chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 5:30 pm on 9/11/21 She got dizzy, hot, weak, short of breath, her chest got very tight, she saw spots then saw just solid white and then she passed out for a moment. Sat for a while and someone got her water and after a while she started feeling better.  She described it as a very scary feeling and moment and a feeling it was a feeling of like she was dying but thankfully she did not. We did not go to ER or doctor because she started feeling better. Later that night under her left arm she started having pain and swelling of her glands, that is the arm she had injection in, it stayed very painful for quiet a few days. She is still having some pain under that arm and a small swollen gland but it is getting better. We wanted to report this because we are afraid if she gets the 2nd injection that something terrible might happen to her. This is such a sad situation that these kids are being put into to be forced into these shots just to attend college abs have to put there lives in jeopardy and possibly bad harm or possible death. I don't think she should have to take the 2nd vaccine. She is still recovering from the reaction and tye being scared for her life that this has caused her.
Information has been received from a registered nurse, concerning a 20 year old female patient, who on an unknown date was vaccinated in the dorsogluteal area with the third dose of Gardasil (lot # not specified).  The patient experienced pain with the vaccination.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Swollen glands in neck and loss of voice, weak, lightheaded, vomiting, chills, body aches, extreme thirst, constant sleep, heart rate high within 48 hours.  At 48 hours, severe breathing issues and small sores on upper arms and chest. Now on day 5, shortness of breath continues, spells of sweating, no sleep for 2 days, and a fluid filled Knoton lower front neck. Had to miss a day and a half of work so far this week
18 hours post vax, the infant experienced a seizure. Treated with anticonvulsant medication.
Breakthrough Covid + 10/3/2021. 90-year-old female with a past medical history significant for irregular heartbeat and osteoporosis presents today for further evaluation and treatment of diarrhea that started a couple days ago. Partially imaged hyperattenuating structure in the right posterolateral chest wall measuring up to 5 cm, which may represent a hematoma. Congestive changes in the lung bases.
Following anthrax vax on 2/27/03, member developed skin redness on chest and arms (scattered).
Breakthrough Covid Symptoms first developed on 05/22/2022 Symptoms: cough, sore throat, runny/stuffy nose, fatigue
Arm was swollen and sore. Patient said she was having problems breathing 2 days later and went to Dr. Dr told her not to get Tetanus shot again.
pt admitted to hospital with CP and SOB on 7/31/22; found to be positive for COVID; AKI; pt's demand for O2 increased and on 8/16/22 he was transferred to ICU; pt's condition continued to decline and the family transitioned him to comfort focused care; he passed away in the hospital
Evening she received vaccination, onset of flu-like symptoms (myalgia, fever, chills, fatigue) which lasted for 4 days.  Large local reaction started on Saturday 08/23-red, warm, swollen, pruritic which gradually increased.  Today, 08/28, left upper extremity with erythema and edema (7.5 x 5 inches), TTP, warm to touch.  No U/A, Temperature 98.9F.  Prednisone for 5 days.
Patient presented in pharmacy about 36 hours after immunization with redness and swelling of right arm.
consistent with Primary Membranous Nephropathy Stage II; This is a literature report for the following literature source(s):   A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine headaches" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: GLOMERULONEPHRITIS MEMBRANOUS (medically significant), outcome "recovered", described as "consistent with Primary Membranous Nephropathy Stage II". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: negative; Antinuclear antibody: negative; Antiphospholipid antibodies (14-20): 247 IU/ml; Positive, notes: antibody came back positive; Biopsy kidney: showing global 3+ Subendothelial electron dense, notes: deposits (IgG, C3, Kappa, Lambda), 100% foot process effacement, IF staining positive for PLA2R, consistent with Primary Membranous Nephropathy Stage II; Blood albumin: 1.1 g/dl, notes: hypoalbuminemia; Blood cholesterol: 572 mg/dl, notes: elevated; Blood creatinine: 0.85; Blood triglycerides: 220 mg/dl; Blood urea: 9; Creatinine urine: 79.9 mg/dl; DNA antibody: negative; Glomerular filtration rate: greater than 60; Hepatitis viral test: negative; HIV test: negative; Immunology test: positive, notes: PLA2R; Protein urine: 11000 mg/g, notes: 11g/day, 24hr Urinary protein excretion estimation; Protein urine: 869.9 mg/dl, notes: nephrotic-range proteinuria. Therapeutic measures were taken as a result of glomerulonephritis membranous.  Clinical course: The patient was having abdominal and lower back swelling, facial edema and foamy urine. Patient received her 3rd dose of COVID-19 vaccine 1-2 weeks symptoms appearance. Patient starts on High-dose steroids and later switched to Tacrolimus 2mg BID, and received Rituximab 2 dose with major improvement in symptoms and proteinuria.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-GLOMERULONEPHRITIS MEMBRANOUS The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt recv vax on 11/6/98; on same day pt exp tingling & numbness of rt arm & hand, decreased mental acuity
felt like I was getting COVID again; felt like I was getting COVID again; could barely walk; chills; nauseated; wasn't breathing well; swollen, red cheeks; red cheeks; headache; constant pain in my body; fever never got higher than 99.46F; A 94-years-old female patient received the first dose of dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included covid-19 from Mar2020. Concomitant medication included Tylenol and Tramadol. The patient reported that the evening I got the first dose, I had chills for 24 hours, I was nauseated, I wasn't breathing well. I had swollen, red cheeks. My fever never got higher than 99.46F. I called because I could barely walk. I went to the hospital. I felt like I was getting COVID again. I took me about 3 days to get over the side effects. I had a bad headache. I told the doctor in the ER my problem and he asked why I thought it was reaction. I'm 94 years old. I take Tylenol every day. I take Tramadol for constant pain in my body. I finally just told them I wanted to go home; they weren't doing anything for me at the hospital. The outcome of the events chills, nauseated, wasn't breathing well, swollen, red cheeks, fever never got higher than 99.46F, I could barely walk, felt like I was getting COVID again, bad headache was unknown.  Information on Lot/Batch number requested
Fever started 8 days later on 4/29. The fever started on 4/29/13, with no other symptoms, and was around 101F. It progressed the next day to 102.8F on 4/30/2013, by 5/1/13 it was 104.5F. I believe we went to the ER on 5/3 and he had a temp on 105F with a full dose of Advil already. He barely ate and was extremely lethargic (mostly sleeping in my arms) during the day the entire week, and at night he would often cry, scream, and thrash around, as if in pain, and would arch his back.  It was after this fever that we observed loss of developmental skills such as loss of eye contact, he would not respond when we called his name, he became obsessed with watching the wheels on his car/trains roll, stopped eating all types of foods except soft refried beans and smoothies. He started to scream in settings that seem to overstimulate him (such as the grocery stores and restaurants). He stopped singing and we notice a regression in verbal language, and developed unique self regulating features like flapping his hands and rubbing his fingers together repeatedly. He was also not able to sit for more than a minute after this week of fever, without getting distracted. He would start laying on friends and seem to be unaware of his body proximity to others. He often tries to dart into the street if he sees something of interest there. We have been successful at keeping him from doing that. Often sick due to mitochondrial dysfunction.
pt recvd vax 18NOV94 & exp generalized weakness 48 hrs later w/fever 102.6, general malaise; dx post flu vax react-hospitalized 24NOV94 w/nausea & vomiting; hx known diabetic, hypertension controlled w/diet; 1DEC94 transferred to hosp;
lethargic; body aches; his arthritis has really been bothering him; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PAIN (body aches), ARTHRITIS (his arthritis has really been bothering him), FATIGUE (fatigue) and CHILLS (chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 23-Mar-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. On 24-Mar-2021, the patient experienced LETHARGY (lethargic), PAIN (body aches), ARTHRITIS (his arthritis has really been bothering him), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, LETHARGY (lethargic), PAIN (body aches), ARTHRITIS (his arthritis has really been bothering him), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.            Concomitant drugs not provided . No medical history and Treatment drugs not provided.
arm appears a half inch long tiny blood vessel that may be burst; feels hard; above the injection site is red; above the injection site is hot; inch and a half in size; dark discoloration in the center; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (above the injection site is hot), VACCINATION SITE MASS (inch and a half in size), SKIN DISCOLOURATION (dark discoloration in the center), SKIN HAEMORRHAGE (arm appears a half inch long tiny blood vessel that may be burst) and INJECTION SITE INDURATION (feels hard) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Enlargement of lymph nodes (Patient noticed a week before getting Moderna vaccine, the patient is scheduled for a biopsy) and Cataract. Concomitant products included ALPRAZOLAM for Anxiety, SIMVASTATIN for Cholesterol, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression, ATENOLOL for Heart disorder, CLONIDINE (CATAPRESS) for Hypertension, GABAPENTIN for Neuropathy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE WARMTH (above the injection site is hot), VACCINATION SITE MASS (inch and a half in size), SKIN DISCOLOURATION (dark discoloration in the center) and VACCINATION SITE ERYTHEMA (above the injection site is red). On 11-Apr-2021, the patient experienced SKIN HAEMORRHAGE (arm appears a half inch long tiny blood vessel that may be burst) and INJECTION SITE INDURATION (feels hard). On 11-Apr-2021, VACCINATION SITE WARMTH (above the injection site is hot), VACCINATION SITE MASS (inch and a half in size), SKIN DISCOLOURATION (dark discoloration in the center) and VACCINATION SITE ERYTHEMA (above the injection site is red) had resolved. At the time of the report, SKIN HAEMORRHAGE (arm appears a half inch long tiny blood vessel that may be burst) and INJECTION SITE INDURATION (feels hard) outcome was unknown.            This case was linked to MOD-2021-073063, MOD-2021-073063 (Patient Link).
A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin (age 2 years, weight 29 lb). The patient's past and current medical history included asthma (ongoing). The following demography was reported for the patient's parent:   Sex: Female Concomitant medication included salbutamol and fluticasone propionate. The patient received FLUMIST QUADRIVALENT via nasal route, for immunization, on 24-Jan-2019 with unknown dose, frequency, and lot number. She reported the patient had the flu (preferred term: Influenza) on Friday, 25-Jan-2019, and was taken to the ER care on Saturday, 26-Jan-2019. The patient was prescribed generic Tamiflu 5 mL twice daily for five days and Cefdinir with both having started on Saturday, and she was also prescribed Prednisolone every morning, started on Sunday, no dates specified. The outcome of the event flu was unknown. The event flu was considered non-serious.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 8:27 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 8:27 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 72.73. No concomitant product use was reported. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  On 17-Feb-2021 Batch 022M20A, Excursion at 9 am, temp 22 taken using a Fisherbrand traceable temperature monitor in F at every hour.  On 17-Feb-2021, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vials were moved to clinic. Vaccine BUD date was 13-Mar-2021 for batch number 022M20A.  Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Increased temp of 104 (R). Began 24 to 36 hrs after the shots.
(9-9) swelling & redness tender, warm @ injection site next day (9-11) called pt & she said it had resolved
Early in the am of 2/2/2007, patient woke with sudden onset of vomiting, dizziness, and severe headaches.  Seen by primary care physician later in the day with noticeable hypotension.  Remained in bed over the weekend, sleeping most of the time and taking Motrin for headache.
Pt recvd 3 doses of Engerix-B & 9OCT91 found to be a non-seroconverter;
The patient called the pharmacy after receiving the flu vaccine stating there was a lump and swelling at the inject site (no redness or fever reported). The patient applied an ice pack for the swelling. The patient was told to take Tylenol if any pain occurs and to call the pharmacy if fever or any other side effect arise. The patient refused to take Tylenol or any other over-the-counter pain medications.
Approx. 5 min after vaccine administration, pt became agitated, crying, vomited multiple times. He was noted to have splotchy rash on his trunk. Shortly after that he developed respiratory distress, wheezing, became pale, limp and minimally responsive. Oxygen applied, epinephrine 0.15mg given at 1617, pt transported by EMS to Hospital.
This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (a little tiredness) and PAIN IN EXTREMITY (a tiny bit of sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (allergic to some medications as well). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (a little tiredness) and PAIN IN EXTREMITY (a tiny bit of sore arm). In March 2021, FATIGUE (a little tiredness) and PAIN IN EXTREMITY (a tiny bit of sore arm) had resolved. The concomitant medication was not reported by reporter. Patient said that patient was on medications for certain pre-existing conditions. Patient said that patient had a tiny bit of sore arm and a little tiredness that lasted no more than 2-5 days after receiving the 2nd dose of the Moderna COVID-19 vaccine. No treatment information was reported. This case was linked to MOD-2022-640751 (Patient Link). Reporter did not allow further contact.
A week after vaccine felt a pain on her arm, no redness. Had lumps on the arm initially did compressions and no reaction.  Pain is similar to shingles pain.  When she works on it it comes down but it's still there.  Pain is tolerable but is annoying due to it lingering.  Still has the discomfort today.
Approx 12 hours after vaccine administered developed fever (approx 102 degrees) headache, chest pains, stomachache. Given TYLENOL, ADVIL, and symptoms gradually resolved within 48 hours.
Developed an acute Guillain Barre' Syndrome. Fell to ground , landing on my buttocks as I had been walking and taking the garbage out to the street. Unable to move lower extremities at all for approximately 8 hours. My son had to carry me from driveway to my bed . I began to wheeze and he wanted to call 911, but the wheezing did not get worse, so I finally fell asleep for about two hours. Then, my legs were very weak and difficult to ambulate first 48 hrs, but I was slowly returning to normal over a few days and am finally almost better completely today about 5 days after the onset of the event. I Cannot really recall if it was ascending as it happened so acutely. Scary!
noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; Large brown circle surround site of shot; bruising surrounding it; some welting. Some tenderness; some welting. Some tenderness; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:30 (at the age of 71-years-old) (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. Medical history included, neuropathy peripheral, drug hypersensitivity, diarrhoea, vision blurred blurred/double vision since Feb, hypertension Mild high blood pressure. Drop in blood pressure and increase in blood pressure month after Covid, chills, MGUS, non symptomatic ascending aorta aneurysm, pronounced cough, fever, sore throat, flu symptom. I had the virus on 30Nov after being unknowingly infected with virus by someone unknowingly with virus, some 8 feet away, with no direct interaction. Experienced fever 4 days later. tested. Virus positive. Excessive flu symptom-pronounced cough, fever, sore throat. treated w/antibodies some 8 days later. The patient received first dose of BNT162B2 for COVID-19 immunization on 10Mar2021 ({Product=COVID 19, brand=Pfizer, Lot number=EN6199, Lot unknown=False, Administration date=10Mar2021, Administration time=12:30 PM, Vaccine location=Left arm, Dose number=1}]. Concomitant medication included hydrochlorothiazide, lisinopril (ZESTORETIC); bupropion hydrochloride (WELLBUTRIN); naproxen (NAPROXEN). Large brown circle surround site of shot, with additional bruising surrounding it. Not noticed until 18 days after 2nd shot, some welting. Some tenderness. Don't know when first appeared, does not appear to be fading. No reaction after first shot. (There was sudden unexpected loss of consciousness after sudden slumping. Wednesday eve before noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes. Mild concussion with symptoms. Amnesia at time of loss of consciousness. Do not know if two are related. Deep brown circle on left arm noted 2 day later. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Nov2020. The outcome of the events was not recovered.
shoulder pain started about 24 hours after administration and is still an issue.  The only treatment that has been tried is acetaminophen 100mg at bedtime, which does seem to help.  Pain is only an issue during the evening.  The  pain seems to be very slowly getting better