chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm/ Sore leg muscle; Extreme fatigue; Fever 100.9; Extreme chills; I was light headed; off balance; Unable to walk without assistance; shortness of breath more than usual; Upset stomach; Not much appetite; Not much thirst; My blood pressure was running quite low; This is a spontaneous report from a contactable consumer (patient himself). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 04Feb2021 15:30 (age at vaccination: 74 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history included hypertension, chronic obstructive pulmonary disease, peripheral arterial occlusive disease, cardiac failure congestive, diabetes mellitus, neuropathy, hyperlipidaemia, obstructive sleep disorder, sinusitis and allergy conditions. The patient received the vaccine in a hospital. The patient did not have any other vaccine in four weeks. The patient was taking several prescribed meds and Supplements. The patient did not have any known allergies. On 04Feb2021 20:00, the patient experienced sore arm, sore leg muscle, extreme fatigue. On an unknown date in February2021 (from the 4th day), the patient experienced fever 100.9 which broke with in an hour , extreme chills. For 10 days afterward he was light headed, off balance, unable to walk without assistance, shortness of breath more than usual, upset stomach, not much appetite, not much thirst and his blood pressure was running quite low. The patient was encouraged to eat and drink, extreme fatigue had continued. The patient saw his primary care physician on 17Feb2021 and his cardiologist on 23Feb2021. On the 17Feb2021, primary doctor lowered my blood pressure medication dosage. Then on the 23Feb2021, his cardiologist lowered it more, as well as adjusting a few other medications. 3 weeks after vaccination, he began feeling better. He was concerned about receiving booster on 05March2021. The adverse events resulted in physician's office visit. It was unknown if the patient received treatment for the adverse events. The patient did not have covid prior vaccination and was not tested for covid since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Fever started on Jan 31 2020 followed by the eruption of a rash on Feb 02 2020
Posterior auricular and post neck cervical lymph adenopathy, mild sore throat, low grade fever, abdominal cramps, yellow diarrhea, mild cough, tender spleen, no rash. Still recovering as of 3/22/2000.
I had severe fatigue felt feverish. Later on I started coughing & my chest was very tight. Days later I got tested at at drive through Testing Site & was positive for COVID-19.
No additional AE information; Improperly stored vaccine administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product.  On 03-MAR-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) prefilled syringe injection, 0.5 milliliter, lot # T033369, expiration date 26-MAY-2022 (injection site and route of administration were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of 11 degrees Celsius for 1 hour. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There was no additional adverse event information. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T033369; expirationdate: 26-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Severe head and body aches from 4 am until 24 hours later,  6 am , took Tylenol at 5 pm that evening which helped a lot for the aches.
Heart palpitations, chest pain, shortness of breath, headaches, head pressure, ringing in ears, ear aches, loss of appetite, loss of balance, diarrhea, weakness & fatigue
Significant swelling and inflammation to Left Thigh  Treated with Benadryl and Prednisolone
A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning a 19-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 22-Dec-2010. On 19-Jan-2011, the patient received the expired FLUMIST. 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. Additional information was received on 10-Jun-2011: The patient did not have any late occurring adverse events.
This spontaneous report as received from a nurse practitioner via field representative refers to a 60 year old female patient. The patient's pertinent medical history included none. On 22-APR-2014 (Reported as 9 days ago) the patient was vaccinated with ZOSTAVAX (Dose/Frequency: 1 single shot, Therapy Route: Injection). Concomitant medications were not reported. Approximately on 24-APR-2014 (Reported as a couple days) a rash was began to form. The patient was diagnosed with shingles on 05-MAY-2014. The outcome of shingles was unknown. The causality was not reported. The patient sought medical attention by visiting the office of the reporting nurse practitioner. Additional information has been requested.
Sore arm; Severe headache; Body/joint aches; Body/joint aches; nausea; Dizziness; Chills; Sweating; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 03May2021 at 13:45 at the age of 43-years-old as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), hashimoto's disease, allergy to gold, cobalt, nickel, disperse blue dye, and adhesives. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included unspecified birth control pill from unknown date and unknown if ongoing, also ATORVASTATIN and SYNTHYROID, both for unknown indication from unknown date and unknown if ongoing. The patient previously took THIMEROSAL and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 at 13:45 at the age of 43-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 21:00, the patient experienced sore arm, severe headache, body and joint aches, nausea, dizziness, chills, sweating, and diarrhea. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, severe headache, body and joint aches, nausea, dizziness, chills, sweating, and diarrhea was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt developed calf pain ~ 1-2 week after COVID vaccine. Diagnosed with DVT/PE on 5/6 with platelet count decreased from baseline at  92,000.
weakness and numbness in the lower legs, rubbery feeling below the knees in both legs, had to support myself to keep from falling twice once at approx. 3:30 AM and at approx. 6:30 AM. slight tingling and numbness continuing throughout the day into the night.
New onset Afib; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced new onset Afib.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On the evening of 15 Jan 2021, the patient was hospitalized for new onset Afib. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, new onset Afib, was not reported.; Reporter's Comments: This spontaneous report refers to a case of female patient who experienced a serious event of new onset Afib on the same day after administration of the first dose of mRNA-127 (lot unknown, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors, a causal association cannot be excluded
This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced Covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid-19 test positive was not reported. This report was non-serious. This report was associated with Product quality complaint: 90000213435. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Patient into clinic on 1/26/2021 reporting fever, redness, swelling, soreness to injection site. Patient states temperature on Sunday was 104.0. He self-administered Acetaminophen and no fever since. Left arm appears swollen around injection site with redness extending about 1 inch above the bend of the elbow.
Fever 101.7, exhaustion, chills for about 34-48 hours after. On day 13, was hospitalized (4/28/2021) excessive rectal bleeding and fever of 101.1.
I started having a cough when I had COVID-19. The cough would go away some yet has persisted to always be in the background. In December of 2022 it came back enough that I went back to the doctor, I was given steroids and antibiotics that helped some. The cough was gone during the day but was always there during the night. I have been back to see my doctor every month since December trying to find something to alleviate this chronic cough. I will be having a CT scan done next Monday, the doctor is hearing something in my lungs. I am hoping to have more information and diagnosis.
After getting the vaccine, the patient felt dizziness and started throwing up. Paramedics have called and checked and all the vitals were ok. The patient did not want to go to the hospital. After taking some rest, patient left for home.
Intestinal adhesions with complete obstruction - Patient underwent exploratory laparotomy, LOA and revision of J-J anastomosis. Recovery in hospital. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a pharmacist (P.Ph) refers to a patient of unknown age and gender. On 06-SEP-2013 the patient was administered an expired dose of ZOSTAVAX (lot# 0563AE, expiration date: 21-MAR-2013) (formulation, dose, and frequency unspecified) subcutaneously. No adverse effect was reported. Additional information has been requested.
With flesh colored to slightly reddish papules with erythematous base noted on his extremities and trunk for 2 days.
LOW TEMPERATURE 97.2F; FATIGUE; SORE THROAT; SORE ARM; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included coronavirus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 26-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced sore throat. On 27-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced low temperature 97.2f. Laboratory data included: Body temperature (NR: not provided) 97.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, sore arm, and fatigue, and had not recovered from low temperature 97.2f. This report was non-serious. This case, from the same reporter is linked to 20210356147.
MMRV given after the age of 12. New to working with pediatrics and was not aware of the age. Also this was the 3rd dose of MMR and Varicella which was not needed. Patient tolerated injections well. No adverse reactions known.
Mild headache progressing to moderate headache.  Fatigue.  Woke up at 3am with severe chills.  Covered with 3 blankets and woke next morning with 99.8° temperature.    Felt drained from chills. Arm hurt.  Back to normal mid day after shot (24 hours)
Local hospital reported patient had no prior cardiac history. Patient was found in her bed around noon on Tuesday, 10/19. They believed she had died from a hemorrhagic stroke early Tuesday morning.  Nurse follow up on 10/27/04 states: "intracranial hemorrhage."
On or about the same date, I had a minor URI on or about the 12th of November and ran its course at which point in, that developed into bronchial pneumonia treated by Dr. with azithromycin relieved temporarily. On or about December 8th went to urgent care two albuterol treatments, steroid injection in left arm. Prescribed on December 9th prednisone 60mg days, then 40mg for three days at 20mg.
A few hours after getting my first shot of the Pfizer vaccine, my left arm started to hurt.  It was hard to move without intense muscular pain.   Later that night, I woke up with severe upper back pain.   After taking a Tylenol and putting a heating pad on my back, I tried to go back to sleep but couldn't.  The pain lasted until a little after 5 am.   On the day after my injection, I started to get a fever around noon.  I accidentally broke my thermometer while washing it.  My last reading (around 3 PM) was 100 degrees.  I definitely felt feverish throughout the rest of the day and into the evening.  My muscles throughout my body also felt tired/sore.  My husband said that my forehead was really warm.  Later in the evening (around 7 PM), my legs began to have intense pain.  The muscular pain was centralized behind both thighs and calves.  I put a heated massage pillow against the areas to try to relieve the pain.  It helped for small intervals, but did not cure it.  I also used a heating pad and Tylenol to try to fight the pain.  I also tried to drink lots of water.   At 10:30 PM, the pain was unbearably intense, causing me to have a panic attack (which of course made things worse).  After another Tylenol and session with the heating pad, I was finally able to fall asleep (over an hour later).  I woke up around 3:00 AM drenched in sweat from breaking my fever.   Since breaking my fever, I have had almost no further adverse symptoms (besides my muscles feeling "slightly" sore).  I feel it should be noted that I had COVID-19 twice before getting the vaccine and am considered a "long-hauler."  The first time was last March (2020) and the second time was in October (2020).  With these illnesses, I have had many ill effects.  My hair began thinning a lot, I lost over 30 pounds (now considered underweight), was diagnosed with POTS, struggle with gastrointestinal problems (was put on low-FODMAP diet), and my extreme fatigue never really went away.
Per patient she began feeling weak and hot and she had pain in the back of her neck.  Her hands were also shaking.  She tried taking one Tylenol and going to bed but she woke up at 4 AM and the symptoms continued.  She then went to the ER at 5 AM.  Approximately 24 hours later she continues to feel weak.
she just had a sore arm; her arm was was a little red, puffy, and a little warm; her arm was was a little red, puffy, and a little warm; her arm was was a little red, puffy, and a little warm; Use to be 5'2 now she is about 5'1 she shrunk.; it is blotchy but the redness is about gone now it has been 3 weeks; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205, Expiration date: unknown) via an unspecified route of administration on 25Feb2021 (at the age of 80-year-old) as dose 1, single for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, patient stated in May2019 she had severe cold and cough, she was sick for 3 weeks, she lost her sense of smell for 3 months unknown if ongoing, in Jan2020 , patient had a sore arm for 3 days with the shingles shot. The patient's concomitant medications were not reported. Patient stated she is borderline she thinks but she thinks they done blood work and everything was under control so she imagines she was not actually diabetic she was not over the line, not considered diabetic, she just needs to watch what she eats and stay away. On an unspecified date, patient had sore arm, her arm was just red puffy and a little warm, the redness is finally fading after 3 weeks, it is blotchy but the redness is about gone now it has been 3 weeks, patient stated she used to be 5 feet 2 in now she is about 5 feet 1 in she shrunked. Outcome of event use to be 5'2 now she is about 5'1 she shrunk was unknown and outcome of rest all events was recovered on an unspecified date of 2021.  No follow-up attempts are needed. No further information is expected
This spontaneous report as received from a registered nurse refers to a 27 year old female patient. The patient has no relevant medical history or past drug history. On 27-DEC-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H018608, expiry date 02-JUL-2014) 0.5 ml, subcutaneously in the left deltoid. Other suspect therapies included unknown influenza virus vaccine (manufacture unknown) (lot number and expiry date unknown) (dosing regimen and frequency unknown) into the right arm. The patient's relevant concomitant medications are unknown. On 28-DEC-2013, the patient left arm became red, swollen, and difficult to lift. The prescriber recommended that she apply ice and take ADVIL 200 mg as directed on the product label. It was reported that there was no relevant laboratory data. The outcome of the events was reported as not recovered. The relatedness of the events to the therapy with vaccine, PNEUMOVAX23 and influenza virus vaccine (manufacture unknown) was unknown. Additional information has been requested.
SMALL BUMP ON ARM; ARM SWELLING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced small bump on arm, and arm swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the small bump on arm and arm swelling was not reported. This report was non-serious.
Diarrhea; fatigue; her stomach is churning/nausea; abdominal pain; upset stomach; can't keep any food down; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th December 2019, 3 days after receiving Shingrix, the patient experienced diarrhea, fatigue, churning of stomach, abdominal pain, upset stomach and appetite lost. The patient was treated with loperamide hydrochloride (Imodium). On an unknown date, the outcome of the diarrhea was not recovered/not resolved and the outcome of the fatigue, churning of stomach, abdominal pain, upset stomach and appetite lost were unknown.   It was unknown if the reporter considered the diarrhea, fatigue, churning of stomach, abdominal pain, upset stomach and appetite lost to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and she stayed in bed for 3 days sleeping round the clock.  The patient had diarrhea in which her stomach was churning and she can hear it making noises. She reported that the last two days that she woke up at 4am and had diarrhea till 6 am. The caller stated that she did call her doctor and her doctor recommended she take Immodium.  She states she was not sure which Immodium to take.No additional information was given.Advised caller to follow up with her health care professional or pharmacist.  The reporter consented to follow up.The caller was questioning symptoms occurring after receiving Shingrix the reporter wanted to know if these symptoms can be from the shot symptoms included diarrhea, upset stomach, and fatigue.  The caller stated that she stays in bed and can't keep any food down. The reporter did not consent to follow up. The caller had mentioned that she also had nausea and abdominal pain when going through the side effects listed in the clinical trials. She initially reported fatigue and diarrhea but then mentioned the other two events later in the call when discussing side effect information in prescribing information.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Dec-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment medication was reported.   Reporter did not allow further contact