chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up at 7am for work and by 7:15am I began to feel lightheaded, cold, and my vision began to blur.  Soon after, my I only saw white and then became extremely hold and had short of breathe.  I fainted and did not become conscious again until paramedics came around 7:30am.  Later that day, I also had a headache that lasted the remainder of the day and light fatigue.
Pain,redness, heat, swelling at site and stiffness at left shoulder.  About 3 inches long and 2 inches wide which migrated down from deltoid to area above elbow then over anticubital area to forearm over several days. Phone call  Clinic  placed same day11/1/22:  I talked to someone-who consulted Dr. Suggested Tylenol/ ibuprofen as directed and  benedryl p.o. PRN.and use ice pack at site.  I used 200 mg Ibuprofen that day at 4:20 pm, , 11/2/22  2:38 am  Tylenol 500 mg for pain. 11/3/22 @ 4:38 pm 500mg Tylenol . Resolved over 3 weeks
sore arm; muscle aches and pain; Slight headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches and pain) and HEADACHE (Slight headaches) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperthyroidism. Concomitant products included LEVOTHYROXINE, PREDNISONE, TIZANIDINE and APIXABAN (ELIQUIS) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches and pain) and HEADACHE (Slight headaches). At the time of the report, PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches and pain) and HEADACHE (Slight headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Thyroid function test: (High) thyroid levels had doubled from her previously good thyroid levels checked in Oct2020. On 07-Feb-2021, Body temperature: 101.8 (High) 7Feb2021 had a temperature of 101.8. On 07-Feb-2021, SARS-CoV-2 test: (Negative) COVID test  came back negative.. On 09-Feb-2021, Computerised tomogram: They found two new pulmonary embolisms in the right lung and an old PE in the left lung. On 09-Feb-2021, X-ray: They found two new pulmonary embolisms in the right lung and an old PE in the left lung.         Treatment information was not provided.  Event outcome was not reported.   This case was linked to MOD-2021-018427 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Non-significant information was updated.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: BLINDNESS (medically significant), outcome "unknown", described as "I am blind now, blindness"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "unknown", described as "Thyroid eye disease"; ILLNESS (non-serious), outcome "unknown", described as "being sick after this vaccination". Consumer stated that he/she was blind now. Consumer handed over the phone to the reporter. Reporter added to the concern, "Thyroid eye disease. Is the patient also the reporter: No. Reporter type could not be probed over the call hence captured as Consumer or other non health professional by default. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
01/08/22 presents to EC ED for "chills and fever and fatigue". PMHx of "AML(chemo 2 weeks ago), HTN and anemia"
15 year old received primary series of possibly Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received primary series of possibly Moderna COVID-19 vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received primary series of possibly Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received primary series of possibly Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown   Reporter did not allow further contact
I have developed tetanus, severe neck pain, seizures, anxiety, and insomnia from the covid vaccine
pain all over the body; small bump below the left arm; mild headache; left arm soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain all over the body), VACCINATION SITE MASS (small bump below the left arm), HEADACHE (mild headache) and VACCINATION SITE PAIN (left arm soreness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (pain all over the body), VACCINATION SITE MASS (small bump below the left arm), HEADACHE (mild headache) and VACCINATION SITE PAIN (left arm soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (pain all over the body), VACCINATION SITE MASS (small bump below the left arm), HEADACHE (mild headache) and VACCINATION SITE PAIN (left arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication consisted of Triglyceride medications and Diabetic medications.   This case was linked to US-MODERNATX, INC.-MOD-2021-076682 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076682:case for dose 1
Discharge Provider:  Primary Care Provider: PA-C Admission Date: 4/17/2023 Discharge Date: Apr 21, 2023  PRESENTING PROBLEM: Hypoxia [R09.02] COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE:   Patient is a 84 y.o. male with a past medical history of dementia, chronic obstructive pulmonary disease, hypertension, hyperlipidemia, BPH, type 2 diabetes, OSA on CPAP, hypothyroidism, chronic anemia, GERD who presented with shortness of breath from his assisted living facility. COVID 19 positive on admission requiring 2L NC. Remainder of work up relatively unremarkable. Started on dexamethasone and remdesivir. He was weaned quickly to room air.    He completed 5 day course of remdesivir while in hospital and discontinued dexamethasone at discharge.   Pulmonary have evaluated patient prior to discharge and he was able to ambulate on room air without significant symptoms.  He did not qualify for home oxygen.   In stable condition patient is discharged to facility with home health care.
patient experienced lower back pain, nausea, dizziness, tightness in chest, asthma symptoms  patient went to see the primary doctor and was evaluated
No further Adverse event /No additional AEs reported; a patient inadvertently received a third dose of VAQTA instead of the recommended two doses; This spontaneous report was received from a medical assistant concerning to a 17 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.    On 23-AUG-2021, the patient was inadvertently vaccinated with the third dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported)  lot # T035720 expiration date: 15-APR-2022, 0.5 milliliter for prophylaxis; instead of the recommended two doses (extra dose administered).     For hepatitis a vaccine, inactivated(VAQTA SYRINGE (DEVICE)), the lot number was reported as T035720 and the serial number was not available. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
On April 11, 2021 patient experienced joint pain and all of her joints. Pain very severe. No red hot swollen joints
R side effect from vaccine; localized redness, swelling, mild induration surrounding the injection site.
Severe headache x 4 days despite Tylenol Temperature high of 101.5 x 3 days Sore muscles even teeth hurt Fatigued
patient stated she felt ill, nauseous, had chills, shaking, and she believed her heart was racing. sought no medical treatment and stated that at noon the next day she had felt better
About 3 or 4 hours after vaccine, I developed tightness in my chest and shortness of breath.  I felt like I did when at high altitude. When climbed basement stairs (10 stairs), had to stop at top and take deep breaths.  While sitting or laying down, felt needed to take deep breath. Felt breathing was shallow. Tightness in chest went away next day. Shortness of breath went away on evening of day 5.
After patient received COVID Pfizer shot patient went to sit on stool in waiting room. Patient didn't sit on regular chair to sit closer to sister and mom. After a few minutes patient got lightheaded and fainted falling back and to the right, hitting head against wall and blood pressure machine and floor. Mom and sister tried to catch patient during fall. Patient had light shaking for a few seconds before becoming conscious again. I went out and called 911 for paramedics, lifted patient legs up to improve blood flow to head. After a few minutes and after finishing call with 911 had other employees help lift child onto regular chair to sit. Patient got a small bottle of water to drink. Paramedics soon arrived after and evaluated patient. Paramedics determined child fine and mom decided to take child home. Called mom for follow up a few hours later and child doing fine per mom.
Legs hurt so bad he thought he was being paralyzed.  Achy for 2 days then lost appetite, became unsteady, and then became disoriented!!!  Hospitalized on or about 08/30/2015.  Unable to tell name, date, wifes name, where he was, etc.
DTaP was ordered and documented, but Pediarix was given. Per Manufacturer and CDC recommendations, no patient action is needed. Although not recommended, CDC states that an accidental dose of Pediarix can count as a 4th dose of DTaP.  At this time, no known patient reaction to medication error.
(L) deltoid swelling, redness, erythema and warm to touch - 20 cm red area underside of (L) arm and 10 cm red area inside of (L) arm.
PREVNAR 13 and ZOSTAVAX vaccines had already been administered by Primary Care Physician so pt received second dose of both. Physician called pharmacy after we notified of vaccination.
Suspected vaccination failure/had them, don't think vaccine made any difference; I've had them 32 times I've had them 32 times so far. I don't think the vaccine made any difference.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 08-Apr-2022 Reporter's comment: The case was received from patient via interactive digital media. The patient had shingles 32 times so far and did not think that the vaccine made any difference. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Date the vial was initially stored in the refrigerator: 24-Sept-2021. Date(s) of administration of vaccine: 24-Oct-2021-27-Oct-2021.
11-19-2021 at 6pm started to present paralysis on face right side and eliminating excess saliva.
Swelling and tenderness at Rt quadriceps with some swelling of the knees.
pt became pale, clammy, grunting appeared to stiffen but no other sz movement, lasted min, no remaining abnormalities;
10/16/2014: Child had low fever and raised bump on leg at injection site 10/17/2014: Fever, bump still present, hard patch larger than a dime underneath and centered on bump.  Hot and cold packs alternated on the leg, switching every 45 seconds for roughly 25 minutes. Hard patch shrinks but still present. 10/18: Fever worsens, hits 103.1 10/19: Fever hits 103.5, bump and hard patch still present 10/20: Fever hit 103.5 roughly two hours after the child was given Advil and had a cooling gel pad on her forehead. 10/21: No indication of fever at any point in the day; temperature checked every 30 minutes from 8:00 AM to 9:00 PM. Highest temperature reached is 98.9. 10/22: Child develops full-body rash.
Pt reports within 1 hr of receiving vaccine, he started with L sided lip/tongue swelling, L neck and "side swelling", chills, HA, body aches. Denies SOB, respiratory distress, difficulty swallowing, chest pain, confusion, changes in speech, numbness/tingling. Per pt this occurred 2/12/2021, angioedema, neck, side swelling resolved 2/13/2021. Persisted with HA, body aches, chills. Reported events to PCP office 2/17/2021, at time of call pt asymptomatic, symptoms fully resolved. Pt seeking advice from PCP prior to next dose which is scheduled 03/12/2021
Erythema and swelling- likely cellulitis. Appeared 2 days after the injection.
6/22/99 t102 advil given;redness & swelling 4" circumference around inj site by swelling under lt axilla-much discomfort  when moving lt arm advil regime dec temp;T100-swelling & redness;
After the first vaccine I started with fatigue. Following the seond vaccine I began to have adverse reactions. On May 26 was the first Urgent Care vist ,  I was told it was a side effect of the vaccine and sent home . On May 30 I went back to Urgent Care were I was told I was just dyhydrated so I was give 2 IV?sand did a blood panel . On June 4th they just did a blood panel. On June 7th I was called into the Emergency room because the blood work showed my organs were slowly shutting down. I emmited to the hospital and was give IV?s and some medication for 8 day . After that I was put on Home Health for 10 days were my IV?s were still give with medication . There have been no improvements, I am now waiting for my 3rd treament plan a IVIG. Since the first vaccine my life has completely changed I was an independent active healthy adult . Now I have to use a walker to move and need family to help me get up from bed , eat , go to the bathroom
This spontaneous report as received from an Immunization Coordinator and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M000757, expiration date 06-JAN-2018 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluents (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.5 degrees Fahrenheit for 36 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009334.
C/o feeling nauseated.  Started vomiting.  Appeared nervous and shaking.  B/p:  134/7.  11:05 C/O tongue and throat swelling.  Epinephrine 0.3 mg given in lateral thigh with Epi-pen.911 called.  EMS arrived 11:15, took over persons care and transported to hospital.
A round circle, was dark red; Feels a bit warm; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore), VACCINATION SITE ERYTHEMA (A round circle, was dark red) and VACCINATION SITE WARMTH (Feels a bit warm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes. Concomitant products included INSULIN GLARGINE (LANTUS), ATORVASTATIN, OLMESARTAN and LEVOTHYROXINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (A round circle, was dark red) and VACCINATION SITE WARMTH (Feels a bit warm). On 16-Jan-2021, VACCINATION SITE PAIN (Arm was sore) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (A round circle, was dark red) and VACCINATION SITE WARMTH (Feels a bit warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
1/4/21:  Patient called PCP to report:  Cough; Diarrhea; Fatigue; Muscle pain; Severe headache; Sore throat; Weakness; + COVID exposure Was swabbed / tested for COVID - Tested POSITIVE for COVID-19 on 1/7/21
This RN called out to observation for a medical emergency. RN, reported that patient's tongue was feeling "numb" and throat was feeling "dry". Patient laid back in his seat. Vitals signs taken, BP 116/76, HR 78, O2 sats 96%-98%. As this RN was talking to the patient, he c/o tongue swelling and throat feeling "tight and beginning to close" and chest tightness and "tingling" down his left arm. RN was instructed to give 0.3mg epinephrine injection IM into left thigh at 1535 and 911 called by other EMT on site. Patient's VSS. Patient remained laying down in chair. Breathing stable, VSS. Patient stated that he was starting to feel better but tongue still tingling. Paramedics arrived on site at 1545 and care turned over to them.
Itching at site; Swelling at the site; Had some leak; A spontaneous report was received from a female consumer consume who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine leak and then developed some itching and swelling at the site.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, patient experienced some of the vaccine leaked. On 8 Jan 2021, the patient developed some itching and swelling at vaccine site. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, experienced vaccine leak was considered resolved on 31 Dec 2020. The outcome of the events, then developed some itching and swelling at the site, were unknown.; Reporter's Comments: a)~The case concerns female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine leak after the first dose. Additionally, eight days after the first dose patient experienced non serious, related events of itching and swelling at injection site. Swelling at injection site is listed, however itching is unlisted. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Causality assessment for vaccine leak was assessed as not applicable.
Arthralgia Inflammation under axilla on 1/2/2020 arounf 10am
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Sep2021 (Lot number: FF8841) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing); "antacid" (unspecified if ongoing). Concomitant medication(s) included: ESOMEPRAZOLE taken for antacid therapy. Vaccination history included: Bnt162b2 (First dose, LOT: EL3246), administration date: 12Jan2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Second dose, LOT: EL3246), administration date: 03Feb2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "second dose they did have headaches". The following information was reported: HEADACHE (non-serious), NAUSEA (non-serious) all with onset 29Sep2021, outcome "not recovered" and all described as "They began to have symptoms of headache, nausea after eating". Therapeutic measures were not taken as a result of headache, nausea.  Additional information: It was reported that patient when he don't eat, he don't feel as bad and don't notice the nausea, and as soon as he eat he feel nauseated. He takes concomitant medications as stomach one, and a blood pressure medication.  No follow-up attempts are possible. No further information is expected.