chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Home oxymeter registration 92 oxygen.  Respiratory distress.  Extreme fatigue. Unable to stay awake.  Severe continuous headache.  Short term memory loss. Severe body aches. Leg stremors. Nausea. Confusion.
He got his vaccine, had a little soreness in the arm, kind of typical of many vaccines he has had in the past.  The next couple of days it felt stronger which lasted for 2-3 days.  During the night at about 2-3 morning and his bed was soaking wet under his body, and he was shivering.  He got up, drank some water, went back to bed, and slept.  When he got up in the morning he felt much better.  He did not have any more night sweats or chills after that.
Extremely itchy all over body. Breaking out all over the body in hives. Experiencing dermatographia. Never had an allergic reaction to anything before, and no family history of anything like this. Difficulty sleeping because I am in so much pain.  Took benadryl but symptoms are not going away. Hesitant to take prednisone because I am only a few weeks into my pregnancy.
Information has been received from an RN concerning a 15 month old Caucasian female child with no known drug allergies and no past medical history who on 8/16/01 was vaccinated SC in the left arm with the 1st dose (lot 639617/0739L) of MMRII. Concomitant therapy on 8/16/01 included the 3rd dose (lot 639122/0484L), IM in the right thigh of HIB. There were no other concomitant therapies or illnesses at the time of vaccination. On 8/24/01, the pt's mother called the physician's office and reported that on 8/22/01, the child "began to have head jerking episodes" as though she was nodding her head "no". It was noted that the episodes lasted just a few seconds but occurred every few hours. The episodes decreased in number and the child had only 1 episode on 8/24/01. No other symptoms were reported. It was noted that the pt had no other reactions to other immunizations. No medical attention was sought. It was reported that the pt recovered. No further information is available.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 04-DEC-2012 was vaccinated with an improperly stored PROQUAD (dose and route unknown, Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Charlie horses in legs; multiple cold sores on lip; Chills; Fatigue; headache; cold sweats; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unable to locate or read the details), via an unspecified route of administration on 19Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included psoriasis, high blood pressure, thyroid removal. The patient had no Known allergies. The patient other concomitant medications in two weeks included guselkumab (TREMFYA), levothyroxine sodium (SYNTHROID), aspirin (acetylsalicylic acid), bupropion hydrochloride (WELLBUTRIN), nebivolol hydrochloride (BYSTOLIC). Prior vaccination, the patient had not had COVID, not tested post vaccination. No other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 19Dec2020 at 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced charlie horses in legs, multiple cold sores on lip, chills, fatigue, headache, cold sweats on 20Jan2021 07:00. The patient did not received treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jan2021.  The outcome of the events charlie horses in legs, multiple cold sores on lip, chills, fatigue, headache, cold sweat was recovered in Jan2021.   Information on the Lot/Batch number has been requested.
Case number PHEH2013US014352, is an initial spontaneous report received from a pharmacist on 02 Jul 2013. This report refers to a 16-year-old male patient. He received only Men A lyophilized conjugate component of MENVEO, (batch number: A12093) reconstituted with sterile water intramuscularly on 02 Jul 2013 at 14:25 PM. He did not receive the MENVEO vaccine. No adverse reaction was reported following this administration error.
sore injection site arm; little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (little tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 031A21A and 032M20A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included SILDENAFIL and OMEPRAZOLE for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (little tired). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (little tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received second Moderna Covid 19 vaccine booster dose on 08-MAY-2022, Lot number 049L21A, expiration date was not known, right arm of administration. Patient reported no Adverse Reactions.        The patient received first Moderna Covid 19 bivalent vaccine booster dose on 17-OCT-2022, Lot number 060F22A, expiration date was 31-OCT-2022, right arm of administration. Patient reported no Adverse Reactions.  No treatment medications were reported.   This case was linked to MOD-2022-663250, MOD-2022-663256 (Patient Link).
He reported severe nausea and chest pain that occurred about 3 hours after getting the vaccine. His wife reported nausea after receiving the same vaccine.
developed a cold sore below my lower left lip; Herpes simplex1; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 at 09:30 (at the age of 53-years-old) as single dose for COVID-19 immunisation. The patient's medical and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), dose 1 administered in left arm on 23Mar2021 at 11:00 for COVID-19 immunisation. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021, the patient developed a cold sore below her lower left lip and Herpes simplex 1. First cold sore ever in her life. Herpes simplex 1 with COVID social distancing and constant hand sanitizing for over a year, no idea how else she contracted that, or what would trigger it if 'dormant' in her body for years. Therapeutic measures were taken as a result of the events included Valtrex and Denavir. The outcome of the events was recovering.  Information on batch number has been obtained.
Patient was at the doctor's office to receive an immunization, and the nurse noticed his red, inflamed arm. Patient states that he had not noticed the reaction until then. Injection site reaction.
After the dose 1 and 2 that immediate burning sensation in chest, it got better. The 2nd time it a sat for 20min. Burning sensation in chest. Had Covid in December 2020. Had covid symptoms, headache and fatigue. 2 months later - Mother's day and was in the mountains and felt horrible and if the altitude was getting to me and went to Urgent care on 12 May. Symptoms started on 9May2021. Endocrinologist in June and was diagnosis with Graves disease. Around the time, had purple spot was diagnosed by dermatologist - Lichen Planus diagnosed on 3 sep2021
MD reports the past yr pt has seen an inc in # of pts w/small knots @ the Tetramune inj site;physician is using a 5/8" length needle, 25 gauge;
muscle twitching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25May2021 (Batch/Lot number: unknown) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Previous dose brand unknown: False,, Previous dose lot unknown: True,, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Prev dose administration date=05May2021 , Prev dose number=1, Prev dose vaccine location=Left arm), administration date: 05May2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 26May2021, outcome "recovering", described as "muscle twitching". Therapeutic measures were not taken as a result of muscle twitching.  Additional information:If covid prior vaccination: No; If covid tested post vaccination: No;Known allergies: None;Other medical history: None;If other vaccine in four weeks: No;Other medications in two weeks: None  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and AFib. Concomitant products included FLECAINIDE for Atrial fibrillation.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.            Patient had all 5 shots of Moderna brand vaccines, up to date with vaccinations including the new Bivalent version  It was reported that patient experienced sore arm for a couple of days.  No treatment medications were reported.   This case was linked to MOD-2023-704762 (Patient Link).
Fever, redness, swelling, heat at injection site left upper arm beginning within hours of administration.
Pt recvd 1st dose of Hep B vax & subsequently exp fatigue;
No adverse event; Patient was inadvertently administered to a patient via the intramuscular route as opposed; This spontaneous report has been received from a medical student and refers to a patient of an unknown age and gender.  The patient's medical history,concurrent conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On 18-JUN-2022, the patient was  inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rhA) (M-M-R II)  at a dose of 0.5 milliliter, administered intramuscularly as prophylaxis lot number U029620 expiration date 22-SEP-2022 (strength and vaccination scheme were not provided) (product use issue). No additional adverse event was reported.
low to medium grade anxiety, shakes, vertigo, dizzy, body slight quiver, high blood pressure,
08/24/2021, had immediate soreness at vaccination site and the pain increased over the next few days. Pain in movement in upper arm at the vaccination site location at twisting, moving it back and forth, rotational movement at the arm he could feel it, or any quick movement of the arm. Had a test done at Hospital. Did a scan and found arthritis small about and did not notice any of this before. Minimal improving, do exercising and still feel pain but improvement in last few weeks.
pt recvd vax on 16FEB94; that noc pt had 4 hrs period of non stop uncontroable crying, then slept & was irritable for another 24 hrs;
Pt developed a rash spreading from the diaper area to the limbs.  The rash is macular, 1-2 mm in diameter, without secondary lesions.  Some coalesence of lesions in the diaper area. Ddx also includes viral exanthem and heat rash.
shoulder/upper arm pain.; shoulder/upper arm pain.; Adhesive Capsulitis; This is a spontaneous report from a contactable consumer (patient).   A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0150, Expiration date were not provided), via an unspecified route of administration on administered in Arm Left on 09-APR-2021 at 11:30 (at the age of 68-years-old) AM as DOSE 2 SINGLE for covid-19 immunisation. Medical history included, BPH, cataracts, basal & squamous cell carcinomas. The patient had known allergies penicillin. Concomitant medications included calcium citrate (CALCIUM CITRATE) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number=EN6202), via an unspecified route of administration on administered in Arm Left dose 1, on 09MAR2021 at 01:00 for covid-19 immunization. On an 12Apr2021, the patient experienced shoulder/upper arm pain, the pain is dull, but can be sharp, difficult to localize (no specific area), average severity about 5/10, and aggravated by almost any movement of the upper arm. I thought it was just covid arm, and that it would go away in a few days or weeks, but it's still hurting and unchanged over 4 months later. My PCP was stumped so sent me to an orthopedist who diagnosed me with Adhesive Capsulitis. I've never had my arm immobilized, nor have I had any recent trauma, so the mechanism of onset doesn't fit the diagnosis; therefore, he could not rule out that the injection may have caused it. Just thought this reaction should be reported and wondering if others have reported anything similar. I'm a bit apprehensive about getting the booster. The patient underwent lab tests and procedures which included pain assessment: 5 on 12Apr2021 (average severity about 5/10). The patient visits to physician office. The patient not received treatment. The outcome of the events was not recovered.  No Follow-up attempts are possible. No information is expected further.
This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (frequent bowel movements/constant pressure in the rectum that I have to go to the bathroom immediately), POLLAKIURIA (frequent urination/I have a constant feeling that I need to go to the bathroom every 15 to 30 minutes), DISCOMFORT (little discomfort in general but manageable) and VACCINATION COMPLICATION (If i drink water, I need to go to bathroom in 10 mints and once if I eat anything , then immediately I need to go to the toilet) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for Diabetes.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced FREQUENT BOWEL MOVEMENTS (frequent bowel movements/constant pressure in the rectum that I have to go to the bathroom immediately), POLLAKIURIA (frequent urination/I have a constant feeling that I need to go to the bathroom every 15 to 30 minutes), DISCOMFORT (little discomfort in general but manageable) and VACCINATION COMPLICATION (If i drink water, I need to go to bathroom in 10 mints and once if I eat anything , then immediately I need to go to the toilet). At the time of the report, FREQUENT BOWEL MOVEMENTS (frequent bowel movements/constant pressure in the rectum that I have to go to the bathroom immediately), POLLAKIURIA (frequent urination/I have a constant feeling that I need to go to the bathroom every 15 to 30 minutes), DISCOMFORT (little discomfort in general but manageable) and VACCINATION COMPLICATION (If i drink water, I need to go to bathroom in 10 mints and once if I eat anything , then immediately I need to go to the toilet) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Patient developed little discomfort after receiving the 2nd dose but he felt manageable. Later on the same day he experienced frequent bowel movements, and frequent urination and he had a constant feeling that he needs to go to the bathroom every15 to 30 minutes. He also felt a constant pressure in the rectum that he felt like going to the bathroom immediately. He did mention that if I drink water then I need to use the bathroom immediately and if I eat something then I need to use the toilet immediately.
pt reports shortly after sitting in the observation he felt dizzy and felt " like the vaccine was traveling through my body". Pt reports that he began to feel cold and had a brief episode of shortness of breath. RN nurse observer came over an stabalized pt and called for assistance. Pt was pale , diaphoretic and had bluish tinge to face upper extremities cap refill > 3 seconds. negative for facial swelling, skin redness, rash, chest pain, SOB, or NV. VSS  EMS activated.   after approximately 15 min. pt reported that he was feeling much better. EMS escorted pt out to ambulance for further evaluation.
Painful, red edematous injection site soon after injection that lasted "few days." Also, pallor and weakness soon after receiving injection.
Bivalent vaccine applied as a Second Primary Series dose; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Bivalent vaccine applied as a Second Primary Series dose) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. Unknown) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Bivalent vaccine applied as a Second Primary Series dose) and NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Bivalent vaccine applied as a Second Primary Series dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Bivalent vaccine applied as a Second Primary Series dose).    No Concomitant medication were reported.  It was reported that Patient had an appointment to receive Moderna's second dose from primary series but instead patient received Moderna's newBivalent Booster dose.   No treatment drug were reported.
Itching sensation on palms and feet; Redness; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included lichen planus rash history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medication included amoxicillin; clavulanic acid (AUGMENTIN) 875mg/125mg for 12days (04Apr-17Apr). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination.  Since the vaccination, the patient had been tested for COVID-19. On 08Apr2021, the patient underwent a RT PCR (real time reverse transcription-polymerase chain reaction) (nasal swab) test and tested negative. On 21Apr2021 at 13:00, the patient experienced itching sensation on palms and feet. He had no rash yet, but could see some redness. The events did not result in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with loratadine (CLARITIN) or cetirizine hydrochloride (ZYRTEC) OTC (over the counter) medicine, as needed. The clinical outcome of the event itching sensation on palms and feet and redness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient started experiencing headaches and low grade fever within 24hrs of vaccination.  As of this writing, pt is still having symptoms.
Vaccine given approx 5PM 10-3-12. 9PM Scratchy throat - tongue swelling - hypertension did not go to ER or take anything restless night. 10-4-12 Sinus problems - flu symptoms.
I started getting a lot of built up mucus and pain in my leg. I'm still having the mucus at this time.
new A fib started on Eliquis 5 mg BID, carvedilol 6.25 mg BIDWC, amiodarone 200 mg BID, and aspirin 81 mg discharge home
I had the expected side effects for four days. The headache and Nausea lasted the full four days. I had a rash on my right shoulder four days after the shot. It was a red patch that was itchy and lasted for two days.   Two weeks after the shot I had leg fatigue and weakness. I normally get tension headaches but the pain in my left leg was from my knee to my groin. It started as a sharp pain and then it became a dull ache that was there all day. The leg pain was spreading, and my headache had been there for four days. I was advised to go the ER because of family history and the current news about the vaccine.  I was discharged after eight hours and all tests were negative. I was told that the headache had progressed to a Migraine and prescribed Toradol.
VACCINE GIVEN AT 9-28-09 @ 16:00. REPORTED FEELING LIPS TINGLING AND LIKE THEY WERE SWELLING, BUT NO SWELLING ACTUALLY NOTED. ALSO HAD CHILLS. REPORTED THAT WHEN SHE WOKE THIS AM 9-29-09 HER FACE AND LIPS WERE VISIABLY SWOLLEN. NO TREATMENT. BUT WAS INSTRUCTED TO TAKE SOME BENADRYL.