chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left lower nose, lt upper lip, proximal cheek numbness extreme fatigue x 5 days; left lower nose, lt upper lip, proximal cheek numbness extreme fatigue x 5 days; left leg weakness; low grade fever; nausea; dizziness; frontal and lt maxillary headaches for 7 weeks; This is a spontaneous report received from a contactable other HCP (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), via Intramuscular in the right arm on an unspecified date 17:00 as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route, in the right arm on 10Feb2021 16:15 as a single dose for COVID-19 immunization. Medical history included colon cancer (medication induced hon). The patient did not have any allergies. The patient was Covid-19 positive prior vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included amlodipine, multi vitamin, Zofran and dexamethasone all for unknown indications and from unknown dates and unknown if ongoing. No other vaccine was received in four weeks. The patient experienced left lower nose, lt upper lip, proximal cheek numbness extreme fatigue x 5 days, left leg weakness, low grade fever, nausea, dizziness, frontal and lt maxillary headaches for 7 weeks on an unknown date in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The patient did not receive any treatment for the events. Outcome of all the events were reported as recovered with sequale on an unknown date in 2021..; Sender's Comments: As there is limited information in the case provided, the causal association between the events hypoesthesia, fatigue, muscular weakness, nausea, dizziness, headache,pyrexia and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.
Started with R)hand tingling and itching at injection site at 15 min check.  Pt denied SOB or wheezing no hives or rash  noted. NP looked at pt who started to feel nauseated.  Pt placed in  treatment room with cold pack and vitals collected (charted) had pt  wait 10 min more to monitor.  Pt was feeling better 12 min. later.  Nausea with  movement, no more itching at injection site.  Provider released pt and work  excuse note provided.  Pt took benadryl 25mg PO at 11:55.  Instructions were if  pt become worse to call or go to ER. Pt verbalized understanding.  Denies any  other question.
abdominal pain; vomited; acute appendicitis; appetite decreased steadily; increasing discomfort in my abdomen; my left breast was experiencing significant stabbing pain around nipple area; This is a spontaneous report from a contactable consumer (reporting for herself). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 10:30 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunization. Medical history was reported as none.  The patient's concomitant medications were not reported. On 12Apr2021, immediately within 15 min. of injection, the patient's left breast had significant stabbing pain around nipple area. This lasted all day, until she went to bed at 9:30 PM. On 17Apr2021 throughout the week, her appetite decreased steadily and she had increasing discomfort in her abdomen. Saturday morning, she woke up at 5 AM in severe abdominal pain, she vomited, and was still horribly uncomfortable for hours. Finally, she went to the emergency room at 11 AM, where they performed a computerized tomography (CT) scan and told me she had acute appendicitis and required surgery to remove my appendix. The events resulted in emergency room / department or urgent care and hospitalization. The patient was hospitalized for 1 day and had emergency appendectomy. The patient underwent lab test and procedure which included nasal swab negative on 17Apr2021. The outcome of the event breast pain was recovered on 12Apr2021 at 21:30 while the outcome of the other events were recovering. The patient had no COVID prior to vaccination.
Gradual onset of right knee intraarticular joint pain, began about 7 hours after the N1N1 IM vaccine administered in the left deltoid. (lot# UPO 21AA Sanofi exp. 4-9-2011). Spontaneous right knee pain increasing in severity until trouble weight bearing. Monoarthritis. Hurts with passive motion, flexing and extending, and weight bearing.   No recent injury or unusual other activity. Afebrile. Mild pain radiating to right hip, but may be due to altered mechanics.  800 mg Ibuprofen q 6 hours and rest and elevation has not yet helped in 1 day. Otherwise healthy 37 year old female with no other health problems.  No other medications, other than MVI.
patient had a syncope; was sweaty, then felt a little dizzy then fainted.  This happen within about 5 minutes while waiting after the vaccination.  Patient was laid on the floor before fainted for about few seconds (@5sec).  Patient waited in the pharmacy for about 30 mins and felt better.  After follow up with patient, she said she felt tired for couple more days then felt better
Fever, chills, sleepiness and inflammation of the gland under my Axilla on the left side where the PFIZER (Booster) vaccine was placed.
I?m not sure exactly what?s going on but my left arm is extremely sore. It?s to the point where I can?t put it all the way down. It?s a throbbing pain that shoots to my elbow. It started the day after my vaccine.
Pt. called 12/9/11 to report to triage RN at clinic "have little rash; small patch on (L) chest appeared 2 days post shingles vaccine". 12/7 Rash bright pink with tiny papules, none broken at this time. Not taking anything at this time. Concerned this may be vaccine rx.
ACHY; FEELING WEAK; CHILLS; HEADACHE; DISCOMFORT AT SITE OF INJECTION; RAPID HEART BEAT OF 120; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced discomfort at site of injection. On 10-MAR-2021, the subject experienced rapid heart beat of 120. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) 120 (units unspecified). On 11-MAR-2021, the subject experienced achy. On 11-MAR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from discomfort at site of injection, rapid heart beat of 120, chills, and headache on 11-MAR-2021, and achy, and feeling weak on MAR-2021. This report was non-serious.
Fever 101F (not controlled by acetaminophen), chills, and headache.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. 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 and expiry date: Unknown) dose was not reported, 1 total administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In AUG-2021, the patient had COVID-19 antibody test which showed no antibodies (confirmed immunological vaccine failure).  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000193282.; Sender's Comments: V0: 20210925740-Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Headache, Lethargic, severe bone and joint pain, chills then sweats, this lasted over 8 hours , large welt at injection site along with a large hive.
Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021; vaccine administered past its 30-days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022 at 5:59 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Feb-2022 at 5:59 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   It was reported that, booster dose of vaccine was administered on 11-Feb-2022 at 17:59:31.  No treatment medication was reported.
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. No historical or concurrent conditions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L024122. expiry: 30-DEC-2016). No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of two reports received from the same reporter. Additional information is not expected as consent for contact was denied
Extremely sore arm, almost couldn't move it. Redness at injection site. Flu-like symptoms.
45 minutes of being weak, limp, not sucking well 3 hours after vaccines, breathing OK no seizure. Had a few myoclonic jerks. Color good. After 45 minutes was perfect.
Moderna vaccine administered outside of BUD. BUD was 6/3/23 and vaccine given on 6/9/23.
Swelling, edema, redness to left deltoid at injection site.  Periorbital edema to left eye.  Improved with BENADRYL.
I started seeing double around 04/19, if I kept one eye closed I could drive. I went to the ER and they did an ultrasound, MRI and EKG. I stayed overnight and was discharged the next day. I followed up with my doctor and the ophthalmologist and he stated I have binocular diplopia. They told me to come back in 6 weeks. I am still having vision problems.
Muscle soreness in arm (non-dominant arm) where vaccine received that started on 11/4/19 (18 days post-vaccination) that feels like normal/expected soreness that was experienced/is expected to be experienced in days immediately following vaccination. At time of this report on 11/5/19, soreness persists. No strenuous activity has occurred that would be expected to cause this.
Fever (102 degrees) & seizure within 36 hours of administration of vaccine. No prior seizures ever.
Headache, Fever chills, body aches, nausea,  loss of appetite,  little stinging pains multiple places on body, light headed, dehydration and a slight cough. All of this continued to get worse by the day. Cough started on 6-10-23. Called doctor's office on 6-12-23. Advised me to continue with hydration,  pain reliever and start taking Bendryl.  I did and started to feel better the next day.
Chills, fever, fatigue, headache, body aches. Chills and fever lasted off and on for 6 hours. Ibuprofen helped. Headaches has lasted most of the day after receiving the vaccine, and ibuprofen didn?t help.
Vaccine given on 3/20/21 and patient developed symptoms consistent with bells palsy on 3/26/21. Diagnosed and treated at urgent care
my arm is a little bit weaker than it was / left arm lost strength, received vaccine in left arm; it feels a little different, it functions and everything/ left arm is not functioning at 100% like used to; a little bit swollen in the right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "my arm is a little bit weaker than it was / left arm lost strength, received vaccine in left arm"; MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "it feels a little different, it functions and everything/ left arm is not functioning at 100% like used to"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "a little bit swollen in the right arm". Additional information: On Mar2021, Patient received two doses of vaccine from Pfizer and last year on Feb patient was given third booster shot. Ever since he received, his arm was little bit weaker than it was, it felt little different, its function and everything. He did workout all the time and he could tell difference in the arm. His muscle was little bit swollen in the right arm when before it was pretty even. Patient does not have pain, it just felt different. Caller was advised Pfizer does not provide treatment recommendations. Patient never had COVID prior or after the vaccine and that he has been tested few times. Over the period of a year and some change left arm lost strength, received vaccine in left arm, left arm strength is about 80% of what it was. left arm is not functioning at 100% like used to and the left arm is where caller received the vaccine. Left arm was not functioning at 100% like used to and the left arm was where caller received the vaccine. On 14Jul caller has physical coming up, going to discuss this information at that time with doctor.
Nausea; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. Treatment information provided included Hydration and antiemetics.  It was reported that it was patient's second dose of Moderna vaccine, and the patient had a reaction to the vaccine which included Nausea and vomiting and visited the Emergency room for hydration and antiemetics.  The vial from which the vaccine was taken was removed from the refrigerator and administered after it was in the refrigerator for a week. The refrigerator raged from 5.2C to 6.5C while the punctured vial was in it.
pt presents w/fever 104.6 duration few hrs sleepy but easily aroused, diarrhea 8x in 24 hrs grunting post 24 hrs; pt adm to hosp for work up;
extreme fatigue; feeling of faint; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318) at the hospital, via an unspecified route of administration on 03Feb2021 at 17:00 at a single dose on the right arm for COVID-19 immunization.  Medical history included 10 nerves killed in back lumbar region on an unknown date (reported as '5/02'). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (manufacturer unknown), gabapentin (manufacturer unknown) and tamsulosin hcl (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme fatigue and feeling of faint on 05Feb2021 at 07:00. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date. The events were reported as non-serious.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was sitting for 15 minute observation when I heard a thump outside. Came out to patient face down on the floor. Immediately woke up when I called out, but was unaware he had fainted. Gave patient water and gatorade and continued to monitor for 40 minutes. Patient continued to feel clammy and lightheaded but eventually felt okay to go home.
Post vax, the pt developed loss of coordination to left hand and foot. She also has 3rd Bells Palsy of right eye. Per F/U 6/12/02: The pt is a 13 year old female with a 10 day history of headache and vomiting. She was admitted to the PICU with frequent neuro checks and she was started on Decadron 16mg IV q6h. Her left eye was with lateral gaze and ptosis. She was noted to have a left facial droop. Over the following day, her level of consciousness increased. Her hypovolemia was corrected, her headache decreased to a level controlled with Tylenol and her nausea ceased. The pt was discharged with prescriptions of Pepcid 20mg po bid and Decadron 16mg po q6h. The brain lesion etiology could not be determined but conferring MD's suggested that acute demyelinating encephalomyelitis was a possible etiology. Therefore, it was decided to initiate treatment with steroids. She was placed on IV Solu-Medrol on 5/17/00 and continued for a total of 4 days. She was discharged on 5/20/00 with an oral steroid taper and follow-up. DX: Astrocytoma recurring with new growth.
He has been not feeling good; He is in severe pain today/starts in his arm and goes across his chest; He is in severe pain today/starts in his arm and goes across his chest; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a male patient who received Herpes zoster (Shingrix) for prophylaxis.  On 08-MAY-2023, the patient received Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: He has been not feeling good), pain in arm (Verbatim: He is in severe pain today/starts in his arm and goes across his chest) and chest pain (Verbatim: He is in severe pain today/starts in his arm and goes across his chest). The outcome of the feeling abnormal, pain in arm and chest pain were not resolved.  The reporter considered the feeling abnormal, pain in arm and chest pain to be related to Shingrix.  The company considered the feeling abnormal, pain in arm and chest pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 10-MAY-2023 The reporter was a friend of the patient. He called the GlaxoSmithKline (GSK) and stated that, he had a friend here who got the shingles shot on Monday afternoon. He had been not feeling good. This was 2nd day now (at the time of reporting) since he got the shot. He was in severe pain today (On the day of reporting). We were wondering as what to do. It had started in his arm and goes across his chest. He just did not felt good, at all. The patient was here at his house. The reporter had denied consent to follow-up.
Pt recvd vax & the morning p/vax felt grumpy, moody & on edge; did not sleep well;
Sometime in Sept 2019 began having random itching. 10/10/19 at dermatologist for skin cancer check and mentioned itching to her; she could tell by my back something may be going on; to come back if happens again. Oct 20; Nov 22; Dec 20; Jan 4 - Each time breakouts on trunk from waist upwards to breast/side with severe itching and very red and swollen. Jan 6 returned to dermatologist; scratch tests on back were positive releasing histamines; Biopsy - Chronic Urticaria and Angioedma - auto immune. Referred to Allergist. Blood Tests ordered. Subsequent breakouts - Some with severe itching and inflamation; others small patches itching only. Each date is a new breakout: Jan 26; Feb 9, 27; Mar 8, 11, (On March 17, I noted that I had been itch free for two days!) Mar 29; Apr 1, 12, 16, 20, 21, 22, 25, 28, 29, 30; May 13, 25; July 12. Stopped Allegra on Aug 9 and the Zyrtek on Aug 21, 2020.  Since that time my back itches off and on and I have random small areas of itching but no hives, inflammation or severity as before.  Shringrix contains polysorbate 80. In the fact sheet on the Pfizer and Moderna Covid vaccines it reads: "If you have had a serious allergic reaction or immediate reaction to any vaccine ingredient, you should not get the vaccine.  This includes a reaction to polyethylene glycol (PEG) and polysorbate.  Although polysorbate is not in either of the vaccines mentioned above, it is closely related to PEG, which is in the vaccines."
This spontaneous report as received from a pharmacists refers to a 65 year old female patient with no known allergies. On 19-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000493, exp date 14-APR-2014) (dose and route not reported). Concomitant therapy was not reported. On 20-JUL-2013, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as a large raised red area (rash) at the injection site that was painful. The red area had gotten larger since it started. The patient sought medical attention by contacted the pharmacist and no treatment was given for the adverse event. Laboratory diagnostic studies were not performed. At the time of the report the patient's outcome was not recovered. Additional information has been requested.