands and feet which feeling came back after a few minutes.  However patient still complained of feeling pins and needles in his fingers.  After 20 to 30 minutes patient reported feeling ok and was released under parents care.
Patient reports (R) arm itching on 5/30/18 late evening, states she scratched her arm; arm started hurting - pain level 7 on scale 1-10; did not take pain meds or put anything on the site; states never had chickenpox; redness noted to site measuring 5 inches x 3 inches - completely resolved on 6/5/18.
I had confusion headache and bodyache. I had cramps in my lower back and legs. I had gotten anxiety I could not sleep, extremely tired. I had chills without fever and cough. I had a virtual visit with my Doctor.
Patient presents to the ED secondary to generalized malaise, fatigue, dry nonproductive cough. Initially presented to local urgent care was reportedly tested positive for COVID - 19 and told to go to the ER because his oxygenation was in the low 90s. On arrival here, satting 96% on room air. Overnight pt desturated to Sp O@ 88% and required 2 L NC.  His labs showed elevated troponins without EKG changes or chest pain.  Chest X ray show bilateral patchy opacities.  Treatment:  steroids, lovenox, not a candidate for remdesivir.  Discharged to home.
HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and muscle aches was not reported. This report was non-serious.
My first 3 doses were of Pfizer. I had allergies 2 weeks prior. Then, I started getting symptoms of achiness, tiredness, and sore throat. The next day I was more tired. I did a home COVID-19 test which was positive. I contacted my doctor and was prescribed Paxlovid due to being immune compromised. Within 24 hours, I was feeling better. It took a week to test negative. The only symptom that lingered more was the fatigue.
Tinnitus was acting up; Ocular rosacea was also worse; Left hand was hurting with psoriatic arthritis; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus was acting up), OCULAR ROSACEA (Ocular rosacea was also worse) and ARTHRALGIA (Left hand was hurting with psoriatic arthritis) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (Tinnitus was acting up), OCULAR ROSACEA (Ocular rosacea was also worse) and ARTHRALGIA (Left hand was hurting with psoriatic arthritis). At the time of the report, TINNITUS (Tinnitus was acting up), OCULAR ROSACEA (Ocular rosacea was also worse) and ARTHRALGIA (Left hand was hurting with psoriatic arthritis) had not resolved.            It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  It was reported that after getting COVID booster shot her tinnitus was acting up, her left hand was hurting with psoriatic arthritis and her ocular rosacea was also worse. Patient got the booster shot in her left arm. Patient stated normally her right hand could act up with psoriatic arthritis but not left. Her skin was getting better.  No treatment medication reported by reporter.  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.
Rash on left thigh, itchy  Noticed on 11-8, no open lesions or vessicles.
Pt recvd vax on 3DEC92 & that evening pt devel a sore throat; following day exp body aches, fever, vomiting & inc pain due to sore throat; exp mottled, swollen, red & sore skin opposite arm from inject site;
Heaviest menstruation of my life, causing migraines before the period, and once the period ends. I have never had heavy periods my whole life (age 12-31). I also am having some issues with fertility, which I hope isn't due to the vaccine.
Pancytopenia; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A male patient of an unspecified age received first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pancytopenia on an unspecified date with outcome of unknown. It was reported that there was a patient who was hospitalized to had Covid vaccine, number 1, 3 days prior to the hospitalization, he came into the hospital.  The patient had Pancytopenia and the reporter was trying to find out what are Pfizer recommendation for Covid vaccine related Pancytopenia.  Information about lot/batch number has been requested.
I was driving when my vision in my right eye became blurry. The rightside on my body started to go tingly and then numb. As I was driving my vision got worse I was starting to barley be able to see out my eye. I also developed a severe headache on the right side of my body. I drove the the ER and go checked in because I thought I was having a stroke.  I was immediately put on stroke alert.I feared for my life as my condition was worsening. I was rushed back to have a Cat scan after some initial test. Then two MRIs. One doctor said it was a result of the vaccine another said it wasn?t. After being observed for 10 hours I was discharged. My symptoms were almost gone at discharge.  Six days later I begin that severe neck pain. Then a day after the initial neck pain it becomes unbearable. I got to my PCP where I am diagnosed with shingles. Ive never had shingles, ive never had anything like this. I am 100% pro vaccine but the hell this has put me through has been just awful.
swelling under my armpit; it was kind of swollen and tender; This is a spontaneous report from a contactable consumer (Consumer). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Jun2021 (Batch/Lot number was not reported) as dose 1,single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. When probed for the concern, consumer stated," I went today to my local right now getting my second dose of Covid vaccine. I was explaining to the Pharmacist that when I took my first dose on the 26th of last month. I was telling him that the day after I had a swelling under my armpit, near I guess it was under my lymph node and my armpit, first of all I thought it was normal. It was kind of swollen and tender for like first two days and then on the third day, on the fourth day I believe it went away, it went down and at the time I believe that I was normal. So when I went to my Pharmacist because today is my two weeks now also and I have to take my second dose vaccine. I told him that and he said that is not normal and I should call this number to see what they would say."When probed to confirm if received Vaccine second dose today, consumer stated, "No, Pharmacist told me that it is best for me to not take it and call you guys to see what you say first." Consumer was informed about Pfizer Medical Information Department. Consumer was informed about the Roles of Pfizer Drug Safety. In response, consumer stated, "I would see, I just took the time to get (second dose) vaccine. I am actually here right for work." The outcome of the events were recovered on an unspecified date in 2021.  Information on lot/ batch number has been requested.
Brain fog and fatigue on day 1 and 2 after administration.  Diarrhea and extreme fatigue beginning on day 7 and today (day 8).  COVID test negative yesterday.  Plan another test tomorrow.   I am an RN at the Health Center on campus.  Unsure if the latter symptoms are adverse event to vaccine, but felt it should be reported.
Ringing in ears; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunization. On an unspecified date the patient experienced ringing in his ears  4-5 days after the Pfizer covid vaccine. The patient knew people in his area that had the same complaints. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Covid 19 age 5-11 year old was given instead of 12 year old and up
From initial information received on 11Mar05 from a health care professional regarding an adverse event occurring, it was reported that a forty-nine-year old male pt was injured on the job and presented with a laceration to the tip of his fourth finger. He received a dose of Decavac vaccine with lot number U1211DA on 10Mar05 between 11 and 12AM. The route and site of administration were not reported. He also received four sutures on his fourth finger with Lidocaine and local care with Betadine on his fifth finger. The pt returned to work. Later the same day, at approx 6 PM, the pt was found dead at the plant where he worked. It was sometime between 4 and 6 PM that they think he passed away. An autopsy was being performed. Received Autopsy Report which stated COD as acute MI, coronary artery disease secondary to dilated cardiomyopathy.
started with a mild itching left armpit 24-48 hours after vaccine, rash on 4/20/2021 armpits and chest initially mild and progressively worse, called dermatologist, RNP at clinic on 4/22/2021 and made appointment for 4/23/2021. (I had had allergy testing on 4/20/2021 at another clinic, mild allergies to cats, mice, dust, mold and a few trees and grasses) RNP took pictures and thought it might be due to testing, prescribed Prednisone and Clobetasol ointment..  Zoom appointment with Dr. (allergist) said I had hives and cut down the prednisone because it would effect the efficacy of vaccine.
On 11/23/21  developed chest pain  and diagnosed with pericarditis. He returned to the hospital 12/4/21 with a pericardial effusion.
Bright red itchy rash with pain on upper arm around injecting site. Took Zyrtec  and seems to be clearing it up.
Mild to moderate hallucinations for about 10 hours, starting about 6 hours after vaccine.  insomnia & restlessness - at its worst during first 24 hours, then tapering off in severity but continuing for 48 hours. Both were tolerable but uncomfortable. These were very unusual symptoms that were not listed as expected symptoms so I thought they should be reported.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand=Pfizer / BioNTech, Vaccine administration date=12Nov2021 / Vaccine brand other=Moderna, Vaccine administration date=11Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 31Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2021, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine administration date=12Nov2021 / Vaccine brand other=Moderna, Vaccine administration date=11Mar2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Anti-viral Product Paxlovid from 03Jan2023 till 07Jan2023 for covid-19 treatment. When asked about lot number of vaccines stated as unknown reason, unable to locate or read the details.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Red, itchy arm rash appeared the next day after my second dose of Moderna's COVID-19 vaccine. My left arm had a warm and swollen area covering much of the upper arm which lasted for about 8 days.    I saw my family doctor 5 days after injection.  He diagnosed my condition as cellulitis of left upper extremity and prescribed Cephalexin 500 Mg Tablet.  After reviewing information on the internet, I believe that I had 'Covid Arm' since symptoms mimicked this condition instead of an infection.    Although dealing with my second Moderna injection for this questioner, this reaction (Covid Arm) also occurred after my booster on 10/29/2021.  I did not see my doctor, and symptoms cleared in about 8 days without meds.
The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023; No adverse event; Administered expired Moderna Vaccine to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023).    No concomitant medications were reported. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date. The vial size was 2.5 ml.  The vial did not undergo any temperature excursions. No treatment medications were reported.  This case contains information for the 9th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product administration date was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Patient 1
Presents with rash across chest four days after receiving smallpox vaccine. Missed four days of work.
Fever of 100.1, vomiting, nausea, very tired, body aches.
Pt recvd shot @ 4PM & @ MN awoke w/severe h/a was feverish & explained that the rt lower extremity was swollen & covered w/red blotches; Rash present 29OCT;
11/24/22 presents to ED for "SOB, mild cough". PMHx of "HTN, CKD-IV, anxiety, anemia of chronic disease, L-breast CA s/p mastectomy, and  CVA