chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has had persistent pain in left upper arm/deltoid area since having vaccine.  Pain has progressed to having limited range of motion in upper arm/shoulder
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, muscle pain, fatigue and viral infection. On an unknown date, the outcome of the injection site pain, injection site erythema, muscle pain, fatigue and viral infection were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, muscle pain and fatigue to be related to SHINGRIX. The reporter considered the viral infection to be unrelated to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient presented local redness pain at site, common, severe muscle aches and fatigue lasted for weeks then got viral bug that felt unrelated but they were having a hard time determining if should give second dose of SHINGRIX vaccine. The side effects, lasted for 2 to 3 weeks.
rash/itchiness at the injection site.; rash/itchiness at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (rash/itchiness at the injection site.) and VACCINATION SITE RASH (rash/itchiness at the injection site.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042130A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (rash/itchiness at the injection site.) and VACCINATION SITE RASH (rash/itchiness at the injection site.). At the time of the report, VACCINATION SITE PRURITUS (rash/itchiness at the injection site.) and VACCINATION SITE RASH (rash/itchiness at the injection site.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Flu like symptoms. Body aches, hot and cold with chills, bad headache, back hurts, slight fever
Flushing/Sweating, dizziness; BP 114/83; 81 RR 17
DEATH; COVID-19 INFECTION; This spontaneous report was received from literature. This report concerned a 62 year old of unspecified sex, race and ethnic origin. The objective of this study was to report the demographics of patient who developed SAR-CoV-2 (severe acute respiratory syndrome coronavirus 2) after being vaccinated.  The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis (MS). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included ocrelizumab for multiple sclerosis.  In this report, (ocrelizumab) patients vaccinated, 31 patients developed a documented COVID-19 infection with a mean age of 46.8 (12.7) and a median disease duration of 11.3 [4.0. 19.6] years. 17% had PMS (Progressive multiple sclerosis). Median time on OCR was 42.8 [20.1, 50.4] months. 60% had been on OCR for 3 years or more. Median time from first vaccine to positive COVID-19 test was 7.3 [4.8, 8.9] months. Median time from last dose of OCR to positive COVID-19 test was 4.5 [3.2, 5.7] months. COVID-19 negative patients were older with a mean age of 52.3 (12.3), p=0.03. There were no other significant differences based on median disease duration, MS pattern, and median time on OCR. Median EDSS for patients who developed COVID-19 (19 patients) was 2 [2.0, 6.5].  On an unspecified date, the patient experienced covid-19 infection who had received ocrelizumab for 3.6 years. Laboratory data (dates unspecified) included: Expanded disability status scale (EDDS) 8.0. The patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. The authors concluded that, the patients hospitalized for a COVID-19 infection were older, and the patient who died had an EDSS of 8.0. This data was alignment with previous reports that older and more disabled patients were at risk for more severe disease. This report was serious (Death).; Sender's Comments: V0: 20221216464-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Subsequently, the pt experienced a red sore arm. Additional information has been requested. It was noted that two other pt's also developed reactions post vax.
delayed response to the first shot of the vaccine; quite itchy; red; swollen; warm; it's not as swollen but the redness has extended to her elbow; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (delayed response to the first shot of the vaccine), PRURITUS (quite itchy), ERYTHEMA (red), SWELLING (swollen) and FEELING HOT (warm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (delayed response to the first shot of the vaccine), PRURITUS (quite itchy), ERYTHEMA (red), SWELLING (swollen), FEELING HOT (warm) and ERYTHEMA (it's not as swollen but the redness has extended to her elbow). At the time of the report, SKIN REACTION (delayed response to the first shot of the vaccine), PRURITUS (quite itchy), ERYTHEMA (red), SWELLING (swollen), FEELING HOT (warm) and ERYTHEMA (it's not as swollen but the redness has extended to her elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Headache, severe arm pain, skin pain, muscle aches, fatigue, dizziness
Redness and firmness around injection site (size of 2 half dollar coins), redness spreading towards elbow, slightly itches, warm and painful to touch.
Information has been received from a physician assistant concerning a 16 year old female with no pertinent medical history and no drug allergies, who in March 2010, was vaccinated with her third dose of GARDASIL (lot # 663451/0216Y). There was no concomitant medication. After the vaccination, the patient missed her period. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. It was reported that the last time the reporter heard from the patient was in April 2010 so they did not know how she was doing. Additional information has been requested.
crying lasting for 3 hrs (non-stop) rash over entire body, redness in area of inject; 2" circumference;
-Swelling of arm, shoulder to elbow. -Area of vaccination administration warm to touch. -Severe pain in arm of vaccine administration.
Information has been received from a registered nurse referring to a 6 month old patient of unknown gender. On 01-JUL-2015 the patient was vaccinated with ROTATEQ (oral, lot # K017573, expiration date and dose were unknown) which was excursion the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
When I got home my heart started beating rapidly and really fast, and I could feel it in my chest and back, pain in the arm. I now have a constant cough that wont go away and gets worse when I wear the mask.  I can't breath at night when I sleep and now have NO menstrual cycle.  The next day after the shot I felt a really sharp pain in my uterus ad it was painful I thought my cycle was coming but it was really painful.  I went home and went to bed because I felt a like I was getting sick like the flu.    Now I have had no menstral cycle since the shot and no I was not going thru menopause  It is gone but now I have chest pains no menstrual cycle and mucus in my nose and a cough all the time.  Not feeling the best and upset.
No energy, No appetite, dizziness, since day of vaccination & still today 7/30 - five days later. Brother has some symptoms form also faxed.
My biggest complaint is that I am now  66 days out from the first shot and no period. I did get sick from both the first and second shot (sore arm, fevers, fatigue, unable to function - especially on the second shot). But I should have had a period between the 1st and the 2nd - and there was nothing. I finally had some spotting last week. But still literally nothing. This is really frustrating and frankly scary.
This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 49-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 48 years for Covid-19 immunization (Patient received vaccine in Workplace clinic). The patient's family history included: "wife sick 13May and tested positive" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient's relevant medical history and concomitant medications were not reported. It was unknown If other vaccine in four weeks. It was unknown If Covid prior vaccination: Unknown. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15May2022, outcome "unknown" and all described as "he tested positive 15May with SX same day mild cold like SX". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: wife sick 13May and tested positive and he tested positive 15May with SX same day mild cold like SX. The patient was positive for COVID-19 in home AG, Covid test on 15May2022. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and Covid-19 and BNT162B2.
I started to get a flat wart on my hands. As time has progressed it got the worst. The warts were itchy. The were small clusters that were fluid filled. It started to spread all over my hands on both the palms and the backside of my hands including fingers. I used a topical ointment. After two months I went to see a dermatologist and he advised it may be stress induced. I was prescribed some more topical creams to do spot treatment. It didn't really help much. It never really went away, but it was manageable.  On 01/13/2022 I had a breakthrough COVID case and the warts really flared up. After about a month the warts subsided. Then in 04/2022 the worsts have flared up again and have not gone away.
got symptoms of mild cold; running nose; cough; This is a spontaneous report from a contactable physician (patient). A 81-years-old male patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, unspecified route to administration on 23Dec2020 (at the age of 81-years-old) as a single dose for COVID-19 immunization.  Medical history included hypertension and mild diabetes Concomitant medication included nebivolol hydrochloride (BYSTOLIC), clonidine, hydralazine, losartan, nifedipine. The physician got symptoms of mild cold, running nose and cough in Dec2020. "It just came a last two days and it's been cough and runny nose. I don't have a fever." Outcome of the events mild cold, running nose and cough was unknown.
Fever and 2 episodes vomiting developed about 12 hours after vaccination. Fever to 103 in our office about 20 hours after vaccine.
Headache; Chills; Tired; Itching; Swelling at site of filler; This is a spontaneous report received from a contactable consumer (reporting on herself). A 68-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, lot number: el9262 and Expiry date was not reported), via an unspecified route of administration in Arm Left on 28Jan2021 09:30 as single dose for COVID-19 immunization. Medical history included Very Slight to shrimp and other shellfish, other medical history none. The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), in Left Arm on 07Jan2021 09:30 for COVID-19 immunization. Concomitant medication(s) included thyroid (ARMOUR THYROID); bupropion hydrochloride (WELL-BUTRIN) both taken for an unspecified indication, start and stop date were not reported. Patient did not have covid prior vaccination. Patient did not receive vaccine in four weeks. It was reported that patient experienced headache, chills, Tired, Itching-Swelling at site of filler-tired. The patient did not received any treatment for adverse events. Patient was not tested covid-19 post vaccination. The outcome of the events was recovered on an unspecified date.
Almost 1 hour exactly after the vaccination I felt numbness in my right cheek that lasted for maybe 30-60 seconds.  About 2 minutes later I felt a flush and odd overall/dizzy feeling with some trouble swallowing.  This lasted about 40-60 seconds. Over the next few hours I had additional brief episodes where my throat felt like it was closing up.  All was well by about 3 hours after, and today (the day after the vaccination)I have had no additional numbness or dizziness/trouble swallowing type symptoms.  My only symptoms today are mild pain at the injection sight and slight tiredness.
Information has been received from a physician concerning a "19 years old" female with no known drug allergies/reactions who on 14-MAR-2011 was vaccinated with the second dose of GARDASIL (dose not reported) (Lot number: 666595/0992Z). There was no concomitant medication. On 14-MAR-2011, the patient presented to the physicians office with a fever of 101.3, headache, body aches and restlessness. The patient was given unspecified treatment. Upon the time of report, the patient present status was unknown. Additional information has been requested.
Extreme pain and weakness right arm.  Injection arm.  Headache, chills, fever, crying, trouble breathing, body aches, dry mouth, cannot move arm today at all. Had to miss work.
Patient with right upper arm skin redness pain and slight swelling, symptoms started Wednesday evening of Nov 29 2017, discomfort and redness spreads into right axillary area, no lymphadenopathy noted on exam. Patient started on BACTRIM DS with improvement in symptoms.
It appeared as if the patient had syncope within one minute of injection completion. She had a loss of consciousness for approx. 10-15 seconds. The patient became extremely diaphoretic with nausea and vomiting. While unconscious, her head fell back hitting a wall quite hard.
he is immunocompromised; 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 31-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "he is immunocompromised". Caller also asked if the second booster dose is available for the general population.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
All symptoms began 12 hrs after administration of vaccine.  Moderate fatigue Severe muscle and joint pain- extremely painful to get up and walk around  Chills - whole body Headache and tingling  sensation in skull Fever 103.8-104.1°F - peaked at 104.1, came down to 103 after Tylenol 800mg, cold water, cold cloths on forehead, neck and arm pits  Symptoms lasted for 24-36 hrs
Sometime mid Nov 2022 before the 11/8/22 Heart rate went up to 188 and went back to normal after 15 min and it happened again a couple days later. I see a Cardiologist every 6 months and saw her and got a heart monitor. This happened again 2/20/23 and I wore a heart monitor for 2 weeks and had Afib over 1100 over 2 weeks. They gave me beta blocker. I will see my cardiologist again in May2023 to see of the medicine is working.
This infant is shaky, not acting right, suddenly started screaming. Calmed down but couldn't eat, he went limp, staring, not responding, temp 101, breathing funny, no apnea, sleepy 1 hour later. 1 to 2 hours later acting fine, no fever.
Headache, Myalgia, Fever. Diarrhea, NauseaVomiting,  chills Narrative:
Fever of 102.5 F to to 104 F with PR of up to 125 requiring PCP visit and two ER visits. Performed blood, urine tests, chest x-ray and ekg - all normal showing no other underlying cause. No pain or other symptoms. One IV for saline to rehydrate. Fever still ongoing to date. Infectious disease physician consulted - appears to be reaction to booster shot.
Infection associated with internal left knee prosthesis, initial encounter - hospitalization. Congestive heart failure. and MRSA - ED visits. These visits were within 6 weeks of receiving the COVID vaccine.
pt recv vax 11JUN96 AM & devel fever of 103 R by evening;6AM 12JUN96 had sz taken too ER given ATB for resolving OM;dx febrile sz, resolving OM
other vaccine same date; other vaccine same date; Chills; upper arm soreness; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered on an unspecified date (at the age of 29-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took unknown vaccine of dose number 1 on same date as of COVID-19 vaccine administered on upper arm. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination. On an unknown date, the patient experienced chills, upper arm soreness and other vaccine administered on same date as of COVID-19 vaccine. The patient did not receive any treatment for adverse events. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test found to be negative post vaccination via nasal swab. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Had a reaction to COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Had a reaction to COVID-19 vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 30-Jul-2021, the patient experienced ADVERSE REACTION (Had a reaction to COVID-19 vaccine). In 2021, ADVERSE REACTION (Had a reaction to COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication mentioned. No treatment information provided.  Patient took the vaccine on 30JUL2021 and had an adverse reaction to it. Got resolved sometime that year.  Reporters causality for events with Skyrizi was reasonable possibility.
Arm, at site of injection throbbing. Eventually all deltoid muscle involved as well as in the back. General malaise, feeling of not being well.
Headache, general muscle aches, stomach pain, nausea, pain at site of injection, dizziness
Received TC from RN at ER that, per mom, child had seizure in car after leaving the clinic. Went directly to ER and had rectal temp at 103.3, in postictal state.
Swelling & redness in arm, hives over entire body, fatigue, persistent non-productive cough/wheezing as per PCP 11/8 office visit note. Treated with prednisone, VENTOLIN HFA, Guaifenesin-codeine syrup.
Just letting you know that the child received early Dtap, extra PCV. Mom assured this nurse that child got only one set of imm. with PCP but actually got 2 thus child receive extra doses.
Received first dose of Moderna Vaccine at 14:11. during observation time, complaint of itchy throat, tightness in throat, and SOB. Pt given Epi pen x1  at 14:25. Symptoms remained, 911 called at 14:27 and pt was transferred to ED
48 hrs p/DTaP given had fever of 103 no other sx-controlled by APAP;
After the second dose of the Covid-19 vaccine, I had the same mild allergy reactions as I had with the 1st dose: mild-moderate numbness of nose, throat - all subsided by taking Benadryl that afternoon/eve.  However,  for the next 36-48 hrs after this 2nd dose, I experienced mild-moderate "flu-like symptoms":  exhaustion,  total body aches, scratchy throat, only slightly elevated temperature.  This reaction was strong enough to prevent me from going to work for 2 days,  sleeping 12-13 hrs at a time.