chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillen-Barre syndrome; weakness in her legs; Chills; little bit of a temperature; not felt good; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. She was taking another unspecified medication. She had her first dose on either 03Fed2021 or 04Fed2021, and instantly, within a few days, it started with the weakness and she had after the vaccine either. The next day and that night she had felt chills and a little bit of a temperature and then the next day that went away but she felt so weak. She felt like her legs were dragging, literally. She got the crutches from work and she was going to walk with the crutches to at least make sure that she would not fall. She went back to her doctor and asked if she should still get the second vaccine and her doctor said yes, she needed to get it and so the caller said okay and she got it. She then had the weakness again and then she ended up having pain in her legs that was so bad she had to go to the emergency room and they said that she was positive for her D dimer test, it has been more than 5000 since she had the vaccine. Her last D dimer was on 29Sep2021 and it was 6337. She was put on Xarelto for 22 days when she at first had the pain in her legs being so bad. Periodically it comes with weakness in her legs and the pain is so bad that she can't walk. Here she is now 4 days into this bout with it again and she is not able to walk without crutches because of the severe pain she has when she is walking. It is like nerve pain and it hurts so bad, it is like a 9 out of 10. This has been absolutely crazy and she is a practice manager at an orthopedic surgeon's office and she has been working from her bed because of how bad it is and she wanted to get a copy of what is in the COVID vaccine. She has been treated with a doctor in the beginning of this and they thought that maybe it could be Guillen-Barre syndrome and said that they were going to keep an eye on her and send her to a neurologist. Now she is with Scripts and she was sent another medication yesterday because of her D dimer and they said that her side effects are from the vaccine. They said it is an effect from the vaccine and that she needs to see a neurologist and she cannot get into one until Dec2021. She doesn't know what will happen to her before Dec2021. This has been destroying her lift and she is just working from her bed and it is absolutely crazy. The outcome of chills and little bit of a temperature was recovered in Feb2021, outcome of other events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101319916 same patient/drug, different dose
erythema, ecchymosis, pain & edeam @ inject site are reported in a pt receiving 1 dose of fluogen-sx occurred 12 hrs p/vax & resolved w/in 48 hrs of vax;
rash on my elbow; loss of appetite; tired; dizzy; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 10:00 on Arm left at single dose (Lot # EL3246) for covid-19 immunisation. No medical history and concomitant therapy. She woke feeling dizzy on 24Jan2021, went to bed feeling dizzy and woke up feeling dizzy and the feeling isn't going away and she has a rash on her elbow on 25Jan2021. She took an antihistamine for it. She took the (Pharmacy name) off brand antihistamine. She does not know the name of it. She doesn't have an appetite on 25Jan2021. She doesn't feel sick but she usually loves her breakfast. She also maybe is a little tired on 25Jan2021. She also reports that her second vaccine dose is due today and feeling like this she doesn't know if she should get it. Outcome of the event dizzy was not recovered. Outcome of other events was unknown.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0. 5ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 120, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The pt, on 5/30/00, was vaccinated with pneumococcal vaccine 23 polyvalent and on about 5/30/00, the pt experienced redness and swelling of the arm down to the elbow and hand, severe pain, skin was hot to touch and had a tight feeling of the skin. The pt was afebrile. Medical attention was sought. He was administered a cool compress, Benadryl and Tylenol. No further information is available.
PATIENT COMPLAINED OF TINGLY TONGUE AND SLIGHT ITCHINESS ABOUT 10 MINS AFTER VACCINATION
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a company representative on behalf of a health care professional concerned a male patient of unspecified age, race and ethnicity. 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, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date after vaccination, the patient experienced suspected covid-19 (suspected clinical vaccination failure). On an unspecified date in AUG-2021 (same week of this report), the patient was hospitalized and was intubated. The duration of hospitalization was not specified. On an unspecified date in AUG-2021 (same week of this report), the patient died of covid-19. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected clinical vaccination failure and suspected covid-19 on AUG-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This case was associated with the Product Quality Complaint number 90000188817.; Sender's Comments: V0: 20210815127- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected COVID-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210815127- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: COVID-19
Big Hard Red Knot at injection site; Knot at injection site was hot; Felt Bad; No Energy; Mouth was red; Irritated Mouth; Knot at injection site was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big Hard Red Knot at injection site), VACCINATION SITE WARMTH (Knot at injection site was hot), VACCINATION COMPLICATION (Felt Bad), ASTHENIA (No Energy) and ORAL MUCOSAL ERYTHEMA (Mouth was red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to sting (Yellow sting allergy.) and Allergy to vaccine (allergy shots she receives for yellow jacket sting allergy.).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE MASS (Big Hard Red Knot at injection site), VACCINATION SITE WARMTH (Knot at injection site was hot), VACCINATION COMPLICATION (Felt Bad), ASTHENIA (No Energy), ORAL MUCOSAL ERYTHEMA (Mouth was red), STOMATITIS (Irritated Mouth) and VACCINATION SITE PRURITUS (Knot at injection site was itchy). At the time of the report, VACCINATION SITE MASS (Big Hard Red Knot at injection site), VACCINATION SITE WARMTH (Knot at injection site was hot), VACCINATION COMPLICATION (Felt Bad), ASTHENIA (No Energy), ORAL MUCOSAL ERYTHEMA (Mouth was red), STOMATITIS (Irritated Mouth) and VACCINATION SITE PRURITUS (Knot at injection site was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.  The patient was scheduled to get second shot on 19-Feb-2021.
body aches, chills, feeling of being unwell, swollen lymph nodes.   the body aches, chills and feeling of unwellness, i treated with aleve cold and sinus. but the swollen lymph nodes  is on going.
Patient got redness & swelling below injection site in left arm below the elbow approximately 2.5" x4". Patient states no pain or itching.
Vaccines administered. Patient at elevator and fainted. Did not hit head. Disoriented for seconds per parent report. Patient A & O x3. To ED in wheelchair for observation.
20 months male baby was administered Boostrix instead of Infarix; 20 months male baby was administered Boostrix instead of Infarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 20-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   On 01-JUN-2023, the patient received Boostrix (left thigh). On 01-JUN-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 20 months male baby was administered Boostrix instead of Infarix) and inappropriate age at vaccine administration (Verbatim: 20 months male baby was administered Boostrix instead of Infarix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter was the medical assistant who stated that the vaccine was administered in left thigh at the medical office.  The reporter consented to follow up. On the day of reporting, a 20 months patient was administered Boostrix instead of Infarix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Eye twitching, shaking motion for 6 minutes.  rule out seizure.  Fever 102.9
pt recv vax MAY96 & on 3FEB97 pt exp chickenpox;9 other pt were reported as well (WAES 97030177-97030184);
Father called 8 hours after vaccine was administered stating patient was experiencing dizziness. Father stated patient was sleeping but was reporting dizziness as instructed by vis sheet. Father was advised by triage nurse to continue to rest and adequate fluid intake. Provider unable to reach family for an update.
Patient had chills, very cold, shaking all over head, arms, confused. Symptoms lasted for 1 day.
Headache, ErythemaMultiform & UrticariaPruritus Narrative:
PATIENT DEVELOPED HIGH FEVER OF 104.5, SIX HOURS AFTER VACCINE GIVEN NO OTHER SYMPTOMS. FEVER PERSISTED FOR 24 HOURS, NOT RESPONDING TO TYLENOL.
12/28/2020 1st Covid Vaccine Moderna 025J20-2A Left Arm 10am 1/25/2021 2nd Covid Vaccine Moderna 030L20A Left Arm 1pm 4/24/2021 ill 4/25/2021 Covid + LTC POC Testing 5/5/2021 Potential to RTW
pt recvd booster dose of MMR vax on 27AUG91 & on 6SEP91 pts mom noticed some inc bruising on both legs & hands; 3 days later pt devel nose bleed; lab eval revealed dec level of platelets dx w/ITP;
BELLS PALSY - CAME ON FAST (WOKE UP WITH IT), DIAGNOSED IN EMERGENCY ROOM AT HOSPITAL. WAS GIVEN PREDNISONE AND ACYCLOVIR - BOTH FOR 7 DAYS OF TREATMENT. FACIAL MOVEMENT WAS FULLY RESTORED WITHIN 5 WEEKS OF TREATMENT, BEGAN ACUPUNCTURE AFTER 2.5 WEEKS THROUGH RESTORATION OF FACIAL MOVEMENT.
ACUTE NON ST ELEVATION MI 4/26/2023 ACUTE NON ST ELEVATION MI
Patient is a 59 y/o F with asthma, COPD, CAD, HLD, HTN, migraines who presents form for COVID pneumonia.   Per ED note, patient had been feeling well until this morning when she woke up with headache, body aches, chills, and mild SOB. States she felt similar to when she received her COVID vaccines back in April. Denies runny nose, congestion, cough, wheezing, chest pain, N/V/D, abdominal pain, pain/blood with urination. On arrival vitals notable for T 39.5, HR 124, 142/98, O2 88% requiring 2L. Found to be COVID (+). CMP and CBC WNL. CT PE neg. Of note, patient has history of COPD but has never required home O2. Feeling much better after tylenol, but still feels like she has to work a bit harder to breathe.
Experienced vertigo the day following the second vaccine.  Symptoms included dizziness, spinning sensation and severe nausea.  Symptoms lasted for 2 days. Symptoms began again after booster vaccine taken on 1/21/22--same vaccine, Lot: FF8841.  Symptoms are milder, but have been ongoing since the booster.  I waited to see if symptoms would go away on their own,  this has not occurred so I made an appointment with my physician.  Dr. performed Dix Test for positional vertigo, still awaiting outcome.
Tested positive on PCR; Tested positive on PCR; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 10Jan2021 as dose 2, single (Lot number: EL0140), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Apr2022 as dose 4 (booster), single (Lot number: 003J21-2A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "not recovered" and all described as "Tested positive on PCR". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: Tested positive on PCR on 14Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had taken oral paxlovid, as COVID 19 treatment dated start date: 15Jun2022, to stop date: 19Jun2022, with lot number: NDC: 00069-1085-30. The patient received other medications in 2 weeks Bupropion HCL SR 100mg with lot number NDC: 43547-288-50 from 31Dec2010 to 27Jun2022 via oral route. Fexofenadine HCl tablet 180 mg with lot number 21K716 from 31May2022 to 27Jun2022 via oral route.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Site: Pain at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Numbness and tingling of the arm in which the vaccine was administered, and difficulty moving fingers at times
Pericarditis; Transaminitis; This is a spontaneous report from a contactable Other- Health Professional (patient). A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) via an unspecified route of administration on 13Jan2021 15:15 at single dose on left arm, for covid-19 immunisation. Medical history included chronic immune Idiopathic thrombocytopenic purpura (ITP), allergies to Mushroom. The patient did not have covid prior vaccination. The patient's concomitant medications were not reported. The patient experienced pericarditis and transaminitis on 03Feb2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 6 days. The patient received treatment medications for the events. The lab test included Nasal Swab, covid test: negative on 05Feb2021. The outcome of events was not recovered.; Sender's Comments: Based on the limited information provided, causality relationship cannot be clearly established and cannot be excluded.The case will be reassessed should additional information become available.~ The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Post flu shot administration, pt. became unresponsive and had seizure like activity that lasted approximately 60 seconds.
Patient presented to Emergency Room with was believed to be a reaction to medication. Patient had a redness at site of band aid that was applied to vaccine site as well as what appeared to be as hives per Emergency Room Physician.
Patient reports no issues with the administration of the vaccine and having myalgias a few hours after the vaccine as she expected. The rest of the day was uneventful and she went to bed as usual. She reports waking up from sleep (approximately 16 hours after the vaccination) needing to urinate. This is unusual for her as she typically sleeps through the night without having to get up. She stood up and was immediately incontinent of a large amount of urine. Again this is unusual as she doesn't have issues with urinary incontinence normally. She cleaned up and went back to bed. In the morning she arose and again was incontinent of a large amount of urine upon standing. She denied having any other urinary symptoms at the time. The patient reported going to the toilet the rest of the day about every 2 hours and did not experience any further episodes of incontinence or any other urinary symptoms. She did not inform us of these events until her follow up appointment on 12/13/18. It should also be noted she had a normal gyn exam in July 2018.
pt recv vax 24DEC96 & 25DEC97 pt devel breakthrough chickenpox;
Tachycardia Ears became very hot Narrative:  Employee was evaluated by the rapid response team and released.
After I got sick with COVID I had sore throat and lots of throat clearing that wouldn't go away. I also kept feeling like something was stuck in my throat. This all kept going on for a while and then I went to see my doctor and I was given a chest X-ray and was given prednisone and antibiotic. The symptoms continued and then I was sent to an ENT doctor. The ENT doctor found Chronic Sinusitis and I was sent to another ENT. This other ENT prescribed 30-day prednisone and antibiotics. None of this stuff has helped and I feel like I am just sick all the time. I tested last week and it was negative.
pt recv vax & was hosp for full-blown sz;pt is currently medicated & developmentally delayed;
Moderna Covid-19 vaccine (bivalent) was mistaken as Lidocaine and was inadvertently administered to a patient who was going to have a lesion excised on the left upper arm; The vaccine was given subcutaneously; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Covid-19 vaccine (bivalent) was mistaken as Lidocaine and was inadvertently administered to a patient who was going to have a lesion excised on the left upper arm), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine was given subcutaneously) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history information was provided.  Concomitant products included LIDOCAINE (EXYGRA [LIDOCAINE]) and EPINEPHRINE (BOSMIN [EPINEPHRINE]) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Subcutaneous) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Covid-19 vaccine (bivalent) was mistaken as Lidocaine and was inadvertently administered to a patient who was going to have a lesion excised on the left upper arm), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine was given subcutaneously) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Covid-19 vaccine (bivalent) was mistaken as Lidocaine and was inadvertently administered to a patient who was going to have a lesion excised on the left upper arm), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine was given subcutaneously) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Subcutaneous), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Moderna Covid-19 vaccine (bivalent) was mistaken as Lidocaine and was inadvertently administered to a patient who was going to have a lesion excised on the left upper arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine was given subcutaneously).    It was reported that Moderna Covid-19 vaccine (bivalent) was mistaken as Lidocaine and was inadvertently administered to a patient who was going to have a lesion excised on the left upper arm. They had the vaccine in the room which was supposed to be given to the patient at the end of the procedure. Instead of the Lidocaine with epinephrine to be given to locally numb the area of the excision, the vaccine was the one that was given. The vaccine was given subcutaneously at 0.5 ml while the compound lidocaine and epinephrine (2%) was given anywhere between 1-3ml within 1-10 minutes after the Covid- 19 administration. No treatment drug details was reported.
Pt developed extreme fatigue for the past 2 years which is treated with prednisone and Imuran for auto immune hepatitis.
Ten minutes following administration of vaccine, pt c/o warmth over her body, then hives, then immediate respiratory distress and throat closing. 911 called, and she was given stat Epi pen 0.3 mg subq with relief. She was transported to the ER and observed until stable.
Felt weak soon after, thought would pass. Called pharmacy 26 hr after vaccine. Felt moderately lethargic. Usually run 3 mile every day and could barely walk 10ft. 48 hr felt 90% better.