chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; tiredness; Chills; Feverish feeling; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 27Mar2021 at 14:30 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin and pollen allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 06Mar2021 at 14:15 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 06:00, the patient experienced injection site pain, tiredness, chills, feverish feeling and feeling unwell. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events vaccination site pain, tiredness, chills, feverish feeling and feeling unwell were resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
rash like little spots and lightly pink; itchy at times; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash like little spots and lightly pink) and PRURITUS (itchy at times) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced INJECTION SITE RASH (rash like little spots and lightly pink) and PRURITUS (itchy at times). At the time of the report, INJECTION SITE RASH (rash like little spots and lightly pink) and PRURITUS (itchy at times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Following Hep A vaccination pt immediately reported that her chin felt warm and numb, she stated that she felt dizzy, and localized itching at site. Cold compresses pack was placed at the injection site, Pt was monitored and assessed for about 24 minutes and instructed to call us if symptoms persist.
sub-q injections was given in the abdomen; No adverse outcome; per the CDC, the doses will count as valid and do not need to be repeated but this is seen as an error. A VAERs report needs to be completed.
In May of 2022 I noticed tingling in my feet especially when I was in bed.  In August 2022 I noticed my A1C and it was 8.2 which was high.  Three months before that it was 6.8.  I got another glucose monitor and began to check daily.  Average daily is 189.  Mine for about the last month and every morning it is 180 or so constantly high.  I have an appointment with an endocrinologist at the end of Halloween.
Started with migraine "flashes" almost immediately, then turned into steady migraine. Within two hours, pain/heat/swelling at injection site, back muscles and neck tightened, right lymphoid in the throat felt swollen, mild muscle shakes. Through the night, intense migraine, massive night sweats, and random muscle cramps (similar to 'charlie horse' cramps.) Morning after(As of 9am 07 April 2021), arm still in pain, shoulders and back muscles tight, slight migraine, overall feel exhausted and weak.  Treated with 800mg ibuprofen at 16:30 on 06 April 2021, 1 tab generic benadryl at 20:00, zero effect or reduction in syptoms.
Nausea; Stomach cramps; Tiredness; Feeling very cold; Feeling tightness in stomach; Tightness in chest muscles; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07Apr2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, chronic back / neck - degenerative disc disease. Concomitant medications included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), empagliflozin (JARDIANCE), ibuprofen (MANUFACTURER UNKNOWN) and cinnamomum cassia (CINNAMON); all from an unknown date for unknown indication. The patient previously took exenatide (BYDUREON) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021, started 3 days later, the patient experienced nausea, stomach cramps, tiredness, feeling very cold, feeling tightness in stomach and chest muscles on Monday morning. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of nausea, stomach cramps, tiredness, feeling very cold, feeling tightness in stomach and chest muscles was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
one week after vaccine left arm swelled, became extremely hard, hot and itchy.  I also had swollen glands.
Received Moderna vaccine on 1/7/21.  She waited the required 15 minutes and then left.  At that time she started getting palpitations.  Her glucose level was 130. She also noted flush neck and chest.  Went back to the vaccine site where they took her BP and noted vitals of HR 130, BP 200/109.  Also noted to have petechial rashes on both arms.  Given 500 mL of NS and monitored in the ER.  It took about 2 hours for HR to improve and 3 hours for BP to improve.  Petechiae subsided the following day. The next day, noted low grade fever.  100.2F temp.  Muscle pain. Injection site swollen to elbow and used warm compresses.  Noted lymph node enlarged under left arm, last 5 days.  She now notes getting itchy all over.  She notes her symptoms are daily for several weeks.
The day after the vaccine I had body aches all over and then from my waist down my legs were very numb to the point where I could not walk.
Pt was found by his father at home in full arrest. 911 contacted and taken to the ER. Vaccines were administered on 3/19/02. COD as per autopsy report: SIDS. Per F/U 5/28/02: Pulmonary vascular congestion, bilateral, severe, with mild edema and generalized visceral congestion, moderate.
Diagnosed with shingles 2-2-2017 rash and pain in right arm. VALTREX 1 gram, BENADRYL, Acetaminophen.
Tinnitus. It began the morning after and has been constant since. I have had previous bouts of it, about 1 per month that would last 2-4 hrs. This has been constant.
1:30 am 3/26 woke with chills, severe headache, all over body & joint aches, nausea, cough. No temp. Injection site swollen, red & painful. Minimal oral intake. 4:00 pm zofran. 8:00 pm Tylenol. Midnite zofran. 8:00 am 3/27 chills decreased. Allover aches & headache continue. No temp. Arm still red, swollen & painful. Zofran.  Headache & body pain continue thru day. Tylenol noon & 8 pm. 3/28 Headache & all over pain continues. Decreases some with Tylenol aporox every 6-8 hours. Arm remains red, swollen & painful. No help with cold compress. 3/29 Reviewed with primary care doctor. Encouraged ice to site today & Aleve 3 tabs every 12 hours x 3 doses. May then use Aleve 1 tab every 12 hours & heat to site Tues. Continue fluids & small meals as tolerated.
Flare up with her psoriasis; Feet felt like they were on fire, burning sensation on her feet; Feet red in color; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Flare up with her psoriasis), BURNING SENSATION (Feet felt like they were on fire, burning sensation on her feet) and ERYTHEMA (Feet red in color) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Psoriasis. Concurrent medical conditions included Penicillin allergy. Concomitant products included ENALAPRIL MALEATE (ANAPRIL), PRAVASTATIN and VITAMINS NOS for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PSORIASIS (Flare up with her psoriasis), BURNING SENSATION (Feet felt like they were on fire, burning sensation on her feet) and ERYTHEMA (Feet red in color). The patient was treated with ADVIL [IBUPROFEN] at an unspecified dose and frequency and AMMONIUM LACTATE (AMLACTIN) at an unspecified dose and frequency. At the time of the report, PSORIASIS (Flare up with her psoriasis), BURNING SENSATION (Feet felt like they were on fire, burning sensation on her feet) and ERYTHEMA (Feet red in color) outcome was unknown.            Reporter did not allow further contact
Hot flashes within 30 minutes which lasted for approximately 12 hours. Within approximately 4 hours, felt a surge of mental clarity and began hyperfocusing on a subject for approximately 7 hours, which is unusual for me unless I am experiencing a mood episode. I have experienced hypomanic episodes, around 1/year, and I started noticing the signs shortly after the dose which hadn?t been present in the days leading up to the day of the vaccine. I was awake all night and could not sleep. Finally slept for a few hours and woke up feeling okay. I noticed extreme irritability during the whole day and heightened psychomotor agitation (not caused by stimulant use or any other drug) including motor tics which I perform when I?m having a mood episode of hypomania. They don?t occur when I?m in a normal mood. I?m wondering if the immune response caused by the vaccine triggered a hypomanic episode. Also experiencing teariness at minor frustrations and slight muscle pain and fogginess like I cannot focus my energy but at the same time have an excess of it. None of this had started until a few hours after the vaccine dose
both hands covered in a rash; fatigue; pain at injection site; chills; headache; This is a spontaneous report from a contactable consumer. A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 18:45 (at the age of 46 year) as dose 1, single for COVID-19 immunisation. Medical history included none. Patient had known allergies to Reglan. No Covid prior vaccination. Patient had covid tested post vaccination. Concomitant medication(s) included melatonin (MELATONIN). The patient previously took Reglan [metoclopramide hydrochloride] and experienced drug hypersensitivity. On 30Jan2021 at 13:30, first day patient experienced with pain at injection site, by afternoon had chills and then headache started and on 31Jan2021 second day had chills, fatigue, and headache and on 01Feb2021 third day had fatigue and woke up with top of both hands covered in a rash. Worse on left hand, which was arm that patient got the shot in. Because patient hands broke out into a rash and no new body products were introduced and it was occurring during the chills, fatigue and headache of the shot, patient was told to report the reaction to help others. Patient just got second shot last night 19Feb2021 and was also told that if any reactions occur to report the symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 29Jan2021, sars-cov-2 test: negative on 12Feb2021. AE did not result in physician office and emergency room. Therapeutic measures were taken as a result of all AE which included treatment hydrocortisone for rash, aleve/ Zolmitriptan. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Low grade headache; arm site pain; un-wellness/feeling unwell; muscle ache; fatigue/ tiredness; anxiety; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (COVID-19 vaccine, Lot Number: EL9264), via an unspecified route of administration in the arm on 28Jan2021 (at the age of 68-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. On unspecified date in 2021, the patient experienced low grade headache, arm site pain, un-wellness, muscle ache, fatigue/ tiredness and it has lasted beyond 72 hours, and anxiety, but it's hard to tell if because the patient have been feeling unwell that's causing anxiety or if that was a side effect somehow. On unspecified date in 2021 (72 hours ago), the blood test was taken with unknown result. The patient will have the second dose on Thursday, 18Feb2021. No treatment was received for the events. The outcome of the event anxiety was unknown while the other events recovered on unspecified date in 2021.
Felt like she was paralyzed; Could not move or lift arm; Weak; Fever of 100.4; A spontaneous report was received from a consumer concerning a 84-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt like she was paralyzed, could not move or lift arm, fever of 100.4, and weak.  The patient's medical history mentions COVID-19 in Dec 2020 and blood pressure. Concomitant medications provided were blood pressure medicine NOS and vitamins.  On 09 Mar 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 030a21a) intramuscularly for prophylaxis of COVID-19 infection.   On 09 Mar 2021, patient stated she had a bad reaction. Patient stated it felt like she was paralyzed, and she could not move or lift arm. Patient stated she had a fever of 100.4 and weak . The event, felt like she was paralyzed was deemed medically significant.  Treatment information was not provided. Lab tests were not provided.  Action taken with respect to mRNA-1273 was not reported.  The outcome of the events, felt like she was paralyzed, could not move or lift arm, fever of 100.4 and weak was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Facial numbness - mental nerve.  I checked with my dentist and they didn't find anything dental involved.  My doctor checked it out, ruled out Bells Palsy (no dropping face), ordered blood work, and eventually an MRI.  Possible abnormailities - MGUS was found in my blood work. I had a brain MRI, with nothing found.  My doctor said the numbness is not likely related to my Covid booster shot.  I am now involved with a Oncologist, and have a CAT, additional blood work, and other possible tests to look for Multiple Myeloma issues.   My numbness is still  there.  It is very localized between the lips and chin on the right side, from the centerpoint to about an inch or two to the right.  Some tingling occurs randomly.
Pt received second dose of Pfizer Covid19 vaccine on 8/18/21 (first dose given on 7/28/21). The following day he c/o chest pain and had a witnessed syncopal episode. Paramedics were called but he was not transported. On 8/20 he went to the ED with complaints of emesis and chest pain. His CXR, electrolytes and CBC were normal so he was sent home. On 8/23 he returned to the ED where his head CT, EKG and CXR were normal but his troponins were elevated (0.9) so he was transported to Hospital with concern for myocarditis.   8/24/21: troponin 0.72, then 0.65, then 0.61, then 0.48 8/25/21: chest pain resolved. troponin trended down to 0.28.  discharged home with cardiology follow-up.
Terrible case of hives which required Prednisone for almost 2 weeks ***I volunteered for the AstraZeneca Covid vaccine research study in the fall of 2020.  I did receive the actual vaccines in November and December.  In May, my primary doctor had me tested for antibodies as it had been over 6 months since vaccinated.  The test showed I had no antibodies to Covid so my doctor recommended that I get the Pfizer vaccines which I did in May and June of 2021
30 min - 1 hour long crying spells and Fever 100 degrees treated with Tylenol duration 24 hours. 18 hours after shot, diarrhea, vomiting, lack of appetite and increased sleepiness. Vomiting treated with Zofran. All symptoms except fever still on going as of 11/8/2010.
SARS-CoV-2 infection; Vaccination failure; This case was received via European Medicines Agency (Reference number: AT-BASGAGES-2021-054241) on 12-Nov-2021 and was forwarded to Moderna on 12-Nov-2021.    This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3002920 and 3001943) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications was provided.  This case concerns a 47-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of COVID-19 (AESI) and vaccination failure. The events occurred 3 months, 24 days after the second dose of mRNA-1273. The rechallenge for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events term, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Translation Received on 15-NOV-2021,Information on Sender of Case Safety Report, Dosage Relevant is translated; Sender's Comments: This case concerns a 47-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of COVID-19 (AESI) and vaccination failure. The events occurred 3 months, 24 days after the second dose of mRNA-1273. The rechallenge for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events term, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting.
flu like symptoms and arthritic pain in knees, ankles , elbows, hands and shoulders.
Initial report retrieved on 19 October 2011 via a search of the scientific literature. Lichen planus (LP) is an inflammatory dermatosis of unknown etiology that is primarily associated with liver disease. Recently, there have been several reports of LP developing after administration of the hepatitis B, influenza and MMR-DTAP-IPV vaccines. Here we report the first case of LP developing on the lower extremities of an otherwise healthy adult male after administration of the Tdap vaccine. We present this case to draw awareness to this observation in light of recently updated Tdap vaccination recommendations. A previously healthy 34-year-old male presented with a pruritic skin eruption on his lower extremities of three weeks duration. Physical examination revealed multiple scattered violaceous polygonal plaques with fine scale on the anterior lower legs, without any associated lesions on the skin, nails, or oral mucosa. The clinical diagnosis of LP was suspected and shave biopsy was performed. Histopathology demonstrated epidermal acanthosis with a focal saw-tooth-like pattern, hypergranulosis, hyperkeratosis with parakeratosis, scattered dyskeratotic keratinocytes within the epidermis and a band-like lymphocyte-predominant inflammatory infiltrate with associated basal vacuolar alteration. Based on the clinical and histopathologic findings, a diagnosis of LP was made. Routine laboratory tests, including complete blood cell count and liver function tests, were normal. Further inquiry revealed that four weeks prior to the eruption, the patient had received a single dose of ADACEL (lot number not reported) in his deltoid muscle. The vaccine was administered in accordance with recent Center for Disease Control guidelines, advising family members of young infants to receive the vaccination in order to minimize the risk of pertussis contraction in infants. Given the patient's otherwise non-contributory past medical and medication history, a diagnosis of LP subsequent to Tdap vaccination was made. The patient was treated with clobetasol 0.05% ointment over an eight-week period, resulting in gradual resolution of the eruption. Documents held by sender: None.
Right arm, neck scapula 2+ edema, redness and warmth. symptoms started on 04/22/2002 at 9pm. NO medication taken for discomfort. Prescription for Benadryl 12.5mg given. Returned to clinic on 04/25/2002 for further evaluation. Follow-up appt. on 05/22/2002 scheduled.