chrisvoncsefalvay/vaers-outcomes huggingface dataset:
paralyzed from the waist down; Guillen Barre/ Guillain-Barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PARAPLEGIA (medically significant), outcome "not recovered", described as "paralyzed from the waist down"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillen Barre /Guillain-Barre syndrome". Clinical course: The reporter had 4 male patients, who had been paralyzed due to Guillen Barre from the Pfizer COVID 19 Vaccine. She stated one of them was paralyzed from the neck down and the others from the waist down. The treatment had been different based on income. She reported one could not do anything financially due to income. The other was getting neurological shots that worked from the brain down to re-insulate his nerves to get more movement in the body. The shots were done in a series of shots and he had to be able to afford the shots to get better. If the patient did not have the money to pay for that, they were sitting in the hospital or at home. She stated they did therapy with them to get them moving as much as possible but they still had a long road to recovery. The reporter stated the most recent patient's seemed to be fine before the contracted Guillen Barre, they may have had arthritis or something but they were working full time and everything.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110001 same reporter/drug, different patients/events.;US-PFIZER INC-202300110873 same reporter/drug, different patients/events.;
The injection was suposed to go into deltoid muscle at my upper arm.  They did not asperate but just gave me shot.  when needle was removed their was blood on my arm so obviously a blood vessel was hit it was not given intermusclular.  I have no side effects yet but there has been a lot of publicity about side effects caused by hitting  a blood vessel by mistake. I wanted to report this now so If I develop cardiac or other new  conditions you can relate these e vents together.
Within 1/2 hr. - hives and swelling throat, took BENADRYL - 50 mg, then another 25 mg 6 hrs. later. Ok next day.
HUGE BLISTERS ALL OVER TOES AND FEET; FEET HURTING; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included elevated heart rate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included losartan for elevated heart rate, and metoprolol for elevated heart rate. On 05-JUN-2021, the subject experienced feet hurting. On 06-JUN-2021, the subject experienced huge blisters all over toes and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feet hurting, and huge blisters all over toes and feet. This report was non-serious.
24 hr after shot my eyes, mouth swelled up.  48 hr after shot my throat began to swell shut, Called 911, ambulance, ER. IV drugs to reduce swelling from severe allergic rxn.  Came home.  Resting heart rate 100 bpm (vs 59 bpm normally)  for next 8 days, with extreme fatigue, no appetite, loose stool, bedridden and needed help. Periods of elevated resting heartrate and extreme fatigue for next 3 weeks, so, 4 weeks total.
Received vaccine Thursday at 8:10 am and by approximately 8 pm was feeling body aches.  The body aches intensified during the night and when I got up at 6:00 am Friday had a temperature of 102.2 orally and felt lightheaded, weak headache, significant joint and muscle pain .  Took 400 mg Ibuprofen by 11:00 am temperature dropped to 101.4.  Took additional 400 mg Ibuprofen and temperature dropped to 100.6 by 3 pm.  8 pm temperature rose to 101 with worsening body aches, took 400 mg ibuprofen at that time and awoke at 1:30 am Saturday and was diaphoretic with temperature  of 99.  Body aches significantly improved, but not resolved.  As of 4 pm on Sat improved.  I did not call the doctor about the above, but I think it is  very important that you know that there are people who have significant adverse reactions to  vaccines and that your data should reflect rather than minimizing the side effects of vaccines.
Right breast mass detected near 8/2021. Mammogram on 10/26/21 found complex cystic mass in R breast.  Ultrasound and biopsy revealed  R breast intracystic papillary and ductal carcinoma in situ. Subsequently underwent surgical excision complicated by inadequate margins on 12/3/21.  Revision of R breast central lumpectomy done on 1/6/22.  Surgical pathology consistent with biopsy result, margins were clear.  Although not clinically apparent that this event was caused by the vaccine, patient and family compelled to ask for report to have formally documented.  Advised to follow up with oncology to discuss if they felt any correlation to vaccine administration.  To my knowledge soft tissue/breast tissue not associated with Covid vaccine. I can however attest that the tumor was diagnosed after the vaccine was administered. Further, patient and family with concern that her two sisters have also subsequently developed breast masses/ breast cancer following vaccine for Covid.
Patient developed macular erythematous rash over the trunk of the body, no breathing difficulties.  Treated with diphenhydramine 12.5mg/5ml oral Observed in office for one hour - rash disapated
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 18Jan2022 as dose 3 (booster), single (Lot number: FJ1614) at the age of 26 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, outcome "not recovered" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had not received any other vaccine in four weeks. Patient had not experienced COVID prior to vaccination and Covid was tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974734 Same reporter and product, different dose;
pt recv vax & reported itching on legs p/lunch;by 330Pm mom noted fist sized area on rt inner thigh w/irregular welts, largest about 1/4 across;itching w/welts;
3 1/2 hours after the shot exhausted (2/13), went to sleep and woke about 3 AM (2/14) with fever and chills, headache, nausea and injection site pain, body aches and muscle pain. This continued with fevers up to 101.3, which when treated with tylenol went to 99.8 for about 5 hours and went back to 101.3. Fevers were less 24 hours later (Monday 2/15) about 99, with some chills but less body ache but new cough and chest tightness (pulse ox was still 95). Site had red circle about 2 inches in diameter and was still painful, still had headache and nausea.  body aches and pain had decreased, fatigue present throughout the whole time.  Slept as much as possible from 2/13 until Monday 2/15, during that day had to sleep twice. little appetite and some nausea until 2/15 in the evening, when fever was finally gone. Toady, 2/17, still fatigued with slight headache.
Information has been received from a physician concerning a 14-year-old male with no known drug allergies and no past medical history who on 04-Sep-2001 was vaccinated SC with a dose of varicella virus vaccine live (Lot #635607/1153K). There was no illness at the time of vaccination. In September 2003, the patient developed chicken pox lesions. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a physician indicated that in September 2003 the patient recovered. There were no adverse events following prior vaccinations of the patient or his siblings. No relevant diagnostic test or laboratory data were reported. No further information is expected.
Tinnitus has been going on in top section of my head since about 3 hours after the vaccine.  I believe I have a compromised blood brain barrier due to the fact that I had taken prescribed anti inflammatory for 15 years for my lower back pain. So now if I take anything with anti inflammatory effects I get tinnitus but it goes away soon afterward, depending on strength of dose.  It has been 4 days now with no sign of relief. I am eating a low salicylate diet right now to help my body process any anti inflammatory.
she received Covid 19 Booster (Dose #3) of Pfizer on 11/16/2021 at an outside facility center for drug development, she was apart of a study she stated. She reports on 11/17 she was feeling fever-ish temp 102, headache numbness of the arm (right) and numbness  that she received the vaccine in  she was advised to take Tylenol or ibuprofen to help alleviate pain drink fluids and rest.
w/in 24 hrs p/vax, pt exp an inject site reaction which included swelling of upper arm, neck & clavicle; no swollen lymph nodes present; pt also had pain & erythema @ the inject site; no temp taken; given cytotec & lodine for 18 days;
administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
Very red and swollen in the area of the injection. 5" x 2" long.
one week after vaccination heat, tenderness, red area 1" x 2 ", itchy skin.
Insomnia, malaise, soreness of entire body, nausea, vomiting (over the course of two hours), dizziness, fever, and chills
This is a very pleasant 73-year-old male with hypertension, hyperlipidemia, peripheral neuropathy, patient presented to the emergency department due to progressively worsening cough and shortness of breath, he has known positive COVID-19 infection in the outpatient setting, he reports that he is vaccinated with Moderna vaccine 1st dose in April 2021 and the 2nd dose in May 2021, P started to have symptoms about 7-10 days ago, he also received a dose of Regenerone in the outpatient setting about 4 days ago per his report, he denies any known sick contacts, lives with his wife at home, his symptoms have been progressively worsening including shortness of breath, nonproductive cough, overall generalized weakness and fatigue.  He denies any chest pain, nausea, vomiting, sweating, dizziness or focal weaknesses.  In the emergency department, his resting pulse ox is 90-91%, requiring minimal supplemental O2 via nasal cannula.  Nothing seems to improve or worsen his symptoms.  He is currently afebrile and hemodynamically stable Tested positive on 9/2/2021
My son got his 2nd Covid shot in his left arm and within 24 hrs developed a large grape sized lump in his neck. The doctor examined and determined it to be a significant inflammation of the supraclavicular lymph nodes on the left side. It pains if it is pressed. For now doctor has suggested we wait for 1-2 weeks to see if the swelling goes away. There was no fever or any other typical symptoms.
First Dose-  I had a headache after the shot and tremors started that even and throughout the night. No fevor. Arm very sore, going into neck.   Second Dose-  Felt find the night. Woke up that morning at 1am and with tremors and in a night sweat. Checked temp and it was only 96, but felt hot and was sweating. Woke up the next morning and my entire body, muscles and joints ached. My knuckles, ached, kept getting sharp pains in my knuckles. My jaw ached, difficulty eating. My entire body, my muscle ached, difficulty moving. I didn't get a headache till that evening. I also had severe heart burn that night, not sure if it was related, but I have never had heart burn that bad. The next morning when I woke up (5am) (now two days after my shot), again my joints hurts, I couldn't even stand.  Its like my knees couldn't even support me and I had a massive headache.  I went back to bed and woke around 9am, no longer had a headache, muscles still hurt. Around 11am, all of a sudden, muscles and joints felt fine.   The only thing (day three) is my arm pit on my left side where i got the shot is bothering my extremely bad.  I was able to put an ultrasound probe on my axilla area, and I have swollen lymph nodes in my axilla in the area that is very painful. I also have a dull pain in my elbow.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-FEB-2016 the patient was vaccinated with an improperly stored dose of GARDASIL lot # K016966, expiration date 10-MAY-2017, dose and route not reported. No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion six times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 72, 29 and R; 24, 34 and R; 104, 33 and R; 88, 32 and R; 208, 31 and R; 112, 30 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
SORE KNEES/SORE ANKLE; FEVER; This spontaneous report received from a patient concerned a 20 year old male. The patient's weight was 165 pounds, and height was not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced sore knees/sore ankle. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and sore knees/sore ankle. This report was non-serious.
Under my right arm in my arm pit is hurting and it feels like maybe my lymph nodes are swallen.
Soreness 2 hours after administration lasting until currently (12/30/2020 2354), redness and warmth around injection site about 5 hours after receiving vaccine
Patient followed up with pharmacy a week after receiving immunizations to state she had swollen lymph nodes in arm that received flu shot and that she couldn't raise that arm initially. And she was in bed for several days.
36 hours after injection I started having headaches. Then nausea, regurgitation extreme chills with muscle pain. 6 days later 4/15/21 I still have nausea with lower stomach pain.
warm; red; arm feel a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm feel a little sore), INJECTION SITE WARMTH (warm) and INJECTION SITE ERYTHEMA (red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm feel a little sore). On 25-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm) and INJECTION SITE ERYTHEMA (red). The patient was treated with ALCOHOL at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm feel a little sore), INJECTION SITE WARMTH (warm) and INJECTION SITE ERYTHEMA (red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided Treatment Rubbed with alcohol and took Tylenol. Reporter said patient was fine now.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Event outcome updated from Unknown to Recovering/Resolving.
03/05/2021: Increased SOB, DOE, increased HR and RR, pain on inhalation, agitation 3/06/2021: increased work of breathing, using accessory muscles, sweats, low-grade fever 3/07/2021- death
Headache, Fever, body aches, fatigue and pain under left armpit . Narrative:
This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to a 23 year old patient. No medical history and concurrent conditions were reported. On 13-OCT-2016 the adult patient was vaccinated with a 1 pediatric dose of 0.5 ml dose VAQTA (drug administered to patient of inappropriate age) (incorrect dose administered) (lot number M007124, expiry date 20-OCT-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse effects were reported. The action taken and the outcome of the events was unknown. There was no product quality complaint reported. This case is linked to case number 1611USA002885 via same reporter link. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP. Concomitant medication(s) included: HCTZ, start date: Feb2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events vaccination failure and Covid-19 are related to BNT162b2 (COMIRNATY) cannot be excluded. This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202201274826 same patient, different dose/event.;
patient came to my door stating she felt sweaty and a bit nauseas  at 3:21.  she continued to worsen while her head was between her legs.  I administered 2 oral 25mg diphenhydramine at 3:25 with 6oz water.  she reported palpitations at 3:31, but started feeling better by 3:35. I held her in my clinical room until 3:41 when her partner came in and walked with her to their car.  I followed up with a phone call around 8:15pm and patient stated that she'd taken a nap and feels improved.  she does still have palpitations and had talked to a physician assistant in the family who agreed with me that it sounded like a vaso/vagal response.
After getting the Shingrix vaccine, I contracted shingles. Rash on lower right back moving to stomach, fever.  Went back to doctor and he prescribed Valacyclovir hcl 1 g.   Started feeling better (no or low grade fever) in about 3 days.  Rash was still itchy and painful.
Had the first dose of the Moderna vaccine on 05Mar2021 and has not received the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Had the first dose of the Moderna vaccine on 05Mar2021 and has not received the second dose yet) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MRN496914) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS on 16-Feb-2021. Concomitant products included BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), MIRABEGRON, SOLIFENACIN SUCCINATE (VESICARE), HYDROCHLOROTHIAZIDE, CETIRIZINE HYDROCHLORIDE (ZYRTEC R), ATORVASTATIN CALCIUM (LIPITOR), VITAMIN B COMPLEX, CLONAZEPAM, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]), LEVOTHYROXINE SODIUM (SYNTHYROID), ZINC, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), PROBIOTICS NOS, VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Had the first dose of the Moderna vaccine on 05Mar2021 and has not received the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Had the first dose of the Moderna vaccine on 05Mar2021 and has not received the second dose yet) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The second dose of vaccine had not been taken because of his knee surgery on 19-Apr-2021 and surgery had not been scheduled before getting Moderna vaccine. Treatment information was not provided.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot#K011188 exp. 12-AUG-2016 (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.