chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nauseous; vomiting; dizzy; weak; no appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (unspecified if ongoing). Concomitant medication(s) included: CARBIDOPA/LEVODOPA, start date: 19May2022. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; manufacturer unknown), for covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 17Oct2022, outcome "not recovered", described as "Nauseous"; DIZZINESS (non-serious) with onset 17Oct2022, outcome "not recovered", described as "dizzy"; DECREASED APPETITE (non-serious) with onset 17Oct2022, outcome "not recovered", described as "no appetite"; VOMITING (non-serious) with onset 17Oct2022, outcome "not recovered"; ASTHENIA (non-serious) with onset 17Oct2022, outcome "not recovered", described as "weak". Therapeutic measures were not taken as a result of nausea, vomiting, dizziness, asthenia, decreased appetite.  Additional information: No Known allergies. Nauseous vomiting dizzy weak no appetite. If treatment ae: No.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA: Patient received Moderna COVID-19 vaccines from physician office on 12/28/2020 and 1/25/2021. Patient presented to Emergency Department on 5/3/2021 complaining of watery, green diarrhea that started on 4/25/2021. Stool studies were done as an outpatient that were reported as negative. He was prescribed Flagyl and Bactrim which initially improved symptoms, but then symptoms returned. EGD and colonoscopy were performed.  EGD revealed some inflammatory changes in the duodenum where biopsy was taken. Per the pathologist, H pylori organisms were not observed. Within the colon small polyps were noted as was mild inflammation of the entire colon.These studies were followed by CT enterography  which revealed a known 3cm duodenal diverticulum and fluid filled colon compatible with diarrheal state as well as some inflammatory changes of the colon as was seen on lower endoscopy.
Witnessed Syncope event approximately 30 -45 seconds after administration of flu vaccine and lasting 1.5-2min.  Pulse ox 100% and HR In 50s during event.  Vital signs stable following event and mental status at baseline.  Paramedics were called given prolonged non-verbal response despite strong pulse and good O2 sats.  Pt was at baseline by time of their arrival and declined medical transport after mental status assessment.  EKG completed and pt scheduled for follow up within 1 week.
Pfizer booster; interchange of vaccine; heart palpitations/but they were accelerated after the Pfizer booster.; a severe headache like a migraine; dry mouth; body aches; a severe headache like a migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-173571 (Moderna).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "heart palpitations" (unspecified if ongoing), notes: due to her blood pressure medicine. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1), for COVID-19 Immunization, reaction(s): "body aches"; Moderna covid-19 vaccine (Dose 2), for COVID-19 immunization, reaction(s): "body aches". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "interchange of vaccine"; PALPITATIONS (non-serious), outcome "recovered", described as "heart palpitations/but they were accelerated after the Pfizer booster."; MIGRAINE (non-serious), HEADACHE (non-serious), outcome "recovered" and all described as "a severe headache like a migraine"; DRY MOUTH (non-serious), outcome "recovered", described as "dry mouth"; PAIN (non-serious), outcome "recovered", described as "body aches".  Additional information- Patient states that her sister suffered greatly after getting a Pfizer booster after her Moderna Covid-19 Vaccine primary series. Her sister had body aches after her primary series. Four hours after her Pfizer booster she had heart palpitations. She experienced those before due to her blood pressure medicine, but they were accelerated after the Pfizer booster. She also had dry mouth, body aches, & a severe headache like a migraine after the Pfizer booster. She said these effects lasted about a day & a half after the Pfizer booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My arms swelled up and it's red; My arms swelled up and it's red; I had a rash; I had the Pfizer booster shot; This is a spontaneous report from a contactable consumer(patient). A 78-year-old female patient received a third dose of BNT162B2 (BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number FE3590 and Expiry date 01Nov2021) via intramuscular route of administration, administered in left arm on 07Oct2021 (at the age of 78-year-old) as dose 3 (booster), single for COVID-19 immunization. On 07Oct2021 patient received Flu (INFLUENZA VACCINE) for immunization. The patient had no medical history. The patient concomitant medication included metoprolol for blood pressure and cholesterol. The patient previously received first dose of BNT162B2 (BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number EL9261 and Expiry date 31May2021) via intramuscular route of administration in left arm on 26Jan2021 as dose 1 and second dose of BNT162B2 (BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number EN6201 and Expiry date 20Jun2021) via intramuscular route of administration in left arm on 17Feb2021 as dose 2, single for COVID-19 immunization (at the age of 78-year-old). On an unspecified date, the patient experienced my arms swelled up and it's red and I had a rash. On an unspecified date patient reported that I had the colonoscopy last week (no further details provided). Patient reported that no treatment was taken for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
I developed a huge baseball size lump under my left underarm. It has gone down but there is still pain and seems to be a bump deep in my underarm. It is taking so long to go away and hurts.
The patient presented to the pharmacy on 10/11/22 at about 3:00 p.m. with a painful, red, whelped up rash in 2 areas about 2 inches in diameter on her neck and chest that she stated had begun on 10/6/22. The patient was instructed to contact her primary care doctor. The healthcare personnel in charge reported the event to the patient's primary care physician as well as the per protocol physician.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 at 10:00 as dose 1, single (Lot number: ENG205), in left arm, on 22Mar2021 at 19:00 as dose 2, single (Lot number: ER8730), in left arm and on 09Oct2021 at 19:00 as dose 3 (booster), single (Lot number: FD0809), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Cats" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Feb2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2023) Positive. The patient reported that symptoms (sore throat, runny nose, wheezing, headache, dry cough, cough with mucus, muscles aches, small fever) started Monday 27Feb2023. Tested positive Tuesday 28Feb2023. The patient was treated with Paxlovid from 28Feb2023 to 05Mar2023. The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5 has been requested and will be submitted if and when received.
Patient states that her physician advised against second dose. She states she had a severe headache for days following  vaccine, she collapsed at work and was hospitalized for a few days. She also reports ongoing dizziness. All information was left in a private message sent to the health departments social media page. Further requests for information have been unsuccessful thus far.
Developed fever 101, 3 hours after immunizations with fussiness. Gave Tylenol. Temperature increased to 103. Had 2.5 minute shaking episodes (probable seizures) above with perioral cyanosis. Approximately 4 hours after immunizations and 4.5 hours after immunizations. No further seizures. Temperature went down to 100.6 after Tylenol.  Pt experienced well at 7PM. Medical records state pharyngitis. msv
Erythematous pleomorphic generalized macular rash and fever. Admitted and given steroids and anti-histamines.  Nurse follow up on 07/21/04 states: "
1 day after receiving flu vaccine, I developed pain medial to my (L) eye. 3 days later, I had a painful rash in area. Doctor did culture, and it was positive for shingles.
Arm mildly sore few hours post injection (second injection).  Awoke @ 0100: restless, body aches, chills (shivering), fever (questionable?), headache. Felt malaise & existing symptoms all next day (2/18), including very sore left arm. Slept most of day. Relief from Tylenol 1000mg every 5-6 hours.   Next day (/2/19) just minimally tired, but able to resume normal activities.  Arm soreness subsided each day, but lasted about 5 days.      After 1st injection on 11/20/2019, just very sore arm
This spontaneous report as received from a physician refers to a 13 month old female patient, whose medical history included pneumonia and urinary tract infection. Drug reactions/allergies were reported as none. On 01-JUN-2015 the patient was vaccinated with VARIVAX (Merck) (Lot # K010337 exp. date not reported) (0.5 ml, frequency and route were not reported). Concomitant therapies included iron (unspecified) and ceftriaxone. A 7-days course of prednisolone (manufacturer unknown) was started on 26-JUN-2015 (25 days after vaccine). On 01-JUL-2015, the patient experienced chickenpox, 5 days after she received prednisolone (manufacturer unknown) and 30 days after she received VARIVAX (Merck). The rash was described as clean vesicles, erupting to maculopapules from head-to-toe (including, but not limited to, vaccine administration site) and "spawing" palms/soles. Number of lesions was reported as 100s. On an unspecified date the patient's body temperature was 102.5 (units not provided). The patient did not have recent varicella zoster virus (VZV) exposure neither to chickenpox nor to shingles. On 08-JUL-2015 the patient was admitted to hospital. On 09-JUL-2015 a sample from vesicles, papules and scabs was collected for the varicella zoster virus identification program (VZVIP). Varicella-Zoster Virus (VZV) packet was faxed as requested by physician. No product quality complaint (PQC) was involved. The patient sought medical attention but did not receive treatment. Lab diagnostic studies were performed (complete metabolic panel, CRP, CBC, serum immunoglobulin, HIV, chest x-ray, blood culture) with unknown results. At the time of the report, patient was still hospitalized. The outcome of chickenpox was reported as recovering. The physician did not assess the causal relationship between the VARIVAX (Merck) and the chickenpox. Additional information is not expected because all follow-up has been received.
Patient was given 0.25ml dose instead of 0.5ml  dose. There were no reported adverse  symptoms.
Hormonal disruption. Post menopausal heavy bleeding, swollen breasts, profuse sweating( 72hrs post), hand/nerve pain (immediate)
LIP SWELLING 48 HOURS AFTER VACCINATION, HIVES OVER ENTIRE BODY
no adverse event; they inadvertently administered a dose of the bivalent vaccine (blue cap with gray border) which was beyond the BUD.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered a dose of the bivalent vaccine (blue cap with gray border) which was beyond the BUD.) and NO ADVERSE EVENT (no adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7647B and AS7647B) for COVID-19 prophylaxis.     Concurrent medical conditions included Venous malformation NOS and Plagiocephaly.   On 24-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Aug-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-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 (they inadvertently administered a dose of the bivalent vaccine (blue cap with gray border) which was beyond the BUD.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered a dose of the bivalent vaccine (blue cap with gray border) which was beyond the BUD.) 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 (they inadvertently administered a dose of the bivalent vaccine (blue cap with gray border) which was beyond the BUD.).    No concomitant medication was reported. There was no report of adverse event experienced by the patient after the administration. No treatment medication was reported.
pain and swelling on left deltoid, lasted 5 days, progressively got less and less painful as the days went by, from day after injection to Saturday. Lethargy, and foggy headedness, with slight dizzy sensation, the morning after the shot, lasted one day (treated with sleep, rest, acetaminophen, and pseudoephedrine).
High grade fever with chills almost like rigors 103.8 F Happened after 9 pm  Initially started with malaise  Fever being monitored throughout the night
no adverse reaction.  Patient was given Pfizer in error as 3rd dose.  Patient's previous 2 doses were Moderna.    (I don't know how the 3rd dose appt was made; unclear from the information I have access to whether this patient is immune-compromised and was supposed to actually get a 3rd Moderna dose.)
Patient got flu shot and started new BP med (coreg, replacing metoprolol) on the same day. That evening she became tired and felt as though she may pass out and has been feeling that way since. She has taken her BP several times since then and it is running higher than usual (diastolic number staying around 157). I advised her that her symptoms could be caused by her high blood pressure and that she should see a doctor today. I called her several hours later and she stated that she was feeling a little better and decided not to see a dr today but to wait and call either her doctor or nephrologist in the morning.
Dizziness; poor memory; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and MEMORY IMPAIRMENT (poor memory) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]) for Hypertension.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizziness) and MEMORY IMPAIRMENT (poor memory). At the time of the report, DIZZINESS (Dizziness) had not resolved and MEMORY IMPAIRMENT (poor memory) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. He is scheduled to get the second shot on 05 May 2021.
Patient fainted 30 minutes after shot and fell. Pt fell on card rack and cut lip & nose.
4 days after receiving Vaccination #2, I suffered from appendicitis.  The appendicitis caused a massive abscess that eventually created a bowel obstruction and and hospitalization.  The appendix was eventually removed as a result.  Based on the reports from the mRNA vaccinations, I read there was an increase in cases of  appendicitis in the test groups so i believe this is relevant.
PATIENT DEVELOPED REDNESS, RASH, INFLAMMATION. TREATED WITH BENADRYL, STEROIDS, AND ANTIBIOTICS AT EMERGENCY ROOM.
Visual floaters, headache, dizziness, and nausea for about a day. Blurred vision for an additional day and a half. Symptoms characteristic of an ocular migraine but affecting both eyes.
pt recv vax 13OCT & devel dizziness, itching, hives, red spots, some swelling & SOB lasted 4-5 days;didn't call to see a MD -2wk later called to report  rxn & advised to see MD;
Pt got 2 vaccines 2-2-10, HPV and Hep A. During checkup ran fever most of night. Got as high as 104. Also c/o headache, aches generalized all over.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administrated vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Pt developed flat red splotcy rash over anterior chest, neck, face within 10 minutes of receiving vaccines.  Also flat red area surrounding site of MMR vaccine with increased warmth developed at same time.  Pt complained of itching area of rash and feeling "hot all over".  Given Benadryl immediately after rash noted, remained in clinc for 1 1/2 hrs after receiving vaccine during which time rash faded
I started my period 2 1/2 weeks earlier than usual, which was very odd to me. My period is usually on time, so I thought it was peculiar when I got my period significantly early. I will be visiting my doctor soon regarding this.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-JAN-2016 the patient was vaccinated with two improperly stored doses of RECOMBIVAX HB 5 microgram/0.5 mL(lot # J009051, expiration date 26-MAR-2016, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion twice. The total cumulative excursion time was 32 hours and 24 hours. The lowest recorded temperature was 34 Celsius degree. The highest temperature was 48 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Flu shot rt arm, chills and fever 8 hours after shot. Lasted several hours. Pneumococcal left arm, within 8 hours upper arm extremely sore, soreness lasted 5 days.
SHORTLY AFTER RECEIVING HIS COVID VACCINATION, PATIENT COMPLAINED OF A SLIGHT FACIAL RASH ON THE EDGE OF HIS HAIRLINE.  GAVE PATIENT A DIPHENHYDRAMINE TO TAKE ORALLY AND ADVISED THE PATIENT TO CONTINUE TO WAIT IN THE LOBBY SO WE COULD CONTINUE TO MONITOR HIM.  PATIENT LEFT THE STORE A SHORT TIME LATER WITHOUT WAITING IN THE STORE AS REQUESTED.
Severe scratching.  Hives from injection sight across back at shoulder blade level, to other arm.  Then spread as follows:  hives across lower back and buttocks, then inner thighs, then ankles and feet, then neck and across face.  As new hives appeared, established hives remained.  Hives resolved within ten minutes of administration of 1 benadryl allergy fastmelt.  Skin remained itchy. Hives returned 24 hours later.  same pattern, but as they spread across body, first would resolve as new errupted...no benadryl given.  Third night hives again less severe, but benadryl given because itching was interfereing with sleep.  Fourth day slight hives.  No more incidents after this.  Skin was itchy even when hives not present during first four days.
Discomfort in (L) shoulder almost immediately that got worse over the next few days. Went to Dr on 9/6/14, received oral steroids that helped some but pain has continued even Kw/ a steroid injection and physical therapy.
Vomiting forceful x 10 minutes beginning <1 minute after shot, then red rash with hives then had/foot/face swelling and itching all over.
I started feeling bad like I had a cold so I started taking over the counter medications. I was sick all January and February and went to the doctor on March 15th; at that time the doctor gave me a COVID-19 test it was negative she thought it was a cold or flu she gave me a antibiotic to take for 10 days I also got a x-ray, then I had a follow-up with doctor and she got the x-ray results and saw I had pneumonia. Then she gave me another antibiotic for 10 days a well and cough syrup. I finished the medication and when back to my doctor and did another x-ray. The x-ray showed that the pneumonia was gone.
PASSES AWAY ON 7/25/21 OF UNKNOWN CAUSE BUT HAD PERICARDITIS
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after receiving 1st dose, see case US2018GSK148175). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced local injection site pain lasting 2 days. The reporter agreed to be contacted for follow up.