chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 1, single (Lot number: EL8982), on 06Mar2021 at 12:00 as dose 2, single (Lot number: EN6199) and on 05Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 67 years for Covid-19 immunisation; CoviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 045L2IA) for Covid-19 immunisation. The patient's relevant medical history included: "Nephrectomy" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication was for Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: The patient did not received other medication in 2 weeks. Anti-viral treatment given for COVID-19, treatment start date on 15Jul2022, treatment stop date on 21Jul2022. Follow-up attempts are completed. No further information is expected. Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out.
Patient returned to office 30-45 mins after vaccines given, complaining of itching, facial swelling, no difficulty breathing. Exam positive flushing, urticaria and slight wheezing, swollen lips. Treated with BENADRYL, Prednisone and Epinephrine.
Upper and lower extremity weakness and numbness with difficulty ambulating over 3 days. Diagnosis of Guillain Barre Syndrome made. Treated with IVIG.
About 20 minutes after injection the right side of my tongue began tingling. It was very noticeable, and persisted all day.  About 4-5 hours after injection, the right side of my face and right side of my lips also felt slightly tingly and slightly numb.  No noticeable swelling, but my husband detected less movement on the right side of my face and said that my speech sounded like I had a bit of a fat tongue. I took ibuprofen to relieve symptoms. The next day the tingling in my tongue was gone. The weird feeling on the right side of my face was improved, but still there. It was distracting enough that I continued taking ibuprofen which seemed to help. It has now been 72 hours since my injections. The weird feeling of the right side of my face/lips being slightly tingly and numb persists. It improved that first night, but has not improved any more since then.
Woke with up chest, arm and jaw pain on 03/21/2021. Presented to the ED. Her initial EKG was negative for any acute changes but her troponin was elevated. Cardiology was consulted. Her echo was negative for cardiomyopathy or hypertrophy. But after her troponin continued to rise she was taken to the cath lab to look for ischemia. Her cardiac angiography was negative for obstructive disease, and coronary arteries were completely normal. Had low magnesium and potassium- so started on oral supplementation. Discharged on 03/22/2021 with nitroglycerin (which was not helpful and made her feel worse/nauseated) and to follow up with outpatient cardiac MRI and cardiology. This imaging revealed significant myocardial edema consistent with myocarditis.   04/01/2021 Per Cardiology: -Given that the patient had covid 19 back in November 2019 I believe she may have had a low yield subacute myocardial infection at that time that was somehow exacerbated by her 1st covid vaccine. Therefore, after some consideration and careful discussion I am advising against the 2nd vaccine at this time.  -No physical exercise for 6 months given her current myocarditis and family hx of sudden cardiac death -May trial PRN NSAIDS for pain relief -Recommend birth control and no pregnancy until at least after her follow up cMRI  -Follow up in 6 months with cMRI prior
High fever like systems body aces and pain , sensitive skin, Headace. Pain at the ejection arm.
Pt and pt's daughter were in triage area, post-vaccination (1st dose PFIZER), c/o dizziness and non-radiating chest pressure located in midsection of chest, at approximately 7:50PM. On-site NP and clinic lead notified. Pt denied experiencing SOB or any other new/abnormal sx. Pt denied hx of smoking or taking BP meds. Pt was offered and given water.   V/S @ 750PM: BP - 150/102, HR - 86, O2 - 98% V/S @ 758PM: BP - 167/106, HR - 90, O2 - 99% V/S @ 800PM: BP - 160/102, HR - 90, O2% - 99%   Continued to monitor pt. Pt denied experiencing improvement to sxs.    V/S @ 810PM: BP - 155/95, HR - 97   Pt denied experiencing any improvement to sxs. ED precautions given. Pt was encouraged to see ED. Pt agreed and requested to be transferred to ED via w/c. Pt was accompanied by NP, RN, and pt's daughter to ED. Report given to ED nurse.
6 hours post injection started to experience sever headache and chills with a low grade fever. 14 hours post injection was experiencing chills with moderate fever, body aches, and uterine cramping. 26 hours after injection was experiencing high fever over 102 that was holding with Tylenol along with chills and hot cough. 36 hours after injection fever broke. (over the course of this reaction I was in-contact with medical providers and felt there was no need to seek emergency care) (I was also 19 days post positive covid test result at time of injection)
Felt feverish/little fever; Headache; Nausea; He is very hot; severe cough; Presented weakness; Felt sleepy; Felt 'down'; Severe flu; Very congested; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). An 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Apr2021 (at the age of 18-year-old) at dose 1, single for covid-19 immunisation. Medical history included covid-19 from 13Jan2021 to an unknown date. Concomitant medications were not reported. On an unspecified date the patient experienced presented felt feverish/little fever, headache, nausea, he is very hot, severe cough, on an unspecified date in Apr2021 severe flu, very congested, on 13Apr2021 presented weakness, felt sleepy, felt down. Reporter stated that his 18-year-old son had his last Covid-19 positive test on 13Jan2021 and on 13Apr2021 he had the first dose of the Pfizer Covid-19 vaccine. On the same day he presented weakness, felt sleepy, felt 'down' and three days after he had a severe flu, he was very congested, felt feverish, presented severe cough and headache. As if he had Covid-19 again. Stated that she gave him cough syrup, something for the headache and flu and two days later he felt better. Reporter would like to know if after presenting these events he should take the second dose of the vaccine on 02May2021. She is calling for her son. He is 18 years old. He had first dose and then developed symptoms which she said were: little fever, headache, nausea. He thinks he has COVID, and she said it is the reaction from the vaccine and not that. He is very hot. She would like to know if Pfizer recommends 2nd dose or not. It is scheduled for 04May2021. The patient underwent lab tests and procedures which included COVID-19 Test: positive on 13Jan2021. Patient received treatment with cough syrup, something for the headache and flu and two days later he felt better. Outcome of the event presented weakness, felt sleepy, felt down, felt feverish/little fever, nausea, he is very hot, very congested was unknown and severe flu, headache, severe cough was resolving. There is a Product Complaint. Description of Product Complaint: Received call from consumer regarding the Pfizer COVID vaccine. She is calling for her son. He is 18 years old. He had first dose and then developed symptoms which she said were: little fever, headache, nausea. He thinks he has COVID, and she said it is the reaction from the vaccine and not that. He is very hot. Product strength and count size dispensed: not provided. Additional lot numbers: none. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact: not provided.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received vaccine on 9/18/17 had muscle soreness next day which became worse over the next 4 days. Went to the hospital for treatment hospital referred patient to primary care physician. Patient went to see Dr. who referred patient to a neurologist. Patient has been going to physical therapy for seven weeks now. Neurologist told patient she has a virus in her radial nerve caused by the flu vaccine given on 9/18/2017. Patient notified Board of Health who called me on 12/08/2017, I later spoke to the patient and gathered this information.
Patient had history of bilateral breast cancer. Requested that the high dose flu shot be given in her left gluteus as she did not want IM injections in her arms. She stated she had both covid shots in her arms and was scheduled to received the covid booster in her arm in the next week. She was concerned about multiple injections in her arms with history of bilateral axillary lymph node removal.  Administered the high dose flu vaccine at the left gluteal space. Package insert stated that the gluteus is not an approved administration site. Immunization is valid and does not need to be repeated, but was given in an inappropriate anatomical site.
Severe itchng of face, eyes neck. Developed swelling around eyes and dry skin. Per patient sx have persisted.
Pt exp rxn within 4-5 hr p/vax of erythema,whelps. Rx - Pediapred,Benadryl
Above named client received Influenza vaccine on 09Dec2006. On 10Dec2006 at 0500, client noted red rash to abdominal region and up toward mid-torso with itchiness and slight fever. Client did not complain of shortness of breath, she did not seek treatment on 10Dec2006. On 12Dec2006 client presents to this clinic complaining of some areas of redness, but with heightened redness and increased itchiness. Also reservist complain of increased itchiness to bilateral arm without noticeable rash, client does not complain of shortness of breath and speaks in full sentences. Advised patient and referred to nearby medical facility community hospital/personal MD (of client)
Pt in "50's" experienced elevated LFT's,AST at 541 and ALT at 536,reporting DR unsure if pt vaccinated w/ Hepatitis A vaccine inactivated or Hepatitis A vaccine (Havrix) ,additional information has been requested
3/23/2021 about 10 am headache, about 11am chills, fever, joints ache, lower back pain, tired, sore arm slight bump and redness.  Went to bed at 6pm. 3/23/2021 bump on arm getting bigger, warm, more sore and larger red spot.  Chills off and on. 3/24 - 3/28 just the arm now - bump is about 2.5" in diameter.  Warm, red and sore. Random pain twinges often - better with ibprofin. 3/29 and today 3/30 redness has decreased.  Not as warm.  Lump is like a large marble and not soft.  Sore if you touch it.  Random twinges are getting better.  No ibprofin anymore.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist, recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JAN-2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-SEP-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Pt developed rash and hive at injection site. Pt developed fever of 101 the following am.
Felt disoriented, tired and my face was very swollen and hot. I think I may have had a temperature.
Seen at Pediatric 2/1/17 Redness, swelling at the site of meningitis B vaccine. BENADRYL PO Q six hours. 2/2/17 Urticaria possibly due to Men B vaccine. Very itchy and uncomfortable. Started Hydroxyzine 25 mg.
I developed a large, circular skin rash at the injection site.  The area was slightly inflamed with a mild itch on the  day that I noticed it.  I treated it by applying hydrocortisone cream 2-3 times a day for 3 days. The rash has gradually decreased in size and color over the past 5 days and hasn't itched since the first day. Although there is still some faint skin redness, there is no inflammation and I consider this reaction recovered.
Lethargy. Multiple unformed stools. Eyes feel ?heavy.? Mental foggiest. Decreased appetite. Decreased motivation - hard to get going. Feeling cold but no fever.
Initial and follow-up information has been received from a nurse practitioner concerning a 26 year old female patient with no pertinent medical history or concurrent conditions and no drug reactions/allergies, who on 29-JAN-2008 was vaccinated with the first dose of GARDASIL (lot # 655327/1287U) 0.5 mL, IM. On 03-MAR-2008, the patient received the second dose of GARDASIL (lot # 655604/0052X) 0.5 mL, IM. There was no concomitant medication. The patient was subsequently determined to be pregnant in April 2008. In April 2008, the patient's urine pregnancy test was positive for pregnancy. The patient sought medical attention with an office visit. The last menstrual period was on 09-FEB-2008. Therapy with GARDASIL was discontinued. The patient's estimate date of conception was 23-FEB-2008 and estimated date of delivery was 15-NOV-2008. No problems reported. Prenatal testing included. On 23-Apr-2008 ultrasound: Routine test - Within normal limits. On 16-Jun-2008 serum alpha-fetoprotein test: Negative. Time 4. Routine test. On 07-Jul-2008 ultrasound: Routine test. Within normal limits. The patient had five previous pregnancies and five (previously report that on 21-NOV-2008, the patient delivered a normal and healthy female baby weighing 8 lb and 14 oz and apgar score 9/10. No complications during the pregnancy and labor/delivery, no congenital anomalies, and no complications or abnormalities. During the pregnancy, prenatal laboratories were performed. There was infections or illness during the pregnancy, a laboratory test was positive for HSV I and II. The patient received prophylactic Valtrex, 500 mg, BID, started on 06-OCT-2008 to delivery day 21-NOV-2008. Other medications used during this pregnancy included Metronidazole 500 mg for 7 days on 20-OCT-2008 for bacterial vaginosis and Diflucan 150 mg one time oral dose that same day for a vaginal yeast infection. Additional information is not available.
felt like a bruise; Vaccination site pain; Vaccination site movement impairment; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (felt like a bruise), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Psoriatic arthritis. Concurrent medical conditions included BP. Concomitant products included LISINOPRIL for Blood pressure, ETANERCEPT (ENBREL) for Psoriatic arthritis.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced CONTUSION (felt like a bruise), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment). At the time of the report, CONTUSION (felt like a bruise), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was provided as she took two ibuprofen tablets 30 minutes before receiving the vaccination and two ibuprofen tablets 6 hours later.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The pt developed a red lump on left leg bigger than mom's fist. Had inconsolable crying on 12/17 and was given ibuprofen. On 12/19/01, she guards to walk. Is recovering.
Starting about 8 minutes after injection a rush of light-headedness, right side of body felt heavy and tingly, tongue felt tingly, dry mouth, brain fog, mild trouble focusing, sluggish feeling; all lasting for about 10 minutes before subsiding, then came back in waves every few minutes. Dry mouth and tongue tingling stayed consistently for several hours, other symptoms subsided and came back in waves every few minutes, decreasing in frequency over a two hour period in which I was not allowed to leave the Health Department. Blood pressure and heart rate remained normal and consistent, irregular heartbeat noted at about 10 per minute with heart rate of 74-82 bpm (history of frequent PVCs, roughly 8% of heartbeats irregular previously) Symptoms improved significantly over 2 hour period and I was allowed to leave as long as someone else could drive me home, not allowed to return to work for the day.
On February 18th, a small area around my injection point became somewhat itchy, which has persisted since then. The area, about 2 inches in diameter, has a slight pinkish hue.
Hives; Became itchy; Sensation that wants to scratch as if it was an itch; A bump that appears in the skin, some big and some little, and is mainly on her arms; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (Hives), PRURITUS (Became itchy), SCRATCH (Sensation that wants to scratch as if it was an itch) and SWELLING (A bump that appears in the skin, some big and some little, and is mainly on her arms) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0D1A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN E NOS (VITAMIN E [VITAMIN E NOS]), MULTIVITAMIN [VITAMINS NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), PRURITUS (Became itchy), SCRATCH (Sensation that wants to scratch as if it was an itch) and SWELLING (A bump that appears in the skin, some big and some little, and is mainly on her arms). At the time of the report, URTICARIA (Hives), PRURITUS (Became itchy), SCRATCH (Sensation that wants to scratch as if it was an itch) and SWELLING (A bump that appears in the skin, some big and some little, and is mainly on her arms) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-SEP-2014 the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, lot # H015870, expiration date: 22-AUG-2014). No adverse experience reported. The patient did not seek medical attention. Additional information has been requested.
Vomiting that began 12 hours after taking the vaccine.  She states she vomited 2 to 3 times per hour. She states she took Zofran that she had on hand and it did not help.  She states she did not seek medical attention.  States her  symptoms resolved after 16 hours.. She states her symptoms were severe.
After the injection I had what I thought the normal soreness at the injection site, but after 4 days I had a hard time moving my left arm. I did not think anything of it and just tried to keep exercising it thinking that maybe I pulled a muscle, but now it has been 2 months and the muscle hurts constantly and it is hard to move my arm in different positions. I am going to finally seek medical care for it because it has gone on long enough. I am not sure if it is from the flu vaccination, but I thought it was important enough to report.
Information has been received from a physician concerning a female nurse who was drawing up a syringe of MMR and after reconstituting the vial, the needle exploded and aspirated into the nurse's eyes. None of the vaccination went into the pt's arm. The nurse immediately flushed her eyes with water and sought unspecified medical treatment. Additionally, the reporting physician noted "nurse is not immune (or partially immune) to rubella by titers." No further information is available.