chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left ankle/foot is swollen; Left ankle/foot is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left ankle/foot is swollen) and JOINT SWELLING (Left ankle/foot is swollen) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced PERIPHERAL SWELLING (Left ankle/foot is swollen) and JOINT SWELLING (Left ankle/foot is swollen). At the time of the report, PERIPHERAL SWELLING (Left ankle/foot is swollen) and JOINT SWELLING (Left ankle/foot is swollen) outcome was unknown.            No concomitant products were reported.  No treatment information provided.
pt recv vax & hives worsened on 27NOV96;hives appear to worsen in the cold;pt will be seeing an allergist on 18DEC96;
patient received expired Flublok vaccine with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid  non-serious case received from a consumer or non-healthcare professional in the United States.  This case involves a 60 years old female patient who received expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 09-Mar-2021, the patient received a dose of suspect once 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (frequency: once, strength: standard, solution for injection, batch number: QFAA2017 and expiry date not reported) via an intramuscular route in the left deltoid.  No other vaccines.  It was reported ''There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients.''  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Developed erythema, warmth and tenderness around vaccine site 2 days later that progressively increased in size over the next 24 hours. Causes some mild limping. No fevers at this time (did have temp to 102 the day after the vaccine).
13-year-old patient received Moderna booster (0.25mL), administered in error. Patient's father notified March 4, 2022. Denied adverse reactions. Stated patient does not have any injury at this time. Patient offered counseling by medical director. Advised to contact pediatrician.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Paralysis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Unknown. On an unknown date, the patient experienced PARALYSIS (Paralysis). At the time of the report, PARALYSIS (Paralysis) 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 and treatment information not reported.  Company Comment: Based on the current case data, this case has been classified as invalid.; Sender's Comments: Based on the current case data, this case has been classified as invalid.
developed an infection in his gums; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dental issue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GINGIVITIS (non-serious) with onset 2021, outcome "unknown", described as "developed an infection in his gums". Therapeutic measures were taken as a result of gingivitis.  Clinical Course: The patient was dealing with dental issues since before the vaccine. He developed an infection in his gums and was prescribed amoxicillin (took 2 pills of amoxicillin). He is due for his second Pfizer dose on 10Apr2021 and she wants to know if it is safe for him to get the vaccine while on this antibiotic. He needs a root canal and wondering if her husband can take the second dose tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT FELT DIZZY AND FAINTED IN THE WAITING AREA WITHIN MINUTES OF RECEIVING THE VACCINE. SHE FELL ON THE FLOOR AND NO ONE WITNESSED IT. PHARMACIST WHO ADMINISTERED THE VACCINE RUSHED TO THE SPOT AFTER HEARING A LOUD THUD.  PHARMACY STAFF CALLED 911 AND WITH IN 5 MINUTES PT WAS OK BUT SHE WAS STILL DIZZY.  911 PERSONNEL CHECKED FOR VITALS AND OTHER ROUTINE CHECKS.
leg rash; fever; fatigue; no appetite; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2020) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th May 2019, 3 days after receiving Shingrix, the patient experienced fever, fatigue and appetite absent. On 11th May 2019, the patient experienced rash. On an unknown date, the outcome of the fever, fatigue, appetite absent and rash were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue, appetite absent and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix in left arm. Five days after the vaccination, the patient developed a rash on her leg. The patient was unsure that how long these symptoms lasted, but that they were all resolved at the time of reporting. The reporter consented to follow up.  In the source document, the outcome of events was reported as recovered/resolved with sequel, while it was reported as recovered/resolved.
Rheumatoid arthritis flare up; Bilateral tendon; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program, facilitated collect. The reporter is the patient. Other Case identifier(s): 21K-163-4170024-00.  A 49 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single, and intramuscular, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single; for covid-19 immunisation; and adalimumab (HUMIRA, (reported as citrate free)), subcutaneous (Batch/Lot number: unknown) for moderate to severe rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Rheumatoid arthritis flare up"; and TENDON DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Bilateral tendon". The action taken for adalimumab was unknown. Clinical course: Solicited report from the USA by a consumer of an adult female with events of non-serious BILATERAL TENDON and RHEUMATOID ARTHRITIS FLARE UP with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced BILATERAL TENDON and RHEUMATOID ARTHRITIS FLARE UP. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 09Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.  Causality as per reporter of Humira for events tendon disorder and rheumatoid arthritis flare up was not reported. Causality as per reporter of Humira PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN)(TOZINAMERAN) for events tendon disorder and rheumatoid arthritis flare up was possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.  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.
Sore arm; Nose Bleed; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), EPISTAXIS (Nose Bleed) and PRURITUS (Itching) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Historical condition not provided.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), EPISTAXIS (Nose Bleed) and PRURITUS (Itching). At the time of the report, PAIN IN EXTREMITY (Sore arm), EPISTAXIS (Nose Bleed) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The day of the vaccine I was feeling normal until later on in the afternoon  when I started  woozy and a bit weak. The next day Saturday I started feeling  a bit weak and not  sick but also as if something was wrong. I also had some throat discomfort.  Sunday was similar but some lingering headaches began. I also felt weaker and some slight muscle aches. Sunday night I slept 10 hours (I had had seen friends on Saturday  evening for a birthday so  i didn?t  get much sleep). Monday came around and the throat discomfort persisted along with the lingering headaches and slight weakness.  By then my blood sugar levels were getting higher and I would not be able to lower them  with the number of units of insulin I normally take like I used to prior to vaccine injection (this happens when my body is sick or reacting to something)   Monday night I fell asleep and woke up at 3 am with a piercing headache ( the most painful headache I?ve ever felt) along with radiating pain to my neck and drenched in sweat. It felt like I had just gotten out of a shower but wet with sweat. My body and bed were soaked. I barely stumbled to my counter to take an Advil and Xanax ( prescribed) to ease the pain of the headache luckily after an hour I fell asleep.  When I woke up on Tuesday I still experienced weakness and a woozy feeling like I?m sick but really wasn?t.  I was getting some chills and hot flashes but did not develop a fever.  Tuesday evening I took an Advil before bed to try to avoid the painful headache. I again woke up at 3 am with no headache, but once again drenched and soaked in sweat. I had to sleep on the other side of my bed. I drank water and took an Advil and Xanax and managed to fall asleep. From then on, on Wednesday and forward I was waking up with sweats but they were getting better.  I did notice extreme levels of dehydration during the day and night (I never had them before) a heart rate which was at 100bpm resting and blood sugar that not decrease  even when I injected 3x my normal insulin amount.  Again, this has happened a couple of times in the past only when I?ve been sick or my body has been reacting to something. It was very alarming. Nothing that I took lowered my heart rate nor did 3-4x the amount of insulin lower my blood sugar. I had the lingering headaches still and just felt very worn out and achey.   It?s not Wednesday 3/10 and thankfully my heart rate and blood sugar stabilized over the last 2/3 days and I am not waking up drenched in sweat. At all as of last night.  These affects were very concerning and alarming. I got anxiety and a lot of tension which I?m sure did not help.  This all lasted 8-9 days from the time of injection.  Lastly the injection site on my arm does not look normal. It looks like there are some bruise spots and it seems like it may be swollen (looks bigger than before)
Expired dose administered. expiration date 9/21/2021 given on 9/24/2021
Patient is a 13 y.o. 10 m.o. male with no significant previous medical history. He presented to the ED due to chest pain. He received the second dose of COVID vaccine on Friday 6/11/2021. The next day he had chest pain in the anterior left upper area throughout the day. The chest pain got worse when laying completely flat or if standing up. He also had fever up to 100.4 and shortness of breath. The symptoms persisted on day of admission and he was brought to an Urgent care where ECG showed diffuse ST elevation. He was transferred to our emergency department for further evaluation.    In the emergency department he had intermittent tachypnea and complained of chest pain. ECG confirmed diffuse ST elevation concerning for myopericarditis. Troponin was also elevated with elevated inflammatory markers. Echocardiogram with mildly decreased LV systolic function.
fever; body pain; severe headache; Sneezing; arm pain; congestion; right ear pain; A spontaneous report was received from a nurse concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain, severe headache, body pain, right ear pain, congestion, fever, sneezing.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) arm pain. On 11 Feb 2021, the patient experienced the event(s) severe headache, body pain, right ear pain, congestion. On 17 Feb 2021, the patient experienced the event(s) fever, sneezing.  Treatment details included 2 Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm pain, severe headache, body pain, right ear pain, congestion, fever, sneezing was unknown.
Soldier received vaccinations in November of 03 and reported onset of rash starting at neck in late December of 04. Rash continued to worsen over the following 16 months with the rash presenting at it's worse in Dec. 04 according to the patient. Non-pruritic and non painful. Rash is located over the entire torso accept for the palms and soles. Very minimal rash occurance to the face, with facial involvement not occuring until December of 2004. White pigmentation is present over a large majority of the skin possibly suggesting permanent scarring. Rash is raised with crusty appearance noted on some of the lesions. No other health issues have been noted by the patient. Patient reports that lesions have opened on occasion but were non draining. Was treated with topicals periodically and completed a course of Prednisone in early March 2005 with no effect noted. Has been seen by numerous specialists with no definitive diagnoses being made.
Client received second dose of pre-exposure Rabies vaccine on 2/3/2009, and telephoned health department on 2/10/2009 with concerns over vaccine.  Stated approximately 8:00 PM the prior evening (2/9/2009)he noted a rash on the palm of his hands and his hands felt like "needle pricks".  Client denied any other symptoms; nor did he have exposure to any new foods, clothes, soap, or medication.  States he was fine after receiving first injection one week prior (January 27, 2009). He stated the top layer of skin on his hands "feels as though they are burned and it hurts" with sweating or stretching his hands.  Encouraged client to follow up with PMD and to call back with physicians findings.  On February 11, 2009, client called stating he had seen his physician the previous day.  Client had no fever, peeling skin, or carpal tunnel symptoms, and rash was somewhat better.  Physician was unsure of cause, but suggested watching progression. Client returned to health department on February 17, 2009 for third, and final, dose of Rabies vaccine.  At that time, the rash had resolved and he had no furhter compaints.
Pt received his vaccine and was being monitored.  He mentioned he was feeling short of breath.  He had an altered level of consciousness but did not pass out, but ammonia salts were used.  He had his BP taken which was normal, Blood glucose was 70, pulse ox was 97% on room air.  He appeared to have a seizure x 15 seconds. He has no hx of seizure activity.  An onsite physician examined him and was supported by a PharmD and RN.
Received vaccination on Friday, by Saturday evening developed rash at site of injection. Two days later reaction (rash, swelling) was appro 2" x 2". At day four rash disappeared. On day 11 another rash at the site of the injection developed. Upon awakening on day 13, the rash had spread to be approx 4" x4" and red "dots" had appeared on entire body. At this point uncertain to outcome of reaction!
7/27 - Patient called to complain of arm soreness and concerns regarding pharmacist that gave injection. 7/28 - Patient was seen in acute care because her arm was getting worse. It was red, warm, and tende to palpitation. Patient was diagnosised with cellulitis and given an antibiotic.
Patient noticed symptoms of nausea and pain in legs about 24 hours after receiving the J&J COVID-19 vaccination. On Friday, April 9th, a pounding headache developed and is still currently ongoing.  Patient visited their doctor soon after symptoms began to check if there were underlying conditions requiring medical attention. Doctor did not find any issues. Patient has been taking ibuprofen 800mg every 4 hours as needed but without relief for the headaches. Headaches still persist even now.
Patient returned to clinic with mother.  Right leg swelling to upper thigh and red.  Slightly cool to touch.
Patient was inadvertently administered the Fluzone High-Dose Quadrivalent vaccine, rather than the Fluzone Quadrivalent vaccine, with no reported adverse event; FLUZONE HIGH DOSE QUADRIVALENT was given to a consumer under 65 with no adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist and consumer/ non healthcare professional via Media Information (under reference 00791217).  This case is linked to case 2021SA326021 (CLUSTER).  This case involves a 63 years old female patient who was inadvertently administered the QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), rather than the QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) [wrong product administered and product administered to patient of inappropriate age].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a 0.7 mL dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (Total, lot UJ733AA and expiration date: 30-Jun-2022) via intramuscular route to the left deltoid for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (same day latency).  It was reported "HCP (Healthcare Professional) stated FLUZONE HIGH DOSE QUADRIVALENT was given to a consumer under 65 and wanted to know if there was any data? pharmacist stated that two patients under age 65 had inadvertently been administered the Fluzone High-Dose Quadrivalent vaccine. Pharmacist reported that the patient is not experiencing any adverse effects so far."  At time of reporting, no adverse event reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
COVID-19 breakthrough. I had a scratchy throat two days ago then Thursday evening I was feeling congested. The next day I had sinus drainage, which comes with periodic cough.
itchy sites on my back and thighs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy sites on my back and thighs) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy sites on my back and thighs). At the time of the report, PRURITUS (itchy sites on my back and thighs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Concomitant medication was not provided.  Patient stated that he had two shots and started with itchy sites on back and thighs.