chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. It was reported that since 29-AUG-2014, unknown number of patients were administered LIQUID PEDVAX HIB (dose, route of administration, lot numbers and expiration dates were not reported) which was improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
~ 5 days after #1 - fatigue, hot flashes, dizziness and syncope     x 3- After #2 - single incident of hot flashes and dizziness~ 14 days after #3 - fatigue, hot flashes, dizziness, short term    memory loss, loss of balance, inability to focus - elevated    WBC (13-19) with no apparent cause
I am currently pregnant with my first child.  Approximately thirty minutes after receiving the vaccine, I began to feel a strange sensation in my vaccinated arm.  It felt as though cold IV fluid was moving through my upper arm down to my hand.  I began to feel dizzy and light-headed to the point I was considering pulling my car over.  After a few minute the dizziness began to subside, but the sensation in my arm continued for approximately 45 minutes.
got shingles on my eye; mild case of shingles on my face; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the first Shingrix shot and a month later the patient got shingles on face and in eye. It was a mild case.  The patient was due to get the 2nd shot the first week of November.  The patient asked if it was okay to get the 2nd shot 3 weeks after having shingles.
Information has been received from a physician concerning a 11 year old male with no past medical history of immunocompromise or immunosuppressive therapy and otherwise healthy who on 21-SEP-1998 was vaccinated with the first dose of VARIVAX (Oka/Merck). The patient received his second dose of VARIVAX (Oka/Merck) on 15-OCT-2008. The patient was also received BOOSTRIX and MENACTRA on 15-OCT-2008. Twenty-four hours later (the following day), the patient developed a maculopapular rash on the face with  few lesions, two scabbed lesion on scalp, lesions behind ear, upper chest, torso and thighs. Lesions were maculopapular. Some with halo effect. Patient also had some post auricular lymphadenopathy on the left side. The mother of the patient called and stated that her son had more lesions and some "have water in them" on 17-OCT-2008. The patient sought medical attention at the physician's office at 2PM on 17-OCT-2008. The physician noted a normal throat. The patient was afebrile and initially diagnosed with a viral illness. The physician also noted that the patient had exposure to a schoolmate who had a rash on the face. The school nurse could not role out Varicella. At the time of the reporting, the patient had not recovered from the adverse experiences. Additional information has been requested.
12cm redness, swelling around central infection sites. 3 cm induration. Treated with Prednisolone
Resident had been having sob, coughing with sputum, encephalopathy, over the weekend .
c/o lightheadedness, clammy hands 5 mins p/recvd vax; observed pt in clinc x 20 mins; sx resolved; return 1 hrs later c/o h/a & aching;
Psuedogout in both wrists. Very painful. Never had anything like it before. Psuedogout is still in right wrist. Left wrist is better now
Hives starting on upper body that appeared ~36-48 hours after vaccination and slowly spreading; Dose number=3; This is a spontaneous report from a contactable reporter (pharmacist).   A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Dec2021 (Lot number: FH8027) at the age of 70 years as dose 3 (booster), single 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 : EN6200, Route of Administration : Intramuscular, Anatomical Location : Right arm), administration date: 20Feb2021, when the patient was 69 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number : EN6202, Route of Administration : Intramuscular, Anatomical Location : Right arm), administration date: 13Mar2021, when the patient was 69 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Dose number:3"; URTICARIA (non-serious) with onset 02Dec2021 at 22:00, outcome "unknown", described as "Hives starting on upper body that appeared approximately 36-48 hours after vaccination and slowly spreading". Therapeutic measures were not taken as a result of urticaria was unknown.  Additional Information: The patient had no known drug allergies (NKDA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The events resulted in emergency room/department or urgent care.
Left arm was red, hard and swollen the size of a baseball. Mom states that his entire upper arm was swollen yesterday (3/14/02). Temperature on 3/14/02 was 99F-101F.
swollen lymph node; shortness of breath; upper chest pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node), DYSPNOEA (shortness of breath), CHEST PAIN (upper chest pain) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia (cholesterol) and Gastrooesophageal reflux disease (Acid reflux).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced LYMPHADENOPATHY (swollen lymph node), DYSPNOEA (shortness of breath), CHEST PAIN (upper chest pain) and FATIGUE (fatigue). The patient was treated with IRON (intravenous) in May 2021 for Iron low, at an unspecified dose and frequency; IRON (intravenous) on 30-Oct-2021 for Iron low, at an unspecified dose and frequency and IRON (intravenous) on 05-Nov-2021 for Iron low, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph node), DYSPNOEA (shortness of breath), CHEST PAIN (upper chest pain) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood iron: 7 (Low) iron level went down to 7. In May 2021, Colonoscopy: negative (Negative) negative with no polyp. In May 2021, Haemoglobin (13-17): 9 (Low) blood level was 9 when normal level is 13~17.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had taken medications for cholesterol and acid reflux Patient had had colonoscopy on upper and lower GI on Monday to see bleeding, and it showed negative with no polyp It was reported that the Patient cannot do a lot of strenuous stuffs due to his symptoms
patient denied any c/o after getting the shot and then after leaving had syncopal event in car and c/o dizziness
Pt described swelling of his left arm and a rash. He said his arm swelled to about twice the normal size. He said it did subside in size today.
Pt. received 1st dose approximately at 08:53 a.m. Pt. stated that she could feel her heart beating fast and complaint of feeling light. Pt. denied shortness of breath and chest pain.   Pt's heart rate increased to 140-160m. Oxygen @3L via nasal cannula given by  LVN. Oxygen saturation 100%, Respiration 20. HR started to improve and decreased to 84, BP taken manually 142/78. Pt. stated she was feeling better just  weak. 09:19, pt's vital signs were monitored for 45 min. Pt. refused to see one of the providers at clinic. Stated she feels better. C/o of headache, 5/10. Pt. discharged in good spirits when discharged to son who took her home. Was advised to go to ER if symptoms of shortness of breath, chest pain, dizziness, lightheaded, or heart palpitations occur and to follow up with provider.
immunodeficient patient given a "booster" dose for a 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunodeficient patient given a "booster" dose for a 3rd dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency, Leukemia and Blood pressure high. Concomitant products included VALSARTAN, AMLODIPINE and HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HCL) for Blood pressure high, INFLUENZA VACCINE (FLU) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunodeficient patient given a "booster" dose for a 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunodeficient patient given a "booster" dose for a 3rd dose) outcome was unknown.            Patient does not had any allergies and not had any Covid-19 diagnosis prior to or after getting the vaccine. 1st booster dose lot number was reported as 088_21A(cannot decipher the 4th character in the lot number) It was reported that patient had flu vaccine in Sep2021. It was reported that patient took 2rd booster dose on 04Feb2022 with lot number 042J21A , they were told that they was given 1/3 of the regular dose. It was also reported that he will clarify with the pharmacy that the dose was administered to him on 08Aug2021 and 04Feb2022. No treatment medications were provided.   This case was linked to MOD-2022-529251 (Patient Link).
fainted; This case was reported by a physician via sales rep and described the occurrence of fainting in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Shingrix and Tdap Vaccine. On an unknown date, less than a day after receiving Shingrix and Tdap Vaccine, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Shingrix and Tdap Vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and a Tdap vaccine at the same time in the morning. That night, the patient got up to use the restroom and fainted.  An ambulance was called, but it was unknown if he was taken to the emergency. It was not reported what brand Tdap was administered, but the account does use Boostrix.
1hr post vax extreme nausea chills x 4hr-vomited x 3 times, eyes red, burning, mucus in the eyes-excessive-had to clean eyes several times;
Two to three days after the 3rd Pfizer COVID vaccine shot (or 'first booster'), she started her full period/menstruation.  It's only been about a week and menstruation is still ongoing--which I think is normal. The timing may just be coincidental but I wanted to report it anyway.  FYI, she's also had 'spotting' (or 'false starts' for better lack of the proper term) a few times over the past year, which I think is also normal.
By 9:00pm I was feeling a  little sick, like the flu. By morning I had a temp of 100.1 and felt very sick but did not get out of bed.  At 1;00PM  I woke up and stood up out of bed and collapses onto the floor.  I was unable to get up.  I found my phone which had fallen onto the floor.  I was shaking so bad I kept dropping it.  I looked and my phone and was  unable to figure out how to make a call.  The screen did not make sense.  Eventually I was able to call my daughter who decided to call 911.  The paramedics came, picked me up  off of the floor and helped me walk to the living room.  My legs kept giving out like I was going to fall again.  They were asking questions but I was unable  to answer coherently. I was so confused.  My brain was not working.  They took me to the hospital where I was admitted and many tests were done.
I got the vaccine in the left arm about 5 mins injection site started feeling itchy spreading down my arm.  Around 10 mins I started feeling hot, really warm. I asked the proctor at the monitoring site what should I be feeling. There was firefighter there that looked at my throat offered Benadryl shot however I  took a oral Benadryl. I had a lump size of ping pong ball at the injection site. At the 9th day I began redness and itchy again and day 1/2 after I haven't any symptoms.
Extreme pain in the shoulder joint and total immobility of the left shoulder. NSAIDs  would not  ease the pain. Required a cortisone shot in the left shoulder joint to relieve pain, inflammation and immobility.
6 hours after receiving the vaccine l went to shower and noticed chicken pox like blister on my torso from my underwear line to my bra line. They were mostly located on my sides are were in a vertical pattern. I have initial pictures I can share if needed.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes PAXLOVID (COVID-19 treatment) from 11Feb2023 to 16Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This case was reported by a physician and described the occurrence of hive in a pediatric subject of unspecified age and gender who was vaccinated with Pediarix. for prophylaxis. The subjects medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date the subject received a dose of Pediarix (dose and lot numbers not specified). At an unspecified time after vaccination with Pediarix, the subject experienced hive. At the time of reporting the outcome of the events was unspecified. The reporting physician stated the pediatric subject had been referred to him, however, at the time of reporting the physician had not seen the subject. The physician considered the event was possibly related to vaccination with Pediarix.
Tested Covid-19 positive on 12/14/2021.  Not admitted to hospital for Covid-19
I WAS SUPPOSED TO SEE MY PERIOD ON THE 17TH OF JULY OR LATEST 23RD of July but still haven't received it. My period is usually regular so this is very odd for me. Did a pregnancy test twice and they were all  negative.   Today's date is 8/25/2021 and i still haven't had my period. Its scary and i request this adverse effect be looked into because i have friends going to their 4th month without a period.
Felt Feverish, Chills, Runny Nose, Headache, Fatigue, Cough
This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The reporter stated that improperly stored doses of ZOSTAVAX lot # M038864 expiration date 12-DEC-2019 (dose and route of administration were not reported), were administered to the patients from "09-MAR-2017-21-MAR-2017" for prophylaxis. No adverse reactions. Administered doses of vaccines experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 15 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA010052.
Malaise; Brain fog; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), FEELING ABNORMAL (Brain fog) and FATIGUE (Tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise), FEELING ABNORMAL (Brain fog) and FATIGUE (Tiredness). At the time of the report, MALAISE (Malaise), FEELING ABNORMAL (Brain fog) and FATIGUE (Tiredness) was resolving.            No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-089067 (Patient Link).
This was a booster. I originally had Janssen one dose in April 2021. About 20 min after the shot my nose started to tingle, my neck was tingling and it was hard to swallow. I drank water and sat in my car for about 15 extra minutes. The tingling stopped then I had right arm pain which was opposite from the arm I received my injection. I?m now dealing with regular side effects that are documented
Pericarditis- classic pericarditis chest pain, worsening with position change.  persistent palpitations with exertion
Patient received vaccine at 606 pm, began having reaction symptoms at 612 pm, reports symptoms as feeling dizzy/lightheaded, also reports tingly lips.  Patient stayed for observation for 30 minutes, once complete, reported still feeling slightly dizzy/lightheaded, but this is a normal reaction for her to vaccines per patient.  Offered patient juice, and patient felt OK to leave, no medications given.
Tension; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of TENSION (Tension) and BACK PAIN (Back pain) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENSION (Tension) and BACK PAIN (Back pain). At the time of the report, TENSION (Tension) and BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported. No concomitant medication was reported.
Mom called in to let us know that pt. had an allergic reaction to the vaccines he got at our office on 09/06/2022.  It was his Right leg.  mom states it was the vaccine given on the top of the thigh, not off to the side in the fatty part. starting Thursday, two days after, he had a red square shape red raised area around the injection site.  Saturday he started with a 101 temp, forehead thermometer. Sunday he developed rash all over body. mom took to ED for evaluation and they said they believe he has had a reaction to a vaccine but he is ok and was discharged the same day.  mom calling to just let us know and ask which vaccine it was. Let her know that the dtap and the polio where both in once shot and that was given on the top of his right thigh.
approx 4 hrs p/vax pt exp an acute sz activity & was transported via ambulance to hosp ER; upon admission pt had a fever 103.8 (ear); no further sz activity;
Had redness and itching to the injection site within 5 minutes. About 10 minutes after the injection complained of itching all over body.
shingles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Bed. 2/26/02 onset severe pain L shoulder with increasing weakness proximal LUE over next week resulting in atrophy of spinati and continuing pain. Medrol dose pak, ubuprofen, percocet, physical therapy.
Got it on my left arm and of course that did hurt in a while; Right arm still hurt like where the shoulder connects to my arm; it's a little hard, a little painful when I lift my arm up; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 17Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced got it on my left arm and of course that did hurt in a while on an unspecified date, right arm still hurt like where the shoulder connects to my arm; it's a little hard, a little painful when i lift my arm up on an unspecified date. It was reported that consumer got first shot of Pfizer Vaccine on 17th of last month. Got it on my left arm and of course that did hurt in a while but then my right arm started hurting. Do not know if there is any connection or it is just a coincidence, but right arm still hurt. Like, you know, like where the shoulder connects to my arm and this past week, it is a little hard, a little painful when lift my arm up. The clinical outcome of the events were unknown.  No follow up attempts are possible. No further information was expected.
Extreme fatigue, muscle pain and weakness.  Felt like I had caught the flu.  Slept over 15 hours.  Felt better the following day.
Pt due for Meningococcal B Cat B vaccination and Meningococcal Conjugate administered instead.  Error was not discovered until after pt left facility.  Attempted to contact pt's mother without success.  Left message to call back to our facility.
w/in 7 days p/vax pt devel severe onset of autism spectrum symptoms; later dx as encephalopathy; regression noted w/in 3mo (3/98);evaluation 6/98;dx 11/98; tx w/pred 3/99;recovering w/steroid tx