chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rec'd PNUPS (pneumococcal poly) 6/4. Reported she's developed rash & some wheezing. By 6/5 am -> onset of chills, dizzy, HA, malaise -> sent to ED. W/u for infection -> ID consulted - dx sepsis, RUE cellulitis. Fever, vomiting, tender, red site to shoulder. Tx vancomycin & AVELOX IV. Plan to dc on po antibiotic AVELOX 6/8 on 6/9/12.
severe h/a then nausea & severe vomiting;extreme nausea cont;pain in abd & chest;went to ER via husband transported;still had severe h/a;med given; hosp over noc on monitor;
This spontaneous report was received from a physician concerning an unspecified number of patients of unknown gender and age. On an unknown date the patients were vaccinated with ZOSTAVAX vial 19400 PFU. The physician reported that he had been purchasing ZOSTAVAX for about three years. He stated that he had a freezer in his office, so he freezes the gel packs which accompany his ZOSTAVAX shipments and store them that way while in the office. He stated that he then transports them to and from his home every day where they were stored in a residential freezer that did not have a thermometer that he stated that he believed was colder than 32 F. No adverse events were reported. Additional information is not expected.
blister like, itchy bumps on my arms that then spread to my legs; blister like, itchy bumps on my arms that then spread to my legs; This is a spontaneous report from a contactable Other Health Care Professional (Patient).  A 47-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 08:00 (at the age of 47-years-old) (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Diabetes, blood pressure, asthma, depression, anxiety and covid-19 prior vaccination, all from an unknown date and unknown if ongoing. Concomitant medication included alprazolam 25mg, acetylsalicylic acid 81mg (ASPRIN) and cranberry 500mg all drugs were taken for an unspecified indication, start and stop date were not reported. Patient had known allergies to statins, estrogen and Lisinopril. Patient previously took first dose of bnt162b2 (Lot number: EN6206) administered in Left arm on 12Mar2021 04:00 PM (at the age of 47-years-old) for covid-19 immunisation. Patient did not have pregnancy at time of vaccination. Patient did not receive any other vaccine in four weeks. The patient experienced blister like, itchy bumps on my arms that then spread to my legs on 09Apr2021 08:00, 1 week after second shot. It was reported that, she tried Benadryl first and that did not work then cortisone 10 and that didn't work. She even tried essential oils of lavender and teatime and that didn't work. Today (on reporting date) she went to urgent care and got a prednisone shot for the events. Post vaccination patient did not test for covid. The Outcome of events were not recovered.   No follow-up attempts are possible. No further information is expected.
I got really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got really sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if the patient had allergies to medications, food and other products. It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if the patient was given any other vaccines within 1 month prior to Moderna COVID-19 vaccine.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got really sick). At the time of the report, ILLNESS (I got really sick) had resolved.            No concomitant medications were reported.  The patient received the second full dose a month later after the 1st dose. After the second dose the patient got really sick. The patient said the adverse event got recovered and the symptoms improved.  It was unknown if the adverse event did cause the patient to seek medical care. It was unknown if the patient had experienced a similar event in the past.  The patient also received the first booster dose and reported that they didn't get that sick, though and it got recovered and the symptoms improved.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-608471 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-608471:Husband's case (Same reporter)
Moderna COVID-19 Vaccine EUA  Patient has no severe allergies to ingredients in the vaccine.   10 minutes after injection: severe increase in blood pressure, feelings of dizziness, severe nausea, heaving, sweating 8 hours after injection: feeling feverish, soreness near injection site, tiredness  Treatment: soft foods and cola to ease nausea immediately after injection
Morderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 7/28/21 and 8/25/21. Admitted 1/24/22 for acute hypoxemic respiratory failure 2/2 Covid PNA. Transferred to ICU 1/27 w/renal failure requiring dialysis, a-fib with variable ventricular response, severe septic shock on multiple pressors, severe hypercapnic and hypoxemic respiratory failure that required proning. Continued to decompensate with worsening shock and respiratory acidosis despite maximal ventilator settings. Transitioned to comfort care. Treated with remdesivir and decadron. Expired 02/08/22.
Soreness on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the injection arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), FLUOXETINE HYDROCHLORIDE (PROZAC), ROSUVASTATIN, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and VITAMINS NOS (MVI [VITAMINS NOS]) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness on the injection arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-292274 (Patient Link).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history reported. On 26-MAR-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot # K010628, expiration date: 30-OCT-2015) 0.65 ml, subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient is a 14 years old girl that was given the Janssen Vaccine that is only approved for 18 years and above  Vaccine was Given at the Facility where the mother works without authorization from Pharmacy so far no unusual or abnormal side effects has been reported
My legs /ankles started to swell. My body started to itch, particularly my legs and arms and middle around my waist and slightly higher. I got a rash. I took Benedryl every 4 hours starting around 7:45 pm on June 6th to present/ continuing to take.  I also took an extra Lasix (which was already prescribed for water in my legs.)  I also washed my legs, arms, middle in case there was some other allergen that had nothing to do with the shot and applied generic anti-itch cream every few hours.  The rash is going away.
vomiting; spiked a high fever; body aches/whole body was sore; felt like she had a stomach virus; flu-like symptoms; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting"; PYREXIA (non-serious), outcome "unknown", described as "spiked a high fever"; PAIN (non-serious), outcome "unknown", described as "body aches/whole body was sore"; GASTROENTERITIS VIRAL (non-serious), outcome "unknown", described as "felt like she had a stomach virus"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Sister of reporter had strong side effects after receiving Pfizer Covid-19 Booster. Individual experienced vomiting and spiked a high fever, body aches; "felt like she had a stomach virus during the night and one day of flu-like symptoms the next day"; whole body was sore, no localized arm soreness; chills, fever, throwing up. 37-Year-old female reporter received Pfizer COVID-19 doses 1 and 2: experienced arm soreness after both doses. When receiving the first dose, the person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly: "went it at an angle/" stabbed reporter a little" ; experienced arm soreness for the next couple of days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
experiencing a heavy cough, he did not have prior; he is coughing consistently; This is a spontaneous report from a Contactable consumer (mother reported for son). A 17-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration in arm left (at the age of 17 years old) on an unspecified date in Oct2021 as dose 1, single for COVID-19 immunization. Medical history included migraine. Concomitant medications included Amitriptyline for migraine. On 18Oct2021, the patient experienced a heavy cough, he did not have prior, he was coughing consistently. The patient received Mucinex as a treatment. The outcome of the event was unknown. This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Systemic: Fatigue-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-, Additional Details: Patient received first Moderna dose on 10/28/21 and received Pfizer dose 12/13/2021. Did not receive the same manufacturer for the first 2 dose series of the mRNA vaccines.
Janssen COVID-19 Vaccine EUA  Patient received Janssen vaccine 4/9/2021. Patient presented to ED 4/14/2021. Patient is a very pleasant 32-year-old  female, with past medical history significant for taking bromocriptine for prolactin issues as well as metformin for type 2 diabetes, presents to the emergency department for evaluation of continued headache over the last 1 week.  Patient also reports chills, sweats, body aches ever since receiving the Johnson and Johnson coronavirus vaccination 1 week ago.  The headache started after receiving the vaccination and has been continuing ever since.  It does not fluctuate in intensity.  It is caused her blurred vision and difficulty focusing.  No tinnitus or hearing loss.  No slurred speech, vomiting, numbness or weakness or tingling to the extremities or any facial droop.  No history of strokes or aneurysms.  She is not on blood thinning medication at all.  No upper nor lower extremity swelling or redness.  No abdominal pain, nausea, vomiting or diarrhea.  She reports the continued subtle shortness of breath and body aches since the vaccination as well.  No rapid heart rate, long flights, long car rides, surgeries nor oral contraceptive use. Patient started on heparin drip. Neurologist recommended transferring patient to higher level of care. emergency department physician is willing to accept the patient at their facility.  Patient transferred to the facility.
Tendernes at site of injection pm of injection.  Am 10/08/2012 pain, redness and swelling at site about 8x6 cm. By 10/09/2012 slight swelling, slightly pink.  Took Tylenol during this period.
High fever (up to 103 degrees) for three days, extreme muscle pain, joint pain, fatigue, brain fog, nausea, joint pain, weakness
Got shaky; Dizzy; Was burning up; Sleepy; Bacterial  infection; Viral infection; Talking kind of delirious; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Got shaky), DIZZINESS (Dizzy), BURNING SENSATION (Was burning up), SOMNOLENCE (Sleepy) and BACTERIAL INFECTION (Bacterial  infection) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (He had Covid on April and may), Wound and Surgery. Concurrent medical conditions included Fibrillation, COPD and Lung cancer.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (Got shaky), DIZZINESS (Dizzy), BURNING SENSATION (Was burning up), SOMNOLENCE (Sleepy), BACTERIAL INFECTION (Bacterial  infection), VIRAL INFECTION (Viral infection), CONFUSIONAL STATE (Talking kind of delirious) and PYREXIA (Fever). At the time of the report, TREMOR (Got shaky), DIZZINESS (Dizzy), BURNING SENSATION (Was burning up), SOMNOLENCE (Sleepy), BACTERIAL INFECTION (Bacterial  infection), VIRAL INFECTION (Viral infection), CONFUSIONAL STATE (Talking kind of delirious) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include Blood thinner.  Patient was prescribed with  antibiotics and tylenol for a bacterial infection or a viral infection, is not sure.  Patient had radiation therapy for lung cancer.  Treatment medications were not reported.
pt recvd vax;had rash on face,stomach head & upper legs;MD said it was dermititis, however 2nd rash on 15MAR, MD felt may be rxn to a component of vax;
Headache, nausea, diarrhea,  tiredness.    Started about 4 hours after dose . Diarrhea resolved about 24 hours later.  Tiredness and nausea resolved about 48 hours later
C/O A PAINFUL LUMP @ INJECTION SITE. AREA IS RED. NO FEVER.
pain; entire lateral aspect of rt arm swelling, erythema & pain, nausea, generalized body aches, vomiting & severe h/a; 72 hrs later, is still having some sx;
Typical fever, body aches, dizzy, exhausted, but as those resolved on day 3 itching began at firm reddened injection site, also hot to touch, irregular borders, no raised rash. Not a skin infection. Called my PCP   for a large part of the winter this year as I was last year and got doses 11 & 2 at PHARMACY. Office told me to ice it.  Pharmacy said apply hydrocortisone cream. MY CONCERN IS DOES THIS INCREASE MY CHANCES OF A SYSTEMIC ALLERGIC REACTION WITH MODERNA DOSING IF WE HAVE TO REPEAT COVID VAX IN FALL OF 2022.
I developed 2 large bruises on my left arm in the vicinity of the injection sites. They developed all of a sudden exactly 4 weeks after my second shot of the Moderna vaccine.  I had no treatment and the bruises are beginning to dissipate.
Tinnitus ringing in right ear and muffled left ear. Not subsiding after 16hrs
pt recv vax 21AUG95 & 12FEB97 pt devel chickenpox;It was reported that two other pt WAES #97021046 7 97021047 who recv varicella vax;
No signs, no symptoms reported >24 hrs after receiving expired lot. Merck states vaccine is viable 6 months post-expiration.
can you get the vaccine while pregnant?; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (can you get the vaccine while pregnant?) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (can you get the vaccine while pregnant?). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (can you get the vaccine while pregnant?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Upon internal review on 17-Nov-2021 Gender should be female, pregnancy type, Birth type and Fetal outcome are Corrected
myopericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myopericarditis) in an adult male patient 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, the patient experienced MYOCARDITIS (myopericarditis) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to MYOCARDITIS. At the time of the report, MYOCARDITIS (myopericarditis) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (myopericarditis) to be related.    No concomitant and treatment medications were reported.  Patient age was reported to be between 18-24 years  Company comment: This is a literature-non-study case concerning a adult male patient of unknown age with no reported medical history, who experienced the expected, serious, AESI event of myocarditis. The event myocarditis exact occurrence unknown but stated that the event occurred after the second dose of mRNA-1273 vaccine administration and resulted to hospitalization. No reported treatment information. The outcome of the event myocarditis was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-467841 (Patient Link).; Sender's Comments: This is a literature-non-study case concerning a adult male patient of unknown age with no reported medical history, who experienced the expected, serious, AESI event of myocarditis. The event myocarditis exact occurrence unknown but stated that the event occurred after the second dose of mRNA-1273 vaccine administration and resulted to hospitalization. No reported treatment information. The outcome of the event myocarditis was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
PT ADMINISTERED VACCINE IN THE LEFT ARM WITH A 25G 1" FLIPLOCK NEEDLE.  THE PATIENT DEVELOPED A LUMP UNDERNEATH THE INJECTION SITE AFTER ADMINISTRATION. PT'S MOTHER IS A NURSE AND SHE MASSAGED THE AREA. THE PT ALSO APPLIED AN ICE BAG PROVIDED BY THE PHARMACY. DURING THE 15 MIN POST VACCINE WAIT PERIOD, THE SWELLING HAD MOSTLY RESOLVED AND PT SAID HE DID NOT HAVE ANY PAIN
pt recv vax; exp over 100 varicella lesions in the mouth, scalp, etc...
Drank coffee 2-3 minutes after taking first dose of Vivotif; Spontaneous report received on 11MAR2020.  A male consumer reported that he "drank coffee 2-3 minutes after he took his first dose of Vivotif" (PT: Product administration error). The consumer was receiving Vivotif for immunisation. On 09MAR2020, the consumer took his first dose of Vivotif and after 2-3 minutes drank coffee. In the morning of 11MAR2020, he took his second dose of Vivotif with lukewarm water and had no coffee. Additionally, he reported that he took both doses an hour before eating food. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer drank coffee 2-3 minutes after he took his first dose of Vivotif ( Product administration error). Vivotif should be taken with cold or lukewarm water only. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer drank coffee 2-3 minutes after he took his first dose of Vivotif ( Product administration error). Vivotif should be taken with cold or lukewarm water only. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.
Tingling, burning sensation in lower legs and feet 2 weeks after receiving the shot. Symptoms continue at all times of day and night., keeping me awake at night.
I was vaccine injured after receiving second dose of Pfizer COVID 19 vaccine. This start September 2021 four weeks after my second shot. My symptoms were very similar to COVID infection that included tachycardia, shortness of breath, nausea, diarrhea and burning of both arms. I couldn?t work for three months. After a month of sickness, I finally was able to a neurologist. I had EMG, MRI and lumber puncture done. All results were negative. The lumber puncture had made my condition worse as the burning and tingling spread to my back. For about three weeks, I could not sit up or stand up. Simple activity such as shower and eating was difficult to handle. At the same time, the burning had spread to my leg. I could not walk like I use to. The neurologist started me on pregabalin. I ended up with a dose of 200mg twice a day. My condition started to improve by December and I return to work although I was not one hundred percent. I was ok for few months. Then in March, when I over excreted physically, tachycardia, SOB and burning returned. I started back on pregabalin but did not help at all. The symptoms went away for few hours then returned. Every day was a struggle.  The burning and numbing seems to travel to different part of my body. First, my arms which I could not move like I use to. Then to my legs and I could not walk like I use to. Then to my back to my head. Some days even my tongue and throat stings. Even my nasopharynx burns. I struggled to work and carry out daily routines.   My feet is numb and inside of my heal up to lower leg is numb and weak. My arms and legs are very weak. I can perform 35% of physical activity compare to before getting vaccinated. I can?t drive, cook, shop and any activity that require physical endurance. My arm, fingers and legs are very weak.
Pain and stiffness in left arm and shoulder. Has persisted without any relief to this point.  Treatments include X-ray, oral corticosteroids, massage, chiropractic therapy, physical therapy, MRI.