chrisvoncsefalvay/vaers-outcomes huggingface dataset:
colds and sore throat now; colds and sore throat now; This is a spontaneous report from a contactable consumer via Pfizer sponsored program Covax Support. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had colds and sore throat and asked if they need to reschedule the second dose on 17Feb. The outcome of the events were unknown.   Follow-up attempts completed. No further information expected.
Redness on both of arms; Itching on both of arms; Flushing on both of arms; This case was reported by a nurse and described the occurrence of erythema in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included niacin tablet for product used for unknown indication.   The patient's past medical history included skin breakout (usually breakout or have side effects when takes tablets).   On 19th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started niacin at an unknown dose and frequency. On 20th October 2021, 1 days after receiving Shingrix, the patient experienced erythema, pruritus and flushing. Niacin was discontinued (Dechallenge was positive). On an unknown date, the outcome of the erythema, pruritus and flushing were recovered/resolved.   It was unknown if the reporter considered the erythema, pruritus and flushing to be related to Shingrix.   Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine intramuscularly on right deltoid and on the following day, she experienced flushing, redness, and itching. The patient was also taking Niacin tablet during that time. The patient was unsure whether the side effects came from Shingrix or Niacin. The patient mentioned that this time Niacin that she received was tablet form and not capsule.  The patient also stated that she usually breakout or had side effects when she took tablets. The patient discontinued taking tablets and the side effects was disappeared. The reporter did not provide lot number, expiry date and dose. The reporter did not give a consent to follow-up. It was unknown if the reporter considered the erythema, pruritus and flushing to be related to Niacin.
Within a few hours my arm began to turn red, by bedtime it was hurting very much.  In the morning it was a little more red at the injection site and it was hurting even more.. I went back to the Doctors office ( 4/6/22 @ 10:am)  that gave me the vaccine and was told this was normal on the second shot. ( It was the first time I had had a pneumonia vaccine in over a year and the last one did not do this.)  The red area is about 8 inches in length and 6 in in width,  It is extremely painful and swelling today. I am just keeping ice and taking Ibuprofen.  The nurse said this was very normal. I do not know how much longer it will take for this to clear up. It has only been since yester day.   I did have Severe Covid in February  1 , 2021.  The only shots I had were my Covid Vaccines  5/27/24  and  6/24/21 ... The first one made me feel a bit flu like, The second one was fine.
About 2 weeks after vaccination, patient complained of hives/itching. Symptoms resolved after antihistamine administered.
Information was received from a lawyer regarding a case in litigation concerning male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about May 2011, the patient was vaccinated at physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, he developed severe and painful rashes on the right side of his face, which radiated upward onto his right ear and scalp. He presented to his primary care physician and was diagnosed with shingles. Thereafter, he presented to a neurologist and was diagnosed with post herpetic neuralgia in the right trigeminal distribution. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had hot flashes; skin pain; joint pains; numbness of the whole arm; site pain; Headaches; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 39-years-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EJ1685, Expiration Date: 31Mar2021), via an unspecified route of administration in left arm on 28Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included obesity, asthma, hypothyroidism, vitamin D deficiency, multiple tendonitis, allergies to horses, cats, and dogs and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included mometasone furoate (ASMANEX), colecalciferol (VITAMIN D), levothyroxine sodium (SYNTHROID) and hydroxychloroquine, all received within 2 weeks of vaccination.  The patient stated for hours post injection she had hot flashes but the worst was 12hrs after. She experienced severe muscle pain/ skin pain, joint pains, burning of eyes, Headaches, low grade fever, site pain, numbness of the whole arm, hot flashes followed by rigors. The events started on 28Dec2020 21:00. Treatment received for the events included Tylenol. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
Pt came to the store on Wednesday 10/24/2018 and reported soreness, redness, no fever, pain when pressure is put on the site, warm and no trouble sleeping because of vaccine. I told her injection site reactions were common with such vaccine and if gets worse within 2 days she should call the doctor. Apparently later the doctor called and was concerned that the redness was a little bit bigger.
Tested positive after fully vaccinated, assytomatic at time of diagnosis Narrative: tested positive for COVID 19 after fully vaccinated
Left arm pain spread during the afternoon following the shot.  By the morning pain continued, and a two inch red band was visible around the injection site. The red band continued through the next day.  On day three the bad was smaller but very warm and itchy through day four. By day three the pain in arm stopped. By day four smaller red spot and no pain.  No fever. Very tired following the shot.
sick; diarrhea; finds it uncomfortable to leave his house; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 61-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sick, diarrhea, finds it uncomfortable to leave his house. Therapeutic measures were taken as a result of sick (illness). The outcome of the events was unknown.  This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
flu-like symptoms; fever; chills; fatigue; body aches, pain; stuffy nose; weird cough; sore throat; pain; rash all over his chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over his chest), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      No Medical History information was reported. No concomitant medication reported.    On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced RASH (rash all over his chest). On 18-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), PAIN (body aches, pain), NASAL CONGESTION (stuffy nose), COUGH (weird cough), OROPHARYNGEAL PAIN (sore throat) and PAIN (pain). At the time of the report, RASH (rash all over his chest), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), PAIN (body aches, pain), NASAL CONGESTION (stuffy nose), COUGH (weird cough), OROPHARYNGEAL PAIN (sore throat) and PAIN (pain) outcome was unknown. Not Provided
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 010A21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication details were provided. No Treatment medication details were provided.
Systemic rash R and L thigh, lower back, and stomach. Rash warm to touch with blanching. No difficulty breathing Lungs clear to auscultation, heart regular rate rhythm.
right eye lower than left; Arm swollen; could not close hand; confusion; Problem/difficulty speaking; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: fh8020), via an unspecified route of administration, administered in right arm on 14Oct2021 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously took ibuprofen and experienced allergy. Historical vaccine included BNT162B2 (Lot number: fe3592), via an unspecified route of administration, administered in right arm on 23Sep2021 (at the age of 40-years-old) at dose 1, single for COVID-19 immunization. Prior to vaccination, the patient did not have COVID-19 infection and did not receive any other vaccine in four weeks. The patient reported that next day at 6 pm, her arm was swollen, could not close hand, had confusion, problem/difficulty speaking, and right eye was lower than left. No treatment was received for the events. The patient was not COVID tested post-vaccination. Outcome of the events was unknown.    Follow-up attempts are completed. No further information is expected.
Mistakenly administered the Jansen Covid-19 vaccine to a 14 year old kid.  I called and discussed the possible side affect with the father.
rash after 1 week to 10 days after receiving the vaccine; Hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset May2022, outcome "not recovered", described as "Hives"; RASH (non-serious) with onset May2022, outcome "not recovered", described as "rash after 1 week to 10 days after receiving the vaccine". The events "rash after 1 week to 10 days after receiving the vaccine" and "hives" required physician office visit. Therapeutic measures were taken as a result of rash, urticaria. Additional information: the patient had the second regular booster dose, not the bivalent. After 1 week to 10 days after receiving the vaccine, she had rash. She wanted to know if there was more information on this case. She received the COVID-19 vaccine and had a severe delayed reaction from it, she stated that she was fine after the first three shots, it was after the first and second booster that she had this reaction. She clarified that she experienced the reaction after her second booster dose of the vaccine. She went to three dermatologists and they all agreed clinically that it was from the COVID vaccine. She did not know what to do at this point. Antihistamines were no longer working. Normally she can take antihistamines and it will go away, but in this instance, it did not go away at all. She stated that it was weird. This seemed different, it was bilateral, if she got the rash/hives on one side, it will be in the same spot on the other side simultaneously. She stated that sometimes it was rash and sometimes it was welts, which were hives. She had no prior vaccinations within four weeks. She had no medical history nor relevant tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient presented to the ED for hematoma of knee region within 6 weeks of receiving Covid-19 vaccination.
approx 45 mins p/inject exp tremors, blurred vision, weakness, hot feeling; this am c/o swelling & pain lt deltoid, pain lt neck, lt axilla & basicaly entire lt arm;
patient came to the pharmacy on Monday 05/29/23 around 4:50 pm stating that she had received a vaccine  where she experienced pain at the injection site (left arm).She states the pain has not gone away and describes it as sharp shooting nerve pain. She has tried OTC pain meds and her pain still persists and is really bothering her. Pharmacist informed that temporary pain and soreness was normal, but it should not have lasted this long. Pharmacist asked why she did not notify pharmacy right away, but patient states because she did not want to get the person who gave the vaccine in trouble. Patient informed she visited her doctor about the issue, but does not recall when.  Patient informed she visited her doctor about the issue, but does not recall when. Her provider ordered x-ray of her left arm and it showed that she had arthritis. But she states that she does not agree that her pain is due to arthritis, she believes that the pain was caused by the vaccine. Her provider gave her medication for the pain but did not help, she stated that the medication was a tablet, but she does not know the name and she denies it being gabapentin or naproxen.
Patient received vaccine on 4/7/21, noticed pain near inject site a few days after administration. On 4/12/21 he noticed a large bruise spanning from the injection site in his deltoid down and around to his bicep.
p/reaching home from clinic-pt cried & screamed for approx 4-5 hr;temp 103.6 phoned pvt MD & inc APAP dosage;
Immed p/vax given a bump, smaller than dime sized, devel; the bump became penny sized & look more like a large hive or wheal;  pt having no other problems; red & warm;
Local reaction (L) arm. Pink and swollen 4 inches by 4-5 inches. C/o area being "hot" and itching. She reports that she is taking BENADRYL and it is better than yesterday. She does not have a fever. I advised a cold compress and BENADRYL prn. If it does not resolved, call her doctor and our office.
Muscle pain in left shoulder next AM after flu shot. (9/17) states that now, 4 wks later, has pain now in right shoulder, very painful in AM, lessening to very little pain, if any by the evening. More painful when laying down, much better when standing. Pt initially went to MD, he said it was normal with HD shot, but now after 4 wks, pt feels it might not be normal and reported to me.
At the moment the patient does not present with any adverse event, It's reported now that the second dose was administered before the required 21 days. In this occasion what is being reported is a vaccination error.
Patient reported swelling and didn't feel well on 9/21/16. On 9/22/16, patient developed 103F fever, arm very red and painful.  Patient wen to ER and was admitted to the hospital for fluids and antibiotics.
Temp to 99.9, headache in the evening of injection day. Hives at injection site and contralateral deltoid, cervical lymphadenopathy, and soreness/desquamation of the patient's soft palate by the next morning. Resolved fever, headache by second day, but malaise continued for four days.
PT REPORTED REDDNESS SORE ARM FEVER OVER 101 CHILLS 1 DAY AFTER SHOT IN THE RIGHT ARM. PT WENT TO DR AND HE GAVE AN ANTIBIOTIC AND PREDNISONE.  PT SAID STARTED TO FEEL ALITTLE BETTER THE NEXT DAY. PT GOT ON A WED AND WAS FEELING BETTER BY SUNDAY. I WAN CONTACTED BY THE SCHOOL NURSE AND TRIED MULTIPLE TIMES TO GET BACK TO NURSE WITH DETAILS AND CALLED PT WITH NO ANSWER. FINALLY GOT IN TOUCH WITH PT 9-29 AND GOT ALL THE DETAILS. PT IS FINE AT THIS TIME
I also caught COVID on Christmas of 2021; I also caught COVID on Christmas of 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I also caught COVID on Christmas of 2021". Clinical course: Description of Potential AE: would like to take pay in study SBXSN25C. Wondering if there was any studies around me that could use me for research.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recv vax on 9/23/97; on 9/24/97 pt exp erythema at vax site
This 58  year old male received the Covid shot on  3/27/21    and went to the ED on 4/3 /21  with the following diagnoses listed below. U07.1 - COVID-19 J12.82 - Pneumonia due to Coronavirus disease 2019
After patient received first dose of Shingrix, patient reports the development of lesions all over body approximately two to three days after injection.  Lesions were located bilaterally on back, legs, torso.  Lesions eventually produced a yellow secretion.  Lesions would disappear over a few days and then new lesions would appear.  At two months post injection, patient reports all lesions were mostly cleared with only a few areas of hyperpigmentation left.  Lesions did not appear at the injection site.  Pt reports having sores in mouth as well, which she is unsure if this was related or not.   Pt reported to urgent care and then was seen by PCP.  Pt was prescribed oral antibiotic and benadryl oral.
Different practices do it differently / It's confusing and it's not clear; Different practices do it differently / It's confusing and it's not clear; This case was reported by a nurse via call center representative and described the occurrence of product label confusion in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced product label confusion and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the product label confusion and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse asked about recommendations of use of Menveo for patients with Sickle Cell Disease. The instruction were like dose 1 at age 8 weeks: 4-dose series at 2, 4, 6, 12 months, Dose 1 at age 36 months: 3 or 4 dose series (dose 2 and dose 3 if applicable at least 8 weeks after previous dose until a dose is received at age 7 months or older, followed by an additional dose at least 12 weeks later and after age 12 months), Dose 1 at age 723 months: 2 dose series (dose 2 at least 12 weeks after dose 1 and after age 12 months) and Dose 1 at age 24 months or older 2 dose series at least 8 weeks apart. Some offices interpreting that can choose between all four option and some interpret as first option was the recommendation and the other three were the catch up recommendation if did not start on time. Upon medical information callback to the reporter, she states she cut and pasted centers for disease control recommendations into email to GSK (GlaxoSmithKline).  Different practices do it differently, asked what are the differences between the recommendations. It was confusing and was not clear on your part and on Centers for Disease Control part and therefore not clear on Health and Human Services part and wanted to clarify on the intention so there was not misinterpretation, which led to product label confusion and circumstance or information capable of leading to medication error. The reporter consent to follow up.
I got my 2nd vaccine on April 12. My arm was sore. It wasn't with the first shot. I was fine until Thursday. By April 15 I almost vomited, which I never do, but instead had a violent burst of painful, cramping, burning bowel movement. I looked in the mirror and my face was white. My lips were white. I had no problem breathing or with my heart pounding. It was all gastrointestinal. Each day since I've gotten less sick to my stomach each day. For the first few days I could only drink. Then I had popsicles and finally ice cream. Nothing else appealed to me. I never had another violent episode, but my stomach has been upset since April 15, 2021. Even though I continue to get better, I'm calling the doctor tomorrow.
Rt arm L40mm W35mm redness - hot touch - nodule L arm 25mm L & 25mm width/red/hot to touch.