chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle Ache on injection site; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 47-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an intramuscular route of administration, administered in Arm Left on 19Jan2021 16:00 (at the age of 47-years-old) as dose 1, single for COVID-19 immunisation. Medical history included uterine leiomyoma from 03Oct2013 to 03Nov2013 (myomectomy Nov2013), gallbladder disorder from 03Jan2001 to 03Feb2001 (gallbladder removed Feb2001), uterine leiomyoma from 03Mar2018 to Dec2018 (myomectomy Dec2018), myomectomy from Nov2013 to an unknown date, myomectomy from Dec2018 to an unknown date, diabetes mellitus (grandparent- diabetes) and pancreatic carcinoma from an unknown date and unknown if ongoing (father-pancreatic cancer). The patient concomitant medications were not reported. Patient received vaccine facility in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810) , via an intramuscular route of administration, administered in Arm Left on 09Feb2021 16:00 as dose 1, single for COVID-19 immunisation and experienced muscle aches, headache, sore throat, chills, low grade fever and fatigue on 10Feb2021. Short term side effects after seconds dose, Less than 24 hours. The patient experienced muscle ache on injection site on Jan2021. No treatment was received for the events. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Vomiting x 1 2-3 hrs p/vax, then pale & hyporesponsive x 24-36 hrs;
Fatigue and aches started at 8 pm on 4/14. Major chills at 9 pm.  Fatigue and aches continued through 4/15.
This spontaneous report as received from a nurse and a healthcare worker refers to a 5 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is a 46 yr/o female who presents with vaginal bleeding, started 3 to 4 days ago, states she is used 3-4 tampons this morning in the last 4 hours, states seems to be better currently, but waxes and wanes.  She has had some clotting.  Last.  She believes was 1 week later than normal, around the first of this month.  Denies sexual activity in the last 10 months, denies concern for STIs.  No dysuria or flank pain.  No fever or chills.  Thought she could be anemic secondary to her fingers tingling earlier today.  She does have an OB/GYN but has not seen them for a couple of years.  Did have uro-Guynn surgery last year.  Diffuse lower abdominal pain, fairly constant.  No treatment prior to arrival.  Denies weight gain or concern for pregnancy.
3 seizures 2 minutes apart lasting a few seconds.  EMS called and he was transferred to the hospital.  BP:117/72 98% 66 Pulse
AT THIS TIME NONE. PT HAD 1ST DOSE VIA DATABASE 5/24/21, 5/27/21
Patient said he felt like someone was holding his throat but he mentioned that he had a history of throat tightening. We gave him 2 Benadryl and checked on him about 8 times (roughly every 10 minutes or so) and he said he felt like normal. We checked on him a couple more times and he said he felt fine. We left him 2 more Benadryl just in case he needed it and we alerted the facility
she is in such pain; face & neck pain; headache; back pain; shoulder pain; face & neck pain; This is a spontaneous report from a contactable consumer (reporter's husband). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 18Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On 18Feb2021, the patient experienced headache, back, shoulder pain, face & neck pain and she is in such pain. Patient had their 2nd Pfizer vaccine dose yesterday. She was fine up until last night, but she was in such pain this morning and the middle of the night. Caller stated his wife was having a headache, back pain, shoulder pain, and face & neck pain which started last night. Caller enquired about anything that she can take and how soon can she take Tylenol. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She got her vaccine, she quite a bit of dizziness after she got home, and heart palpitations started.  She had the normal things of fatigue, muscle pain, nausea, fever.  No vomiting, a lot itching but no rash, and horrible confusion and knew that she was confused and a nose bleed/blackish/bright red in nature.  She was having trouble walking and at some times could not walk.  She went outside and came back in and collapsed and a neighbor caught her before she fell, and was using a walker.  She lost track of time and everything.  She had a lot of confusion and knew it and stayed in her room, and stayed in bed.  She feels that she had a TIA, did not go to the doctor as she had nobody to take her.  She had a TIA in the past and had the same reaction as this time so knew that's what it was.    She still has fatigue and muscle aches, but has been a slow recovery.    Her first vaccine was the J&J and felt punky for a day and a half, but nothing else.
Patient reported to Hospital ED on 6/14/21 and 6/17/21 with left sided face dropping. Patient was told of diagnosis on 6/17/21 of COVID-19 vaccination associated Bell's Palsey after multiple tests performed on both visits. Patient was alert when coming to pharmacy and had clear signs of face dropping on left side. He was told to report to pharmacy by ED to submit a VAARS.
patient says they got a STEMI (from a clot) and is now in the hospital. also left arm bruise where shot is.
Received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19. Unable to reach for f/u after several attempts.
large reddened, raised area on deltoid, heat filled;ice applied;lasted 4+ days then resolved;spot was also very itchy during rxn;reporter feels the vax was given SC instead of IM because 5/8" needle provided by Wyeth;
fever, headache, lasted for 2 days. Exam findings indicative of sinusitis.
injection site still sore; More so when I use my right arm more thanusual. Always aware of the pain.; This is a spontaneous report from a contactable consumer, the patient. A  non-pregnant female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on unknown date in 2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on  2021 25Mar2021 at 17:15 as a single dose for COVID-19 immunisation. Medical history included neuropathy in feet. concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced injection site sore. The sensation was running up to neck and down to her hand and fingers. It was more so whenever she used her right arm more than usual, she was aware of the pain. It was not always severe but constantly there. She had no problem with second dose in her left arm. The patient just wanted it to get away as it was very annoying both physically and mentally. The clinical outcome of the events injection site sore and pain was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
HCP reported VARIVAX was administered after a temperature excursion to patient. Date of administration is Sep 1, 2023. No further information provided. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): VARIV; No additional AE reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.     On 01-SEP-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # X006981, expiration date: 07-MAR-2025), given once (dose, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion at 6 Fahrenheit (F) during 20 minutes (product storage error). No additional adverse event (AE) reported.
Headache, Myalgia, Arthralgia, Fever, Diarrhea & NauseaVomiting Narrative: 102 fever, myalgia, arthralgia, N&V, diarrhea. ED visit -IV fluids, Zofran, Toradol (unknown dosages). Released after a few hours
9x9cm diameter area at the injection site that is red, hot, painful, tender, and swollen/fluctulant. Started on Keflex, presumed cellulitis.
Experienced insomnia for one day before the first period after the first vaccination dose.  Symptoms developed into premenstrual dysphoric disorder (insomnia, anxiety and depression) before the first period after the second vaccination dose.  Since then, I have been experiencing PMDD till report day.
Started with rash all over body on Saturday with severe itching. Saw her physician on Wed. 07/14/2010. Placed on Valtrex and Steroids.
No adverse event. Was discovered that vaccine was administered past the BUD expiration. BUD was 1/13/2023, was given to patient on 1/19/2023. Patient is 30 weeks pregnant but no complications/adverse events reported thus far.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine.  However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
pt exp edema & pain of the injected arm which lasted 4 days p/receiving Typhoid vax; In addition, pt exp lethargy & achiness, beginniing 2 days p/vax & lasting 3-4 days;
This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported on behalf of his 18-year-old daughter that received the second dose of TRUMENBA at 0.5ml single dose on unknown date for immunization. Medical history and concomitant medication were not reported. On unknown date the patient had received the first dose of the same vaccine. The patient experienced high fever and headache on unknown date 12 days after receiving her second dose of vaccine. The events were assessed as serious per hospitalization. The outcome of the events was unknown. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect drug contributed to the development of the reported events.
COVID-19 diagnosis after the first dose; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid-19 diagnosis/covid-19  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) COVID-19 diagnosis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), covid-19 diagnosis was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Tdap in (L) deltoid, MENVEO in (R) deltoid given approximately 3:20 pm on 09-30-13. Child started complaining of pain shooting from right deltoid into her neck. Pain comes and goes. Mom received phone call about 10:30 AM today from child letting her know she was having this pain.
Patient reports rash on groin initially that progressed to her ankles and later noted on her arms/both upper and lower.  Described as a numerous small patches with red bumps on the surface. Non pruritic.
Severe diarrhea for 2 days, emesis x 2 post 4th dose oral Typhoid.
Patient was given vaccine using a Vanishing Point syringe-needle combination.   Pressing the plunger normally causes retraction of the needle.  In this case the needle retracted and a significant unknown volume of vaccine splashed on the clients arm.     Using a saline sample to show the normal size of the dose, we could estimate that perhaps half of the dose was not properly injected.
An infection. Three days later; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, 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 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: INFECTION (non-serious) with onset Oct2023, 3 days after the suspect product(s) administration, outcome "unknown", described as "An infection. Three days later".  Additional information: Caller stated "Patient received 2324 Quadrivalent Booster on Monday, 09Oct. An infection. Three days later."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Biceps below injection site red, swollen and sore. Patient took TYLENOL and BENADRYL.
Low fever, chills, vomiting, disoriented, bad headache, adversion to light and sound, weakness, tired
1323 Pt c/o tingling of lips. No SOB. HR-60. Pt given benadryl 50mg PO. Pt reported feeling better and left at 1338
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD lot number M014301, expiration date: 22-SEP-2017 and lot number M001151, expiration date: 05-JUL-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of -11 degrees Celsius for 352 hours and 51 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter (linked with MARRS# WAES1609USA011329). Additional information has been requested.
Exactly 1 week after receiving the first dose of the Moderna Vaccine, I started getting a red rash at the injection site. It started approx. 2 inches wide & 2 inches high and over the next few days, the rash grew larger until it was about 4 inches high and 3 inches wide at the largest. I googled it and it seems that it was probably a rare reaction known as "Covid Arm". It faded away fully within 5 days to a week.
Very high blood pressure 4 days after the first vaccine - went to urgent care. Headache lasted 12 days with elevated BP. Headache for six days with intermittent headaches for six weeks after the second vaccine with elevated BP. BP returned to normal in June 2021. Heart palpitations, face flushed, elevated HR, very high BP with 70 point swings, extreme anxiety, unexplained weight loss, unfavorable glucose changes seven months after the second vaccine.
01/10/2022: Event occurred after 2nd vaccine. Patient presents to the emergency department secondary to weakness times approximately 1 week. History of renal transplant on antirejection medications has not missed any doses. Patient admits to intermittent nausea and some mild abdominal discomfort but no overt abdominal pain. Denies vomiting.  Patient denies chest pain but admits to intermittent shortness of breath, rhinorrhea and congestion has been present for approximately 3 or 4 days. Denies any productive cough, or hemoptysis. Patient denies: vomiting, diarrhea, fever, blurred vision, sore throat, back pain, palpitations, dizziness, and rash. He suspects he is in DKA as he presented very similarly approximately 2 months ago. Remains in hospital.
Immediately following the PCV 13 injection client c/o feeling dizzy.  After sitting for approx. 10 minutes she reported feeling better and left the clinic.  She returned at 11:50 AM with her spouse and reported having heart palpitations.  Denied dizziness, chest pain, shortness of breath, hives, itching, or any other symptoms.  Her BP was taken and was 192/82 and heart rate was 77.  She was advised to go to ER to have complaint of heart palpitations assessed.
Every night I get hives on my skin. Specific area varies, but typically on my elbows/forearms, inner thigh, knee area, waistband, back and ankles. They look like a cluster of mosquito bites - raised, white. Extremely itchy. Can't sleep because of them.
Soreness at injection site, warm, painful, slightly bruised. Treated with OTC pain med and ice pack.
Pt had a syncopal event. Vitals: 86/47,57,14,98.9F Pt stable and released from the vaccination site w/parent.
Information has been received from a physician concerning a 17 month old female patient who on 4/19/02 was vaccinated with a dose of MMR (second generation) (lot number 639694/1212L). There was no concomitant medication. On 5/1/02 the patient developed thrombocytopenia and was hospitalized. She was given IV immunoglobulin (IVIG) for a platelet count of 13,000K down to 7,000. The patient's thrombocytopenia persisted and she was still being treated. Additional information has been requested.
pressure behind my eyes; tested positive for Covid-19; He had tested positive for COVID using rapid test 16Mar2021; This is a spontaneous report from a contactable Consumer. A 52-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Batch/Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included Deficiency of Vitamin D. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]) at 2000 iU, once a day taken for hypovitaminosis. The patient experienced tested positive for covid-19 and drug ineffective (medically significant) on 16Mar2021. It was reported that patient had the 1st dose of the Pfizer-Biontech Covid-19 Vaccine last 10Mar2021 - 2 days after (12Mar2021) he experienced sinusitis then few days later he developed cough on 16Mar2021. He had tested positive for COVID using rapid test 16Mar2021. He was asking if he was still eligible to get the 2nd dose of the vaccine which is scheduled on 31Mar2021. Consumer also stated that he had symptoms on Friday which were sinus and then Saturday he was not that bad but on Sunday he had sinus, pressure behind his eyes and then slight headache and then his cough, he developed a cough once in a while, then on Monday he had the same symptom it felt like, he was really fatigue, he got tired very easily and then on Tuesday he woke up and it felt better so he work and then he still feel pressure, the slight of pressure and the cough and then he start to get tired again, so he went for the test that night, so yesterday he had and that was how he tested positive. Outcome of the event pressure behind my eyes was not recovered and outcome of other events was unknown.
After receiving the 1st dose on November 9th immediately started feeling numbness in the feet and leg weakness. This began a slow deterioration over two months that ended with complete paralysis from the waist down on January 2nd.