chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got positive result; I got positive result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 17Oct2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I got positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2022) Positive, notes: BinaxNOW Covid-19 Antigen Self Test kit to test myself. I got positive result. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
A lot of weakness; Menstrual cycle cramping; Discomfort; Back ache; Two menstrual cycles in less than one month, second menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Two menstrual cycles in less than one month, second menstrual cycle), ASTHENIA (A lot of weakness), DYSMENORRHOEA (Menstrual cycle cramping), DISCOMFORT (Discomfort) and BACK PAIN (Back ache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POLYMENORRHOEA (Two menstrual cycles in less than one month, second menstrual cycle). On an unknown date, the patient experienced ASTHENIA (A lot of weakness), DYSMENORRHOEA (Menstrual cycle cramping), DISCOMFORT (Discomfort) and BACK PAIN (Back ache). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram. At the time of the report, POLYMENORRHOEA (Two menstrual cycles in less than one month, second menstrual cycle), ASTHENIA (A lot of weakness), DYSMENORRHOEA (Menstrual cycle cramping), DISCOMFORT (Discomfort) and BACK PAIN (Back ache) outcome was unknown.            Patient had her booster shot on 14-Jan-2022, unknown if were intramuscular. No Concomitant information was reported. Patient had second period on 04-Feb-2022 and undergone symptoms of menstrual cycle from on 04-Feb-2022 and Patient had an appointment with HCP.
Syncope, Flushing/sweating, Dizziness; provided hydration + rest
Missed her 2nd dose which was scheduled in Nov2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose which was scheduled in Nov2021) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Has a thyroid problem and has medication) and AFib.  On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose which was scheduled in Nov2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose which was scheduled in Nov2021) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  The reporter stated that the patient has a thyroid problem for which she has medication, and no other concomitant medications were reported.  The patient received the first dose of the Moderna Covid-19 on 28-Oct-2021 at a local pharmacy but missed her second dose which was scheduled in Nov-2021 because she was kind of worried about that.   Treatment information was not provided.
Very sore at injection site and right shoulder joint, red rash, swelled up about the size of an egg, hot at injection site, extreme dizziness about 30 hours later - after exercising (could barely stand up, when turning head or looking up or down it would come on, only staying really still would stop it, had to move very slowly to get around), weakness, nausea - took BENADRYL which helped to mitigate the symptoms, still taking ALLEGRA after a week because the site keeps getting red and sore again, along with upset stomach and more dizziness if I stop taking it. The doses are not large, using children's liquid versions and taking the young child dose because I respond strongly to it.
Stabbing chest pain on the right side under breast bone and right shoulder blade after the second booster; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Stabbing chest pain on the right side under breast bone and right shoulder blade after the second booster) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 003121-2A, 048B21A and 025B21A) for COVID-19 prophylaxis.     The patient's past medical history included Heart valve replacement (It was reported that for the very first time, the patient got a heart valve) in May 2021. Concurrent medical conditions included Blood pressure high (patient has been taking blood pressure medication for years).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Stabbing chest pain on the right side under breast bone and right shoulder blade after the second booster). At the time of the report, CHEST PAIN (Stabbing chest pain on the right side under breast bone and right shoulder blade after the second booster) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal Normal. On an unknown date, Electrocardiogram: normal Normal.         Concomitant medication included blood pressure medication (patient did not remember the name).  On 20-Oct-2021, the patient received first booster dose of Moderna COVID-19 vaccine.  On 31-Mar-2022, the patient received second booster dose of Moderna COVID-19 vaccine.  It was reported that the patient's arteries in the neck were normal.  It was reported that the chest pain used to be like a stabbing pain for the patient that was hard to put up with.  It was reported that the physician told the patient that the patient needed a heart valve replacement and scheduled surgery.  The patient's chest pain had improved 2 months after second booster dose.  No treatment information was reported.
Lower right lip started getting swollen and numb, it went to the whole lip, and then on to my tongue; Lower right lip started getting swollen and numb, it went to the whole lip, and then on to my tongue; Lower right lip started getting swollen and numb, it went to the whole lip, and then on to my tongue; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 23Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypertension, acid reflux, asthma and hypersensitivity. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) for asthma, atorvastatin, amlodipine and unspecified vitamins. On 23Jan2021, 45 minutes after the vaccination, the patient's lower light lip had started getting swollen and numb; it went to the whole lip, and then on to the tongue. The reported events had resulted to an emergency room visit. The patient had received an unspecified steroid as treatment for the events. The patient's CAT scan (unknown results) and electrolytes were fine; both on an unspecified date. The outcome of the events, 'lower light lip had started getting swollen and numb; it went to the whole lip, and then on to the tongue', was not recovered.
Weakness; Tachycardia; "Looks sick"; shortness of breath; Cold sores on lips; difficulty hearing from both ears; Anxiety; Body aches; "Stronger fever"; Headache; Chills; This spontaneous case was reported by a non-health professional and describes the occurrence of ASTHENIA (Weakness), TACHYCARDIA (Tachycardia), ILLNESS ("Looks sick"), DYSPNOEA (shortness of breath) and ORAL HERPES (Cold sores on lips) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Prediabetes. Concomitant products included OMEPRAZOLE, PINAVERIUM BROMIDE and SENNA GLYCOSIDES for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced ASTHENIA (Weakness), TACHYCARDIA (Tachycardia), ILLNESS ("Looks sick"), DYSPNOEA (shortness of breath), ORAL HERPES (Cold sores on lips), HYPOACUSIS (difficulty hearing from both ears), ANXIETY (Anxiety), MYALGIA (Body aches), PYREXIA ("Stronger fever"), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), ORAL HERPES (Cold sores on lips), MYALGIA (Body aches) and PYREXIA ("Stronger fever") outcome was unknown and TACHYCARDIA (Tachycardia), ILLNESS ("Looks sick"), DYSPNOEA (shortness of breath), HYPOACUSIS (difficulty hearing from both ears), ANXIETY (Anxiety), HEADACHE (Headache) and CHILLS (Chills) had not resolved.            No other treatment information was reported.   This case was linked to MOD-2021-233164 (Patient Link).
Severe pain in Lt arm, Lt axillary, and Lt flank area.  Progressed to Lt trap.  On approximately 9/17/16 started to have bruising in above areas. Skin on Lt trapezius & upper back w/ some petichiae & diffuse hematoma.
everybody was sick all winter; Initial information was received on 30-Sep-2021 regarding an unsolicited valid social media non-serious case received from a Patient.  This case involves a patient (unknown age and unknown gender) reported that everybody was sick (Unevaluable event) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was sick all winter (Unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " I never get one i hate the flu. everybody i know are sick after they get one".  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Vaccine in arm 2/15/2021. Still pain at vaccination site 3/6/21. Injection site red dot (deep scab) for2.53 weeks. No rash, redness or swelling. Just feels like a deep very localized bruise at injection site... Like vaccine didn't move and is just sitting there like a lump. No other adverse effects. Plan to get 2nd shot ontime... but in other arm.
Patient last seen 10/30 for WCC, was given KINRIX in left deltoid region, MMRV was given in the right deltoid. As per mom after 24-48 hours she noticed the arm start to swell and feel warm, she also noticed blister like lesions last night. Deny: fevers, vomiting, pruritus, discharge. Patient states her arm hurts when it is touched. Tolerating PO with normal UOP. Diagnosed with Cellulitis of arm (disorder) - Given swelling and heat will treat with course of abx for presumed cellulitis. Rx KEFLEX 50mg/kg Q6 hours x 10 days. ER precautions discussed in detail. RTC prn or for f/u in 2 week.
104f fever max, Fever >100f for 2 days. Shaking, Muscle spasms.
Father states 2 days post vaccine administration child had swelling on R side of face lasting 3-4 days. Also stated red rash on face, neck, trunk lasting 1 wk. Given Tylenol, not seen by physician or at ER.
C/O abd pain/nausea approx 2 wks after injection. Seen physician approx 1 mo after injection 9-14-11 cont PREVACID no difference with med cont episodes. Abd pain after prob 2-3 mo pain subsided then June 2012 knee pain/hip pain spondyloarthropathy. Dx autoimmune disorder dx during tx of juvenile arthritis. Abd pain/nausea returned again H2 blockers added, referred to GI, multiple diff meds for stomach, upper endoscopy performed - normal, US, gallbladder tests - neg, HIDA scan - abn w ejection fx, gallbladder surgery March 2013 continued abd pain/ nausea numerous tests referrals to GI, US endoscopy performed - normal, pain ctr. Still with abd pain episodes and nausea.
PATIENT RECEIVED THIRD DOSE IN OUR FACILITY. PATIENT HAD ALREADY HAD 2 DOSES AND THIRD DOSE WAS GIVEN BEFORE 5 MONTHS (BOOSTER).
right eye started burning on 03/20/2021, a few hours later I noticed my mouth was affected and couldnt spit toothpaste, within 48 hours everything on the right side of my face was paralyzed; blurred vision, couldnt smile, chew or blind, no sensation
This spontaneous report was received from a Nurse Practitioner, regarding a female patient "over the age of 65 years" with no pertinent medical history reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot number and expiration date not reported)(dose, route or anatomical location not reported). No other co-suspects were reported, no concomitant medications were reported. The Nurse Practitioner reported that on an unknown date (reported as later that day) the patient developed flu-like symptoms. It was reported that within 48 hours the patient felt fine. No treatment information was reported. The reporter did not assess the causality between flu-like symptoms and PNEUMOVAX23. Additional information has been requested.
Patient had a left renal mass; procedure - robotic left radical nephrectomy which he tolerated without complication. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pain; This is a spontaneous report from a Pfizer-sponsored program, . A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (Pfizer Covid-19 vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient asked if it is ok to take pain medicine (ibuprofen) while she already had the 1st dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Patient received injection at 1508. Around 1528, patient states pain and numbness in right arm below injection site, along with shakiness in hand. Blood pressure taken at 1529, reading 120/62, pulse at 66, oxygen sat at 98%. Tylenol 500mg given with water and orange..
I was given a Zostavax shot for the prevention of Shingles. My husband developed a case of shingles the week of Christmas, 2009. The shot was injected by pharmacy personnel on December 28, 2009. As of this date, I can still see an area on the back side of my right arm, between the elbow and shoulder, where the shot was administered. For the last month, the affected area remained bright red, an area approximately 1/1/2" wide x 2-1/2" length and at times was feverish. When I checked with a physician, I was told to do nothing, not apply cold or heat the area, that is would take time for this raised area to go away. the shot did not make me ill or cause me to be bedridden, but it was very uncomfortable and I was able to sleep on my right side for 2-3 weeks. This is what I consider an after effect of the medication.
POOR QUALITY VACCINE ADMINISTERED; VACCINE AFTER BEING AT ROOM TEMPERATURE FOR OVER 2 HOURS AFTER FIRST PUNCTURE; This spontaneous report received from a health care professional concerned a female 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, intramuscular, batch number: 205A21A, and batch number: 205A21A expiry: 23/JUNE/2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced vaccine after being at room temperature for over 2 hours after first puncture. On an unspecified date, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and vaccine after being at room temperature for over 2 hours after first puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545147.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jun2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200696992 same reporter/drug/event, different pt
After recieving her 1st Pfizer vaccine, patient became diaphoretic and lethargic. She also stated that it was very bright. Her mother stated that she had this response to another type of vaccine in the past. Vitals B/P  70/50 Pulse 72, O2 93%. Ice packs to back of neck.  Seat was reclined and feet elevated. After 10 minutes patient stated feeling much better. No longer sweating, seeing clearly and alert. Vitals B/P 70/50, P 76, O2 98%.
This spontaneous report was received from a health care student referring to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions or concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 for prophylaxis (dosage information, route and lot number was not informed). Additionally, it was reported that and an unspecified patient was vaccinated with an improperly dose of ENGERIX-B. It was also reported that the temperature experienced was 47°F to 77°F, the time frame was 48 Hours, there was no previous temperature excursion. The call because was no of a "data logger".
On 5/14/09 - pt had swelling & redness of the (L) thigh. Pt instructed to Ice area & admin APAP. Pt was seen in ofc. 5/15/09. Was given XY2al 2.5 mg susp. & ORAPRED ODT 30 mg.
Pt. received HPV #2 in left deltoid via biojector, approx. 10:00AM 6/18/08.  On 6/19/08, 10:30AM, pt. telephoned RN to report pain from left armpit to left rib area, and lethargy.  Pt. advised to see PMD for continued pain or if pain worsens.
Following the vaccination she saw within 2 days gross hematuria which prompted us to see her Nephrologist.   Previous she was not experiencing any IGA Nephropothy.  After the vaccine she has hematuria, protenuria and compliment issues.   Labs and biopsy confirmed IGA nephropothy that was suggested to be triggered by the vaccine.  She will need to take ace inhibiors until this resolves itself.   There is a concern with future boosters
Pt vaccinated with DTP 15 hrs after immunization child began high-pitched screaming, shaking persistant for 8 hrs. MD dx Hyperirritability, no evidence of seizure. Administered Phenobarbital IM followed by oral Phenobarbital for 4 day.
Hospitalization: 9/17/2022 - 9/25/2022 Presentation to the ED: fatigue/generalized weakness associated with chills and decreased p.o. intake.  COVID-19 + date: 9/17/22. Treatment: dexamethasone, remdesivir.  discharge to: Home or Self Care
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received  on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves an adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   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.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.