chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bottom of my feet was sore, when I walk I feel very uncomfortable and it also affect my ankle/ I started having soreness in the bone and in the heel on both of my feet; bottom of my feet was sore, when I walk I feel very uncomfortable and it also affect my ankle/ I started having soreness in the bone and in the heel on both of my feet; soreness in the bone and in the heel on both of my feet; I am having from 2, 3 days chills/I had just two or three chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took the Pfizer COVID-19 Vaccine on the 10th of this month (Feb2021) and the patient having from 2, 3 days chills but after the following days, after the first day on the second day (12Feb2021), the patient started having the bottom of feet was sore, when the patient walk, felt very uncomfortable and it also affect ankle. The patient stated that patient took the Covid Vaccine, Pfizer Vaccine on 10Feb2021 and on that day (10Feb2021), the patient had just two or three chills and the patient was sleeping but after the next day, on 12Feb2021 the patient started having soreness in the bone and in the heel on both of feet. The patient was wondering if that was anything related to the vaccine shot or what. The patient wanted to know what should be done about that. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient is 17 years old and did not meet age requirement for vaccine and was given the shot by mistake.  Staff was notified and re-trained on administration requirements of Moderna Vaccine in order to prevent future errors.
Inconsolable irritability almost immediately after receiving the vaccines lasting approximately 4 weeks or longer & then gradually subsided. There was a fever after the immunization to 101.3 (R?) & this lasted less than 24 hrs.
This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient was vaccinated intramuscularly with a first, second and third 0.5 ml doses of GARDASIL on 28-MAY-2012, 18-JUL-2012 and 25-JUL-2012, respectively. No adverse effect reported. Additional information is not expected.
Pfizer 3/26/21, 4/16/21, 10/19/21, 10/5/22. Positive on 2/12/2023
Throat/esophageal swelling and difficulty swallowing noted approx. 3 hours after 2nd dose was administered. Symptoms were the same as they were after my first dose, so I'm managing them at home with Benadryl, warm packs, soft food and liquids and continuing to monitor at home. No respiratory issues to note. I met with my PCP after my reaction to the first dose. He suspects lymphedema in response to the vaccine. I waited until all symptoms were clear to receive my second dose per my PCPs instructions.
No adverse reaction to first 2 doses of Moderna.  However, broke out in hives all over body beginning 2 weeks after receiving 1st Booster.  Hives/rash appeared in one area or areas, itch severely for approx. 15-30 min. and then go away only to resurface on another part of the body.  Areas where hives/rash have been most severe have been the neck & groin but virtual parts of the body have been affected, including soles of feet and palms of hands.   GP and dermatologist recommended 2 doses of antihistamine per day to treat symptoms.  5 months after 1st Booster, symptoms still occur and require treatment with Zyrtec once or twice/day to help control hives/rash and itching.  Despite short intervals when symptoms have been less severe or frequent, there has been no appreciable long-term decrease in severity or frequency of symptoms over time.
This spontaneous reports as received from a male patient of unknown age refers to himself. The patient was vaccinated with ZOSTAVAX (route, dose and lot # were not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient experienced that after receiving ZOSTAVAX his arm has turned red, swollen, and itchy. No treatment was given. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
adverse event; First dose was in february 2018, the patient had not had her second dose; This spontaneous report was received from a physician via a company representative and concerns to a 12-year-old female patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  In February 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, anatomical site, lot# and expiration date were unknown) for prophylaxis.  On an unknown date, the patient experienced an unspecified adverse event. The reporter also stated that the patient had not had her second dose of and inappropriate schedule of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  At the reporting time, the outcome of the unspecified adverse event was reported as recovered on an unknown date.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the unspecified adverse event was not reported.  The reporter stated that the unspecified adverse event was not life-threatening.
Pfizer 5/26/21, 6/17/21. Positive on 12/12/22.
The injection site was the right deltoid.  Client presented and was seen at the Health Department on 5/25/04 at 4:30 pm.  The site was pink and edematous, measuring 75cmx50cm.  A 3cmx5cm ulceration was noted inside the edematous area.  Site warm to the touch and child stated area hurt when palpated.  Referred to ER for physician follow up.
COVID -19 vaccine given to 11 yr old patient. No adverse symptoms known to date.
a stiff arm; 53 days has pasted since his first dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (a stiff arm) and PRODUCT DOSE OMISSION ISSUE (53 days has pasted since his first dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (a stiff arm) and PRODUCT DOSE OMISSION ISSUE (53 days has pasted since his first dose). At the time of the report, MUSCULOSKELETAL STIFFNESS (a stiff arm) had not resolved and PRODUCT DOSE OMISSION ISSUE (53 days has pasted since his first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided. Patient was supposed to get vaccinated on 16-APR-2021 but 53 days has pasted since his first dose
Pain and tenderness caused by swelling the size of a baseball in lymph nodes in the left armpit, swelling in lymph nodes below collar bone, swelling in lymph nodes above collar bone at the base of the neck. I was told that the swelling should go down and to keep an eye on it. Apply warm compresses and take Advil/Tylenol as needed for pain.
pain and welling at injection site3inches in diameter. Fever over 100F, chills, body aches, headaches, dizziness, weird taste in mouth, loss of appetite.  injection site pain started about 10-15 minutes after injection and worsened. Now 36 hours after injection and pain is still very bad.   Other symptoms started about 18 hours after injection
Treatment: - Pfizer-BioNTech COVID-19 Vaccine EUA  Resulte - Mild Diharrea two days after vaccine was administered.
Started with feeling light headed... then dizziness... then severe dizziness and loss of equilibrium....followed by nauseousness and vomiting.....including sweats...... Disorientation persisted.  Symptoms became severe and extended.  Unable to stand without holding onto furniture or walls.  Symptoms lasted approximately 15 hours until about noon the following day.  During this time period, there was no pain (other than described)... no headaches.  No problems since other than sore ribs and stomach from the violent vomiting as well as exhaustion from the event and lack of sleep..  The soreness subsided after about three days or so.  Feeling fine ever since..... no recurrences.  Never had a previous reaction in over 40 years of getting the flu shot.  Very strange.
burning and swelling in the genitalia; burning and swelling in the genitalia; This is a spontaneous report from a contactable consumer. This consumer reported for female (patient) that includes:  A 5-decade-old (a woman in her 40's) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced burning and swelling in the genitalia on 2021. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101029567 Same reporter/ drug, different patient/ AE
Date and time adverse event started: started 2-8-2021 at approx 9:50am with numbness & tingling to tongue lasting about 2hr and resolved. Reports not seeking emergency treatment due to symptoms resolving.  recommended they make an appointment for their PCP and advise of occurrence. Also advised they needed to have a conversation with their physician to out weigh risks/benefits of continuing with the 2nd dose. Informed wife she needed to call 911 immediately if symptoms of numbness/tingling confusion, paralysis occurred. Informed her the nature of that being a time sensitive matter if symptoms began. Verbalized understanding
apparent apneic event followed by possible sz;intubated @ hosp;vent x 24hr then stabilized;
Patient reported tongue swelling and difficulty swallowing on the day after the vaccine was given.  Symptoms were mild and were not brought to my attention for 10 days.  She is still having some tongue swelling after 10 days, however she appears perfectly fine.  She has no difficulty breathing or swallowing.
Cold; they got COVID in August. They tested positive; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (they got COVID in August. They tested positive), DRUG INEFFECTIVE (Lack of drug effect) and NASOPHARYNGITIS (Cold) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (they got COVID in August. They tested positive) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, COVID-19 (they got COVID in August. They tested positive), DRUG INEFFECTIVE (Lack of drug effect) and NASOPHARYNGITIS (Cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant use were reported. No Treatment were reported. The patient states that she also had a breakthrough case.  Company comment: This case concerns a 54-years-old female patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 4 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  Further information received states that the patient had cold symptoms and no hospitalization was required.  No further information was disclosed.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-415883 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Follow-up received and patient demographics, events and batch number details were added.; Sender's Comments: This case concerns a 54-years-old female patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 4 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  Further information received states that the patient had cold symptoms and no hospitalization was required.  No further information was disclosed.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
p/vax pt exp general malaise, a fever, & body aches;over next 24 to 48hr pt cont to feel ill w/T101, nausea, severe h/a, arthralgia;rt arm was swollen, erythematous & tender to touch from shoulder to elbow;
7 hours after shot  got the chills and felt weak. Went to be early. Chills got worse I was so cold I piled blankets on    Got so weak I could hardly move  By about 10:00 P.M. hallucination started and lasted for about 5 hours I was so weak I could not call for help if I wanted to.  First reaction ever to a vaccine
My period is late and changed after my 1st dosage of Moderna. It seems like I am now irregular. I am waiting for my period to come on now but no signs as of yet. When I did have a period in the beginning of April, it appeared as if I was spotting for days - 1 week and no cramps.
When she removed the bandaid, she found 2 red spots in her arm. Large circle rash. It feels warm.  On 10/13: No more rash, just a small bruise. Itchy, but no pain.
Developed unexplained Bell?s palsy on the left side of my face with mild swelling on the right side of my face.
Herpes Zoster diagnosis in a two dose varicella vaccine recipient on 7/14/14. Treated with acyclovir. Painful rash in one dermatome. Lasted <4 weeks. Unknown history of disease.
Dizziness, Vertigo, High Blood Pressure-189/  : Headache, Uncontrollable chills and shaking, Sick to stomach feeling, Foggy thinking
Patient presented to the ED and was subsequently hospitalized for acute respiratory failure with hypoxia within 6 weeks of receiving covid vaccination.
Patient reported to the pharmacy last night saying that she had a large rash on her right upper arm beginning at the injection site and moving down to her elbow. Patient stated that the rash began on Wednesday and was hot and slightly itchy. Advised patient to take over the counter benadryl and call us back on 5/12/18 to let us know how she was doing.
Site received refrigerated Pfizer vaccine from hub site. Date marked on delivery container: 10/10/2021. Site personnel looked at the vial expiration date, not realizing that 10/10/2021 was the refrigeration expiration date. Vaccine expired 10/10/2021 given on 10/11/2021 to 8 people. 12 doses given on 10/18/2021 and 8 more doses on 10/22/2021.
Pt developed fever and body aches the evening the injection was administered. Did not have thermometer to check actually temp.
Information has been received from an RN concerning a 28 yo female pt with PCN and Codeine allergies who on 06FEB2004 was vaccinated SC into the left arm with MMR. On 13FEB2004 the pt called the nurse stating she had a slight fever of 99, a tender, warm one inch lump on left arm the size of a quarter on the left arm, malaise and HA two nights prior. There was no rash reported. No lab or diagnostic studies were done. The pt hadn't yet recovered as of 13FEB2004. Additional info has been requested.
1. Was hospitalized 9/16/08. 2. Hospitalized 01/30/09. 3. Hospitalized for GBS - 02/06/09.  12/11/09 DC summary for DOS 09/16/08  09/20/08: Final DX: R upper lobe pneumonia. Pt c/o malaise, decreased appetite, fever, weakness bilaterally.  On examination: leukocytosis.  Tx: antibiotics.  Pneumonia resolving.  Pt discharged home.    12/11/09 ED note for DOS 01/30/09 DX: paresthesias. Pt c/o numbness BLE and BUE. Decreased sensation hands and feet. Pt discharged with cardiology f/u.  12/03/09 DC summary for DOS 02/06/09  02/10/09. Final DX: GBS. Pt c/o weakness and tingling of U and L extremities. Pt had transthoracic echocardiogram:  moderate enlarged LA, mild L inferior hypertrophy, mild enlarged RA. Also, LP performed.  12/03/09 DC summary for DOS 02/13/09  02/16/09 Final DX: GBS. Pt readmitted for further observation of GBS.  On 02/14/09, Pt had unsteady gait.  Pt's GBS was slowly progressing, but there were no health concerns during the hospital stay.  Pt was stable and able to ambulate with cane.  Pt discharged home with OT/PT f/u.
A non-serious spontaneous report of false positive for amphetamines has been received from a consumer concerning himself, 49-year-old male, subsequent to H1N1, Intranasal. The patient's past medical history was not reported and concomitant medications included ranitidine and other medications for blood pressure. The patient did not use methamphetamine. On 04-Jan-2010, the patient received H1N1, Intranasal, for an unknown indication. On 08-Jan-2010, the patient was tested positive on a urine test for amphetamines. The outcome for the reported adverse event was unknown at the time of reporting.
Injection site turned red, hard and swelled up; Injection site turned red, hard and swelled up; My axilla and peck muscle was swollen to 3 times it's size; feel a big swollen node; Flu type symptoms; This is a spontaneous report from a contactable other-HCP (Patient). A 57-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via unspecified route of administration, administered in left arm on 04Feb2021 at 09:30 AM (at the age of 57-years) as single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249), administered at left arm on 12Jan2021 at 09:45 AM as single dose for COVID-19 immunisation. The patient medical history included osteoarthritis. Patient had no known allergies. Concomitant medications included levothyroxine and acyclovir. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Feb2021 at 11:30 AM (26-hours after vaccination), patient experienced flu type symptoms and at 09:30 PM (36-hours after vaccine), injection site turned red, hard and swelled up. On 06Feb2021 (morning), axilla and peck muscle swollen to 3 times its size. Patient received ibuprofen and Benadryl for treatment, and it went down a little however, patient can still feel a big swollen node that appeared a day before. No specific treatment was given for swollen node. Since the vaccination, patient was not tested for COVID-19. The outcome of all the events was not recovered.
Arm is very sore, I cannot lift it; Have feel the pain with first one, but with this one they put in the injection and I can feel the pain right away; Nausea; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administration date 19May2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization, reaction(s): "Headache", "Sore arm"; Bnt162b2 (Dose:1, Verbatim:When confirmed if it was the first Pfizer COVID shot, Consumer stated, "Yes It was for COVID shot the first shot, for two days I have like nausea, like headache and my arm I cannot lift it,), for COVID-19 immunization, reaction(s): "Naussea". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19May2021, outcome "not recovered", described as "Arm is very sore, I cannot lift it"; VACCINATION SITE PAIN (non-serious) with onset 19May2021, outcome "unknown", described as "Have feel the pain with first one, but with this one they put in the injection and I can feel the pain right away"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache".  Addition information:I think I am not able to go work today because my arm cannot lift things which are heavy. I just need a note so that I can take it tomorrow because I work from Saturday to Wednesday, I work at nights. So if you can email or notes, so that they can see that because they ask me for the mail after two days, three days. I have felt the pain with first one like that, but with this one they put in the injection and I can feel the pain right away."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I am currently being treated for a frozen shoulder that occurred immediately following what I believe was an incorrectly administered flu shot.
At 1500 on 10/4/2018 patient presented w/shortness of breath, chest tightness, and swelling of the left anterior and posterior upper arm extending to the left antecubital and anterior chest wall at the pectoral muscle. SOLU-MEDROL IM 125mg, BENADRYL 50mg IM given. EKG completed was normal. Patient was monitored for 2 hours after injections. At time of discharge anterior/posterior swelling in the (L) arm was subsiding, and patient was no longer short of breath. Patient was scheduled a follow up appt on 10/5/18. On 10/5/18 all symptoms were resolved except for redness and swelling of the left upper arm which is continuing to improve/subside.
Damaged heart muscle and caused a state of non-corrective atrial fibrillation with a persistent elevated resting heart rate and regular episodes of tachycardia.
RIGHT THIGH 30 CM WARM/ERYTHEMATOUS.  LEFT THIGH 28 CM WARM/ERYTHEMATOUS.