chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: COVID infection following COVID vaccine series 01/16, Pfizer dose #1 02/06, Pfizer, dose #2 10/08 ESR: 41 10/08 BNP: 243.6 10/08 COVID swab, result: detected 10/08 PT/INR: 12.8/1.14 10/08 pt cc: chest pain exposure: unknown 10/08 pt admit to medicine cc: "sharp  non-radiating CP" dx: AECHF, COVID+ LOS: 4 days 10/08 ABG: i-pH 7.41, i-PCo2 33.1 i-PO2 77, i-HC03 21.0 10/08 TROPONIN I: 0.198 10/08 CTA PE impression: 1. Negative for pulmonary embolus. 2. nonspecific bilateral lower lobe and RIGHT middle lobe slight patchy infiltrates with large, RIGHT greater than LEFT pleural effusions. Correlate for potential pulmonary edema. 3. New and enlarging upper mediastinal  lymph nodes now measure up to 15 mm in short axis. 10/09 CXR Impression: Slightly decreased mild pulmonary vascular congestion with associated cardiomegaly. 10/08 CXR impression: Negative for pulmonary embolus. 2. Nonspecific bilateral lower lobe and RIGHT middle lobe slight patchy infiltrates with large, RIGHT greater than LEFT pleural effusions. Correlate for potential edema. 3. New and enlarging upper mediastinal lymph nodes now measure up to 15 mm in short axis. 10/09 SARS-COV2IIgG: 0.67 10/09 procalcitonin: 0.09 10/09 ESR: 43 10/09 FIBRINOGEN: 469 10/09 DDIMER:  0.81 10/09 SARS-COV-2 Variant Sequencing results: pending 10/10 FIBRINOGEN: 480 10/10 DDIMER: 0.42 10/10 ESR: 58 10/11 FIBRINOGEN: 449 10/11 DDIMER: 0.45 10/11 ESR: 33 10/12 COVID swab, result: NOT detected
tooth extracted on Tuesday; This is a spontaneous report from a Pfizer sponsored program. A Contactable female consumer reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 06Feb2021, as a single dose for COVID-19 immunisation. The patient's medical history included knee replacement. Concomitant medications reported was amoxicillin (manufacturer unknown), for knee replacement. The caller ask if she could take her antibiotics that was prescribed to her because she will be having her tooth extracted on Tuesday. She had her first dose of the COVID-19 vaccine last Saturday. The reported event was considered as non-serious by the health authority. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested
Approximately 3 minutes after receiving the shot I began to see white spots in my eyes, then my face felt numb (cheeks especially). My chest felt tight and my breathing was as if I was running.  The nurses from clinic called 911. EMS checked my vitals and all BP and O2 levels were normal.  The symptoms eventually went away within an hour or so. Later that evening around 5:30PM I began to have muscle aches, headache and had a fever of 101. The next day the symptoms were gone.
Within 6 hours, pain at site of injection, joint and body aches and pains, fatigue, headache, mild nausea, flu-like symptoms. Around 12 hours post shot, addition of severe chills for 2 hours.. Morning fever temperature of 101.7. Daytime range from 101.3 F -103.1 F. Sent to company urgent care for more thorough eval after calling employee health the day after vaccination.
Low grade fever (99) , chills, headache, right arm pain (severe) general malaise, fatigue, poor concentration, joint pain (all joints), burning eyes, kidney pain (both but more so on right side than left.
Day of vaccination, felt some anxiety but no symptoms aside from sore arm after injection. 6 days post-vaccination - began to feel increased anxiety, nausea, GI upset/diarrhea, tingling and numbness in limbs, fatigue, headaches, and panic attacks with no prior history. 9 days post vaccination, symptoms increase and large delayed skin reaction at injection site, continued unprompted panic attacks with all over body symptoms including elevated heart rate, nausea, headaches, tingling and numbness in limbs. Symptoms are slightly more mild 18 days out, but still present. ER and PCP visit present no findings with basic tests.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild chronic seasonal allergies" (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 Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid took from  27Sep2023 to 01Oct2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Gave patient vaccine at 3pm. Observed patient from 3-3:20pm. Pt said she was fine but came back at 3:25pm stating she felt like ants were crawling up & down her arms & legs; it originated at site of injection. I monitored her from 3:25 pm - 3:45 pm; gave her water. She said that it all went away at 3:45 except for at the injection site. She never had difficulty breathing or any other s/sx = At 3:50pm I gave her - diphenhydramine 25 (see back) capsule and monitored her until 4 pm. Pt said she felt fine except for pain at injection site. I sent her home w/another diphenhydramine 25 mg capsule: told her to take it in 8 hours if the reaction got worse or came back at all. I recommended that if she felt uncomfortable at all, the symptoms worsened and/or she developed elevated heart rate or chest pain or difficulty breathing, to seek medical attention immediately at ER. Patient's daughter in law was driving her. The vial w/ the 1 capsule of diphenhydramine had written on it "if itching still occurs in 8 hours, take capsule and if s/sx worsened or she didn't feel well to see ER."
Engerix-B administered instead of Twinrix second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 38-year-old female patient who received HBV (Engerix B) (batch number 79S54, expiry date 04-APR-2022) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 26-JUN-2023, the patient received Engerix B. On 26-JUN-2023, an unknown time after receiving Engerix B, the patient experienced wrong vaccine administered (Verbatim: Engerix-B administered instead of Twinrix second dose). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 27-Jun-2023 The nurse reported that the patient was intended vaccine was second dose of Twinrix. The reporter consented to follow-up via email. The patient received Engerix-B by mistake, which led to wrong vaccine administered.
1/2AM. Satelite lesions times 2 left lateral upper deltoid and adjacent mild deltoid erythema.
itching nose and had some swelling/welts nose that he could not see but he could feel.   Itchy inflamed and swollen left arm distally   3 days after vaccine had some swelling and itching more proximally on left arm   4 days after had itching and welt right side of jaw.   No shortness of breath No tingling of lips or tongue   No fevers.
Redness, warmth in shoulder and spreading across upper torso. Also implied that she was diagnosed with pneumonia as a result of vaccinations.
Shooting Pain at injection sight on upper right arm (flue vaccine) Continued pain for weeks Burning sensation Limited movement Ice, antinflammatory,  Diagnosed with SIRVA on Oct 29 Began Physical Therapy and steroid injections
pt recvd vax;devel approx 100 chicken pox style lesions;no known exposure to chicken pox;
Patient and family disclosed at the most recent appointment, Jan. 18th, that the patient had significant altered mental status lasting 1-2 weeks after each dose of the vaccine. This included the initial dose, second dose, and most recent, booster dose, in Dec. 2021.
Hospitalized COVID 19 positive weakness, metabolic encephalopathy, acute hypoxic respiratory failure, NSTEMI type 2 without chest pain.
I tested positive for Covid-19 and I had a fever, congestion, coughing, sore throat and exhaustion for about one week. I lost my sense of smell and taste during that time as well. The loss of smell and taste has continued to this day still. The coughing lasted from August to about 5 days ago (9/24) and the same with the exhaustion.
received diluent only; received diluent only; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2021, the patient received Shingrix. On 30th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient received only diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No additional details were provided. The reported consented to follow up. This case was linked with the case US2021AMR205919, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205919:same reporter
The day after first vaccine, I woke up feeling very sick with a metal taste in my mouth and blurry vision with dizziness that lasted for eight days.  I could only taste metallic for this time period. This only happened after first dose.
Began to itch all over body with back and right shoulder worse. Took 50 mg Benadryl at 7:00, 8:30 and 11:30 PM. Had visible "hives" on back, right shoulder. No fever but did have diarrhea 9x in 6 hours. Continued to take Benadryl for 2 days due to itching and rash.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (8 inch significant rash on arm) and RASH PRURITIC (very itchy, red and irritating rash) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (8 inch significant rash on arm) and RASH PRURITIC (very itchy, red and irritating rash). At the time of the report, RASH (8 inch significant rash on arm) and RASH PRURITIC (very itchy, red and irritating rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-246976, MOD-2021-246976 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow-up received on 05-JUL-2021 : Events updated.
Not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included HEPATITIS B VACCINE (1st dose received in 1st January1988   ).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 21-JUN-2023 The pharmacist reported that a patient received their first dose of a hepatitis B vaccine in January 1998 but did not continue the series and wishes to continue with Twinrix.  The information about the previous vaccine was unknown, but the pharmacist gave partial information about the patient. Till the time of reporting, the patient did not receive 2nd dose of Hepatitis B, which led to incomplete course of vaccination. The reporter consented to follow up.
During the night on January 28, 2023, my nose was congested, and I began to get a sore throat. I could not sleep that night due to the congestion and breathing problems. The symptoms continued the next day. I had a runny nose, a slight headache and body aches. I tested myself for COVID-19 on January 29, 2023, and it was positive. That night I had the same issues so on January 30th, I called my doctor, and she recommended that I take Paxlovid. I started the 5 days on the same date. I did take Tylenol PM on the night of the 30th and 31st. I slept better.  By the 1st of February I was feeling ok. I don't recall having any symptoms on that day. I have recently had a cold but that is gone.
dose 1 3/9/21  Moderna  023M320A dose 2 4/8/21  Moderna 047A21A
Information has been received from a nurse concerning a 5 year old white male who on 02AUG1999 was vaccinated with a dose of varicella virus vaccine live. On 03JUN2003 the patient developed a generalized rash with less than 50 lesions. There was no localization at the injection site and the patient did not have a cough or a fever. Unspecified medical attention was sought. Additional information has been requested.
Headache (moderate to severe), nausea, dizziness, fatigue (moderate to severe), mild joint and muscle discomfort, mild pain at the injection sight.
Fever, Myalgia treated with acetaminophen. Resolved in 24 hrs
This case was reported by a other health professional and described the occurrence of injection site tenderness in a patient who received BOOSTRIX (batch number L7J44, expiry date 31st May 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced injection site tenderness, irradiating pain and diarrhea. On an unknown date, the outcome of the injection site tenderness, irradiating pain and diarrhea were unknown. It was unknown if the reporter considered the injection site tenderness, irradiating pain and diarrhea to be related to BOOSTRIX. Additional information received: Patient who received BST yesterday now has tenderness in the left arm (the arm that she received the BST injection), and pain, and the pain is radiating up the neck, also the patient has diarrhea.
all over red raised rash with burning and severe itching , which cause lots of nervousness. I can provide pictures if needed. i was prescribed Prednisone dose pack/ Hydroxyzine/ triamcinolone acetonide cream/ Zyrtec and Benadryle Then the prednisone was upped to 10mg instead of 5  mg/ along with Aveeno bath soaks
Got a shot. He broke out I shingles/Suspected vaccination failure; Shingles on face around his eyes; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got a shingles shot and he broke out with shingles, on his face around his eyes. They said it was good thing the patient got the shot or it would have been much worse.  The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not given.
Dose was administered two days after their expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered two days after their expiration date) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2022. Concurrent medical conditions included Allergy to antibiotic (Levaquin allergy).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered two days after their expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered two days after their expiration date) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter had been informed that the patient received Moderna vaccine dose several days after their expiration date. The booster Moderna dose was administered 2 days after expiration date.  The Expiration date was 22-Sep-2021 and the booster dose was administered on 24-Sep-2021.  The vaccine arrived on 30-Aug-2021 and was placed in refrigerator and the doses were administered on day 25 after receipt and refrigeration.  No other events were reported by the patient.  No treatment information was provided.   This case was linked to MOD-2022-508128 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Significant follow-up was received: Updated the reporter details and added patient details. Added allergic condition and historical conditions in the patient's medical history and lab test was added. Dose 1 and dose 2 details of the suspect drug was also added.
After 2 weeks of the first shot. The left arm where the injection took place got rashes and swollen. Went to Clinic to get Doctor's advise and treatment. Was given triamcinolone 0.5 % cream to put on affected area to ease the swollen and less itchy.
C/o dizziness and diaphoresis after vaccination. EMS called and take to hospital evaluated and discharged with diagnosis of allergic reaction.
Dizziness, Headache, Fever, arm soreness, double vision, hands/feet tingling, Unbalanced walking, Narrative: Headache Dizzy, Fever, arm soreness, double vision, hands/feet tingling, unbalanced walking, intestinal lining "sloughing"; better today, took ibuprofen and drank fluids, did not seek further medical attention 1/29 follow up-mostly resolved some tingling in hands, lingering diarrhea.
Breakthrough COVID infection. Identified by positive PCR covid-19 detection test conducted at laboratory. Patient displayed mild symptoms including loss of smel; Breakthrough COVID infection. Identified by positive PCR covid-19 detection test conducted; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6205), via intramuscular route of administration in the right arm, on 25Feb2021 (age at the time of vaccination was 38-year-old), as dose 1, single and dose 2 received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6207), via intramuscular route of administration in the right arm, on 17Mar2021, as dose 2, single for COVID-19 Immunization. Medical history was not reported. Concomitant medications included emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and alprazolam (XANAX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had tested for COVID-19 and the result was positive. The patient was breakthrough COVID infection. Identified by positive PCR covid-19 detection test conducted at laboratory. Patient displayed mild symptoms including loss of smell and sinus pressure. On 06Aug2021, the patient underwent lab tests which included positive PCR covid-19 detection test (also reported as: Nasal swab test) conducted at laboratory and the result was obtained as positive. The patient received unspecified treatment by consulting with doctor via phone. The outcome of the event was recovering.   Follow-up attempts are completed. No further information is expected.
Chills, fever, headache, awful aches, nausea for 2 days, 3rd day fever  & headache mostly gone but still body aches & very tired for several more days.
This case was reported by a nurse via call center representative and described the occurrence of seizure in a 16-year-old female patient who received MENVEO (batch number M17075, expiry date July 2019) for prophylaxis. Previously administered products included MENVEO (1st dose received on 27th March 2018). On 27th September 2018, the patient received the 2nd dose of MENVEO (intramuscular) .5 ml. On 28th September 2018, 1 days after receiving MENVEO, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the patient experienced injection site erythema and extra dose administered. On an unknown date, the outcome of the seizure and injection site erythema were recovering/resolving and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the seizure and injection site erythema to be related to MENVEO. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient experienced two seizures following a dose of MENVEO which was administered in error. The HCP stated that the patient received 1st of MENVEO, and also received their 2nd dose in error, which led to extra dose administered.
1415: Pt reported to staff that she felt lightheaded and that her left arm was itching and felt swollen. Pt BP at that time noted to be 110/88, heart rate 92. Redness and edema moving down left arm noted, pt had some redness/rash around injection site. Denied difficulty breathing or constricted throat. 1420: Pt given 50mg IM Diphenhydramine in right deltoid per DPH Nursing Protocol for allergic reaction. At that time, pt BP 116/90, heart rate 86.  1428: Pt reports decreased itching, BP 120/90, HR 82, respirations 16. 1435: BP 122/80, HR 80, respirations 14. 1442: BP 122/82, HR 78, respirations 16. 1450: BP 112/88, HR 72, respirations 14. Pt discharged from service feeling sleepy, but noted decrease in redness and swelling in left arm. Pt is alert and oriented x 3, pt to have husband come pick her up, no other complaints. Pt reported she is not itching and verbalized that she felt "back to normal."