chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient given vaccine that had been opened for more than 6 hours, but kept refrigerted; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine that had been opened for more than 6 hours, but kept refrigerted) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine that had been opened for more than 6 hours, but kept refrigerted). On 18-Feb-2021, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine that had been opened for more than 6 hours, but kept refrigerted) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-027809, MOD-2021-027749 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Add race, ethinicity. Add 2nd dose batch number. Add event outcome; Reporter's Comments: This report refers to a case of Expired product administered  for mRNA-1273, lot # unknown  with no associated AEs.; Sender's Comments:  MOD-2021-027749:same reporter,same event, different patient MOD-2021-027809:same reporter,same event, different patient
PATIENT CONTRACTED COVID, DATE OF COLLECTION 3/18/2021, DIED ON 3/21/2021
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
not as bad if I didn´t get the shot/suspected vaccination failure; came down with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's son had them).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: not as bad if I didn´t get the shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: came down with shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-Mar-2023 The case was received from the patient via interactive digital media. The patient heard about shingles because his or her son had them so, he or she wanted to get the vaccine to prevent coming down with shingles. The physician wrote it up wrong so it cost the patient 400 dollars. 2 or 3 weeks later, the patient came down with shingles. The patient stated that but not as bad if he or she did not get the shot. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a healthcare worker and refers to a 16 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 10-SEP-2015, the patient was vaccinated with improperly stored doses of MMR II (lot # J010208, expiration date 23-AUG-2015, exact dose and route of administration were not reported) and VARIVAX (lot # K002046, expiration date 10-FEB-2016, exact dose and route of administration were not reported). The dose of MMR II was expired. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a healthcare professional (nurse) and described the occurrence of mouth open breathing in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 10 October 2012 the subject received a dose of FLUARIX (.5 ml, unknown route, right arm) and experienced mouth open breathing, injection site redness, injection site pruritus, injection site pain, hot all over, watery eyes, anxiety and crying. A discrepancy existed in the administration record and the incident report from the reporter as to the site of injection versus the site of the adverse events. "The vaccine was administered at a Flu clinic at a local business. Patient had itching and pain in her left upper arm with a large area of redness. She complained of feeling hot all over. She was breathing through her mouth, but there was no wheezing or shortness of breath. Her eyes were slightly watery. The patient was anxious and crying." Based on the report it was unclear which arm the events and injection occurred. The reporter indicated that the injection site was right arm and the adverse events at the injection site occurred in the "LUA" (left upper arm). The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with EPINEPHRINE and BENADRYL. The subject was encouraged by the flu clinic to "call her doctor or go to ER if symptoms persisted." The subject contacted her physician, but it was unknown if she visited the office. The "practice called the (subject) this morning (11 October 2012) and (the subject) report(ed) improvement but not 100 percent."
Red, itchy rash, hard spot adjacent to injection site.  Approximately four inches in diameter.
Woke up shivering at 1 A.M. Saturday  so bad that my husband thought I was having a seizure, took my temp it was 104. Took Tylenol, held cool compress on my forhead, the next day had bad chills, throbbing headache, and temp never dropped below 100. I was very weak, every muscle in my body ached, couldn't eat, yet my blood sugar was high all day. Kept checking my temp. It was avg. 102 . Read about the side effects, seemed like I just had it worse than others. Then into Monday morning, still felt awful, but had woke up in a pool of sweat, temp finally fell to 99 . Seemed like the worst was past, was able to eat a little breakfast, but then the diahrea started! I called in sick again, and went to Urgent care. The Dr. said I had a severe adverse reaction to the second vaccine. I asked for a Covid test just in case. Now Tuesday, felt better today, still a bit tired, temp has been avg. of 98 today, got results from test, negative.
UNILATERAL HEADACHE, PHOTOPHOBIA, NAUSEA, MIGRAINS. PT HAD LAST MIGRAIN SYMPTOMS AT AGE 15.
Patient complained of muscle aches and cramping in bilateral arms, legs and left side. She states she is well hydrated and has not experienced muscle cramping in the past, has no known other causes of these symptoms.
got the shot I got the shingles/suspected vaccination failure; shingles; awfully painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (when patient was 28 years old).   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got a shot several years ago, two years before the date of reporting the patient got the shingles 3 times throughout the summer.  The patient said by the time he/she was able to finally get the shot and asked was it cheaper to get the shingles.  The patient also said do what ever you could, because they were awfully painful and could cause scars. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Narrative:  Patient was seen in emergency department after vaccines were administered and was sent home with prednisone 60 mg po daily for 5 days.
No adverse effects reported; Expired vaccine used; This spontaneous report has been received from a nurse referring to two female patients (twin girls) of unknown age. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-MAR-2019, both of the patients were vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # N024562, expiration date 06-MAR-2019; dose number and route were unknown) for prophylaxis (expired vaccine used). No adverse effects reported. The outcome of the events was unknown. No product quality compliant (PQC) presented.
itching to arms and face, progressing to the Bilateral arms and back/ residual itching; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient. A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EN6201), via intramuscularly, on 10Feb2021 09:30 AM (at the age of 53-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history included allergies to NKDA food, shellfish, shrimp, citrus, poultry, nuts, mushrooms and other medical history HTN (hypertension), anxiety and hypothyroidism. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: unknown), via unspecified route of administration on unspecified date as a dose 1, single for COVID-19 immunziation. The concomitant medication of the patient included levothyroxine sodium (LEVOTHYROXINE SODIUM) and bupropion hydrochloride (WELLBUTRIN). It was unknown if patient had taken other vaccine in four weeks and it was unknown if patient had COVID prior vaccination. It was unknown if patient tested post COVID vaccination. On 10Feb2021 10:15 approximately 10 minutes after vaccine the patient experienced itching to arms and face, progressing to the bilateral arms and back. Patient was taken to the first aid station and denies any SOB, swelling, no CP and patient was A & O x 3, VSS at blood pressure was 1238/76, heart rate was 76, RR 18, SaO2 at 95% on RA. On 10:25 AM patient Itching had improved with blood pressure of 126/68, heart rate of 80, RR 16, SaO2:96% on RA. On 10:45 itching improved but residual itching continues. Patient was observed for 45 minutes and discharged. Patient received the treatment of Benadryl 25mg Oral liquid. Patient communicated understanding and had no further question prior to discharge. The outcome of the event was recovered on unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Mother called to report patient has rash on trunk, arms, complained of itching last evening 1/16/08.  Took OTC Benadryl last evening.  1/17/08, still has rash but no itching.  Also medicated with Tylenol.  Did have residual cough from cold but needed immunizations in order to get into school.
pt recvd 3rd dose of pedvaxHIB on 8JAN92 & later that evening devel rash, swelling & erythema @ inject site on lt thigh; w/in 2 days rash spread to lt thigh, lt arm & back; rash was described as papular but nonpruritic;
diagnosed with pulmonary embolism on 13Apr2021; date of first covid vaccine was 08Apr2021. PE was diagnosed at hospital so unknown exact length of hospital stay; This is a spontaneous report from a contactable physician. A 65-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 1 intramuscular, administered in Arm Right on 08Apr2021 (65-years-old at the time of vaccination), (Batch/Lot Number: EW0150) as DOSE 1, SINGLE for covid-19 immunisation in hospital. Medical history included gout, chronic obstructive pulmonary disease (COPD), coronary artery disease (CAD), osteoarthritis, type 2 diabetes mellitus (T2DM), hypertension (HTN) from an unknown date and unknown if ongoing. Patient had known allergies to NKDA. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient received prescribed medications as other vaccine in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient stated, he was diagnosed with pulmonary embolism on 13Apr2021; date of first covid vaccine was 08Apr2021. PE was diagnosed at hospital so unknown exact length of hospital stay. Adverse event resulted in Emergency room/department or urgent care, Hospitalization. Number of days of hospitalization was zero. Therapeutic measures were taken for the event as anticoagulation, now on apixaban. The clinical outcome of the event was recovering at the time of the report.; Sender's Comments: Based on the plausible temporal relation, the association between the event of Pulmonary Embolism and the suspect product of BNT162B2 cannot be completely ruled out. The confounding factors for the event are patient's medical history of Hypertension, Diabetes Mellitus (Type II) and Coronary artery disease The impact of this report on the benefit/risk profile of the Pfizer product 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, solution for injection), on 06Jan2021 as dose 1, single (Lot number: EK9231), in right arm, on 27Jan2021 as dose 2, single (Lot number: EL3247), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 28Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: Other medical history: History of breast cancer. Psoriasis. Gluten Intolerance.; "Psoriasis" (unspecified if ongoing), notes: Other medical history: History of breast cancer. Psoriasis. Gluten Intolerance.; "Gluten Intolerance" (unspecified if ongoing), notes: Other medical history: History of breast cancer. Psoriasis. Gluten Intolerance. Concomitant medication(s) included: LETROZOLE, start date: 07Apr2020; ATENOLOL.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 18Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive, notes: Symptoms more severe than first round of Covid (18Jun2022); (26Jun2022) Positive, notes: Symptoms returned 6/26/2022 with positive antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: It was reported that, the patient received vaccine. Received other medication in 2weeks. Covid Rebound after finishing Paxlovid RX. Finished on 22jun2022. Symptoms returned 26Jun2022 with positive antigen test. Symptoms more severe than first round of Covid (18Jun2022). Had Known allergies.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Felt very tired in the morning. Went back to bed after breakfast. Got up a little before noon and mouth was very dry. Drank several 8 oz. glasses of fluid. Later that afternoon, felt like a fever and it was 101.9. Slept some more and after supper it was down to 99.6. Slept extra overnight and felt pretty normal the next morning. Was okay yesterday although maybe was a little weaker than normal. Feel fine today.
About 25minutes after shot, I started having a tingling feeling near my left eye/cheek bone area followed immediately by slight swelling.   I took 2 Diphenhydramine 25mg and and two Tylenol pills and felt better within a couple hours.  I later had chills at night, but my husband said I felt hot to the touch.
Extreme fatigue for 2 days s/p 2nd shot and pain at injections site. Approximately 2 wks after 2nd shot,  pain in right shoulder, upper arm. Pain increase and tx with cortisone injection.  Pain disappeared.  Approximately 10 days after pain in cervical spine, coccyx, left upper arm and right upper arm began and continues.  It feel very stiff as if it need to be  led and aches continually.  I have high pain threshold .  I've tried heat and range of motion exercises and the range of motion gives the most relief.  It's like no other pain/ache/stiffness I've ever had.
On December 5, 2022, I noticed I was becoming short of breath when I would do my walking. I felt pressure and I was struggling to get enough air. It became so unpleasant I did not want to go for a walk. I noticed I had swollen glands and then a sore throat. I would wake up in the night and having trouble to get enough air, but I was able to get back to sleep. The swollen glands and sore throat went away. I continue to have difficulty breathing especially upon activity such as climbing stairs. I notified the neurologist that I was visiting at the time, and I was encouraged to go the emergency department. I went to the urgent care instead and they ran several tests, but none were conclusive. My blood pressure was high, though. I cannot remember the names of the tests they performed but they checked for heart attack.
pain in his chests; pain in his chests and swallowing; abnormal ekg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old male patient 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: CHEST PAIN (non-serious), outcome "unknown", described as "pain in his chests"; ODYNOPHAGIA (non-serious), outcome "unknown", described as "pain in his chests and swallowing"; ELECTROCARDIOGRAM ABNORMAL (non-serious), outcome "unknown", described as "abnormal ekg". The events "pain in his chests", "pain in his chests and swallowing" and "abnormal ekg" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was required to get the vaccine for him to continue with school and go to school settings and the only vaccine offered to minors was Pfizer. Since the shot he has been experiencing issues with pain in his chests and swallowing and had seen numerous specialists from GI to cardiology that only says he shows an abnormal ekg but can't find any reason and the parent just want some sort of reason their way to help him.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling and itching at the injection site; Swelling and itching at the injection site; This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 01144534).  The primary reporter is the physician. The primary reporter reported that a 34 year old female was administered a dose of PREVNAR 13 (unknown lot or expiration date) on an unspecified date ''12 years ago.'' The primary reporter reported that on an unknown date after the administration the patient experienced ''Swelling and itching at the injection site.'' No additional information was provided.  Information on lot/batch number has been requested.
Late long lasting reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Late long lasting reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Late long lasting reaction). At the time of the report, VACCINATION COMPLICATION (Late long lasting reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No Treatment information was reported.
Left upper arm pain, left neck stiffness. Diarrhea. Blurred vision,
pt recvd vax 2MAR92 & 3MAR92 devel t102; 4MAR92 devel diffuse myalgias including muscle spasms in neck, weakness, flu-like sx including hot & cold sweats, scratchy throat which became swollen & diff breathing; dx anaphyl react;
Meningococcal mixed with Hib conjugate et administered IM to pt instead of Diluent mixed with Hib.
At approximately 30 minutes following my vaccine I could not remember the name of my Dog or my horse.  I repeatedly was asking my husband who was driving " what is the name of our new dog? What is the name of our new horse?" though we had them for several months
pt recv vax; pinching sensation; soreness, high T; Stiffness; red hard, swollen spot size of quarter at inject site; tenderness, itching  for 6 days;
pt recv vax & devel an inj site rxn characterized by impressive redness & soreness;pt also had a lot of arm pain;rxn has lasted 5-7 days;this is one of 3 patients from this site who exp above rxn;