chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the Moderna Bivalent booster for COVID-19 on 10/21/2022. On the evening of 11/28/2022, I had a little bit of a cough, which is unusual for me. My throat was also somewhat scratchy. When I woke up on 11/29/2022, I still had a mild cough. The scratchy throat from the previous evening was gone that morning, but it returned later in the evening. On 11/29/2022, I took a home antigen test and got a strongly positive result. I immediately contacted my doctor, who prescribed me PAXLOVID. He instructed me to wait a little before taking it, because at that point, my symptoms were just a mild cough and a mildly scratchy throat. He thought it would be better to wait until the symptoms worsened before beginning the medication. When I went to bed on 11/29/2022, I had a fever of 99 degrees and was still coughing. When I woke up the morning of 11/30/2022, I had a fever of 100, an aching throat, and a very strong, productive cough. I emailed my doctor and informed him of the situation, and he instructed me to begin the PAXLOVID right away. I then slept for a while and continued coughing. I kept an eye on my oxygen saturation level, and it was 93% at one point that morning. Fortunately, my oxygen saturation level gradually improved throughout the day. When I checked it again on 12/1/2022, it was at 96-97%, and it has stayed at that level ever since. Not only that, but my temperature was normal again. However, my throat still hurt, but the pain was less intense. I took acetaminophen to treat the pain, so I could swallow more easily. Ever since then, my condition has been stable. By 12/2/2022, I felt completely normal again. I took home antigen tests on 12/2/2022 and 12/8/2022 and still got positive results both times. However, the line on the 12/8/2022 test is a bit fainter than the line on the 12/2/2022 test.
Her heart rate high and was fast paced; aggravation from the vaccine went down her arm across her shoulder to her other shoulder and arm; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiry date was not reported), dose 1 via unspecified route of administration on left arm on 24Feb2021 as single dose for COVID-19 immunization. The patient's medical history Diabetes, Triple bypass since 2019 (Ongoing) were reported. The patient concomitant medications were not reported. Reported stated that her first dose was on 24Feb2021. She said that she did not even feel the shot that she had on Wednesday 24Feb2021 and said that by Thursday, the aggravation from the vaccine went down her arm across her shoulder to her other shoulder and arm. It was really strong. On Friday 26Feb2021, her heart started to act up and act wonky. She clarified that her heart rate was high and was fast paced on the pulse ox. She tried to call her primary care physician but could not get a hold of them. She said that she controlled it herself. Caller said that she has had a triple heart bypass in the past. She was due on 24Mar2021 to get her second dose. She said that everyone says that it was worse. With her history of the AFib, was this going to cause undue episode or what is the experiences that have been reported. She said that she never had aggravation that travelled from one arm to her shoulder and across to her other shoulder and arm before with any other vaccine. Caller stated that she took aspirin to treat her heart rate. The patient developed aggravation from the vaccine went down her arm across her shoulder to her other shoulder and arm started on 24Feb2021 and stopped on 25Feb2021 and Her heart rate high and was fast paced start date 26Feb2021 and stopped on 26Feb2021 was updated. The outcome of the event was recovered.   No follow-up attempts are possible. No further information expected.
No adverse event; Dose administered after 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture), PRODUCT STORAGE ERROR (Dose administered after 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingrix (right deltoid) on 08-Mar-2023. Past adverse reactions to the above products included No adverse event with Shingrix.  On 08-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 12 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture), PRODUCT STORAGE ERROR (Dose administered after 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered after 12 hours post puncture).    No concomitant medications were reported.  The patient received 1st dose of Moderna COVID-19 vaccine on 08-Apr-2021, lot number 026A21A and 2nd dose on 05-May-2021, lot number 048B21A.  No treatment medications were reported.
after receiving their vaccine, they have contracted the Covid-19 infection; after receiving their vaccine, they have contracted the Covid-19 infection; This is a spontaneous report from a contactable pharmacist via medical information team. A patient of unspecified age and gender received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), 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. After receiving their vaccine, the patient experienced contracted with the covid-19 infection an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: they have contracted the covid-19 infection. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the events drug ineffective and COVID 19 are possibly related to BNT162B2.
Patient called in 09/24/19 that last night 09/23/19 she was having trouble walking and had to force her legs to move. Is better this morning, but is having some redness and heat on location of both vaccine sites. Patient reports using a cold pack and benadryl.
On going complaints of headache, lethargic, dizziness, vision problems, stomach ache, joint pain, neck ache.
History per a colleague. I was present at time of appt of 2nd COVID vaccination. Decided not to give vaccine given what happened after first COVID vaccine.  Patient with lightheadedness within 1 hour of receiving COVID vaccine #1 (not sure exact timing). Had persistent tachycardia > 150 (? SVT) EMS called. Taken to ED.  ED records not available. Patient remembered being told her BP and HR were too high. She was not admitted. HR since were in the 60-80s.
Narrative: During a large drive thru vaccine event, a pt receiving a covid booster vaccine of 0.25ml had an issue. While administering, orange top needle separated from barrel of syringe and remained in patient's arm as syringe and remained in patient's arm as syringe removed. Appears that at least some of 0.25 ml dose failed to be injected into arm. Of note, this has happened before with these needles. The needles require extra tightening at both her luer lock hub and again at the needle cover. During the 1000+ vaccines prepared by pharmacy this day, this one must have not been extra manually tightened at both parts. It is unknown the amount of vaccine pt did not receive. At this point pt did not experience any harm from this event.
Bit of tough breathing; Stomach problems; pain in the abdomen; slight aches and pain; Discomfort; Aches in his back; Chills; temperature which was only 1 degree above his normal; Aches in his shoulder; Aches in the extremities; achy; body aches; Sweats; Almost like the flu; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Almost like the flu), DYSPNOEA (Bit of tough breathing), ABDOMINAL PAIN UPPER (Stomach problems; pain in the abdomen) and PAIN (slight aches and pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee pain (start/stop date, ongoing details not provided).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Almost like the flu), ABDOMINAL PAIN UPPER (Stomach problems; pain in the abdomen), PAIN (slight aches and pain), DISCOMFORT (Discomfort), BACK PAIN (Aches in his back), CHILLS (Chills), PYREXIA (temperature which was only 1 degree above his normal), ARTHRALGIA (Aches in his shoulder) and MYALGIA (Aches in the extremities; achy; body aches). On an unknown date, the patient experienced DYSPNOEA (Bit of tough breathing). At the time of the report, HYPERHIDROSIS (Sweats), PAIN (slight aches and pain), CHILLS (Chills), ARTHRALGIA (Aches in his shoulder) and MYALGIA (Aches in the extremities; achy; body aches) was resolving, INFLUENZA LIKE ILLNESS (Almost like the flu), ABDOMINAL PAIN UPPER (Stomach problems; pain in the abdomen), DISCOMFORT (Discomfort) and BACK PAIN (Aches in his back) had not resolved and DYSPNOEA (Bit of tough breathing) and PYREXIA (temperature which was only 1 degree above his normal) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 1 degree higher than normal (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medication included pain medication for knee pain (not specified).   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Follow-up information included additional adverse events. On 16-Apr-2021: Follow-up information contains no new information.
Prolonged crying-onset 1 hr p/vax & lasting 12 hrs;
Soreness of left deltoid Saturday morning then numbness and tingling in left arm from shoulder to fingertips beginning around 10:00 pm lasting about 45 minutes. Reports she "did not feel like herself from Saturday through Monday". Began feeling better on Tuesday 5/3/16.
Headache starting around 11:00 pm, with lethargy, severe chills starting at about 12:00 am for an hour, fever of 101.6.  Fever gradually came down and was gone by the next evening.   Severe left arm pain with any attempt to lift it started the 15th  and swelling and redness in left upper arm started on the 16th.  All symptomes were gone after about 5 days.
8/18/16 MMR and varicella vaccine administered 607pm. At 6:21pm pt began coughing and wheezing. Face was flushed chest with a few hives. Resp 36 HR 96. No lip or tongue swelling pulse ox 100%. Epinephrine given (1:1000) 0.15 ml. Albuterol 0.083% via neb. 635pm BP 110/50 - clear lungs except for slight exp wheeze. Ambulance called. 648pm transported to hosp.
I started spotting the afternoon I received the 2nd shot. Spotted next day, then week and a half period (last period had just ended 1 week before). Next period was 3 weeks late followed by a 4 week long period starting off with spotting then heavy flow/clots, then spotting. About 2 weeks no bleeding, then another week and a half period. One week no bleeding, spotting starting again.
Fever started on 6/14/06. Fever persisted through 6/16/06. At approximately 20:00 on 6/15/06, had a tonic/clonic seizure lasting 10 seconds with fever. Went to ER. Temp 106.1 in ER.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
?Moderna COVID-19 Vaccine EUA"  Day after receiving second dose started having major body aches and headaches off and on. Now I have a tickle in my chest whenever I breathe in which then makes me cough.
Patient left store after 15 minutes observation, but stated later that she was feeling a little off when she left.  As she travelled home her face began to feel numb and felt a tightness in throat, then began to have trouble swallowing , so she came back as she wasn't far away.  Patient was taken to patient care room, laid on the floor, and 0.1mg of Epinephrine was administered at 12:09pm.  9-1-1- was called by a technician.   Blood pressure reading was attempted, but could not be obtained due to incorrect cuff size.  Patient was alert, talking, and breathing throughout the episode.  EMS arrived at 12:14pm.  After evaluating her, they allowed her to travel with her partner to the closest ER.  She was not transported by ambulance.
Fever; severe headache; body aches; exhaustion; This is a spontaneous report from a contactable Health care professional. A 50-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:45 (Batch/Lot Number: EL9261) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included (Since Childhood), Sessional envirmental Allergies, Casein Allergy from an unknown date and unknown if ongoing. Patient's historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm left on 31Dec2021 (Batch/Lot Number: EL0142) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) 150 Mg orally Daily taken for hypersensitivity from an unspecified start date and ongoing; nifedipine 30 Mg orally Daily taken for hypertension from an unspecified start date and ongoing; montelukast sodium (SINGULAIR) 10 Mg orally Daily taken for asthma from an unspecified start date and ongoing; atorvastatin taken for blood cholesterol from Sep2019 and ongoing. The patient experienced fever, severe headache, body aches, exhaustion on 22Jan2021 21:00. The patient underwent lab tests and procedures which included body temperature: 103 degree F on 103 degree F. Therapeutic measures were taken as a result of fever, severe headache, body aches, exhaustion (Tylenol: 1000 mg orally (31Dec2021) and Ibuprofen). Hx of Vitiligo reaction after fw Vaccine 10 hrs ago, Vitiligo appearal where bondaid adheoine contacted skin. Bandaid first removed for approx. 24 hrs. Post vaccine vitiligo remained for 4 months then resolved. Outcome of event s was resolved on unspecified date in 2021. additional information has been requested  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist regarding 2 patients of unknown demographics. There was no information about concurrent condition and historical medication. On 22-AUG-2016, the 2 patients were vaccinated with improperly stored GARDASIL 9, Intramuscular (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Flu symptoms for two days and extreme psoriasis outbreak manifesting as a red rash across face.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 01-AUG-2013 the patient was vaccinated at the same office visit with PROQUAD (Merck), injection (lot number, exp date and route not reported) and VARIVAX (Merck), injection (lot number, exp date and route not reported). No adverse effects were reported. The outcome of patient's events was unknown. Additional information has been requested.
Loss of taste; This case was reported by a consumer via interactive digital media and described the occurrence of taste loss in a 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 taste loss. On an unknown date, the outcome of the taste loss was unknown.   It was unknown if the reporter considered the taste loss to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and had a loss of taste. The patient asked was that normal. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Pharmacist, administered Moderna vaccine to underage (16 year old) girl at a COVID vaccine clinic. ALERT iis shows no other COVID vaccines administered.  Circumstances unkown.
Information has been received from a healthcare student concerning a female who on 3-APR-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 658325/1429U). On 14-DEC-2008 the patient developed shingles. The patient sought medical attention by office visit. Additional information has been requested.
lymph nodes hurting; fever; sweats; 1st Dose left arm heavy after 2 hours, no pain, by 5pm increase a bit; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration, administered in left arm on 26Mar2021 at 08:15 (at the age of 52-year-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included patient was admitted to the Err prior on 28Feb2021 for anemia. Concomitant medications included FERROUS SULFATE 325 mg. The patient previously took recephin and experienced allergies. Prior vaccinations within 4 weeks were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for COVID-19. On 26Mar2021 17:00, the patient reported that left arm heavy after 2 hours no pain, by 5pm increase a bit. On an unspecified date, the patient experienced, by midnight lymph nodes hurting and fever and sweats. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected
Tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031I20a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia and Benign prostatic hyperplasia. Concomitant products included AMLODIPINE, ROSUVASTATIN, LOSARTAN and TAMSULOSIN for an unknown indication.   On 27-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had tested positive for COVID-19 3 days later he received the booster vaccine on 20-Dec-2021. No treatment medications were reported.  Company comment: This spontaneous case concerns a 76-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19. Vaccination failure was considered as an additional event. The event occurred approximately 10 months after the second dose of mRNA-1273 Vaccine. Patient tested positive for COVID 19 by rapid test. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-503367 (Patient Link).; Sender's Comments: This spontaneous case concerns a 76-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19. Vaccination failure was considered as an additional event. The event occurred approximately 10 months after the second dose of mRNA-1273 Vaccine. Patient tested positive for COVID 19 by rapid test. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt given vaccine on 1/10/03. Went to ER on 1/11/03 for swelling in leg. Went to office on 1/13/03. Swelling from knee to thigh in left leg.
This is a spontaneous report from a contactable consumer. A 64 year-old female patient of an unspecified race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified day in Jun2015 for immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified day in Jun2015 the patient experienced extreme pain and tendinitis. Outcome was unknown.