chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a rash on my left back side about 6 inches from the vaccine shot location; This spontaneous case was reported by a consumer and describes the occurrence of RASH (I have a rash on my left back side about 6 inches from the vaccine shot location) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (I have a rash on my left back side about 6 inches from the vaccine shot location). At the time of the report, RASH (I have a rash on my left back side about 6 inches from the vaccine shot location) outcome was unknown.            No relevant concomitant medications were reported. No treatment medications provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FE8839) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "myotonic muscular dystrophy" (unspecified if ongoing), notes: other medical history: myotonic muscular dystrophy; "myotonic muscular dystrophy" (unspecified if ongoing), notes: other medical history: myotonic muscular dystrophy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Antiviral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 18May2022 and stop date: 23May2022, indication is used for treatment of COVID-19, Administrator route: Oral. The patient did not receive other medication in 2 weeks. The patient had Known allergies to NKDA. Adverse event experienced on 24May2022 and stop date on 27May2022. Rebound positive age test after testing negative after she took the course of Paxlovid. Mild s/s mainly a "raspy" voice. The patient did not receive treatment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.
diarrhoea; 9 years patient received FLUZONE HIGH-DOSE QUADRIVALENT; 9 years patient received FLUZONE HIGH-DOSE QUADRIVALENT; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from nurse and consumer/non-healthcare professional via call center via Regulatory authority (Reference number- 00793047).  This case is linked to case 2021SA328686 (CLUSTER).  This case involves a 9-year-old patient (unknown gender) who experienced diarrhoea, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age, overdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  On 25-Sep-2021, the patient received a 0.7mL {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (solution for injection, lot number: UJ747AA and expiry date not reported) via an intramuscular route at a the left thigh for prophylactic vaccination.  On an unknown date, the patient developed a non-serious diarrhoea (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was also a case of actual medication error due to Inappropriate age at vaccine administration and overdose. (latency was on same day).  It was reported "Nurse manager reports that two of their patients; a 9 year-old child and a 7 year-old child, received a FLUZONE HIGH-DOSE QUADRIVALENT. She is seeking information to provide to the children's mother."  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the event (diarrhoea).  At time of reporting, outcome of the events was 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 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.
A female reported that she received an injection of tetanus toxoid adsorbed, purogenated and subsequently developed an 8 inch by 6 inch oval shaped area of redness at the injection site. She was seen by a physician who told her she had an allergic reaction. No further information was available at the date of this report.
Starting a little over an hour after the vaccination, I experienced the kind of dizziness I get when I have a flare-up of lupus, followed by inflammation of the joints in my hands, elbows, and feet: all very similar to symptoms of a lupus flare (I have lupus).
itching on her body; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021. The most recent information was received on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on her body) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (itching on her body). At the time of the report, PRURITUS (itching on her body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.  Per report, the itching lasted for about three and a half weeks before resolution. The patient reported experiencing no adverse events after receiving her second dose of  the Moderna COVID-19 vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received and event outcome was updated from unknown to recovered/resolved
Initial Onset: itchy, red at injection site on 09/12/2013; followed by circular dark red/purple color & swelling - approx. half dollar size at injection site, right upper arm (09/13/2013). Followed by dark red spots on chest (09/14/2013). Followed by breakout of dark red spots on face, ears, then forearms, upper arms, and thighs within a 2 day period (09/15/2013).  As of this date 10/26/2013 dark red spots continue to cover the entire body other than the abdomen and below knees. Patient seen at primary physician office by NP on 10/07/2013, noon. Given cephalaxin antibiotic and steroid cream for injection site only. Seen by dermatologist for the spots (triacinolone acetonide).
Vesicular rash on (R) palm, wrist, middle finger/painful. Dx: ? shingles - Dx 12/9. Recheck on 12/12 - pain & slight worsening - tx with NEURONTIN & doxycycline. Rash not yet resolved but not worsening.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Allergy", notes: Known allergies: Bactrim. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) Negative, notes: Antigen test on 03Aug2022 was negative; (06Aug2022) Positive, notes: Antigen test on 06Aug2022 and it was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received COVID 19 Treatment, Paxlovid, Treatment start date= 27Jul2022,  Treatment stop date= 01Aug2022,Indication=Treatment of COVID-19. Antigen test on 03Aug2022 was negative. Cough persisted. Achiness and headache started on 06Aug2022 so took antigen test on 06Aug2022 and it was positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
One hour after receiving 1st pfizer dose patient started to experience trouble swallowing. Headache then body aches followed shortly after. For about 4 hours client experienced increased breathing then went to bed. Duration of 48 hours for difficulty swallowing, headache, and body aches and they all self resolved (no medications taken). Client did not follow up with primary care physician. Client then experienced throat symptoms of difficulty swallowing after having 1 beer at family party 4 days after pfizer 1st dose vaccination date. Symptoms lasted for about 3 hours and then the client went to bed. The next morning symptoms self resolved. Medical consult was elevated through health care coordinators. Janssen as second dose was recommended by MD.
on Wed 1/6/21 I had an allergic reaction and am unsure what set it off.  My eyes became itchy, watery and my corneas swelled.  I was sneezing and coughing.  I had a runny nose. on Sun 1/10/21 I had an allergic reaction; I think it was set off by a type of sunblock I've never used before.  But I've never had a reaction to any type of sunblock before. I went into anaphylactic shock: eyes swollen shut, flushed face, tight throat, rapid heart beat, shortness of breath, severe abdominal cramping.  I had to go to the ER.
Approximately 3 months after my booster I contracted COVID and had the following symptoms: sore throat, congestion, fatigue, cough (lasted about a month, intense back pain, vomiting. I called my doctor and was advised to go to the emergency room.
Hard knot at vaccine site for 8 days with stiffness in shoulder, elbow and wrist persisting. Physician dx pt with tendonitis. He received two cortisone shots at the elbow and shoulder and placed on 10 days of light duty. Pt did not know if the Anthrax vaccine caused the joint pain or not. The onset of pain did run concurrent with his third dose of Anthrax.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX. concomitant products included atenolol, BUMEX, JANUVIA, KLONOPIN, lisinopril and SINEQUAN. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and less than a day after vaccination, the patient experienced fatigue, muscle pain and headache. The patient was treated with TYLENOL and (NOS) BENADRYL. SHINGRIX was discontinued. In May 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the fatigue, muscle pain and headache were not recovered/not resolved. The reporter considered the injection site pain, fatigue, muscle pain and headache to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient received SHINGRIX on the left arm. Immediately after receiving SHINGRIX, the patient experienced injection site pain which lasted 2 to 3 days and then it diminished. The patient went back in to the pharmacy where he received the vaccine and the pharmacists recommended him to take TYLENOL and BENADRYL to help with the symptoms. The patient stated that, he does not think he would be getting the 2nd dose of the vaccine. The patient denied permission to contact his physician.
Case number PHEH2012US018712, is an initial spontaneous report received from a physician on 05 Sep 2012. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: unknown) on unspecified date. The patient was vaccinated with only CYW-135 liquid conjugate, lyophilized A powder component was not received. No adverse event was reported.
10 1/2 hr p/vax pt had temp of 103, APAP was given w/no change; several hr later pt was lethargic, had vomiting & diarrhea; temp remained 103, did not want to be touched; mom called MD 7AM took to ER sx diminished by mid morning;
Jan. 16 10pm: achey neck, limbs,head ache,,  Jan 17, 9am.. -19th. Pain became extremely achy in entire body, stomach, ribcage, arms, thighs , and neck.Weakness in stamina. Freezing unmanageable chills,itchy watery eyes, extreme  arm pain. Severe lethargy, sleepiness.Unable to walk out of the house for 3  days.These symptoms be came less intense beginning Jan. 19 about 12PM. I am still incredibly tired and now my ulcerative colitis has flared up and I'm losing blood through stool.
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPOXIA
February 13: Fever of 100.0, delirium (probably also associated with PTSD), aches and pains, fatigue, dizziness, arm and shoulder pain February 14: Fatigue, dizziness, shoulder pain, irregular heartbeat February 15; Fatigue, dizziness, shoulder pain Fatigue and dizziness have reocurred at some points.
w/in 608hr p/vax pt devel an inj site rxn w/redness, swelling, warmth & pain;pt was seen by MD 1 day post vax;pt seen by MD 1 day post vax;MD dx cellulitis & tx w/DPH &  ice;
Joint swelling and joint pains in the hips and both knees. A swollen posarisi plaque at the injection site about 6inX6in. It was diagnosis as Psoriatic Arthritis which lasted about 4 months. Tremor in right hand and brain fog. About 3wks after the vaccine he had some gastrointestinal issues. He had a feeling of fullness and lost some lbs. He has significant Psoriasis flare that covered his legs, truck, arms, chest, butt and scalp. He also had some blood in stool between 2 to 5wks after vaccine. He had severe muscle weakness that got better.
Dizziness and weakness - lasting approximately 45 minutes. Slight dizziness continues now (approx 11am) but is subsiding, but continues. Pfizer's information sheet said this may be a sign of an allergic reaction.  No medical follow up seems necessary right now, but important to report.
Patient reports a very red rash about 2.5 inches long by 1 inch wide at the injection site.  Her doctor prescribed desoximetasone cream on 2/17/10. Her symptoms are improving today 2/20/08.  She reports that arm is faint red and tender to touch from shoulder to elbow.
Acute Hypertension started on 11/14/09.  I went to the ER on 11/15/09 with BP 174/117, severe headache, decreased ability to concentrate on tasks at hand.  No previous history of HTN.  Very health lifestyle.  I am submitting this because I think it is a strange coincidence that both myself and another nurse that I work with both had unexplained episodes of acute HTN requiring Urgent Care/ER visits approx. 2 weeks after the H1N1 vaccine was given to us at work.
Leg pain for 3-4 hours; Itchiness at the injection site; Pain at injection site; Redness at injection site; Swelling at the injection site; Bloating; Flatulance; Neck pain; Back pain; Shoulder pain; Diarrhea; This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (Neck pain), BACK PAIN (Back pain), DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Bloating) and FLATULENCE (Flatulance) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2020, the patient experienced DIARRHOEA (Diarrhea). On 27-Dec-2020, the patient experienced NECK PAIN (Neck pain), BACK PAIN (Back pain) and ARTHRALGIA (Shoulder pain). On 03-Jan-2021, the patient experienced ABDOMINAL DISTENSION (Bloating) and FLATULENCE (Flatulance). On 04-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain for 3-4 hours). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Jan-2021, PAIN IN EXTREMITY (Leg pain for 3-4 hours), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, NECK PAIN (Neck pain), BACK PAIN (Back pain), DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Flatulance) and ARTHRALGIA (Shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Polymerase chain reaction: unknown PCR test for covid-19. On an unknown date, Blood test: unknown bloodwork. On an unknown date, Viral test: unknown stool sample.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
12/17 vaccination 12/20  Wen to use restroom. Reddish hue in urine. Went to urgent care. UTI was negative. Positive for blood in urine.  Next day, urine back to normal.  Arm soreness
Lip swollen; I was experiencing high temperature/always there like 100.5 and 100 something/fever; I am lying down always on bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101638041 (Pfizer).  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Migraine" (unspecified if ongoing), notes: Verbatim: Migraine; "COVID-19", start date: Mar2020 (unspecified if ongoing), notes: I got Covid back in March 2020. Concomitant medication(s) included: AIMOVIG taken for migraine. The following information was reported: LIP SWELLING (medically significant) with onset 19Nov2021, outcome "unknown", described as "Lip swollen"; PYREXIA (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was experiencing high temperature/always there like 100.5 and 100 something/fever"; BEDRIDDEN (non-serious) with onset Nov2021, outcome "unknown", described as "I am lying down always on bed". The event "lip swollen" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (19Nov2021) 100.5, notes: 100.5 and 100 something; (19Nov2021) 100, notes: 100.5 and 100 something. Therapeutic measures were taken as a result of lip swelling. The patient's lips swollen. So, patient read all side effects and went to the hospital and they treat with some steroid and they told that had to report this as it was probably side effects from the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
3RD DOSE PFIZER COVID VACCINE GIVEN 9/16/21, LOT #30145BA;  7/18/22 pt had a positive COVID test; tested positive on 8/1/22 also and was given Lagrerio; 8/8/22 had worsening fatigue and chest congestion; was seen at The local Clinic where she again tested positive for COVID; was given Doxycycline; 8/12/22 pt to ED (name of hospital not in medical record) 12:12 with generalized weakness and diarrhea; admitted with UTI and pneumonia; given Rocephin and Azithromycin; developed hypoxia and placed on BiPAP; eventually on high flow O2 via NC; given Decadron; bronchoscopy done, negative; pt's condition worsened; family transitioned pt to comfort care and pt was dc'd to home with hospice; PCP: Private, pt passed away at home
Both eyelids drooped down 1 hour after shot. The right was more swollen than the left.  This lasted 24 hours. Then for 9 days she felt listless. She is just reporting this today.