chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Overall weakness; Severe headache; Fever; Vomiting; This is a spontaneous report from a contactable Nurse via Pfizer sales representative.   A 20-years-old female patient received meningococcal group b rlp2086 (TRUMENBA, Lot: W95252; Exp 31Jan2020) , via an unspecified route of administration on 17Jul2019 16:15 at single dose for immunisation .  Medical history included hypercholesterolemia and familial hypercholesterolemia. Concomitant medication included rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA).  The patient experienced overall weakness  on 17Jul2019 with outcome of recovered , severe headache on 17Jul2019 with outcome of recovered , fever  on 17Jul2019 with outcome of recovered , vomiting on 17Jul2019 with outcome of recovered.  The patient was hospitalized on 17Jul2019 because of all the reported events. During hospitalization the patient underwent lab tests and computerised tomogram of the head which gave normal results.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported events weakness, headache, fever, vomiting.
Patient felt light headed post vaccination.  History of same issues post vaccinations. resolved shortly and refused care.
I have had inflammation on the left side of my right ankle. It is the soft tissue on my right ankle it is very sore and inflamed, it has been this way since the vaccine. I also felt under the weather for a week and had 102 fever and felt tired.
Petehia Bilaterally Lower legs, below knees, irritable x 1d.  No treatment
woke up with shaking chills, body aches, fatigue, developed fever of approx 101.5 fever lasted < 10 hours fatigue lasted about 2 days
3 hours, post vax, mother reported slight local reaction and a fever. The fever lasted 5 days. Mother said the child screamed constantly and didn't sleep for 4 days except for 20 minutes at a time.
Tightness in muscles. Lasting 5 days. Inner elbow, Severe pain to touch. Continuous to date. Visible swollen tendon. Massage and stretching reduced swelling, pain persists. Swelling returns periodically. Left Forearm muscles ache mildly, but continuous. Ache in shoulder. Stretching feels better, pain returns within hours. Left Clavicle discomfort. Continuous dull, occasional sharp. Outer elbow pain. Radiating pain is occasional. Wrist pain, near thumb.   Brain fog. Noticeable delayed verbal response. Failure to Connect memory to speach is really disruptive and frustrating.
PERIPHERAL NEUROPATHY ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a six-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 25-Dec-2011. On 09-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Severe joint pain, stiffness, severe muscle pain, dizzy, lightheaded, fatigue, slurred speech. Treated with 5 day course prednisone.
At the time of the vaccine administration the vaccine was burning going in from the injection site up to my shoulder.  I think the shot was given to high.  The pain in the arm was bad for the first 3 days.  The pain in the shoulder, almost right on the bone, is still present.
After the vaccine, patient felt fine and was moved to our waiting area.  Within 5 minutes of being seated, patient fell out of the chair and hit his head.  The person he was with asked for our help.  When my intern and I approached him, he was awake and alert.  He said he just passed out.  He did have a bump on his head.  I went to get ice and when I came back my intern noticed he was more pale and disoriented.  Within a minute or so, patient was more alert and we were able to take his BP/HR.  His HR was low but patient confirmed he has a low resting heart rate.  His BP was elevated slightly (around 145/75, HR 59).  He was still pale and sweating so we kept talking to the patient and got him more water.  We checked his BP again and it was about the same but patient was feeling better.   Patient denies having had this reaction before from any vaccine or medication.   He later said that he sometimes gets nervous when he gets the flu shot so it could have been him psyching himself out.  We kept monitoring patient and after about 45-60 minutes, patient left and had someone drive him home to be on the safe side.  Patient denies having any primary care md.  I called him around 726pm and patient said he was stable and took some Motrin and felt fine. He will contact us if anything changes.
This employee was vaccinated on 1/27 and 2/17. On 3/9 employee saw her Uncle for 10 minutes, no masks but hugged each other. Uncle had been living with family for one month.  On 3/10 Uncle tested Covid +.  Patient immediately isolated from Uncle (he was removed from the household). Patient phoned Covid EHS on 3/11 and was set up for testing on 3/16 (asymptomatic).  Patient obtained her own Covid test on 3/11 (not at Hospital) and resulted Covid negative.  Hospital test completed on 3/16 (5 days post exposure) and tested Covid Positive. Patient's 5 year old brother now is Covid Positive, and employee's father is being tested, no results yet.
Raised bump, redness and itchiness occurred 6 days, in the injection site.  I took Zyrtec and it went away and was fine within 24 hours. I had mild soreness in that shoulder for about 48 hours after that reaction.
No adverse effects were reported; one patient received one dose of improperly stored MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R028526, expiration date 04-OCT-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 (47.1) degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported.
blood clot from ankle the groin; flu like symptoms; difficulty walking; soreness in Left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot from ankle the groin) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 10-May-2021, the patient experienced THROMBOSIS (blood clot from ankle the groin) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (difficulty walking) and MYALGIA (soreness in Left arm). The patient was treated with RIVAROXABAN (XARELTO) ongoing since an unknown date for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clot from ankle the groin), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (difficulty walking) and MYALGIA (soreness in Left arm) outcome was unknown.            No concomitant medications were provided.  The patient went to the ER after experiencing the blood clot (from her ankle to the groin area) and was provided treatment with Xarelto.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Left arm reaction felt like a bee sting and itched.  Experienced an itchiness around the waist and stomach.  Since it felt like an allergic reaction, I took a Benadryl and the pain and itchiness lessened.
Information has been received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot # K007264 with an expiration date: 02-MAR-2017 (dose and route of administration were not reported). Administered doses of the vaccine experienced temperature excursion of 53.8 degrees Fahrenheit for 23 hours, on an unknown date. There was previous temperature excursion which took 12 hours and 30 minutes with the temperature of 54.6 degrees Fahrenheit. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
14 hours after second shot had flu-like symptoms lasting 14 hours. Stuck in bed. Wouldn't be safe to drive; not capable of working. Symptoms were normal flu-like, but no sinus involvement. Neighbors had same lot. The male had no symptoms at all. The wife had symptoms like mine. Mild memory loss lasting up to 4 days.
inner ear (left) and sinus infection requiring 10-day course of antibiotics to clear infection. Symptoms included diminished ability to hear clearly and feeling of "fullness" in ear; increased ringing in ear, runny/stuffy nose. After course of antibiotics, all symptoms cleared up.
Post vax, the pt experienced a sick feeling, flu-like symptoms, and had heart palpitations.
Family called me today- patient developed a itchy  rash all over her body about a week after she received her Covid Vaccine.  Family has been giving the patient Benadryl and rubbing her with calamine lotion.  They have and appointment with the dermatologist tomorrow, to see what else they can do. Dermatologist had them call us to report the rash.
Itchy; Patient states her HCP stated the injection was given below the muscle and not in the muscle; Red spot has turned pink and seems to be clearing up; Big red circle on her arm; A spontaneous report was received from a consumer concerning an  83-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and  experienced big red circle on her arm, itchy, red spot has turned pink and seems to be clearing up, and injection was given below the muscle not in the muscle.  The patient's medical history, was not provided by the reporter, and included no known allergies. No relevant concomitant medications were included.   On 11 Jan  2021, the patient received their  first  of two planned doses of mRNA-1273 (lot number  unknown) intramuscularly  for prophylaxis of COVID-19 infection.  On 15 Jan  2021, the patient noticed big red circle on her arm.  On an unknown date, the patient reported feeling itchy and also noticed that her arm turned pink and had seemed to cleared up.  On 25 Jan 2021, the patient visited her health care professional and was informed that the injection was given below the muscle and not in the muscle.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events   red spot has turned pink and seems to be clearing up, itchy, big red circle on her arm were unknown. The outcome of the event injection was given below the the muscle not in the muscle was resolved .; Reporter's Comments: This case concerns an 83-year-old female with Product administration error for mRNA-1273 (lot # unknown) with associated adverse events of NS expected vaccination site erythema and NS unexpected rash macular, pruritus.  Adverse event onset 5 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was waiting for 15 minutes post-vaccine time in the vaccine clinic lobby and experienced shortness of breath. Patient chose to be evaluated at the facility's Emergency Department on the same site as the State's vaccine clinic.  Shortness of breat stared about 15 mintues after receiving 2nd COVID vaccine today. Had shot in left deltoid. No allergic reaction the first time (with 1st vaccine in series).  EKG and chest xray were completed as well as nebulizer treatment of albuterol. Patient relieved of symptoms and dismissed home.
Information has been received from a physician concerning an unspecified number of patients who on unspecified date were vaccinated with a dose of ROTATEQ (dose, route and Lot# not reported). On an unspecified date an unspecified number of patients developed intussusception. At the time of the report the patients' outcome was unknown. The physician stated that she was starting to use ROTATEQ again since "the cases of intussusception have not been showing up like she claims she once used to see with the medication". She did not mention any specific number of patients. Upon internal review intussusception was considered to be other important medical event. All telephone attempts to obtain follow up information have been unsuccessful. Attempts to verify the existence of an identifiable patient have been unsuccessful. Additional information is not expected.
Pt. Reported Developing Hives the night of her vaccination (Apx. 4-5 hours after injection), First on her right arm, then spreading across the rest of her body. Pt. reports  that the hives got better and went away over the course of "about a week". Pt. also reports slight tightening of the throat, but did not go in to be seen by a medical provider for the incident.
Experiencing facial droop and partial paralysis Bell's Palsey like symptoms. Grade 3 pain at injection site as well as malaise and fatigue for first 3 days post vaccination. Received flu vaccine at the same appointment.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/24/2023 HYPERCHOLESTEROLEMIA ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/4/2023 HYPERCHOLESTEROLEMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/24/2023 PNEUMONIA ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/4/2023 PNEUMONIA
Fatigue the following day after second shot; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution.  A 59-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eng205), via an unspecified route of administration, administered in left arm on 15Mar2021, at 15:30 as single dose for covid-19 immunization at the age of 59 years.  Medical history included allergy from an unknown date. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included Pris, methylphenidate hydrochloride (RITALIN), taken for an unspecified indication, start and stop date were not reported; meloxicam (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported; simvastatin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; triamterene (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took BNT162B2 for covid-19 immunization as dose 1.  Past product experience included drug allergy to Bactrim.  The patient experienced fatigue the following day after second shot on 16Mar2021.  No  treatment  was received for the adverse event. The outcome of event was unknown.
After 2 hours, pt's heart rate increased, cough. After 8 hrs pt has high fever, headache. After 10 hours, pt feels very dizzy, pt had to take aspirin for her headache. Headache still remain on 9/21/10.
He visibly looks like he has lost some weight; Can't breath very well; Asthma medication not effective; Unable to stay asleep/Has to sit on a chair to sleep; He did not feel well/He has not felt good due to getting the vaccine; Stomach ache; Has no appetite/Does not feel like eating anything; Diarrhea; A spontaneous report was received from consumer concerning an 85-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like he visibly looks like he has lost some weight / weight decreased, he did not feel well, he has not felt good due to getting the vaccine/ vaccination related malaise,  stomach ache/ abdominal pain upper, has no appetite ,does not feel like eating anything/decreased appetite, diarrhea, unable to stay asleep/ has to sit on a chair to sleep/insomnia, can't breathe very well/ dyspnoea, asthma medication not effective/therapeutic product ineffective.  The patient's medical history was reported as asthma. Concomitant medications taken by the patient included inhalers (albuterol sulfate and formoterol fumarate, mometasone furoate)  On an unknown date, prior to the onset of the event, the patient received their first two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 5 Mar 2021, prior to the onset of the events, the patient received their second two planned doses of mRNA-1273 (Lot number: 003A21A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.   On 8 Mar 2021, the patient did not feel well at all and had a stomachache, diarrhea, and didn't feel like eating anything. The patient was fine for a couple of days but then the last few days would wake up in the middle of the night because he could not breath very well. The patient had to sit on a chair to sleep and had not been able to lay down to sleep for the last 6 days. The patient had not been able to eat due to lack of appetite the last 6 days and had not felt good due to getting the vaccine. The patient has asthma and his inhalers were not effective in helping him to breathe.  Treatment activities for the event of having trouble breathing included albuterol sulfate and formoterol fumarate/mometasone furoate.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of events, he visibly looks like he has lost some weight , he did not feel well, he has not felt good due to getting the vaccine, stomach ache, has no appetite ,does not feel like eating anything, diarrhea, unable to stay asleep, has to sit on a chair to sleep, can't breathe very well, asthma medication not effective, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of Asthma remains a contributing factor.
Itchy at vaccine site that turned red and hard by 4/18. No soreness to the touch.
Smallpox vaccination scar is inflamed/swollen/itchy; appeared 8 days out; 9th day Moderna injection site is also inflamed/itchy.
Varicella after Varivax rash on stomach, chest - arms -legs and injection site. Varicella like lesions onset 7-1-07. Resolved by 7-10-07
they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32; they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32 hours previously and was also stored at room temperature for 32 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32 hours previously and was also stored at room temperature for 32 hours) and PRODUCT STORAGE ERROR (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022 at 5:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-May-2022 at 5:00 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32 hours previously and was also stored at room temperature for 32 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32 hours previously and was also stored at room temperature for 32 hours) and PRODUCT STORAGE ERROR (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Pharmacist stated that they might have given a dose of the Moderna COVID-19 Vaccine from a vial that was punctured 32 hours previously and was also stored at room temperature for 32 hours.   The number of doses/vial reported as one dose/one vial.  Dose administered more than 12 hours post puncture and after exposure to room temperature for more than 24 hours. The vial was initially stored in the refrigerator on 28Apr2022. Vial was first punctured on 03-May-2022 at 9 am. Vaccine was administered on 04-May-2022 at 5 pm. The vial was stored in room temperature post punctured. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 32 hours.  No treatment drug was reported.
A patch of fairly intense shingles about 1.5 by 0.75 inches on chest, just below heart. Included blisters. Started to spread 10/15/2016 in a minor way, a few red spots on the side, same side as initial outbreak. Also itching, discomfort on back at approximately the same spot as on the front for the entire time. Returned to clinic on 10/15/2016 where shingles was confirmed.