chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 diagnosis; myalgias; arthralgias; headaches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19 diagnosis), MYALGIA (myalgias), ARTHRALGIA (arthralgias) and HEADACHE (headaches) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 diagnosis), MYALGIA (myalgias), ARTHRALGIA (arthralgias) and HEADACHE (headaches). At the time of the report, COVID-19 (COVID-19 diagnosis), MYALGIA (myalgias), ARTHRALGIA (arthralgias) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   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. COVID-19 infection was likely started before vaccination as the patient had an exposure three days earlier.   Reporter did not allow further contact; 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. COVID-19 infection was likely started before vaccination as the patient had an exposure three days earlier.
Patient experience extreme fatigue, arthralgias and a welt at the injection site.  Treated with Tylenol and antihistamines with resolution.
Patient seen in office - pain, redness, lump, mottling of left breast breast.  Fever.
Myalgia, Fever, Erythema Multiform, LA streaking from site of injection down arm - resolved  Narrative: Symptoms resolved. Advised to seek medical attention with worsening and additional severe symptoms
pt recvd vax & exp severe gastorintestinal sx; @ the time of report pt had not received 3rd vax & gallbladder surgery is impending; No further details are provided
Client received the 1st dose Sinovac vaccine on 07/30/2021 and 2nd dose Sinovac vaccine on 08/25/2021. Client reported to Lead RN that he would like to receive the Janssen Booster. Client reported no adverse reaction to the Sinovac vaccine series. Lead RN provided medical consult to RN Supervisor.  RN Supervisor received approval for the Janssen vaccine booster dose from County MD. Client received the Janssen Booster  (lot#1855194) at 1020 in the L deltoid. No adverse reaction was observed during clients observation period of 15 minutes.
Patient received first booster dose of Moderna COVID-19 vaccine on 6/28/22 following previous primary dose series with Pfizer COVID-19 vaccine. During 15-minute observation period, patient exhibited no adverse effects. Patient presented the next day reporting inability to move right arm from above the elbow and reports shooting pain when attempting to move ever since approximately 15-30 min post vaccination (on the ride home). He is able to shrug shoulders but cannot lift arm more than slightly from the position of arm at his side. The pain impacted his sleep and ability to get dressed himself. Upon examination on 6/29/22, the arm has no sign of inflammation or irritation (no redness, swelling, or bumps).   Patient was advised to continue to monitor arm mobility and pain and to get it examined by a doctor if this persists after 48 hours since vaccination (6/30/22 noon). Patient will be contacted by pharmacy tomorrow (6/30/22) to follow up with patient and patient has been scheduled for primary care assessment on 7/1/22 in case the issues persists. Patient's regular primary care physician is notified of incident.
1st dose administered to patient from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Updated patient ethnicity, route of administration and anatomical location.
Pt came to the ED with dizziness and a fall.  He had 5 stents placed one week prior.  He had a COVID test done on 1/24 prior to colonoscopy that was positive.
feeling dizzy/dizziness; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at 09:45 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. This evening or later this afternoon of 21Jan2021, the patient started feeling dizzy. She took something for the dizziness and then went to sleep. The reporter wanted to ask if that be something they need to worry about. They were wondering if this could come from the shot since it came on later. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
SHORTLY AFTER RECEIVING JANSSEN VACCINE, PATIENT LEANED BACK IN SEAT IN PARKED VEHICLE AND LOST CONSCIOUSNESS FOR APPROXIMATELY 15 SECONDS. MEDIC APPROACHED PATIENT JUST AS HE WAS GAINING UNCONSCIOUSNESS.  AFTER CONDUCTING A FULL COGNITIVE ASSESSMENT THE PT RESPONDED WITH FULL CLARITY. PT WAS PROVIDED WATER AND SNACKS AS WELL A FULL SET OF VITALS IN ADDITION TO AN EXTENDED OBSERVATION PERIOD. PT WAS RECOMMENDED TO CONSULT A HIGHER LEVEL OF CARE(PCP). RR 18 BP 124/78 PR 91 SPO2 97 SKIN: WARM GCS: 15
Had the shingles shot and he now has the shingles/Suspected vaccination failure; Had the shingles shot and he now has the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.  It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient received shingles vaccine and he now had shingles bad case at that. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
day 7 after vaccine (1/5/20), about 6p in the evening, site of injection became sore again. mild redness and hard, kind of indurated (2x2 inches in area). little bit swollen, raised. no systemic issues, all localized to site. i applied heat and took zyrtec -- mostly resolved the next morning. totally resolved 2 days later.
Booster; got a PE; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 71 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "got a PE". Clinical course: the patient got a pulmonary embolism (PE) after receiving his third Pfizer vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Limited information precludes a comprehensive causality assessment of events with BNT162B2 Vaccine ,however causal role cannot be excluded due to possible temporal association..Case will be reviewed further on receipt of FU information  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
Advised to take Ibuprofen by nurse that gave injection, took 2 ADVIL about 2 pm. Starting at 7 pm: feverish, achiness all over, right deltoid began to swell/get red/be tender. By 9 pm nausea began and the swelling to the right deltoid was approximately 4 inches in diameter from injection site. By the next morning, temperature was between 102 to 103 degrees Fahrenheit, called the Nurse Hotline and was advised to take TYLENOL. Began TYLENOL every 6 hours with Ibuprofen in the middle. Symptoms lasted for about 3 days. Today, October 30, 2017, the right deltoid is still swollen about 6 inches around the injection site with mild bruising and redness, tenderness. No streaking noted. Warmth noted in a 2 inch diameter around injection site.
On 3/30/2021 at about 10:30PM, I thought the left of my mouth was having an allergic reaction, because I felt a swelling and pulling sensation there. I looked in the mirror, and the right side of my face was drooped. I had had a stroke previously, so I knew I wasn't having a stroke this time. I then went to bed. On the morning of 3/31/2021, I went to the ER . They treated me as a stroke patient and did an assessment and an MRI. They determined then that I had Bell's palsy. They prescribed 3 medications. I don't remember the names, but one was an antiviral, one was an antibiotic, and one was an anti-inflammatory. They advised me to see my PCP. I saw Dr. that afternoon, and he reaffirmed I had Bell's palsy. We discussed the antiviral, and he said, "This could be related to your COVID vaccine, but we will probably never know."  He mentioned that Bell's palsy  was a known side effect of the vaccine. He said that the symptoms would gradually disappear and advised me to make the best of it in the meantime. As of now, most of the symptoms have diminished, though I still feel it on my upper right eyelid, the right side of my nose, and the right side of my mouth. If I move the muscles in them, they freeze until I use my finger to pry them back into place.
Entire left arm and armpit painful and warm to touch.  Tightness in chest and trouble taking deep breath.  Took 2 doses of Benadryl 4 hours apart.  Trouble sleeping.
Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GS3227) at the age of 42 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FH8018), in left arm 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: "Non alcoholic fatty liver disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin"; Sulfa, reaction(s): "known allergies: sulfa". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received no other medication in 2 weeks. The patient received anti-viral treatment with Paxlovid from 23Feb2023 to 27Feb2023. The patient experienced adverse event of mild symptoms (congestion) and just tested positive on antigen 7 days after end of Paxlovid treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300096893 same reporter/patient, different product/AE;
Tachycardia higher than normal; Some Tiredness; A spontaneous report was received from a health care facility staff member concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced feeling tachycardia higher than normal and having some tiredness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received her first of two planned doses of mRNA-1273 on 30-Dec-2020  intramuscularly for prophylaxis of COVID-19 infection.   After receiving the Moderna vaccine on 30-Dec-2020, the patient began to experience tachycardia as well as some tiredness (Fatigue).  She stated that she was unsure if she was having a reaction.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/not reported.  There was no causality assessment provided by the reporter for the events, feeling tachycardia higher than normal and having some tiredness (Fatigue).; Reporter'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.
Severe pain in my shoulders, arms and weakness in my legs, had difficulty walking - red swollen eyes, visual disturbance and headache. (I will not get another flu vaccine again!)
Received my second vaccine on 1/13/21 at 10:10am. I felt perfectly fine initially, no soreness in my arm. By 7 pm my left arm felt sore. By 8 pm I began to have chills, my temp was 98.1 and I had muscle aches. By 10 pm I had a fever of 101.5, chills, muscle weakness, aches, and a headache.
Post vaccine redness, swelling at injection site. Required topical antibiotic oint and KEFLEX 4 x daily for 10 days vaccine administered 11/17/10.
Information has been received from a nurse concerning a 14 year old female patient who was vaccinated with the entire series of GARDASIL vaccine (yeast). The nurse reported that the patient experienced muscle spasms after each of her HPV vaccine doses. It is not known when the spasms began or how long they lasted. At the time of the report the patient had recovered. The patient sought medical attention by phone. Additional information has been requested.
weakness, low BP 92/43, low HR 36, less responsive, shallow breathing - chest compressions - Vitals improved
Patient stated she developed a itchy rash on top of the head, chest, and back of the neckline on Sunday 5/9/2021 after receiving her vaccine on Tuesday 5/4/2021.  Patient reported the face rash developed 5/12/2021.  She denies any trouble breathing or swelling of the throat.
Some side effects; This spontaneous case was reported by another health care professional and describes the occurrence of VACCINATION COMPLICATION (Some side effects) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some side effects). At the time of the report, VACCINATION COMPLICATION (Some side effects) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
dizziness, dizziness lasted for 3 weeks, dizziness subsided; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness, dizziness lasted for 3 weeks, dizziness subsided) 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 DIZZINESS (dizziness, dizziness lasted for 3 weeks, dizziness subsided). At the time of the report, DIZZINESS (dizziness, dizziness lasted for 3 weeks, dizziness subsided) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Huge bruise about 4 inches, red hot skin from shoulder to elbow, sore shoulder blade, sore arm
5 hrs p/DTP pt had sharp cry, threw arms out & apnea (but was not resuscitated) until several min later; remained cyanotic & 02 desaturated 77% for an hour or so;
The patient received vaccine. The patient was browsing a few minutes later. Per customer witness, patient steadied herself on counter, then collapsed. Per customer witness, patient quickly regained consciousness. She was confused at first but that quickly went away. Customer got pharmacist, pharmacist assessed patient who seemed coherent and normal. 911 activated. EMS arrived at scene and assessed patient and took statement from customer. EMS said patient's assessment and vitals were fine. Patient refused transport to a medical facility. Patient then relocated to pharmacy waiting area to continue to rest   Patient said they did not have anyone to call for ride
Prior to receiving vaccine patient was normal healthy 24 year-old male, with no underlying health conditions. Pain and Swelling in Groin area/Testicular Pain (on 4/12/2021). Started as discomfort at 9:00 a.m. and gradually worsened during the day. By midnight pain was sever, no position would give relief. Pain intensified to causing loud painful screams. Took 600 mg of Ibuprofen waited 20 minutes with no relief. Taken to local hospital ER, Emergency Department,   Upon release from ER- recommended to see Urology Specialist. As of 4/14/2021 patient is still taking Ibuprofen for discomfort. Pain has lessened and is not as intense but is still present.
On 2/1/2021, the patients daughter, who claims is a nurse, reported this incident to me.  She stated that the evening after the patient received the vaccine, she felt some mild injection site pain.  The morning after, the patient reported severe abdominal pain, diarrhea and vomiting.  The patients daughter then called her physician to report these symptoms and attributed them as an adverse reaction to the vaccine at that time.  These symptoms were intermittent for one week and no other adverse reactions were noted.  In the early morning hours of 1/27/2021, the patient was toileting and had expired while doing so.  An ambulance was called and cause of death was not found. An autopsy was not performed.
pt recv vax; rash started on lt arm day p/ vax; progressed on both arms p/ 3rd day; raised, itchy; pt c/o burning; dx as dermatitis by dermatologist;
Full body rash covering 95% of my body.; 3 valve heart regurgitation.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "HTN" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ambien, reaction(s): "Known allergies: Ambien", notes: Known allergies: Ambien. Vaccination history included: BNT162b2 (Prev dose lot Number: LL8982, Prev dose administration date: 28Jan2021, Prev dose dose number: 2), administration date: 28Jan2021, when the patient was 36-year-old, for COVID-19 immunization; BNT162b2 (Prev dose lot Number: EJ1685, Prev dose administration date: 07Jan2021, Prev dose dose number:1), administration date: 07Jan2021, when the patient was 36-year-old, for COVID-19 immunization. The following information was reported: HEART VALVE INCOMPETENCE (disability) with onset 10Feb2022, outcome "recovered with sequelae" (2022), described as "3 valve heart regurgitation."; RASH (disability) with onset 10Feb2022, outcome "recovered with sequelae" (2022), described as "Full body rash covering 95% of my body.". The event "full body rash covering 95% of my body." required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy skin: Unknown results, notes: Multiple skin biopsies; Echocardiogram: Unknown results. Therapeutic measures were taken as a result of rash, heart valve incompetence.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received from a licensed practitioner nurse which reported that on 13-JAN-2015, dose of packed PROQUAD (Merck) was inadvertently placed into refrigerator rather than the freezer (dose, frequency, and lot number were not reported), the was due to the similarity in packaging of the M-M-R II (dose, frequency and lot number were not reported). No adverse effects noted and no product quality complaint was involved. This case must be VOID because it was not mentioned a patient was vaccinated. Additional information has been requested.