chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (soreness) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Patient have none allergies (medications, food and other products). Previously administered products included for Product used for unknown indication: Flu shot (Flu vaccine given within 1 month prior to Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Blood pressure high (No change in status such as improvement or worsening), Blood cholesterol abnormal (No change in status such as improvement or worsening) and Thyroid disorder (No change in status such as improvement or worsening). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) had resolved. Patient height is reported as 5'6. Concomitant medicine includes regular medications for high blood pressure, cholesterol, and thyroid issues. It was reported as patient did not experienced any similar event in the past and AE cause patient to patient called a doctor. No treatment information were reported by the reporter. This case was linked to MOD-2022-606972 (Patient Link). Reporter did not allow further contact
Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) 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.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not reported.  It was reported that patient might had cold virus. The caller stated that they were all sick as they had the flu and had lot of problems in the family.  Treatment medication was unknown.   This case was linked to MOD-2022-596889, MOD-2022-597292, MOD-2022-596527 (Patient Link).
2 days to 1 week after receiving HPV, started with "hot flashes," face gets red and has increased perspiration. This happened with all three doses of HPV vaccine.
Initial and follow up information has been received from a healthcare professional, concerning a 25 year old female patient, who on 11-JUL-2007 was vaccinated IM in the left deltoid, with the first dose, 0.5ml, of Gardasil (Lot #658222/0927U). Concomitant therapy included LOESTRIN. On 11-JUL-2007, 10 to 15 minutes after the vaccination, she felt dizzy and lightheaded, and also seemed to be confused. She was observed in the physician's office for 45 minutes, examined by the nurse practitioner, and then sent home as she stated she "felt fine." On 12-JUL-2007, the patient called in the morning and complained of dizziness and lightheadedness when she arose. She was referred to the emergency room for follow up. At the time of this report, the patient had not returned to the office, and the outcome of dizziness and lightheadedness was unknown. The reporter clarified that the events of dizziness, lightheadedness and seemed confused were considered to be non-serious events. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a medical assistant (MA), concerning a 25 year old female patient, with no known drug allergies, who on 11-JUL-2007 was vaccinated IM in the left deltoid, with the first dose, 0.5ml, of GARDASIL (Lot #658222/0927U). Concomitant therapy included LOESTRIN. On 11-JUL-2007, 10 to 15 minutes after the vaccination, she felt dizzy and lightheaded, and also seemed to be confused. She was observed in the physician's office for 45 minutes, examined by the nurse practitioner, and then went home as she stated she "felt fine". On 12-JUL-2007, the patient called in the morning and complained of dizziness and lightheadedness when she arose. She was referred to the emergency room for follow up if the symptoms continued, however the MA confirmed that the patient had recovered on 12-JUL-2007, 20 minutes after she woke up. The reporter clarified that the events of dizziness, lightheadedness and seemed confused were considered to be non-serious events. No further information is expected.
diarrhea;  fever; has chills;  is vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA ( fever), CHILLS ( has chills) and VOMITING ( is vomiting) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B NOS, VITAMIN E NOS, FISH OIL;VITAMINS NOS and MULTIVITAMINS, PLAIN for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIARRHOEA (diarrhea), PYREXIA (fever), CHILLS (has chills) and VOMITING (is vomiting). At the time of the report, DIARRHOEA (diarrhea), PYREXIA (fever), CHILLS (has chills) and VOMITING ( is vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication was provided.
59kg 14 yo M with NKDA and PMH of headaches had a syncopal episode after receiving first Covid19 vaccination in left deltoid at 1458 5/14/21 (lot # EW0179) .  Patient described feeling light headed and does not recall losing consciousness.  Fell face side down and had trauma of right knee and nose and above the left eye.  Bruising on his nose.  Reportedly hit the metal base of the curtain that separated the vaccination area from the observation area.  EMS called for concern of facial fractures.  BG 98/48 and HR 75 with O2 sats 99% post event.  EKG negative.  BG within normal limits.    Patient did have sustained loss of consciousness.  Followup BP 101/69 with HR 77.  Event attributed to vasovagal reaction.
Pt's wife states that pt became confused 6 hours post vaccination. Pt refuses to be seen in the ED, despite concerns for stroke or neurological deterioration
Fever chills, fever to 101 F with 1000 mg tylenol Narrative:
Dose 1: 01Apr2021, Dose 2: 15Apr2021; Extremely enlarged lymph nodes: left collarbone, neck; The lymph nodes have been sore and enlarged (about a golf ball size) for more than 8 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the right arm on 15Apr2021 at 14:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced extremely enlarged lymph nodes in the left collarbone, neck. The lymph nodes had been sore and enlarged (about a golf ball size) for more than 8 weeks. The issue remained the same. The blood test did not detect any issues. The events resulted in a visit to the doctors or other healthcare professional office/clinic. Therapeutic measures were not taken as a result of the events. On an unknown date in 2021, the patient underwent blood test and the result was the blood test did not detect any issues. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely enlarged lymph nodes: left collarbone, neck and the lymph nodes have been sore and enlarged (about a golf ball size) for more than 8 weeks was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
8:30 pm. Dizziness, HA, chest pain, chills, labored breathing. 10 pm. Went to ER - lips swollen, slurred speech, increased HR & CP. No treatment given, just monitored.
Pt left exam room after receiving vaccines. Pt was witnessed by father, fainting in hallway. Pt carried to exam table, legs elevated, BP/HR monitored, given juice and cold compress. Pt A and O x 3 and MAE.
Tired; Shortness of breath with slight exertion; Increased swelling in face; Increased swelling in hands, legs; Increased swelling in ankle; Weight gain; Sensitive mouth; Slight fever; Headache; Pain in ankles; Pain in face; Pain in hands, legs/ sore arm; This is a spontaneous report from a contactable other HCP of pharmacy reported for a consumer.  A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 52-year-old) as dose 2, single for covid-19 immunization. Medical history included renal cancer. The patient concomitant medications were not provided. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 52-year-old) as dose 1, single for covid-19 immunization and experienced no reaction on previous exposure to vaccine. Patient also had Sutent 50 mg/daily orally for 4 weeks on, 2 weeks off at start Oct2020 to current, 50 mg/daily for 2 weeks on, 1 week off per md verbal order since Jan2021 for renal cancer. Written order now matches as of May2021. On an unspecified date, patient experienced being tired, shortness of breath with slight exertion, increased swelling, pain in hands and legs, sore arm, pain in ankles, pain in face, weight gain, sensitive mouth, slight fever, headache after second covid vaccine 2 weeks ago but that was better seeing, with lab next week and plans to discuss. The outcome of the events was reported as unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A 23-month-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jul2022 as dose 2, single (Batch/Lot number: unknown) at the age of 23 months intramuscular, in left leg for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 Immunization. The following information was reported: SWELLING OF EYELID (non-serious), ERYTHEMA OF EYELID (non-serious) all with onset 22Jul2022, outcome "unknown" and all described as "unilateral upper eyelid swelling with redness". The event "unilateral upper eyelid swelling with redness" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of swelling of eyelid, erythema of eyelid. Additional information: No other vaccine in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. Unilateral upper eyelid swelling with redness. Received 2nd Pfizer dose in Left leg with development of left upper eyelid swelling and redness Day 2 post vaccination. No involvement of conjunctiva, no style, no changes in vision and no pain with extraocular movement. Treated with cool compress, antihistamine, over-the-counter pain medication as needed. Follow up with pediatrician with strict return precautions. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swelling lead to a superficial clot and later a DVT; left leg started to swell on occasion and go back down; swelling lead to a superficial clot and later a DVT; This is a spontaneous report from a contactable consumer or other non-healthcare professional reporting for himself (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EWO158, expiry date unknown) via an unspecified route of administration in left arm on 06Apr2021 (at the age of 49-year-old) as dose 2, single for covid-19 immunization at a Public Health Clinic/Military Administration facility. The patient medical history included severe case of COVID in Jan2021 on an unknown date and was allergic to sulfa. Patient's concomitant medications included carvedilol and levothyroxine sodium (SYNTHROID). The patient previously took first dose of BNT162B2, formulation: solution for injection, Lot Number: ENG208, expiration date: unknown) via unknown route of administration in left arm on 16Mar2021 (at the age of 49-year-old) as dose 1, single for covid-19 immunization. No other vaccines were administered within four weeks. On 20Apr2021, patient stated after second dose in Apr2021 his left leg started to swell on occasion and go back down (Thrombophlebitis leg). He started going to the doctor in Jun2021. This swelling lead to a superficial clot and later a Deep vein thrombosis (DVT). The patient hospitalized due to the events and AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test (PCR; Nasal swab) negative on 09Sep2021. Therapeutic measures were taken as a result of events and treatment included Advil then Xarelto. The outcome of all events was recovering.  Follow-up attempts are completed. No further information is expected.
Myalgia, Arthralgia, inj site sore, muscle aches, joint pain, flu-like symptoms, fatigue, tiredness Narrative:  muscle aches, joint pain all over body, tired and fatigue; self admin ibuprofen on day 3 and 4 with good results
Sometimes they are accompanied by raised skin; Hives are very itchy; Hives on her torso, back of her legs, and upper arms; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Sometimes they are accompanied by raised skin), PRURITUS (Hives are very itchy) and URTICARIA (Hives on her torso, back of her legs, and upper arms) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A, 046B21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced SKIN MASS (Sometimes they are accompanied by raised skin), PRURITUS (Hives are very itchy) and URTICARIA (Hives on her torso, back of her legs, and upper arms). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SKIN MASS (Sometimes they are accompanied by raised skin), PRURITUS (Hives are very itchy) and URTICARIA (Hives on her torso, back of her legs, and upper arms) outcome was unknown.            Patient started hives which randomly appear and disappear.These episodes lasted 10-15 minutes.  Concomitant product information was not provided   This case was linked to MOD-2021-090609 (Patient Link).
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Before giving the vaccine, I asked the patient the questions on the vaccine consent and administration record. Then, I further asked the patient if she had any problems with the flu shot in the past. She said no. The patient was seated and I was seated beside her. Once I gave the patient her vaccine, she got really nervous. I stated that she was done and she did great. The patient then stated that she was terrified of needles. She remained seated for a few moments then walked away. Once of my technicians clocked out for the day and noticed the patient had passed out at the end of the aisle. She notified me and I immediately went to be with the patient. When I got to her, she stated that she was fine and was sitting up. She remained in the floor for about 5 minutes. Another customer grabbed her a water. I came back to the pharmacy to get the manager of the store. The patient asked if she could sit in the chair for a few more minutes and I said absolutely. The patient stated that she was fine and did not hit her head. I made small talk until the manager came to fill out an incidence report. This is when the patient stated this is the 5th time this has happened. She stated that she got her flu shot last year with no problems and thought she grew out of it. Patient and her husband both stated that she was fine. I stated that I would be filling out the VAERS and that store management would need to fill out a report as well.
Itchy 7 cm  erythematous raised eruption at site if injection, 12 cm in diameter total induration, left axillary tenderness. Onset 24 hours after injection. Also malaise and myalgias.
Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  Treatment medication included taking Valtrex for the past 7 days.  The patient was currently scabbed over and scheduled for his second dose on Saturday. He should have 1-2 days left of his Valtrex treatment at the time of vaccination.   This case was linked to US-MODERNATX, INC.-MOD-2021-025136 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-025136:Cross linked case
24-36 hours after the first vaccine was administered, I've been having the following symptoms: intermittent dizziness; migraine headaches; lower back pain; rib cage pain; lower abdomen pain; upper legs pain. The symptoms are present to this day.
pt recvd vax & pt devel redness, tenderness & warmth @ the inject site;
On 4/4/02, the vaccinee received a booster dose of Engerix-B (lot ENG5272B2; expiry 8/29/03). The dose number in the series was unspecified. Two days later, she experienced rash on her trunk, but not at the vaccine site. The pt had been taking Benadryl "with no relief". As of 4/15/02, the event was ongoing.
I had my vaccine with no health event. No side effects maybe a sore arm. When I had Covid I had running nose, sore throat, I got diarrhea after the end of November, but when I COVID-19 it was worst, it turned to be Micro Colitis, I also had, minor fever 99 degrees.
A non-serious spontaneous report of 55 year old got a dose of H1N1 LAIV was received from a registered nurse/ health professional concerning a 55-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 02-Dec-2009, the patient received H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Sore arm day 1 and 2. Day 4 joint pain on lower half of bodies. Cough during night only for past 10 days. More body aches and headache.  Middle of the night on 21 st fever, severe body aches, chills, bone pain, got rapid test for covid negative, negative for flu, and strep, fatigue, headaches continued until today. Still have mild body aches.
The second day my heart begin hurting. My chest felt heavy and I had a constant noticeable pain in the middle of my chest. This last for a approximately a week. On 12/21/2021 I started to feel under the weather with common cold symptoms, and again, my chest begin to hurt. I noticed that when I took over-the-counter medicines to help with the cold symptoms it helped with the chest pain, but it didn't go away entirely (more mild, but still noticeable).
Patient felt fine day of shot.  Next day started to experience muscle tightening, flulike symptoms, scratchy throat, leg numbness, dizziness, cold sweats, shortness of breath and headaches.  She was seeking care today, 7/15.  I advised patient to go to hospital.
Mom reported 8 hrs possibly more of inconsolable crying began about 6 hrs p/immun; Temp to 103 rectal; No sz, stiffness, hypotonia; moderate local erythema, induration;
60 yo female pt s/p J&J COVID vaccination on 5/3. PMH significant for COPD, Bipolar, Hepatitis C, HTN, hx osteomyelitis s/p 2nd toe amputation, and polysubstance use disorder coming in with shortness of breath, fever, chills and found to have COVID 19. No evidence of PNA on imaging or exam. However, did have orthopnea and elevated BNP so concern there may have been component of CHF exacerbation on admit. Pt was started on remdesivir given comorbid risk factors. At discharge patient was hemodynamically stable and on room air.