chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 83-year-old male patient received bnt162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6203), in left arm and on 31Mar2021 as dose 2, single (Lot number: EP7534) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "COPD" (unspecified if ongoing), notes: COPD; "Known allergies: No/egg" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
positive line on rapid antigen test Day 13 after initial symptoms; positive line on rapid antigen test Day 13 after initial symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 4 (booster), single (Lot number: FK9895) at the age of 74 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stage 3 kidney disease" (unspecified if ongoing); "AFib" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "not recovered" and all described as "positive line on rapid antigen test Day 13 after initial symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (05May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Course: Patient taken Other medication in 2 weeks was Pravastatin. Patient did not had any known allergies.Anti viral details:COVID 19 Treatment,Pfizer Paxlovid, Treatment start date 26Apr2022, stop date 20Apr2022.  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA 7 small itchy marks/ bumps on left wrist progressively worsening to swelling, warmth surrounding left wrist (day 6). 2 red marks above left clavicle and 1 red mark on right eyelid (day 5).
The wrong dose was given of the Pfizer 5-11years covid vaccine.  The dose given was 0.3 ml instead of 0.2 ml.
Pt is 96 years of age; admitted on 8/6/2021 for c/o upper respiratory cold symptoms and cough, and sore throat.  Pt is currently still an inpatient.
Information has been received from a 74 year old female who in 2008, "a few months ago" was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On an unknown date, the patient developed gout after receiving ZOSTAVAX (Oka/Merck). The patient was not sure if the symptom was caused by ZOSTAVAX (Oka/Merck). The patient's outcome was unknown. It was unspecified if the patient sought medical attention. No further information is available.
Patient received 1st dose on 3/14/21 at mass vaccine clinic. Patient was confused about 28 days between doses and registered for another appointment 4 days after 1st dose was administered. When asked if Patient had received COVID-19 vaccine before or any vaccines 14 days prior, patient stated no to both answers. Patient was given 2nd dose 4 days after receiving her 1st dose. When nurse handed patient her vaccine record card patient stated she already had one. Lead doctor was contacted immediately and was able to speak to the patient on site.
Pfizer-BioNTech COVID-19 Vaccine EUA. The area below my right arm pit is swollen and my right arm hurts when I raise it (both in the place where I received the shot and in the swollen area under my right arm pit). I've tried ice and allergy medicine - sometimes that minimizes the pain but the swelling is still there.
Fever of 104 by the morning of November 2nd (1 day after the shot). Rash over whole body classified as a symptom of mono. Diagnosis of Mono by hospital despite having a negative mono test from doctor's office. Dehydration. No appetite. Sore throat. Suppressed immune system. Multiple sinus infections and respiratory infections. Constant cough. High CRP and ANA lab tests. Constant rash around eyes that spreads if not controlled with high strength steroid creams. Rash on the body in patches of very dry skin. I haven't gotten well since the shot and it is now February 6th.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (still have the fatigue) and FATIGUE (After 3/28 2nd dose, 5 days later I again had extreme fatigue times 10/can describe as chemo fatigue which I had after chemotherapy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced FATIGUE (still have the fatigue). On an unknown date, the patient experienced FATIGUE (After 3/28 2nd dose, 5 days later I again had extreme fatigue times 10/can describe as chemo fatigue which I had after chemotherapy). At the time of the report, FATIGUE (still have the fatigue) and FATIGUE (After 3/28 2nd dose, 5 days later I again had extreme fatigue times 10/can describe as chemo fatigue which I had after chemotherapy) outcome was unknown. No concomitant medication provided. No treatment medication provided. Reporter did not allow further contact.
Patient received 1st dose in January. Patient was advised by her provider to restart the series and was adamant to get the 3rd vaccine.
subsequent to receiving vax, the pt developed hives. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPV.
Patient said they experienced a migraine after being vaccinated and also reported they are prone to migraines
The injection site seems to be high compared to other vaccines ever given. I have lost all range of motion in my shoulder and am in severe pain.  If the shot missed the deltoid muscle, it could bother me for a long time. Will be calling an orthopedic specialist tomorrow.
Information has been received from a health professional concerning a 14 year old female with depression who on 14-FEB-2008 was vaccinated with a second GARDASIL (lot# 659657/1487U) injection. Concomitant therapy included CELEXA and LOESTRIN. On 15-FEB-2008 the patient developed fever. On 16-FEB-2008 the patient developed hives. On 19-FEB-2008 the patient had swelling at the injection site about the "size of a fist". On 20-FEB-2008 the patient came into the office and only had a "pin head size papular at the injection site". All other symptoms were gone. At the time of reporting the patient had recovered. It was reported that the patient had no reaction to the first dose and the patient will not be receiving the third dose. No further information was provided. Additional information has been requested.
Body on fire went to emergency rm - after 2 hrs blisters all over arms and crotch/legs! Admitted in isolation for what they thought was Steven Johnson Syndrome - Blisters for 3 weeks and still have a skin issue.
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other Health Professional (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiry date unknown, via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that the patient got the first dose of vaccine 28Dec2020 and tested positive for COVID on 04Jan2021 but mentioned that her quarantine period is already over. She stated that she is scheduled to get the 2nd dose of the vaccine tomorrow, but wants to know if she should still proceed to receiving it. The patient underwent lab tests and procedures which included covid: positive on 04Jan2021. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (7 days in this case). However, a causal relationship between event "tested positive for Covid " (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.
presents emergency department today after having fallen at home.  He reports that he fell in the bathroom and slipped on some water or urine that was on the floor and fell into a heap on the floor.  He reports he did not hit his head.  He denies loss of consciousness.  He did not experience any tunneling of vision.  No history of seizures.  No urinary incontinence during the episode.   He denies pain anywhere currently.  He reports he has been feeling weaker in the last day
Pt recv vax on 1/29/99; 24 hr post vax pt exp red hives on waist & legs
Pt was given adult Td spoke with mom 06/08/05- soreness, bilateral to legs, no analgesics needed.
Approx 15 minutes after vaccine given, pt while standing became limp and fell to ground. Father reports eyes rolling into back of head. Pt seemed dazed for about a minute then started crying. Vital signs were normal, pt responsive and able to answer to name
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Pt experienced dizziness, fatigue; general malaise for 3-4 days post vaccine. Pt noticed rash, erythema, itchiness at the injection site.
Post 1st vax in April 1999 and 2nd in May 1999 pt developed the following adverse reactions. In October after training for my 4th marathon, I suddenly became extremely fatigue and sluggish. I could no longer physically run, as if my legs were knocked from under me. I then developed severe joint and muscle pain throughout my body in January 2000. My auto immune system was also greatly affected. I developed full blown Raynaud's Disease in my hands in March 2000. There has been total lack of circulation in my hands and severe cracking of my finger tips. I have never felt so fatigued and depressed over no longer being able to exercise. There has been no improvement even though i have been on anti-inflamatories since May 2000 and antibiotics since October 2000.
TD given 11JUN91 later that day  & on 12JUN91 fever, shaking, et chills;
Patient with Hodking's lymphoma (bendamustine and brentuximab since 4/28/21), admitted for subacute onset of SOB and hypoxia w/ CT showing bilateral pulmonary opacities concerning for pneumonitis or infection.
headache; Numbness in arm; Joint pain; fatigue; fever; body aches; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program. A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0180), intramuscular, administered in left arm on 20Jun2021 (at an unspecified age) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were none. Prior vaccinations were none. The patient experienced headache (hospitalization) on 21Jun2021, fever, body aches on 21Jun2021, Numbness in arm, Joint pain, fatigue on 22Jun2021. The patient underwent lab tests and procedures which included on 20Jul2021: Blood work: high sugar level, computerised tomogram (CT): normal, echoencephalogram (Echo): negative, electrocardiogram (EKG): negative, magnetic resonance imaging (MRI): normal, Covid-test: negative. The outcome of the events headache, numbness in arm, Joint pain, fatigue was not recovered, outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
The pt's younger sibling had the chicken pox 2 weeks prior to the pt breaking out. At present she has 12 lesions.
Abdominal rash started 2 weeks out of first shot.   5 days out from second shot, rash came back and continued to spend across entire body - tights, abdomen, back, arms, ankles, lets.  Extremely itchy and not responsive to antihistamines.   Just started prednisone for relief.
Nerve pain/ Pins and needles in legs, arms, stomach and scalp began on 12/4. Got worse on 12/5 but has not seemed medical assistance unless advised
Two and a half to Three weeks later  my gallbladder became inflamed had to be removed, then two weeks later toes presented with blisters, burning, discoloration of toes, numbness, chronic pain.
No other AE was reported; The first dose was administered on 10-MAY-2021 and the second dose was administered on 28-MAY-2021; This spontaneous report was received from a certified medical assistant (C.M.A), referring to a 38-year-old female patient. No information regarding medical history or concomitant medications was provided.  On 10-MAY-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and on 28-MAY-2021 with the second dose, both of 0.5 milliliter (ml) as prophylaxis (formulations, concentrations, anatomical sites of vaccination, lot numbers and expiration dates were not reported) (inappropriate schedule of product administration). No additional adverse event was reported.
received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs; received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs; received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs), VACCINATION SITE PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs) and ARTHRALGIA (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs). On 19-Nov-2021, the patient experienced VACCINATION SITE PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs) and ARTHRALGIA (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs). At the time of the report, PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs), VACCINATION SITE PAIN (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs) and ARTHRALGIA (received booster dose of vaccine and arm got sore from the needle site to elbow, pain throbs) had not resolved.            No concomitant and treatment medications were reported.   This case was linked to MOD-2021-398577 (Patient Link).
Initial report received from a consumer on 04 October 2010. A 25-year-old female patient, with a history of a heart murmur as a child and an allergy to bee stings, received on 30 September 2010 a left deltoid intramuscular injection (prefilled syringe) of FLUZONE, lot number unknown. The patient was pregnant and takes prenatal vitamins. She had no illness at the time of vaccination and had no other vaccinations within 4 weeks prior to FLUZONE. She received a flu vaccine annually. The patient's gestational weeks at the time of vaccination was not reported. The patient's date of last menstrual period was 23 June 2010 and her estimated date of delivery was reported as 30 March 2011. On 01 October 2010, the patient noticed her arm was swollen, red and itchy at the injection site which extended down toward the elbow. The area also turned ecchymotic. The patient was still in the process of resolving but she was improving. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 18 November 2010. The reporter reviewed and had no additional information to provide. Follow-up information was received 16 December 2010 from a health care professional. The vaccine received by the patient was FLUZONE, lot number U3564AA. The patient was recovered as of their prenatal visit on 28 October 2010 and the patient had no complaints at that time. According to the reporter, the patient's current pregnancy was uneventful and they had not experienced any pregnancy complications or adverse events since receiving FLUZONE. Follow-up information received from a nurse on 08 April 2011. The patient delivered via C-section at 39 weeks gestation on 25 March 2011. She delivered a single live baby described as being "fine". The baby had no congenital anomalies. The patient did not experience any adverse events since vaccination on 30 September 2010; and she had no complications of pregnancy, labor and / or delivery. No further information is expected. Documents held by sender: None.
Vaccine was initially stored in refrigerator on 11-Jan-2022 and administered on 27-Apr-2022; Expired vaccine was administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 11-Jan-2022 and administered on 27-Apr-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 11-Jan-2022 and administered on 27-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 11-Jan-2022 and administered on 27-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  A pharmacist, the vaccine coordinator in their health care facility reported that they inadvertently administered expired dose of the Moderna COVID-19 vaccine. Date the vial was initially stored in the refrigerator was on 11-Jan-2022, which meant that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. Patient received 2nd booster dose on 27-Apr-2022 and not reported adverse reaction to the HCP's knowledge.  No treatment medications were provided by the reporter.
Extreme Body Aches, headache . . . . low-grade fever (99.7 was highest recorded
Pt presents 3 days after flu vaccine with swelling & itching to (L) arm approx 3" below injection site. No fever. Arm warm to touch.
To Right arm pt described redness at the site that developed 1 day after receiving the vaccine. 2 days later pt developed a rash/blotchy red area from the top of shoulder to mid upper arm. Pt stated it was sore. Pt developed a 101 degreee F temp.
First shot on 04.02.21,...injection hurt (may have been result of person administering it).  sore arm at injection side Second shot on 04.30.21...injection itself not  painful (person good at administering). , felt fine until 24 hours later.  Hit me like a ton of bricks all of a sudden.  Body aches everywhere, freezing cold (had heat blasting), fever all night of about 101.8.  Took NyQuil with acetaminophen.  Fever broke by 9:00am in morning.  Still very achy.
Walks into office stating that he needs his scheduled shots before school. Mother was called when explained that she needed to sign consent and arrives shortly after call. Consent given and signed.  VIS given with no questions or concerns at this time. Injection given in left deltoid without incident or difficulty at 12:05pm. Pt. walks 25 feet to from back office to reception area and sits down to wait recommended 15 minutes. At 12:09pm, pt. becomes diaphoretic and less responsive but remains in sitted position with mother be side. Pt. does answer questions but is slow to respond.  Cool cloth applied to back of neck and fan turned to blow on pt. Pt. also complains of headache.  BP checked 102/76 with heart rate of 77. Within 20 minutes pt. alert, no longer diaphoretic and alert and oriented x 3, answers questions without difficulty. BP rechecked 104/72, pulse 78, respirations 16, Temp 97.6 and O2 sat 99% on room air. At 12:40 pm, pt. denies lightheadedness or dizziness, stands up and walks 10 feet with steady gait noted. Sat down for a couple of minutes and then leaves ambulatory in stable condition accompanied by this RN and pt's mother to private vehicle.
gave  Flu, aduvanted 65+ to a 35 ylo patient. No adverse signs or symptoms noted.