chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; BODY ACHES; FEVER; SHAKINESS/TREMBLING; CHILLS; NAUSEA; TIRED; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 58.96 kilograms, and height was 158.49 centimeters. The patient's concurrent conditions included non alcoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no illicit drug usage. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 10:25 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 10-MAR-2021, the subject experienced shakiness/trembling. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 10-MAR-2021 22:48, the subject experienced body aches. On 10-MAR-2021 22:48, the subject experienced fever. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakiness/trembling, chills, fever, nausea, and tired on 12-MAR-2021, and the outcome of body aches and headache was not reported. This report was non-serious.
Mother reports that child had fever on evening of 12/17 and swelling and redness of arm on 12/18.  Child was seen by doctor at Medical Center on 12/18 and Tylenol plus another medication (unknown) was prescribed.  Child was seen by vaccine provider on 12/19; left upper arm was markedly swollen, reddened and warm to touch.
hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; severe respiratory infection; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  Approximately, on 18-APR-2017, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered a severe respiratory infection, and the patient was hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.  As a direct and proximate result of her receipt of vaccination, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. At the time of the report, the patient had not recovered from the aforementioned events, and the reporter considered them to be related to Zoster Vaccine Live (ZOSTAVAX). The reporter considered the events of pneumonia, mental status changes, atrophy, dysarthria, ataxia and respiratory tract infection to be disabling.  Upon internal review, the event of pneumonia was considered medically significant.
Complained of systemic flushing, abdominal discomfort with vomiting, dyspepsia. States began occurring hours post vaccination, states relaxed, slept and woke up next morning with symptoms resolved.
Previously healthy baby taken to ER by EMS unresponsive, with no pulse, no respirations.  Details of what occurred prior to EMS arrival to apartment are unknown.  One report is that the baby was in the bath with an older sibling, or mom was in the bathroom with another child, heard something in another room and then went and found the baby unresponsive.  Mom started CPR, it took 5 - 10 minutes before the fire department arrived  and continued CPR, the EMS arrived and found the baby on the floor with vomitis in hair, continued CPR, intubated, were unsuccessful in placing an IV line and administered Epinephrine via the ET.  Upon arrival to the ER the baby was asystolic, IV started, 3 rounds of Epinephrine and Atropine administered via the IV and one dose of Na Bicarb, the ET tube was removed and another one placed, NG tube placed.  All attempts were unsuccessful.  The baby was pronounced at 10:48 PM.  Medical Examiner to handle case.
Narrative:  Patient described headache after vaccination. He states he took acetaminophen last night. Symptom resolved today.  Other Relevant Hx:  Symptoms:   Headache Treatment:
About 2 hours after getting the vaccine I became very tired. I did not feel hungry so did not eat dinner and went to bed early from the extreme fatigue. The entire next day I spent asleep with headache and fever. I was unable to eat, drink, or even get out of bed from the extreme fatigue.
Information has been received from a consumer concerning her approximately 17 year old daughter with no medical history or allergies who was vaccinated with three dose of GARDASIL. Concomitant therapy included "LOLESTRA". The consumer reported that after receiving the first and second dose of GARDASIL the patient experienced injection site soreness but then was fine. Then about three weeks after receiving the third dose of GARDASIL. The patient experienced bruising in her leg which caused immobility, which they thought was a blood clot so they took her to the emergency room and had to stabilize her leg and then shortly after the bruising cleared up. Then in September 2008 the bruising came back in her leg and starting in November 2008 the patient started to get sick constantly. The patient could not move, was very exhausted, lost about 7 pounds, could not eat, and had breathing problems. The patient was taken to a pulmonologist because her pediatrician thought she may have walking pneumonia, mono or asthma, but they were all ruled out. Then the patient was taken to a physician who ran a bunch of blood test, and computerized tomography scan (CT) of her brain and a magnetic resonance imaging (MRI) of her left leg. The MRI and CT scan came back fine, but the physician stated that through the blood work the patient's immune system was compromised and believed it was from GARDASIL " The patient then started to get a lot of sinus infections and developed cyst in her sinus so she had out patient surgery (name of hospital, address and phone number unspecified)." The consumer reported that in mid May 2009 the patient developed mono and had been doing better but still got exhausted pretty fast, and had missed about 45 days of school this past school year. The patient was seen by the pediatrician to seek medical attention. At the time of report, the patient was recovering. Upon internal review, mononucleosis and bruising in leg were considered to be disabling. Additional information has been requested.  7/24/09 Clinical summary rec'd from PCP including 2 consults-Heme/Onc and Allergy/Asthma. Dx since vaccines: Mononucleosis, infectious. Sinusitis, acute. Viral syndrome.  Weight loss, abnormal. Depression. Splenomegaly. Fatigue.  Bronchitis.  Chest pain. Leg pain.  Seen by allergy/asthma MD 1/26/09 for: Chronic rhinitis with possible allergic trigger, Chronic cough, resolving most likely related to post-nasal drip from rhinitis, possible tongu angioedema vs irritation. Exam WNL. Heme/Onc consult for MTHFR mutation heterozygosity. C/O fatigue, tiredness, arthralgias/myalgias as well abdominal sx.  (+) features of Chronic Fatigue Immune Dysfunction syndrome.
Fainted post vaccination. Recovered almost immediately. Cool compresses to neck/face, head placed between knees. Moved to cot when safe to do so. Observed x 30 min without further incident. (Seated at time of vaccination).
On 10/04/2022, I had a scratchy throat, I took a COVID-19 test and it was negative. The next day, no fever, cough, no energy, no pain. On the 7th, I tested again, negative, no energy, cough, sneezing, congestion with no production. On the 8th, I had head cold, headache, stuffiness. On the 9th, cough, energy low. On the 10th, hoarse, beginning to feel better. On the 17th, I was still coughing but I felt 98 percent better.  By the 19th, cough was gone.  In November, I had food poisoning with diarrhea and took an antibiotic.  On November 27, I had a vertigo episode and spent two days in the hospital. I had fallen and cracked my head and went by ambulance. I required 4 stitches beneath my eyebrow.  In January, I started a slight cough on the 11th. I went on a cruise and I started coughing and had a temperature of 100.2 on January 26. On the 27th, I had a deep cough at night. On the 28th, I coughed all day, chest pains, minor body aches.  On the 29th, I had 101.2, coughing, red and sore eyes and diarrhea. On the 30th, I felt better, still diarrhea.  On the 31st, no fever but diarrhea. On February 8, still mucous but felt great.  On the February 24, my congestion cleaned.  On the 28th, phlegm and cough were gone. I went on another cruise and came home March 12.  On the 13th, I had sinus congestion, fatigue, throat clearing, runny nose, I took Tylenol for headache.  On Tuesday, still sneezing, runny nose, fatigue and diarrhea, dry mouth. I tested positive for COVID-19.  Today I took my temperature and I was at 98, stuffy nose, annoying headache, body aches. Head feels full. I have a slight non-productive cough and I am tired.
Pt appeared lethargic, t103, APAP given & tepid bath; temp down approx 4 hrs temp inc again; pt was taken to ER; t105 R;
TASTE CHANGE / BITTERNESS IN MOUTH; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 56 year old adult male. The patient's height, and weight were not reported. The patient's past medical history included: gall bladder removed, COVID-19, and pulmonary embolism, and concurrent conditions included: sleep apnea, fatty liver, hypertensive disorder, and diabetes, and other pre-existing medical conditions included: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: unknown) dose was not reported, 1 total administered on 11-APR-2021 on left arm for prophylactic vaccination. Age at time of vaccination 55 years old. Concomitant medications included amlodipine, rivaroxaban, metformin and omeprazole. It was unknown if patient experienced any adverse reactions following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine tozinameran (Pfizer) (dose number in series 2) (form of admin, route of admin, were not reported, batch number: FH8030 and expiry: unknown) dose was not reported, administered on 21-NOV-2021 on left arm for prophylactic vaccination.   On 10-MAY-2022, the patient received Paxlovid (nirmatrelvir/rotinavir) (form of admin, route of admin were not reported, batch number: FY7031 and expiry: unknown) dose was not reported for treatment of Covid-19. On 11-MAY-2022 at 8:00, the patient experienced taste change / bitterness in mouth (dose number in series 2). The patient did not receive any treatment and was not hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from taste change / bitterness in mouth. This report was non-serious.
Shortness of breath but likely from her asthma which had been flaring up even before getting the vaccine
Pt stated: body aches, sweats, chills, feeling hot, localized erythema (Left pectoral), and general malaise. Pt came in to clinic on 11/22/2013.  Pt stated the above symptoms for the past 3 days.  Pt was seen by attending physician and was instructed to take Tylenol and/or Ibuprofen, rest and to monitor symptoms.  If no improvement, report back to clinic on 11/25/2013 or the emergency room.
vaccine expiration date. It appears that vaccine was given 3 days after expiration date; No adverse reaction after vaccination
Dose of Tdap given in addition to PENTACEL and PCV13. Infant was more irritable than normal however appetite was good, no unusual swelling or redness noted by the mother.
chills, dizzy, weakness, body aches, sinus symptoms-Headache. Lasted for 3 days.   Consulted his family practice clinic on the 2nd day  and was prescribed Doxycycline.
patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired) in a  patient of an unknown age and 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
3 pt recv vax 7 all 3 pt exp redness, swelling & inj site pain;
I had PMS symptons whole month of March and April with breast tenderness/bloating/fatigue all month.  I stopped having my period in June.     March 10-13 period occurred, April 15-19 period occurred, May 13-17 period occurred.  No period June, July and August   Sept 20-22 period occurrs. Booster 10-8-21  I have my period 10-13- 10-16 then no period November, December and January.  In late december/january ghost period symptons of pain, breast tenderness and bloating.
Develop a lump in the back of neck and a rash around the neck area went for a physical October 8 wasn?t feeling well and now my t4 thyroxine levels are extremely high 14.7 my glucose is 51 and potassium is 5.4 which is high this all happened after vaccine that was all in range before and I heard a few people having issues with thyroid as well please review this awful side effects I have a lot of pain and not feeling well
Pt had DTaP given on 9/27/04. This was her 5th DTaP on 9/30. She presented with erythema,  tenderness at shot site. Almost the entire circumference of the arm. Treated for cellulitis.
Vaccine on 9/29/05. On 9/30/05 started with body aches, headaches, malaise. Lasted 4 days.
"Pt w/ Latex allergy, hx of allergy to an unknown food, and environmental allergies (treated with Claritin).  Pt PMH of Asthma. Pt was observed for 30 mins. She left the vaccination site but came back stating she had nausea and had a small rash/hives on dorsum of left hand.  Denies dyspnea. She was speaking in full sentences. She reports working all day and have not eaten anything today. She was provided crackers and apple juice. She states is feeling better-- back to normal Assessment of her body and face does not show any rash or urticaria. Pt given 25mg PO Benadryl 36mins after vaccination.  BP 140/86, HR 74, RR 16 -- > 133/78, 74, 16. Denies itching. She was provided ER precautions and instructed to eat her meal.  Pt stable and re-released from vaccinations site 50mins post vaccination. She was accompanied by her husband and son. Husband will be driving her home."
Swollen  painful stiff joints Advised by rheumatology doctor I had a rheumatoid  flare up following Covid 19 vaccination. Prednisolone worked well after first vaccination but effects were much worse after 2nd and have not improved. Other problems  feeling sick unable eat or sleep extremely tired falling asleep middle of morning. I was also told I was not the first patient seen with similar symptoms following Covid  vaccination. Until vaccination I was fit and well and had not experienced any problems like this.
First started on 10/26/06-red right ear lobe and neck-swollen lymph node-flush-painful-minor emergency same evening. EPP shot and prescribed Allerga/Claritin. Next day worse prescribed Methyprednisone over phone. Sunday was covering face, eyes swollen, doctor's office directed to emergency room, was given EPP shot and Benadryl shot, took out flush hot, lobster color. Prescribed Zantac, Prednisone and Benadryl.
Within 3 hours of 2nd dose, fatigue, aches, chills, arm pain. After 24 hours, fatigue, chills, nausea and vomiting. no fever. Food tastes bad.
dizziness, like vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (dizziness, like vertigo) in a  patient of an unknown age and 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (dizziness, like vertigo). At the time of the report, VERTIGO (dizziness, like vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
TWO DAYS AFTER VAX DEVELOPED LOCAL REACTION (REDNESS AND TENDERNESS) AROUND INJECTION SITE, CHILLS, FEVER, ACHINESS, SWEATING AND SORE THROAT
Approximately 30 minutes post vaccination, patient became c/o of palpitations and confusion with syncope and loss of consciousness. Later the patient developed hives.
Varicella immunization given 7/22/15. Injection site began swelling with pain, warmth and redness on 7/24/15 at 2 AM. Pain is moderate to severe shooting down to hand. 8 cm diameter area of redness and swelling to R upper arm.
PATIENT HAD EPISODE OF DIZZINESS AND VOMITING. PATIENT WAS GIVEN SOMETHING SWEET, SALTY, AND WATER. SYMPTOMS RESOLVED AFTER ABOUT 15 MINUTES.
Hives on both arms and neck. Edema to left forearm which extended to upper shoulder/neck and lower left arm. Positive for shortness of breath. Still have a rash around mouth and lips are still swollen.
Inappropriate schedule of vaccine administered; Lymph nodes swelling/ Lymph node of the size of a grape fruit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swelling/ Lymph node of the size of a grape fruit) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (The patient received the 1st and 2nd dose of Pfizer). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In November 2021, the patient experienced LYMPHADENOPATHY (Lymph nodes swelling/ Lymph node of the size of a grape fruit). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 12-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph nodes swelling/ Lymph node of the size of a grape fruit) outcome was unknown.            Other concomitant medications included Birth control pill.  The patient received the 1st and 2nd dose of Pfizer and the booster shot of Moderna.  The patient got lymph nodes swelling and lymph node of the size of a grape fruit. To treat the symptoms, the patient took Advil last night and this morning.
After 15 minutes patient reported chest pressure which increased with inspiration.  could not report rating on pain scale.  Initial BP with complaints was 168/138.  HR 88, RR 16, 98 o2sat, Temp 98.8.  Follow BP 137/85 5 minutes later .Sent to ED at 12:53.  12 lead EKG, Normal sinus rhythm, no ischemia. CXR negative.   Shortly upon arrival in ED chest pressure resolved with out further intervention. Pt discharged to home.
very bad nausey; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (very bad nausey) in a 31-year-old 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (very bad nausey). At the time of the report, NAUSEA (very bad nausey) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Case number PHEH2015US019589, is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 48 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) at a dose of 0.5 ml intramuscularly on 23 Sep 2015. It was reported FLUCELVAX was at room temperature for 24 hours before administration. No adverse event was reported.
Multiple Psoriatic spots on arms and hands bilaterally started on 5/7/21. Moderate joint pain in left hip and left shoulder started about 2 days prior on 5/5/21.  I have never had multiple spots on both arms. Used some steroid ointment to see if the break out resolves. Using cool compress on joints with some temporary relief of pain.
Red blisters slowly appeared around the injection site on arm below shoulder. Became painful. Slowly healing but taking some time. May leave discolored skin after it heals.
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot number M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.