chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am the epidemiologist reporting on behalf of 61-year-old female patient. The patient received an initial vaccine series with two doses of the Moderna vaccine on 1/15/21 and 2/12/21. They later received a third dose of the Moderna vaccine on 8/19/21. The individual reports to contact tracers that they began experiencing COVID-19 symptoms 8/20/21, the day after their third dose. On 8/23/21 (four days post third dose), this person experienced a heart attack and tested positive for COVID-19 via a rapid test the same day. They subsequently tested negative via a PCR test on 8/25/21. This is a probable vaccination breakthrough infection post Dose 3. I do not have further information regarding immunodeficiency status or underlying health conditions that may have contributed to the heart attack/positive test.
did not feel too great; felt drained; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel too great) and FATIGUE (felt drained) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 19-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (did not feel too great) and FATIGUE (felt drained). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (did not feel too great) and FATIGUE (felt drained) outcome was unknown.            Concomitant medication included birth control.   This case was linked to MOD-2021-006655 (Patient Link).
chills, headache, nausea,.2/2 headache on 2/2 sent me to hospital er on 2/3  they gave me tylenol,benadryl,toradol,and compazine,after headacvhe eased sent me home  went to bed and didn,t wake till noon on 2/4  at time of this report I was still felling hazy and shacky  hopefully feel better tomorrow
This spontaneous report as received from a dentist refers to his wife who was a 66 year old female patient with none Pertinent Medical History. On an unknown date in the end of September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # was not reported). The concomitant medicines included estrogen supplement. On an unknown date in October 2012 the patient experienced painful oral lesion resembling mucoceles on the tip of her tongue and cheeks after vaccination with ZOSTAVAX. The lesions had a yellow center and last only about 3 hours. The patient contacted the dentist for medial attention and no treatment was given to the adverse event. The outcome of the adverse event was reported as not recovered/not resolved. Additional information has been requested.
MOM STATES LATER IN THE DAY ON 8/17/2020 SHE TOOK OFF THE BANDAID TO THE INJECTION SITE AND IT WAS RED AND SWOLLEN, SHE STATES SHE DREW A LINE AROUND IT WITH A PEN AND THEN THE NEXT DAY THE INDURATION HAS GROWN SO THAT IS WHEN SHE TOOK HIM TO THE URGENT CARE. SHE STATES IT IS RED, RAISED, HAS A RASH DOWN THE LE AND IS HOT TO THE TOUCH. MOTHER STATES CHILD WAS PRESCRIBED AND ANTIBIOTIC FROM THE URGENT CARE THAT STARTS WITH A "C" AND ARE TO GIVE 8ML PO BID.
PATIENT RECEIVED VACCINE; NOTED SHE HAD ALLERGY TO PENICILLIN/AMOXIL; COUNSELED TO WAIT 30 MINUTES AFTER VACCINATION TO MAKE SURE SHE DOES NOT HAVE LATE ALLERGIC REACTION TO VACCINE. WHEN 30 MINUTES WAS OVER I ASKED THE PATIENT IF SHE WAS FEELING OKAY. SHE STATED "HER JOINTS FELT STIFF LIKE WHEN SHE TAKES AMOXICILLIN." QUESTIONED THE PATIENT IF SHE WAS LIGHTHEADED/DIZZY OR HAD TROUBLE BREATHING? PATIENT RESPONDED "NO, JUST ACHY JOINTS AND SWEATING." AT THAT POINT SHE HAD ANAPHYLACTIC SYMPTOMS. INFORMED PATIENT I COULD GIVE HER SOME TYLENOL FOR THE PAIN. TOLD HER TO GO HOME AND RELAX. INFORMED PATIENT I WOULD CALL HER IN 30 MINUTES TO CHECK IN. 30 MINUTES LATER I CALLED PATIENT AND NO ANSWER AND LEFT VOICE MAIL. 1 HOUR LATER CALLED AGAIN AND NO ANSWER AND LEFT ANOTHER VOICEMAIL. PATIENT CALLED 2-3 HOURS AFTER GOING HOME STATING SHE REPORTED TO "HOSPITAL." SAID SHE STARTED TO DEVELOP DIZZINESS, SWEATING, MORE JOINT PAIN, NAUSEA, AND SHORTNESS OF BREATH "BUT MAY BE DUE TO NERVOUSNESS." I ASKED PATIENT ABOUT RECONSIDERING SECOND DOSE OF VACCINE, BUT SHE THEN SAID "THE HOSPITAL STILL RECOMMENDS ME GETTING THE SECOND DOSE." THEREFORE LEADS ME TO BELIEVE IT WAS NOT A REAL IMMUNE RESPONSE BUT A PSYCHOLOGICAL RESPONSE. ANNOTATED IN PT PROFILE AND INSERTED ALLERGY TO PFIZER VACCINE IN PT PROFILE
consumer reports that daughter recvd DT/OPV/MONO vac on 2AUG93 & on 12AUg exp a partial complex sz; treated in ER as of 31AUg; no further sz; pt taking Tegretol; MD reports pt had sx; seen in ER-had addtl sz;
Site: Swelling at Injection Site-Mild, Systemic: cellulitis of elbow-Severe, Systemic: Joint Pain-Severe, Additional Details: pt reports 3.5 days post vaccination severe pain, redness and swelling at elbow.  She states that provider did not think was related to vaccine but pt wanted reported anyway.
patient has had persistent fatigue and lymphadenopathy for 3 weeks with associated fullness in her left supraclavicular fossa most consistent with lymphedema based on evaluation thus far
Breakthrough case admission after 3 vaccines Pfizer 4/15/21 Lot# Ew0150;  Pfizer 5/6/21 Lot# Ew0164;  Pfizer 12/30/21 Lot# 33036BD
leg muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia of lower extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced myalgia of lower extremities. On an unknown date, the outcome of the myalgia of lower extremities was unknown.   It was unknown if the reporter considered the myalgia of lower extremities to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. Patient had the shingles shot and experienced leg muscle pain. The follow-up would not possible as no contact details were available
Patient was given 30 micrograms dose of Pfizer who was suppose to receive  10 micrograms dose of Pfizer. Patient waited 15 minutes with no adverse effects noted. Patient family was called and notified who was okay with the dose; "Okay. Thanks for letting me know."
Fever, fatigue and joint pain and moderate to severe neck pain.  Broke out with rash on all limbs and 60% of abdomen on 06/15/2016.
No adverse event.  Prevnar 13 was given instead of Pneumovax 23.
36 hrs after the first dose I had a severe headache and body aches, that lasted 12 hrs. then 7 days later my injection site became itchy, inflamed and red, which lasted for 3 days when I then took Zyrtec. Then the reaction subsided. The day of the second vaccine about 9 hours after the injection I got a severe headache, and this time severe body aches and chills that lasted for 24 hours. after the 24 hrs, I had a mild headache and body aches for 2 more days.
Information has been received from a registered nurse concerning her 11 year old daughter with asthma, penicillin allergy and drug hypersensitivity to cephalexin (KEFLEX) who on 25-JAN-2007 was vaccinated with a dose of Gardasil vaccine (yeast). Concomitant therapy included lansoprazole (PREVACID), triamcinolone acetonide (NASACORT) and diphenhydramine HCl (BENADRYL). On 26-JAN-2007 the patient developed nausea, lethargy and a rash with pruritus on back. Unspecified medical attention was sought. There was no laboratory or diagnostic tests performed. At the time of the report, the patient was recovering. The registered nurse considered nausea, lethargy and pruritic rash to be disabling events. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/9/2007; 5/28/2007. On 26-Jan-2007, it was reported that the patient "may have had swollen glands in her neck area." On 27-Jan-2007 the patient experienced lethargy. On 28-Jan-2007, the patient developed nausea and a rash with pruritus on back. The paiten took BENADRYL and "felt that this helped." On 30-Jan-2007, the patient was seen by a dermatologist, fulll cutaneous examination revealed that the left scapular back had a diffuse area of scale and erythema. the right upper abdomen had on 0.6 cm erythematous lesion with a central erythematous papule. The left abdomen had2 similar 0.6 cm lesions that were slightly more urticarial in their erythema. the remainder of the complete cutaneous examination failed to reveal any additional nuspicion or active lesions. Impression include dermatitis, fever papular urticaria and to consider hypersensitivity. The patient was treated with CUTIVATE. The dermatologist did not feel that the reaction was necessarily related to GARDASIL and recommended that she compete her vaccination course. On 29-Mar-2007, the patient was vaccinated with her second dose of GARDASIL ("lot # 02446"). The patient's mother, a registered nurse reported that she developed hives on her forearms, trunk and buttocks. The patient did not seek medical attention for the hives. At the time of the report, the patient recovered. The dermatologist felt that since the patient may have a sensitivity to beans and other legumes this may be the source of the eruption. The physician considered the events to be non-serious (previously reported as disabling events by the registered nurse). No further information is available. This report no longer meets the criteria for expidited submission to the FDA. Follow-up information reported that the events were considered to be non serious. Medical records are available upon request.
FEELING ACHY; LARGE REDNESS AT INJECTION SITE; AREA AT INJECTION SITE IS SWOLLEN; This spontaneous case was reported by a consumer and describes the occurrence of PAIN, VACCINATION SITE ERYTHEMA and VACCINATION SITE SWELLING in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN, VACCINATION SITE ERYTHEMA, and VACCINATION SITE SWELLING. At the time of the report, PAIN, VACCINATION SITE ERYTHEMA, and VACCINATION SITE SWELLING outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Covid-19 breakthrough. 1st vaccine received on 01/16/2021. 89 y/o with PMHx CVA, HTN, HLD, arthritis, Hypothyroid, cardiac arrhythmias, melanoma, and smoking presents to ED with c/o Covid-19 symptoms that started 9 days ago. Patient tested positive on 02/07/2022, had monoclonal tx with Sotrovimab on 02/09/2022. Patient c/o SOB, decreased appetite, decreased sleep, diarrhea and extreme fatigue. Room air sat 90%, placed on O2 2L NC with sat 100%.  Afebrile and CXR with no acute infiltrates. Treated with IV steroids and Remdesivir.
SUSPECTED CLINICAL VACCINATION FAILURE; SARS-COV-2 BREAKTHROUGH INFECTIONS; This spontaneous report was received from literature. This report concerned an 81 year old female of unknown race and ethnic origin. Initial information was processed along with the additional information received on 14-SEP-2021. The patient's height, and weight were not reported. The patient's past medical history included: CVA (cerebrovascular accident) and concurrent conditions included: heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure and SARS-COV-2 breakthrough infections (shortness of breath, cough), and was hospitalized (date unspecified). Laboratory data (date unspecified) included: RT-PCR test was positive and viral load was 18.8 Ct (cycle threshold). Viral load was evaluated and RNA was isolated from the nasopharyngeal swabs and evaluated for the presence of SARS-CoV-2 RNA using RT-PCR. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and SARS-COV-2 breakthrough infections was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000193362; Sender's Comments: V0: 20210918885-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210918885-COVID-19 VACCINE AD26.COV2.S-sars-cov-2 breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
The pt received vaccinations on 2/16/00. Began nausea, vomiting and diarrhea on the evening of 2/25/00. The pt experienced generalized macular rash of trunk that appeared on 2/28/00. Rash resolved by morning of 2/29/00. Remained afebrile for entire duration.
Pt received flu vax in (L) upper arm, higher than usual, admins. by a co-worker (CRNA) @ flu clinic for OR employees. 0 immed pain but dev. pain @ injection site within a few hours. minimal redness or swelling. He has had pain @ site since then, now (seen 10/12/20) almost 3 days later increased pain with movement of L upper arm. 0 weakness numbness or tingling 0 radiation Rt hand dominate 0 prior prob with any vaccine. (L) arm was fine prior to vaccine administration
I went to the doctor for Swollen Lymph nodes under the left armpit and lower abdomen pain. They scheduled an ultrasound of my left breast and a CT of my lower abdomen and pelvis. I have a 3-month follow-up for the lymph nodes and they found minor prostatitis in my abdomen. I was proscribed CIPRO for prostatitis. I then had a rare reaction to the CIPRO which caused my Achilles and patellar tendons to swell and become inflamed. Now I can hardly walk. Prior to all this, I was very active.
soreness around the injection sight within 12 hrs of the injection, progressed over next 3 days, fever and body aches the night of the shots and in to the following 24 hrs.  nausea, fatigue x 48 hrs.  injection site reaction with erythematous "welt" down the injected arm 2 inches wide by 1 inch high x 5 days
Fever, aches, tiredness, weakness, chills, sore throat. The flu.
Vaccine may have been store under condition that departed from the manufacturer's recommended specification, so the the manufacturer deem vaccine not viable and recommends a repeat dose.
After receiving the vaccine, I experienced a high fever, coughing, nausea, severe headaches, foggy, disoriented, aching all over, and just totally feeling bad and exhausted. I went to the ER on August 8, 2021. My white blood cells and symptoms I had looked like I could've had Covid but when I did the Covid test it was negative. The doctors gave me steroids. I couldn't eat. I have had trouble breathing ever since I got sick.
arm was very sore; This is a spontaneous report from a contactable consumer (patient's neighbor) reporting for a patient.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. On an unknown date the patient experienced their arm was very sore. It was reported the arm was sore, but after a couple of days, it was annoying, but it went away. The clinical outcome of the arm was very sore was recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Severe left arm pain started within 2-3 hours of injection with loss of mobility due to pain.  Pain caused increase in COPD symptoms.  Went to ER at Hospital about 8:00 pm  and was diagnosed with Adverse Reaction to vaccine and exacerbation of COPD  Followed up with PCP, Dr. on 8/9/2019 with persistent moderate to severe left arm pain.  The predisone was discontinued and Diclofenac topical was prescribed to left arm in area of deltoid
Information has been received from a registered nurse concerning a 35 year old female who while attending college, in approximately 2001 (5 to 6 years ago) was vaccinated with the first 0.5 mL dose of varicella vaccine live (Oka/Merck). The patient never received a second dose. Titers were recently drawn but results showed that the patient was not seropositive. No adverse event reported. The patient was vaccinated by different provider in a different state. There was no product quality complaint. Additional information has been received frrom registered nursthat the negative titer was an adverse event, therefore WAES # 0703USA00951 is being deleted from our files on varicella virus vaccine live.
Blood pressure spiked to 159/98 and 169/92; tachycardia (pulse rate 152); irregular rhythm; This is a spontaneous report from a contactable consumer (patient). An adult female patient received (BNT162B2, Solution for injection, Lot: ENS318), via an unspecified route of administration on Jan2021 in left arm at single dose for covid-19 immunisation. Medical history included Allergies to medications, food, or other products: Yes, and had severe adverse reaction to an unrelated vaccine in 1988 that resulted in epi-pen administration. The patient previously took epi-pen. On Jan2021, the patient stated that roughly 7 minutes in, she began experiencing tachycardia (pulse rate 152). She requested help and doctors examined her, it was nothing. She also had an irregular rhythm. Blood pressure spiked to 159/98 and 169/92. Bp and pulse came down somewhat over the next 90 minutes, but remained significantly higher than normal for 11 hours (bp: 140s-150s/high 80s-low 90s compared to high-end norm of 110-120/65-70); pulse: 112-114 sitting compared to high-end norm of low 70s). More importantly, the irregular rhythm had continued for 10 days now and she was being followed by a cardiologist. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient was treated for the adverse event. But not so much treatment, as much as monitoring. The outcome of the event irregular rhythm was not recovered and rest of the events was unknown.
No adverse event; a vaccine was inadvertently administered past the expiry date/The vial expired on 18-Jun-2023 and was administer on 20-Jun-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a vaccine was inadvertently administered past the expiry date/The vial expired on 18-Jun-2023 and was administer on 20-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     The patient had not reported any relevant medical history/conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).  It was reported that the patient did not have any reaction of her covid vaccine.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (lot number 043A21A) on 09-Apr-2021, COVID-19 VACCINE JANSSEN (lot number 213D21A) on 12-Nov-2021, PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5) (lot number GH9702 and bivalent booster) on 20-Sep-2022. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN, COVID-19 VACCINE JANSSEN, PFIZER BIONTECH COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/5).    On 20-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a vaccine was inadvertently administered past the expiry date/The vial expired on 18-Jun-2023 and was administer on 20-Jun-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a vaccine was inadvertently administered past the expiry date/The vial expired on 18-Jun-2023 and was administer on 20-Jun-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (a vaccine was inadvertently administered past the expiry date/The vial expired on 18-Jun-2023 and was administer on 20-Jun-2023).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The department of Health informed that a few lot numbers had an extension from September to October. Since one of the lot numbers that was extended had a very similar number and letter to the one that was not extended. The vaccine was inadvertently administered a vial past expiration. The expiry date was reported as 18-Jun-2023. No PQC was reported. No treatment medication was reported.
Pt has a history of hypertension and hemorrhagic stroke with mild residual expressive aphasia. He presents with generalized weakness, gait unsteadiness, and confusion for one week. He has increased fatigue and a nonproductive cough. Pt is admitted with new onset Afib, NSTEMI, and is found to be COVID positive.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 75-year-old female patient who received SHINGRIX (batch number 3GY56 ?, expiry date 7th March 2021) for prophylaxis. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm, pain in arm and erythema of extremities. On an unknown date, the outcome of the swelling arm, pain in arm and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the swelling arm, pain in arm and erythema of extremities to be related to SHINGRIX. Additional details reported as follows: The patient reported to the pharmacist she experienced swelling, redness, and pain below the injection site and the swelling was the size of her hand.
Pt recvd 3 doses of Engerix-B 31OCT90, 30NOV90, & 03MAY91 & it was determined that pt did not seroconvert;
I developed shingles in January that affected my right arm. I went to the emergency room where they treated me and gave me prednisone, valacyclovir and gabapentin. It took about six weeks before I started to feel better. I have recovered, I still have a little bit of the rash and some pain in my shoulder, but I am no longer taking medication.