chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt soreness in the area of the injection site; first dose of BNT162B2 on 01Feb2021/ second dose of BNT162B2 on 18Feb2021; first dose of BNT162B2 on 01Feb2021/ second dose of BNT162B2 on 18Feb2021; This is a spontaneous report from a contactable consumer. A 57-Years-Old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266), via an unspecified route of administration in left arm on 18Feb2021 at single dose for covid-19 immunisation. The relevant medical history was not reported. Concomitant medications included atorvastatin calcium (LIPITOR). The patient previously received first dose of BNT162B2 on 01Feb2021 at the age of 57 years old for COVID-19 immunisation (lot number=EL9262, vaccine location=Left arm, dose number=1). The patient felt soreness in the area of the injection site on 20Feb2021. No treatment received for the event. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine in four weeks. The outcome of the event felt soreness in the area of the injection site was recovering.
Post vax, pt awoke with swollen face, lips and hands. Treated with Benadryl and Decadron per ER report. Symptoms resolved.
dT vaccine administered 6/27/03.  Patient reported pain, swelling, bruise by 6/28/03.  Over next weeks, patient reported paresthesias from injection site into forearm on left upper extremity with associated myalgias.  Patient was treated conservatively initially with NSAIDS but with minimal improvement, tylenol #3 was used as well.  Lab evaluation revealed an elevated CRP but no other notable abnormalities.  Pain has persisted and worsened, and he was referred to Neurology for further evaluation.  The neurologist felt he had dysaesthersias in left arm with decreased relexes in distribution of C5-C7 concerning for a plexopathy related to vaccine associated edema, or possibly a demylinating neuropathy.  An MRI and an EMG have been ordered and are pending.
pt recvd vax & exp numbness & tingling p/1st & 2nd doses; exp severe nausea, vomiting, chills, fever, severe h/a; tx APAP, PEpto-Bismol, Emetrol;
emphysemic changes to the lungs; This is a spontaneous report from a contactable consumer (patient herself). This female consumer of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced emphysemic changes to the lungs. The patient underwent lab tests and procedures which included computerised tomogram: showed emphysemic changes to the lungs on last two CT scans which have been since she received the vaccination. The outcome of event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
A sore in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 25Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 90 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262), administration date: 23Jan2021, when the patient was 89-year-old, for COVID-19 immunization, reaction(s): "A sore in her arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: FM9810), administration date: 13Feb2021, when the patient was 89-year-old, for COVID-19 immunization, reaction(s): "A sore in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "A sore in her arm".
Warm to the touch at injection site (L) upper arm; Coldness and tingling on left arm from the injection site to the fingertips; Swollen lymph nodes under left arm; Coldness and tingling on left arm from the injection site to the fingertips; Coldness and tingling on left arm from the injection site to the fingertips; Fever up to 101.0 F; joint aches; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: PE3950), via intramuscularly administered in left arm on 08Oct2021 19:00 (at the age of 36-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included hypothyroidism, known allergies: oral allergy syndrome and walnuts. Concomitant medication included levothyroxine sodium (SYNTHROID) 100 mcg. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscularly administered in left arm on 23Mar2021 15:00 (Lot Number: EN6205) as dose 2, single for COVID-19 immunization (at the age of 36-year-old) and dose 1 intramuscularly administered in left arm on 02Mar2021 15:00 (Lot Number: EM9810) as dose 1, single for COVID-19 immunization (at the age of 36-year-old). The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 09Oct2021 06:00, the patient experienced warm to the touch at injection site (l) upper arm, coldness and tingling on left arm from the injection site to the fingertips, swollen lymph nodes under left arm, fever up to 101.0 f and joint aches. On 09Oct2021, the patient underwent lab tests and procedures which included fever: 101.0 Fahrenheit. The patient was treated with OTC Acetaminophen 2000 mg as a therapeutic measure of all the events. The clinical outcome of the event received events was not recovered.  Follow-up attempts are completed. No further information is expected.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID". Patient thought that it was a reaction to the booster but she did a PCR test that took 4 days to come back and found out that it was covid. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) covid. The lot number for bnt162b2 was not provided and will be requested during follow up.
some of the fluid had leaked out onto her daughter's arm; some of the fluid had leaked out onto her daughter's arm; some of the fluid had leaked out onto her daughter's arm; no additionall adverse event; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, concomitant therapies and drug reactions and allergies were not reported.  On an unknown day, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, administered to arm (lot # and expiration date were not provided) for prophylaxis. During the vaccination some of the fluid has leaked out onto the patient's arm, therefore the patient experienced product leakage, exposure via skin contact and underdose. The reporter was concerned if the patient did not receive the full dose, however the nurse administering the vaccine mentioned that the patient received the full amount required. The reporter inquired about the full dose needed for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse event details were reported.
TC from mom had low temp, lethargic since 30JUL96 had red, raised tender rash on rt arm where inj was;pt to MD to be checked;
right arm started getting red over 24 hrs with lump forming underneath skin.  By 36 hrs, arm swollen to size of tennis ball with red color & warmth at touch. Took 50mg benadryl for it.  Also on cleocin 300 mg qid for infected laceration, ibuprofen 600mg q 6 hrs pain, lortab 7.5 prn pain.  Two days later from shot time slightly improved but still red swollen warm.  Dr in urgent care said need to watch close for abcess forming.  The next day same s/s & then itching began at site as well. Added hydrocortisone cream around outside of injection site. This is helping with redness. Lump remains approx slightly bigger than the size sliced golf ball.
The patient was unresponsive, pale, and diaphoretic when I arrived at their vehicle. The patient rapidly regained consciousness and was alert. The patient was repositioned with legs elevated. Hydration was given.  There was one episode of emesis, which resolved the patient's nausea.   This was a vasovagal episode with true syncope. The patient improved rapidly with supportive care, increased monitoring, and hydration. He was returned home with his father as the driver.
Fluttering heart (main symptom being reported)  Fever  Headache  Shortness of breath   Fatigue
pt recv vax 2MAY97 & 5MAY97 pt exp swelling of lt hand & approx 18MAY97 pt exp joint pain on hand & feet;
Information has been received from a pharmacist concerning an adult patient who was vaccinated with an initial dose of pneumococcal 23v polysaccharide vaccine and five days later was inadvertently give a second dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient developed congestion and a high fever and was transferred to the hospital. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient fainted very briefly. He was sitting in the chair talking with his family member his face went white and he dipped his head as he fainted. He did not fall and came back very quickly. I gave him a bottle of water and called 911. 911 came and evaluated him and he did not leave with them
Patient received his flu vaccine and stood up to rejoin his family members and immediately (within one minute) felt dizzy and lightheaded. He proceeded to pass out and fall to the ground. He seemed mostly out of it mentally but his grandpa and I helped helped him to the the ground to lay down. We kept him talking and continued to monitor his mental status changes. He came out of it pretty quickly but was very sweaty, clammy, and a little confused. After resting a few minutes, he drank some water and moved up to a chair. He felt back to normal after about 10 minutes.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reaction/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VAIRVAX (lot #, expiration date, dose and route were unknown). No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
on 2/4/21 I woke up with an swollen area just below the injection site.  An area approx 3x3ins. It was a little itchy.  (fyi:  The day before I had had major abdomen surgery to remove large, benign growths from my ovaries and was in Hospital at that time)  nurses were informed, they didn't take any action. I also had the same reaction when I had the second COVID Vaccine on 2/22/21
Injection site felt hot and achy very quickly. 1400 hrs I started feeling flushed, diaphoretic, thinking unclearly, injection site very hard, red, swollen (4 inch diameter) with red streaks down past elbow. Neck and face flushed, itchy all over, small hives dispersed over body. Felt like I was going to lose consciousness but did not. Hives, itching, flushing continue today but injection site improved. My upper lip is still swollen, left lower eyelid is still swollen and I still feel itchy especially on my back. I had a lot of phlegm for about 12 hours. My knees were extremely painful yesterday. Today my left knee still has pain and I can't squat down due to intense pain. I started taking 25mg of Benadryl every 4 hours and I am still taking it.
red rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red rash on arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (red rash on arm). At the time of the report, RASH (red rash on arm) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
pt recv vax & never seroconverted;it was also reported that the nurse had some of the vax squirted into eye while vaccinating a pt;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR, start date: 31Dec2020, stop date: 20Jun2022. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin", notes: known allergies: Aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Decrease in amount of menstruation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HYPOMENORRHOEA (non-serious), outcome "unknown", described as "Decrease in amount of menstruation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021450627 same reporter, drug, event/different patients
One hour after vaccination, experienced chest pain with breathing; three hours after vaccination experienced fever, chills, and rapid heart rate.
Injection site pain (mild); Developed pain/sensitivity to touch (mild) around whole left shoulder from back of shoulder (trapezoid to collarbone); Moderate pain under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration in left arm on 17Mar2021 at 19:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. On 18Mar2021, the patient experienced injection site pain (mild). On day 2-3 on an unknown date in Mar2021, the patient developed pain/sensitivity to touch (mild) around his whole left shoulder from back of shoulder (trapezoid to collarbone) with moderate pain under left armpit. The armpit pain was totally resolved after day 4, but general mild pain/sensitivity around left shoulder from left trapezoid to front of left collarbone persists even to the day of this report. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event armpit pain was resolved on an unknown date in Mar2021 (after day 4) while that of vaccination site pain and shoulder pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Dizziness, Headache, Myalgia, CoughWheeze, Diarrhea, NauseaVomiting & Palpitations Narrative: aFTER2 HOURS OF TAKING THE VACCINE THE EMPLOYEE COMPLAINED OF DIZZINESS, NAUSE AND VOMITING. SHE WAS GIVEN LEAVE AND REPORTED MYALGIA, VOMITING, FEVER THROUGH THE FOLLOWING 3 DAYS.
Information has been received from a nurse practitioner concerning an other nurse's daughter, who on unspecified date was vaccinated subcutaneously with her first dose of GARDASIL (lot# unspecified).  Subsequently the patient experienced local injection site reaction with "achiness".  Unspecified medical attention was sought.  At the time of this report the patient's outcome was unknown.  No other information provided.  Additional information has been requested. This is in follow-up to reports previously submitted 6/11/2008. Initial and follow-up information has been received from a nurse practitioner concerning an other nurse's (23 year old daughter, who on 21-MAY-2008 at 4:00pm was vaccinated subcutaneously with her first dose of GARDASIL (lot# 659964/1976U). Subsequently the atient experienced local injection site reaction with "achiness". Unspecified medical attention was sought. At the time of this report the patient's outcome was unknown. No other information provided. Additional information has been requested.
general weakness, headache, numbness in the left arm, muscles pain, sore throat, runny nose,  nausea, dizziness, forgiveness.
This spontaneous report was received from a doctor of pharmacy refers to an 82-year-old male patient. On 09-APR-2013 (reported as today) the patient was vaccinated with an expired dose of 0.65 milliliter (ml) ZOSTAVAX (lot # 671451/1193AA, expiration date 25-OCT-2012) subcutaneously. No adverse effects reported. Additional information has been requested.
11.5 x 13 cm redness at injection site, nontender, no warmth, not indurated.  No fever.
earache opposite side of vaccine; tenderness on right side of my head not painful just sensitive to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EL9267) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart attack" (unspecified if ongoing), notes: other medical history: Heart attack 6 years ago but am in great condition no heart defects. Concomitant medication(s) included: VENLAFAXINE; LEVOTHYROXINE; IRBESARTAN; VIT C; TURMERIC [CURCUMA LONGA RHIZOME]. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer, Lot No = EL9267, Lot unknown = False, Administration date=15Feb2021, Administrator time= 12:00 PM, Vaccine location=Left arm), administration date: 15Feb2021, when the patient was 70 years old, for COVID-19 IMMUNISATION, reaction(s): "Bleeding ear same side as vaccine", "earache opposite side". The following information was reported: EAR PAIN (non-serious), outcome "recovered" (2021), described as "earache opposite side of vaccine"; TENDERNESS (non-serious), outcome "recovered" (2021), described as "tenderness on right side of my head not painful just sensitive to touch". Therapeutic measures were not taken as a result of ear pain, tenderness. Additional information: No other vaccine in four weeks. Adverse event: Bleeding ear same side as vaccine 10 days later earache opposite side. 2nd vaccine earache opposite side of vaccine and tenderness on right side of my head not painful just sensitive to touch. No covid prior vaccination, no covid tested post vaccination and no known allergies.  No follow-up attempts are possible. No further information is expected.
legs ache; lumpy area on injection site; dry skin round the area; feels there is a hole; extreme fattigue; rediculously exhausted; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (legs ache), VACCINATION SITE NODULE (lumpy area on injection site), DRY SKIN (dry skin round the area), FEELING ABNORMAL (feels there is a hole) and FATIGUE (extreme fattigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (legs ache), VACCINATION SITE NODULE (lumpy area on injection site), DRY SKIN (dry skin round the area), FEELING ABNORMAL (feels there is a hole), FATIGUE (extreme fattigue) and FATIGUE (rediculously exhausted). At the time of the report, PAIN IN EXTREMITY (legs ache), VACCINATION SITE NODULE (lumpy area on injection site), DRY SKIN (dry skin round the area), FEELING ABNORMAL (feels there is a hole), FATIGUE (extreme fattigue) and FATIGUE (rediculously exhausted) had not resolved.        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.   No relevant concomitant medications were provided. No treatment information was provided.
Pain near shoulder joint - limit ROM (Rt) shoulder. Concern for vaccine administered too high.
I had very severe vomiting followed by diarrhea and fever that lasted 2 complete days, now I am in  vaccination +6 days and now my wife is sick and I still have very bad nausea and near vomiting, I also still have sweating and fever but it is getting better, terrible light headedness when I stand and brain fog all day, still continues.
Information has been received from an unspecified reporter referring to a 15 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.