chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching all over, moderate amount of redness and swelling at the injection site (13cm diameter), rash (eczema -like)
Immediate swelling at injection site, approximately 1.5cm  diameter and raised about 1 cm
c/o stomach discomfort immediately p/immun; skin became clammy, skin pale; had circumoral pallor & was listless for approx 1 min; resp remained even/unlabored; nail beds were cyanotic; BP 86/60, P120, Resp 20; pt was placed in trendelenburg
Very tired; vertigo; the arm which was injected was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the arm which was injected was sore), VERTIGO (vertigo) and FATIGUE (Very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date. Previously administered products included for an unreported indication: Shingles. Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GLIMEPIRIDE, ROSUVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 31-Mar-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (the arm which was injected was sore). On 01-Apr-2021, the patient experienced VERTIGO (vertigo). On an unknown date, the patient experienced FATIGUE (Very tired). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Vertigo, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (the arm which was injected was sore) had resolved, VERTIGO (vertigo) had not resolved and FATIGUE (Very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received her first Moderna Covid-19 dose at 1:15 pm on 31Mar2021 injected intramuscularly into her left, non-dominant arm.   Within three to five hours after the Moderna first dose, the arm which was injected was sore. The symptom resolved within three or four days later. Since the morning following the dose, she has had ongoing vertigo. She iced the sore arm and just tried not to lay on her left side. She has tried Dramamine for the vertigo symptom. She thinks that the Dramamine made her very tired. It was reported that She could not drive for a couple of days, because the vertigo was so bad. Because of the vertigo, she was crashing into furniture and having to hold onto walls while walking.
trouble breathing; cough; sore; body aches; headache; No energy; lethargic; trouble sleeping at night; swelling on left arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing), ASTHENIA (No energy), LETHARGY (lethargic), INSOMNIA (trouble sleeping at night) and COUGH (cough) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient reports he had COVID before - diagnosed March 17, 2020.) on 17-Mar-2020.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling on left arm). On 18-Apr-2021, the patient experienced ASTHENIA (No energy), LETHARGY (lethargic), INSOMNIA (trouble sleeping at night), PAIN (sore), MYALGIA (body aches) and HEADACHE (headache). On 19-Apr-2021, the patient experienced DYSPNOEA (trouble breathing) and COUGH (cough). At the time of the report, DYSPNOEA (trouble breathing), ASTHENIA (No energy), LETHARGY (lethargic), INSOMNIA (trouble sleeping at night), COUGH (cough), PAIN (sore), PERIPHERAL SWELLING (swelling on left arm), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs provided.  Treatment for the events included albuterol, Tylenol, and Nyquil.
I am a regular hiker and hikecat a good pace for my age. A week or so after 2nd vaccine, I started getting terribly out of breath and pounding fast heartbeat when hiking.  I was also tired .  I scheduled Stress Test which indicated I had newly diagnosed Mitral Valve Prolapse with regulation.  I believe the vaccine cause heart inflammation and valve issues.  A prior stress testv2 years earlier showed no issues with mitral valve.
Patient developed Vitiligo one week after 2nd COVID vaccine, she thinks she may have had an area of depeigmentation after the first vaccine. The vitiligo affects the face and neck area.
Cellulitis (L) upp. extrem. Keflex 250 g/5cc one cap, qid Flu daily until improved
Pt in observation area, felt lightheaded Pale/ diaphoretic  Laid to floor with feet elevated, cool rag to forehead Vitals:  104/58, HR 58, 99% (laying on floor)  1345 Pt states feeling much better Vitals:  101/68, HR 84, 99% SpO2  1350 Pt sitting on floor, eating granola bar and drinking water Vitals: 110/72, HR 79, 99%  1400 Pt sitting up in chair, states feeling well BP 107/75, HR 91, 98%
PCR covid test date=18Jul2022, covid test result=Positive; Pfizer Dose 1, 2, 3; PCR covid test date=18Jul2022, covid test result=Positive; Pfizer Dose 1, 2, 3; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL0140), as dose 2, single (Lot number: EL3249) and as dose 3 (booster), single (Lot number: EW0183) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Lot number: 068H21A) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shrimp" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: Vespids" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Sessional rhinitis" (unspecified if ongoing); "Hx concussion" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "unknown" and all described as "PCR covid test date=18Jul2022, covid test result=Positive; Pfizer Dose 1, 2, 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300135046 same reporter/patient/product, different dose/event;
accidentally received an expired dose and Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA701A, expiry date 30-APR-2023) for prophylaxis.   On 15-AUG-2023, the patient received the 1st dose of Menveo. On 15-AUG-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: accidentally received an expired dose and Menveo). The outcome of the expired vaccine used was unknown.   Additional Information: Receipt Date: 16-AUG-2023 The reporter was a pharmacy student. The reporter report that a patient accidentally received an expired dose and Menveo and wished to know how to proceed.  The information about the vaccine and event provided. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The patient accidentally received an expired dose and Menveo, which led to expired vaccine used.
Pfizer 1 dose COVID vac given 2/10/21, lot # EL9264; pt had a positive COVID test on 1/5/22 and 1/18/22 was recuperating at home; 2/8/22 pt to ED with worsening SOB and altered mental state; worsening pneumonia - bacterial; started on ABX; neg COVID test; admitted; respiratory status worsened; PCU; intubated with mechanical ventilation; given steroids; remains hypoxic; pt went into asystole, code blue called, but pt expired in the hospital
thoart closing; went to ER & was treated w/DPH; 2DEC93 no response to f/u request;
I WEEK AFTER RECEIVING VACCINATION - INJECTION SITE BECAME RED, WARM AND ITCHY
Diarrhea, headache, "eyes feel puffy" (though no visible swelling), fever of 100.0F, tired, generalized aches, stomach pain, nausea without vomiting, stiff neck, slight photophobia.
This spontaneous report as received from a medical assistant refers to a 14 year old patient who on 15-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot numbers reported as J012816, Exp. Date: 10-OCT-2015 and J009986, Exp. Date: 12-AUG-2015) .5 ml, subcutaneous and a dose of MMR II (lot numbers reported as J002866, Exp. Date: 12-MAR-2015 and J008154 Exp. Date: 08-JUL-2015) that were improperly stored. Doses and routes were not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
44 yo female who was vaccinated against smallpox as a child and has no known cardiac disease, vaccinated first on 3/27/2003.  One week later was determined to be a no-take and was re-vaccinated on 4/03/2003.  Developed fever on 4/3 and tender axillary lymph nodes the following day.  Lymph node tenderness progressed and spread to her left breast.  She denies any SOB, nausea or diaphoresis.  Tenderness in axilla and breast were worse with palpation and improved somewhat with aspirin.  She reported her symptoms to an MD colleague who performed an EKG (since pain was in left breast) on 4/6, which was normal per patient.  She called the clinic today to report her continuing axillary lymph node and breast tenderness.  She denies redness or warmth over lymph nodes.  Temp reached a max of 99.8 on 4/2 but she has been afebrile since.  She does c/o some chills.  She missed work today because of the discomfort.  Has been taking aspirin q6 hours.
the dose was given 14 hours after it was diluted, there was no any reaction or adverse effect reported by the customer.
Patient received COVID vaccination on 12/29/2020 - at 230 PM, starting having symptoms on 12/30/2020 at around 12 AM.  Overnight he had severe shaking chills with pounding headache. He started having 101- 102.5 high grade fever with shaking chills and sweats. He had a ED visit for the same , where he had high blood pressure 150- 160 systolic and high heart rate. He got discharged home, however continues to have high temperatures and chills.  He is COVID test and FLU negative done at ED.
5 min. after receiving vaccines patient syncopized and had loss of consciousness for about 5 s. Awoke briefly and then had 5-10s of seizure like activity. Patient was then post ictal and vomited x 1. Office called ambulance. Patient was reexamined and fingerstick done.
Information has been received from a physician and practice manager referring to a patient of unknown age and gender. On 02-OCT-2014 the patient was vaccinated with an improperly stored PNEUMOVAX 23 (strength: 0.5ml, lot # K004281, expire date 22-MAR-2015; dose and route of unknown). The total cumulative excursion time was 1368 hours with the lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient has VWD, Type 3 (a bleeding disorder) and had a muscle bleed in her arm post vaccine. The bleed required infusions of HUMATE-P.
DID NOT COMPLETE IMMUNIZATION ONE WEEK PRIOR TO TRAVELING; This spontaneous case report (PVX2019-2097) was received from a nurse on 14-Aug-2019. It described a female consumer who "did not complete immunization one week prior to traveling" (PT: Inappropriate schedule of product administration), while being on Vivotif (lot number: 3003248) for travelling to an endemic area.  Case report: The consumer took the first dose of Vivotif on 13-Aug-2019. On 15-Aug-2019, she will be leaving to endemic area.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not complete immunization one week prior to traveling" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete immunization one week prior to traveling" was considered as not applicable.
Pt stopped in office today reporting that the late morning after receiving the PNEUMOVAX 23 vaccine he developed dizziness (off & on), weakness (that was continuous), pain in his right bicep, and a swelling in his right anti cubital space. Sx's lasted "the rest of that day and the whole next day(yesterday)". Today Sx's have resolved, except for "slight trace of pain in the right bicep".  VAERS filled out an sent in.
c/o being hard to wake up & limp from 408PM; APAP given @ 345PM; no fever, no treatment; sx resolved;
Cold; This is a spontaneous report received from a contactable reporter (Consumer or other non-healthcare professional). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EN6202) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "Cold".  Additional information: NDC number, UPC number and Expiry Date of Covid-19 Vaccine was Unknown. It was reported that the patient was scheduled to have second Pfizer Vaccine (Covid 19 vaccine) today and the patient had turned down with the cold. The patient does not have a fever and haven't been around anybody past 3 weeks since the patient had one. The reporter asked, was it safe for the patient to go and get that? Or should the patient postpone that? In response to further probing, reporter stated, "I do not have a lot of time before my appointment out there." Expiration date of Covid-19 Vaccine: reporter stated, "They did not put that on here."  No follow-up attempts are possible. No further information is expected.
Patient reported that 10 minutes after vaccination, she started having a hot flush that started just below the waistline and went down to her vagal, and it went away in 30 seconds; Soreness at the injection site; A spontaneous report () was received from a consumer concerning a 86 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient reported that 10 minutes after vaccination, she started having a hot flush that started just /hot flush, soreness at the injection site /injection site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Feb 2021, approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) patient reported that 10 minutes after vaccination, she started having a hot flush that started just, soreness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), patient reported that 10 minutes after vaccination, she started having a hot flush that started just, soreness at the injection site was unknown.
Pt has a history of non-insulin-dependent diabetes, hypertrophic cardiomyopathy with an EF of 50 to 55%. He has recently been short of breath with a productive cough and was positive for COVID-19. His chest xray indicated left lower lobe pneumonia.
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter stated she had been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID. Vaccine was given within current guidelines except seven were under 65.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50% or more  Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient 38 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case Patient 1
A burning sensation started in the face, then spread to torso, breaking out in lesions (similar to acne). The symptoms lasted three weeks. Patient reports it was very uncomfortable. Patient did not seek medical attention. The patient did not self treat. The patient is concerned about getting a second dose.
At 0908, RRT was called at the post-vaccination monitoring area for an 89 y/o male that was experiencing dizziness after administration of the Pfizer vaccine at 0900. Client?s car was off, 4 RRT nurses responded to the scene with the E-kit, stethoscope, and pulse oximeter. Head-to-toe assessment done, all WNL. Reports a Sulfa allergy and denies taking any medications today. Initial vitals ? HR: 79, RR: 18, BP: 137/70, denies pain. Client reports that he fell once last week and once this week. With the second fall this week, client reports he hit his head but he states it wasn?t a big deal. He is AA0x4, in no acute distress. During RRT, client was on the phone with his doctor?s office and doctor?s office reported that his PSA level was elevated and he was positive for E.Coli in the urine. 911 called by Site Manager, Deryl Bactad, at 0923. Fire Engine #94 arrived at 0942 and report was given to them. Their initial vitals were: HR: 79, BP: 146/106, O2: 98% on RA. Client denies pain and remains AAOx4. He stated he was fine to drive home. Client refused transport to the hospital at 0957. Last BP before paramedics left: 146/95. Client remains AA0x4, no acute distress noted. Client advised to wait in monitoring area for an additional 15 minutes. Client verbalized understanding. Upon leaving, client was AA0x4, in no acute distress, reported feeling fine to drive. Client advised that if symptoms worsen or if he is SOB, to contact his PCP and/or call 911 and/or get to the nearest hospital. Client verbalized understanding of all information given. All questions answered, all concerns met. Client left at 1015 via car, by himself.
Vaccine was administered 6 days after vial expiration date. Parent notified by provider. Provider has chosen not to revaccinate. Parent agreed, child doing well.
Long-lasting shortness of breath and feeling of anxiety following the vaccines. Occasional light-headedness. I've had a stress test, EKG and pulmonary function test. None of these have revealed anything conclusive, however, I still feel shortness of breath daily.
Patient called pharmacy 14 days after vaccinations and explained she has a local reaction of arm swelling, stiffness in the arm, pain in the shoulder/arm, has a decreased movement  and it seems to not not improved over time. She is following up with her PCP to determine the cause as it has not improved or resolved.
6FEB92 pt devel fever 101 ax; eyes red & light sensitive; also blotchy rash all over; pt taken to MD; had sz which mom states lasted 5min; pt hospitalized x 2 days; also devel joint stiffness w/some difficulty walking;
Patient never received his 2nd dose of Moderna COVID-19 vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient never received his 2nd dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-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 ADMINISTRATION INTERRUPTED (Patient never received his 2nd dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient never received his 2nd dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient never received his 2nd dose of Moderna COVID-19 vaccine).    No concomitant medications were reported. Patient never received the second dose. Patient has not reported any adverse reactions to the first dose. No treatment medications were reported.
Patient didn't have any adverse reactions. Patient was given an extra dose of these vaccines as it was not yet in System and mother of child did not have patients vaccine record.
Five hours post vax the pt developed swollen lips. The next day the pt developed hives with itching all over her body. She was seen by an allergist and a dermatologist. She received prednisone 10 mg daily and her symptoms were slowly resolving. When the prednisone was stopped her symptoms returned within 24 hours (this happened twice). Other treatment drugs included Allegra one daily, Atarax 4-6 daily, Periactin 4 daily, and Zantac 2 daily. As of 08/28/2000 the outcome of the event is ongoing.
chills, fever 101.5, weakness, dizziness, fast heart beat, stomach cramps by 3:00PM Took Advil