chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination was administered right under armpit. Within hours it blistered up like poison ivy with watery blisters. Next morning woke up in a pool of pus, blood and skin coming off. There was swelling and extreme pain. By 10/20 same situation but double in size. Skin was coming off in layers. Pain radiated to shoulder and hands. Went back to the pharmacy and showed wound to pharmacist on duty who mentioned he had never seen anything like it and encouraged patient to go to the ER. At 3pm went to ER and doctors that looked at it had same response. He was asked whether he had a recent tetanus vaccine and since he did not have recent vaccine he was given one. Later on patient found out that the tetanus vaccine cannot be given 30 days post or prior to the shingles vaccine. Patient admitted to the hospital and cultures and blood samples were taken. About 20-30 doctors stopped by to look at wound but no one had answers or could answer questions. At one point patient had 3 different types of IV with 3 different medications going on. During whole time patient's blood pressure fluctuated-went up and down. He had no relief with medication, in severe pain and at one point had to beg for medication because nurse was not stopping by. Wound became larger while at the hospital. Released on 10/24; that day was switched medicine to Valacyclovir (pill) and silver sulfadiazine (cream)-given this prescription to use at home. He was told that they were not sure if he was contagious when he asked what precautions to take with family including grandchildren. At home continued to take medication and did not feel better. Changed bandages twice a day and they continued to have pus and blood. Over the weekend patient felt dizzy and with pain traveling up and down the arm. Saturday 10/25 went to pharmacist to pick up medication but pharmacist was surprised that the hospital released him. Patient is still waiting for insurance approval to refill meds. Today area is bigger than before and symptoms continue. He is going to Dr this afternoon.
Scratchy throat appeared first. Then thick mucous, cough, headache. I am young and healthy, therefore rest, fluids, and MUCINEX are helping with symptoms. I am still not 100 percent recovered almost 2 weeks post vaccine. I have never had any issues with the flu vaccine in the past.
Patient complained of Rash on abdomen and back. Patient  Childrens benadryl last night on 1/4/2022 and morning of 01/5/2022.
She got her vaccines, left the doctors office afterwards and went to the grocery store.  Came home, unloaded and put away her groceries and said at the time to her sister who was there, told her that shd did not feel too good and was going to go upstairs and lay down, which she did for about an hour or so.  Her stomach was sort of queazy and did not feel good.  Already had a headache between the time of the vaccine and getting home.  She got up and came down the stairs (3), and walked into the kitchen and she took a bite of some chicken and mid chew she spit it into the sink as she felt really bad, and felt tht it was not right and tried to call out to her sister and fainted.  Her sister was trying to bring her arouaround, and her sister said that before she came to she was mumbling, garbled but her eyes rolled out and felt that she was going to pass out again.  Her sister let her lay there and come conscience.  Probably 1-2 minutes later she said that she was OK, but that she needed something as she was soaking wet from sweating.  She got her a cold wet rag to put around her neck, and she laid on the floor for 15 minutes before she could get her wits to get up.  She has had 2 knee replacements and did not want to kneel and she pulled herself up when she had a thick foam dog bed to get up.  She could not get her legs under her so sat in the chair for 15 minutes.  She does not know if when she fainted her knee overextended or her knee overextended and that she had pain.  Then her sister helped her walk into the living room and sit in her lazy boy.  She then got chills, and then around an hour later she took some Tylenol and went to bed.  She was then in bed for 3 full days.  Her muscles hurt, she was tired and lethargic and thought that her head was going to explode as it hurt so bad.  She did not want to eat as she felt so bad.  She did not call her doctor.  Her knee was doing fine until she fell, she had total knee replacements 2 years and 7 years ago and now they are in severe pain.    Her sister and herself could not figure out what caused her to faint.  She just happened to notice that Shingrix pamphlet and read it and knew that it was due to that vaccine as the literature mentionend it.  It showed all the issues that she had had, and how she felt before and after.  She has regained some of her appetite, but not really hungry.
TOOK THE THIRD DOSE A DAY LATE; This spontaneous case (PVX2019-1421) was received from a consumer on 03-Jun-2019. It describes a female consumer who "took the third dose a day late", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first and the second dose of Vivotif on 28-May-2018 and 30-May-2018, respectively. Then, she took the third dose a day late, on 02-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took the third dose a day late" was unknown.  Company's Comment: The causality of the event "took the third dose a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the third dose a day late" was considered as not applicable.
When mother returned for shots on 11/06/2001, she reported that after receiving 10/16/2001 DTaP that left leg was red and hot, with 2 small bumps and that the child cried "high pitched" for 3 straight hours.
Bump at vaccination site in the forearm lasting more than 4 weeks. I still have the bump to this day.. Such a long side effect exceeds the expected duration of the bump that was  communicated at the time of vaccination.
Patient c/o dizziness, BP taken & was elevated. Patient took prescribed medication for vertigo. Patient was monitored for additional 30 minutes until EMT was called because symptoms started to worsen. At approximately 11;45 am patient received 1st dose covid vaccine 15 minutes patient stated that she was feeling dizzy. Patient was given water while being assessed. BP was taken and was 200/1214, second take was 195/120. After that BP was taking manually and was 180/110. I asked patient did she have a hx of HTN. She stated that she did and takes lisonpril, Carvediol, and Telmisartan. Patient also stated that she has dizzy medication in her purse and wanted me to get it from her purse. Patient is also taking meclizine for previous diagnosis of vertigo. I then asked patient if she would like me to call EMT, pt stated that she did but wanted to wait for her brother to come so he could get her son. At approx. 12:23 EMT was called Patient was still being observed until EMT arrived . At approx. 12:35 EMT arrived and assessed pt. Patient was transferred at 12:41pm.
I have had 5 shots and I have continued to get worsening arthritis, I don?t know if it is related and didn?t think anything  about it but a few weeks ago I talked to some neighbors that I haven?t seen in awhile, they both said the hadn?t had arthritis before and had developed it in the last 2 years and it was severe now, they said after they got a shot it got worse
I received my 2nd dose on 12/28/2021. My FLU symptoms started on 12/26/2022 in the morning around 8:00AM. I had a headaches, cough and congestions. I went to the clinic on 12/28/2022 they did a combination of FLU and COVID-19 test. My FLU was positive and COVID-19 was negative. They prescribed me with TAMIFLU for 5 days and TESSALON PERLES as per needed. On 2022 my doctor did a CT scan for a pain that I was experiencing. In the CT scan they discovered that I had nodules in my liver. The result showed that it wasn't a cancer it's unidentified. No one knows for sure if it's related to the vaccine or not.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 20-NOV-2015 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. This is one of the many reports from the same source. Additional information has been requested.
Phantosmia.  recurring, inconsistent, strong sensation of cigarette smoke despite being in non smoking area and confirmed that no smokers any where nearby.  Never had this occurrence prior to Moderna  vax
The morning following the immunization the pt experienced joint pain, feeling hot and flushed, sluggishness and back pain. He went to the hospital around noon and was diagnosed with a blood infection. He also experienced brain swelling and was in ICU for several days. The back pain was found out to be due to injury to vertebrae not associated with the blood infection.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), FEELING OF BODY TEMPERATURE CHANGE (One time it was really hot for short period then back to chills), ILLNESS (felt sick an hour after the dose was given), HEADACHE (headache) and MYALGIA (Whole bodyache almost all the times) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE for Inflammation, CYCLOBENZAPRINE for Muscle relaxation, TRAMADOL for Pain.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), FEELING OF BODY TEMPERATURE CHANGE (One time it was really hot for short period then back to chills), ILLNESS (felt sick an hour after the dose was given), HEADACHE (headache), MYALGIA (Whole bodyache almost all the times) and CHILLS (chills). On 15-Apr-2021, FEELING OF BODY TEMPERATURE CHANGE (One time it was really hot for short period then back to chills), HEADACHE (headache) and MYALGIA (Whole bodyache almost all the times) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the arm), ILLNESS (felt sick an hour after the dose was given) and CHILLS (chills) outcome was unknown.            Treatment medications include Ibuprofen 800mg one time only as soon patient felt sick. Ibuprofen 200 mg (4 tablets) 3 times.   This case was linked to MOD-2021-086907 (Patient Link).
Child noted to have cheek swelling and low grade fevers over past 18 hrs, initially left cheek & then right side without redness or pain noted. This is 6-7 days post-vaccination w/MMR. Symptomatic case recommended at this time for suspected mumps infection.
Left calf and thigh pain and swelling on the 6th day following vaccine which continued intermittently for a total of 12 days. I was seen at an urgent care, a left leg ultrasound was completed and I was diagnosed with deep venous thrombosis. I was prescribed Xarelto.
Headache, Myalgia, Fever, Fatigue, Runny nose Narrative:
Temp 103(ax)- tylenol given to relieve temp; Child wanted to be held, did not sleep well when laying down; Examined by PMD 18MAR91 dx ear infection, tx antibiotics;
Patient presented 12 days after varicella vaccine with erythematous area and several papules at injection site. No fever/systemic illness. As a precaution pt was treated for cellulitis. Mother states redness began shortly after vaccination and persisted.
Received the vaccine the 18th. Woke up on the 19th at 3am  with 102 temp, chills, fatigue. I slept the entire day. The next day I woke up and the fever was gone. I had severe pain in my entire body. My joints hurt so bad I can't even function. The pain is debilitating. I have 5 children and a job and i can't function. My taste and smell has changed and everything smells and tastes so bad I can't even eat most foods.
Pt recv vax on 2/1/99; on 2/2/99 pt exp red, firm, painful vax site-LA
Currently 9 months pregnant  From around 6pm the evening until the next day, I had a fever that got up to around 101.6, aches and chills all over, I was nauseous and a sore arm. Around 8pm the next day, it gradually started to resolve, but by the following morning I was totally fine.
full body rash, lasted over a week, took Benadryl and ibuprofen, rash cleared up
Normally, when I am on birth control my periods are light or nonexistent. Shortly after I had the COVID vaccine, my periods came back (I hadn't had one since I got pregnant with my son in the fall of 2018). Since March, I've had extremely heavy, long (10+ days), and painful periods.
Developed sore throat, low grade fever, congestion/rhinorrhea & cough 48 hrs after visit on 10/8.
Did not feel insertion of needle.  Upon injection, felt hot, burning pain flow down the interior of upper arm.  3 hours post-injection ? upper left arm hurting, took Tylenol.  7 hours post-injection ? arm and shoulder hurting so much that it was very difficult to remove pullover shirt, took Tylenol.  10 hours post-injection ? arm and shoulder pain was 10 on a scale of 1 to 10; very difficult to sleep.  11 hours post-injection ? some nausea, pulse rate was 79 (normal at rest for me is 59), got up to go to bathroom, fainted, woke up on floor about 30 minutes later, extremely difficult to get up to sitting position because of pain / weakness in arms.  12 hours post-injection ? severe pain in upper arm and shoulder blade and back of neck, shivering, thirsty, clammy, heavy breathing, (no chest pain, no shoulder pain, and no headache, so ruled out heart attack - but the reaction was severe enough that we considered this possibility), no signs of stroke, slight nosebleed resulting from fall.  By 16 hours post-injection, felt minor bump on head and bump on left knee, and later noticed some hurting in jaw when trying to chew (all presumably caused by fainting fall).  2 days post-injection ? rash at injection site which looks like online photos of shingles rash, left eyelid discolored (presumably caused by fainting fall).  Rash did not disappear until 11 days post-injection.  From 2 days post-injection, and still continuing at 2 weeks post-injection, pain between right shoulder blade and base of neck, painful to sleep on sides or stomach, and periodical pain in shoulder blade / base of neck area that interfered with sleep.  Unable to determine whether shoulder blade / base of neck pain is due to vaccination or due to fainting fall.
1st dose just sore arm mild headaches, body aches lasted 2 - 3 days.  2nd dose had not in arm, sore arm hot for about a week, mild headaches, body aches, diarrhea, chills out of breathe, fatigue - but no temp.  This has being going on and off for last 2 weeks. Just had diarrhea on 1/25/21 again with chills, fatigue, little out of breathe, mild headache. 1/28/21 went back to work with chills, mild headache, out  of breathe but no temp. 97.1 this morning.
sinus congestion, sore throat, little nonproductive cough, shortness of breath starting on 9/28/21, significant other recently tested positive and he was hospitalized
Refridgeration excursions identified; No adverse event; There were excursions noted; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 11:33 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milligram. On 26-Sep-2022 at 11:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted).    The patient received first, second and third dose on intramuscular route in deltoid region. The patient received fourth dose on deltoid region. No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654537, US-MODERNATX, INC.-MOD-2022-654158 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654537:Crosslinked case US-MODERNATX, INC.-MOD-2022-654158:Crosslinked case
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-392935 (Patient Link).
7/13/22 pt had a positive COVID test in; brough to hospital on 7/18/22 with increased lethargy, SOB, decreased UOP; O2 supplementation; CXR showed right pleural effusion combo with right basilar atelectasis; sepsis secondary to right lower lobe pneumonia and CHF exacerbation; given dexamethasone, ABX, DuoNebs tx; plaed in IUC; pulmonary and cardiology followed pt; eventually transitioned to comfort measures only and pt passed away in the hospital.
Patient was administered the Pfizer vaccine at age of 10 years. Patient was here past 15 min and no side effects presented. Patient was seen by provider and answered any questions patients mother had.
no adverse event; Caller states that GARDASIL-9 was administered off-label to an 8 year old.; This spontaneous report has been received from a nurse, regarding to an 8-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 16-OCT-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (Off label use) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   No additional adverse events were reported in the patient.
Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse). The patient was treated with IBUPROFEN at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse) had not resolved.            No concomitant medication reported.  It was reported that in late August rash appeared everywhere in her legs and was ongoing.   This case was linked to MOD-2021-324028 (Patient Link).
Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): ABBVIE-4136226.  A 46-year-old female patient received BNT162b2 (BNT162B2), 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), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "Rheumatoid arthritis flare up". The action taken for upadacitinib was unknown.  Clinical course:It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Adverse event information provided by patient related to COVID vaccine. Therapy Dates (From/to): 22Sep2022 to .  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causalities: The reporter's causality for the event(s) of Rheumatoid arthritis flare up with Upadacitinib was Not Provided. The reporter's causality for the event(s) of Rheumatoid arthritis flare up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility Regulatory authority opinion was that the causality for the event(s) of Rheumatoid arthritis flare up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided Regulatory authority opinion was that the causality for the event(s) of Rheumatoid arthritis flare up with Upadacitinib was Not Provided  Assessment Results: Pfizer BioNTech COVID-19 vaccine: Rheumatoid arthritis flare up, Market Authorization Holder (MAH). Pfizer BioNTech COVID-19 vaccine: Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Possible  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the event  and the suspect drug  BNT162b2   The impact of this report on the benefit/risk profile of the Pfizer drug 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.