chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluid overload; shortness of breath; Graft clotted off; This is a spontaneous report from the Pfizer sponsored program. A contactable Nurse reported that a 73-year-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK4176), via an unspecified route of administration, on Right Arm on 21Jan2021 at single dose for COVID-19 vaccination. Medical history included ongoing Diabetes, ongoing Vascular problems, ongoing Congestive heart failure; all (At least 15 years ago), blood thinners, dialysis from Sep2020 (husband has been on Dialysis since Sep2020. last time he was dialyzed was 11Feb2021) and Allergic to seafood and nuts. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) for blood thinner and acetylsalicylic acid (ASPIRIN) for blood thinner. The patient experienced fluid overload and shortness of breath on an unspecified date, graft clotted off on 13Feb2021. The patient was hospitalized for fluid overload from 16Feb2021 to an unknown date. She stated that her husband is on dialysis in the hospital and is going to miss the second dose appointment for the Pfizer covid 19 vaccine. She wanted to know what to do about the second dose. She wanted to know how long a person has to be off steroids before getting the vaccine and if she can reschedule the second dose appointment as he was hospitalized. Her husband is allergic to seafood and nuts. His appointment is at 10:30 (On 17Feb2021). She reported that he is on dialysis and his graft clotted and he has not had any dialysis in about a week. Her husband had fluid overload and shortness of breath. She said that he had to have an emergency port put in and they dialyzed him in the ER. He typically goes Tuesday or Thursday or Saturday. She said that he had not been dialyzed in over a week and he was getting fluid overload. She said that the last time he was dialyzed was 11Feb2021. She clarified that her husband has been on Dialysis since Sep2020. She said that when he got his Covid vaccine they checked that he was on Plavix and Aspirin. She said that they are supposed to hold the site because he has the tendency to bleed more while on blood thinners, but she does not know if that was the reason. She said that she knows what it was and he had to be dialyzed because of the fluid, but she was not told that her husband had fluid overload by the physician. She said that her husband has congestive heart failure as well. The patient was hospitalized due to Fluid overload from 16Feb2021 to ongoing. Outcome of all events was unknown and for remaining event Graft clotted off was not recovered. ; Sender's Comments: The causal assosciation between the suspect, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the events, fluid overload, graft clotted, shortness of breath is unrelated. The impact of this report on 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.
pt recv vax & was pregnant;pt exp severe abd  pain & was hosp w/dx of kidney failure;
swollen and tender under his arm pit on the side where he got the vaccine. It is visibly swollen; swollen and tender under his arm pit on the side where he got the vaccine. It is visibly swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent (patient's mother) .  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 08:00 (Lot number: EW0185) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Allergic to Azithromycin; "Swollen lymph nodes" (unspecified if ongoing), notes: Diagnosed 5 year ago: Swollen lymph nodes all over his body. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: First, Lot number: EW0170), administration date: 27Apr2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 19May2021 08:00, outcome "unknown" and all described as "swollen and tender under his arm pit on the side where he got the vaccine. It is visibly swollen".  Additional Information: NDC number and Expiry Date of Pfizer covid vaccine was unknown.  No follow-up attempts are possible. No further information is expected.
Patient called and said he received a flu shot and Prevnar. The next day his left side/lower leg then food felt "like knives were stabbing him in the leg." He tried Bengay and soaked in the tub for longer than an hour with Epsom salts
BODY ACHES; SWEATING; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced body aches, sweating, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sweating, chills, fever, and headache. This report was non-serious.
I felt like I had a very congested head cold, never ran a fever nor did I have a sore throat. I started coughing and currently still have the lingering cough. The cough is now making my throat sore. I took the PAXLOVID as well as OTC medication. I started feeling better around this time last week, but then over the weekend I started feeling crappy. I'm not testing positive for COVID-19 anymore and the doctor feels I could have caught a virus and not a rebound case. My voice is raspy currently. I feel worse today than I did when I had COVID-19 from coughing so much and not sleeping.
2AM morning p/vax pt devel high fever & had projectile vomiting;vomiting & fever cont throughout the day & ER visit was required;temp went to 104.2 & was eventually controlled w/APAP suppositories;pt was also described as unresponsive
Patient was given 12+ Pfizer Covid 19 Vaccine when they were supposed to get the 5-11 formulation..
The day after the vaccine I had a low fever of 99.8, chills, and muscle soreness.
The nurse mixed 1.3 instead of 1.8 of 0.9 % NaCl diluent with COVID vaccine
Patient started with vomiting developed bloody stools. Transferred from one medical center hospital to another one for intussusception - reduced by air contrast barium enema on 11-14-06 and again 11-15-06.6/1/07 Received hospital medical records which reveal patient experienced vomiting, bloody stools & decreased appetite w/low grade fever.  Seen at outlying ER which abdominal x-ray reveled possible SBO & IS. Transferred to higher level of care & admitted from 11/14-11/17/2006.  IS successfully reduced but recurred next day.  Repeat air contrast enema again reduced IS.  Progressed well after 2nd enema, tolerated oral feeds & was d/c to home. FINAL DX: Intussusception. 6/1/07 Vax records received from CDC.  VAERS database updated.
This is a serious spontaneous case, initially received from other non-health professional (consumer) via Merck (reference number: 01056278) on 22-Jan-2019, concerning a female patient of unknown age. On 31-Oct-2017, the patient was administered Influenza vaccine, dose: 1 DF (reported as 1 shot), route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication. On an unspecified date, after administration of vaccine, the patient experienced hand, wrist, feet and leg pain. The patient also experienced worsening of rheumatoid arthritis and felt very sick all the time. The patient was treated with prednisone for the events and she experienced racing and pounding heart after treatment. The outcome of the events was not reported. Reporter's Comments: A female patient of unspecified age experienced worsening of rheumatoid arthritis, unspecified period after receipt of INN flu vaccine. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and worsening of rheumatoid arthritis, company assessed the causality as unassessable. The event palpitations was assessed as not related to vaccine as the event appeared with plausible temporal relationship with prednisone. The company assessed the case as serious (medically significant).
HA over R-eye, dizzy, shaky, no breakfast, no BS check., BS @ 14:18:  294
he has been having blurry vision; soreness in the right eye.; experienced pain and soreness in the arm where he received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (he has been having blurry vision), EYE PAIN (soreness in the right eye.) and VACCINATION SITE PAIN (experienced pain and soreness in the arm where he received the vaccine) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VISION BLURRED (he has been having blurry vision), EYE PAIN (soreness in the right eye.) and VACCINATION SITE PAIN (experienced pain and soreness in the arm where he received the vaccine). At the time of the report, VISION BLURRED (he has been having blurry vision), EYE PAIN (soreness in the right eye.) and VACCINATION SITE PAIN (experienced pain and soreness in the arm where he received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Child was given flu mist at 10/20/07 clinic, not yet 2 yrs. old DPH recommends revaccinate in one month with Inactivated flu vaccines.
received Engerix after a cold temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 1-day-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2023, the patient received Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. In January 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's comments:  The physician reported that 5 patients received Engerix B after a temperature excursion of too cold. Reporter consented to follow up. Additional supportive information: Received Engerix B after a temperature excursion of too cold, which led to incorrect storage of drug. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR009449:same reporter - female case US-GSK-US2023AMR009450:same reporter - female case US-GSK-US2023008735:same reporter - male patient US-GSK-US2023AMR009387:same reporter - male patient
Child received meningococcal vaccine (R) forearm at health clinic. In the AM site was red warm and swollen. He was seen by his DR and at the health dept was given script for antibiotic. Keflex (per mother) which was started on Friday and swelling gone by Sunday. No other complications noted by mother.
sanofi-pasteur manufacturer Pt came into pharmacy complaining that her right thigh has been itching since she got the flu vaccine, she has applied some neosporin and bactroban on site and has also taken at least 1 dose of benadryl. I counseled to continue benadryl and apply hydrocortisone to site. She has a dermatologist appointment in 3 weeks.
About 36 hours after vaccine, I had a severe tremor episode that lasted for about 45 minutes. Since then, I?ve had muscle weakness, fatigue, and tremors in my arms and hands. It?s been 2 weeks now. Not sure if it?s vaccine related or not.
This spontaneous report was received from a licensed practitioner nurse refers to a patient of unknown age. On 19-JUL-2016, the patient was inadvertently vaccinated with a dose expired ZOSTAVAX, lot # L001203, expiry date 07-JUL-2016. No adverse effects were reported. Additional information has been requested.
Pt noticed eye swelling, described "like having been stung by a bee". Also, blistery rash on forearm and underside of right (vaccination) arm. Rash then spread to torso. One spot was reported on right upper thigh. Pt was treated at an emergecy room facility with prednisone and BENADRYL. She reported that prednisone suppressed the rash, but it returned when prednisone was dc'd. Pt reported the adverse reaction to me today, 8/18/2018, and there were still some remnants of rash on both forearms, but no blisters or swelling. She was told by emergency room personnel that she may have been allergic to a preservative in the vaccine.
Allergy; rashes; feeling funny; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling funny), HYPERSENSITIVITY (Allergy) and RASH (rashes) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D20JL4U) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRBESARTAN for Blood pressure management.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (feeling funny). On 28-Feb-2021, the patient experienced HYPERSENSITIVITY (Allergy) and RASH (rashes). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Allergy, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling funny), HYPERSENSITIVITY (Allergy) and RASH (rashes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up information received included events outcome were updated to resolved.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 23-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I started getting symptoms of left shoulder pain and left knee pain which had swelling. It eventually moved to all joints with inflammation. I went to my doctor and got some anti-inflammatory medication. It was not working and went back and had a medication change. He was wanting to put me on HUMIRA which I did not want to take. The pain was progressing and months went by. I had to miss working for a few days and could not walk. It was very painful. When I would wake up, I could not move. I was worried that I could not work again and did have to miss work often. I could not move my left hand and had to do everything with my right arm. All of my joints including feet, wrist, neck, back, and hips were in pain. Now I am having to take HUMIRA injections every 2 weeks. I am walking better now but still pain in the joints. I did go to urgent care 4/17/2021 because I was feeling dizzy and had an EKG. Then I called my doctor and cardiologist. At the cardiologist I had a stress test which came back normal. I did have arthritis 15 years ago and it has been in remission with no major issues.
This is a literature case, initially received on 19-Feb-2018, concerning a 20-year-old, adult, female patient. This is a review of safety profile of aIIV3 vaccine by analysing the reports of aIIV3 submitted from 01-Jul-2016 through 30-Jun-2018 to the vaccine adverse event reporting system (VAERS).   On an unspecified date, the patient under 65 years was administered FLUAD (TIV) (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication (explicitly coded as inappropriate age at vaccine administration). On an unspecified date after vaccination, the patient developed fever chills and myalgia. At the time of the report, the outcome of the events was not reported. The reporter assessed the case as serious (medically significant).; Reporter's Comments: A 20-year-old, female patient developed fever, chills, and myalgia, on an unspecified day after administration of FLUAD (TIV) Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported events, vaccination details, concurrent medical conditions and investigations to provide alternate aetiologies, the causal role of the suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information. The event of inappropriate age at vaccine administration appears to be an informed medical decision making by the physician and/or accidental in nature and is not related to any property of the vaccine, per se.
PATIENT DEVELOPED CHILLS, GENERALIZED BODY ACHES "I HURT ALL OVER" . PT WAS IS TEARS FROM THE PAIN.
PER EMPLOYEE STATED FEELING HEADACHE AND DIZZINESS ABOUT 2HOURS AFTER RECEIVING VACCINE. SOME JOINT PAIN THROUGHOUT THE DAY.
Gave H1N1 vaccine in our office.  Later received a call from local clinic stating that they gave same vaccine earlier that day. Client guarding didn't declare that it had be given when asked.  It wasn't in the state vaccine system when I looked because the clinic hadn't entered it yet. The documentation the clinic had given her did not have this vaccine listed as given.
HCP believes that diluent for Proquad was used to reconstitute YF VAX. Is this okay? Is it the same diluent? with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered with yellow fever vaccine [YF-VAX] which was reconstituted with diluent for proquad with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect yellow fever vaccine (formulation, strength, dose, route, lot number not reported) for immunization  On an unknown date, the patient was administered with yellow fever vaccine [YF-VAX] which was reconstituted with diluent for proquad with no reported adverse event (product preparation error).  Action taken was unknown.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Left deltoid 8.5 cm long 5 cm wide redness, pm some swelling. Treatment: Tylenol, Benadryl.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 23-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 272 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
My heart beat fast before my shot because I was afraid. After my shot I felt weak, and sat in the chair about 10 minutes. I thought I was better and headed for my car. I got dizzy and leaned against the wall after about 30 steps. Several times I walked some steps to Starbucks, (way closer than my car) and leaned against the wall, in-between. I was starting to feel better and sat in Starbucks about 30 minutes. I felt better still after that and walked to my car.  I waited until 1:55 PM, when I felt completely back to normal and drove home. That night at work I felt dizzy for about 5 minutes and leaned against the wall. Then felt better. Probably completely coincidental, but never before or since are the following: A few funny heart beats the next day, and some bright light flashes in my eye a few days later. Tingly leg too. Well, better now, 100%. I am going to check life threatening only because, what if I had fallen? Next time I will sit down longer.
I originally experienced scratchy throat, chest tightening which a typical symptoms of my asthma acting up. However, I developed additional symptoms such as swollen gland, cough and  chest congestion. I contacted my providers office and was given prednisone and antibiotics. A chest x-ray was ordered but I was unable to comply as I was unsure if what I was experiencing was COVID and the providers office was not able to test me until  later in the week. I was able to recover even though I experienced a minor setback in symptoms once the prednisone was completed.
Fever onset (102 F) approximately 8 hours post injection. Treated with 400mg ibuprofen every 6 hours. Fever resolved approximately 40 hours after onset. Impacted ability to work.  Approximately 24 hours post injection experienced a mild orthostatic hypotensive episode. Persisted for approximately 90 minutes. Treated with fluids and episode resolved. Impacted ability to work.  Persistent fatigue. Has not resolved, yet does not impact my ability to work.
SLIGHT LIGHTHEADEDNESS ON 7/6/02 AND 7/7/02. EXTREME DIZZINESS, NAUSEA, FATIGUE ON 7/8/02, BEGINNING 5:30 AM. NAUSEA ABATED AROUND 9:00 AM 7/8/02, BUT FATIGUE CONTINUED THROUGH 7/11/02. DIZZINESS CONTINUES AS OF 7/13/02 PM AT A POINT WHERE I CAN FUNCTION CAREFULLY. NO TREATMENT WAS SOUGHT.
I had a vaccine site reaction, cellulitis, which resulted in an ER visit and a follow up PCP visit because meds provided by the ER did not work and the reaction got worse.