chrisvoncsefalvay/vaers-outcomes huggingface dataset:
white patches and stuff in cheeks of mouth; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Lot number: EW0217) at the age of 48 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ORAL DISORDER (non-serious) with onset Jun2021, outcome "not recovered", described as "white patches and stuff in cheeks of mouth". The events "white patches and stuff in cheeks of mouth" required physician office visit.  Additional information: When received the first dose Pfizer COVID vaccine, white patches and stuff in cheeks of mouth came out. The doctors were having trouble figuring out what was going on. Patient reported it still hadn't gone away. The doctor was going to try to treat it. Patient read up online and is something that was people who took Pfizer Vaccine caught, called Lichen planus. Patient received second dose of BNT162b2 (BNT162B2, lot: EW0181), left arm on 02Jul2021; first booster of BNT162b2 (BNT162B2, lot: FK9896), left arm on 25Jan2022 and second booster of BNT162b2 (BNT162B2, lot: FT7139), left arm on 26Aug2022. Patient also received Hepatitis A and Hepatitis B Vaccine (manufacturer unknown) on 02Jul2021.
itchy; I feel like I have a slight cold; stuffed up; big red blot on injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), NASOPHARYNGITIS (I feel like I have a slight cold), NASAL CONGESTION (stuffed up) and VACCINATION SITE ERYTHEMA (big red blot on injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PRURITUS (itchy), NASOPHARYNGITIS (I feel like I have a slight cold), NASAL CONGESTION (stuffed up) and VACCINATION SITE ERYTHEMA (big red blot on injection site). At the time of the report, PRURITUS (itchy), NASOPHARYNGITIS (I feel like I have a slight cold), NASAL CONGESTION (stuffed up) and VACCINATION SITE ERYTHEMA (big red blot on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and Concomitant medicines were not provided
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: 1433), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL; LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; SIMVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300000099 Same patient, different product and event;
Fatigue, severe muscle aches all over body - sore muscles with touch. 3/20/09 Note received from PCP. Pt has not been seen at all since DOV. TC from parent 3/16/09 reporting fatigue, muscle aches-especially in arms since 3rd Gardasil in 12/2008. Will f/u PRN.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 at 15:00 as dose 1, single (Lot number: 33030BD), in right arm, on 03Mar2022 at 15:00 as dose 2, single (Lot number: EN6205), in right arm and on 24Mar2022 at 17:45 as dose 3 (booster), single (Lot number: FR2613) in right arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Oxygen saturation: 95; Vital capacity: 104/62/99, notes: 104/62/99. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks included Ezetimibe, Lisinopril , Metoprolol ER and Spironolactone. Paxlovid pills started throwing up on morning dose and now have diarrhea with anything eat in or drank just like slim and uncontrollable stop taking pills B4 the evening just taking Tylenol and cold medicine 3D days now no control still and cough tighter and in chest but no trouble breathing with meds im on is there a interaction to cause the diarrhea vitals 104/62/99.  No follow-up attempts are needed. No further information is expected.
I first started feeling symptoms on the Monday before testing positive that was on 12/05/22.  I was having congestion, running nose, sore throat and coughing. I started having a fever the next day. In between all that I had a case of diarrhea. I developed a headache that I developed from my congestion. It was like a really bad cold. I contacted my PCP on 12/07/2022, I had gotten a call from my sister that were we exposed at a holiday party. I was sent to my pharmacy to pick up a at home COVID19 test. It was positive, the doctor office told me I was going to have to monitor my fever and if I get the feeling of a need to come in they would send me to the ER. I didn't test negative for two weeks. It was right on the 14th day I was negative.
13 hours after the vaccine, I experienced intense headache, body aches, and nausea.  I vomited violently 3 hours after the onset of symptoms.  I took 400 mg of ibuprofen and was able to sleep.  The following day I had intense body aches and extreme exhaustion all day long.  I managed it through doses of ibuprofen.  I was able to sleep all night the following night with some NyQuil.  The second day, I woke up feeling still a little weak and tired, but the body aches have subsided significantly.  It's nothing crazy, but it felt like I should report so there is more information for the researchers and public.  I did have COVID March/April 2020.  I had body aches, fatigue, chest tightness, loss of taste and smell, but NO FEVER.  It was undiagnosed at the time (no fever), but in October 2020, I gave blood and I did have COVID antibodies.  I gave again in January 2021 and I still had the COVID antibodies.  I received the vaccine March 10.  Thank you!
Info has been received from an RN concerning a pt who was vaccinated with a dose of MMRII. Subsequently, the pt developed swelling and induration above the elbow in the arm that the injection was given. The reaction was not at the injection site but was in the same arm. Unspecified medical attention was sought. There was no product quality complaint involved. Additional info has been requested.
Mother of 16 y/o registered the child with the incorrect birthdate.   The reason is unclear.   Upon administration of the second dose, SCHD staff determined the error.   The second dose was administered.    There were no side effects reported.
VISION ISSUES COULD SEE FAR OR CLOSE UP LIGHT SENSITIVITY 10/10 EYEBALL PAIN
pt in hospice facility; tested positive for COVID on 1/5/22; per death certificate pt's causes of death were:  AHRF, Acute Viral Pneumonitis, COVID 19 Viral Infection, End Stage Dementia
Sore arm at injection site all the way around to arm pit, still sore after 3 days,  chills, fever of 102.5, muscle aches and pains, head ache, lasted for 24 hours
Tinnitus, mild was noted the day after the first vaccination on 22 Apr 2021.  The tinnitus worsened on the day after the second vaccination on 13 May 2021.  The second vaccination was received on 12 May 2021.
1/8/21 Area of blue/purple discoloration measuring 5cmx4.5cm, to where injection of the Pfizer Covid-19 vaccine was given on 1/7/21. Resident moves arm when area touched. Scant amount of dried blood noted to area where resident appears to have been scratching. Resident afebrile without rash to area. Minor swelling noted at site.
Injection date-1/11/21  adverse event started 1/19/2021.  left upper arm itching intensely, hot and red. itching stopped on its own. 1/20/21-left upper arm still red with small amount of swelling around injection site and pain around the site.  no treatment as I didn't have any Benadryl. Message left on primary provider at 10:22 am I have not heard back from provider yet as I fill out this form, therefore, not able to answer item 21 below
I started getting symptoms of scratchy throat, headache, fatigue, and congestion. I had a positive COVID-19 test from an in home test and at a testing facility. I contacted my doctor and was prescribed a Mon Lupardiar. This seemed to help. My symptoms lasted 2 days. Day 9, I tested negative. Then On day 17, I took another test and it was positive again. Then 8 days later I took another test which was negative.
Fever 100 degrees F; This is a spontaneous report from a contactable consumer (parent). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown), via an unspecified route of administration in left arm on 12Apr2021 at 09:15 (at the age of 36-year-old) as a single dose for COVID-19 immunization. The patient's medical history included hypertension. The patient did not have allergies to medications, food, or other products. Concomitant medication included lisinopril received within 2 weeks of vaccination at 40 mg, once a day. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown) on 22Mar2021 in left arm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever 100 degrees F on 12Apr2021 at 13:00. The patient underwent lab test and procedure which included body temperature: 100 degrees F on 12Apr2021. No treatment medication was received for the adverse event. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient received his second vaccination  2 days prior to presentation. States he woke yesterday feeling tired with associated chills, nausea, decreased appetite and hoarse voice. He was able to go to work as usual. He came home and ate some fish and clam chowder for dinner. Around 7pm that evening, his voice became muffled. Symptoms progressed to difficulty swallowing and sensation of throat swelling so he came to the emergency department for evaluation. On arrival to the ED, he was noted to have water bag edema of the uvula. O2 sats 98% on room air, no respiratory distress. He was treated with diphenhydramine, famotidine, and methylprednisolone and observed. No progression of symptoms noted.
On 9/29/09 child received VARIVAX vaccine (L) posterior upper arm. Returned on 10-1-09 to swollen red arm.
heart rate slowing down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE DECREASED (non-serious), outcome "unknown", described as "heart rate slowing down". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated, Patient don't know exactly, he took his booster shot. When he took his first two shots, he had a problem with heart rate slowing down. Patient just wanted to know if anybody if has something have or not.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This case meet criteria for vaccine breakthrough review. Patient was admitted , is asymptomatic for COVID symptoms.  Per chart review, may have been symptomatic ~1 month prior.   Patient delivered on 10/15/21.
She had congestion, runny nose, and a cough for three days.  She also had mild diarrhea for 7 days and was fussier than normal.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-JUN-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (strength: 0.5ml, lot # K020188, expiration date 22-OCT-2016, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 168 hours with the highest recorded temperature of 7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was Frozen (F). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient developed fever to 104 on evening of vaccinations. She went to Er the next night and was diagnosed with pneumonia. She was treated with antibiotics, but developed wheezing that has persisted despite oral and inhaled steroids, atrovent and albuterol.
p/vax pt exp weight loss;pt dx cystic fibrosis;MD attributed the weight loss to cystic fibrosis;MD further stated that cystic fibrosis was not caused or aggravated by rota shield vax;
Started as severe chills at bedtime same day as vaccination. The next day was body aches, fatigue and chills again at night. I have had all these symptoms in varying degrees every day since I was vaccinated. On some days the fatigue and body aches can be so severe as to be debillatating.
No signs or symptms have been reported; temperature excursion / Gardasil 9 was administered to a patient on 29/JUL/2021; This spontaneous report has been received from a registered nurse concerning a 16-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 29-JUL-2021, the patient was vaccinated with the second dose, of 1 time dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) on the patient's left arm (dose, route of administration and vaccine scheme were not provided; lot number T028929 has been verified to be a valid lot number, expiration date reported and established as 08-MAR-2023), as prophylaxis, and which was improperly stored.   The vaccine was improperly stored at minus 0.5 Centigrade degrees during a time frame of 1 hour 30 minutes; 13.6 Celsius degrees during a time frame of 1 hour 40 minutes. The cumulative time frame was 2 hours 10 minutes (product storage error), which was detected by digital data logger. It was reported that the temperature excursion occurred due to power outage and a storm. There was a miscommunication when reporting high and low readings of temperature. Initially received a clearance to use vaccines on 28-JUL-2021.  There was no previous temperature excursion. No signs of symptoms were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028929; expirationdate: 08-MAR-2023; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
WITHIN 40 MINUTES OF RECEIVING VACCINE REDNESS AND ITCHING TO ARMS BEGAN - URTICARIA DEVELOPED OVER ARM - ADVISED ORAL BENADRYL. SEEN 9/18/2020 IN OFFICE WITH URTICARIAL AND BULLOUS LESIONS OVER BOTH ARMS - PRESCRIBED ORAL PREDNISONE AND ORAL BENADRYL. LESIONS CONTINUED TO WORSEN AND SPREAD OVER ALL LIMBS - 9/25/2020 SEEN AT HOSPITAL ED. STABLE AND DISCHARGED. 9/27/2020 - SEEN AGAIN AT HOSPITAL ED, THEN TAKEN TO ANOTHER HOSPITAL. ADMITTED 9/27-9/29/2020. DIAGNOSIS RASH, ADVERSE REACTION TO VACCINE, BULLOUS RASH, TONGUE LESION, ANXIETY. BIOPSY TAKEN OF LESION, TREATED WITH ORAL AND TOPICAL STEROIDS. DISCHARGE HOME STABLE.
Booster dose (3rd dose of pfizer vaccine) given to patient.  Patient not eligible for booster dose due to only being 13 years old
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (2023) Negative, notes: testing negative for the 2nd time within 48 hours; (2023) Negative, notes: testing negative for the 2nd time within 48 hours; (2023) Positive, notes: positive immediately with a high load within 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24May2023 to 29May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error, on 3/16/2021.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. An ID requirement has been put in place to prevent this situation from occurring in the future. Per supervising doctor, this patient is able to receive the second dose of Moderna on an off-label, compassionate use basis.
Unilateral hearing loss 2 weeks after receipt of flu vaccine, idiopathic, being followed by ENT.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: After receiving the Johnson & Johnson vaccine (Lot #204A21A), patient sat down as directed. Several minutes later, patient walked to the pharmacy counter complaining of feeling dizzy immediately before falling. No injuries were sustained. Upon examination, patient was conscious and alert, but dizzy and profusely sweating. Patient recovered within several minutes and stated it was likely anxiety that caused the fall.
I was a G1P0, 36 weeks 0 days at the time of my 2nd dose of the Moderna vaccine. I received the injection at 8:25am and my water broke at 6:35pm. I had been lying down for about 5 minutes prior to the water breaking, with no physical exertion or contractions orior to that. I had no prior risk factors (other than advanced maternal age), but delivered my preterm baby about 5.5 hours later. Nearly 48hrs after delivery, baby and I are both doing fine.
Spent entire day after shot asleep. Spot where shot was given has raised red area warm to the touch.
SUB-CLINICAL HYPERTHYROIDISM; GRAVE'S DISEASE; BLURRY VISION; FELT ILL; FELT TIRED AND EXHAUSTED; HEART COMPLICATIONS; CHEST PAIN; FLU-LIKE SYMPTOMS; BODY ACHE; This spontaneous report received from a patient concerned a 49 year old white, not Hispanic or Latino female. The patient's weight was 65.3 kilograms, and height was 67.5 inches. The patient's past medical history included: Smoker. concurrent conditions included: HIV infection, alcoholic, anxiety. Other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the patient experienced heart complications that her heart felt weird and fluttering, however, this symptom decreased. Heart symptoms began four to five hours after receiving the vaccine. She could not work all day after she received the vaccine. She experienced chest pain, flu-like symptoms, body ache, felt ill, felt tired and exhausted. On 05-APR-2021, she experienced blurry vision. In MAY-2021, Patient was diagnosed with sub-clinical hyperthyroidism, grave's disease at her annual check-up. She was tested again in JUN-2021 to confirm initial findings. She received sodium iodide as a part of thyroid test in AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, flu-like symptoms, body ache, and felt ill on 06-APR-2021, and felt tired and exhausted, had not recovered from sub-clinical hyperthyroidism, and the outcome of grave's disease, heart complications and blurry vision was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210840811-Covid-19 vaccine ad26.cov2.s-Sub-clinical hyperthyroidism, Grave's disease . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
devel rt arm pain & stiffness about 1/2hr p/vax; had pain from neck downn  to hand especially w/movement of shoulder;seen by MD: given Advil;sxs subsided over several days
Swelling, redness, itching, pain, heat at and around the injection site. The signs and symptoms increased over the next 5-6 days (6X10mm). One week later (7th day), the injection site is smaller, but still red and itchy.