chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Friday around  5:30pm a  headache began  and then tongue swelling began around midnight Then the  swelling of tongue went away around 3pm on Saturday afternoon.  On Saturday The nausea and diarrhea started around 7:30am and subsided by 9am. The headache went away by Sunday afternoon.
This spontaneous case reported by a consumer, describes the occurrence of gastric disorder (stomach problems) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced gastric disorder (stomach problems). At the time of the report, gastric disorder (stomach problems) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Headache, Myalgia, NauseaVomiting, HEADACHE, CHILLS, BODY ACHE, NAUSEA
Burning eyes; Burning nose; Severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning eyes), THERMAL BURN (Burning nose) and ARTHRALGIA (Severe joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced EYE IRRITATION (Burning eyes), THERMAL BURN (Burning nose) and ARTHRALGIA (Severe joint pain). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) at a dose of 1 dosage form. At the time of the report, EYE IRRITATION (Burning eyes), THERMAL BURN (Burning nose) and ARTHRALGIA (Severe joint pain) had not resolved.            Concomitant medications were not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow up received and does not contain any new information.
Probably unrelated but the next day I experience a left upper eyelid stye (swelling)
This spontaneous report was received from a physician via a company representative refers to a 14 year old female patient. On an unknown date the patient was vaccinated with her third dose of GARDASIL (dosing regimen unspecified). No concomitant medications were reported. The physician reported that 6 months after receiving her third dose of GARDASIL, an unspecified patient had warts on her hand. There was no product quality complaint involved. The outcome of had warts on the hand was unknown. Causality assessment was not provided. Additional information has been requested.
Fever; Aches; Tiredness; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain and tiredness. On an unknown date, the outcome of the fever, pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the fever, pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received 2nd dose of Shingrix vaccine and experienced fever, aches and tiredness. The patient wanted to know how long these events might last. No further information was reported.
Event occurred after 2nd vaccine. First vaccine was on 2/18/21 and the second one on 3/18/21. Pt tested positive for COVID-19 on  11/22/21.
sore arms at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (mild case of shingles experienced in 2008).   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:     The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had sore arms at the injection site. The patient commented that patient was glad to receive the dose. For tolerance of 2nd dose, refer case US2021AMR025883. This case has been linked with US2021AMR025887 and US2021AMR025893, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025887:same reporter US-GLAXOSMITHKLINE-US2021AMR025893:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same patient, same reporter, 1st dose
Patient participated in a COVID vaccine clinic at his workplace. Received a COVID vaccine and was discovered through the state health tracking that it was his 4th dose.
fatigue, soreness, cold chills, cold symptoms, chest tight, fever, severe muscle spasms
fever; Initial information regarding an unsolicited valid serious case was received from the other health care professional via Regulatory Authority (Reference number- 00685816) and transmitted to Sanofi on 16-Jul-2021.  This case involves a patient (unknown demographics) who had fever (pyrexia) after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Information on concomitant medications was not reported.  On an unknown date in Jan-2017, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5216AA; expiry date: 06-Jun-2019) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) the patient developed a serious fever (pyrexia) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for this event.  It was reported, "They have been advised to research the ingredients of the Adacel at that time to compare to the ingredients of the COVID 19 (corona virus disease -19) vaccines. Is that something you would be able to assist me with"  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.; Sender's Comments: This case concerns a patient (unknown demographics) who had pyrexia after vaccination with ADACEL. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
pt recvd vax & devel redness & swelling was approx 3" long & 1 1/2" wide; inflamation had spread to be about 6 long; called urgent care they recommended hot compresses & APAP;
Had stroke 20 days after flu shot. Prior to Oct. 10-2015 I was active and in good health, driving and doing all the shopping plus charity work, gardening and canning and freezing all summer, life was good then on Sept. 21-2015 I got the flu shot and 20 days later I had a stroke on the left side and was in the hospital 13 days, prior to that I always had low blood pressure and still don't have clogged arteries, no strokes in my family history. I always got my flu shot every year but not like the one they gave me this year. The medicine I was taking at the time before I got the shot SYNTHROID 75 mg 1 tablet a day, RELAFEN 500 mg 1 a day, omega 3 fish oil 2 a day, lutein 25 mg 1 a day, multi. vit 1 a day liquid calcium 600 mg daily, B-12 injection 1 cc each, estrogen 1/2 tablet daily. Now I'm on COUMADIN 10 mg daily and blood pressure 1/2 tablet daily. I can't walk, cook, clean or do much of nothing. I'm getting therapy at home 4 times a week I'm not able to go to them. I thought you needed to know what happened to me after the flu shot. I am allergic to statin drugs.
Adult failure to thrive, weakness. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
become cold; temperature which was recorded at 99.9 F / increased to 100.; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2020, the patient received the 2nd dose of Shingrix. In May 2020, 9 hrs after receiving Shingrix, the patient experienced feeling cold and fever. The patient was treated with analgesic, nos (Pain Reliever (Drug Name Unknown)). On an unknown date, the outcome of the feeling cold was unknown and the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the feeling cold and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix around 3 pm in right arm from a local pharmacy. At midnight, the patient started to become cold and grabbing a blanket. At that time, she also checked her temperature which was recorded at 99.9 Farhenite.  On 22nd May 2020, morning after waking, fever increased to 100.6, and the patient suspected this might be due to sleeping with the additional blanket.  The patient reported fever reduced back down to 99.9 F and had taken extra strength pain reliever for fever relief.  The patient made a doctor's appointment and due to symptoms office wants to see her to rule out Covid-19.  The patient mentioned not having a physician but had made an appointment due to fever. She might consent for follow up to be sent to physician she would see on the day of reporting.
Vomitting, Diarrhea, Chills, Body Aches and Headache
Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage  Pt. non oriented & unable to give history - History provided by S.O and daughter
It's gotten really red and itchy; It's gotten really red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It's gotten really red and itchy) and PRURITUS (It's gotten really red and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (It's gotten really red and itchy) and PRURITUS (It's gotten really red and itchy). At the time of the report, ERYTHEMA (It's gotten really red and itchy) and PRURITUS (It's gotten really red and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients received improperly stored (Oka/Merck) VARIVAX (route, dose, frequency and lot # not reported). No adverse effects were reported. Additional information has been requested.
Physical exhaustion; No appetite; Body aches; Fever of 104.1/Fever of 102 throughout the day; No sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (No sleep), DECREASED APPETITE (No appetite), MYALGIA (Body aches), PYREXIA (Fever of 104.1/Fever of 102 throughout the day) and FATIGUE (Physical exhaustion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Type of test: PCR) on 30-Nov-2020. Concurrent medical conditions included Seasonal allergy and Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 05-Jan-2013 to an unknown date for Anxiety, DROSPIRENONE, ETHINYLESTRADIOL (SYEDA) from 05-Jan-2012 to an unknown date for Birth control, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 05-Jan-2020 to an unknown date for Seasonal allergy.   On 24-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (No sleep). On 21-Apr-2021 at 3:00 PM, the patient experienced PYREXIA (Fever of 104.1/Fever of 102 throughout the day). On 22-Apr-2021, the patient experienced DECREASED APPETITE (No appetite) and MYALGIA (Body aches). On 23-Apr-2021, the patient experienced FATIGUE (Physical exhaustion). The patient was treated with ACETAMINOPHEN for Fever, at an unspecified dose and frequency. On 22-Apr-2021 at 12:00 PM, PYREXIA (Fever of 104.1/Fever of 102 throughout the day) had resolved. At the time of the report, INSOMNIA (No sleep), DECREASED APPETITE (No appetite), MYALGIA (Body aches) and FATIGUE (Physical exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test: positive (Positive) positive. On 21-Apr-2021, Body temperature: 104.1 (High) 104.1. On 22-Apr-2021, Body temperature: 102 (High) 102.         No treatment information was provided by the reporter for rest of the events.   This case was linked to MOD-2021-146059 (Patient Link).
Same day post vax, the pt complained of lip swelling and left cheek edema.  At 10:00 am the pt's lungs were clear bilaterally, heart rate 160, left upper lip edema and mild left cheek swelling noted. Sent to ER and received liquid medicine. Dx with hives.
About 11 minutes after her second dose of Moderna vaccine, patient reported seeing floaters and having tunneled vision. She felt light headed and flushed. Blood pressure was checked and BP was 77/43, P70s, O2 sat 98%. Patient was put in supine position and rapid response was called. Given no respiratory compromise, no angioedema, and no hives, epinephrine was not administered. Felt to be vasovagal event. BP recovered up to 120s/80s. Patient was observed in clinic for 2 hours and had 3 more episodes of lightheadedness but BP remained >90s/50s. She was given juice, crackers as she had not eaten for 4 hours prior to vaccination. She was sent home with family member for observation.
Patient presented on Monday 5/10/21 with site reaction with redness, swelling and pain. The redness was approximately 3 inches diameter at site of injection. Patient complained of pain, fever and chills that began Friday, 5/7/21. Patient states she is still experiencing pain and burning at injection site.
pt recv vax 26NOV97 & w/in 10min of vax pt exp numbness & tingling of the lips, vertigo & abd pain which persisted throughout the day;also exp inj site pain when laying upon the arm which was vaccinated;
Mom called office on 7/19/01, stating pt's right thigh was red, warm and swollen to softball size. No temperature, SOB or N/V. States pt voicing no complaints. Told to ice and give analgesics. On 7/24/01, mom called to follow-up with pt's status. States pt is better. No redness or warmth but continued with hard, swollen, quarter-sized area.
Patient developed green, mucousy, bloody stools the night after receiving her first dose of Rotateq.  She continued to have such stools for 3 days.  Throughout this course she did not have fever, diarrhea, vomiting, or severe abdominal pain.  She came into the office on the second day and the stool was tested and was heme positive.  As the patient was exclusively breastfeeding, we asked mom to eliminated milk, soy, and wheat from her diet for presumptive allergic colitis.  No other interventions were performed.
I am not certain this had anything to do with the vaccine, but mentioned it on a text report.  The CDC contacted me today and asked me to report the following:  Heart palpitations began the morning of 4/9/21.  They continued in frequency until 4/18 when I went to the ER to confirm that these were benign PVC's, having had one or two prior instances of these 15-20 years ago.  It was later confirmed that they were still benign PVC's.  Prior to the palpitations beginning, I experienced the following:  the evening of 3/16 my lips were red and  inflammed a tiny bit.  This can happen (rarely) after eating something so I attributed it to that.  The following morning, lips were still a little reddish, and I was very anxious (my typical reaction to allergies).  Again I thought I must have eaten something so I bought some Benedryl and took it.  It took another does later to get me back to normal.  At the time I did not attribute this to the vaccine altough in retrospect, who knows?  By 3/29 I am experiencing seasonal allergy symptoms - itchy eyes, runny nose and slightly constipated.  I again did not attribute this to the vaccine but rather to going on a trip later than normal and attributing it to vegetation that I don't normally see because we are usualy home. This continued up until the palpitations began.  The palpitations finally tapered off and stopped in  July.    When I received my booster on 11/4, I had a few palpitations again but they were fleeting.    Other than a very slight fever with the booster, I didn't see anything else.  I wouldn't have thought to fill this form out but since the CDC asked, I have done so.
12 hours later and lasting 24 hours: flu like symptoms. Headache, nausea, chronic fatigue, chills, dizziness, vertigo.  12 hours later and lasting to present day: Dizziness/Vertigo while performing physical activities. Vertigo lasts for 3 seconds, feels almost like I will pass out, have to take deep breaths, goes away in 3-5 seconds. This vertigo started after vaccination and is still happening. Vertigo was frequent, daily, multiple times a day for a month, recently vertigo happens once per day, maybe once every other day.
When I first woke up, I felt like I had a chill. It didn't last very long. That happened a couple of times during that period after the vaccine. I don't recall having anything else, really. The site was a little sore and that only lasted a couple of days. I did not see any rashes at the time. Later on down the road, I began to experience these areas around my chin kind of like acne. They were like cysts. I still have them, but I don't know why I'm having them. I am not sure if it is because of the vaccine. I did not address my symptoms with my doctor when I saw my doctor. I see my doctor every 3 months for a check up. I thought I just needed to exfoliate my skin.
Fatigue, lip sores 06/5/2020, Rash left side of face 06/06/2020 & 06/07/2020  Appointment with clinic Doctor 6/0702020, Treatment of antiviral and prednisone for5 days
Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 25 year old female with no drug allergies and had recently immigrated from other country and a PPD had converted but a chest X-ray was negative so she had been referenced to the tuberculosis clinic (possible latent tuberculosis vs. exposure) who on 23-FEB-2010 was vaccinated at the health department with the first 0.5 mL dose of VARIVAX (Merck) (LOT# not reported). There was no concomitant medication. It was reported that the patient now was pregnant; and ultrasound had not been performed yet but was being scheduled. The pregnancy was confirmed by positive home pregnancy test and later confirmed by positive urine pregnancy test. The LMP was possibly on 20-JAN-2010; EDD is approximately on 27-OCT-2010. The patient would possibly need to be treated with isoniazid and vitamin B-6 for tuberculosis. Prenatal vitamins had started. Follow-up information has been received from a completed questionnaire, the physician concerning the female patient with none previous pregnancy history and positive for TB scan test before currently pregnancy (not on anti-TB medications for now) who during this pregnancy was taken prenatal vitamin with folic acid and pynoxide 1 tablet once a day from 09-APR-2010, and ferrous sulfate, 325 mg once a day indication for anemia from 10-SEP-2010. There was no complication during pregnancy or complication during labor/delivery or infections/illnesses during pregnancy. Monthly ultrasound for pregnancy performed on 22-APR-2010, 24-JUN-2010 and 08-OCT-2010 were normal. On 24-OCT-2010 at the 39 weeks from LMP, the patient delivered a male infant, weight 6 pounds and 6 ounces. The male infant was healthy with no congenital anomalies or other complications/abnormalities. Additional information has been requested.
Starting about 5 or 6 hours after the injection I became extremely tired and that persists through today, 7 days later. At times, I found even a small exertion like walking up a couple of flights of stairs to be exhausting. At times my head felt buzzy, although I haven't had a fever. At times I also felt fine but then would relapse. My sleep has also been erratic, although not very good normally. Arthritic joints are more painful.
A Covid vaccine (Moderna) was being given to a pt and as soon as the staff member went to inject the vaccine the needle separated from the syringe leaking the vaccine out and the needle hit and broke the skin of the staff members thumb before hitting the ground. Both the pt and staff member had labs drawn and saw a medical provider. The pt was given another vaccine by a different staff member since the other vaccine leaked out before entering her arm.
No additional AE reported; an improperly stored dose of VAQTA was administered to a patient; This spontaneous report was received from a Licensed Practical Nurse and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date in May 2022, the patient  was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #U033212, expiration date: 07-NOV-2022) administered for prophylaxis (strength, dose, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of above 9 degree Celsius (9.04 degree Celsius) for a time frame of 30 minutes. There were no previous temperature excursions. No additional adverse effects were noted.
Approximately 31 hours after getting the 2nd dose, felt tingling feeling in pit of stomach area that would go outward and throughout entire body from that starting point. This continued for approximately 90 minutes. My 18 year old daughter experienced the exact same feeling after her 2nd shot. Also had the COVID rash after 48 hours.
Flu shot given about 1:30 pm on 10-29-14, she started turning red from head to toe shortly after. At 3:30 pm Dr checked her and ordered SOLU-MEDROL 125 mg and BENADRYL 25 mg.
A day or two after receiving the vaccines rash developed on right abdomen and left ribcage. The rash has spread to most of my abdomen (below the breast and above the bikini line) and on most of my back