chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started right after the vaccine having headache then fever and body pain the next day.  Fatigue, body pain, head ache, temperature of over 100 degrees F, temperature not changing will only go away after taking Acetaminophen. It has been 2 days still monitoring, no actions taken yet just taking Acetaminophen for the fever.
LITTLE PAIN IN BODY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced little pain in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little pain in body. This report was non-serious.
Stated she felt malaise, headache, chills, body aches & joint aches.
I'm trying to recover from my COVID booster with lots of sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US079420_NS (regulatory authority).  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "I'm trying to recover from my COVID booster with lots of sleep". Additional Information: Product: COVID Vaccine. Relationship to patient: Self Event: I'm trying to recover from my COVID booster with lots of sleep. DOB/Age: 38 Years. Gender: Female. (Docket No. #) dated Mar1992 (Part VI, I), require that: "Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant." Additionally, per 21 CFR 314.80, Post-marketing Reporting of Adverse Drug Experiences, updated 01Apr2016, the requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section, concerning the submission of post-marketing 15-day Alert reports, also apply to any person other than the applicant whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor (non-applicant). To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs (c)(1)(i) and (c)(1)(ii) of this section, obligations of a non-applicant may be met by submission of all reports of serious adverse drug experiences to the applicant. If a non-applicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the non-applicant must submit, by any appropriate means, each report to the applicant within 5 calendar days of initial receipt of the information by the non-applicant, and the applicant must then comply with the requirements of this section. We are, therefore, forwarding the information below relating to your product which was obtained by one of our employees during the normal course of business.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 2/17/03, noticed raised, red blotches on/around site; itchy and burning, fever that night. OTC medication and slept. She worsened the next day, 2/18/02 and went to ER on 2/19/02, approx. 8 hours. She was treated with Motrin, Tylenol and deconamine. In 48 hours, saw results of healing. Generalized vaccinia.
problems with her eyes; constantly thirsty; ANA teether/pattern reflex test with results higher than the normal range; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 67 years old female patient who had problems with her eyes, constantly thirsty and ana teether/pattern reflex test with results higher than the normal range after receiving vaccine influenza quadrivalent recombinant vaccine [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of influenza quadrivalent recombinant vaccine (Formulation, strength, dose, frequency, route, batch number, expiry date and anatomical location: Unknown) for prophylactic vaccination.  On an unknown date the patient had a non-serious events problems with her eyes (eye disorder) and thirsty (thirst) and ana teether/pattern reflex test with results higher than the normal range (antinuclear antibody positive) (unknown latency).  Relevant laboratory test results included: Antinuclear antibody - On an unknown date: results higher than the normal range  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.  Outcome: Unknown
swelling; red ring around injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (red ring around injection site) and FATIGUE (fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (red ring around injection site) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (red ring around injection site) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Event occurred within 5 minutes of receiving vaccines. Patient was standing next to her mother, tapped her mother's shoulder, and fell backward to the floor. She was responsive after hitting her head, but does not remember the fall. Patient was observed and had no further difficulty.
swelling of lower lip & hard sore spot lasting from 21NOV to 27NOV;
Pt was given Janssen vaccine around 9AM and started to feel lightheadedness a few minutes after. He then began to lied down on the floor. I gave him an ice pack and he started to feel better afterward. I checked on him every 5 min and gave him water. After 10-15min, he left the pharmacy.
This is a spontaneous report from a contactable physician reported for her son. A 19-year-old male patient received first dose of TRUMENBA (NDC number: 00005-0100-05), intramuscular on 16Jun2016 at 0.5 ml, single. The patient medical history was not reported. There were no concomitant medications. The patient experienced severe headache, chills, shaking, muscle soreness all on 16Jun2016. The outcome of the event headache was reported as recovering, the outcome of the event muscle soreness was reported as not recovered and for the other adverse events recovered. Treatment was gave TYLENOL and BENADRYL. The vaccine was not prescribed by any doctor, the University required that he had his vaccine before he came back to school because they had meningitis outbreak. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
PATIENT REPORTED ITCHINESS ON 4/22/22   THROUGH THE EARLY MORNING INTO 4/23/22,  ARM BECAME SWOLLEN AND RED AND RAISED AND PAINFUL AT INJECTION SITE
Began experiencing heart arrhythmia the Sunday adn Monday after my second shot. (Never experienced previously) I had another two day episode on Thursday and Friday of that same week. Went to cardiologist, got an ekg which showed the abnormal heartbeat. I am currently scheduled for stress test on the 28th of June.  Dr. said it is not too worrisome but I am still experiencing the arrythmia occasionally.
Tinnitus (ringing in ears) that started after receiving the booster on 10/12/21. Still present nearly 4 months later. Had a hearing test to confirm no other causes.
Aches in legs, lower back and burning in bottom feet (both). Dizziness followed by body heat, sweating and diarrhea.  Still experiencing events where body gets hot and skin becomes irritated with a burning, itching rash (ie. on arms, neck, face, eyes, legs, inside of ears, hands, palm of hands, back and personal areas).  Event is at its peak.
First shot kicked my fricken butt!; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got Shingles vaccine and stated that shot kicked fricken butt, still worth it. The follow up would not possible, as contact information was not available.
This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 13-MAY-2015, the patients were vaccinated with RECOMBIVAX HB (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On 13-MAY-2015, the patients experienced incorrect product storage as improperly stored doses of RECOMBIVAX HB were administered to them. No adverse event. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested. This is one of several reports received from the same source.
Information has been received from a registered nurse concerning a patient who was vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) due to human error. No product confusion. The patient visited the office on unknown date. No adverse effect noted. Additional information has been requested.
Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster given greater than 12 hours after vial was punctured) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster given greater than 12 hours after vial was punctured). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported.   This case was linked to MOD-2021-416295 (Patient Link).
Information has been received from a pharmacist concerning a male with a pacemaker and other medical history unknown who on approximately 29-MAR-2011, "1 week ago", was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not reported). On approximately 29-MAR-2011, "1 week ago", the patient experienced headache and tingling or twitching on the upper lip. The patient made a phone call to seek medical attention. No treatment was given for the events. At the time of the report, the patient had not recovered. Additional information has been requested.
malaise; pyrexia; rash macular; swelling face; This case was reported by a consumer via other manufacturer and described the occurrence of malaise in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 29th March 2019, the patient received Pediarix. On an unknown date, less than a month after receiving Pediarix, the patient experienced malaise, fever, macular rash and facial swelling. On an unknown date, the outcome of the malaise, fever, macular rash and facial swelling were unknown.   It was unknown if the reporter considered the malaise, fever, macular rash and facial swelling to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced malaise, fever, macular rash and facial swelling.
experienced fatigue and tiredness; feeling sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Batch/Lot number: unknown), administration date: 29Jan2021, for covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "experienced fatigue and tiredness"; SOMNOLENCE (non-serious) with onset 2021, outcome "not recovered", described as "feeling sleepy".  Additional information: the reporter stated that 4 weeks later she experienced the events. Asking if these were the reported side effects after 4 weeks of getting the vaccine. The reporter is feeling fatigued and sleepy even a month later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
There was inflamation, swelling, pain and redness of the injection site. Pt had to go to the doctor and was prescribed an antibiotic and a steroid.
pt recv vax 15JAN97 & 3FEB97 pt exp numbness from elbow down & joint swelling;
The patient had bruising on the left arm around the injection site where she received her Pneumovax injection. She also had redness from injection site down to her elbow. It was warm to the touch. The patient also had pain that radiating from the injection site down to the elbow area.
The patient was accidentally administered an expired dose of Pentacel by the Medical Assistant. There was no immediate adverse effect witnessed. This was discovered during charting of the vaccine into patient's chart. The family was immediately notified via phone by Dr.; the family reported the patient, 4 hours later, continues to have no witnessed adverse effect. An incident report will be filed by the Practice Manager.
Dizziness; Extreme fatigue; Weakness; This is a spontaneous report from a contactable consumer. An adult male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 29Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 02Oct2021, the patient experienced dizziness, extreme fatigue and weakness. The event resulted in emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events dizziness, extreme fatigue and weakness was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning female patients who were vaccinated with Gardasil. The patients had fainting episodes when seeing size of the syringe. Some had fainting episodes after receiving the vaccine. Subsequently, the patients recovered. Additional information has been requested. This is in follow-up to report previously sumitted on 5/14/2007. Information has been received from a physician concerning female patients who were vaccinated with GARDASIL. The patient had fainting episodes when seeing size of the syringe. Some had fainting episodes after receiving the vaccine. Subsequently, the patient recovered.
A non-serious spontaneous report of 56-year-old female patient received FLUMIST was received from a healthcare professional concerning a 56-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pt came to ER c/o fever, head pain, SOB, nausea. Tested covid positive 3/24/21.
Headache, NauseaVomiting, fatigue Narrative:  Employee experiencing headache, nausea and fatigue, tested for COVID on 1/5/21; negative. s/s have self resolved.
facial flushing, weakness, and fatigue. patient stayed for observation for 2 hours then left without symptoms
Client's mother called on 8/24/2006, concerned because for 1 day, client's Left arm has become increasingly swollen and sore, warm to touch, with redness and reported streaking.
Patient stated that she has been getting weaker for the past month or so and came to hospital for evaluation.  Patient found to be hypoxic, and anemic.
Note I sent to Dr. about a week after:  "From: Patient  Sent: 9/28/2019 4:04 PM  To: MD Subject: RE: Non-Urgent Medical Question  Received a flu shot little more than a week ago. Initially had sore shoulder in general and more acutely in my shoulder joint toward the front. It is painful to lift my arm last 90. It is painful to put on a coat ( swinging to the rear motion). Buckling seat belt motion is painful. I'm concerned something isn't right. The injection felt "bubbly" toward the end."  The shot didn't feel right. The Pharmacist did not pinch the muscle and the shot felt high in the arm. At the end of the injection before he removed the needle I felt a "burst, or bubbling" sensation in my shoulder joint immediately followed by the pain that I still have today. I've had several flu shots in the past and I'm familiar with the soreness that comes on after the shot and lingers for about a day. I had that pain as well, but it came and went like it usually does.  I always bleed after an injection and there was no blood this time.  Wife commented about how high the bandaid was on my shoulder. Do not remember seeing a bruise.  Today, December 6th, 2019, I am still experiencing pain. Pain lifting or lowering the weight of a milk jug or more past horizontal. Pushing down to lift my weight. Cross body motions like coats or robes. Sometimes feels like the arm is weaker, like I cannot lift my coat to swing it on.   The pain feels sharp, comes on quick and goes away quick. Though sometimes if I lift an object that causes the pain, it will be sustained.
Sore arm; May have also had chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were unknown.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix  Additional details were received as follows: The patient had sore arm after first dose of Shingrix.  Caller had Shingrix first dose.  The patient might have also had chills but she was not sure. Caller did not remember which arm she had the first dose administered into. The reporter did not consented to follow up.  The reporter did not wish to give physician's information. The reporter were not able to be given information about efficacy beyond 6 months for second dose. Ref to hcp and gave info regarding Medical information speaking to hcp's in regards to any other data available. The reporter did not wish to give address.  This case was linked with case US2020051451 (Husband's case), reported by the same reporter.
Patient became hot and receiving the injection and he passed out.  Upon arrival, patient was sweating profusely and was pale.
Baby seemed fine when she was put down for a nap. When the parents checked her she was dead on 10/15/02. SIDS.
Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated blood pressure  causing headaches. I have been unable to send this via the phone/text. I am exhausted from this continued distress. Normally very active and healthy.
I had a bumpy texture to the skin of my vaccination site one day after my vaccine. These hives spread to my chest going wide and above the clavicle to the sternum. I took Benadryl on the 12th and on the 13th and no reduction in the hives occurred. They are small skin-tone bumps that are not itchy or irritating. The bumps feel similar to sandpaper in texture. It has been one week past my vaccination and they have not decreased.
Pain; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M30A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.        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.
With the first does, the left arm got sore immediately and never went away; just got worse.  It was swollen and red, and I hurt so bad I was basically screaming putting clothes on and off (for 3 days straight).  It started not hurting as tremendous on the 4th day, but continued to hurt for over 2 weeks.  Then 1-2 days after the shot, I started getting a rash all over my hands.  Doctors thought it was just me washing my hands so much due to 2 kids in diapers.  the 2nd-3rd day after the shot, I started getting some red rash and swollen eye lids (upper and lower). I went to my eye doctor and dermatologist but they couldn't figure anything out.  I couldn't do much else about it as had to take my baby up for open heart surgery over 3 hours away.  She was the priority.  Things got a tiny better when I was with her during her surgery recovery, but as soon as I came home (was up there for almost 2 weeks) everything got worse.  The eye lids were so red, swollen, itchy, and burned; it makes me look like a racoon but red instead of black.  My hands got worse and the rash is covering 1/3 of my hands.  It hurts, itches, and is dry; yet sometimes oozing.  I can't remember how long after the first vaccine, but after the second vaccine, I have a horrible itch in the crotch/growin area that never goes away unless I use extreme pressure and hot water from the shower head to make it go numb.