chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu-like symptoms; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. . The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 the patient experienced flu-like symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if patient received treatment for the events. The clinical outcome of the event flu-like symptoms was recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever, chills, body/muscle aches, headaches, fatigue for approximately 24 hours.  Mild improvement with Tylenol.
Information has been received from a nurse practitioner concerning a female with extremely anxiety about receiving vaccine who was administered her first dose of GARDASIL, 0.5 ml, IM.  The patient experienced severe vasovagal reaction, seizure like activity and difficulty in breathing within seconds of administration.  The patient was given oxygen and transported to the hospital via ambulance.  It was unknown if the patient was hospitalized.  On an unspecified date, the patient recovered from all symptoms.  Severe vasovagal reaction, seizure-like activity and difficulty breathing were considered to be other important medical events because oxygen was given.  No further information is available.
15-20 min after administration, I was very dizzy and lightheaded. The following day I continued to have dizziness and trouble lifting both legs. I also had joint pain in every joint. Symptoms lasted for 5-7 days.
The day following the injection, I had vaginal spotting that was bright red, not clots, and severe cramping. Note that this was not during the menstruation portion of my cycle.  It lasted for about 2 hours.
10 days of diarrhea following vaccine, developed diaper rash from diarrhea.
Inflammation at the injection site; Hot felling at the injection site; Redness at the injection site; Itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Hot felling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Hot felling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site). At the time of the report, VACCINATION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Hot felling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Starting 05/10/2022 I tested positive for COVID. I could go about my daily activities as usual but stayed home. All of the symptoms I had lasted for about a week then they were gone. I would have a scratchy throat one day then it went away the next day and I would have a runny nose. No fever, No loss of taste and No loss of smell. Most of the symptoms resembled a mild cold and resolved fairly quickly. I developed slightly more constipation after recovering and that was bothersome but otherwise feeling pretty much back to normal. Since receiving the vaccines and having COVID, I feel like I've been having more brain fog lately.
Low fever; chills; severe headache; body aches; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6204) via an unspecified route of administration on the left arm on 18Mar2021 at 10:15 as single dose for COVID-19 immunisation. The past drug history included BNT162B2 (BNT162B2); Lot no: EN6202 via unspecified route of administration administered on 25feb2021 as a single dose for COVID-19 immunisation. 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 the vaccine. Medical history included High Cholesterol, heart disease on an unknown date. Concomitant therapies were not reported. The patient experienced Low fever, chills, severe headache, body aches, sore arm on 19Mar2021 after vaccination. No therapeutic measures were taken for the events. The clinical outcome of the events Low fever, chills, severe headache, body aches, sore arm were reported as resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Erythematous, edematous site of injection that progressively worsened with induration, scabbing of R thigh. Lesion became 3 cm in diameter with red margins extending out another 3 cm. No drainage from site.
This is a spontaneous report received from an employee and patient's mother regarding a 4-year-old male with a medical history of asthma, allergies, reflux, and chronic sinus infections who received PNEUMOVAX 23 injection on 15-AUG-2013. Concomitant medications included SINGULAIR, ADVAIR, VERAMYST, ALLEGRA, PREVACID, and  ASTELIN. On an unspecified date in October 2016 the patient had an immune panel blood test done and the titers were low for pneumococcal disease. It was reported that treatment was given but was not unspecified. The physician recommended a booster shot of PNEUMOVAX 23 and the patient is scheduled to receive this injection on 20-OCT-2016. No further information was provided. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with MMR II (dose and route of administration were not reported, indication reported as vaccination). On an unknown date, the patients who have been vaccinated with MMR II, failed to seroconvert. The nurse also statd that the patients verbalized their vaccination history, and sometimes were unsure if they got one or two doses of MMR II. The outcome of the event was unknown. The relatedness between the event and vaccination with MMR II was not reported. Additional information is not expected. The nurse did not want to be contacted.
This spontaneous report was received from a health professional, refers to a female patient of unknown age. Pertinent medical history, drug reaction/allergies were not provided. On an unspecified date, reported as several years ago, the patient received the first and second doses of GARDASIL, (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that the patient would now like to receive her third dose. No adverse symptoms were reported. Additional information has been requested.
No adverse effects until approximately 10 hours after vaccination. Began feeling very tired. Woke up in the middle of the night with 102 fever, chills, sweats and muscles in pain. No significant soreness at shot site and only a mild headache. All of this persisted until about noon on Monday, March 5, though in lessening degree the last 8 eight hours.
Diffuse hives on all extremities, abdomen, and back. Still ongoing at time of report. Will take an antihistamine for symptoms.
This case was reported by a pharmacist via sales rep and described the occurrence of shivers in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivers. On an unknown date, the outcome of the shivers was recovered/resolved. It was unknown if the reporter considered the shivers to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. After receiving SHINGRIX, the patient experienced shivers for a day.  The pharmacist reported that she did not report this as an adverse event due to shivers being one of the known side effects. No other information of patient was provided.
Patient received vaccine on the 16th and then on Thursday started feeling sensation of nerve pain, tenderness to cheek area. Pain increases and by Saturday night the pain woke up patient. On Sunday there were a few blisters and then it continued to accelerate and by Monday morning patient saw MD and was diagnosed with shingles on the side of his face.
11/4/23 fever  99.3 . 11/5/23  awoke with severe sharp headache . Required taking Tylenol about every 6 hours. All  joints ache even with taking Tylenol.
Caregiver called and stated that patient had a stroke on 12/19/22 and was concerned it could be related to the vaccines.
Patient was supposed to get a 0.25 ml dose of Moderna and was also signed up for dose of Flucelvax. Patient was mistakenly given two doses of moderna 0.25mL instead of one. I followed up with patient over the next few days and the only side effects he reported was a mild soreness in his left arm and fatigue, similar to his first two shots of moderna
Pt recvd vax & exp serum sickness, arthralgias, fatigue, fever, facial erythema; seen by MD;
On 07/07/2021, immediately after receiving the vaccination I had a headache. I called the doctor about the headaches and he said it was normal and to give it 2 or 3 weeks and the headache should go away. That afternoon my left arm at the injection site swelled up to the size of a golf ball. It was raised, if you put your palm of your hand it was that big around, over a couple of days it got that big. On 07/28/2021 I went to see my doctor for the headaches, he said to keep taking the Tylenol and should probably go away very soon. By 08/28/2021 the main constant headache was gone, but they were appearing sporadically. It is unknown if I have recovered from my AE's, I have noticed having joint pain, and I noticed them more since the 2nd Dose. I am also having more frequent headaches than I used to.
30 minutes after receiving 1st dose, headache set in and my tongue and the inside of my mouth starting itching.  Arrived home 15 min later.  Immediately took a Benadryl.  Suspected I was having an allergic reaction.  It stopped the itching.  A Tylenol stopped the headache.   A 2nd headache set in later in the afternoon.  Another Tylenol stopped it
Chills and muscles aches, pt felt like he was coming down w/ flu. Had sweats and chills at night. These symptoms developed night of vaccine. Temperature was 101 deg F the first night after receiving the vaccine. The second night after the vaccine, temperature was increasing; 103 deg F. Pt made apt for urgent care on day 3 after vaccine. Pt had worsening chills (staying hydrated, alternating Ibuprofen and APAP). Pt then noticed blood in urine. Had (+) blood and urine culture, received antibiotic IV in urgent care; diagnosed w/ bladder infection. Pt sent home after IV abx + oral ciprofloxacin Rx. Pt took first ciprofloxacin, could not make it to take second oral CIPRO dose. Pt was then taken by ambulance to hospital; temperature 108 deg F. Pt ended up with AKI, septic shock and myocardial injury.
Severe vertigo "room spinning", stomach upset (from dizziness), arm very sore for 2 days, no redness. Treatment prescribed: lorazepam 0.5mg 1/2 tab per mouth three times a day as needed.
Case number PHEH2014US019861 is an initial spontaneous report from a medical assistant received on 01 Oct 2014 with a follow up information received from a medical assistant on 24 Nov 2014 and a follow up report from the medical assistant received on 12 Jan 2015. This report refers to an 11-year-old female patient. Historical conditions were not reported. Her vaccination status was up to date. Concomitant vaccination included 0.5 ml of BOOSTRIX (batch number: LF444) and 0.5 ml of GARDASIL (batch number: J009788, other manufacturer) intramuscularly on 16 Sep 2014. She was administered only MenCYW-135 liquid component of MENVEO (batch number: M14067) initial dose without being reconstituted with MenA intramuscularly in the right arm on 16 Sep 2014. No adverse event was reported following the administration error. Follow up information received from a medical assistant on 24 Nov 2014: Patient demographics (height and weight), vaccination status and concomitant vaccination updated. Follow up report from the medical assistant received on 12 Jan 2015: Updated concomitant drug (GARDASIL), batch number of BOOSTRIX and vaccination site of MENVEO.
3-13 developed dizzyness with room spinning, cleared after 1 hour of additional sleep. 3-14 repeat of dizzyness with room spinning, did not clear.  Diastolic B/P elevated  from 87 to 107 mmHg; Systolic from 143 to 166 mmHg; Tilt Test Positive.  Symptoms onset around 0715 hrs and lasted until 1600 hrs when EMS called and taken to Hospital
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. On 07-JUL-2015 the patient was vaccinated with improperly stored doses of PROQUAD (Merck) lot # K025761. No adverse effects were reported. The outcome of incorrect product storage was unknown. This case was linked to 1507USA010868 and 1507USA010869 as it was received from the same source. Additional information has been requested.
Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021; patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 3:19 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 3:19 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medication was reported by reporter.  The reporter was reported as EMT. Vaccine was in thaw state 2 to 8 degree Celsius from about 20 Dec 2021. Patient received the dose on 06 Feb 2022 15:19:13.  No treatment medication was reported by reporter.
On Dec. 1, 2016 I went into Clinic and received a flu vaccine. The nurse hesitated after she injected the shot and the site was high up on my shoulder. Within 24 hours my arm was extremely sore and becoming difficult to move and sleep. Within a week, I was unable to sleep more than 45 min at a time because of the pain. I was unable to use my left arm or put pressure on it.  I could not straighten or raise that arm. I went to Urgent care and had an Xray. The doctor prescribed a stronger ibuprofen and a pain medication so that I could sleep. Over the course of the next week my shoulder became more stiff and still was not able to sleep. My primary doctor ordered an MRI and there was swelling to my should.
Pt. presented to clinic with c/o dizziness, nausea, vomiting and headache.  Sent to ER for further evaluation.
Fever; Nausea; This is a spontaneous report from a non-contactable reporter (other healthcare professional).  A 51-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 51 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose number unknown (booster), single (Lot number: GJ3277), in left arm and on 02Aug2023 as dose number unknown (booster), single (Lot number: GK0923), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure high" (unspecified if ongoing); "Sulfa allergy" (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 Sep2023, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 19Sep2023 to 23Sep2023.
Low immune system, tired all the time, no ambition to do anything, body aches, flu like symptoms, chills; can not get warmed up.
Red patch at their waistline; Rash has not grown in size; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red patch at their waistline) and RASH (Rash has not grown in size) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OO7M20A) for COVID-19 vaccination.     On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ERYTHEMA (Red patch at their waistline) and RASH (Rash has not grown in size). The patient was treated with HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN H [HYDROCORTISONE;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red patch at their waistline) and RASH (Rash has not grown in size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient faints after receiving any vaccination, (known reaction by parents). EMS was called, patient was monitored, patient left pharmacy (walked with no support) with father after paramedics left the store.
I began having COVID-19 symptoms on 1/15/2022. I took an at-home test on 1/18/2022, and the result was positive. Since I had previously received my Pfizer booster on 10/21/2021, this was a breakthrough case.
Gynecologist found a lump in patient's breast after the 1st dose.  The lump was there before she received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Gynecologist found a lump in patient's breast after the 1st dose.  The lump was there before she received the 2nd dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced BREAST MASS (Gynecologist found a lump in patient's breast after the 1st dose.  The lump was there before she received the 2nd dose). At the time of the report, BREAST MASS (Gynecologist found a lump in patient's breast after the 1st dose.  The lump was there before she received the 2nd dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant and treatment medication information was not provided by the reporter. The gynecologist found a lump in patient's breast after the 1st dose.                           This case was linked to MOD-2021-403944 (Patient Link).
Headache; shivering; sweats; glandular pain in neck; Sore throat; Fatigue; This is a spontaneous report from a contactable other healthcare professional(patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283) intramuscularly into the left arm on 11Jan2021 08:00 at a single dose for covid-19 immunisation. The patient's medical history was not reported. Patient was not pregnant. Concomitant medication included bupropion (BUPROPION). The patient previously took her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek5730) intramuscularly into the left arm on 21Dec2020 at a single dose for covid-19 immunization and morphine (MORPHINE) and experienced drug allergy. On 13Jan2021, patient experienced headache, shivering, sweats, glandular pain in neck, sore throat and fatigue. Patient did not receive treatment for the reported events. Outcome of events recovered on an unspecified date in Jan2021.
Upper"L" arm soreness especially when moving or lifting arm.  No swelling or redness at injection site.