chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 72 years 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: "Artificial aortic heart valve" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Statins for known allergies: statins. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Severe pain, skin was red, some swelling and hot to the touch. Right arm diffusely TTP.
Shaking Chills, aching from her head, back and shoulders, shivers. Feels like she had a fever, but did not take her temperature. Also a severe headache. Symptoms continued through most of the night until 2 am.
an adult patient received as a first dose a pediatric dose instead of an adult one; an adult patient received as a first dose a pediatric dose instead of an adult one; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comment: Clinical pharmacist reported that an adult patient received pediatric dose instead of an adult one. Registered pharmacist had no information regarding patients' demographics and/or vaccination date. The consent to follow up was given. Additional Supportive Information: An adult patient received pediatric dose instead of an adult one, which led to underdose and adult use of a child product.
No Adverse Event; 7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.) and NO ADVERSE EVENT (No Adverse Event) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     The information was unknown about any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.).    The date of last administration was 27-Feb-2023. The vaccine was frozen with no known temperature excursion before being thawed today for administration. Dose administered after manufacturer date of expiry. The vial was initially stored in the refrigerator on 27-Feb-2023. The vial had undergone no temperature excursion. 7 doses of Monovalent vaccine was administered to the patients.  The concomitant medication was not reported. The treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712698, US-MODERNATX, INC.-MOD-2023-712708, US-MODERNATX, INC.-MOD-2023-712766, US-MODERNATX, INC.-MOD-2023-712974, US-MODERNATX, INC.-MOD-2023-713012, US-MODERNATX, INC.-MOD-2023-713027, US-MODERNATX, INC.-MOD-2023-713031 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712698:Same reporter US-MODERNATX, INC.-MOD-2023-712708:Same reporter US-MODERNATX, INC.-MOD-2023-712766:Same reporter US-MODERNATX, INC.-MOD-2023-712974:Same reporter US-MODERNATX, INC.-MOD-2023-713012:Same reporter US-MODERNATX, INC.-MOD-2023-713027:Same reporter US-MODERNATX, INC.-MOD-2023-713031:Same reporter
This morning I noticed two red spots at injection site that are a bit itchy. Injection site feels firm.  Aside from this, I felt fine after initially receiving the vaccine last Friday. The day after it was very sore to lift my arm but the following day it felt much better. The next two days, Monday and Tuesday, I felt very tired.
Patient began to complain of feeling dizzy. Was found to be anxious, flushed and tachycardia. Was asked to lay down. Medical emergency was called to respond. Patient refused further medical treatment. Continued monitoring for an additional 45 minutes after receiving the vaccine, and left in good condition.
COVID-19 infection on 2/17/21 with headache x 2 days, followed by runny nose, congestion, cough, diarrhea.
Presetned to hiospital on 12/6 from assisted libing with acute hypoxemia andn latered mental status. Diagnosed COVID + on 12/3. Started on dexamehtasone, borad spectrum antibiotics and IV diuresis. With increasing oxygen requirements, baracitinib was added. Patient's daughter requesteed pallative care involvemnt for goals of care. On 12/9 had an abrupt increase in oxygen reuqirements and CT angiogram obtained with no signe of pumonary embolism but worsening pulmonary opacities. His anitibiotics were broadened and diursis was increased. Despite aggressive measure he failed ot improve. Discussions with pallative care and family elected to persue comfort measures onm 12/11.
Received vaccine Friday, May 7. Evening of May 7 - brain fog started two hours later, chills, night sweats throughout the night. Day of May 8 - Severe fatigue, lethargic, brain fog, napped. Night of May 8 - took a Tylenol PM, slept 8 hours. May 9 - Lethargic, brain fog, achy body. May 10  nothing. May 11  nothing. May 12 - Fever spiked randomly, chills again, lethargic. May 13 - severe headache. May 14 - severe headache. May 15 - headache, lethargic. May 16  nothing. May 17  nothing. May 18  nothing. May 19 - rolling chills - period came 10 days early. May 20- rolling chills. May 21- rolling chills/exhaustion. May 22- rolling chills/exhaustion. May 23- rolling chills/exhaustion. May 24 - rolling chills, extreme lethargic/exhaustion. May 25 - present: rolling chills, extreme lethargic/exhaustion, night sweats sporadically, severe headaches every few days.
p/ pt recv vax pt exp chickenpox w/approx 136 lesions & was afebrile
About 12 hours after receiving pneumonia vaccine, patient experience some swelling, very tender to the touch, area felt hot to touch. Swelling has reduced, site still warm, but patient feels it is dissipating. Ice has been intermittently applied.
Preexisting Tinnitus increased in severity by about 10x; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 at 13:15 as dose 2 (initial pfizer dose), single (Lot number: FJ1620) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Tinnitus" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: 011A21A, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 10Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 17Dec2021 at 07:30, outcome "recovering", described as "Preexisting Tinnitus increased in severity by about 10x". The event "preexisting tinnitus increased in severity by about 10x" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: If other vaccine in four weeks: No, Other medications in two weeks: N/A, If covid prior vaccination: No, If covid tested post vaccination: Yes, Covid test post vaccination: Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=Nina Now, Covid test date=29Dec2021, Covid test result=Negative, Known allergies: N/A, Other medical history: None
Started with redness around injection site, examined office approximately 72 hours. 9cm x 8cm indurated/ red. Mildly tender area, left upper arm at site of IPV injection.
Rec'd vaccine 10/7/13 on the morning of 10/8 awoke spinning and dizziness - no other symptoms. Urgent care MD checked thoroughly for other causes of vertigo - none found.
I began to feel a scratchy throat on June 9th and 10th. In the evening of June 10th I had a sever cough that persisted through the night and prevented me from sleeping. I  took an at home Covid test on June 11th which was positive. I spoke with my doctor on June 12th who advised that as long as my symptoms remained mild, I would not need prescription medication and to contact her if symptoms progressed. But so far, my symptoms have been improving.
This spontaneous report was received from a physician, via a company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 30-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to temperatures excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
while administering the 2nd shingrix  dose  the syringe malfunctioned by leaking from the top, so the patient barely got any in her left deltoid, it ran down her arm.
Breakthrough case admission after 2 vaccines  Pfizer 3/19/21 Lot# ER2613;  Pfizer 4/9/21 lot# EW0150
an adverse reaction 10-minutes after injection; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demography who experienced an adverse reaction 10-minutes after injection (vaccination complication), while he/she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 09-Oct-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, 10 minutes after the vaccination the patient experienced an adverse reaction 10-minutes after injection (vaccination complication).  (Other relevant tests included no lab data.)  Final diagnosis was vaccination adverse reaction.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 28-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & devel lesions described as a rash;no further details were provided;
extremely sore arm, shoulder, neck pain. Unable to lift arm for 12 hours. fever
This literature market report has been received from authors of a Letter to the Editor referring to 23 children of unknown gender. They had two sets of pneumococcal titers to 23 serotypes drawn 4-12 weeks apart between January 2005 and December 2014. The patients' exclusion criteria included treatment with an immunosuppressive agent in the 3 months prior to the testing, history of solid organ or bone marrow transplants, and diagnosis of another immunodeficiency. Information of concomitant medication was not reported.The reporters thoroughly reviewed the patients' chart to ascertain that the specific or selective antibody deficiency (SAD) patients did not have clinical or laboratory features that may raise concerns for other immunodeficiencies that could potentially present with impaired response to vaccines. On unknown dates between January 2005 and December 2014, the patients were vaccinated with PNEUMOVAX 23 (one dose, strength, frequency, route, lot# and expiration date were unknown) for prophylaxis. A second set of antibody levels were obtained 4-8 weeks following the booster. To define an adequate response to PNEUMOVAX 23, the reporters utilized cutoffs recommended by a task force of the Academy: a post-immunization level is more than 1.3 microgram per milliliter (mcg/mL), or at least a 4-fold rise in a titer, compared to the pre-immunization level to greater than or equal to 50% of serotypes tested for 2-5 years of age, or greater than or equal to 70% of serotypes tested for children 6 years and older. On unknown dates, these 23 patients demonstrated inadequate responses to PNEUMOVAX 23 and were diagnosed with specific or selective antibody deficiency (SAD). The outcome of the event was unknown. The reporter considered the event was related to the PNEUMOVAX 23. These patients were diagnosed with SAD because they had an inadequate response to PNEUMOVAX 23, but demonstrated normal total immunoglobulin levels and had documented protective titers to tetanus toxoid and Haemophilus influenza type b. Multiple univariable analyses that evaluated the ability of a post-immunization antibody level of more than 1.3 mcg/ml to each serotype in predicting SAD revealed a wide range of predictive abilities for each individual serotype (area under the receiver operating characteristic (ROC) curve (AUCs) range from 0.57 (unit not provided) to 0.81 (unit not provided)). A multivariable stepwise regression revealed that the post-immunization levels of five specific serotypes: 4, 5, 11A, 18C, and 20 were negatively associated with the presence of SAD, P was less than 0.05 (unknown unit), and indicated that among children with post-immunization antibody level more than 1.3 mcg/mL to each of these serotypes, the predicted odds of a SAD diagnosis decreased by 88%- 99%. The estimated ROC, AUC, using the post-immunization levels to the combination of these five serotypes alone to predict whether or not the patient had SAD, was 0.96 (95% CI 0.92-1.0 (unknown unit)). Upon internal review, specific or selective antibody deficiency (SAD) was determined to be medically significant.
I WAS SICK (NON-RESPIRATORY) WITH COVID FOR TWO WEEKS, THEN FATIGUE FOR TWO WEEKS. RECEIVED THE COVID VACCINE ~ 5 WEEKS AFTER  COVI D  SYMPTOMS/DX. ONE WEEK AFTER VACCINATION ONSET OF A GENERALIZED ERYTHEMATOUS, BLANCHING RASH, AND SWELLING OF HANDS AND FEET; NO ITCHING OR PAIN. NO SYSTEMIC  SIGNS (NO CONJECTIVAL  OR MUCOUS MEMBRANE INVOLVEMENT). IS THIS A LATE COVID RASH OR A RASH 7 DAYS AFTER VACCINATION IN SOMEONE WHO RECENTLY HAD COVID?
big red itchy rash on the thighs; big red itchy rash on the thighs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (big red itchy rash on the thighs) and PRURITUS (big red itchy rash on the thighs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced RASH (big red itchy rash on the thighs). On an unknown date, the patient experienced PRURITUS (big red itchy rash on the thighs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH (big red itchy rash on the thighs) and PRURITUS (big red itchy rash on the thighs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.
Menstrual spotting; Menstrual spotting and cramping; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Sep2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Concomitant medication included prucalopride succinate (MOTEGRITY) for an unknown indication from an unknown date and unknown if ongoing. On an unknown date in Sep2021, the patient experienced menstrual spotting and cramping. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual spotting and cramping was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
High pitched screaming x 48 hr post immunization. Wakes with tremor. Temp 102. Appetite down.
Flu vaccine 11-13-20 in Left Arm. Mom reports on 03-12-2021 that child c/o numbness of arm limited rom starting mid January 2021. Symptoms improving now. Full rom returned. numb spot smaller
Numbness/Tingling sensation in extremities, developed foreign antibodies in bloodstream, viral infection, scar tissue in left deltoid (site of injection) appriox 2-4 weeks after vaccine.
Sudden onset of feeling feverish (temp. normal), weak all over, staggering, out of breath. Subsided gradually during evening. Meanwhile called Advice nurse, Doctor recomm. ER. Did not go because of spontaneous recovery.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). Concomitant product use was not provided by the reporter. The date of vaccine administration and dose number was not reported. The date the vial was initially stored in the refrigerator was 07-Jun-2022. Number of doses/vials were 35 doses and 4 vials. The vial did not undergo any temperature excursions. Date of administration of the vaccines were 1-Apr-2022, 5-Apr-2022, 6-Apr-2022, 8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. The date of vaccine administration was not reported, and it was unknown whether patient took first, second, first booster or second booster doses. Treatment information was not provided. This case was linked to -MODERNATX, INC.-MOD-2022-589423 (E2B Linked Report).; Sender's Comments: -MODERNATX, INC.-MOD-2022-589423:Master case
This spontaneous report was received on 19-JAN-2017 from a female medical assistant referring to a 32-year-old female. The medical assistant reported the female patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies. It was reported that the patient who received doses of M-M-R II during childhood (dates unspecified; Lot numbers and expiration dates not reported) has "inadequate titers." The indication reported for the M-M-R II was "Prevention of Measles, Mumps, and Rubella". The medical assistant reported the patient had seen an unspecified allergist on an unspecified date who performed lab work on unspecified dates and the lab work results show that the patient "needed a MMRII trigger dose". The patient had no hospitalization for the adverse experience. No further information was reported. Additional information has been requested.
Initial report received from a non-health care professional (consumer) on 23 October 2013. A female patient (whose age and date of birth was not reported)  had received an unknown dose of flu vaccine (influenza vaccine) (lot number unknown and route and site of vaccination was not reported) on an unspecified date. The medical history of the patient and concomitant medication was not reported. It was reported that the patient had multiple allergies due to flu shot. The corrective treatment was not reported. At the time of this report, the outcome of adverse event was not reported. Documents held by sender: none
Per patient- Temp got as high as 102 F on 6/3/06. He called in to after hours nurse line on 6/3/06 and spoke with MD, who recommended taking Tylenol prn. He called in to clinic 6/5 for a work excuse letter and we had him come in to clinic to check his injection sites. Right arm was benign. Left upper arm was red, hot and swollen. Patient was sweaty and warm, but afebrile. He had taken Tylenol approximately 2 hours prior. MD examined him. Recommended using ibuprofen and acetaminophen to control continued fevers, ice arm prn, and to call if symptoms did not improve or worsened.
Headache, Fever and chills starting about 7 hours after and lasting for 6 hours.  Headache lingered for about 36 hours