chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022; No adverse event; Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022) and PRODUCT STORAGE ERROR (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022).    No concomitant medications were reported.  Vial size was reported as 2.5ml The vial was initially stored in the refrigerator on 18-Oct-2022. The via did not undergo any temperature excursions. Beyond use date was reported as 17-Nov-2022.  No treatment medications were reported.  This case contains information for the 10th of 14th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268, US-MODERNATX, INC.-MOD-2022-675259, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675270 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260: US-MODERNATX, INC.-MOD-2022-675268: US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675269: US-MODERNATX, INC.-MOD-2022-675259: US-MODERNATX, INC.-MOD-2022-675270:
Individual received booster dose of Moderna on Monday 11/8/21 at around 10 am.  When the Moderna dose was administered, she immediately noticed it was given high in the shoulder near the back and it was painful.  She also describes that it was "too much over bone"  by her shoulder blade.  2 days later, she noticed a bump in the injection site which was filled with fluid, like a boil.  after she removed her bandaid, she rubbed her hand over the blister which burst and clear fluid oozed out.  A dry scab developed subsequently.
Tight chest, chest discomfort, fluttering heartbeat.  Shortness of breathe, especially when laying down.  Restless leg.
Thi spontaneous report as received from a registered nurse refers to a patient with unknown age and gender. On an unknown date the patient received a dose of improperly stored (Oka/Merck) VARIVAX (1 dose). No adverse effects reported. It was not specified if the patient sought for medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
On Thursday March 11, 2021 I received my first dose of Pfizer COVID vaccine. Within about 5 second after administration I began to feel severe arm pain spreading from the injection site down to my fingers that were tingling and numb. Then within about 20 seconds of the vaccine I  fainted.   The fainting spell was brief, a few seconds, but the symptoms that continued after were long lasting.  My blood pressure after was about 80/50, I was diaphoretic, pale, had moderate arm pain (tingling, numb, painful to move) and severe nausea. I was also light headed. These symptoms lasted through the night but I felt overall improved the next day other than fatigue and lingering arm pain. Then on March 16, 2021, 5 days later, I woke up with extreme fatigue. Over the course of the day I then began to get a headache. I got back in bed and then in the afternoon started to feel moderate arm pain again at the injection site and down the entire arm. Then severe nausea set in again along with more diaphoresis, chills and light headedness. The symptoms this time again lasted through the night and I felt better again the next morning.
WE GOT REALLY KICKED; This spontaneous report received from a patient via a company representative via social media concerned multiple patients. No past medical histories or concurrent conditions were reported. On an unspecified date, the patient previously received with covid-19 vaccine ad26.cov2.s from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series was 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patients received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified dates, following vaccination with covid-19 vaccine ad26.cov2.s, multiple patient got kicked with the booster (captured as feeling abnormal). As per the reporter, "We got really kicked with the booster 2 days worth ugh". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the multiple patients for event got really kicked was not reported. This report was non-serious. This case, from the same reporter is linked to 20211214651.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported that a patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness, swelling and pain at injection site after use of product. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
Congestive heart failure, pt is a 53 y.o. male seen by cardiology today for shortness of breath. Hx  PAF, s/p ablation, had what sounds like LE edema and DOE that improved with lasix. The a/p as above.
Had vaccines on 4/1/11. Starting that evening pt began with hand tremor (right hand only). This continued until 4/9/11 when pt appeared to have seizure with eyes rolling up & falling down in AM. This continued & pt was sent to ER that day.
Pt completed COVID-19 vaccination series at outside facility (doses on 4/13 & 5/4). On 11/4, diagnosed with acute, symptomatic COVID-19 infection.
Information has been received from a female medical assistant concerning herself who on an unspecified date was given an oral dose of ROTATEQ (Lot # unknown) to a baby. The medical assistant stated that the baby coughed and spitted out the vaccine into her eye. Her eyes were burning and blurry. She did flush her eyes with water and they were not as burning but still blurry. At the time of the report, the patient had not recovered. It was unknown if the patient sought medical attention. This is one of several reports from the same source. No further information is available.
Yesterday my back started having the same problems; Arms hurt; My lips and eyes were swollen; Neck swelling; My lips and eyes were swollen; I got hives and rashes all over my face, arms and chest thighs; I got hives and rashes all over my face, arms and chest thighs; chills; My muscles were hurting so much; Fever; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient herself) reported that a 25-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported) via an unspecified route of administration on 08Apr2021 as single dose for COVID-19 immunization. Patient medical history included She was allergic to clams and COVID-19. Concomitant medications were not reported. Lab data included as blood work on an unspecified date results reported as allergic to clams (seafood) and COVID-19 test on an unspecified date in Jan2021 with positive results. On 23Apr2021 she got hives and rashes all over face, arms and chest thighs. On 23Apr2021 at night she went to the ER. They gave her Benadryl and steroids to see what happens. They did not prescribed anything, got one Benadryl and one steroid. They told her to just to observe. The next day she was fine. On 24Apr2021 started to get the hives again. On 27Apr2021 it was reported as patient lips and eyes were swollen and she saw her doctor and had blood work to see if she was allergic to anything. She was allergic to clams (seafood) but nothing else. In Apr 2021 she experienced chills, fever it was normal but two weeks later she got all these rashes and hives. Her doctor gave me Benadryl for 10 days and steroid for 5 days. She was scheduled on 29Apr2021 for the 2nd dose. She did not get, doctor wanted me to wait until she was done with steroids. Two days ago, her steroids were done, hives were going away it was the 28th and 29th her arms hurt. On the 29th her back started the same thing (like my hands and arms). Her muscles were hurting so much, felt like poking me with needles. On 02May2021 back started having the same problems. She was COVID positive in Jan and got better from it. Caller asked if there was seafood in the vaccine. Response was received as shellfish, fish, seafood and emailed as requested. She had a side effect after the first dose of the vaccine. It was asked as should she get the second dose and response was she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. She had a bad reaction on the 23Apr had a swollen lips and neck. The outcome of events (Fever and chills) was recovered on an unspecified date in Apr2021 and unknown for other events.  Information about batch/lot number has been requested.
I had my vaccination on 10/03/2022. On 02/14/2023 I had an EKG. I was referred to a Cardiologist.  I was informed I had increased blood pressure and low resting heart rate. On 02/14/2023 I was told that I had had a heart attack in the past. I do have follow up appointments in 04/2023. I have a stress test scheduled for 04/05/2023 and the resting test to be done on 04/06/2023. I do have extreme fatigue presently on 04/04/2023. I did test COVID-19 Positive 04/2022.
I was feeling fine and then all of a sudden from one split second to the next I was instantly in pain, weak, dizzy, overall feeling of death sick, I had to get into bed before I collapsed.  I was not able to move, I was not able to take care of myself, I could not wake up, I could not reach for the glass of water that was 12 inches away from me, I was hot, feverish, sweaty and chills, I could barely get up to go to the bathroom, but because I was not eating or drinking I only urinated once in the morning and once in the evening. I finally went to the emergency on day 4, I had not changed my clothes at all during this time, the doctor at the emergency said I did not test positive for the flu, well that was not just the sniffles I received an IV, I was so incredibly weak. I felt like I was dying. I went home with no answers from the doctor. I still did not take or change my clothes until day 6. The flu vaccine I received from my place of employment,  I was told it was the Cadillac version and was very lucky to get it, as it was the quad dose. I will never never get a flu vaccine again.
My Watch alerted me to an irregular heartbeat about 2.5 hours after rising for the day. I had already taken my atenolol am dose.
Diffuse itchy red rash developed about a week after second covid vaccination. Was not fleeting and persisted after first prednisone course.  She underwent skin biopsy, allergy testing and several office visits for the rash which was severe and debilitating for her. No systemic symptoms. Received a second course of po prednisone end of June into July after which the rash finally resolved.
at onset of inj pt c/o pain;pt was unable to lift arm & felt a burning in deltoid & could not sleep on side of inj;10NOV98 pain began to reduce along w/burning;
Throat swelling and stridor reported starting 15 minutes after receiving first dose.  IM Benadryl administered onsite and patient declined ambulance transfer.  Improved upon arrival by private vehicle.
A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 1 year old female vaccinee experienced fever and cold symptoms one week after inadvertently receiving 0.25ml Fluvirin on 12/2/03. The vaccinee recovered after approximately 4 days. Follow up pending.
fever, chills, nausea. the injection site and the entire upper arm was red, warm and she was diagnosed with cellulitis.
On the day listed for the adverse reaction, when I got up I noticed  red spot about the size of a quarter at the site  of injection. My upper arm was very swollen and somewhat tender to the touch. It took about two weeks for the spot and swelling to go down. I had no fever or chills, nor other signs of illness.
BY THE NEXT MORNING, THE INJECTION SITE WAS RED, RAISED, QUITE TENDER AND THE SIZE OF MY PALM.   THIS LASTED ABOUT A WEEK.  AS THIS ABATED, THE MUSCLE ITSELF BECAME QUITE TENDER AND MY RANGE OF MOTION AT THE SHOULDER WAS LIMITED BY PAIN AT THE EXTREMES.   IF I PERSISTED IN PUSHING IT?, THE PAIN WOULD RADIATE DOWN ALONG THE RADIAL NERVE AND INTO THE WRIST AND THUMB.  ALL OF THIS HAS PERSISTED TO THIS TIME.  THE PAIN IS SOMEWHAT RELIEVED BY NAPROXEN AND ACETAMINOPHEN AND LOCAL APPLICATION OF HEAT.
Within 8 hrs pt was shaking, heaving, nauseated. From there, his fever rose to 103. He threw up a few hours later. During this time, pt complained of sore/hurting, muscles and joints and a hurt throat. Also headache. Observing.
BODY ACHE; HEAD POUNDING; DULL HEADACHE; BED RIDDEN; SICK; REALLY BAD; WIPED OUT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced really bad. On MAR-2021, the subject experienced wiped out. On 23-MAR-2021, the subject experienced bed ridden. On 23-MAR-2021, the subject experienced sick. On 23-MAR-2021, the subject experienced head pounding. On 23-MAR-2021, the subject experienced dull headache. On 23-MAR-2021 03:00 a.m., the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dull headache, and the outcome of bed ridden, head pounding, body ache, sick, really bad and wiped out was not reported. This report was non-serious.
This spontaneous report as received from medical assistant refers to unspecified patients of unknown demography. On an unknown date, the patients were vaccinated with improperly stored PROQUAD lot # M006104 (expiry: 01-AUG-2017) (incorrect product storage). It was reported that the vaccine reached -14.1 C for 20 minutes. They also had a prior excursion reaching 9 F for 10 hours. These details were captured by a data logger and the vaccine was back in range. No adverse effects were reported. No product quality complaint (PQC) involved. This case is linked to case 1608USA009123 (same reporter link). Additional information has been requested.
Breakthrough case admission after 2 vaccines  Moderna 1/5/21 lot# 039K20A ; Moderna 2/2/21 lot# 028L20A
localized rxn from inj;area raised, hard, pink, warm 35x25cm approx;no resp distress noted;
Extreme swelling of lips, painful, dryness. Required constant application of mineral oil. Abating after 2 weeks, but still present. Incredible dryness regardless of water consumption.
This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received PREVNAR 13 (lot number and expiration date requested) via an unspecified route of administration in the left upper arm on 07Feb2018 at a single dose as the patient had pneumonia in 2006 so her physician thought she should get the vaccine. The patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) at the physician's office. Medical history included pneumonia from an unspecified date in 2006. The patient has no family medical history. The patient's concomitant medications were not reported. It was reported that the patient has no previous vaccination within 4 weeks. On 13Feb2018 six days after vaccination, the patient noticed a red mark that got progressively worse in size to about 2.5x2.5 or 3x3. The patient went to her physician on an unspecified date so that she could take a look at it. The physician told the patient to take Allegra for 3 days and maybe prednisone for 5 days depending on the outcome. The patient stated this was the second day that she put an ice on it and has taken Allegra and felt much better. The patient was recovering from red mark that got progressively worse in size.
Pfizer-BioTech COVID-19 Vaccine  Site of shot is red, swollen, warm, itchy It is better but still there
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "barely talk right now/woke up like this/it's in the throat". Additional information: Consumer stated "I got a stack of papers that was giving the free shot. I can barely talk right now. I took the COVID-19 shot (Suspect Captured as per verbatim; Manufacture not clarified, hence tab left unchecked) and that I had at free shot place at Walmart's, they gave me a stack of papers. I am not understanding this. When I went in this say what should I do about side effects, it maybe a side effect. I have a paper here, reports vaccine side effects to FDA, vaccine adverse event. I understand that's why I am calling, I woke up like this, I wasn't like this when I went over there.". When paraphrased, consumer stated "I was fine but right now, its in my throat.". When probed to clarify if consumer has any questions regarding the side effect, consumer stated "That's why I am calling you. I can breathe, no chest pain. I can look at the paper real good, I got them, I have these swollen lymph nodes, no diarrhea, no vomiting but I do have the arm pain. I am not paining but I don't know why I took this shot. I have been having, I have to test that COVID-19 in one hospital and then I got over it and it was months ago. I just want to know, I don't want to go through these issues, I want to call with held  but I should see someone now because I don't have this before.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itch, redness, fever, swelling at site of injection on left arm 11 days after vaccination
On 6/19/98 pt. recv. vax. and 30 hours later pt. exp.diarrhea, fever, nausea, night sweats, and pain.
pt taken to ER @ hosp; fever started @ 101.4 730PM then went to 102 to 103 @ time of discharge; swollen lt leg from shot site to knee; crying uncontroable
Patient reported feeling body aches and pains starting 9/21/23 and started taking OTC Ibuprofen. He admitted taking medication on an empty stomach and in quantities more than recommended by manufacturer. He said that he continued feeling ill and took Ibuprofen until he went to the ER on 9/29/23. The physician onsite sent him home with the advice of stopping the Ibuprofen and switching to Tylenol. He returned to the ER on 10/3/23 with blood in his stool and dark urine. He was kept overnight in the hospital for observation and an endoscopy on 10/4/23, and was subsequently diagnosed with a bleeding ulcer. He was discharged on 10/5/23 with prescriptions for Sucralfate and Pantoprazole.
COVID-19 test Positive; COVID-19 test Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: PFR FIC 9893) at the age of 83 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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) for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "not recovered" and all described as "COVID-19 test Positive". No Known allergies. Patient tested positive for Covid on 22Jul2022. Patient started Paxlovid and took it for 5 days. On 02Aug2022 Patient tested positive again for Covid and had all the same symptoms as the first time. AE resulted in: None of the above. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive; (02Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.