chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given 6 doses of undiluted pfzier vaccine. Patient given injection 10/07/2021 and mistake was caught 10/8/2021.   fatigue, headache, body ache, arm feels numb
inadvertently administered an expired Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug used in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27-OCT-2023) for prophylaxis.   On 02-NOV-2023, the patient received Boostrix. On 02-NOV-2023, an unknown time after receiving Boostrix, the patient experienced expired drug used (Verbatim: inadvertently administered an expired Boostrix). The outcome of the expired drug used was unknown.   Additional Information: GSK receipt date: 03-NOV-2023 The Medical Assistant reported they inadvertently administered an expired Boostrix (expiry 27th October 2023) dose to a patient yesterday on 2nd November 2023, which led expired vaccine used. The reporter did not consent to follow-up.
Pt described fatigue Friday evening thru Saturday. Adverse event-pt describes having teeth chattering, possible sz in the late night/early morning of Sat/Sun. The remainder of Sunday pt describes feeling achey and having a low grade fever. As of Monday 2/13/2012 pt is feeling "better". Recommended making an appt with PCP.
Severe continual heartburn for about a week IMMEDIATELY following the vaccine, tingling and numbness on the left side of my body (some in leg, lots in my arm, but largely in my face) that persisted on and off for several months. No weakness or pain or loss of mobility, just numbness and tingling. This was after my second dose, the first one did not seem to have side effects. I also had increased incidence of acne and boils for months afterward as well. None of these things (except a much milder version of the heartburn) were a problem for me before or since, and I have had no side effects aside from any vaccine before other than the usual soreness of injection site and tiredness. I have virtually no allergies that I know of, only an extremely mild rash from amoxicillin
Pneumonia; Low blood Pressure; Flu-like symptoms; Fever; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and HYPOTENSION (Low blood Pressure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion hospitalization), HYPOTENSION (Low blood Pressure) (seriousness criterion hospitalization), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever) and VOMITING (Threw up). At the time of the report, PNEUMONIA (Pneumonia), HYPOTENSION (Low blood Pressure), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever) and VOMITING (Threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
High fever, droopy (eyes both) and left cheek, slur in speech, unstable in walking, neck and shoulder and arm (left) very warm to the touch and unable to move. Pain level was high. (Documentation by parent) and called in on 4-6-2013) advise nurse.
Patient developed redness and swelling about the size of a quarter at the injection site.; Patient developed redness and swelling about the size of a quarter at the injection site.; This spontaneous report was received from a registered nurse (R.N.) via an employee, and refers to a 4-year-old patient of unknown gender.  The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. Historical vaccines included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), and varicella virus vaccine live (oka/merck) (VARIVAX), both received at 12 months with no reaction.  On 13-JUN-2022, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), administered as an injection for prophylaxis (strength, dose, lot #, expiry date, and anatomical location were not provided).  On the same day, the patient experienced redness and swelling about the size of a quarter at the injection site. The patient was given "Benedryl" and ice, then sent home. On an unknown date in June 2022, the patient recovered from the events.  The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.
Partial dose of 0.3ml as 2nd dose; 1st shot of Pfizer and second shot of Moderna COVID 19 Vaccine; A spontaneous report was received from a other health professional (nurse) concerning a 78-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273), received first vaccination of Pfizer vaccine and was given second vaccination of Moderna COVID vaccine which was a partial dose of 0.3ml.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, the patient received the first vaccination dose of Pfizer vaccine.   On 19 Feb 2021, the patient was given a second vaccination dose of mRNA-1273 (041L20A) intramuscularly for prophylaxis of COVID-19 infection, which was a partial dose of 0.3 ml of Moderna COVID vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event patient received first vaccination of Pfizer and was given a second vaccination of Moderna COVID vaccine which was partial dose of 0.3ml was considered resolved.; Reporter's Comments: This report refers to a case of wrong product administered and accidental underdose for mRNA-1273, lot # 041L20A with no associated AEs.
Severe mouth inflammation and pain. My dentist said I have tiny pock marks on roof of mouth and skin sloughed off. Can't eat for several days now.
administered dose expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HAV (Havrix adult) (batch number EK59B, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-JULY-2022 Reporter's Comment: The reporter stated that patient was administrated with an expired dose of Havrix. The patient had not reported any side effects, thus far. Reporter consented to follow up. Additional supportive information The patient administered expired dose of Havrix, which led to expired vaccine used.
Patient received two vaccines. Was in the process of checking out and fainted. She also hit her head on the counter and fell to the floor.
BlurredVision NauseaVomiting & Syncope Narrative:  15 minutes after vaccine was given, employee reported visual changes and nausea. Then she lost consciousness for several seconds while seated. Emergency response team was called, no treatment was provided except supportive care and ginger ale when she regained consciousness. She was placed on cardiac monitor and observed for 30 minutes, initial HR was in 50's sinus bradycardia and BP 102/62. No further issues after 30 mins of observation time and employee was released to return to work. Employee reported having a similar reaction after giving blood in past.
I tested positive for COVID-19 on 12/27/22. I had a cough, congestion, scratchy throat, and fatigue. I contacted my doctor and was not prescribed medication. I took over-the-counter medication, MUCINEX. I am still dealing with my cough, drainage, and fatigue.
8/25/14 Evening: soreness, swelling around injection site, body aches, headache. 8/26/14 Morning:  Headache, stomach upset, vomiting, body aches.
- Visual changes - Narrowing of peripheral vision and not being able to see clearly. - Felt unsteady on feet when walking duration 20 minutes No Rx.
Moderna COVID-19 Vaccine EUA- dose given 16 days past BUD for refrigeration
My husband and I spent time with some friends over the holidays. One of the friends tested positive for COVID-19, and we stayed to help take care of them. At this point, I had never had COVID-19 before, though my husband had been infected one month earlier. I began having upper respiratory symptoms (cough, runny nose, slight wheeziness) about 12/29/2022. I took a home antigen test that day and got a positive result. I called my doctor, who prescribed Paxlovid, which I began taking that day. Within 48 hours I began to feel better. My cough began to improve. I never really had a fever. I think I got better at one point and then had a slight rebound in which I had runny nose, though I didn't test myself at that point. I isolated for about ten days. I took a home antigen test in the middle of February 2023 and got a negative result. Before I got COVID-19, I would use two different respiratory inhalers. One inhaler is budesonide formoterol, and the other is Ventolin, which I almost never use. While I was taking the Paxlovid, my doctor advised me not to take budesonide formoterol, but ever I finished my Paxlovid round, I have been using the budesonide formoterol. Originally, I was on two puffs twice a day, but I am currently on one puff twice a day. I would like to add that I used a pulse oximeter during my time with COVID=19, and my oxygen levels were normal.
Systemic: Lymph Node Swelling-Medium, Additional Details: Per MD office, pt had localized axillary lymph adenopathy
Vaccine date Fri 4/23/21 Starting at 5pm I had a low grade Fever  99.1 and Chills lasted until approx 9pm and then went away.  Sat 4/24/21 woke up with Sore L. Arm at site of Vaccine, but felt better.  Sun. 4/25/21 woke up at 7:30am and didn't feel well, nausea, chills, needed to lay down, about 8:00am severe Headache at my Sinuses, Behind my Eyes, Forehead, and Back of Head at Base of Neck through 10pm.  I took Speedy Release Tylenol, 3 hrs later Headache was returning I took 2 Ibuprofen and slept.  Slept most of the day until 9pm when I felt I could tolerate Chicken Noodle Soup.  I woke up Mon. 4/26/21 w/mild Headache just behind my Eyes.
The patient came to the office with rash for 11 days.  She received the flu vaccine on 10-15-09 and was seen in the office on 10-28-09. The rash was red raised and itching. The rash came on her the next day. Has taken flu shot yearly and has never had a reaction. Rash itches and states it is driving her crazy. Denies fever or chills. No acute joint pains or muscle aches. No shortness of breath, difficulty breathing, or difficulty swallowing. Except for the flu shot patient denies any change in personal hygiene items, medications, or food. No other acute complaints.
With both doses (2), I was very ill. Pain throughout body, chills, achiness, feverish. Slept all day, feeling sick and unable to function or barely move. Dizzy when trying to stand up. No energy. For first shot, I was like that for 2 days. Second shot one day. Have never felt that sick before.
Patient received Moderna vaccine at 12:36 pm.  Patient c/o nausea, pruritus, and skin reddening  skin.  V/S 138/78, HR 113 O2 97% on RA at 12:50 pm.  Patient given 2- 25 mg Diphenhydramine po.   Patient c/o worsening pruritus.  V/S  110/70 , HR 109, O2 97% on RA.  Epinephrine 0.5 mg administered IM into R deltoid at 12:57 pm by EMT.  EMS called.  Patient HR 115, O2 96% on RA with clear lung sounds at 12:59 pm.  1:02 pm BP 122/88, HR 117, O2 98%.  Patient signed AMA for medics and was not transported to hospital.
Mesenteric lymphadenopathy  With persistent dizziness, nausea and vomiting and headache and chills for 3 weeks - dizziness and nausea and headache persists for 4 weeks and running
Extreme headache, 3rd cranial nerve palsy with enhancement to 3rd cranial nerve seen on MRI causing right eye to closed, eye ball to turn outward and down, pupil fixed and dilated
stable patient on warfarin 6.5mg daily received COVID vaccine and began to have elevated INR. eventually requiring a dose decrease.
no adverse event; expired vaccine dose was administered to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not provided.  On 04-OCT-2022, the patient was vaccinated with an expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot #1687291, expiration date: 11-SEP-2022 (strength, dose, dose number, route and site of vaccination were not provided) for prophylaxis (expired vaccine used). No additional adverse events (AEs) was reported (no adverse event).
Dec 15, 2020, Day 0 = inoculation.  Day 3, soreness.  Day 4, bulges.  Day 5, redness.  Day 6, blisters, fatigue, pain, diagnosed with Shingles.
she experienced Pityriasis rosea on her back; This non-serious case was reported by a other health professional via call center representative and described the occurrence of pityriasis rosea in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-AUG-2023, the patient received the 1st dose of Shingrix. In JUN-2023, several hours after receiving Shingrix, the patient experienced pityriasis rosea (Verbatim: she experienced Pityriasis rosea on her back).  The outcome of the pityriasis rosea was resolved.   It was unknown if the reporter considered the pityriasis rosea to be related to Shingrix.     It was unknown if the company considered the pityriasis rosea to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2023 Internal contact was the reporter, stated that a nurse practioner reported to him an adverse event associated with Shingrix. The patient was a 66 year old female. The patient received first dose of Shingrix and few hours after administration she experienced Pityriasis rosea on her back. The adverse event was reported to the nurse practioner on 9th June 2023. In 2023, the Pityriasis rosea lasted approximately one month. The patient reported that she had never experienced Pityriasis rosea prior to vaccination with Shingrix. The reporter consented to follow up.
Felt "fine" initially, then became "lightheaded and dizzy",  felt like having an asthma attack.  This occurred approximately 20 minutes after immunization.  Went to ER,  given rescue Albuterol inhaler, given Benadryl IV, Pepcid IV , monitored vitals
Hospitalized 9/18/2021 COVID-19 positive 9/18/2021; fully vaccinated
cause my tumor in my right armpit and right breast to be inflamed; discharge with blood; This is a spontaneous report from a contactable other hcp via Pfizer sponsored program. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 58-year-old) as dose number unknown single for covid-19 immunisation; palbociclib (IBRANCE), via oral route from 03May2021 (Batch/Lot number was not reported) and ongoing, at 75 mg, daily for 21 days of 28-day cycle for breast cancer. The patient's medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unknown date, the patient had tumour in right armpit and right breast to be inflamed and discharge with blood. The patient reported that noticed the mass was shrinking in right armpit. The covid vaccine caused tumour in right armpit and right breast to be inflamed and have more discharge with blood. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known safety  profile and available information the reported  events tumour inflammation and bloody discharge are assessed as unrelated to BNT162B2.  These events may be due to the current medical history of breast cancer which is ongoing and under treatment. Case will be reassessed if additional information is received.
Information has been received from a physician, via a company representative, concerning a 12 year old female patient who on 24-APR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (manufacturer unspecified), PedvaxHib and Menactra. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of groin pain; blood work (unspecified) testing was performed, and was negative. On 30-APR-2007 the patient experienced a headache and a rash on her leg, and again returned to the physician's office; the patient was diagnosed with zoster, and was given Tylenol and codeine for treatment of the symptoms. On 03-MAY-2007, the patient presented that the patient may have viral meningitis. At the time of this report, the physician reported that the patient may have viral meningitis. At the time of this report, the patient had not recovered from the events. Additional information has been requested.  5/18/2007 Received medical records from hospital which reveal patient experienced shingles, severe HA which continued to worsen, photosensitivity, nausea.  Opthal exam prior to admit was WNL.  Admitted 5/3-5/6/07.  ID consult obtained.  Treated w/IV antibiotics & antivirals.  Symptoms resolved day after treatment started & patient continued to progress well.  D/C home on no meds w/close outpatient PCP f/u. FINAL DX: meninigitis, presumed viral (aseptic), final c/s pending; HA, resolved; herpes zoster right leg suspected.  6/8/07 Received note from PCP stating CSF PCRs for HSV & entervirus were neg.  Also included name of admitting physician at hospital where PCP does not have privileges.
Right arm is swollen red. It started about 1 hour after vaccinating him. Parents reported to us on 2nd day afterwards.
76 y/o male, PMHx of GERD, Hyperlipidemia, Coronary heart disease, CKD, Barrett's esophagus, abdominal aortic aneurysm without rupture, PVD, DM, admitted for confusion on 2/13/21. MRI indicates tiny focus of diffusion restriction within the right occipital lobe suggestive of acute infarction. Pt does not have acute Covid 19 infection. Pt discharged home on 2/16/21.
Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 24 year old female with a history of lactose intolerance and 1 miscarriage who on 30-NOV-2007 was vaccinated with a 1st dose of GARDASIL (lot# 659055/1522U). Concomitant therapy included prenatal vitamins. Subsequently, 2 to 3 weeks after getting her vaccination the patient became pregnant (LMP 12-dec-2007). It was reported that on 31-JAN-2008 the patient has an ultrasound, routine obstetrical diagnostic tests, and cystic fibrosis screening (results negative). It was reported that on 28-FEB-2008 the patient had serum alpha-fetoprotein test (results within range). No adverse event was reported. Follow up information was received from a charge nurse who stated that the patient delivered a healthy and normal male, at term, on 16-SEP-2008. It was reported that the patient's labor progressed to second stage, when she had an arrest of descent and was diagnosed with CPD for this birth. It was reported that the patient had a cesarean section. The reporter stated that the patient had an uncomplicated prenatal course, with the usual pregnancy related complains, nothing more. No further information is available.
Woke up with extreme pain in my chest and back and shortness of breath. I felt like my lungs were being crushed when I bent over. The pain is localized to the left side of my chest. Today is day two, and the pain has lessened and isn?t constant, but I still have shortness of breath.  I am choosing to heal through rest and self-care.
72 Hours after vaccination pt started having loose stool, headache, sore throat, nausea, vomiting, and rash. On 8/27/01 diarrhea was resolved and rash was resolving.
2-3 hours following injection, patient had diffuse pruritus, facial swelling, tongue swelling & difficulty breathing. Reported to ED and received SOLUMEDROL IV and BENADRYL.
on 5/17/2021 pt  developed a fever, pain in the left side of his ribs and had SOB. He was brought to Hospital ER. Pt had Chest x-ray, blood work, Doppler on both legs, and CT.  His DX was pneumonia, blood clot in left lung and bilateral blood clot in legs.  He was admitted and stayed for 5 days.
09/02/22 presents to ED for "shortness of breath and COVID symptoms". PMHx of "cell disease with history of acute chest syndrome"
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3/24/21). Patient was doing well until his return. Which he developed subjective fevers, sneezing, headache and cough on 7/7 and tested positive for SARS-COV-2 on 7/12. On 7/13 he presented to ED for SOB and was D/C'd home on levofloxacin. On 7/15 he returned to ED for worsening SOB and was started on remdesivir on 7/17, tocilizumab, dexamethasone, enoxaparin and antibiotics. On 7/18 respiratory requirements increased requiring NRB and transfer to Hospital with admission to ICU.  In hospital, patient completed two more days of remdesivir for a total of 5 day course (ending 7/21) and was continued on dexamethasone until 7/25 to complete a 10 day course. Today patient remains intubated with improving oxygenation with proning.
pt recv vax & approx 5hr later exp seizure-like activity;this was described as a wrinkling of the forehead & holding hands to chest w/rhythmical bilat spasms that lasted 1-4 seconds;pt to ER;pt devel episode of repeated flexion of arms;
Fever, Chills, Headache, Fatigue, Nausea, Dizziness, Muscle weakness, myalgia  All symptoms lasted for approximately 18 hours after onset
Patient was nervous before vaccination process. After being inoculated he suffered dizziness and a minor episode of vomiting. He was attended and refused to take vitas or assistance from nursing or paramedics
Injection site on arm became itchy after 6 days, on day 8 a red patch appeared... Patch is about 3-4 inches wide. Have read online that this reaction is now called Covid Arm, mainly related to Moderna Vaccine. Others report the red patch will go away in a few days.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".   Additional information: Caller stated that when he received his 4 vaccines "the only thing he ended up with was a sore arm". The caller further stated that in Dec2022 he had Covid and he was annoyed, why was still getting Covid. He did not die but he was very sick not throwing up, a lot of chills and fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.