chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination adverse reaction/Covid vaccine metabolism; Fainting; Fainting; Weight gain; Fluid intake reduced; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4458886-00 (Agency).  A 66-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset May2022, outcome "recovered" (2022), SYNCOPE (medically significant) with onset Jun2022, outcome "unknown" and all described as "Fainting"; FLUID INTAKE REDUCED (non-serious) with onset 2022, outcome "unknown"; WEIGHT INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Weight gain"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "Vaccination adverse reaction/Covid vaccine metabolism". The patient underwent the following laboratory tests and procedures: Weight increased: (2022) about ten pounds. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had Weight gain about ten pounds, covid vaccine changed metabolism, not drink enough water and fainting with Humira. On an unknown date, the patient experienced Covid vaccine metabolism.  The reporter's assessment of the causal relationship of "fainting", "weight gain" and "fluid intake reduced" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "vaccination adverse reaction/covid vaccine metabolism" related to BNT162b2.  Causality for Humira(adalimumab): The reporter's causality for the event(s) of Weight gained about ten pounds, Covid vaccine changed metabolism, Not drink enough water, fainting onset in May2022 and fainting onset in Jun2022 was not provided.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events syncope, fluid intake reduced, weight increased, immunisation reaction and the suspect drug cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality product administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to Department of Public Health, VAERS, Immunization Registry and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 16 th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master
202.2 fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-OCT-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient received second dose of Shingrix and one day after vaccination experienced 102.2 fever with chills and wanted was it normal. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Headache, Myalgia, fatigue. at injection site reddness, swelling, pain. Lymph node near left breast swollen, and lymph node near right brease sore.
Information has been received from a 66 year old white female consumer (62 in 174 lb) with asthma and allergies to mold who on 25-FEB-2008 was vaccinated subcutaneously with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included montelukast sodium (MSD) and mometasone furoate (NASONEX). On 25-FEB-2008 the patient developed pain (also reported as soreness) at the injection site with no redness and a mild headache that was different from usual. She also felt tired and had no energy for about 24 hours. (previously reported as no other symptoms noted). The patient did not seek medical attention and no diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information is not expected.
Tested positive for COVID-19 test; This is a spontaneous report from a contactable consumer (patient) through the Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of the two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 20Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Jan2021, the patient had tested positive for COVID-19 test. The outcome of the event, 'tested positive for COVID-19 test', was unknown. The patient had an appointment to get the second dose on 10Mar2021, and was asking if she should still get the second dose even though she had tested positive.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147922 same reporter/product/events, different patient
Headache started ~ 1-2 hours after injection and lasted ~ 4 hours (treatment was nap and no activity).  ~ 8 hours after injection arm pain near and around injection site.  Still present with slight rise in pain level after 1st night.
Had flu like symptoms day of vaccine next morning Got Sick at stomach  was leaning against bed passes out fell between bed and bed table. Was out for 1  /2 minutes came to and felt ok the rest of day
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: DESCRIBED PINS AND NEEDLES FEELING IN HANDS
Chest tightness, difficulty breathing, coughing (both dry and wet), Hoarseness, dizziness, body aches.
I was having occasional chest pain so I went to my doctor who ran an EKG which identified a right bundle branch block. She referred me to cardiology and I am waiting for them to run further tests.
She denied further AE; administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 14-OCT-2021, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 0.5 milliliter (ml), lot # KP24R, expiration date 24-OCT-2021 (dose number and route of administration were not reported) for prophylaxis (product storage error). The reporter confirmed the lot # and expiration date twice. Lot number KP24R is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB). Lot number KP24R does not match any Company product as confirmed by Lot Verification team.  The vaccine was stored for the time frame of 30 minutes in the temperature of 50.5 Fahrenheit (F). There was no previous temperature excursion.  The reporter denied further adverse event (no adverse event).  This is one of several reports received from the same reporter.
The night after receiving the 4th dose, felt really sick with a headache and fever for the next 2 days.
lightheaded/felt dizzy almost all the time; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded/felt dizzy almost all the time) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DIZZINESS (lightheaded/felt dizzy almost all the time). At the time of the report, DIZZINESS (lightheaded/felt dizzy almost all the time) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she was on a strict diet and was unsure if that was the cause of her lightheadedness and dizziness  No concomitant medications were reported Treatment information was not provided
About 12 hours after the dose, I experienced tachycardia (I went to bed around 9:45 PM and work up around 11:00PM with a racing heartbeat; approx. 110-120 bpm). This persisted for approximately 24 hours and then resolved.
have shingles/ Suspected vaccination failure; Shingles; It's painful and aggravating; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: have shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: It's painful and aggravating). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 26-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles.  Patient states that he/she only hope this is considered a mild case since he/she did have the vaccine, It's painful and aggravating. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
I started bleeding heavily from my uterus, I had a uterine ablation 5 years ago till that day. I ended out bleeding out and coding. They revived me and I need 2 blood transfusions.
Patient returned to the hospital 2 days after receiving vaccine with fever, soreness and swelling of the left deltoid. CT showed concern for nec. fasciitis broad spectrum antibiotics were started. Incision and drainage was surgically performed.
Lot EN6203 .3 ml Table #3  Both the pharmacist and her own physician said that the vaccine was given too close to her elbow-- not intramuscularly; Dr. is treating for infection;
After dose 1 on 8/2/2021, I exprienced hot flashes all day with no fever. Starting that night, I developed persistent allergy symptoms (sneezing, itchy nose and throat, stuffy nose) despite not being exposed to allergens that I am still experiencing as of today, 8/27/2021. After dose 2 on 8/23/2021, I began having diarrhea that evening that has not ceased as of today, 8/27/2021. I know I listed IBS as a chronic health issue but this is different than my typical IBS symptoms.
nose started producing a very thick mucous; coughing; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6205, expiry date not reported), via an unspecified route of administration, administered in the right arm on 27Feb2021 15:15 (at the age of 55 years old) as dose 1, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included budesonide, and budesonide, formoterol fumarate (SYMBICORT), both taken for an unspecified indication, start and stop date were not reported. The patient previously took acetylsalicylic acid (ASPIRINE) and iodine and reported had known allergies to them. The patient was not pregnant at the time of vaccination and of the events. The vaccine was administered in the hospital. There was no other vaccine in four weeks. On 27Feb2021 at 11:00 pm, the patient's nose started producing a very thick mucous and then spent coughing every night. At the time of the report, patient was doing very well, without coughing, since patient had a batch of 5 days of prednisone just 2 weeks before. On the following day, some "head". The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had recovered from cough on an unspecified date in 2021. The outcome of the event nose started producing a very thick mucous was recovering.   No follow-up attempts are possible No further information is expected.
This spontaneous report was received from a male consumer of unknown age who was reporting on himself. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were provided. On 17-JAN-2013, the patient was vaccinated with ZOSTAVAX injection, subcutaneously (dose, lot # and expiry date were not provided) for prevention of herpes zoster. On unknown date in 2014 (reported as "one year later"), the patient experienced shingles and vision problems. On an unknown date, he sought medical attention by visiting ophthalmologist. The outcome of the events was reported as not recovered. The relatedness between ZOSTAVAX and the events was not provided.
Pt developed fever of 101 axillary. The next day it was 100.6. Denies localized redness. Pt "not acting quite right" per mom.
7 days post vax c/o sore throat, & aching allover, had cold chills on 11JUL91; c/o sore throat & glands big in throat, & inc temp about 102 oral; c/o h/a assoc w/this; Given APAP thru nite;
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 1:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 1:41 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Mar-2021 at 1:39 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Regarding vial with batch number: 014M20A Date vial(s) moved from freezer to refrigerator: 24-Feb-2021. Vial moved to Clinic on 02-Mar-2021 Vaccine Use by Date was 26-Mar-2021.  Regarding vial with batch number: 019B21A Date vial(s) moved from freezer to refrigerator: 23-Mar-2021. Vial moved to Clinic on 30-Mar-2021 Vaccine Use by Date was 22-Apr-2021. On 30-Mar-2021 at 1:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion).  Vaccines were not frozen at time of administration. Vials only punctured right before administration - during COVID-19 vaccine clinic all doses were drawn from vial due to high-pace clinic. traceable temperature monitor was used to record hourly temperatures. It was reported that patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient wife called stating his arm was red, swollen, and irritated at reaction site. Also states patient was hospitalized. She states changes in his mental state.
Subsequently post vax, the pt had an unspecified adverse experience. The pt sought medical attention.
105 fever for 4 hours. Then it gradually dropped down. This is the third day and I still feel very weak and fever of 100.4. I ache all over and have an earache. After the first dose, I had  a 102 fever and was fine the next day.   I also had numerous dry heaves this time.
Nine hours after vaccination, pt developed hives on (R) wrist, and her tongue became swollen, over the next day;  Hives spread to both arms from wrists to elbows, and also on abdomen.  Benadryl provided relief.
Day after receiving her vaccinations patient became very sleepy and has not been wanting to eat. Then today 9/26/2018 at 11 am she developed a rash all over her body that still hasn't went away and it is now 11pm. Nothing in our household has changed (no new soaps or anything).
Slight low grade fever Shakiness or jitters in hands  Light headed  Foot Pain in the right foot, near the top of toes, along the nerve/vein line (that leads to big toe) Difficulty walking , created a limp
Patient at gym working out and had a seizure, when 9-1-1 crews arrived patient was post-ictal, while treating the patient he had another seizure, during transport patient went into cardiac arrest, crews provided ACLS care and transported patient to hospital for treatment. Resuscitation efforts were terminated by physician in emergency room.
Adverse Event: Big red itchy inflamed rash, arm pain Treatment: Ice, Triamcinolone Acetonide Cream, 0.1% Outcome: Swelling appears to be going down
Child was given .5ml Flu vaccine and should have been given .25ml. This vaccine was private stock manufactured by manufacturer to be used for ages 6 months and up. We were out of VFC flu so we used our private stock.
upset stomach; Fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (Fever) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (Fever) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 test negative: (Negative) 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.   Concomitant medication was not provided. Treatment information was not provided.
t98.8 fine pink pinpoint rash more around inject site & also on trunk of body;
Systemic: swelling and pain in opposite arm-Medium, Additional Details: patient is having pain and swelling in right arm, not the left where the injection was. went to the hospital on june 21st and received hydrocodone for pain. went to doctor on june 24th with swelling in arm. received medrol dosepak
Fatigue, dehydration, pain at injection site  and muscle pain for 7 days after injection. Feeling of heat during injection at in arm.