chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed out about 16 hours later / next morning after getting up from bed to (successfully) go to bathroom and get a drink. Not first time up that night although no problem other two times.  Maybe fainted just as finished drinking? Have no memory of it. Water bottle was capped and back on counter but there was liquid on the stool and floor. Cut gash in head on nearby door frame. Woke up writhing on refreshingly cold floor,  moaning, sobbing for maybe fifteen/twenty minutes before could get back to bed and phone. May have passed out once more briefly in that period after trying to sit up. Half hour at least before could breath more calmly and call another person who could pick me up and keep an eye on me. Then was okay enough to walk outside to meet them. Wanted to avoid going to walk-in clinic and decided gash was shallow enough that we could avoid going in for stitches. (For what it's worth, next day new symptom early morning started having tender left armpit all day and a little ongoing still.)
The next day of receiving my Moderna vaccine, dose 2, I started to feel sick. On 06-07-2021 I had right ear pain which was intolerable. I went to see a group doctor and where I was diagnosed with stage 3 hypertension.  I also had COVID-19 in March 2020. I had the vaccine 06-03-2021. started the next day did not feel well. I started with right ear ache and by Thursday my right ear ache was bad. I then went to see my PCP who took my BP. My BP levels have been 128/84 even through my pregnancies. The pain I started to have in my right ear radiate down to my neck.  I went to urgent care  where they took my BP and it was 167/92 and it was believed I had an ear infection. Two days ago, my doctor placed me on high blood pressure medication. Before being placed on high blood pressure medication my reading was normal of 120/82. When my blood pressure goes up the pain in my right ear goes up. Also two of my molars have been started to hurt. I also experienced brain fog, I get tired easily and I am trying to fight these symptoms all year long.  Before my first vaccine I also had the shingles vaccine. My doctor wants me to wait to get my second shingle vaccine due to my high blood pressure readings.
Leaking injection site; scab on area of injection; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 08Apr2021 at 14:30 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was not known, if the patient had any known allergies to medications, food, or other products. On 10Apr2021 at 10:00, the patient experienced leaking injection site and scab on area of injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event leaking injection site and scab on area of injection was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
dose was given 1 day post expiration; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 22nd August 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: Registered nurse reported that a dose of Havrix was given to the patient 1 day post expiration. The reporter chatted into Medical Information and disconnected before providing any patient demographics. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
5 MINUTES AFTER VACCINE ADMINISTRATION HE FELT LIGHT HEADED THEN COULDNT SEE (BUT HAD EYES OPEN), BLACKED OUT, WAS DREAMING AND THEN WOKE UP. DURING THE TIME HE WAS DREAMING PHYSICALLY HIS EYES WERE OPEN AND HE WAS MOANING, HIS BODY STIFFENED UP AND FACE WENT WHITE. HEART RATE WENT UP TO 125BPM BUT THEN DECREASED TO 65 BPM AS SOON AS HE CAME BACK. HE WAS MONITORED FOR 35 MINUTES LAYING FLAT ON FLOOR, ATE CHOCOLATE BAR AND HAD SODA. FELT MUCH BETTER BEFORE LEAVING AND REGAINED COLOR.
None- vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2021-395985 (Patient Link).
Thrombocytopenia; Blood clots in brain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 13:00 (Batch/Lot Number: EN6206) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Mar2021, patient developed thrombocytopenia and was brought to emergency room/department or urgent care leading to admission, surgery was performed (mechanical thrombectomy) on 30Mar2021 at 10am to address blood clots in the brain. Patient was currently in ICU until he fully recovered. Patient was hospitalized in Mar2021 for 2 days. The events were reported as life-threatening and have caused disability. Outcome of the events was unknown.  Information on lot/batch number has been available. Additional information has been requested.
Face flushing and flat non itchy rash to torso and upper extremities noted. Patient also complained of throbbing sensation of head.
Information has been received from a physician concerning three patients who were recently vaccinated PO with doses of ROTATEQ.  Subsequently the patients experienced rotavirus.  The patients sought unspecified medical attention.  The outcome was unknown.  No other information was available.  There was no product quality complaint.  Additional information has been requested.
8 days p/vax occipital nodes p/MMR rash & rubella;
started as a low throb / gradually got bigger over the next few days, annoying; Goes from the collar bone to the shoulder blade; buzzing in his shoulder; circle around the injection site; sometimes wakes him up; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (buzzing in his shoulder), INJECTION SITE DISCOMFORT (circle around the injection site), PARASOMNIA (sometimes wakes him up), VACCINATION SITE PAIN (soreness at the injection site) and ARTHRALGIA (started as a low throb / gradually got bigger over the next few days, annoying) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 12-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (buzzing in his shoulder), INJECTION SITE DISCOMFORT (circle around the injection site), PARASOMNIA (sometimes wakes him up) and ARTHRALGIA (Goes from the collar bone to the shoulder blade). On an unknown date, the patient experienced ARTHRALGIA (started as a low throb / gradually got bigger over the next few days, annoying). On 10-Apr-2021, VACCINATION SITE PAIN (soreness at the injection site) had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (buzzing in his shoulder), INJECTION SITE DISCOMFORT (circle around the injection site), PARASOMNIA (sometimes wakes him up), ARTHRALGIA (started as a low throb / gradually got bigger over the next few days, annoying) and ARTHRALGIA (Goes from the collar bone to the shoulder blade) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not provided No treatment medication information were not provided
Recieved second anthrax vaccination in right arm and since that point the patient had pain/discomfort in (R) arm.  Pain/discomfort discribed as arthritic pain.  Pain started a few weeks after the 2nd shot and has persisted for approximately a year.  Pain has subsided within the last few months. Second anthrax vaccination was not available at the time of this report.  The patient suspects adverse reactions occured after second vaccination.
cancer; lost legs/Limb Amputation; Initial information was received on 28-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient) via media.  This case involves a male patient (age unspecified) who developed cancer (neoplasm malignant) and lost legs (leg amputation), while he received INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor  The past medical treatment, past vaccination 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 not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious cancer (neoplasm malignant) and lost legs (leg amputation) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant, life-threatening and were leading to disability.  It is unknown if the patient experienced any additional symptoms/events  There were no lab data/results available  It was not reported if the patient received any corrective treatment.  The event outcome was unknown for both the events.  Information on the batch number was requested.  Follow-up information was received on 28-Nov-2020 regarding an unsolicited valid serious case from a consumer(patient) via  media.  Patient gender and seriousness was added Suspect was updated to Influenza vaccine.; Sender's Comments: Follow-up information received on 28-Nov-2020, changes previous assessment: This poorly documented case involves a male patient who had neoplasm malignant and leg amputation after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with LORATADINE at a dose of 10 mg once a day. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient developed hives 9 days after first dose of vaccination.  The patient was scheduled to receive the second dose on 24-Apr-2021.
Post vax, the pt experienced an increase in stomach upset and nausea. It feels like a ball in his stomach. No treatment was given.
Large cellulitis measuring 20 x 20 cm at site of injection ( R Arm)
Pt started feeling adverse reactions after work hrs on 09/30/16, including headaches, migraines, fever and body aches. Went to clinic on 10/2/16.
1307 Flushing, my heart rate felt like it went up. 1311 feeling better. 1319 back to baseline
Sinus congestion, sinus pressure, headache, earache, throat pain Diagnosed as a sinus infection. Antibiotics were ordered and are currently being taken as directed.
Swallowing issues; Ears congested; Sore throat on the  left side; Red tonsil; Swollen glands in throat and neck; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Swallowing issues), EAR CONGESTION (Ears congested), OROPHARYNGEAL PAIN (Sore throat on the  left side), TONSILLAR ERYTHEMA (Red tonsil) and LYMPHADENOPATHY (Swollen glands in throat and neck) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced DYSPHAGIA (Swallowing issues), EAR CONGESTION (Ears congested), OROPHARYNGEAL PAIN (Sore throat on the  left side), TONSILLAR ERYTHEMA (Red tonsil) and LYMPHADENOPATHY (Swollen glands in throat and neck). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (Swallowing issues), EAR CONGESTION (Ears congested), OROPHARYNGEAL PAIN (Sore throat on the  left side), TONSILLAR ERYTHEMA (Red tonsil) and LYMPHADENOPATHY (Swollen glands in throat and neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, SARS-CoV-2 antibody test: other (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient reported that she had visited  Health Care Professional (Second contact) who advised her to undergo COVID test.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.
Information has been received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patients were vaccinated with an improperly storage dose of VAQTA, lot # K018181 and expiration date of 04-JUN-2017, (route of administration and anatomical location were not reported) for prophylaxis, which was stored at a lowest recorded temperature of 32 Fahrenheit (0 Celsius) and a highest temperature of 36 Fahrenheit (2.2 Celsius) for 34 days, the entire 24 hours each day, and lowest recorded temperature of 46 Fahrenheit (7.7 Celsius) and a highest of 77 Fahrenheit (25 Celsius) for 24 hours. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA002769: US-009507513-1702USA002770: US-009507513-1701USA012928.
constipation; abdominal pain; lack of appetite; weight loss (8-10 pounds in last several months);; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ), (Batch/Lot number: unknown) at 5 mg 2x/day. The patient's relevant medical history included: "eczema" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete , unknown manufacturer), for COVID-19 Immunization. The following information was reported: CONSTIPATION (non-serious), outcome "not recovered"; ABDOMINAL PAIN (non-serious), outcome "not recovered"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "lack of appetite"; WEIGHT DECREASED (non-serious), outcome "not recovered", described as "weight loss (8-10 pounds in last several months);". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports previously reported abdominal pain has improved since switching to Xeljanz 5mg twice daily; however, patient reported 1 episode of abdominal pain while traveling recently. Reports ongoing lack of appetite; weight loss (8-10 pounds in last several months); constipation that has been worse over the last 3-4 months. Patient states Xeljanz has helped the most for his eczema. Patient reports 1-2 missed doses per week and 1 week of missed doses when he received his COVID-19 booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 10 minutes after receiving the injection I felt tightening in my throat. I then felt a hot flush all over, and some chest tightness. I notified one of the nurses at the site who took my VS: BP 200/100, P 100, R 22, O2 sat 99%. Symptoms resolved in about 20 minutes. I went back to work when the symptoms returned. As I was walking to the site where the injections were being given I saw a pharmacist from the hospital. He took me to the pharmacy and recommended Benadryl. Since I was at work and Benadryl makes me sleepy he gave me another Claritin, knowing I had taken one that morning. He also suggested that I use my Albuterol inhaler, which I did. Symptoms resolved within the hour.
Information has been received from a certified medical assistant (CMA) concerning a 9-month-old male who on 05-JUN-2007 was vaccinated PO with the third 2.0 mL dose of Rotateq (1st dose given at 3 months of age, 2nd dose given at 5 months of age). Unspecified medical attention was sought. Follow-up information was received from the CMA who indicated that the third dose of ROATEQ was not administered to the patient. Therefore, WAES # 070608A00874 will be deleted from our files for ROTATEQ. No further information is available.
Patient has redness around injection area and has pain in the left arm with some swelling the day after injection. Has headache and muscle pain that radiates to the left side of back. Took aspirin 325 mg x 3 doses, then took 2 doses on Saturday, 2 doses Sunday, and 1 dose Monday. Symptoms improving. Patient advised to take BENADRYL and TYLENOL instead of aspirin due to blooding thinning of ASA.
feeling like they were dying for a day; fever; flu like symptoms; sniffles,; headache; sick like a dog; Initial and Additional information received on 23-Sep-2019 and 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacy other/non-hcp.  This case is linked to cases 2019SA267183 and 2019SA267182 (same reporter).  This case involves a 66 years old male patient who experienced flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), sick like a dog (malaise), fever (pyrexia) and feeling like they were dying for a day (unevaluable event), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Lot: UJ232AA and expiry date: 10-Apr-2020) via intramuscular route in the left deltoid.  On an unknown date, the patient had flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), sick like a dog (malaise), fever (pyrexia) and feeling like they were dying for a day (unevaluable event) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  Final diagnosis was influenza like illness, rhinorrhoea, headache, malaise, pyrexia and unevaluable event.   It was not reported if the patient received a corrective treatment and Spent the whole day in bed.  The patient outcome was reported as unknown for all the events.  List of document held by sender:  none.
Large area of erythema at VARIVAX site RA - about 3in x 3in area - observation only - resolved in couple days.
fevers of 100.6 with shaking, severe body aches, Headache, nausea, loss of appetite, fatigue, arm pain
hives all over body, swelling of ankles, no wheezing or angioedema, has hx asthma and allergies, no hx allergic reaction or anaphylaxis
pt recv vax; fever of 105 that day;unconsolable crying thru noc; possible virus w/ d;
This spontaneous report was received from a pharmacist via company representative refers to unspecified number of non immunocompromised patients of unknown demographics. On an unknown date the patients were vaccinated with PNEUMOVAX 23, (lot number and expiration date unknown), (dose, dosage schedule, route of administration and anatomical location were not reported). On an unknown date the unspecified number of non immunocompromised patients received two doses of PNEUMOVAX 23 within a two to three year period. No adverse effects reported. Additional information has been requested.
Patient experienced redness & swelling at site of injection & was advised to use topical BENADRYL.
Patient presented to our office as a claimant for work comp. She describes: "Hives, body aches, puritis, joint pain, brain fog and flu like symptoms."  Received vaccines on 10-9-2020, reports that hours after vaccine, she began to itch, she took 25 mg of Benadryl. 24 hours after vaccine, she recalls a quarter sized hive on left arm. She reports joint pain, " brain fog" and flu like symptoms. 48 hours later, she reports hive was size of silver dollar. On 10-14-2020, physician documented a localized skin reaction to the varicella vaccine.