chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At times feels tired, a few chills, and a little warm; At times feels tired, a few chills, and a little warm; At times feels tired, a few chills, and a little warm; felt bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 17:00 (Lot number: EN6202) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Has narrow throat and nasal passages" (unspecified if ongoing); "Has narrow throat and nasal passages" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), CHILLS (non-serious), FEELING HOT (non-serious) all with onset 25Feb2021, outcome "not recovered" and all described as "At times feels tired, a few chills, and a little warm"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "felt bad". Therapeutic measures were taken as a result of fatigue, chills, feeling hot, feeling abnormal.  Additional Information: The patient reported that she had narrow throat and nasal passages and it was hard for her to wear a mask. The patient was reported to be a front line worker. The patient did not take pills because of her narrow passages. She could take pills, but usually chops the pills up. The pills still felt like they were in her throat. The patient did not provide a specific product name when referring to this information. The patient did not take any medications, only reported to took vitamins every day. No further details were provided. The patient received vaccine on Wednesday last week (24Feb2021). The patient had been taking Ibuprofen when she felt bad. Took five ibuprofens (Lot: R85018, Exp.: Sep2022, Dose: 200mg blue mini gels; Only takes on mini gel at a time.) since last Wednesday. Took one dose of Kids Tylenol (Lot: SBM011, Exp.: Jan2022, Dose: Concentration is 160mg/5ml. She took 15ml and an hour and a half later still felt bad. She then took another 10ml. Only did this once). No investigational assessment was performed. It was reported that the patient had Pfizer COVID-19 shot last week. Feels ok, but "at times feels tired, a few chills, and a little warm". The patient wanted to know if this was normal. The patient stated this report was scaring her. The patient stated her symptoms were on the list, but it had been ongoing for more than five days (off and on). Wanted to make sure she was not feeling anything crazy. The patient wanted to know if she could take Ibuprofen or Tylenol. Stated she needed to know now what she could take. The patient was advised to follow up with her primary care physician.  No follow-up attempts are possible. No further information is expected.
Patient received 2 flu shots within 2 months. First flu shot was given on 10/06/2022. Patient came in 12/09/2022 and received another flu shot . Patient is feeling fine, no side effects at all.
Red marks on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red marks on injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red marks on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red marks on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: On 05-May-2021, the patient reports that the events lasted for only couple days and everything is fine no.
Janssen COVID-19 Vaccine EUA I received the dose yesterday in the late morning (around 11:25am PDT), last evening my urine color was changed dramatically to include obvious brown/red.  This has continued today, when I urinated this morning, and at approximately the same visible saturation.  I have not changed my diet in any significant way. I haven't had any alcohol, if that's relevant, since 04/07.
Went to ER in early a.m. on 9/23/2015 due to left side of face drooping-diagnosed with Bells Palsy and given steroids to take po to improve symptoms.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine on or about 20-MAR-2015 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAY-2016, the patient was treated by a physician for a painful rash that was diagnosed as severe shingles. The patient was prescribed acyclovir to manage his symptoms. 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. The outcome of the shingles is unknown. Additional information has been requested.
0805 pt received second dose pfizer vaccine  0810 pt reports "right afterward" noticing that her tongue felt numb. denies respiratory distress. No previous history of anaphylaxis with any vaccine or medication or other source. No problem with first dose pfizer other than sore arm, fatigue. 0825 pt states numbness progressing toward back of tongue 0830 pt escorted to ED  Per ED note: Patient received second Covid vaccine at 8:05 AM, noted onset of central, not lateralized, tongue tingling without swelling/pain after receiving the shot, still notes able to feel pressure on tongue.  Has never had a reaction to previous vaccines, including first dose of Covid vaccine 3 weeks ago.  Denies any tongue biting or recent trauma to the tongue.  She does feel as if the tingling is extending further back since onset...Patient states she can swallow fine without pain, no vision changes, hearing changes, taste changes, lesions in her mouth, facial asymmetry, shortness of breath, headache, rashes, swelling.  Denies fevers, chills, URI symptoms, chest pain, palpitations, lightheadedness, nausea, vomiting, abdominal pain, change in bowel habits, change in urination.   Vitals stable, no evidence of anaphylaxis on exam.  Ruled out CVA, atypical MI, migraine, GERD, trauma. Thought possibly vaccine reaction. Patient was monitored in the emergency department for 4 hours after vaccine, without airway swelling or compromise. Discharged home but still with continued tongue tingling with preserved sensation.
I experienced mild symptoms such as soreness at injection site, slight headache and fatigue about 3 hours after receiving injection. I think these may be normal reactions to the vaccine. I took Tylenol to ease symptoms.  I was advised by my manager  to report anyway.
HYPOTENSION 12/23/2022 BPH (BENIGN PROSTATIC HYPERPLASIA)  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/29/2022 BPH (BENIGN PROSTATIC HYPERPLASIA)  HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/29/2022 BPH (BENIGN PROSTATIC HYPERPLASIA)  HYPOTENSION 12/23/2022 BPH (BENIGN PROSTATIC HYPERPLASIA)  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/29/2022 BPH (BENIGN PROSTATIC HYPERPLASIA)  HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/29/2022 BPH (BENIGN PROSTATIC HYPERPLASIA)  HYPOTENSION 12/23/2022 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/29/2022 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC  HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/29/2022 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC  HYPOTENSION 12/23/2022 CHF EXACERBATION, UNSPECIFIED  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/29/2022 CHF EXACERBATION, UNSPECIFIED  HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/29/2022 CHF EXACERBATION, UNSPECIFIED  HYPOTENSION 12/23/2022 ATHEROSCLEROSIS OF AORTA  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/29/2022 ATHEROSCLEROSIS OF AORTA  HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/29/2022 ATHEROSCLEROSIS OF AORTA  HYPOTENSION 12/23/2022 HEART FAILURE W NORMAL LVEF >=50%, UNSPECIFIED ACUITY  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/29/2022 HEART FAILURE W NORMAL LVEF >=50%, UNSPECIFIED ACUITY  HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/29/2022 HEART FAILURE W NORMAL LVEF >=50%, UNSPECIFIED ACUITY  HYPOTENSION 12/23/2022 ACUTE LEFT SIDED CHF  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/29/2022 ACUTE LEFT SIDED CHF  HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/29/2022 ACUTE LEFT SIDED CHF  HYPOTENSION 12/23/2022 ACUTE ON CHRONIC CHF, UNSPECIFIED  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/29/2022 ACUTE ON CHRONIC CHF, UNSPECIFIED  HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/29/2022 ACUTE ON CHRONIC CHF, UNSPECIFIED
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-FEB-2016, the patient was vaccinated with an improperly stored dose in VAQTA (exact dose, route and anatomical location were not reported, lot # L023232, expiration date 25-FEB-2016) immunization series. The administered dose experienced a temperature excursion of 70 degrees Fahrenheit for 37 hours. No adverse effects were reported. Additional information has been requested.
When I received my moderna booster in November 2021, I noticed I had severe hives for the first time in my life a few weeks after the booster. I have no know allergies. Now, having had recieved my second booster this September, I've noticed I also developed hives a few weeks after the shot. Those are the only 2 times I've ever had hives.
Patient had COVID-19 infection in October 2020, then received 2 doses of COVID vaccines.  On 6/1, COVID-19 tested positive, but patient denies any COVID related symptoms.  Subsequence COVID tests on 6/2 and 6/3 all showed negative.   On 6/1, patient presented initially to his PCP for evaluation of groin swelling. The patient had noticed a left groin swelling since last fall and had not previously bothered him over the last 2 days he noticed the swelling had increased in size and was uncomfortable with walking.  Then he was instructed to ED and CT showed left inguinal hernia, so admitted at hospital for left inguinal hernia repair.
Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Breakthrough COVID-19  infection.  Admitted for painful swallowing.  Progressed to shortness of breath and difficulty breathing.   History of esophageal cancer with recent start of chemo and radiation.  Required intubation and ventilator support.  Developed acute kidney injury, and goal changed to comfort measures.
patient hit the leg and the wound infected; dry cough; throat ache; cold; very little phlegm; This spontaneous case was reported by a consumer and describes the occurrence of WOUND INFECTION (patient hit the leg and the wound infected) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced COUGH (dry cough), OROPHARYNGEAL PAIN (throat ache), NASOPHARYNGITIS (cold) and PRODUCTIVE COUGH (very little phlegm). On 05-Apr-2021, the patient experienced WOUND INFECTION (patient hit the leg and the wound infected) (seriousness criterion medically significant). At the time of the report, WOUND INFECTION (patient hit the leg and the wound infected), COUGH (dry cough), OROPHARYNGEAL PAIN (throat ache), NASOPHARYNGITIS (cold) and PRODUCTIVE COUGH (very little phlegm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is taking antibiotics for wound infecting. Treatment taking  for high blood pressure and diabetes.  This case refers to a 72-year old female patient with relevant history of Diabetes who experienced wound infection, cough, Nasopharyngitis and Productive cough following the administration of Covid-19 vaccine and was assessed as Possibly Related to study drug.  The event of Nasopharyngitis could be caused by viral or bacterial infection.  Wound infection was due to the patient hitting her leg.  The underlying history of Diabetes subjects her to higher risk of infections and poor wound healing.; Sender's Comments: This case refers to a 72-year old female patient with relevant history of Diabetes who experienced wound infection, cough, Nasopharyngitis and Productive cough following the administration of Covid-19 vaccine and was assessed as Possibly Related to study drug.  The event of Nasopharyngitis could be caused by viral or bacterial infection.  Wound infection was due to the patient hitting her leg.  The underlying history of Diabetes subjects her to higher risk of infections and poor wound healing.
Vaccine 10 am- fine all day and evening.  Awoke at 3:40 am and rolled off of arm where injection given and a wave of pain and nausea and malaise overwhelmed me. I passed completely out still lying in bed (so out that I wet myself in bed) and gradually came to, still feeling horrible. Got up, changed clothes, and major chills when I returned to bed. Around 6am I felt nauseous, got up to vomit, but instead passed completely out on the bathroom floor for about 15 minutes.  Remainder of day I felt very stiff, low energy and slightly woozy. By afternoon, energy was returning (I vacuumed the house). Minimal pain in arm this time compared to previous.
This spontaneous report was received from nurse practitioner regarding an unspecified patient of unknown age and gender. The medical history of patient, concurrent conditions were not reported. On 10-FEB-2016 patient was vaccinated with improperly stored VARIVAX (lot # L013827, expiry date 21-APR-2017) dosage regimen and route unknown. The nurse reported that the doses were exposed to several defrost cycles. No adverse symptoms were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 13:15 (Lot number: FJ1620) at the age of 48 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "PCOS" (Polycystic ovary - unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Covid-19 prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: RETINAL ARTERY OCCLUSION (disability, medically significant) with onset 10Dec2021 13:15, outcome "not recovered", described as "I had a retinal arterial partial occlusion"; EYE INFLAMMATION (disability, medically significant) with onset 10Dec2021 13:15, outcome "not recovered", described as "I have alot of inflammation in my right eye". The events "I had a retinal arterial partial occlusion" and "I have alot of inflammation in my right eye" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Nasal swab. Therapeutic measures were not taken as a result of retinal artery occlusion, eye inflammation. Follow up information has been requested. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the evens Retinal artery occlusion Eye inflammation and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Body aches, fever as soon as injection was given. Fatigue experienced next day. 4 days with symptoms.
ER called & said pt had a sz from a temp of 103;ran blood work & urine tests & everything came back fine;shots were given in PM of 29SEP97;rxn happened 30SEP97;pt sent home w/orders to take valium rectally MD believe rxn d/t shots;
Swelling in left leg around calf and ankle. After a blood test and sonogram a Deep Vein Thrombosis was found in my left leg.  Determined "unprovoked" by Dr. after subsequent blood test results came back negative.
Daycare provider called to say that patient had a fever of 103 degree. She did not have a fever or act ill prior to that.
This spontaneous report was received from a registered pharmacist concerning a 70 years old female patient with high cholesterol and diabetes and no known drug reactions/allergies who on 21-AUG-2012 was vaccinated with a dose of ZOSTAVAX 0.65 mL subcutaneous (lot# not provided). Concomitant therapy included "a lot of medications" (unspecified). On 24-AUG-2012, the patient developed "1/2 dollar size" around the injection site that was red, tender and hot. No treatment was given for the events and no event. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
rapid heart rate starting when she got the shot, nausea and fever 99.8 around 5 pm.  Symptoms gone by about 10 pm.  She took her heart medication as ordered and felt better by bedtime.
Sick constantly for six weeks with multiple manifestations  of the same illness. It included respiratory including bronchitis two UTI's strep throat and overall illness so that I could not wash dishes or prepare meals.  Under medical supervision the entire six weeks with a series of multiple antibiotics to cure. I was prescribed Macrodantin which worked Amoxicillin was prescribed but did not work.
This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a female patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Flu vaccine. Additional information was reported as follows: The age at vaccination was not reported. The patient had an adverse reaction (unspecified) to a unspecified flu vaccine in the past. The reporter did not know which flu vaccine it was. No further information was obtained from the healthcare professional.
Patient developed a maculopapular , itchy rash on 3/10/21.  This was 8 days after receiving the 2nd Moderna COVID-19 vaccine.  He had no fever or chills.  No body aches. Diagnosed as delayed hypersensitivity eruption due to the vaccine. Topical Triamcinolone was given for symptomatic relief.  His rash spread and he returned on 3/18/21 at which time the diagnosis of Erythema Multiforms was made based on the target lesions and areas of dusky erythema that had developed. His itching had improved however. He did not have oral lesions.  He was treated with IM Kenalog 60 mg and noted improvement of the rash within 3-4 days
Health professional gave patient Hep B pediatric vaccine rathen than an adult hep b vaccine. Patient was contacted and informed of the situation. Patient was okay with coming in to receive another dose of Hep b pediatric vaccine to count as a fully dose adult.
a patient of theirs received their first dose of Menactra at age 11 and then age 13 (on accident) with no reported adverse event; Initial information received on 10-Jun-2022 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional.  This case involves Adolescent of unknown gender and age patient received their first dose of menactra at age 11 and then age 13 (on accident) with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past vaccination(s) included Menactra with at age 11. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine Solution for injection (dose, route, strength, frequency, batch lot number and expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization). Information on batch lot number is requested.  On an unknown date the patient developed a non-serious event a patient of theirs received their first dose of menactra at age 11 and then age 13 (on accident) with no reported adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (D Conj) Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inappropriate schedule of product administration).  At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Once I received injection my arm had a cold sensation and bit of numbness. Injection site sore. Hour after injection became overwhelmed with fatigue. Slept  15hours. Woke feeling lots of discomfort in joints all over some aching more than others but would not always be the same areas. Injection site sore. Mild headache. Still felt exhausted.  The second evening was the worst with body discomfort. Fever mild 99.0-100.  The next morning woke no joint pains mild headache (forward center) lasted until midday. Symptoms have seemed to dissipate .
PATIENT REPORT HAVING FLU LIKE SYMPTOMS, ABDOMINAL PAIN, NAUSEA, DIARRHEA, AND PASSING OUT IN MORNING DAY AFTER RECIEVING THE VACCINE AND GENERAL FELLING OF WEAKNESS.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient came into the pharmacy on 10/6/21 about 1:25pm with hives. Patient developed hives on arms and legs.  First symptoms started about 30 minutes after recieving vaccine. I instructed him to take benadryl and to go to his doctor or and urgent care to get treated