chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Singles; This is a spontaneous report from a contactable consumer. A 78-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Jan2021 (at the age of 78-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Jan2021 (at the age of 78-years-old); as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and received unspecified treatment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was resolved with sequelae on an unknown date.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored PROQUAD (lot # L019995 with expiration date of 02-DEC-2016 and lot # L031600 with expiration date of 18-FEB-2017, dose and route unknown), which was exposed to the following condition: 8.8 Fahrenheit for 1 hour and 9 minutes with no previous temperature excursion, digital data logger was reported as yes. No adverse symptoms were reported. Additional information has been requested.
This female subject was enrolled in a study. On 4/26/06 and 5/30/06, she received a booster of either combined Boostrix (IM, LD) either Menactra (IM LD). This subject received Menactra at V1 and Boostrix at V2. On 6/26/06, 61 days after the 1st dose of Blinded vaccine, 27 days after the 2nd dose of Blinded vaccine, this 13 year old subject was diagnosed with having leukemia and was hospitalized for further work up and treatment. Laboratory tests were performed. Outcome was unknown at time of reporting. Investigator causality was unknown at the time of reporting. Further information has been requested.
SLEEP RELATED HYPOVENTILATION OR HYPOXEMIA 3/8/2023 CHF EXACERBATION, UNSPECIFIED ACUTE PULMONARY EMBOLISM 4/17/2023 CHF EXACERBATION, UNSPECIFIED ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 12/27/2022 CHF EXACERBATION, UNSPECIFIED ACUTE DVT OF BILAT FEMORAL VEINS 4/17/2023 CHF EXACERBATION, UNSPECIFIED ACUTE RESPIRATORY FAILURE 2/16/2023 CHF EXACERBATION, UNSPECIFIED  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/17/2023 CHF EXACERBATION, UNSPECIFIED HYPOXEMIA 4/17/2023 CHF EXACERBATION, UNSPECIFIED
swelling @ site-immed facial swelling & redness-12 hrs w/rash on arms & thighs-pruritic allergic react e.g. poison ivy vs vax react;
This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, male patient. The patient's medical history and concurrent conditions were not reported. ON 03-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Evening following DTAP, pt became decreasingly alert, decreased appetite and difficult to awaken. Pt was then evaluated in our office, the following day. Mom reported symptoms confirmed and baby was tachycardic. Pt admitted to hospital for observation.
Patient fainted within 15 minutes of vaccination.  Felt better after resting and was released to home.
This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (left arm feels like its tired), FATIGUE ("Like he worked out a lot") and LIMB DISCOMFORT (felt like his other arm received the vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The patient's past medical history included Bariatric surgery (patient has 6 stents). Concurrent medical conditions included Blood pressure high. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced ASTHENIA (left arm feels like its tired) and FATIGUE ("Like he worked out a lot"). On 02-Mar-2021, the patient experienced LIMB DISCOMFORT (felt like his other arm received the vaccine). At the time of the report, ASTHENIA (left arm feels like its tired), FATIGUE ("Like he worked out a lot") and LIMB DISCOMFORT (felt like his other arm received the vaccine) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Added TCR; On 04-May-2021: NNI
Post vax, child cried but reacting appropriately. We walked down a hallway and while standing, waiting to pay, the child faints. Color was pale and child was diaphoretic. We need vaccines combined more; needle stick is very traumatic.
On 03/15/2023 I started feeling sick and dis test positive for COVID-19.  I had a lot of drainage and a sore throat, I felt like a cold. That evening progressed and I developed a fever and congestion. I was extremely tired, I had to force myself to walk. I also had the brain fog everyone has talked about. I called my doctor three days after symptoms started and they put me on Paxlovid. It resolved a few days while taking it. I was negative on the 22nd.  But on 03/25/2023, I did have a relapse of COVID-19. My symptoms were not as bad. I had no fever, just a cough drainage and congestion. I am still having a cough and light drainage, but I will say things are much lighter this round. I am still feeling sinus issues and the brain fog is still here.
Swollen at injection site, hot to touch, painful, itch both at site and systemically. slowly resolved over the course of 3 days with Benedryl. some swelling remains along with bruising after 4 days
Rash  Pain/discomfort at injections site, 1/4 with rash left  Narrative:
flu; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 10-Nov-2020.   This case involves a patient with unknown demographics who experienced flu (Influenza), when received vaccine INFLUENZA VACCINE (flu shot). Relevant medical history, past 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 unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient experienced flu (Influenza), unknown latency following the administration of INFLUENZA VACCINE. Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
By Feb 20, my ability to run diminished. Was slightly SOB and stamina was decreased, VO2 decreased 10 points (on Apple watch), occasional lung burning, as if new at running. (I run 3-4 x per week. 3 miles). When not exercising, I felt ok. Beginning 3/13/21 heart palpitations increased. 3/21/21 was a day with many palpitations that "worried" me and I did not fell well. I was seen by my MD that week . Labs ok. 48 hour Holter had lots of PVCs, but generally ok. Stress test ok. Lung function tests wnl. By May 15, my VO2 was back up to normal. Running was normal in June sometime. By the first week in March, I had occasional right lower abdomen pain. I was seen 3/23/21 for this and had a pelvic ultrasound, which showed dilated blood vessels. I was diagnosed with Pelvic Congestion Syndrome. Mild to moderate pelvic discomfort and pressure remain. I have an appointment in September to follow up.
Day 1: sore arm, headache, fatigue, extreme chills; Day 2: 100 degree fever (even with Excedrin), body aches, fatigue, heavy arm, brain zaps, sweating, headache, nasal congestion; Day 3: 99 degree fever, unrelenting headache, nasal congestion; Day 4: unrelenting headache, weak, fatigue, nausea, nasal congestion; Day 5: unrelenting headache, weak, fatigue, body pain, including soles of feet, foggy brain; Day 6: unrelenting headache, nasal congestion; Day 7: unrelenting headache, indigestion, nasal congestion, vertigo, itchy rash on injection site, painful soles of feet; Day 8: constant headache, vertigo, especially while lying down, itchy all over; Day 9: constant headache; Day 10: constant headache; Day 11: constant headache
per hospital reporting system " Given early dose of Pedvax Hib. System listed the vaccines under separate names and this was not noticed until after the vaccination was administered. Child received 3 doses of this when only 2 are indicated for their age."
Information was received from a registered nurse, regarding unspecified patients (demographics not provided). The nurse reported that PEDVAX HIB; GARDASIL (case #1404USA000049); and ROTATEQ (case #1404USA010716)were potentially exposed to a 33F and a 24F recording, which she believed to be erroneous recordings of a digital Vaccines for Children (VFC) Thermometer, and have been administered to unspecified patients (dates of administration, lot numbers, dosages and routes of administration not provided). The nurse reported that she believed that the thermometer that gave her the readings is inaccurate. She stated that her facility has a mercury thermometer that read temperatures that were in the recommended range. No adverse effect reported. Additional information has been requested.
The patients arm became itchy and hard to move the first night. The second through approximately 5th day, she developed a large red rash/hives down her left arm ending at the elbow.
Rapid heart rate, 1 trip to ER, cardiologist, several EKG?s administered, cardiologist put me on  25 mg Metoprolol
A Patient did not remember that FLuzone HD was already administered 3 weeks ago, and received additional dose today again with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient where a patient did not remember that vaccine influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] was already administered 3 weeks ago, and received additional dose today again with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (lot U8130DA and expiration date- 30-Jun-2024) via unknown route in unknown administration site (dose, formulation, strength: not provided) for Immunisation (extra dose administered)  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
This spontaneous report was received from a registered pharmacist concerning three patients of unknown demographics. On 09-SEP-2013, three unspecified patients were vaccinated with an expired dose of VARVIAX (Merck) (lot number and expiry date were reported as H016329 and 31-AUG-2013 respectively, dose and route unspecified). No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
my COVID-19 symptoms returned; my COVID-19 symptoms returned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 21Apr2021 as dose 2, single (Lot number: EW0170) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), from 05Jan2022 (Lot number: 031H21A) to 05Jan2022 at single (dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Reynaud's Syndrome" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX D, start date: 08Jun2022, stop date: 18Jun2022; ALKA SELTZER PLUS SEVERE COLD AND FLU, start date: 08Jun2022, stop date: 19Jun2022; MUCINEX, start date: 08Jun2022, stop date: 19Jun2022. Past drug history included: Erythromycin, reaction(s): "Allergy:Erythromycin"; Cephalosporin, reaction(s): "Allergy:Cephalosporin"; Fluoroquinalones, reaction(s): "Allergy:Fluoroquinalones". The following information was reported: COVID-19 (medically significant) with onset 16Jun2022, outcome "recovering", VACCINATION FAILURE (medically significant) with onset 16Jun2022, outcome "unknown" and all described as "my COVID-19 symptoms returned". Therapeutic measures were not taken as a result of covid-19.  Clinical course: It was reported that 3 days after finishing Paxlovid course, patient COVID-19 symptoms returned to their initial strength dry cough, runny nose, intermittent fever, sinus and ear congestion and pressure
appendicitis; This is a spontaneous report from a contactable consumer (patient himself). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration on 26Feb2021 02:30 PM at single dose in right arm for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) and doravirine (PIFELTRO). No other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced appendicitis on 16Mar2021 at 09:00 AM. Seriousness was given as hospitalization for one day. Treatment was given for event included surgery. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Since the vaccination, the patient had been tested for COVID-19. Patient has tested COVID on 16Mar2021 with the result negative post vaccination. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Started convulsing. Eyes started rolling back and fainted. Had to call the paramedics. Right after she got the shot she said she was feeling light headed and didn?t feel good.
DEVELOPED BELLS PALSY AND WAS IN ER AND ADMITTED TO HOSPITAL ON 4/10/2021.  DIAGNOSIS WAS BELLS PALSY BY A NEUROLOGIST ON STAFF
Patient was administered dose after expiration. Office will call Pfizer to check for stability data, and revaccinate if recommended.
Injection site arm hot/feeling like I am burning up inside; Aanxiety; Nauseous; Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Injection site arm hot/feeling like I am burning up inside), ANXIETY (Aanxiety), NAUSEA (Nauseous) and VACCINATION SITE PAIN (Sore injection site arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced FEELING HOT (Injection site arm hot/feeling like I am burning up inside), ANXIETY (Aanxiety), NAUSEA (Nauseous) and VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, FEELING HOT (Injection site arm hot/feeling like I am burning up inside), ANXIETY (Aanxiety), NAUSEA (Nauseous) and VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Heart rate: increased (High) heart is racing.         Concomitant medication list was not provided. Treatment information was not provided. It was reported that the patient's arm was very sore and hot for which she needed to ice her arm.   This case was linked to MOD-2021-242206 (Patient Link).
He got his vaccine, a couple of days went by and seemed okay.  He then complained of having no energy, had difficulty getting up and was kind of clammy and bluish.  The next morning they took him to the Hospital and was diagnosed with COVID.  He was in the hospital a couple of weeks, and then was discharged.  He went to the temporary care unit.  He has recovered and doing OK.  He did have to build his strength back up following COVID.    He received 75% oxygen and they thought that he would not make it, but he has survived and improving.  He did have PT to build his strength and continues to improve.    He thinks that the booster gave him COVID.  Son talked to the pharmacist and told him that was not possible.
rash x24hr w/itching;mild fever & URI sx;several clear vesicles on scalp;numerous clear vesicles & excoriated lesions on whole body;
Patient called an stated that he received a Tdap shot on 5/12/07. The following day he had no energy. He slept most of that day. On 5/14 and 5/15 he felt ok. On 5/16 he stated his body ached, he was hot then cold, He had no energy. Temperature ranged between 99.5-100.1degF on 5/17 he slept from 12:30pm Through till 9am on 5/18/07. Patient also has a lump at injection site.
Moderna  vaccine  (NDC  80777-0273 -98) lot# 039D21A + GTIN 00380777273983 was administered  after the beyond date of 10/23/2021. Contacted Manufacturer Moderna = no need to repeat the dose .
Pt with abdominal pain and vomiting, admitted via the ED with acute pancreatitis without clear etiology
After last immunization given (DTaP), a few seconds past and child began mumbling "La La La"; drooling was noted. The episode lasted approximately 3-4 minutes. The patients father stated that the child had never done that before. The child was referred to referred to their private physician for other immunizations.
intractable left arm pain for 6 hours, unable to move arm, started about 9 hours after injection
Information has been received from a certified medical assistant concerning a 16 year old female patient with a penicillin allergy which caused hives who on 15-DEC-2006, was vaccinated IM into the right deltoid with a first 0.5ml dose of Gardasil. Two months ago, on 07-JUN-2007 the patient developed a "tick" and will be seeing a neurologist. On 25-JUN-2007, the patient was vaccinated with a third dose of Gardasil vaccine (Lot# 657737/0552U). Concomitant therapy included LOESTRIN. On 25-JUN-2007, the patient developed severe hiccups. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
No additional AE; Nurse calling to report that a dose of PNEUMOVAX 23 was administered after its labeled expiration date.; This spontaneous report was received from a nurse regarding a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-OCT-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, (lot number W007035 has been verified to be a valid lot number, expiration date reported and validated as 20-OCT-2023) (expired product administered) administered for prophylaxis (vaccination scheme, anatomical location and route of administration were not provided). The product did not undergo a temperature excursion and there was no adverse event.
04/27/2021 10:00 AM - 11:00AM 10 min in twinges in throat strange tongue, 1 Hr bad taste in mouth, throat congestion and sore, tongue feeling odd, 2hr tongue feels normal throat congestion and swelling, 3hr tight chest no problem breath, sore upper back and shoulder, normal tongue, a bit dizzy, 3.2 hr headache, dizzy, foggy head, less dizzy throat feels normal, slight headache, 5hr less foggy, throat same, chest congestion, left trapezius pain persists. 6hr clear mind, slight throat pain, clear chest muscle pain gone. 09:40PM foggy headed and dizzy, 11:00 PM arm hurts a lot, chills, body ache, 09:00 AM headache, arm hurts, low grade temp, 05:00PM after sleeping 5 hours fever, body aches, headaches, took two extra strength Tylenols. Morning after 2nd day feeling better. 3rd day I got Covid arm with pain, swelling and itchiness, and on 5th day headache and back pain on left side became chronic issue for 1 month.
Breakthrough case admission after 2 vaccines Pfizer 4/16/21 Lot# Ew0162;  Pfizer 5/7/21 Lot# Ew0164
On 1/19/99, post vax, the pt had a positive pregnancy test.  14 weeks from LMP the pt experienced hypertension and toxemia. On 8/6/99, the pt gave birth to a normal baby girl.
RAPID COVID-19 TEST POSITIVE; SLIGHTLY UNDER THE WEATHER; WEAK; NAUSEOUS; This spontaneous report received from a parent concerned a 23 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced slightly under the weather. On 06-APR-2021, the subject experienced weak. On 06-APR-2021, the subject experienced nauseous. On 26-APR-2021, the subject experienced rapid covid-19 test positive. Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly under the weather, weak, and nauseous on 07-APR-2021, and the outcome of rapid covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint:  The suspected product quality complaint has been confirmed to be voided (no PQC was identified within the reported complaint reported) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.