chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines administered at 2:52 PM. Pt left W/O C/O's. Returned at 4:18 PM C/O feeling lightheaded, nausea, headache. Pt encouraged to sit and place head between legs. Always eat before receiving vaccines. Offered a lollipop. VS: 110/80, Temp 100.3 degrees F, P: 88, R: 16. Observed for 20 mins until she started to feel better.
BODY ACHES; CHILLS; ARM VERY SORE; SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced side effects of chills, body aches (achy), arm very sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the side effects, body aches, chills and arm very sore on an unspecified date.  On an unspecified date, the patient received additional Non-company suspect vaccine included mrna 1273 (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for an prophylactic vaccination. On an unspecified date, the patient experienced side effects which were familiar to earlier shot (Johnson & Johnson), had chills, body aches overnight, and arm very sore. The pharmacist confirmed it was safe to take Tylenol (paracetamol), so the patient took two capsules starting at around 10 PM that night and every four hours until no longer felt achy, which was until about noon the following day. Also arm felt very sore for about 24 hours, so the patient skipped going to the gym the next day. The action taken with mrna 1273, was not applicable. The patient recovered from the body aches, (achy captured under body aches). The outcome for the events of very sore and side effects was not reported.  This report was non-serious.
S/S: chills, fever (tactile: fever undocumented), drowsiness, HA, malaise, change in appetite, myalgia.
Patient with DOB which is currently 4 years of age was given Pfizer (5yrs-11yrs).
Heart Palpitations and high blood pressure . Started 5 days after Moderna vaccine, and progressed on the 6th day, and ended up in Urgent Care with high heart rate and high blood pressure.   I still feel palpitation episodes almost daily that last anywhere from 1 to 5 minutes
Rapid heart rate-Tachycardia.   resting heart rate at 105 bbm at rest prior to going to the hospital. started on 06/29 in the afternoon. Went to hospital morning of 07/01.
The pt was given the pneumonia vaccine on 11/7/00. The pt experienced severe swelling from shoulder to below elbow.
I developed an outbreak of shingles about 2 weeks after my first dose. I developed a painful rash on the right side of my body. The doctor diagnosed and prescribed me anti-viral drugs. I am still experiencing the rash and some pain. I do not have an auto-immune disease and I am very healthy.
bronchitis; terrible cold; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves patient [age unspecified] who experienced bronchitis with symptoms terrible cold (nasopharyngitis), while patient received vaccine INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bronchitis and terrible cold (nasopharyngitis) for 2 months unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information available on the batch number for this case.
Body aches, strong head aches, heartburn, bloating, nausea, calmly, feel hot but no fever---for 3 days and counting
Leg pain; Muscle cramps; Numbness pins and needles and feet are like cold; Numbness pins and needles and feet are like cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 25Apr2021 (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Leg pain"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Muscle cramps"; HYPOAESTHESIA (non-serious), PERIPHERAL COLDNESS (non-serious), outcome "unknown" and all described as "Numbness pins and needles and feet are like cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upper left arm redness from just below elbow to shoulder. Minor swelling in upper left arm for 3 days.
Received the flu shot 11/9 - a few wks after have undiagnosed inflammation all over body.
PT STATES AREA BECAME RED AND SWOLLEN, PAINFUL. PT BECAME FATIGUED AND SLEPT REMAING OF DAY - FEVER, SWEATS LATER IN EVENING. REMAINS WITH TENDERNESS AND SWELLING TO ARM. STATES IS APPROX 2.5 INCHES X 1.5 INCH
Pt devel high pitched crying approx 5 hrs p/receipt of immun; Also had high fever to 104; irritability, dec feeding; day p/devel URI w/fever; Seen in ER 20NOV for cough; dx viral URI & rxn to Pertussis;
This spontaneous report was received from a physician refers to a 60 years old patient(gender unspecified). The patient had a negative history of chicken pox and negative varicella time. On 02-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # and route not reported) instead of VARIVAX due to a human error. No concomitant medications were reported. No adverse effect was reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
From initial information received on 10NOV2004 from an RN regarding an adverse even occurring in the USA, it was reported that a 53 year old male patient, who is an ER physician , received a dose of FLUZONE, SV 2004-2005 USP, lot number U1427AA, administered IM in the right deltoid on 4NOV2004. Two days later, the patient felt feverish and achy. on 8NOV2004, he developed a severe headache on the left side of his head. On awakening the following morning, the  patient could not talk right and developed drooping of the left side of his face. He was also unable to close his left eyelid. The patient was diagnosed with Bell's Palsy. It was not reported whether he was seen by another physician or treated for these events. It is also unknown whether he recovered from these events.
COVID 19 Treatment; COVID 19 Treatment; 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 46-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EW0150), in left arm, on 12Apr2021 as dose 2, single (Lot number: FJ8762), in left arm and on 01Dec2021 as dose 3 (booster), single (Lot number: EN6205) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing). Known allergies: No. Concomitant medication(s) included: LIALDA; LEVOTHYROXINE; TURMERIC [CURCUMA LONGA]; VITAMIN D NOS; FISH OIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient received PAXLOVID for COVID-19 treatment from 03Aug2022 to 07Aug2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (11Aug2022) Positive, notes: Then, at day 9, I rebounded terribly, tested Positive; (Aug2022) Negative, notes: I tested negative after 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.
could not lift his hand after the vaccine; pain; fever; first dose on 23 Feb 2021 and second dose 3 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not lift his hand after the vaccine), PAIN (pain), PYREXIA (fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 23 Feb 2021 and second dose 3 Mar 2021) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 23 Feb 2021 and second dose 3 Mar 2021). On an unknown date, the patient experienced MOBILITY DECREASED (could not lift his hand after the vaccine), PAIN (pain) and PYREXIA (fever). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 23 Feb 2021 and second dose 3 Mar 2021) had resolved. At the time of the report, MOBILITY DECREASED (could not lift his hand after the vaccine) outcome was unknown and PAIN (pain) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: abnormal (abnormal) Blood sugar level was abnormal. On an unknown date, Glycosylated haemoglobin: increased (High) Glycosylated hemoglobin was increased. On an unknown date, Thyroid function test: 14 (abnormal) 14.         No concomitant medications was provided.  No treatment medications was provided.
A very pronounced metallic taste in his mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (A very pronounced metallic taste in his mouth) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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) (Intramuscular) 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (A very pronounced metallic taste in his mouth). At the time of the report, DYSGEUSIA (A very pronounced metallic taste in his mouth) 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.   This case was linked to MOD-2021-209109 (Patient Link).
A cyst on my left ovary ruptured that evening and I went to the Emergency Room the next day due to the pain
10 pm of 3/23 I started feeling headache and muscle pain.  By 4:30 3/24 I was in great pain across multiple locations across my body. I also had a heaviness in my chest, making it uncomfortable to breath.
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient was administered expired FLUMIST QUADRIVALENT. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Patient had sciatica got better before the 1st shot.  Went to hospital on 2/6/21 and confirmed no clots in leg; sciatica.   After the 1st shot on 2/19 his leg started hurting; after the 2nd shot could not walk without being in excruciating pain and with a walker and assistance.  The doctors and hospital kept saying sciatica and gave him 2 injections in his back.  NO relief.  His right calf was swollen and tender.  But no one questioned the vaccine - not politically correct.  After 2 1/2 months of pain which the meds did not help the patient was taken to another state on May 1st.  Saw a doctor said either blood clots or bone cancer.  At the hospital it was confirmed many, many, many blood clots in his leg.  He had no history of blood clots.  Patient died in hospital from sepsis (much worse then getting Covid).
Approx 8/09/2021 suffered a 'large' floater' in my left eye. Went to see a doctor at Eye Clinic a few days later. Floater was mostly transparent with dark material around the outside of the specimen. Doctor examined and diagnosis was 'Vitreous Detachment'. No medication or other course of treatment is available. Floater is still barely visible with some dark material at the left edge. Retina was not seemingly damaged per the doctor's examination. Followup appointment in about two weeks (approx 9/18/2021)
hallucinations; insomnia; nausea; migraine; This is a spontaneous report from Pfizer. A contactable consumer (patient) reported that a male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced insomnia, hallucinations, nausea and migraine 3 days after 1st dose on 06Feb2021. The event hallucinations was serious for being medical significant. He got the 1st dose last 03Feb 2021. He was scheduled for 2nd dose on April 5. The outcome of events was unknown.  Information on the lot/batch number has been requested.
during administration vaccine leaked from the syringe and ran down the patient's arm; vaccine leaked from the syringe and ran down the patient's arm; during administration vaccine leaked from the syringe and ran down the patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   On 19th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 19th June 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were provided as follows: Pharmacist reported that the patient had received Shingrix vaccine in the left deltoid. During administration the vaccine leaked from the syringe and ran down the patient's arm, which led to accidental underdose and exposure via skin contact and Inadvertent exposure to vaccine. The reporter consented to follow up.
Moderate erythema and swelling at injection site of Zoster vaccine (left subQ).  48 hours later, she developed significant swelling of an axillary lymph node and decreased ROM in left arm
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with case 2018SA302269 (same reporter). This case involves a three patients who was vaccinated with a IPOL lot P1A251M, expiry date 02 May 2020, route and site of administration were not reported on 27-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included FLUZONE QUADRIVALENT for Immunisation; DTAP for Immunisation; MMR for Immunisation; and VARICELLA VACCINE for Immunisation. It was a case of actual medication error due to incorrect product storage. It was reported that the vaccines exposed to a temperature excursion twice on 22-Sep-2018 with temp up to 8.29 C for 1 hour and on 19-Oct-2018, at 8.33 C for 1 hour. The patient didn't experience any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
On the 10/30/2021 I had fever, chills, like I did with other ones, malaise, I felt terrible and that lasted one day. Then about a month later 11/27/2021, I was experiencing night sweats. I was experiencing malaise, I could not even get out of bed. I became very depressed, but that did go away. I am very active, I walk my dog about a couple of miles a day. And I had shortness of breath, I felt exhausted when I came in. I took my BP. It was mildly elevated, I am usually 116/70, and it was 130/69, My pulse was up 160. I have an icon on my BP monitor, indicating I had tachycardia, the next day the same thing. I took my PB again, the tachycardia icon came up again. It continued and got worse and worse and I contacted my PCP  who referred me to a cardiologist. On 12/08/2021 I went to the cardiologist, I had a abnormal EKG, sinus tachycardia, borderline t-abnormalities, low voltage precordial leads. At that time the cardiologist put a Holter cardiac monitor for a period of 14 days. It came back that everything was normal. He also ordered cardiovascular stress test on 01/14/2022, that came back fine. Today I am doing a lot better. I can walk my dog and stuff like that.
Client received the first COVID vaccine ( Pfizer, lot #EW0185, use by 06/24/21 at 0845) at 1528. Client approached EMT at 1542 and asked, " Is it normal if I had a tingling sensation that went down my arm for a second when I got the vaccine? I still have a little tingling feeling on my left hand but when it went down my arm, it was only for a second when I first got the shot."  EMT, informed the client she was going to get the lead nurse. Registered Nurse assessed the client and educated her about how when the vaccine is administered if it hits a nerve, it can cause a tingling sensation that may radiate down the arm. The client denied any numbness or loss of sensation to the arm and hand. Vital signs were taken at 1545, HR- 78, BP- 120/70, oxygen saturation- 99%, RR- 16. The client was alert and oriented x 4. Denied any shortness of breath, dizziness, headache, nausea, or vomiting. The client stated, " It's been getting better and it's almost gone, I just wanted to check and make sure it was okay." RN advised the client to stay for another 15 minutes of observation and also educated the client to follow-up with her primary care provider if symptoms returned or worsened, and to immediately go to the emergency room or call 911 if she experienced difficulty breathing, rash, hives, wheezing, or difficulty swallowing.  RN also educated the patient about V-Safe. Client left at 1550, ambulated with a steady and even gait and told RN "It's almost gone, I feel better."
Report of 5 faulty syringes at site. Syringes for Moderna supplied by source. Syringes leaked at hub even after tightening and were difficult to depress. New lead nurse did not know that names of clients should be provided for documentation so she was unable to know who it was.  2 of the 5 patients were re vaccinated due to less than 50% of dose being given. Incident reported and information provided to MDH. Remaining stock of 1600 syringes will not be used. 3 ml Syringe with needle; 3 ml lock with tip 23G x 1" Lot 181101, expiration 10/01/23.
Fever of 102°, extreme muscle pain, chills while burning up, nausea and insomnia even though I have been very fatigued.
Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing your doing something wrong and unable to correct it; Motor skills slowed; Fuzzy tongue; generally out of sorts feeling; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 42-years, via an unspecified route of administration in left arm at 12:15 AM on 16Mar2021 at single dose for COVID-19 immunisation, in Public Health Clinic. Medical history was reported as none. No other vaccine in four weeks. No COVID-19 prior vaccination. No known allergies. Concomitant medications were not reported. At 08:30 AM on 17Feb2021, the patient had periods of disorientation, confusion. Equatable to the description of Alzheimer's or dementia patients. Knowing you doing something wrong and unable to correct it. Motor skills slowed. Fuzzy tongue, and generally out of sorts feeling. Punctuated by periods of lucidity. No treatment received. Outcome of the events was recovering. No Covid-19 tested post vaccination.
Pt became dizzy and started vomiting lasted for less than five minutes. After drinking water and sitting for another 5 min he felt better.
COVID 19 Treatment: Paxlovid; COVID 19 Treatment: Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 13:00 as dose 4 (booster), single at the age of 61 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral, start date: 29May2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment: Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Rash at injection site, no itching ,no treatment, rash gradually disappeared over the course of a week  By March 15, the rash was completely gone.
HD FLU SHOT GIVEN INSTEAD OF REGULAR FLU SHOT IN THE LINE OF PATIENTS FOR FLU CLINIC; FACILITY TOLD ABOUT MISTAKE AND WERE GOING TO NOTIFY ALL PATIENTS WHO GOT A HIGH DOSE SHOT WHO WERE YOUNGER THAN 65 YEARS OLD; NO REPORTED ADVERSE EFFECTS REPORTED BY FACILITY TO  US