chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling spaced out; Lightheaded, woozy when standing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded, woozy when standing) and FEELING ABNORMAL (feeling spaced out) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Lightheaded, woozy when standing). On 25-Jul-2021, the patient experienced FEELING ABNORMAL (feeling spaced out). On 25-Jul-2021, DIZZINESS (Lightheaded, woozy when standing) had not resolved. At the time of the report, FEELING ABNORMAL (feeling spaced out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications was reported.   No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up information received contains significant information the adverse event feeling abnormal updated.
My COVID-19 symptoms began on 02/06/2023 in the morning. I had green diarrhea, constant cough, and fatigued. I took a home COVID-19 test which was positive in the morning. I then visited the ER where they gave me an option to take the anti viral infusion but the doctor advised me not to take it because I was in a perfect health. At the ER they also did COVID-19 test which was positive. I had no chest congestions or other health problems. I didn't take any medication and I recovered within 4 days. My body fought the infection by itself.
Severe diarrhea for three weeks so far.  Does not respond to Imodium, BRAT diet, Probiotics.
Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, painful making legs feel like 2 cement blocks to walk.  Both shoulders were inflamed and muscles locked causing difficulty in mobility.  Both hip joints felt irritated, the left more aggravated and painful. Also the body experienced being tired and sluggishness  needing more than usual sleep. This lasting about 8 days. Treatment: ActivIce/Biofreeze spray several times daily and elevation to release pressure and blood flow.
Gave Comvax which has Hib and ActHib. Should have given Comvax and DTAP. Called Mother day after immunization were given and she states child is "fine" only symptom is a low grade fever.
2.5 cm circular area of what appears to be shingles on (R) thigh at site of Varicella vaccine - received vaccine 10/11/11 - shingles appeared 10/12/11.
Approximately 10 minutes after vaccine, Patient passed out, difficult to arouse.  Vital signs were taken.  Patient eventually aroused, EMS called.  Patient awake and alert at time of transport.  Patient transported to local hospital.
A patient received their 2nd Moderna vaccine dose 21 days after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received their 2nd Moderna vaccine dose 21 days after the 1st dose) in an adult patient of an unknown gender 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received their 2nd Moderna vaccine dose 21 days after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received their 2nd Moderna vaccine dose 21 days after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Reported that patient was over 18 years of age.
lt arm is tender @ site of inj w/weakness lt arm i.e. lifting, stretching, flexing muscle; constant tenderness; denies redness, swelling;
8 patients received a dose from a vial that was expired / vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature / received doses from the same via yesterday 22JUN2021 between 9am and 6:19pm; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients received a dose from a vial that was expired / vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature / received doses from the same via yesterday 22JUN2021 between 9am and 6:19pm) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received a dose from a vial that was expired / vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature / received doses from the same via yesterday 22JUN2021 between 9am and 6:19pm). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients received a dose from a vial that was expired / vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature / received doses from the same via yesterday 22JUN2021 between 9am and 6:19pm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not provided.  8 patients received a dose from a vial that was expired, Pharmacist states the vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature. Some patients received doses from the same vial yesterday 22JUN2021 between 9am and 6:19pm. Of the 8 patients, 6 received the vaccine within 24 hours and 2 patients received it about 26 hours after it was punctured at room temperature. Caller states that none of the patients have reported any adverse events.
Pharmacist reports he was administering a dose of Arexvy, the patient jumped during administration and some of the vaccine squirted into his right eye; Splash of Arexvy in right Eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while administering product in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 59K92, expiry date 26-MAR-2025) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On 13-NOV-2023, an unknown time after receiving Arexvy, the patient experienced occupational exposure while administering product (Verbatim: Pharmacist reports he was administering a dose of Arexvy, the patient jumped during administration and some of the vaccine squirted into his right eye) and exposure via eye contact (Verbatim: Splash of Arexvy in right Eye). The outcome of the occupational exposure while administering product and exposure via eye contact were unknown.  Additional Information: GSK Receipt Date: 13-NOV-2023 The pharmacist reported he was administering a dose of Arexvy, the patient jumped during administration and some of the vaccine squirted into his right eye, which led to occupational exposure while administering product and exposure via eye contact.  The pharmacist would be open to any safety follow up.  The reporter did not provide date of birth. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023157051:
Outbreak of urticaria approximately 5-7 days post injection #1. Had several months of no hives prior to shot but presented with a significant amount urticaria afterwards and through second shot. Weals on legs (primarily) but also trunk, lower arms, back of neck, check/face. Minimal angioedema in eye areas but only occasionally on random days.  Symptoms (urticaria) present past four days post shot #2 but easing in severity, amount, and duration
Muscle twitching.  Initially started in the chest muscles, then eventually spread throughout the body.  Now one year later, the symptoms persist and may be getting worse.  They are most pronounced in the calves, arms, temples, and eyelids.  Taking B12 and magnesium supplements without improvement.  Seeing a neurologist, but thus far nothing has been diagnosed.    Tinnitus also occurred, most noticeable a few weeks after the vaccination.
About a month after the second dose of the COVID19 (Moderna) I experienced rapid changes in heart rate about 15 to 20 minutes into a workout on an elliptical machine.  I have been working out on an elliptical machine 3 times a week regularly for several yeato rs.  After I experienced the second episode I went to the ED.  History and evaluation found no elevation in troponin concentration.  The ECG was abnormal; it revealed a partial bundle branch block--a new finding compared to previous ECGs.  Discharge diagnosis was ventricular tachycardia with a recommendation that I see my primary care physician for further evaluation.  I continued to experience similar episodes intermittently during workouts on the elliptical machine until sometime in August 2021,  Since then, I have not experienced similar episodes.
Information has been received from a physician concerning a 12-month-old female who on 24-AUG-2007 was vaccinated with a dose of PROQUAD (lot# 658187/0790U).  On 28-AUG-2007 the patient was seen by the physician for a fever of 101F.  In the evening of 28-AUG-2007 the patient had a seizure.  No other seizure activity reported.  No treatment rendered.  No product quality complaint was involved.  Follow-up information has been received concerning a white, 12-month-old female with no pre-existing allergies, birth defects or medical conditions.  On 24-Aug-2007 between 10:30 and 11:00 AM the patient received a first dose in the left arm of PROQUAD (lot# 658187/0790U), and a third dose in the left thigh of PEDVAXHIB (lot# 655546/0075U).  Additional vaccination included a fourth dose of PREVNAR (lot# B26570E).  It was reported that at the time of vaccination the patient had viral syndrome.  On 28-Aug-2007 the patient had a generalized tonic clonic seizure lasting approximately 2 minutes with post-ictal state lasting approximately 5 minutes.  Unspecified medical attention was sought.  The patient recovered from the grand-mal convulsion on 28-Aug-2007.  It was also reported that the patient and her sibling have had no adverse events following prior vaccinations.  Upon internal review, grand-mal convulsion was considered to be an other important medical event.  Additional information is not expected.
Significant swelling to left bottom lip, left foot, and left arm. Swelling began around 5pm on Dec. 14th, and lasted approx. 8 hours.
None that we are aware of. This report is because this individual has been vaccinated a total of 7 times with COVID vaccines, 2 doses of Moderna, 2 doses of Pfizer, and 3 doses of Janssen. He has presented at different clinics to get vaccinated. Tried to get vaccinated again over this past weekend, and was turned away, when his record in the medical records was reviewed and it was found that he had multiple doses of the vaccines.
weakness, tachycardia, elevated blood pressure, irregular heart beat including gallops, chest pain, nausea and shortness of breath in otherwise healthy & athletic male. This took several weeks to return to normal
I had headaches most of my life since junior high. 2 days post vaccine, 10/09/2021, headaches were different and did not respond as well to medication. They were more frequent and stabilized a little bit a week later. 10/15/2021, they still did not respond to my normal taking the medications. Now they are more frequent prior to the vaccine, but I can still manage them. I self-managed the headaches. On 11/03/2021, when I was on military orders, I took the flu vaccine, and the headaches became significantly worse on 11/04/2021. On11/05/2021, I went to talk to one of the doctor's suite surgeons office. The doctor gave me 400 mg of Ibuprofen.  The flu vaccine coupled with the J&J, I wasn't sure if it was an interaction with both vaccines that caused my headaches to become worse, because I never had an adverse reaction to the flu vaccine in the 20 years in the military. I still get the headaches, but it went back to the consistency to the post J&J vaccine headaches. Not back to what I normally deal with.
Moderna COVID-19Vaccine EUA Vaccinated shoulder, arm, armpit, neck and part of shoulder became very swollen. A severe rash developed with an itching and burning sensation. It developed within 24 hours of vaccination and resolved 72 -84 hours later
I tested positive for Covid 19 on February 28, 2023 I experienced sore throat; congestion; fatigue; body aches. I was prescribed PAXLOVID for my symptoms.
0n 02/16/2001 the patient developed a "bad case" of chicken pox. There were about 120 lesions. Unspecified medical attention was sought. The patient has recovered. No further information is expected.
Loss of taste; Loss of appetite; Headache; Chills; Fatigue; A spontaneous report was received from a consumer concerning a 79-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, chills, fatigue, loss of taste/ageusia, loss of appetite/decreased appetite.  The patient's medical history included COVID-19 infection. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010M20A) for prophylaxis of COVID-19 infection.  On 9 Feb 2021 the patient experienced the events full  covid symptoms which included headache, chills, fatigue, loss of taste, loss of appetite.  Treatment details included paracetamol  Action taken with mRNA-1273 in response to the events was not reported.  On 12 Feb 2021 the outcome of events headache, chills, fatigue, loss of taste, loss of appetite was resolved.
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------------------  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/8/2021 HYPOXIA  ACUTE ON CHRONIC RESPIRATORY FAILURE 8/5/2021 HYPOXIA  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/12/2021 HYPOXIA  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/8/2021 UTI (URINARY TRACT INFECTION)  ACUTE ON CHRONIC RESPIRATORY FAILURE 8/5/2021 UTI (URINARY TRACT INFECTION)  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/12/2021 UTI (URINARY TRACT INFECTION)  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/8/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION  ACUTE ON CHRONIC RESPIRATORY FAILURE 8/5/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/12/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
Reaction started on the left side of the body, it was a red rash on the lower part of the abdomen. The forth day It then spread to the stomach, neck and arms. Now it is all over the body as a red raised bumps that itch and are hot to the touch. The doctor started me out on a cream triamcinolone acetonide and a hydroxyzine hcl 25 mg 1 tablet 3 time a day. and told me not to take the potassium due to a possible reaction between 2 of the medications. this is the 7 day and the skin of my stomach is hard to the touch itchy and sore as well as my neck. my arms have raised red bumps as well as my legs and back.
Very tired sleepy/back ache a lot of mood changes.  Rashes on arm and hands.
Client reported red raised rash to (R) forearm with pustules for 2 weeks saw doctor no treatment given.
Pimple like bumps started on lower front part of legs. Itchy, and spread.
fever: 3 days; headache: 2 days; stomach ache: ongoing; back rib pain: started on day 6; shooting pain in head: started on day 5
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and contusion. On an unknown date, the outcome of the injection site pain and contusion were unknown. It was unknown if the reporter considered the injection site pain and contusion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that typically after receiving SHINGRIX, the patients complained of some soreness at the injection site and mild bruising. The reporter included these non specific reports of events she heard of from patients in the past following SHINGRIX vaccine. This case has been linked with US2018171041, reported by the same reporter in which a specific patient presented with a completely different adverse event profile than these, which this reporter considers typical. No specific patient details were available about these more typical events.
Like the worst flu I ever had. Terrible chills, terrible body aches, fever. Lasted about 18 hours. Then mild fever, body aches and chills combined with crippling lower back pain for 18 hours. That was saturday and sunday. Today, monday, feel weak, lower back pain, sniffles. Stayed in bed all weekend. At my desk today at work, but would have preferred another day or two of bed rest.
Rash - 2 inch in diameter - still visible 7 weeks later - initially itching. Treated with hydrocortisone 1% and oatmeal poultices
LUMP UNDER LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1809878 expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On JUL-2021, Laboratory data included: Mammogram everything was normal. On 01-JUL-2021, the patient experienced lump under left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lump under left arm on 2021. This report was non-serious.
This spontaneous report was received from a registered nurse referring a 23 years old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PROQUAD injection, 0.5 ml, subcutaneously (lot number and expiration date were not reported). The registered nurse stated that a dose of VARIVAX was suppose to had been administered to the patient, but due to a human error, a dose of PROQUAD was administered; and she wanted to know what adverse effects to monitor. No adverse effects were reported and no product quality complaint was involved. Additional information had been requested.
Extreme Fatigue. Body aches. Intense painful stabbing pains constantly in various lymph node locations.(like armpits)Headache.  Chills. Lasted about 30 hours. Stabbing pains were so bad it woke me from sleep constantly. Interestingly I did not have the red rash I had after the first vaccine and I had no adverse affects at all after the first vaccine.
There was no adverse event. Pt received Tdap 13 months previously from physician and pharmacist unaware until after injection given.
patient had negative titers for Varivax; This spontaneous report was received from a physician concerning to a 22 years old, non-pregnant female patient. The patient had no concurrent conditions, medical history and concomitant medications  On an unspecified date in 1998, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, (dose, frequency, lot# and expiration date were not provided) for prophylaxis (reported as vaccine). On an unspecified date in 2007, the patient was vaccinated with an additional dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # and expiration date not reported).  On 17-APR-2020, a bloodwork (serologic testing) was drawn and results showed that the patient had negative titers for varicella virus vaccine live (oka/merck)(VARIVAX). The patient sought for medical attention, however no treatment was administered for this event. At the time of the report, the outcome of the event was not recovered.  The causal relationship between the event and varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
Patient is fully vaccinated. COVID positive 1/6/2022 at hospitalization.  79-year-old gentleman with past medical history significant for hypertension, diabetes mellitus type 2, history of dementia, history of chronic kidney disease, congestive heart failure, and obstructive sleep apnea. The patient presented to the hospital with chief complaint of cough, more confusion.  Initial workup in the emergency room showed creatinine level of 2.28.   CT head showed no acute intracranial process and chest x-ray showed no acute intrathoracic process. Treatment:  eliquis, protonix, steriods. Discharged.
Patient received second shot of Imovax 12 to 15 day later/with no AE; Initial information regarding an unsolicited valid non-serious case was received from a health Care Professional via Agency (Reference number- 00467936) and transmitted to Sanofi on 09-Feb-2021.  This case involves adult female patient who received second shot of RABIES (HDC) VACCINE [IMOVAX RABIES] 12 to 15 day later [Inappropriate schedule of product administration].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 25-Jan-2021, the patient received a first dose of suspect RABIES (HDC) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  This was a case of actual medication error due to Inappropriate schedule of vaccine administered (latency was on same day).  It was reported that, patient received prophylactic vaccine and had deviated from schedule. Patient who is received second pre-exposure vaccine today after having received first dose on 25-Jan -2021. Health care professional stated she had to went disconnected.  Product used : Used, Still using product : Yes.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
The next day sore arm, but was awaken with a fever. In the morning fever was 101.8. Midafternoon fever was 102.7. Very tired, took Tylenol, very nauseous. No appetite. Felt very weak for three days. Also, had heart palpitations. Went to ER. Ran EKG that was normal.