chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GA9694) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 at 09:00 as dose 1, single (Lot number: EL3249), in left arm, on 11Feb2021 at 12:00 as dose 2, single (Lot number: EL9262), in left arm, on 02Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FD8448), in left arm and on 30Mar2022 at 23:00 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergy to penicillin" (unspecified if ongoing); "known allergy to iodine contrast solution" (unspecified if ongoing). Concomitant medication included: LUMIGAN, start date: 24Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, which included Paxlovid from 28Oct2022 to 01Nov2022. Clinical course: The patient had Covid rebound following Paxlovid on 04Nov2022 at 03:00 AM, which was not treated and had not recovered at the time of the report.
Rash around the injection site; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), administered in left arm, on 07Mar2021 at 09:30 AM (at the age of 28-years-old) at 1st dose, single dose for COVID-19 immunisation. Medical history was not reported. The patient had not COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medication included triamcinolone injection (reported as other medications in two weeks). No other vaccine received in four weeks. The patient experienced rash around the injection site six days after the first dose of vaccine, on 13Mar2021 at 07:00 AM. No treatment was administered for the event. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
DIED IN JANUARY FROM DIFFERENT  THINGS BECAUSE OF THE VACCINE; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age.. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that " They are coming out with more side effects from the vaccine my sister died in January from different things because of the vaccine." It was unspecified if an autopsy was performed. On an unspecified date, the patient died due to different things because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221152314-died in january from different  things because of the vaccine. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: DIFFERENT THINGS BECAUSE OF THE VACCINE
After the booster shot, I had lots of soreness in my arms and legs. The next day I was having trouble walking due to intense leg pain on the left side. I went to the doctor who said that an abscess had formed on my leg after receiving the booster. It was extremely painful and I had to have emergency surgery to remove this groin abscess.
Myalgia, Fever, CoughWheeze, chills Narrative:  S/S resolved; employee tested for COVID on 1/8 without notifying employee health of any reaction, called 1/11/21 for results, which were negative.
sore arm; slight headache within 12 hours; nausea within 12 hours that subsided within 24-36 hours; fever of 101 within 24 hours that subsided within 36 hours; chills around the 24 hour mark. achy joints and muscles between 12-36 hours.
Left arm stiffness and pain with movement, a week after receiving Fluvax vaccine.  Afebrile, denies weakness, numbness, or coldness.
Almost fainted 24 hours post injection mild dizziness for about 2 0 minutes Redness, swelling and itching  day 8 post injection
DTaP+ IPV WAS ADMINISTERED IN LVL. PT PRESENTED TO THE ER ON 09/12/2017 WITH FEBRILE SEIZURE, ACUTE VOMITING, AND UNSPECIFIED CAUSE OF FEVER.
Hives on face about 3 hrs. after vaccination. Took BENADRYL q 4 hours x 3 doses on 11/7/12 & one dose in arm 11/8/12 with good effect. No diff swallowing or breathing. Hives faint.
I experienced tenderness under my left breast and under left arm pit. I thought I slept on it wrong but it didn't go away after days or weeks. I thought maybe since I'm right handed maybe the left side is a little pudgy. Thought maybe the wire on my bra so I got a new bra with no wire and left breast still slightly bigger than the right breast. I had a lumpectomy in 2016 so I thought it anything the left breast should be smaller. My doctor ordered me a mammogram  for May 19,2022.
pt had a positive COVID test on 9/22/2021; per death certificate, pt died at home with COVID being the significant condition contributing to death; requested med records from doctor that signed the death certificate, the response was there were no recent records on this pt
Information has been received from a consumer concerning her grandson, a now 10 year old male, with no known drug reaction/allergies and no pertinent medical history, who in approximately 1999, when he was 15 to 18 months old, was vaccinated MMR II, 0.5ml, subcutaneously. There was no concomitant medication. The reporter stated that in approximately 1999, right after the injection was given, the patient experienced developed autism. The consumer did not want to provide complete information of the adverse event. She did not want to have a follow up on this adverse event. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Upon internal review, autism was determined to be an other important medical event. Additional information is not expected.
On the 05/15/2021 I noticed that on vaccine site was hot to the touch, itchy, red, & swollen. I took Benadryl it lasted for 14 days but the first 7 day was worse. On 07/27/2021 also had high blood pressure it lasted for 4 days. I went to Urgent Care they said everything was normal.
One day after HEP A & flu inj - rash on chest, back, & face. Headache. Steroid cream helps some.
Information has been received from a doctor of pharmacy concerning a male in his 40's who in April 2001 was vaccinated with the first dose of varicella vaccine. On 04/26/2001 the pt developed chicken pox. No further details were provided. Unspecified medical attention was sought, however, as of 04/27/2001 the doctor has not seen the pt yet. Additional info has been requested.
Pt vaccinated with Influenza developed swelling in lt arm w/low grade temp. Treated as allergic reaction w/short course Prednisone. Developed sterile abscess & fevers. Required hospitalization & surgery drainage .
test came back positive (for Covid-19); This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (test came back positive (for Covid-19)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included TRAZODONE for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (test came back positive (for Covid-19)). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (test came back positive (for Covid-19)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test (positive-negative): positive (Positive) On 28Jan2021 test came back positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
About 6 hours after pt received vaccine she developed tachycardia-120 bpm. The pt was seen in ER. Pt was back to normal in 2 or 3 days. From additional correspondence received on 02/27/01, additional pt, responsible Dr, vaccine administrator and laboratory data were provided. No further information is anticipated. This case is closed.
COVID-19 breakthrough. It lasted for three weeks. I had fever and chills. I felt like I could barely not move. I also had fatigue and body aches. It seemed like it took me a long time to get over it.
Within 2 days my lymph nodes in both arm pits were inflamed and very painful. This lasted a couple of weeks.  Since then I have had inflammation throughout my body.  I have had inflammation and pain in my fingers that started a few days after the injection and continue to this day.  I hope that this is not permanent. I would like to hear if other people have had these issues.
tingling then numbness from left cheek by the eye to the middle of the chin . Was not there 8 hours after vaccine but woke with it .
pt recv vax 4AUG97 & 11AUG97 pt devel a fever which was as high as 103.7;12AUg97 pt was taken to hosp & MD gave pt an OK;following day pt devel a rash on face & chest w/more than 100 spots & fever was noted to have d/c later that day;
Flu; Initial information was received on 02-Dec-2020 regarding an unsolicited valid serious case from a non-health care professional (patient) via social media.  This case involves a patient with an unknown demography details who had flu (influenza), while being received influenza vaccine.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.    On an unknown date of 1998, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient had flat on his/her back for 10 days. The patient went to the doctors and two visits to the lab. The patient had flu (influenza) for three days normally and did not went to doctor. The patient not had the flu for 14 years since retirement. Got away from all the carriers.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
Injection site swelling, pain, erythema.  Lymph node in both arms and neck were swollen, painful and erythemic.  Symptoms started on Jan 7 and lasted about  10-12 days.
pt recvd vax & had a high pitched cry x 3 hrs; t 104; leg of inject site was swollen;
I am magnetic at the site of injections; Objects sticking to me like scissors, butter knife, toe nail clippers, staples, coins, keys, and anything that is mostly stainless steel.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I am magnetic at the site of injections) and STICKY SKIN (Objects sticking to me like scissors, butter knife, toe nail clippers, staples, coins, keys, and anything that is mostly stainless steel.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (I am magnetic at the site of injections) and STICKY SKIN (Objects sticking to me like scissors, butter knife, toe nail clippers, staples, coins, keys, and anything that is mostly stainless steel.).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.    This case was linked to MOD-2021-194086 (Patient Link).
Blood Clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 28-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 2, Manufacturer unknown), for COVID-19 immunization; Covid19 vaccine (Dose Number: 1, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: THROMBOSIS (medically significant) with onset Jun2022, outcome "unknown", described as "Blood Clot". It was unknown if therapeutic measures were taken as a result of thrombosis.  Clinical course: it was unknown that if covid prior vaccination and if covid tested post vaccination   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt exp itching; F/U info indicated MD was not the MD who vaccinated pt, nor did he see the adverse rxn; Pt had reported adverse rxn to Hep B vax not Engerix-B & was going to receive Engerix-B for subsequent vax;
mild headache; congestion on feb 1st; Chills; Fever on Jan 31st; This is a spontaneous report from a contactable 22-year-old (age at vaccination) male consumer reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; E19262) on 23Jan2021 at 2nd dose, single on left arm for covid-19 immunisation. Patient's medical history was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; E4284 dose number; 1 on 02Jan2021 at 12:00 pm on left arm for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced chills/Fever on 31Jan2021 at 11:00 pm and mild headache and congestion on 01Feb2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. The reported events were not considered as serious or fall under any seriousness criteria. Location of injection information is available for all vaccines received on the same date. The outcome of events was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
7 people had died from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (201253).  An elderly (reported as "50-99" and "Age Group: Elderly (greater than equal to 65 years)") male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "7 people had died from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Age + years/months/days: 50-99. Age Group: Elderly (greater than equal to 65 years). Moderna has proven to be effective against COVID-19; Pfizer is not that effective when the reporter first heard about it. 7 people had died from Pfizer; So that made a change in mind about taking Moderna. Plus, the Primary Care doctor suggested Moderna based of these stories that the reporter heard. The reporter considers the event as caused by the suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139954 Same reporter/event/drug, different patient;; Reported Cause(s) of Death: 7 people had died from Pfizer
Chills started, felt feverish. Next day loose stool continued, stomach problems worsened during day and by evening stool was looser. 10/29 developed rash on stomach and diarrhea began. 10/30 rash extended to neck and to knees. Stomach was beet red. 10/31 rash gone now, just itching on back. 10/28 took tylenol to help with malaise.
Raised, red, vesicular rash in patches over left cheek, left side of neck, upper left posterioir, or shoulder around left ear.
10-15 minutes after injection experienced nausea, dizziness, tinlging in hands.  Felt like she was going to vomit but never did. No SOB, no cough, no dyspnea.  Continues to observe for 45 min, nausea continued but was able to walk out to the car.
4MAY94 13 x 11 cm area lt thigh red, hot, erythematous @ site of Tetrammune inject;
Had loud tinnitus I both ears, but left ear is louder. Hard to sleep at night.Saw a doctor and received steroids treatment, and getting better 3 days later, but would not go away.
pt recv vax & 5min later vomited-very pale & wobbly;seen immed weak pulse 60/min, BP 80/60 adult cuff dusky lips but pink tongue, chest clear, no bronchospasm, no rash;no frank loss of consciousness, nl reflexes;abd pain but abd soft, nl BS
PM of vax pt screamed all night long 5-6 hrs; sounded loud & high pitched, like someone was hurting him; would shake while screaming; had staring spells the next day; had high fever 103 for 24 hrs; given APAP;
headache, sinus congestion, sneezing, says its like a cold. starting 11/29/21
Excruciating headaches, blurry vision, face & tongue swelling, dizziness, severe stomach cramping, hot & cold sweats, nasuea.
Fever up to 103.4 starting a few hours after shots and redness, heat, induration and swelling in left arm. Mom applied ice packs and gave Tylenol. Next day no fever. One week later arm back to normal. Mom feels local reaction was severe. Swelling was around arm "like an arm band" and very hard.
Dizziness; Light headed; Increased heart rate; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness), DIZZINESS (Light headed) and HEART RATE INCREASED (Increased heart rate) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLUVIRINE (0.5ml) on 04-Oct-2012, FLUVIRINE (0.5ml) since 03-Oct-2013, TDAP (0.5ml, intramuscular) on 13-Nov-2014, AFLURIA (Flu- 0.5ml, intramuscular) on 13-Nov-2014, HEPATITIS B VACCIN (20mcg, intramuscular) on 01-Dec-2014, HEPATITIS B VACCIN (20mcg, intramuscular) on 09-Jan-2015, FLU VACCINE VII on 12-Sep-2016, FLULAVAL (0.5ml) on 12-Sep-2016, AFLURIA (Flu) on 03-Sep-2018 and FLUCELVAX (0.5ml) on 16-Sep-2020. Concurrent medical conditions included Seasonal allergy, Dust allergy, Mite allergy, Cockroach allergy and Allergy to plants (Sycamore). Concomitant products included ASCORBIC ACID (VITAMIN C ACID) for Immune enhancement therapy, MULTIVITAMIN [VITAMINS NOS] for Supplementation therapy.   On 27-Dec-2020 at 8:23 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 01-Feb-2021 at 1:20 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 01-Feb-2021, the patient experienced DIZZINESS (Dizziness), DIZZINESS (Light headed) and HEART RATE INCREASED (Increased heart rate). At the time of the report, DIZZINESS (Dizziness), DIZZINESS (Light headed) and HEART RATE INCREASED (Increased heart rate) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of the events included, diphenhydramine , cetirizine for 2 weeks. Patient was informed to take paracetamol and ibuprofen id patient was feeling unwell   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: NNI follow up received.  Pt stated has already submitted the forms
swelling at injection site, rash at injection site and several other places on body - with itching and burning, wheezing, itchy eyes, heart palpitations
Injection site warm to touch pain/soreness from wrist to shoulder - patient cannot lift arm without pain.
Pt given Influenza, Yellow Fever, and Oral Typhoid on same day. Oral Typhoid course completed 11/20/14. Ten days after course completion pt developed hives on feet and lower legs. Took BENADRYL and ZYRTEC and CLARITIN. Hives came and went several times over a weeks time.
multiple sclerosis; Back pain; started having fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (multiple sclerosis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (started having fever) and FATIGUE (tiredness). On an unknown date, the patient experienced MULTIPLE SCLEROSIS (multiple sclerosis) (seriousness criterion medically significant) and BACK PAIN (Back pain). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Back pain, at an unspecified dose and frequency. At the time of the report, MULTIPLE SCLEROSIS (multiple sclerosis) outcome was unknown and BACK PAIN (Back pain), PYREXIA (started having fever) and FATIGUE (tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (High) 99.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking steroids for multiple sclerosis.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Significant Follow up received on 15 Jul 2021: Event information updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Allergic reaction, throat closing, hoarseness, a few hives in mouth/tongue, headed to emergency room for treatment
Redness, swelling and tightening of the Lt deltoid.  No pain per patient.
Patient received her vaccination shot on a Sunday, then by Tuesday she noticed a red circle around the injection site so she drew a border around it to measure if it grows. It did not. It was slightly itchy and hurt when pressure was applied on it. She did not visit a hospital or administer any treatment but spoke to a healthcare provider. By Saturday, the mark was gone.