chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not feeling well; I have a very low grade 99 temp; Aching in my back and chest area; Aching in my back and chest area; Full headache and just dont feel good; I was exhausted; Arm became increasingly sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2, dose 2 via an unspecified route of administration on 20Apr2021 09:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported.  The patient previously took the first dose of BNT162B2 on unknown date for Covid-19 immunization and also took Flu vaccine. The patient received 2nd dose vaccine about 9:15 am CST on 20Apr2021. Arm became increasingly sore (Much more noticeable than 1st shot by about 7pm. The patient did take ibuprofen and utilized the arm to keep it from getting as sore). By 7:30Pm the patient  was exhausted and just not feeling well and went to bed. Today (21Apr2021) 24 hours post shot the patient  has a very low grade 99 temp (the patient usually run 97.5). There was kind of aching in ther patient's back and chest area with a full headache and just didn't feel good. If this goes longer than 48 hours post injection the patient will report again but was advised some of this does happen. It makes the patient feel confident the body will be ready to ward off Covid if exposed in the future. The patient considered some symptoms a plus. However the patient was resting and not working today (21Apr2021) listening to the body. When receiving flu vaccines the only time the patient got a sore arm was  when its put in the nondominant arm. The patient chose the dominant arm for Covid and this was a pronounced arm soreness more severe than with flu shot (And much more sore than 1st injection along with these symptoms previously discussed).The outcome of events was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Pain at injection site, headache, nausea, loss of appetite, achy muscles, loss of sleep, chills, night sweats, dizziness, swelling at injection site, dark urine, blood in urine, red rash at injection site/treatment included missing 2 days work to rest, drinking large amounts of water/Five days after receiving vaccine I still have swelling of arm, itchy red rash and dark urine.
Pt. stated he had not yet had vaccine.  It was entered in the system that he had received J&J vaccine. He was given J&J vaccine yesterday.
Fever to 100 degrees F., shaking teeth rattling chills, headache , myalgia, sore muscles, fatigue, joint pains and insomnia
The patient is a 45 year old male with a history of HTN, OSA and hypercholesterolemia. The patient reports he receives all his vaccines in his left arm and he experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever within 1-2 days of vaccine receipt 06 OCT 2011. He reports the fever, resolved after 1-2 days but the edema continued and he developed a mass over the next several months. He had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthem, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve, and waited 6 or month months, but he eventually pursued evaluation and which resulted in mass excision from his axilla. Pathology demonstrated a lipoma and 1 lymph node with otherwise normal pathology. He had two subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately 6 months.
(L) upper arm, red, hot, swollen 6cm x 5cm. Cool compresses and MOTRIN.
an 11 year old was inadvertently given the Flublok immunization with no AE; Initial information received on 03-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA272961.  This case involves a 11 years old female patient who inadvertently received 0.5 ml once dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: UJ463AA, expiry date: 19-Mar-2021) via intramuscular route on left arm on 03-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  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.
Information has been received firm a company representative concerning a 36 month old patient who in approximately 2008 was vaccinated with the first dose of VARIVAX (Merck). There were no any lab diagnostic studies performed. On approximately 10-SEP-2009 the patient experienced a breakthrough case of varicella. At the time of this report the patient's outcome was not recovered. The patient sought for unspecified medical attention. No further information is available.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Well Controlled, No changes.) since 01-Jan-1993 and Alcohol use (5 drinks per week) since 29-Mar-2021. Concomitant products included OMEPRAZOLE from an unknown date to 26-Mar-2021 for Heartburn, HYDROXYZINE for Insomnia.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Jun-2020 and the estimated date of delivery was 31-Mar-2021. On 11-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The vaginal delivery occurred which was reported as Full-term. For neonate 1, the birth weight was 3033 grams (6lbs 11oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. Infant details: Length : 20.25in Sex: Male. On 11-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2020, Glucose tolerance test: normal (normal) Normal. On 05-Jan-2020, Ultrasound antenatal screen: normal (normal) Normal. On 18-Jul-2020, Pregnancy test: positive (Positive) Positive. On 31-Aug-2020, Blood test: normal (normal) Normal, Rh, HIV,CBC, Standard  screen.. On 10-Nov-2020, Ultrasound antenatal screen: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No abnormalities identified for the infant.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up which contains pregnancy outcome details, concomitant medications and medical history updated.
Info has been received from a NP concerning a 9 year old female with no known allergies or drug reactions and a history of a positive tuberculin test who on 1/17/06 was vaccinated SC, with a 0.5 mL dose of varicella virus vaccine live (lot 647538/0784R). Suspect vaccination administered that included a dose of MMRII. On 1/20/06, the pt presented to a walk-in clinic with lesions in her mouth and on her chest, public area and face. She received symptomatic treatment only. On 1/30/06, the pt recovered. There was no product quality complaint involved. Additional info has been requested.
Pt developed aches, pain and headache and felt feverish day after receiving 2nd dose of Moderna vaccine.  Continued on Sunday and on Monday developed leg stiffness and swelling.  Patient presented to the ER with extensive lower leg DVT.
ON 06JUNE2006 I RECEIVED MY 5TH ANTHRAX SHOT. FIRST TWO VACCINATIONS WENT FINE; ON THIRD AND FOURTH I HAD LOCALIZED SWELLING, BURNING, AND ITCHING WHICH WENT AWAY WITHIN A WEEK OR TWO. ON MY LAST VACCINATION (THE 5TH ONE) I WOKE UP THE DAY AND NOTICED THAT MY RIGHT UPPER ARM WAS SWOLLEN WHERE I HAD RECEIVED THE VACCINATION. I FOLLOWED UP W/ MY DOCTOR. HE TOLD ME THAT IS WAS A LOCALIZED REACTION AND INFORMED ME THAT I MIGHT WANT TO CONSIDER TURNING THAT VACCINE DOWN IN THE FUTURE, SINCE IT IS VOLUNTARY, BUT IF I DO DECIDE TO RECEIVE MORE IN THE FUTURE TO TAKE BENADRYL BEFORE RECEIVING ANY MORE. ON OCTOBER 13, 2006 (ABOUT FOUR MONTHS AFTER VACCINE) I NOTICED THAT MY ARM HAD SWELLED BACK UP AND WAS ITCHING BADLY. I WENT BACK TO THE DOCTOR AND HAD HIM LOOK AT IT AGAIN, HE PRESCRIBED ME ATARAX TO REDUCE THE ITCHING SENSATION. HE TOLD ME THAT HE UNSURE WHEN THIS PROBLEM WOULD GO AWAY BUT TO COME BACK IN IF ANY MORE PROBLEMS OCCUR. TO THIS DAY THE ITCHING IS STILL INTERMITTENT/RECURRENT.
Patient noticed injection site was red and tender to touch the next evening after the vaccination. (May have been swollen). I examined the site today when she called to ask about the reaction. No pain or swelling today, but still red.
Arm was pink; Felt nauseas; Was really tired / fatigued; Not feeling well; Had a headache; Had a swollen arm; Felt heat rising up to her head; Felt lightheaded, like she was going to pass out; felt weird; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt lightheaded, like she was going to pass out), FEELING ABNORMAL (felt weird), PERIPHERAL SWELLING (Had a swollen arm), SKIN DISCOLOURATION (Arm was pink) and FEELING HOT (Felt heat rising up to her head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had COVID last year) in 2020.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Felt lightheaded, like she was going to pass out), FEELING ABNORMAL (felt weird) and FEELING HOT (Felt heat rising up to her head). On 13-Mar-2021, the patient experienced PERIPHERAL SWELLING (Had a swollen arm), MALAISE (Not feeling well), HEADACHE (Had a headache) and FATIGUE (Was really tired / fatigued). On 14-Mar-2021, the patient experienced SKIN DISCOLOURATION (Arm was pink) and NAUSEA (Felt nauseas). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 12-Mar-2021, DIZZINESS (Felt lightheaded, like she was going to pass out), FEELING ABNORMAL (felt weird) and FEELING HOT (Felt heat rising up to her head) had resolved. At the time of the report, PERIPHERAL SWELLING (Had a swollen arm), SKIN DISCOLOURATION (Arm was pink), MALAISE (Not feeling well), HEADACHE (Had a headache), NAUSEA (Felt nauseas) and FATIGUE (Was really tired / fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment details included use of ice along with ibuprofen.
Redness, itching, and swelling at vaccination site - left arm. Swelling and erythema worsened overnight and was 4inches in diameter when seen in clinic 30 hrs after administration. Also noted was several blisters at the center of the reaction. Patient did not return for follow up visit as scheduled for following day because she was improving. Seen on 9/13/2013 and documented to be visually improving. Plans to return to clinic in 1 week to ensure resolution of swelling and erythema.
About 10 min after vaccine given patient and mother went to leave and patient felt faint and soon after fell into the aisle shelves and onto the floor. Patient did not appear to lose concsiousness and had no problem breathing and knew where he was.
Clinic staff was notified that a patient was having a reaction to the Moderna vaccine that was administered today at 843AM. Her reaction started around 855AM.  She described her reaction to be tingling and numbing of her shoulders and described it as "it feel like it fell asleep"   noted the injection site to be appropriate.   The patient was asked to stay for additional 15 minutes. She didn't feel any difference after the additional 15-minute observation.  The patient was able to tolerate the reaction and was asked to observe if it gets worse.  Patient was also recommended to call Occ Health if it gets worse for proper triaging.   Per reporter, resolved day following vaccination
Hives to face for 1.5 hours - improved after 1 course of Benadryl
Redness & swelling with lump at injection site. She went to ER for another issue and they looked at arm & said it was normal.
Severe bruises on left upper, inner thigh and smaller bruising down the same leg. Bruising on right hand.
The following morning at 4 am noticed vaccine-site pain/soreness and soreness under left axilla. Throughout the day, she started getting more pain: increased swelling into left chest wall, breast, and left lateral chest wall/axillary region. This continued to where the swelling was in left entire breast and chest wall compared to right and exquisitely tender to palpation. No skin changes or discoloration noted. Pain with ROM but still maintained ROM. Patient used ibuprofen and heat. She said today the swelling has definitely gone down some from prior (although still very obvious to me). Still extremely tender and patient not able to sleep or move around much 2/2 pain.
Tue Mar 23, 2021 @ 20:09 Caller received 2nd Pfizer COVID-19 shot at 11:30 today (3/23/2021).  It was accidentally administered twice.  RN initially felt that there was issue with syringe and that dose didn't go in, administered another, then realized that first had gone in.  One hour thereafter, pt developed diarrhea (which has been nonstop since); then, her arm and body started feeling sore; by time she arrived home, around 13:00, her lungs started burning - this has persisted all day; over last couple of hours, she has started coughing a lot- everytime she tries to take a full inspiration (despite use of her albuterol inhaler)and she now has a fever.   allergic to morphine gh other than hypothyroidism, seasonal allergies meds:  levothyroxine, Effexor  Follow Up Call --- Wed Mar 24, 2021 @ 10:03  Patient did go to ER last night.   Given migraine cocktail, and chest x ray.  She was told she was having  increase inflammatory response due to having 2 injections.  Today much  improved from yesterday:  still have headache, body pain, and arm is so sore can't move it.  She just took ibuprofen  Name of physician or treating hospital (if applicable)
A day after I got the booster I develop severe mental confusion for a period of 2 days.  I couldn't focus on anything.  My brain felt like it was in a storm.  Then I developed Shingles which I have never had.  I did have chicken pox as a child.  I was first treated with antibiotics for infection and then put on antiviral when it was determined I had Shingles.  I've had considerable pain from the shingles on my face and scalp on the left side of my head.  No,  I don't think this was a coincidence.  I'm an active healthy adult.
booster; Resting Heart Rate elevated; headaches; fatigue; exhaustion; elevated D-Dimer level; Ultrasound of my legs to look for clotting; my spleen had enlarged to 20cm; Other vaccine same date vaccine date 11Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Nov2021 11:00 (Lot number: EW0186) at the age of 38 years as dose 3, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose administration date=23Apr2021, Batch/Lot No: EW0164, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 23Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose administration date=02Apr2021,, Batch/Lot No: EW0150, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Resting Heart Rate elevated"; HEADACHE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "headaches"; FATIGUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "fatigue"; FATIGUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "exhaustion"; FIBRIN D DIMER INCREASED (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "elevated D-Dimer level"; COAGULOPATHY (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Ultrasound of my legs to look for clotting"; SPLENOMEGALY (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "my spleen had enlarged to 20cm"; PRODUCT USE ISSUE (non-serious) with onset 11Nov2021 21:00, outcome "recovering", described as "Other vaccine same date vaccine date 11Nov2021"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". The events "resting heart rate elevated", "headaches", "fatigue", "exhaustion", "elevated d-dimer level", "ultrasound of my legs to look for clotting" and "my spleen had enlarged to 20cm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate increased, fatigue, fibrin d dimer increased, product use issue. No follow-up attempts are possible. No further information is expected.
Ten minutes after getting the vaccine on the left deltoid, patient became unconscious for about 2 mins. Patient was seated in the pharmacy observation area and while he was unconscious had a very short seizure with head movement and arm movement (arm rotated clockwise and fully locked in an open position). Patient gained consciousness in 2 mins after which looked pale, clammy and had a little bit of chest tightness. After continuing to wait and rest for about another 20 mins, patient felt okay and was ready to leave. Paramedics were called initially but patient refused their service since he felt better.
HARD TIME SLEEPING; LEFT LYMPH SWELLING; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced hard time sleeping. On APR-2021, the subject experienced left lymph swelling. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, and had not recovered from headache, hard time sleeping, and left lymph swelling. This report was non-serious.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult patient who received FLUARIX QUADRIVALENT. In September 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling was unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. The case was one of the 7 cases reported for adverse events experienced by the 7 patients vaccinated with FLUARIX QUADRIVALENT, at the same facility. This case was regarding the patient who experienced more than usual redness and swelling at injection site. The cases reported for other 6 patients were US2015137455 and US2015137458 (anaphylactic shock), and US2015137461, US2015137462, US2015137464 (redness and swelling at injection site) and US2015137460 (full body rash). There were many employees were vaccinated at the same facility with the FLUARIX QUADRIVALENT, among them 7 patients experienced events.
was ordered to get IPOL and Dtap was given QUADRACEL instead with no reported adverse event; Initial information received on 01-Mar-2022 regarding an unsolicited valid non-serious case was received from a physician.  This case involves a 2 month old female patient who was ordered to get ipol and dtap was given diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (Quadracel) instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine for prophylactic vaccination and rotavirus vaccine for prophylactic vaccination.  In Dec-2021, the patient received a dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  It was reported that the patient was ordered to get ipol and dtap was given diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine instead with no reported adverse event (wrong product administered) (latency: same day). The physician ordered the DTap and IPV separately since they didn't have Pentacel in the office clearly wrote it out but the nurse gave Quadracel back in Dec-2021. They found this when reviewing records.   Action taken with diphtheria, tetanus, ac pertussis and ipv vaccine (Quadracel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (was ordered to get IPOL and Dtap was given QUADRACEL instead with no reported adverse event).  At time of reporting, the outcome was Unknown for the event was ordered to get ipol and dtap was given quadracel instead with no reported adverse 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 guidelines. 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.
Muscle Soreness Pain at injection site  Cloudy/foggy brain Light dizziness