chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  The patient received two doses of Pfizer COVID 19 Vaccine in April 2021 and Jan 2022. The patient tested positive for COVID 19 on 12 Jan 2022. The patient was admitted to a community hospital with dizziness and confusion due to COVID 19. The patient left the facility against medical advice and ended up admitted to the hospital on 19 Jan 2022 with covid pneumonia. The patient was treated with dexamethasone and discharged on 1 February 2022 in stable condition.
This spontaneous report was received from a certified medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical histories or concurrent conditions were not provided. In 2015, reported as ranging 01-MAY-2015 through 31-AUG-2015, the patients were vaccinated with improperly stored doses of GARDASIL, lot # K008931, expiration date: 04-MAR-2017 (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
complaints of right deltoid pain and swelling secondary to vaccination. States she had influenza, meningocco and pneumococco vaccination on 11/18/19 from ID doctor?s office ? 2 shots in her right deltoid, and 1 shot in her left deltoid.  Skin: Skin is warm and dry. There is erythema (patches of erythematous hives noted on right deltoid area; tenderness to palpation.).
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. No relevant medical history of the patient was reported. On an unknown date the patient was vaccinated with dose 2 RECOMBIVAX HB 2.5 microgram/0.5 ml injection (lot number, expiration date and route of administration were not reported, Thimerosal Content was not specified). It was reported that the patient received her RECOMBIVAX HB injection 4 months after her first dose of RECOMBIVAX HB. There were no concomitant medications reported. There were no adverse effects reported. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
First symptom was dizziness and nausea. Then, immediately began sweating profusely . Then began seeing spots that distorted her vision. Immediate pain in the ears, which felt as is the ears were very swollen and inflamed. It was difficult to talk because talking caused pain in the ears. Severe headache. Obviously her anxiety level escalated.   We immediately found wet paper towels to place on her forehead and back of the neck to cool her. I found a hair tie and tied her hair up off her neck to keep her as cool as possible. She was sweating so much she soaked her t-shirt and was pouring sweat down her face, neck and body. We also moved patient from the chair, and placed her on the floor of the pharmacy, leaning against the wall with her legs stretched out.  As a type 1 diabetic, the obvious concern was blood sugar during this reaction. Patient wears an insulin pump and Dexcom continuous glucose monitor. I was able to read her blood sugar levels during all the reaction time. Her blood sugar level spiked up. It then began to drop after a few minutes. I had an apple juice, and gave her the 15 carb apple juice.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. From February 2013 to April 2013, the patients were vaccinated with doses of VARIVAX (merck) (dose and lot # were not reported) that were exposed to multiple excursions and stability information was undetermined. Concomitant therapy was not reported. Doses of VARIVAX (merck) were exposed to temperatures of 12F for 5.5 hours, 11F for 5.5 hours, 10.5F for 5 hours, 11F for 3 hours, 11.5F for 2 hours, 11.5F for 2.5 hours, 11F for 2.5 hours, 11F for 2.5 hours, 10.5F for 2.5 hours, 10.5F for 3 hours, 10.5F for 2.5 hours, 10.5F for 2.5 hours, 10.5F for 3 hours, 10.5F for 3 hours, 10.5F for 2 hours, 11.5F for 2.5 hours, 10.5F for 2.5 hours, 7.5F for 2 hours, 10F for 2.5 hours, 8.5F for 1.5 hours, 9.5F for 1.5 hours, 9.5F for 2 hours, 10F for 1.5 hours, 10F for 2 hours, 10.5F for 2 hours, 10.5F for 2.5 hours, 11.5F for 2.5 hours, 11.5F for 2 hours, 11F for 2 hours, 11.5F for 2.5 hours, 11.5F for 2 hours, 9F for 2 hours, 8F for 1.5 hours, 9F for 2 hours, 9.5F for 1.5 hours, 12F for 1.5 hours, 9F for 2 hours, 11.5F for 2.5 hours, 9.5F for 1.5 hours, 9.5F for 2 hours, 11.5F for 2 hours, 12F for 2 hours, 11.5F for 2 hours, 12.5F for 2 hours, 11.5F for 5 hours, 11.5F for 2 hours, 12.5F for 2 hours, 12.5F for 5 hours, 12F for 5 hours, 11.5F for 2 hours, 11.5F for 4 hours, 11F for 1.5 hours, 10.5F for 2 hours, 15.5F for 3 hours, 9.5F for 2 hours, 10.5F for 2 hours, 11.5F for 3 hours, 12.5F for 2 hours, then 12F for 1.5 hours. No adverse effects was reported. This case is linked to MARRS# 1401USA006142 by the same reporter. Additional information has been requested.
Approx. 16 hrs after injection ptn. began with itchy red swollen warm rash over injection site. Approx 6"x8".
On Friday, Nov. 19, 2021 I was sent by my ARNP to the medical center. They diagnosed cellulitis, adult lymphadenopathy, due to severe swelling under and to the front of the right arm (and above right breast) and hardness and swelling at the injection site.
No adverse events occurred to client during or after vaccines. Yellow Fever vaccine was accidentally reconstituted with incorrect diulent (sterile water). Sanofi has been contact for further instruction and client has been notified. Client does not report any adverse effects or reactions.
Headache, Arthralgia, NauseaVomiting, HA, stiff neck, nausea, fatigue Narrative:
CVA- 4 BLOCKAGES IN SEPARATE LOBES ON LEFT SIDE OF BRAIN, OCCURRED IN TEMPORAL, THALAMUS, OCCIPITAL LOBES HAS EXTREME WEAKNESS ON THE RIGHT SIDE OF BODY, UNABLE TO USE RIGHT ARM AT TIME OF SUBMISSION, CAN MOVE RIGHT LEG MINIMALLY, CAN STAND WITH ASSISTANCE, SEVERE APHASIA
After a couple of week of being short of breath, I started monitoring my heart rate and my blood oxygen levels, on 11/11/2022 my oxygen level was staying between 82-96 and my pulse rate I could not get under 100 beats per minute. So I went tot he nearest emergency room, I had extensive blood work done, EKG, and the Dr. came in and advised that I had multiple blood clots in both of my lungs. I was admitted in the hospital where I underwent heparin therapy. I stopped the therapy on Sunday 11/13/2022 and they put me ELIQUIS, and I was discharged from the hospital at that time. I am now home recovering, my heart rate has come down, but I am still short of breath.
0.2 mL Pediatric formulation Pfizer dose erroneously administered to 12-year-old who should have received 0.3 mL of Adult/Adolescent formulation Pfizer.
Soreness in the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) 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 06-Jan-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 PAIN IN EXTREMITY (Soreness in the arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication was not provided by reporter. Treatment information not provided.   This case was linked to MOD-2021-021769 (Patient Link).
5/9/21 diagnosed with thrombus of proximal portal vein and in the splenic vein; 5/9/21 diagnosed with thrombus of proximal portal vein and in the splenic vein; Anemia diagnosed on 5/9/21; This is a spontaneous report from a contactable consumer (the patient). A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204) via an unspecified route of administration in left arm on 17Mar2021 at age of 48-year-old at single dose for COVID-19 immunisation. Medical history included known allergies: Azythromicine. Concomitant medication (within 2 weeks of vaccination) included ibuprofen (ADVIL 12 HOUR) taken for an unspecified indication from an unspecified date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202) via an unspecified route of administration in left arm on 24Feb2021 at age of 48-year-old for COVID-19 immunisation. 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. Nasal swab was negative on 09May2021. On 09May2021, the patient was diagnosed with thrombus of proximal portal vein and in the splenic vein. No prior history of blood disorder or blood clots (the events onset date reported as "06May2021", pending clarification). The events were serious with seriousness criteria of "hospitalized". The events resulted in emergency room/department or urgent care. Treatment received for the events included Heparin. It also reported anemia diagnosed on 09May2021. The outcome of the events was not recovered.
On 2/16/00, pt here w/rxn to TD given on 2/13/00 to L/arm. Area swollen, warm to touch. Area 10cm x 6cm, area outline. To f/u if sob, fever or n/v. Warm compresses.
45-50 heart rate, dizziness, lightheaded, aches and pains, numb toes, headache, pins and needles.
Nausea; Diarrhea; Kind of not feeling good; Throwing up; This is a spontaneous report received from a contactable consumer (patient's daughter). A 91-year-old (also reported as 92-year-old) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), intramuscular on the right arm, on 25Jan2021 19:00, at single dose, to prevent covid/COVID-19 immunization. There were no medical history and concomitant medications. It was reported that the patient had the first shot of the vaccine on 25Jan2021 at 19:00 (yesterday). The patient was surprised that the shot did not hurt going in and she was not having any pain in the arm. On 26Jan2021 (this morning), the patient was experiencing nausea, diarrhea, was throwing up and was feeling kind of not good. The patient stated that the side effects were ongoing. No treatment was given for the events. The outcome of the events was not resolved.  Information about batch/lot number has been requested.
Awoke at 3am with headache at base of skull (rates 7 on 0-10 scale) and neck soreness.  Reported decreesed Range of Motion with head side to side movement.  Tender with moving head side to side.  Reports tenderness behind ears bilateral with increased tenderness on the left side.  Reports referred pain to the left ear canal.  General tenderness/soreness shoulder blades and up to neck. Rates 4 on 0-10 scale.  Reports feeling better with warm towel around neck.  Reports headache is a 1 on 0-10 scale at 9am today (10/14/10) Reports increase fatigue this am.  Reports approximately 5 years ago feeling general malaise for approx 2 days from flu shot.
Cellulitis (L) upper arm.. injection site (L) deltoid onset of redness, swelling warmth within 1 day of injection.
Awoke with severe chills, low grade fever (100.1), muscle aches and headache at 1:00 AM. Took two Tylenol every 4-6 hours for the following 10 hours. Symptoms did not disappear until 11/09/2014.
Dizziness for days after shot leading up to 4/6/21 , on 4/6/21 passed out unconscious in the shower.  911 called takin by ambulance to ER. Admitted for 4 days, all testing was negative.
Initial unsolicited report received from a nurse via other company (Merck) on 09-May-2016. This case involves a 16-year-old female patient who was vaccinated with a dose of Fluzone, a dose of MENACTRA, a dose of H1N1 vaccine, a dose of BOOSTRIX (other manufacturer, batch number, expiry date, route and site of administration: not reported for all the vaccines) and a second dose of Varivax (Other manufacturer, batch number: 0675AA, expiry date, route and site of administration: not reported) on 12-Oct-2011. Patient's pertinent medical history included hirsutism. Patients drug reactions/ allergies was reported as none. Concomitant medications were not reported. The patient was previously vaccinated with Varivax on 13-Sep-2000 (details not reported). On an unspecified date, following the vaccination, the patients had shingles three times. On an unspecified date, the patient went to see a physician. On 28-Mar-2016, blood titer was performed and the patient was found to be negative for varicella antibodies. The patients received corrective treatment with Valtrex for shingles outbreak. On an unspecified date, the patients recovered from each shingles outbreak. (It was also reported that the "patient's present status was unspecified"). List of documents held by sender: none.
Patient complained oof transient  light headedness. Vital signs were taken, everything within normal limits. patient laid down in medical station for 15 minutes. patient felt fine and went home.
4 knots on his right arm where he was injected,; keeps him up at night; arm is itchy; arm is red; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (4 knots on his right arm where he was injected,), INSOMNIA (keeps him up at night), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (arm is red) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced SWELLING (4 knots on his right arm where he was injected,), INSOMNIA (keeps him up at night), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (arm is red). At the time of the report, SWELLING (4 knots on his right arm where he was injected,), INSOMNIA (keeps him up at night), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (arm is red) outcome was unknown.            TCR information provided that patient used alcohol to stop itchiness. Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines were not reported.   This case was linked to INC.-MOD-2021-079227 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: TCR added on 20 May 2021 and does not get any additional contact information; Sender's Comments:  INC.-MOD-2021-079227: 1st dose.
Day after shot, noticed injection site was inflamed only under bandaid cotton. Same day removed bandaid to shower, hot water on injection site hurt alot. The follow week the skin at injection site followed sunburn like effects. Small amount of boiling, less them 1cm in size, hurt to touch, then lesseded. Skin then peeled/flaked at injection site. 3 weeks after, site still dark in color. no peeling, or pain.
From telephone contact received at manufacturer on 11/04/02, it was reported that a 79 year old female pt was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0882AA) in the left arm on 10/19/02.  Two days after the vaccination, on 10/21/02, the pt complained of pain in her left arm. She was seen in her MD office on 11/04/02.  Her entire arm aches from her shoulder to her fingers. Treatment prescribed with Ibuprofen 800mg three times a day for 10 days.
Tremors and increased altered mental status. Started 2 days after booster shot. Patient was admitted to hospital several times after booster for pneumonia and was treated for that. Tremors/jerking have been persistent since then. Medications have been reviewed by doctor and adjusted to rule out other causes for tremors.
This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 07-SEP-2016, the patient was inadvertently vaccinated with an expired dose of (Oka-Merck) PROQUAD lot # L007230 with an expiration date 03-SEP-2016 (dose and route of administration were not reported). No adverse effect was reported. Product quality complaint PPQC) was not involved. Additional information has been requested.
DEATH; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that his little brother got the vaccine and on an unspecified date, the patient died from it. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211124581-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). In July 2022, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  The patient received booster dose of Moderna COVID-19 vaccine.  Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event of rheumatoid arthritis flare up with Moderna COVID-19 vaccine was reported as possible. The reporter's causality for the event of rheumatoid arthritis flare up with Humira (adalimumab) was no reasonable possibility (Not Related).  Treatment information was not provided.  Company comment: This spontaneous case concerns a 65-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) AESI event of Rheumatoid arthritis (rheumatoid arthritis flare up) which occurred after receiving a booster dose of the mRNA-1273 vaccine in the COVID-19 vaccination series and Co-suspect product of non-company product ADALIMUMAB (HUMIRA). Latency cannot be assessed since vaccination date was not disclosed. No additional information is available regarding diagnostic work-up to support the current diagnosis, concomitant medication and treatment received. The event outcome was resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 65-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) AESI event of Rheumatoid arthritis (rheumatoid arthritis flare up) which occurred after receiving a booster dose of the mRNA-1273 vaccine in the COVID-19 vaccination series and Co-suspect product of non-company product ADALIMUMAB (HUMIRA). Latency cannot be assessed since vaccination date was not disclosed. No additional information is available regarding diagnostic work-up to support the current diagnosis, concomitant medication and treatment received. The event outcome was resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Flu like symptoms including extreme joint pain and achiness, headache which was significant often on, slight fever, a little nausea and decreased appetite.
PATIENT'S WIFE CALLED - PATIENT'S UPPER ARM IS RED AND THERE ARE BLISTERS; HIS ARM IS SWOLLEN AND THERE ARE BUMPS - HE IS NOT HAVING TROUBLE BREATHING - RECOMMENDED BENADRYL - ALSO IF PATIENT IS HAVING TROUBLE BREATHING GO TO THE ER AND CONTACT HIS DOCTOR
This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2, dose 2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Have been to 5 doctors since receiving the Pfizer Covid vaccine series (2 shots). The patient stated she had a bad reaction to first dose and 'horrendous' reaction to second dose. She developed 'tremendous' ear pain and unable to see straight ahead. The patient stated this has been ongoing for over 3 weeks. Also reported that this is day 16 and still no change to her eyes and ears. Stated she developed a bad headache and was throwing up after the 2nd dose. She was unable to look straight without feeling dizzy. Had seen neurologists and had multiple scans; will be having an MRI today. Stated she has no bleeding in the brain. This had affected her daily life; she was unable to work or drive. Took migraine medicine initially. The patient underwent lab tests and procedures which included multiple scans: no bleeding in the brain on an unknown date. The outcome of the events ear pain and unable to see straight ahead was not recovered. The outcome of other event was unknown. The events were reported as non-serious by reporter.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
patient reports tenderness at site of injection. slight redness at area. denies shortness of breath
Urticaria. 10/08/18 Patient presents with rash, child presented to the office for a flu shot. Received left arm standard flu vaccine. Within a couple minutes her left dorsal hand showed acute urticaria. No other symptoms. Patient accompanied by mother.
worsening of ongoing allergic urticaria resulting from previous immunization treated with immunotherapy (cyclosporine) needing additional antihistamines to manage symptoms
approximately one week of receiving the J & J vaccine, I developed symptoms which when diagnosed a couple of weeks later turned out to be acute Myleoid leukemia