chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sharp pain; the episodes repeat as the medication wears off; allergic reaction; sharp pain and numbness on the arms and legs; numbness on arms and legs; headache; palpitations; dizziness; Very very shaken; Tingling on the face and jaws; fuzzy; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), DIZZINESS (dizziness), TREMOR (Very very shaken), PARAESTHESIA (Tingling on the face and jaws) and FEELING ABNORMAL (fuzzy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy and Penicillin allergy.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PALPITATIONS (palpitations), DIZZINESS (dizziness), TREMOR (Very very shaken), PARAESTHESIA (Tingling on the face and jaws), FEELING ABNORMAL (fuzzy), PAIN IN EXTREMITY (sharp pain and numbness on the arms and legs), HYPOAESTHESIA (numbness on arms and legs) and HEADACHE (headache). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction), PAIN (sharp pain) and VACCINATION COMPLICATION (the episodes repeat as the medication wears off). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 mg and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PALPITATIONS (palpitations), DIZZINESS (dizziness), TREMOR (Very very shaken), PARAESTHESIA (Tingling on the face and jaws), FEELING ABNORMAL (fuzzy), HYPERSENSITIVITY (allergic reaction), PAIN IN EXTREMITY (sharp pain and numbness on the arms and legs), PAIN (sharp pain), VACCINATION COMPLICATION (the episodes repeat as the medication wears off), HYPOAESTHESIA (numbness on arms and legs) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non-Significant follow up received on 18-May-2021. Contact information updated.
The day after my vaccination shot, at approx. 3:30 pm on Thursday, 04/18/21 I had some facial skin irritation and upon looking in the mirror noticed that patches of the skin on my face began to peel. I applied anti-itch lotion to the affected areas to help the itching and peeling and the condition cleared up after approx. 4 hrs.
Fatigue, all she wanted to do was lay down, tried to get up multiple times and got back in bed; Fever; Left Arm Soreness; the pain was at the injection site; it was through out, and today it hurts from her armpit to the back of the shoulder; it was through out, and today it hurts from her armpit to the back of the shoulder; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EW0171, Expire Date: Unknown), via an unspecified route of administration, administered in Arm Left on 05May2021 at 15:30 (at the age of 21-Year-old) as a single dose for covid-19 immunization. The patient received vaccination through drive Thru. The patient's medical history and concomitant medications were not reported. The patient received flu vaccines, possibly tetanus vaccines in the past. Family Medical History Relevant to event was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EW0161, Expire Date: Unknown), via an unspecified route of administration, on 14Apr2021 (at the age of 21-Year-old) as a single dose for covid-19 immunisation. On 05May2021 at 15:40, patient experienced left arm soreness. On 06May2021 at 10:00, patient experienced fatigue, all she wanted to do was lay down, tried to get up multiple times and got back in bed, fever. On an unknown date in 2021, the pain was at the injection site, it was throughout, and today it hurts from her armpit to the back of the shoulder. The patient received Tylenol as a treatment drug and was advised to lay in bed. Therapeutic measures were taken as a result of fever, the pain was at the injection site, it was throughout, and today it hurts from her armpit to the back of the shoulder. The clinical outcome of left arm soreness was recovering, fever recovered on 06May2021, fatigue, was recovered on 07May2021 and other events was unknown.  No follow-up attempts are needed. No further information is expected.
OUR PATIENT RECEIVED THE RSV VACCINE (AREXVY) AND FLUZONE HD ON 10/19/23.  HE RETURNED ON 10/24/23 TO LET US KNOW OF THE SIDE EFFECTS THAT HE EXPERIENCED WHICH WERE OUT OF THE NORMAL.  HE SAID THAT LATER THE EVENING AFTER RECEIVING THE RSV VACCINE, HE EXPERIENCE A BRIEF PHASE OF BLURRED VISION AND PROBLEMS SEEING.  HE ALSO NOTICED THAT HIS EYE WAS RED.  THE BLURRED VISION GOT BETTER AFTER FLUSHING HIS EYES WITH WATER, BUT HE IS STILL EXPERIENCING A LITTLE REDNESS.  HE ALSO WAS VERY FATIGUED AND WEAK WITH SOME PAIN IN THE SHOULDER AREA.
Rash on finger, wrist and elbow.  Went to urgent care and doctor said it might be Shingles and prescribed anti-viral medicine.  Rash never got worse and took about 2 weeks to disappear.  Same arm I received shot but no rash at point of shot.
Patient developed a large, red splotch on at the injection side.  The red site is about the size of a deck of cards.  On researching it appears to be "Covid Arm".  It doesn't itch, but is warm to the touch and swollen and red.  His lymph nodes in his arm pit and neck are also swollen.  Redness came up on day 7 after 1st dose.
Patient was given the Moderna vaccine by a floating RPH on 5/26/21. The evening following the injection the patient experienced pain, swelling and redness at the injection site. The patient presented to the pharmacy the following morning with a very swollen, painful red and blistered arm where the injection was administered. The patient spoke to myself, the Manager in charge. I advised the patient the go immediately to the ER. Patient was diagnosed with an infection caused by poor injection technique. The injection site was not properly cleaned before the shot was given and the needle was not placed far enough into the muscle. The patient was given antibiotics and pain medicine. Recovery is expected to take 3-4 weeks.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: En6198), in right arm, on 25Mar2021 as dose 2, single (Lot number: Er8730), in right arm, on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05Apr2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient received vaccine. Other medication in 2 weeks as concomitant. Patient received anti-viral treatment for COVID 19 with Paxlovid from 11Jul2022 to 16Jul2022. It was reported that covid rebound. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
inadvertently administered to a patient SC rather than IM with no reported adverse event; Initial information received on 11-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves  patient with unknown demographics who inadvertently administered to a patient sc rather than im with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Feb-2022, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE with the dose of 0.5ml lot number not reported via unknown route in unknown administration site.  On 11-FEB-2022 the patient inadvertently administered to a patient sc rather than im with no reported adverse event (incorrect route of product administration) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inadvertently administered to a patient SC rather than IM with no reported adverse event).  At time of reporting, the outcome was Unknown for the event inadvertently administered to a patient sc rather than im 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.
Swollen and tender lymph node near my collarbone on my left side where the shot was administered. Upper back soreness on my left side. Sudden arm soreness. The same day I took the shot, about 1 later, I experienced severe cramping where I was uncomfortable sitting and standing, I could barely stand and walking was step by step. I also had my period at the time.
COVID+ 12/30/22.  Vaccination Status - Pfizer x4 + Pfizer BIVALENT x1 BRIEF OVERVIEW: Admission Date: 12/27/2022 Discharge Date: 1/7/2023   Active Hospital Problems   Diagnosis Date Noted POA ? Statin started by Vascular Surgery with Rx to be taken over by patient's PCP 01/07/2023 Unknown ? Multiple comorbid conditions 01/02/2023 Unknown ? COVID-19 09/13/2022 Yes ? Immunosuppressed status 07/29/2022 Yes ? Moderate pulmonary hypertension on echo from May 2019 01/14/2020 Yes ? OSA (obstructive sleep apnea) 04/09/2018 Yes ? Anxiety 03/11/2018 Yes ? History of tobacco abuse: 30 pack years, quit 1999 06/20/2016 Yes ? COPD with asthma   Yes DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxemia [R09.02] COPD exacerbation [J44.1] Chronic obstructive pulmonary disease with (acute) exacerbation [J44.1]   HOSPITAL COURSE: Patient is a 75-year-old female who presented to the emergency department with chief complaint of shortness of breath.  In the emergency department, she was found to be hypoxemic and required increased O2.  In the emergency department chest x-ray with no acute process.  Patient had known exposure to COVID-19 prior to admission.  On admission COVID-19, influenza and RSV were negative.  She was admitted to the Internal Medicine Service with a pulmonology consult.  She was started on IV steroids and DuoNebs.  She completed a course of azithromycin.  CTA chest was obtained which revealed no evidence of PE and no acute thoracic abnormality.  Bilateral lower extremity ultrasound was negative for DVT.  As patient's symptoms improved, IV steroids were discontinued and she was placed on prednisone  Repeat COVID-19 testing was performed due to recent exposure and was positive.   Patient completed a course of Remdesivir while inpatient. She was seen by pulmonary medicine who recommended prednisone taper by 10 mg every 5 days until off.  They also recommended she follow-up with her pulmonologist on 01/13/2023 as previously scheduled,   Patient was seen by PT and OT and recommendation was for home with home health care.   Patient with history of anxiety which is worsened by her acute respiratory failure.  Palliative Care was consulted for assistance with symptom management.  Patient had hypokalemia during her stay and losartan was held.  Potassium level did normalize and patient advised to resume losartan at discharge. Care management did arrange for home care.  Patient had improvement of her respiratory status, had no other acute issues and was discharged home in stable condition on 1/7/2023.
Injection site pain; I had a little swollen underneath my armpit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain and had a little swollen underneath my armpit on an unspecified date. The outcome of injection site pain was recovered on an unspecified date, whereas outcome of I had a little swollen underneath my armpit was recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Developed pain and swelling in the posterior distal aspect of right upper leg several hours after receiving the vaccine. Progressively enlarged until date of evaluation on 10/11/2021. Palpable tender rope like mass with overlying erythema on posterior distal aspect of right upper leg.
Rash & itching neck down to waistline; wheezing (but pt had been wheezing on & off over the prev wk);
Pt. states 4" x 5" area on left arm - redness, had "fever and chills". Apply warm compresses and take BENADRYL.
RIGHT AFTER THE FLU SHOT GIVEN PATIENT STARTED TO FEEL DIZZY. PATIENT ALSO REPORTS ARMS AND FACE TINGLING AND NUMB. PATIENT WAS MONITOR IN OBSERVATION FOR ABOUT A HOUR BY APRN. PATIENT VS WERE STABLE.
Patient initially had Covid at the beginning of January and was diagnosed on January 2 with a positive test.  After recovering from Covid he received the first dose of Covid vaccine at the end of January.  He tolerated that well.  He then got the second dose of Covid vaccine on February 24-he had previously finished a 5-day course of prednisone for shortness of breath.  He was doing okay when he got the second dose of the vaccine; he subsequently developed a fever of up to 103.5 and significant shortness of breath and came to the hospital emergency department-we did not find a cause for his fever, suspect vaccine reaction because it developed after taking the vaccine.  He was admitted overnight to the hospitalist for fever of unknown origin.  ER doctor was reporter
Client received Tdap at 10 am. Returned to clinic complaining of difficulty breathing and swelling to hands and face at 1:40 pm hives to (L) cheek below eye. Nail beds blue. C/O "tongue feeling dry". Epinephrine administered. Transferred to Emergency room by ambulance. Phone call 10/13/14 to client. Client reports returned to ER 10/11/14 for hives, difficulty breathing and continues to have swelling to arms and hands as of 10/13/14.
Information has been received from a consumer concerning her 17 year old daughter with no medical history and allergies, who on 17-APR-2009 was vaccinated with a first dose of GARDASIL. There was no concomitant medication. On 20-APR-2009 the patient started to experience headache, dizziness and did not feel well over her body. No laboratories studies performed. Consumer is unsure if the patient was going to receive the rest of the series. The patient had not recovered. The consumer reported that she had called the patient's physician regarding her experience. Additional information is not expected.
1 1/2 hours after administration, disequilibrium, stumbling, staring, slow to answer questions but oriented x 3. Spontaneous resolution.
approx 48 p/vax devel marked pain, induration & heat @ shot site; on exam 48 hrs had erythema, heat & induration of 7x7 cm around site of injection;
4/17 Chest pain when she takes deep breath that spreads to her left arm 4/20-Follow up call second attempt - Voicemail not set up yet; unable to leave a message.
HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative 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 22-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fatigue was not reported. This report was non-serious.
patient received influenza vaccine with a pediatric size needle. patient was notified they should seek an additional dose IM.
Patient is a 82-year-old female with COVID-19 infection (positive PCR on 2/2/2022),
per telephone call pt exp uncontrollable shaking, paleness & abd was hot to touch (no temp taken); pt reated @ ER w/unspecified inject;
Patient reports having pain across torso and headache the day after receiving the flu vaccine. Patient has received the vaccine in previous years with no issues. This went on for a couple days and has since resolved without any treatment.
Rash to entire torso at extremities for 7 days onset after administration of vaccine.
Swollen lymph gland; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 17Feb2021 10:30 (Lot number: EN9581) at the age of 71 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "lupus  (SLE)", start date: Jun1979 (ongoing), notes: Mild case in remission; "PVC's", start date: Sep2015 (ongoing), notes: Extra heartbeat no effects; "acid reflux" (ongoing); "anxiety" (ongoing); "back pain" (ongoing). Concomitant medication(s) included: NEXIUM taken for gastrooesophageal reflux disease (ongoing); XANAX taken for anxiety (ongoing); TRAMADOL taken for back pain (ongoing); ASPIRIN (E.C.) taken for back pain (ongoing). Vaccination history included: BNT162B2 (Dose:1, time of adminstartion: 10.20 am, Route:intramuscular, Lot no: EL3249), administration date: 27Jan2021, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Feb2021 03:00, outcome "recovered" (19Feb2021), described as "Swollen lymph gland". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient's family medical history included: mother, father and 2 sisters had cancer; brother had a Parkinson's. The patient had no prior vaccination (within 4 weeks). The patient did not undergo any relevant tests.  No follow-up attempts are possible. No further information is expected.
Pt given seasonal influenza injection in clinic @ 2am. About 5 hrs later, developed sudden chill with HA and slight nausea. Also had a fast pulse. Had a friend take her to the hospital ER - denied tightness in the throat or SOB. First influenza injection. BP 122/68, P 82.
after the 2nd Pfizer Covid19 vaccine, she experienced stiffness in her joints and muscles from her hips on down; after the 2nd Pfizer Covid19 vaccine, she experienced stiffness in her joints and muscles from her hips on down; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, had no side effects from either), for covid-19 immunization; Flu shot (had no side effects from either), for immunization. The following information was reported: JOINT STIFFNESS (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovered" and all described as "after the 2nd Pfizer Covid19 vaccine, she experienced stiffness in her joints and muscles from her hips on down".  Additional information: after the 2nd Pfizer COVID-19 vaccine, she experienced stiffness in her joints and muscles from her hips on down which lasted for 4 months and then resolved. Caller states that after she received the Pfizer COVID-19 booster she also experienced stiffness and soreness from hips on down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came in to get his first dose of COVID-19 vaccine (Pfizer), while checking him in he states that he has fear of needles and he gets dizziness sometimes, After he got his shot I asked him to stay with us for 30 minutes to monitor him after the vaccine. Patient fainted and fell on the floor. I went to check on him, he was alert, but laying on the floor. 911 was called and the ambulance came and took care of him
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic bronchitis" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; ZYRTEC-D; LOSARTAN; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Started feeling sick and tested positive for COVID; (07Jul2022) negative, notes: Tested negative on the day after I completed the Paxlovid prescription; (14Jul2022) positive, notes: I had worse symptoms and tested positive again for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. She received other medications in two weeks. She received Paxlovid on 02Jul2022 and stop on 06Jul2022 for COVID 19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.