chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient), based on information received by Pfizer (control number: 21K-163-4125990-00). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), intramuscularly, on an unspecified date in 2021, single dose, for COVID-19 immunization. Patient also had Humira (adalimumab) 40mg/0.4mL, solution for injection, pre-filled pen, subcutaneously, (1 every 2 weeks), from an unspecified date (batch/lot# not reported) and ongoing, for an unspecified indication. The patient's medical history and concomitant medications  not reported. On an unspecified date in 2021, patient experienced a flare-up, high fecal calprotectin and twenty loose bowel movement. Patient hospitalized for flare-up, high fecal calprotectin and twenty loose bowel movement from an unspecified date in 2021 to an unknown date. Clinical course of the events as follows: A female patient with events of flare-up, increased loose bowel movement and non-serious high fecal calprotectin with Humira 40mg/0.4mL (adalimumab). No reported medical history. On an unspecified date in 2021, patient experienced flare-up. The patient experienced increased loose bowel movement and high fecal calprotectin. Pfizer Biontech COVID-19 vaccine (Tozinameran) also considered a suspect. The patient experienced flare-up (unknown) and hospitalized on an unspecified date in 2021. High fecal calprotectin of over a thousand. She took the first dose of COVID vaccine and experienced twenty loose bowel movement. Treatment, concomitant drugs, tobacco and alcohol history, medical history and allergies not provided. Primary reporter declined to provide lot number information. The patient underwent lab tests and procedures, which included fecal calprotectin: Over a thousand (high), on an unspecified date in 2021. The outcome of all events was unknown. The reporter's causality for flare-up, increased loose bowel movement and high fecal calprotectin: not provided. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
First symptom was a sudden feeling of something lodged in my throat with pain when swallowing although there were no breathing issues.   By 7:00 pm i had swelling of my face particularly around my eyes and accompanied by a bad headache.   Feeling weak and fatigued.  Decided to wait to seek medical help mainly because there were no breathing issues.  By morning my throat felt a bit better but the swelling seemed a bit worse and the headache persisted.  Around 1:00 pm on 11/6/19, I took an antihistimine.  Felt better by evening but the swelling didn't subside completely until the morning o 11/7/19.
I got the regular side affects that were warned about, however, I also got allergies for the first time in my life a few days after. I lived somewhere else this time last year and was not affected by the pollen, but after I got the shot I got allergies every time I went outside. I am not sure if it is a coincidence or if the shot had messed up my immune system in any way. My allergy symptoms occur when I go outside and consist of runny nose that turns into stuffed nose, sneezing, and eye irritation. it is worse when it is cold and have occurred every day since it started.  regular side effects that I was warned about that I experienced was pain in the shot area and barely able to lift my arm for about 24 hours. heavy body flu type of symptoms the first night, second night I started having a runny nose and felt a little sick. then the next day or a day after I started having bad allergies when going outside that I am still experiencing 13 days after my first shot.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the left arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. 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: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
At approximately 12:30pm today PT received the Janssen COVID-19 vaccine in the treatment room. He was monitored for 30 minutes; no side effects were reported. At 1:50p, I went to enter the vaccine administration information, I saw that he had completed the Moderna COVID-19 vaccine series. His second dose of Moderna was on  06/16/2021, 26 days prior to today's administration. PT reported no previous administrations of any other COVID-19 vaccines on his consent form. As of 2:45pm still no adverse events for him have been reported
Soreness, Swelling, Itching, Lump 2x3" on left arm
This spontaneous report as received from a medical assistant refers to a 10 month old infant patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 17-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. On 06-SEP-2018, the vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513-1902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009325:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
I miscarried my healthy pregnancy two days after vaccination. I want to report this event for data collection and reporting purposes for future studies. I do not know if the vaccine caused the miscarr; I miscarried my healthy pregnancy two days after vaccination.; This is a spontaneous report from a contactable consumer(patient) reported for herself that: A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 19Jul2021 18:15 (Batch/Lot Number: EW0181) as DOSE 1, SINGLE for covid-19 immunization. The patient past Medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Nov2020. On 21Jul2021 at 11:45 PM, she miscarried her healthy pregnancy two days after vaccination. she wants to report this event for data collection and reporting purposes for future studies. she does not know if the vaccine caused the miscarriage. The events result in doctor or other healthcare professional office/clinic visit. No treatment was reported. Since the vaccination, the patient had been tested for COVID-19. The event outcome was resolving.
She got her vaccine, the arm was just sore and was fine that day.  The next day it was really sore, and it was red and inflamed.  A little bit later she developed blisters and then the blisters started oozing and more blisters started occurring and oozing.  She went to the ER and when the oozing stopped her skin was inflamed and then it started peeling, and the area looks like new skin is growing now.  In the ER they did 2 skin biopsies and wanted to make sure due to the blisters that it was no sign of shingles.  Everything was normal, she stayed until the next day and then sent her home.  The way it started from the arm was spreading to her back and they wanted to make sure it didn't spread and that she did not have any chest or breathing issues.    She did have COVID in January and was supposed to wait, and then they changed that and then had the vaccine.   The 1st and 2nd vaccines she did get a swollen lymph node and saw her PCP to make sure it was OK.  Thinks her body just did not agree with the vaccine at all.    She does note that ever since she received her vaccine that she gets sick more and her bones and joints hurt with pain, more on the left side.  Her wrist, arm has pain in this area since the vaccine.
soreness at the injection site; the thumb feels funny; the thumb feels numb; This is a spontaneous report from a contactable consumer (caregiver). A 49-year-old female patient (Caller's wife) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05May2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Historic vaccine was bnt162b2, via an unspecified route of administration, administered in left arm on Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient received first covid vaccine in Apr2021 and received the second one on 05May2021. Since then she had soreness at the injection site and the thumb feels funny, numb in 2021. The soreness isn't debilitating. Caller asked "have you had other reports of this and will it go away? What light can you shed?". The case is reported as non-serious. The outcome of events was unknown.   Information on the lot/batch number has been requested.
chills, h/a, malaise, vomiting, diarrhea, gen muscle pain, productive cough, sore throat;lasted approx 5-6hr;onset was 2-3hr p/vax;
Mild headache, sudden chills, fatigue, body aches, pain in injected arm - took 1000 mg of Tylenol Rapid Relief, rested the remainder of night and next day and symptoms passed
Anencephaly in pregnancy. First sono 11/24/21. EDD 6/9/2022
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild
Specific sign was of sudden increase in secretions (from eyes, nose, or mouth); allergies ?acting up,?  or a cold; feeling tired. changes in breathing, with  exercises
Chills, following day. Following day difficulty walking and urinating. Being treated with Cestriaxone, Acyclovir. It appears as recovery is pregressing forwar. Another MRI is scheduled in late March. Bladder function continues to improve as does coordination. Pt feels he now has a stutter.
Spoke with Pt. she states she had her flu shot Monday when she saw staff, Pt. states the next morning she woke up with tenderness in her neck, Pt. states she feels that her lymph node is swollen, Pt. has been fatigued for several days. Discussed with Pt. common side effects of the flu vaccine such as soreness, redness at injection site, headache, fever, nausea, muscle aches. Pt. denies having any of these, she states her tenderness starts about 4 inches above the injection site near her clavicle. Pt. is advised to come to UC for an evaluation if she concerned about her symptoms.
Arm pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother) via Sponsored Program Support. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Mother wanted to know if it was okay for her not to have any side effects since everyone she knows including her daughter experienced arm pain. The outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Localized swelling and a rash with itch. Area feels hot to the touch. There was an initial reaction the day of the shot that faded after a few days, however the reaction returned in the exact same spot 12 days after the shot.
2 days after injection, I broke out in Shingles (confirmed by the Dr. on my scalp, left side of forehead and radiating toward my left eye. MD stated it was too coincidental not to be related to vaccine. I had NO s/s of illness prior to injection. MD would not allow me to take 2nd dose.
Psoriasis flare up on back of head, on arms above elbow; Reaction/stiff arm after first covid-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Reaction/stiff arm after first covid-19 vaccination) and PSORIASIS (Psoriasis flare up on back of head, on arms above elbow) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In January 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Reaction/stiff arm after first covid-19 vaccination). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare up on back of head, on arms above elbow). At the time of the report, MUSCULOSKELETAL STIFFNESS (Reaction/stiff arm after first covid-19 vaccination) outcome was unknown and PSORIASIS (Psoriasis flare up on back of head, on arms above elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624067 (Patient Link).
On 12/08/00, this patient had a sudden onset of numbness and weakness. Diagnosed with Guillain Barre' Syndrome. The follow-up reports state hypertension, arthritis, leg cramps cataract surgery benign breast tumor, appendectomy before the onset of GBS symptoms as ongoing medical conditions. And prior to the onset of GBS symptoms, the pt also experienced headache.
day p/vax pt noted some moderate swelling in lt upper arm for dose #2;pt has mild/moderate redness in affected area;also c/o numbness in lt hand & limited ROM of lt arm d/t pain;pt tried ice as soon as swelling began;
arm pain; headache; chills "but no fever"; nausea; unable to lift his arm; "flu and strep" were both negative; "flu and strep" were both negative; This spontaneous report has been received from a physician, referring to a 19 years old male patient (the physician's son). The patient's concurrent condition included attention deficit/hyperactivity disorder (ADHD). The patient's concomitant medication and drug reactions/allergies were not provided.  On "either" 11-FEB-2020 or 12-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis.   On 12-FEB-2020 or 13-FEB-2020 (reported as the next day), the patient experienced headache, arm pain and chills "but no fever". On an unknown date in February 2020, "a couple of days" after receiving dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient then experienced nausea and was unable to lift his arm. The patient went to an unspecified Emergency Room on an unspecified date. The patient was tested for the "flu and strep" while in the Emergency Room and results for both the "flu and strep" were both negative. The patient received doses of ketorolac tromethamine (TORADOL) and ondansetron hydrochloride (ZOFRAN) while in the Emergency Room. On an unknown date, the patient was discharged to home from the Emergency Room. The patient sought medical attention. There was no intervention given to prevent serious criteria. The patient did recover on an unspecified date. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA007859:
Patient given vaccines. Upon leaving room patient stumbled forward hitting wall, then fell backwards hitting wall behind. Pt had passed out. This happened about 10 mins after shots. Pt assisted up once alert and taken back to a room to be assessed. Pt admitted to not eating or drinking all day.
Whole side was hurting, and he was hurting; His arm was sore, he was sore, and that everything started in his arm,felt in the side of his ribs/in the site of injection, and it went right up and then whole side was hurting; Started in his arm, and then swell up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (His arm was sore, he was sore, and that everything started in his arm,felt in the side of his ribs/in the site of injection, and it went right up and then whole side was hurting), VACCINATION SITE SWELLING (Started in his arm, and then swell up) and PAIN (Whole side was hurting, and he was hurting) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066k21a) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (First booster dose) on 15-Nov-2021, Pfizer vaccine (Second dose) and Pfizer vaccine (First dose). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 02-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (His arm was sore, he was sore, and that everything started in his arm,felt in the side of his ribs/in the site of injection, and it went right up and then whole side was hurting), VACCINATION SITE SWELLING (Started in his arm, and then swell up) and PAIN (Whole side was hurting, and he was hurting). At the time of the report, VACCINATION SITE PAIN (His arm was sore, he was sore, and that everything started in his arm,felt in the side of his ribs/in the site of injection, and it went right up and then whole side was hurting), VACCINATION SITE SWELLING (Started in his arm, and then swell up) and PAIN (Whole side was hurting, and he was hurting) had resolved.            No concomitant medication information was provided.  No treatment medication were provided.  Patient received second booster dose of Moderna vaccine.  It was reported that patient took previous 3 dose of Pfizer vaccine he did not had any reaction. Patient had not received other vaccines within or 1 month prior to Moderna COVID-19 vaccine.
After the second shot on 8/19/2021, I was very sick for over 7 days. I started vaginal bleeding that has not stopped in over two and 1/2 months. I have never had a period go on this long. I also am not supposed to have a minstrel cycle as I use NuvaRing and only replace it once a month to avoid a cycle.
Heart started racing right after injection. Pharmacy monitored my heart rate until it came down to  a normal range - 20 minutes. Very sore arm,  severe chills and body aches started that evening.  28 hours later, still have chills, body aches, bad headache, neck pain.
c/o fever, chills, red & swollen from shoulder to elbow;reports feels hard to touch & warm;urticaria rxn;advised cool compresses to arm;
Pt recvd 1st dose of Hep B vax w/no noted problem; Pt recvd 2nd dose of vax 18AUG92 & w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
I had my period that week of my first covid shot and the day before my shot my period was done with, then the day after my shot I immediately started spotting and spotted for about 30 days and had cramps as well, and I?ve never spotted before in my life never ever had any menstrual problems always been regular with light cramps the week of my period never spotted, now I?ve spotted for about 30 days after my first shot and haven?t had a period at all this month.  11-16 September period  17 September received 1 vaccine  18 September started spotting 8 October got 2nd dose  12 October spotting stopped  Due to tracking my period the last 5 years my period should have started 15 October   Still no period  But no spotting currently   I have taken nothing changed no diet and still constant with everything I do