chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight headache; 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 male patient received bnt162b2 (BNT162B2), administration date 26Mar2021 11:00 (Lot number: ER8730, Expiration Date: 31Jul2021) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "spring allergies" (ongoing), notes: spring allergies; "blood pressure" (unspecified if ongoing), notes: he has been taking the same blood pressure medications since around 1997. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 27Mar2021, outcome "recovered" (27Mar2021), described as "slight headache".  Additional information: Anatomical Location of Administration of Pfizer vaccine considered as suspect: left shoulder. The reporter stated that he had the 1st dose of the vaccine and the next day he had a slight headache and that went away by the end of that day and later in the call stated the headache resolved and lasted about 10 hours.  No follow-up attempts are possible. No further information is expected.
This spontaneous case reported by a pharmacist (subsequently medically confirmed), describes the occurrence of device connection issue (needle came loose from the syringe and the vaccine ran down the patient's arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037C21A and 003C21A) for COVID-19 vaccination. No medical history reported. On May 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 27, 2021, patient experienced device connection issue (needle came loose from the syringe and the vaccine ran down the patient's arm). On May 27, 2021, device connection issue (needle came loose from the syringe and the vaccine ran down the patient's arm) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The action taken with mRNA-1273 in response to the event: not applicable.
COVID-19; COVID-19; fatigue; Injection site itching; Injection site burning; Injection site discomfort; This is a solicited report received from contactable reporter (Consumer) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4186948-00 (Abbvie). The reporter is the patient.  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 01May2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single and intramuscular, administration date 30May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for uveitis. The patient's relevant medical history and concomitant medications were not reported. On unknown dates, the patient experienced injection site for humira had been itchy and burning and uncomfortable for a few days and Covid. In 2021, the patient experienced fatigued. In 2021, the fatigued resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The outcome of event Covid-19 was recovering; drug ineffective was unknown; outcome of event fatigue was recovered on an unspecified date in 2021; outcome of other events was not recovered.  The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case provided, the causal association between the events Suspected COVID-19, Drug ineffective, Fatigue, Vaccination site pruritus, Vaccination site pain, Vaccination site discomfort and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship.
At 1249, patient reported tingling and itchiness in lips and left arm. Patient denied difficulty swallowing, breathing, itchiness, rashes, and hives. Patient given water. Patient able to swallow water. Patient reported allergies to olive trees. Patient reported history of hypertension and took her medication in the morning. Lead nurse offered 911. Patient refused 911. At 1254, EMT  assessed patient vitals: blood pressure 160/90 mmHg and pulse rate 67 beats/minute. At 1255, lead nurse administered intramuscular diphenhydramine 50 mg/1 ml in patient's right arm. Patient advised to wait for further observation. At 1305, EMT  reassessed patient vital signs: blood pressure 158/82 mmHg and pulse rate 66 beats/minute. At 1318, EMT reassessed patient vital signs: blood pressure 162/86 mmHg and pulse rate 69 beats/minute. At 1328, EMT reassessed patient vitals: blood pressure 168/86 mmHg and pulse rate 68 beats/minute. Lead nurse  assessed patient. Patient denied tingling and itchiness in lips and left arm. Patient denied drowsiness. Patient offered transportation. Patient refused transportation. Lead nurse educated patient on signs/symptoms of when to seek care, to sign up on v-safe, and to follow up with primary care provider. At 1333, patient left facility with unlabored respirations and steady gait.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "SVT" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: three negative COVID antigen tests; (unspecified date) Negative, notes: three negative COVID antigen tests; (unspecified date) Negative, notes: three negative COVID antigen tests; (unspecified date) Unknown results, notes: COVID 19 Treatment; (06Jun2022) Positive, notes: antigen test was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: After three negative COVID antigen tests symptoms returned and antigen test was positive. This was four days after finishing my course of Paxlovid. I am fully vaccinated with two vaccinations and two boosters. The patient was treated with anti-viral drug of Paxlovid from 28May2022 to 02Jun2022 for COVID-19.  No follow-up attempts possible. No further information expected.
Edema, erythema, induration for 1/2 day on left arm where DTaP-IPV was given. (VZV was given posteriorly to area of erythema).
This spontaneous report as received from a healthcare worker refers to a 4 month old male patient. On 18-AUG-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, 0.5 ml subcutaneous, in the same thigh, right or left not specified, lot # J012773, expiration date 09-OCT-2015. Other suspect therapy administered also on 18-AUG-2014 included MMR II, 0.5 ml, lot # J003790, expiration date 28-MAR-2015 (dose and routed were not provided). Concomitantly, on 18-AUG-2014, it was administered Hib vaccine (unspecified carrier), DT, hepatitis B virus vaccine (unspecified), pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown, dose, route, lot #, expiration date were not provided). On 18-AUG-2014, the patient was mistakenly administered (Oka/Merck) VARIVAX and MMR II. No adverse effect was reported. It was unknown if the patient sought medical attention. The patient's status was reported as recovering. Additional information has been requested.
High fever, shallow breathing, moaning, listless. Cont for 48 hrs. Seen by MD x 2, 3MAY90 & 4MAY90, taken to ER. Had CAT scan, blood work, all negative, Family hx unknown. 2 siblings
Fever for 24 hrs. after injection.  Burning sensation when injection went into arm.  Moderate soreness for two days in deltoid area. Approx. 8 days after injection a large welt formed about 3 inches in diameter surrounded the injection site.  It was also itchy.  It went away about 7 days later but is still slightly itchy.
Felt grooves on legs; Has bruises on leg; Bump on hand; Blue dots in palm/blue dots in bum; Hand under the skin from outside got red; Throat got dry; Couldn't breathe; Had 2 pimples on both shoulders; Itchy; Couldn't sleep for 2 weeks; Ringing in left ear - developed tinnitus as side effects; Beyond 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Felt grooves on legs), CONTUSION (Has bruises on leg), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum) and ERYTHEMA (Hand under the skin from outside got red) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced LIMB DISCOMFORT (Felt grooves on legs), CONTUSION (Has bruises on leg), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum), ERYTHEMA (Hand under the skin from outside got red), DRY THROAT (Throat got dry), DYSPNOEA (Couldn't breathe), ACNE (Had 2 pimples on both shoulders), PRURITUS (Itchy), INSOMNIA (Couldn't sleep for 2 weeks), TINNITUS (Ringing in left ear - developed tinnitus as side effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose). On 06-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose) had resolved. At the time of the report, LIMB DISCOMFORT (Felt grooves on legs), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum), ERYTHEMA (Hand under the skin from outside got red), DRY THROAT (Throat got dry), DYSPNOEA (Couldn't breathe), ACNE (Had 2 pimples on both shoulders), PRURITUS (Itchy) and INSOMNIA (Couldn't sleep for 2 weeks) had resolved and CONTUSION (Has bruises on leg) and TINNITUS (Ringing in left ear - developed tinnitus as side effects) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains no new information.
On the 27th I had a fever of 100.6, body aches, a headache, and my entire arm was sore from neck to hand. I had an ache in the lower back, upper thigh, and my calves both sides. I took Tylenol and that brought my fever down and helped with muscle aches, and body aches. I had a fever again on the 28th in the morning. I woke up with a fever of 100.1. My muscle aches were gone, my left arm still hurt but just from elbow to neck at this time. At 03:30-04:00 pm I noticed that I had a lymph node between shoulder and neck in that hollow. It was very sore. If I moved it hurt, and even if I didn't move it hurt. It was the size of golf ball. I called advice line and they told me that I was still within the range of immediate effects of vaccine but if it wasn't gone by the following day. I should call the doctor. The 29th I didn't have fever or muscle aches. My arm was only sore where I got the injection, but it was still extremely painful to the touch. I called back about 02:00 pm that afternoon and spoke to a nurse at about 04:00 pm. I told her about the lymph node, and she recommended I go to Urgent Care to make sure there wasn't anything else going on. The doctor looked at it and the symptom can persist up to a week. I think my symptoms lasted 5 days on the second dose, but I hadn't had a swollen lymph node before. They said it was in the realm of normal still. The pain is gone now. It's not swollen too much anymore. I can still feel the "bean" on the left side but there's no pain, and it's been more than a week.
The patient was given a pediatric dose of Hep B vaccine rather than adult dose.   No adverse affect to patient.  Patient was contacted and is aware.  Patient will come to clinic for adult vaccine.
5/12/99 fever, abd pain;5/14/99 office eval T102.2, WBC 2,800;
fever, body ache, chills hives all over body that come and go now for 2 weeks
Tested positive greter than 14 days after fully vaccinated Narrative: tested positive greater than 14 post fully vaccinated
This patient had received the Moderna Covid-19 6m through 5 year  vaccines for doses 1 & 2 of the primary series.   Was given Pfizer-BioNTech  Covid-19   Bivalent Vaccine EUA  6m through 4 year vaccine for dose number 3.   Staff personnel had not checked in system for the name of the previous Covid-19 vaccines.
"VOMITING AND HIGH FEVER AFTER RETURNING HOME FROM OFFICE. THIS HAPPENED "SEVERAL TIMES OVER THE WEEKEND" WHEN HE WOULD EXERT HIMSELF DURING PLAYING WITH HIS COUSINS.  THE SITE TODAY LOOKED CLEAR WITH NO REDNESS OR SWELLING.
Immediate reaction: sore arm 12 hours post-injection: Chills Headache Bodyaches Fatigue Loss of appetite These symptoms all resolved in 36 hours Ibuprofen 600 mg every 8 hours to help with headache
A softball size inflammation under the injection site; This spontaneous case was received on 06-Oct-2023 from a pharmacist via Communications (reference number: SEQW23-03074) with additional information received on 09-Oct-2023 (being processed together) and concerned a 49-year-old female patient.  The patient's medical history and concomitant medications were not reported. The patient's procedures included an adenoidectomy. The patient had no known allergies.  On 05-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose:0.5ml; route of administration and anatomical location: not reported) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine, as reported. The batch number reported was 370661 and the expiry date 30-Jun-2024.  On the same date, after receiving Flucelvax Quadrivalent, the patient had a softball-sized inflammation under the injection site. The patient went to the emergency room and took Benadryl (diphenhydramine hydrochloride).   On 06-Oct-2023, the next day, the patient felt better.  On 07-Oct-2023, the patient recovered from the event.  The reporter Assessed the event of vaccination site inflammation as related to Flucalvax Quadrivalent. As reported, the patient was given Flucelvax vaccine yesterday and had a reaction to it.  This case was assessed as non-serious.  Company comment: On the same date, after receiving Flucelvax Quadrivalent, the patient had a softball-sized inflammation under the injection site. The patient's medical history and concomitant medications were not reported. The patient went to the emergency room and took Benadryl. The next day, the patient felt better. Causal role of the suspect vaccine is assessed as possibly related for vaccination site inflammation, based on chronological and anatomical plausibility.; Reporter's Comments: The patient was given Flucelvax vaccine yesterday and had a reaction to it.; Sender's Comments: On the same date, after receiving Flucelvax Quadrivalent, the patient had a softball-sized inflammation under the injection site. The patient's medical history and concomitant medications were not reported. The patient went to the emergency room and took Benadryl. The next day, the patient felt better. Causal role of the suspect vaccine is assessed as possibly related for vaccination site inflammation, based on chronological and anatomical plausibility.
No adverse events. Explained to patient she received the dose intended for the next patient and it was not harmful nor would it have adverse effects with other travel vaccines. Patient stated she is "totally fine with it."
tired; fever; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (tired), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills). At the time of the report, FATIGUE (tired), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills) had resolved.            no concomitant drugs included no treatment drugs included
large area of warmth, redness, tenderness, mild swelling to L upper arm that started about 2 days after receiving
As soon as vaccination administered patient got a sore arm. On 5/21 arm was swollen, very sore and unbelievable pain at injection site. Patient try rubbing it, put compresses, and started turning bruising -blue down to fingers. Taking TYLENOL eased the pain but did not take it away; bruise kept growing. On 5/24 went to doctor, pain was at more than a 10; patient had ultrasound and blood work. In blood work, INR at 4.09 which is much higher than normal since takes Warfarin.  Patient spoke to doctor on 5/29 but did not receive any recommendations. Patient has continued taking TYLENOL and rubbing arm with astringent--it is not improving. Site of injection is swollen the size of a tennis ball and has a red mark. Area still is very sore. Bruise is fading now. Today pain is at 7, better than before.
Muscle spasms on legs - "big time"; Spine pain; Joint pain; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasms on legs - "big time"), SPINAL PAIN (Spine pain), ARTHRALGIA (Joint pain), HEADACHE (headaches) and CHILLS (chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCLE SPASMS (Muscle spasms on legs - "big time"), SPINAL PAIN (Spine pain), ARTHRALGIA (Joint pain), HEADACHE (headaches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) in January 2021 for Adverse event, at a dose of UNK dosage form. On 15-Jan-2021, MUSCLE SPASMS (Muscle spasms on legs - "big time"), SPINAL PAIN (Spine pain), ARTHRALGIA (Joint pain), HEADACHE (headaches) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Symptoms lasted about 3 days and she only took Tylenol.
First developed numbness/tingling and  sensation of tightness/pressure in the left parietal area of my head. About an hour later noticed tightness/pressure in a muscle in my mid to upper, left back. These sensations have continued. A week later I developed numbness and tingling in the left side of my face/jaw. These episodes have also continued to date. There was also an episode in the early morning on 4/21 when I had uncontrolled, extremely painful spontaneous muscle contractions in my lower left leg, involving a few different smaller muscles. About May 2nd, the muscles in my left hand near the base of my thumb began to involuntary/spontaneously contract. This happened a few times over several days.
FELT LIGHT HEADED; HOT AND COLD SWINGS; BODY ACHES; CHILLS; WEAK; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 20 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 11:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 31-MAR-2021 17:00, the subject experienced felt light headed. On 31-MAR-2021 17:00, the subject experienced hot and cold swings. On 31-MAR-2021 17:00, the subject experienced body aches. On 31-MAR-2021 17:00, the subject experienced chills. On 31-MAR-2021 17:00, the subject experienced weak. On 31-MAR-2021 17:00, the subject experienced fatigue. On 31-MAR-2021 17:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, felt light headed, fatigue, weak, chills, hot and cold swings, and body aches. This report was non-serious.
w/in 10 days of exposure to sister, pt devel breakthrough case of chicken pox w/viral septic shock;5NOV97 pt devel mild case of chickenpox 30-40 vesicular lesions involving the scalp & vagina;shock looking;edematous;stress gastritis;
SOB; hives; axilla swelling; This is a spontaneous report from a non-contactable other health professional. This other HCP reported for specific patient that a 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN0161) at the age of 43-years, via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 03May2021, the patient experienced hives, axilla swelling and SOB. The events result in emergency room/department or urgent care. The patient received steroids as treatment to the events. Outcome of the events was recovering/resolving.    No follow-up attempts are possible. No further information expected.
Dose 1 - Right after the vaccine, I had a burnt garlic taste in my mouth, but I was fine until the next day. I wasn't feeling well, but was able to go to work. I had a fever of 101.2 for the next 3 days, along with body aches, no energy--basically felt like I had the flu. I continued to have low energy for the next two day, but was fine after that.  Dose 2 - By 6pm, I had a fever of 102.4. I alternated between Tylenol and Ibuprofen, but couldn't get it below 101. On 2/15, I got it down to 99. I also had flu-like symptoms and remained in bed up until around the 15th. I called doc on 2/16 and he said I had an upper respiratory infection. He gave me antibiotics and cough medicine and said I could return to work after a COVID test, which was negative. In March, I had a cough and sore throat, then was out of work again for bronchitis in April. I still have trouble breathing, but that could be due to my allergy induced asthma.