chrisvoncsefalvay/vaers-outcomes huggingface dataset:
kidney injury; swelling of her lower extremeties; proteinuria; acute tubular injury; This is a spontaneous report from a non-contactable healthcare professional. A 70-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 28Jan2021 (at the age of 70-year-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246), intramuscular in the left arm on 07Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included valaciclovir hydrochloride (VALTREX), atenolol (MANUFACTURER UNKNOWN), zolmitriptan (MANUFACTURER UNKNOWN), alprazolam (XANAX) and multivitamins (unspecified), all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021, 3 days after the second dose, the patient experienced swelling of her lower extremities with proteinuria and acute kidney injury. The patient was hospitalized on 24Feb2021. The patient underwent lab tests and procedures which included creatinine of 0.7 mg/dl in Nov2020, albumin of 4.7 mg/dl in Nov2020, creatinine of 1.02 on 03Feb2021, and on arrival to  Hospital on 24Feb2021: creatinine of 2.2 mg/dl, proteinuria of 19.99g, and kidney biopsy which showed minimal change disease and acute tubular injury. Therapeutic measures were taken as a result of the events which included prednisone 70mg daily. The clinical outcome of the events acute kidney injury, peripheral swelling and proteinuria was recovering; renal tubular injury was unknown.     No follow-up attempts are possible. No contact Information available.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Rash on abdomen and chest for 3 days.  Diarrhea for one day.  Afebrile without vomiting or diarrhea.  Benadryl every 6 hours as needed.  Rash papular without vesicles.
I got my first dose of the Pfizer Covid vaccine on Saturday, 01/02/21, around 12:30 pm. About 12 hours after I got the vaccine (around 1 am), I woke up with a headache, chills, body aches and a low grade fever. During the night, my temp got up to 99.9 and continued to stay around mid to high 99s throughout the day on Sunday. I tried Tylenol without any success and kept going in and out of chills with body aches and headache persisting. Before I went to sleep Sunday (01/03/21) night, I switched to Ibuprofen and woke up Monday morning without a fever but still experiencing fatigue. Throughout the day on Monday, fever did not return. I stayed home from work on Sunday and Monday. On Tuesday 01/04/20, I was still tired but able to return to work.
persistent shoulder pain that has been going on for 11 days , sever to the point that she can not move her arm, feeling tired and sleepy
Patient stated that he was fine in the morning, but vomited and had diarrhea throughout the night.
Pt received the second dose of the Pfizer vaccine. The patient waited 15 minutes  in the observation area. Once the patient left the building, her husband returned with her within 5 minutes of leaving bc, he noticed her having swelling of her left lower lip and itching in the throat with some difficulty breathing.  She was attended to immediately by EMS, PA& physician at the site. Vitals were obtained: blood pressure was elevated at 220/110, PO2 96%  pulse 115 BPM.  A  dose of 50 mg of benadryl was given to the patient orally.  Within 10 minutes she felt improvement in her breathing and the swelling in her lip was not as prominent.  BP remained elevated 200/100 , transported to hospital for further Tx & observation.
Chills; Headache; Cough; Tiredness; This is a spontaneous report from a contactable consumer. This consumer reported for an 83-year-old female patient received first dose of BNT162B2 (Pfizer COVID 19 solution for injection, lot number: unknown, Expiration date; unknown), in left arm on 03Feb2021, 14:00 pm at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient did not have allergies. Patient experienced Chills, headache, cough, tiredness starting about or 7 days after vaccine on 10Feb2021 19:00 pm. Patient did not received treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
little bit sore in the upper arm; A Spontaneous report was received from Consumer concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced little bit sore in the upper arm.  The patient's medical history was not reported. The concomitant medication reported included ACE inhibitor lisinopril (not taking regularly).  On 26-Jan-2021 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A, Expiration date: 06-Jul-2021) on the right arm for prophylaxis of COVID-19 infection.   On an unknown date, after administration of vaccine, the patient experienced a little bit sore in the upper arm. Treatment information not provided.  Action taken with the mRNA-1273 in response to the event was not provided.   The outcome event a little bit sore in the upper arm was considered unknown at the time of this report.; Reporter's Comments: This case concerns a 77-year-old male who experienced a non-serious unexpected event of Pain in extremity.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on 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.
Information has been received on 16-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-JAN-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-JUL-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Started out with a typical rash on right arm from injection.  Then the patient experienced itching on the back at work and all this evening and then noticed she had multiple vesicles spread on the entire back.
Left arm felt like tingling needles; Left arm felt like it fell asleep and he has to shake it to wake it back up; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Left arm felt like tingling needles) and HYPOAESTHESIA (Left arm felt like it fell asleep and he has to shake it to wake it back up) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Shingrix. Concurrent medical conditions included Penicillin allergy. Concomitant products included TAMSULOSIN for BPH, LISINOPRIL and AMLODIPINE for Blood pressure abnormal, PRAVASTATIN for Cholesterol, UBIDECARENONE (COQ-10) for Supplementation therapy.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PARAESTHESIA (Left arm felt like tingling needles) and HYPOAESTHESIA (Left arm felt like it fell asleep and he has to shake it to wake it back up). At the time of the report, PARAESTHESIA (Left arm felt like tingling needles) and HYPOAESTHESIA (Left arm felt like it fell asleep and he has to shake it to wake it back up) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Patient's answer for the question- Was the adverse event most likely caused by mRNA-1273? - Yes.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Additional information received: Medical history was updated. On 30-Jun-2021: Additional information received: Concomintant medications updated. On 26-Jul-2021: No new information was added
Pt vaccinated with meruvax II developed fever w/aching & swelling of the fingers & major joints. Treated w/Ibuprofen (Motrin).
This spontaneous report as received from a 60 years old female registered nurse with drug allergy to cipro and allergy to shellfish refers to herself. The patient was vaccinated with ZOSTAVAX(lot# unknown) in MAY 2012. No other co-suspects were reported. Concomitant medications included: VALTREX. On 15-DEC-2012 the patient developed the shingles. She described her shingles as "full blown blisters" and mentioned she has "itching on her base of her neck going along to the left shoulder". There was no treatment information for the event. The patient had sought medical attention. Action taken on ZOSTAVAX wasn't reported. The outcome was reported as recovering. Additional information has been requested.
Patient's left upper arm (lower deltoid to elbow region) was all red and inflamed.  Patient brought to pharmacy's attention on 10/19/19 and was advised to visit urgent care.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Pt rec'd Rubella immun on 13FEB91 came down w/Rubella on 27FEB91.
Not sure when it started but we noticed it at 7pm on 6/22/2010.
This spontaneous report was received from a Nurse refers to a patient of unknown age. On 14-APR-2014, the patient was vaccinated with expired dose of RECOMBIVAX HB Lot # 1157AA (Expiry: 06-APR-2014) (dose, route and frequency were not reported). No adverse effects reported. No further information was provided. Additional information has been requested.
potentially a 0.3ml dose on Pfizer COVID vaccine administered without diluent. Monitor the resident q 2 hours x 72 hours. only compliant is mild soreness at injection site.
Crying after 1st of three vaccines. After 3rd vaccine-turned pale, limp, eyes rolled back, responded quickly to stimulation. Suspect vasovagal reaction/breathholding spell. Tylenol after vaccines.
I had severe right upper quadrant abdominal pain on the evening of the vaccination 2/11/21.    Ultrasound the next day showed gallstones.  Previously asymptomatic and undiagnosed.  I continued to have pain for several days and made an initial appointment with a gastroenterologist at the recomendation of my internist.  I could not be seen until June of 2021.  My pain continued sporadically until May when it stopped.  By the time I saw the gastroenterologist in June I was asymptomatic.
On June 1, 2020, I took first dose of Varicella-zoster vaccine subcutaneous vaccine at my doctor's office. I had sore arm for 2-3 days.  Not too bad since I expected same.  On August 13, 2020 around 9:30am, I took second dose of the vaccine in my left arm at clinic.  I started feeling noticeably bad around 8pm  that evening.  Overnight I slept very little.  My left arm was sore.  But worst overnight symptoms were pounding left temple headache and substantial pain in upper left jaw when my teeth clenched together.  In the morning, I took my temperature twice and each time it was 99.7.  I took first pain medication at 6:00am.  I took more Tylenol at 10:00am and 2:00pm.  I took afternoon shower and by 6:00pm felt good enough to skip any pain medication.  Slept okay second night.  My arm remained very sore for 2-3 days and a little sore for a few more days.  I have felt normal the past week.
was informed that patient had passed out  like 30 to 45 minutes after shot was adminstered
Injection site exhibits red rash entire area & warm to touch (but no fever); patient feels weeks; has headaches; chest tightness. Advised patient to go see primary doctor.  And asked them to take Tylenol
ErythemaMultiform Narrative: reddness, feels hot, soreness to the rt arm at vaccine site
PT WAS VACCINATED USING PFIZER VACCINE ON 12/23/20 (ELO410) + 1/13/21 (ELO142) + 9/4/21 (FC3182). S/O BEGAN 9/05/21, TESTED + 9/06/21
I had a sore in my left arm.  I woke up with a sore throat, running nose, and no cough.  I felt fatigue and had joint pain.  I was tired for 3 weeks.  After that, I started urinating brown urine and had back pain.  I thought I had a UTI.  I went to the urgent care and they sent me to the ER.  I had a rash a week before.   They did a CT scan and referred me to a Urologist.  They gave me pain medicine and sent me home.
pt recvd vax & 2 hrs later exp itching for 24 hrs; pt took DPH; reporter indicated pt recovered from sx;
Pain injection site started immediately, used ice when I got home, Swelling/redness  injection site started within an hour , took tylenol 500mg  Within 6 hours pain felt in shoulder joint  and redness/swelling in arm increased, 12 hours felt feverish, developed headache , took ibuprofen 400mg used ice, within 24 hours fever 101 severe injection site pain, redness swelling went back to bed on Tuesday AM severe fatigue, lethargy, nausea continued taking ibuprofen, 48 hours still in bed with severe injection site pain, redness , swelling , still taking ibuprofen , used hydrocortisone otc on injection site for severe itching , headache persisted.  36 hours still in bed with pain swelling, redness neasured rash 6 inches by 6 inches, eyes began itching with redness, itching on scalp, still continued otc ibuprofen, ice, hydrocortisone cream on rash. Spoke to RN at Drs office confirmed home measures appropriate
Terrible headaches; Loss of appetite (could not eat or drink for 2 days), lost interest in sweets; Fatigue; Chills; Fever 101-103; This spontaneous pregnancy case was reported by a health care professional and describes the occurrence of DECREASED APPETITE (Loss of appetite (could not eat or drink for 2 days), lost interest in sweets), FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (Fever 101-103) and HEADACHE (Terrible headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 023MA) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to Benadryl).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite (could not eat or drink for 2 days), lost interest in sweets), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever 101-103). On 09-Feb-2021, the patient experienced HEADACHE (Terrible headaches). On 13-Feb-2021, HEADACHE (Terrible headaches) was resolving. At the time of the report, DECREASED APPETITE (Loss of appetite (could not eat or drink for 2 days), lost interest in sweets) outcome was unknown and FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever 101-103) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, COVID-19: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information included paracetamol.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-may-2021,patient demographic details updated ,ADR with significant info. 1st and 2nd dose details; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
After 2 shots of 3, about 8 months on, I started having chronic pain in all my joints. The 60 day follow-up states that the pt still has muscle pain that she never had before and that she is being treated for. The annual follow-ups tates "I still suffer from pain in my joints on hands, legs and arms. I also have chronic muscle pain in legs. Drug therapy has been unsuccessful."
Gave Moderna vaccine to one of our customers. After vaccine she was complaining about dizziness . I checked her blood pressure . It was high .she said that she does not have any blood pressure issue and does not take any blood pressure medications .  I checked three times . It was keep going up .  She waited for almost 30mins. she said that she will check home and if it will be high then she will go to emergency . Her son picked her up from our pharmacy .
15 minutes after getting the vaccine, I felt dizzy for about 30 minutes following the vaccine. About 5 hours after the vaccine, I started getting side effects of a fever, chills, body aches, and a headache. On 2/14/21, I noticed a rash at the vaccination site. It does not itch, but appears to be spreading on the same arm of the vaccination.
I have slight heart paplatations that last for 3-10 seconds..  I also have had one large blister on both hands, in the same exact location...these large blisters are NOT caused by working with my hands, etc, they just started first on my left hand index finger on TOP of the finger, and then one month later the same exact location on my other hand...I have pictures of both as well and reported to Dr
Patient was given an fluzone quad and Tdap. He was in the waiting area and stood up to go to the bathroom approximately  2 min after receiving his vaccinations.  He took about 5 steps and passed out, hitting his face on the concrete.  He was out for a short period and when we woke, he was aware of his surroundings and could answer basic questions. I believe he experienced vasovagal syncope.  He appeared to have a broken nose from hitting the concrete and his parents were going to take him to the ER. I will follow up with family tonight to see if any addition issues occurred.
No additional AE; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from medical assistant and refers to a 12-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) injection, 0.5 milliliter, lot #W029555, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration (Product storage error). No additional adverse event was reported.
COVID Booster; hives; low grade fever; allergic reaction; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (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 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID Booster"; URTICARIA (non-serious), outcome "unknown", described as "hives"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". Additional information: Event took place after use of product. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site pain; Fever; Sore muscles; Sore body; Nausea; Hot flashes; Swelling of tonsils; Throat pain; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 15:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medications within two weeks prior to the vaccination. 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 02Apr2021 at 19:45, 4 hours after the vaccination, the patient experienced injection site pain, fever, sore muscles/body, nausea, hot flashes and swelling of tonsils/throat pain. The adverse events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The patient did not receive treatment for the reported adverse events. The clinical outcome of the events injection site pain, fever, sore muscles/body, nausea, hot flashes and swelling of tonsils/throat pain was resolved on unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.