chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 12 hours after the injection I began to experience the following affects: Fever of 102, chills, aches, nausea, and headache. These lasted about 36 hours followed by a bright red rash on neck & torso. I'm now 4 days past the vaccine but still experiencing pain at injection sight (painful to touch, warm). The rash is almost completely gone.
patient received a 30Jun2019 expired Menactra on 24Jul2019/ no side effects; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any concomitant medication.   On 24-Jul-2019, the patient received a second dose 0.5ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5917AA, expiry date 30-Jun-2019 via intramuscular route in unknown administration site.  It was an actual medication error due to expired vaccine used.  It was reported that patient received a 30Jun2019 expired Menactra on 24Jul2019.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Felt like having a heart attack; feels tightness in chest; heart palpitation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Manufacturer Unknown), for COVID-19 Immunization. There were no other vaccine in four weeks. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "recovered with sequelae", described as "Felt like having a heart attack"; CHEST DISCOMFORT (non-serious), outcome "not recovered", described as "feels tightness in chest"; PALPITATIONS (non-serious), outcome "recovered with sequelae", described as "heart palpitation". Therapeutic measures were not taken as a result of myocardial infarction, chest discomfort, palpitations. Patient experienced heart palpitation on an unknown date. Patient also felt like having a heart attack. Patient still feels tightness in chest after 2 months of vaccination date. There was no COVID prior vaccination. It was unknown if patient was tested for COVID post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Presented with weakness/hypotension; Labs: D-dimer 1.17; CRP 4.82; Lactic Acid normal; CXR  clear; Tx: Maxpime, lovenox, Remdesivir, Decadron, singulair, zinc; minimal O2 @ 2 LPM during stay; down to room air at d/c
First the vaccination site was itchy, then the next day it was red, swollen, and very painful. The redness was about 4 inches in diameter. Also, fatigue, and head ache.
Fever 102, administrator Tylenol, recurring fevers throughput the day and night. Following morning, fever and rash on face and body. Administered Tylenol as needed. Fever broke during the night. On 9/22, no fever, rash has worsen. Skin is hot to touch and inflamed.
Gi upset, vomiting, diarrhea, dizziness, 1 episode of fainting (?vasovagal)
arm hurt; achy; weird lung pain; splitting headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 15Jan2021 at (at the age of 27-years-old) as a single dose in the deltoid (unspecified) for COVID-19 vaccination. Medical history included asthma, Meniere's disease, cold sores and she had COVID-19 with symptoms of splitting headache, all on an unknown date. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA) for asthma from an unknown date and ongoing and supplements (unspecified). On an unknown date after the first vaccination the patient experienced, she is achy, her arm hurts, some weird lung pain and a splitting headache. It took until the next day for her arm to hurt. The clinical outcome of the events achy, arm hurts, lung pain and headache was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Injection site soreness, that has progressed to pain and numbness in both arms. Received flu vacc in right arm on same day. Both left and right arm with pain and numbness, and cramping and sore hands, fingers.. The pain in arms is in central spot where injections were given
Shaking from cold; shaking from cold and it is not cold at all; Soreness at injection site; Pyrexia; Fatigue; Severe chills; Arm looked swollen a good size at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking from cold), NASOPHARYNGITIS (shaking from cold and it is not cold at all), VACCINATION SITE REACTION (Soreness at injection site), PYREXIA (Pyrexia) and MYALGIA (Sore arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021 at 12:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced MYALGIA (Sore arm) and VACCINATION SITE SWELLING (Arm looked swollen a good size at injection site). On an unknown date, the patient experienced TREMOR (Shaking from cold), NASOPHARYNGITIS (shaking from cold and it is not cold at all), VACCINATION SITE REACTION (Soreness at injection site), PYREXIA (Pyrexia), FATIGUE (Fatigue) and CHILLS (Severe chills). At the time of the report, TREMOR (Shaking from cold), NASOPHARYNGITIS (shaking from cold and it is not cold at all), VACCINATION SITE REACTION (Soreness at injection site), PYREXIA (Pyrexia), MYALGIA (Sore arm), FATIGUE (Fatigue), CHILLS (Severe chills) and VACCINATION SITE SWELLING (Arm looked swollen a good size at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) 100.4 Fahrenheit.         Concomitant medication included A-fib Medication and cholesterol medication.  Treatment information was not reported   This case was linked to MOD-2021-307229 (Patient Link).
Edema knees & ankles, which progressed to generalized edema, hands, feet & face. Extreme pain in all joints. Painful to walk or move hands.
A week to two weeks after getting the first dose of vaccine, my heart started skipping beats. Chest pains followed. I am pregnant and was during time of vaccine. The blood flow from the umbilical cord to the fetus was compromised.
Patient was given undiluted Pfizer vaccine - .3 ml in am on 1/18/2022. Patient experienced aching and chills that evening.
Felt sore in the arm and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt sore in the arm and pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0z7Cz1A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included SALBUTAMOL SULFATE (VENEX [SALBUTAMOL SULFATE]) for Blood pressure abnormal.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PAIN IN EXTREMITY (Felt sore in the arm and pain). At the time of the report, PAIN IN EXTREMITY (Felt sore in the arm and pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.   Reporter did not allow further contact
On July 6, she started having a little bit of a cough. On July 7, she was not as energetic as normal. She started to seem congested. Friday the 8th, when she got up she was very lethargic. She had congestion and a cough. We took her to urgent care and she had a fever. They tested her for COVID-19 and she was positive. She was lethargic that day but ate normally. Still that cough and congestion. Saturday, her energy came back a  little bit, but still coughing and congestion as well. She also did have a little bit of a fever that day. Sunday, she was going back to normal. She no longer had a fever that day. Now, she has a little bit of a cough here and there, but it's almost gone at this point.
Bleeding; This is a solicited report based on the information received by Pfizer (Mfr.Control No: 21K-163-4054205-00.) from a contactable consumer (patient).   Solicited report from a country by a consumer of a 69 year old female with an event of non-serious BLEEDING with HUMIRA (ADALIMUMAB). The patient had a relevant medical history of CONGESTIVE HEART FAILURE. In 2020, the patient experienced BLEEDING. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Unknown date , he received 1st dose COVID-19 Vaccine manufactured by Pfizer. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of BLEEDING with HUMIRA(ADALIMUMAB) was no reasonable possibility. On 24Aug2021, received updates to narrative description. Describe Reactions: 31Aug2021: Version one was created to change reporter First name from (with held) to (with held). The correction was done in 5% Sampling. BADWERX  Causality assessment: The Causality as per reporter between bleeding and ADALIMUMAB was No Reasonable possibility. The Causality as per reporter between bleeding and PFIZER BIONTECH COVID-19VACCINE (TOZINAMERAN) was Probable.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Mother of patient stated that she was "sleepy", and that a rectal temp taken was 104 degrees F. Went for MD visit at 4:30pm and told to "keep an eye on her". Increased sleepiness and elevated temps continued through PM of 7/14/11 (103 on 7/12, 102 on 7/13, and 101 on 7/14). Mother denies any other signs or symptoms.
Initial pain at injection site only.  Pain has been spreading down the arm since.  At visual inspection by the pharmacist in duty on 11/23/19 the arm was not red, swollen or inflamed.  Upon calling the patient today, 11/29/19, the husband said her arm was in pain and the injection site looked swollen.  The patient is unable to lift anything without feeling pain.
Approximately 2 hours post vax, the pt returned to the clinic with a complaint of swelling, heat, soreness, redness radiating approximately 3" surrounding injection area.
Swollen lymph node; Tender Lymph node; This is a spontaneous report from contactable Pharmacist. An adult male patient in his late 40's (5 decades), received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported), via intramuscularly, in left deltoid on unspecified date as a single dose for covid-19 immunisation. Patient's medical history and concomitant medication were not reported. On an unspecified date, patient had a swollen lymph node for 19 days on his left side and was also tender. Reporter seriousness for swollen lymph node on the left side has been there for 19 days and was also tender was unspecified. The patient had several questions and caller referred him to his HCP however he did not know how to advised the patient on if he should get the second dose of the vaccine. The patient was hesitant to get the second dose with having a swollen lymph node. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recv vax 7NOV94 & had mild rhinitis; 11NOV94 pt devel gen morbilliform rash & sl cough; 14NOV94 presented to MD who was concerned that pt contracted rubella or rubeola; devel red, not pearl-gray, koplik's type spots on both cheeks;
Injection site is red and patoemt states it is hot to touch. Redness is less than 2 inches diameter, misshapen. Patient also reported that it was slightly itchy. The redness started yesterday (3/16). Patient was advised to use ice/antihistamines as needed for comfort and to notify us or doctor if it got worse. Patient was also advised to go to the ER if rash spread further than injection site or other symptoms, especially trouble breathing, occured.
I thought I had a bad cold; I used a home COVID-19 test that came back positive. I called my doctor, had a telehealth visit, I was prescribed the Paxlovid. I started feeling better, I just had a lingering cough that didn't seem to want to go away. I keep getting mild colds where the cough seems to want to linger. I have been given steroids and antibiotics to help clear it up. During my eye exam, my eye doctor did say that the steroids caused my cataracts to get worse. I did get cataract surgery on both eyes.
Redness, itching, pain-tenderness area of flu shot erythematous with a wheal 3x2cm, warm, min tenderness to palp., non fluctuant. Rash, lesion noted to left.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 17-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.
Pt became very cranky, not eating 2 1/2 wks p/inject; Head according to mom had grown in size; Pt body curving to rt; No use of rt hand, would not turn head to lt; Hospitalized, CAT scan; given Rocephin; spinal tap; sx resolved;
Patient with history of 2 COVID vaccines who admitted with COVID detected test.  Provider d/c note:  "48 year old woman with past medical history of anaplastic thyroid carcinoma s/p tracheal stent undergoing chemo/radiatoin, multiple PE on eliquis, hypothyroidism presents to the emergency department with NG tube removed likely 2/2 to intractable nausea and vomiting from chemotherapy and cough 2/2 +Covid 19. GI consulted and successfully replaced NG tube 12/2 however due to coughing spells it was expelled. Bed side 12F NG tube successful. Patient continues to have upper respiratory symptoms however discussed that this can be managed at home. Patient hemodynamically stable for discharge and will follow up with oncology to reschedule missed chemo apt 12/6."
After the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided by reporter.  Reporter reported that none of the patients experienced any reported symptoms and no treatments or additional doses have been provided.   This case was linked to MOD-2021-413581, MOD-2021-413535 (Patient Link).
Swollen, red itchy area approximately 1 inch from the injection site. Appeared < 24 hours after injection. Started at ~1 inch in diameter. 48 hours after injection it is 2-3 inches in diameter.
3 pm (L) side neck stiff. 5 pm (L) side neck pain. 7 pm (L) shoulder pain, radiating down to elbow with muscle spasm from shoulder to elbow. Could not sleep due to pain, 9/6/08. 9/30/08, increase pain (L) neck to elbow, per MD, use ice/heat/ADVIL 400 mg, every 4 hours. 10/1/08, in MD office, Cortisone injection to (R) arm. TENS unit applied x 30 mins. Amp 1x 15 mg, Hydrocodone 10 mg. Rx given 10/2/08. Back to MD for TENS unit therapy - off work 3 days.
Experienced lightheadness about 1/2 hour after shot. Then days later,  symptoms come and go.  Naseua and shortness of breath continue for months.  Bloodwork done, EKG showed irregular rythm, referred to cardiologist. Feeling better at time of visit, all additional tests ok. Weeks of extreme fatigue and lightheadness occur for periords lasting 6-24 hours at average. Any major activity would cause debilitating weakeness the next day. Felt so badly one night, thought he was dying, didn't go to ER (was affraid of expense). Another day again we drove to ER, but started feeling better during wait time and decided not to stay.  Was going to return if not feeling good, but felt better for 3 days, longest period to date.
Swollen lymph nodes under right arm....pain, redness and bruised. Very painful for a week and swollen for a week and a half. I used heat to help alleviate the pain. The area that was red is where I started noticing bruising and even after almost 2 months the bruising still remains. I did go to the hospital after being advised by my physician. I went to Hospital. They did advise me I had a reaction to the Booster shot.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Moderna COVID?19 Vaccine EUA About five minutes after the shot, I had a slight reaction. I had a hot flash, was light headed, and a little dizzy. I was checked out, given water, and was ok. Four hours after the shot, my teeth and gums were extremely sensitive. I tried to eat corn on the cob and could not finish it. I had to put it in the refrigerator and try again the next day. I had recently went to the dentist and nothing was wrong with my gums or teeth.  I floss my teeth everyday but could not floss for approximately two days after the shot because of the pain. After about a day I would brush my teeth and my gums would bleed. This had not happened before getting the shot. After about 4 days, my gums went back to normal. I was able to eat, brush, and floss normally. If it had not gotten better, I was going to go to the dentist because it seemed something was really wrong. I have been on immune suppressants for over 10 years. I had not heard that sensitive gums was a side effect. So, I thought I should let you know. The other side effects I had were crohn's symptoms due to my immune system becoming more active. My eyes because sensitive and extremely dry. I was woken up one night because my eyes were burning. I had to put eye drops in my eyes to be able to go back to sleep.  I am still having milder side effects one week after the shot. They are manageable. 7 days after the shot I had my depo and botox shot.
This is a spontaneous report from a contactable physician via Pfizer sales Representative. A male patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling and hot to the touch on an unspecified date. The outcome of both events was unknown. Information on batch number has been requested.
2-4 hours after the injection experienced ulnar nerve pain and paraesthesia, tingles and pins and needles sensation in pinky and ring finger of the right (injection side) hand. Over the course of 6 days the paraesthesia spread distally to both hands and feet and cheeks. Symptoms persist at day 38 accompanied by mild fatigue. Per my Dr's recommendation I've skipped the second dose. Reading a lot of folks online are experiencing tingles, paraesthesias and similar side effects. Worried that this may be  nerve damage or cause chronic peripheral neuropathy. Completely healthy with no known medical issues prior to vaccination other than food allergies to certain seafood as a child.
3 mo. old received vaccine at 10:30 - went home - gave infant MOTRIN - at 2:30 feeding infant and noticed pimple like rash (small papular, erythematous) on (R) thigh - Later on rash spread to arms and legs.
fever; vomiting; nauseua; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 18:00 (Lot number: FK5127) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 09Nov2021, outcome "recovered" (Nov2021), described as "fever"; VOMITING (non-serious) with onset 09Nov2021, outcome "recovered" (Nov2021), described as "vomiting"; NAUSEA (non-serious) with onset 09Nov2021, outcome "recovered" (Nov2021), described as "nauseua". Therapeutic measures were not taken as a result of pyrexia, vomiting, nausea.  No follow-up attempts are possible. No further information is expected.
Called to check on patient. No redness or pain at injection site. No signs or symptoms for allergic reaction.