chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-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. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday as reported from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the health care professional. Spikevax COVID19 vaccine bivalent, the dosage given in ml was unknown to the HCP.  This case contains information for patient 31 out of 100 patients reported by the reporter.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752: CASE
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose: 02/27/2021 2nd dose03/202/21 Diagnosed covid positive:09/03/21 Symptom onset: Exposure:travel Symptoms:asymptomatic
Burning red rash all over body; Burning red rash all over body; Welts on arm where vaccine was administered; Skin hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 11:15 (at the age of 20-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had penicillin allergy and zucchini allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced burning red rash all over body, welts on arm where vaccine was administered and skin was hot to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events burning red rash all over body, welts on arm where vaccine was administered and skin hot to the touch were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
rash spreading all the way to her mouth; rash on face; rash over arms; rash on leg; A scaly, red, peeling rash started to develop initially on her chest, spreading to her arm, upper back, legs on the interior side, spreading up her neck and face, spreading all the way to her mouth; This spontaneous case was reported by a nurse and describes the occurrence of EXFOLIATIVE RASH (A scaly, red, peeling rash started to develop initially on her chest, spreading to her arm, upper back, legs on the interior side, spreading up her neck and face, spreading all the way to her mouth), ORAL MUCOSAL ERUPTION (rash spreading all the way to her mouth), RASH (rash on face), RASH (rash over arms) and RASH (rash on leg) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXFOLIATIVE RASH (A scaly, red, peeling rash started to develop initially on her chest, spreading to her arm, upper back, legs on the interior side, spreading up her neck and face, spreading all the way to her mouth), RASH (rash on face), RASH (rash over arms) and RASH (rash on leg). On 21-Jun-2021, the patient experienced ORAL MUCOSAL ERUPTION (rash spreading all the way to her mouth). At the time of the report, EXFOLIATIVE RASH (A scaly, red, peeling rash started to develop initially on her chest, spreading to her arm, upper back, legs on the interior side, spreading up her neck and face, spreading all the way to her mouth), ORAL MUCOSAL ERUPTION (rash spreading all the way to her mouth), RASH (rash on face), RASH (rash over arms) and RASH (rash on leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Blood pressure measurement: high mmHg (High) significantly elevated blood pressure.. On 15-Apr-2021, Body temperature: 102 (High) reported fever of 102 degrees F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication was provided.  No concomitant treatment was provided.  Action taken with mRNA-1273 Moderna Vaccine was  Not applicable.  Other symptoms includes rash started spreading to her upper back   This case was linked to US-CBER-1229655, MOD-2021-230001 (Patient Link).
Soreness at injection site for first 4 days, then the soreness returns on 7th day with intense itching and pink hard slightly raised area expands in circumference over next few days from 1 1/4 inch to 2 1/4 inch and continues.  No fever.
Received Pfizer vaccines on  3/16, 4/6, 9/3/21 COVID-19 positive by PCR on  1/11/22 admitted to hospital on 1/11/22 d/t COVID 19 symptoms underlying h/o kidney transplant
Having covid. Also just received covid vaccine and ended up in hospital; Having covid. Also just received covid vaccine and ended up in hospital; This is a spontaneous report from a contactable female consumer (patient herself) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration in 2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that hard to understand caller. Mentioned having covid. Also just received covid vaccine and ended up in hospital. Believes she had a reaction. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Nausea; vomiting x 1; fever up to 101; weakness; fatigue; gut ache; joint pain; headache; 2 days+.
1/18/03: Myalgia, arthalgia, fever (101-102) for 3 days. 1/24: same, Sx-severe joint, muscle aches, elevated temp. 1/28: Joint pain continues. Sed rate 12mm/hr - given Diclotonec BID for 2 weeks. 2/14: Elbow, shoulder, wrist pain. CBC-sl viral shift.
felt like I was hit by a bat; arm soreness felt like I was hit by a bat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like I was hit by a bat) and MYALGIA (arm soreness felt like I was hit by a bat) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067M20A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN, TESTOSTERONE, SERTRALINE, LISINOPRIL, GLYCERYL TRINITRATE (NITROGLYCERIN), AMIODARONE, ISOSORBIDE MONONITRATE, CARVEDILOL, ROSUVASTATIN, RIVAROXABAN (XARELTO) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced FEELING ABNORMAL (felt like I was hit by a bat) and MYALGIA (arm soreness felt like I was hit by a bat). At the time of the report, FEELING ABNORMAL (felt like I was hit by a bat) outcome was unknown and MYALGIA (arm soreness felt like I was hit by a bat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details reported.  Company comment: 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. However the serious criteria Hospitalization is not captured. As the hospitalization occurred after 2nd dose.   This case was linked to MOD-2021-286939 (Patient Link).; 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. However the serious criteria Hospitalization is not captured. As the hospitalization occurred after 2nd dose.
Patent woke up the next morning after receiving the shots and got out of bed and was dizzy and ran into the wall and cut his forehead. He was convulsing for about an 1.5 hours and his wife took him to the ER. By the time he got to the ER, the convulsions had stopped. The ER fixed the cut on his forehead.
The next day at 10AM, I didn't have much sleep. Soreness overall and dizzy. Fever for 2 days Sore and achy and didn't get better, saw doctor, and didn't get better, Shot of anti-inflammatory with nurse practitioner. BP was low.
Severe shoulder and pelvic girdle pain, swollen left knee  Suspected polymialgia rheumatica
patient receive mrna vaccination.  shortly after developed posterior pharyngeal swelling and edema.  treated with epinephrine and solumedrol and resolved.
Myalgia, Fever, NauseaVomiting, Injection Site Soreness day 1-5, Low-Grade Fever, Myalgia, Nausea, Fatigue day 2-3 Narrative:  Other Relevant History:
Dizziness, lightheadedness within 1-2 min after injection. EMS called.
Pt came back saying she felt lightheaded and faint and hot. I inspected the injection site, there was no visible reaction. I gave her some water, she requested a coke, she requested to lie down on the bench; after about 30 minutes her husband came and picked her up.
All over itching that spread and intensified for several hours after vaccine given and decreased after taking 2 Benadryl.
At 11:05 voiced complaints of tingling in the bilateral jaw.  Attendee's skin was warm and dry. Attendee's respirations were not tachypneic or dyspneic.  Attendee assisted to the cot to lie down.  11:08 - HR:  83   BP:  110/72   O2Sat%:  98 11:11  Benadryl 50 mg administered.   11:15  Tingling getting better. 11:18  Slight jaw tingling.  HR:  78   O2Sat%:  100 11:40  injection site slight discomfort. Jaw no longer tingling.   11:45 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with their mother.
Started with running nose, hard to get breath, next day 2/18/2016, bad, bad, bad, head ache, back hurt, legs hurt, legs very sensitive on top, sore throat, depth cough, chills, high fever 102 plus went to Urgent Care, said look bad.
Chills at onset only; then fever, occassional headache & backache, and lethargy for 48 hours.  Temp averaged 100, hit 101 once, 102 once.  Took acetaminophen 3X during the 48 hour period.  After 48 hours 100% normal.
Patient Started having dizziness, feeling faint at around midnight on 3/3/2021. He then lost consciousness, had seizure-like activity and was taken to hospital via EMS. In the hospital patient was unresponsive and received resuscitation attempts unsuccessfully. Per family, after about 45 minutes, code was called and patient expired.
Developed Urtecaria (hives) when exercising.  Would develop full body hives and at times vomit.  Would treat with Benadryl and resolve within 1 hour.  Currently taking 3 Pepcid and 2 Zyrtec a day to prevent.
pt transferred from Hospital, for higher level of care and possible cardiac evaluation, pt dx with UTI and COVID at HCCH; pt transferred with c/o weakness, AMS, confusion; ABX started; in respiratory distress; O2 supplementation; heparin given for non-STEMI; pt suffered PEA, CPR done with ROSC achieved; pt suffered another PEA event and passed away in the hospital
MY ARM WAS SORE AT THE INJECTION SITE IMMEDIATELY AFTER MEDICINE INJECTED.  MY ARM HAS CONTINUED OVER THE LAST MONTH TO GET WORSE WITH THE PAIN RADIATING DOWN THE ARM AND CAUSING MY HAND TO GO NUMB AND TINGLING AT TIMES.
vaccination site itching; swollen below the injection site; circle with pinpoint red spots below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (vaccination site itching), VACCINATION SITE SWELLING (swollen below the injection site) and VACCINATION SITE ERYTHEMA (circle with pinpoint red spots below the injection site) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site itching), VACCINATION SITE SWELLING (swollen below the injection site) and VACCINATION SITE ERYTHEMA (circle with pinpoint red spots below the injection site). At the time of the report, VACCINATION SITE PRURITUS (vaccination site itching) and VACCINATION SITE SWELLING (swollen below the injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (circle with pinpoint red spots below the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.
Two days after vaccine experienced shortness of breath and tachycardia. Went to ER. After testing, diagnosed with pulmonary emboli in each lung (one each). 1 blood clot also found in ankle.
Pt had 100.2F (rectal) temperature, redness and warmth measuring 5 1/2", won't bear weight on left leg and severely tender and sore.
cried for several min p/vax then became lethargic,pale;no sz activity;BP 85/57,HR 120,RR 40,02 sat 95%;good pulses;arousable w/stimulation
pt recv vax 9AUG96 & 14AUG96 pt presented w/a rash, low grade fever & h/a;The reporter reported two patients w/same exp;
Patient suffered injuries from automobile accident which occurred after vaccinated with Moderna COVID-19 products; Patient was involved in automobile accident which occurred after vaccinated with Moderna COVID-19 products and was suffered from injuries; This spontaneous case was reported by a patient and describes the occurrence of INJURY (Patient suffered injuries from automobile accident which occurred after vaccinated with Moderna COVID-19 products) and ROAD TRAFFIC ACCIDENT (Patient was involved in automobile accident which occurred after vaccinated with Moderna COVID-19 products and was suffered from injuries) 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 COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, 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. On an unknown date, the patient experienced INJURY (Patient suffered injuries from automobile accident which occurred after vaccinated with Moderna COVID-19 products) and ROAD TRAFFIC ACCIDENT (Patient was involved in automobile accident which occurred after vaccinated with Moderna COVID-19 products and was suffered from injuries). At the time of the report, INJURY (Patient suffered injuries from automobile accident which occurred after vaccinated with Moderna COVID-19 products) and ROAD TRAFFIC ACCIDENT (Patient was involved in automobile accident which occurred after vaccinated with Moderna COVID-19 products and was suffered from injuries) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication was provided.
A report was received from a health care professional on 12/3/03 concerning approximately 2-3 children of unknown sex and between the ages of 2 to 3 years who inadvertently received Fluvirin on an unspecified date. On an unspecified date approximately 2-3 children between the ages of 2 to 3 years inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality. Follow up pending.
In recovery pt stated "felt like numb head to feet  I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess:  - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling.  stated she was anxious to get vaccine Left Deltoid site benign,  VS 130/72, HR 95 reg strong, resp 12 reg non labored.  Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed.  Advised if anything  occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe .  Ok'd to exit 9:45 am
Painful injection site right away And within 20 min very painful left side-shoulder blade, shoulder, then pain went into neck, then jaw, then ear- felt blocked up and numb, then to eye- vision off, light headed. Pharmacist observed for 30 minutes and suggested I go to urgent care. I thought I was ok but on way home, jaw and cheek area went numb and sharp pain at left base of skull to top of head  with chest and underarm muscles sharp pains. Went to urgent care. BP, temp & oxygen ok. While observing me for 45 min, also had left leg cramps, and profuse sweating   Gave me 2 prednisone tabs 20 mg. Watched for another 45 minutes. Went home.  7 hours after injection still had these symptoms. Next morning 7/16/21, cheeks flushed, moderate jaw pain, cheek numbness and ear/ hearing not right. As day went on, numbness became intermittent but jaw pain remained.
Passed put while walking in home. Hit head on stair railing. Gashed head. Lots of blood.  Bleeding stopped after 1 hour (pressure applied)
Administered 0.5ml dose of Pfizer booster to the patient instead of the indicated 0.3mL dose.  Expected vaccine reactions: chills and arm ache; No residual symptoms.
A week to 10 days after the shot she experienced covid arm; A week to 10 days after the shot, she experienced red itchy swollen; A week to 10 days after the shot, she experienced red itchy swollen arm; A week to 10 days after the shot, she experienced red itchy swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A week to 10 days after the shot she experienced covid arm), VACCINATION SITE PRURITUS (A week to 10 days after the shot, she experienced red itchy swollen), VACCINATION SITE ERYTHEMA (A week to 10 days after the shot, she experienced red itchy swollen arm) and VACCINATION SITE SWELLING (A week to 10 days after the shot, she experienced red itchy swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A week to 10 days after the shot she experienced covid arm), VACCINATION SITE PRURITUS (A week to 10 days after the shot, she experienced red itchy swollen), VACCINATION SITE ERYTHEMA (A week to 10 days after the shot, she experienced red itchy swollen arm) and VACCINATION SITE SWELLING (A week to 10 days after the shot, she experienced red itchy swollen). At the time of the report, VACCINATION COMPLICATION (A week to 10 days after the shot she experienced covid arm), VACCINATION SITE PRURITUS (A week to 10 days after the shot, she experienced red itchy swollen), VACCINATION SITE ERYTHEMA (A week to 10 days after the shot, she experienced red itchy swollen arm) and VACCINATION SITE SWELLING (A week to 10 days after the shot, she experienced red itchy swollen) outcome was unknown.            No Concomitant medications were reported. No Treatment mediations were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Follow-up received included no new information.
15' after vaccine, developed " tingling in throat" and felt anxious : transferred to ED for E &M. sx resolved upon arrival,  observed for 3 hrs and left AMA