chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report was received from literature. This report concerned a 70 year old male. The objective of this article was to study immunogenicity of Ad26.COV2.S Prime and Two Subsequent doses of mRNA SARS-CoV-2 vaccines in solid organ transplant recipients. The patient's height, and weight were not reported. The patient's past medical history included: kidney transplant (45 years since transplant). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included mycophenolate mofetil (MMF) and steroids for drug used for unknown indication.   On an unspecified date laboratory test included: Antibody test (anti-RBD) which was less than 0.8 U/mL (Highest Post-D1 (ad26.cov2.s) Titers), 1273 U/mL (Highest post-D2 (elasomeran) titers), 2021 U/mL (Highest post-D3 (elasomeran) titers) and negative cutoff value was less than 0.8 U/mL or anti S1 less than 1.1. AU. Hence suspected immunological vaccine failure (Dose number in series 1). Days between D3 and Post-D3 titers was 19 days. The patient additionally received two doses of non-company suspect vaccine (Spikevax) (mRNA 1273) elasomeran (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, start therapy date were not reported for covid-19 prophylaxis. The vaccination days in between ad26.cov2.s and elasomeran was 259 days while second dose of elasomeran was after 27 days.  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the suspected immunological vaccine failure was not reported.  The authors emphasized on the awareness that despite suboptimal antibody response to the Ad26.COV2.S prime, two subsequent mRNA vaccines increased antibody titers to high levels for the majority of participants, with acceptable side effects. This series suggested that a heterologous vaccine regimen may be a reasonable option for SOTRs (Solid Organ Transplant Recipients) though lack of sero-response, despite two mRNA boosters, suggested that some recipients may remain at risk for SARS-CoV-2 infection.  This report was serious (Other Medically Important Condition). This case, from same Literature article is linked to 20221012832, 20221034707, 20221034755, 20221034752, 20221034754 and 20221034625. This report was associated with product quality compliant.; Sender's Comments: V0: 20221034742-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
cough; fever; achiness; sinus congestion; headache; Localized soreness in arm/ Tenderness at local site; inflammation at local site for 2 hours; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COUGH (cough), PYREXIA (fever), PAIN (achiness), SINUS CONGESTION (sinus congestion) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced COUGH (cough), PYREXIA (fever), PAIN (achiness), SINUS CONGESTION (sinus congestion), HEADACHE (headache), VACCINATION SITE PAIN (Localized soreness in arm/ Tenderness at local site) and VACCINATION SITE SWELLING (inflammation at local site for 2 hours). On 12-Jan-2021, VACCINATION SITE SWELLING (inflammation at local site for 2 hours) had resolved. On 15-Jan-2021, COUGH (cough), PYREXIA (fever), PAIN (achiness), SINUS CONGESTION (sinus congestion), HEADACHE (headache) and VACCINATION SITE PAIN (Localized soreness in arm/ Tenderness at local site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Received PREVNAR 13 in 2016 and then received PREVNAR 13 in September 2020, instead of intended vaccine receiving PNEUMOVAX 23; This spontaneous information has been received from a pharmacist, concerning a 74-years-old patient of unknown age. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unknown date in 2016, the patient received one dose of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) as prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not provided) and then on an unknown date in September 2020, received another dose of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) instead of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (wrong vaccine administered).
Woke this morning with a migraine which he gets regularly. So we gave him  Rizatriptan 10mg. He has also taken a Imodium that morning as he had some mild Diarrhea the day before after eating to much clam chowder. He got into the shower around 10am and after being in the shower for a few minutes started to feel like he was passing out. He got out of the shower and felt weak and was disoriented and called us for help. He had a hard time walking to his bedroom with assistance and layed back down in the middle of the hallway. We then got him up and and helped him to bed to rest. He said he felt very weird. We have not taken him to the doctor at this point as we are not sure what to do  and are just waiting to see how he progresses today. His shot was last night.
pt devel severe erythema & swelling @ inject site w/in 48 hrs of receiving Tetanus Toxoid Adsorbed; pt was treated w/Cephalexin for adverse event;
Patient was solely breastfed. Patient became increasingly fussy and irritable immediately after his vaccines on 10/16/2017. His poops started looking and smelling very abnormal (and did not return to normal until months later after initiation of probiotics). on 11/25/2017 I checked his temperature for the first time ever rectally, he was 102. We went to the ER but they sent us home without doing any bloodwork.  Then 12/5/2017 we went to the ER again for fever (as the fevers never went away, they kept occurring daily) and his bloodwork showed he was Neutropenic. His fevers never went away, he had recurrent fevers which led to him being admitted to Hospital on 12/13/2017 for 2 days. It was there that it was discovered he was severely Neutropenic and he was put on Neutropenic precautions. His liver values were also out of range. He was discharged after 2 days later because he was otherwise thriving and there were no explanations for his fevers.  The fevers would frequently occur, almost daily, for months. There were several other trips to the ER per MD advice since that December admission. Further work-up showed his Immunoglobulins were low, his liver enzymes were consistently out of range, his Neutrophils were low several times.  He saw many specialists. We declined further vaccinations due to his recurrent fevers and abnormal bloodwork. An Immunologist, Dr., at Hospital eventually diagnosed Patient with Transient Hypogammaglobulinemia at 9 months of age.
This spontaneous report as received from a registered nurse refers to a 12 month old female patient. The patient's medical history included bronchiolitis. On 22-OCT-2014 the patient was vaccinated with a dose of PROQUAD (Merck) 0.5 ml, subcutaneously (lot# reported as K011311, expiration date: 14-FEB-2016). Concomitant therapies included albuterol sulfate (as needed). On 28-OCT-2014 the patient was taken to an emergency department in Hospital, with fever of 101F to 102F and "over 50 lesions." The nurse reported that the lesions were itchy. The patient was examined by her primary healthcare provider on 29-OCT-2014 and he diagnosed her with "classic chickenpox." The patient has not experienced an alteration in her appetite. The nurse did not know when the patient's symptoms began. The physician prescribed AVEENO bath and calamine lotion to ease the patient's discomfort. At the time of the report, the patient has not recovered. Causality was not provided. Additional information has been requested.
Onset of severe bilateral tinnitus about 8 hours after injection. No previous history of tinnitus.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
Wihin 1 hr of receiving the MMR/DPT vaccination, she       started having partial/complex seizures every 15 minutes. She is still having partial & petit mal seizures 2-4 times daily even with the advent of 3 prescribed medications. She has had these seizures over the last 1 1/2yrs. and continues to have them daily. Information from medical records states developmental delay as problem. msv Our daughter was diasnosed with a brain tumor on 10/06.  We believe as the doctors, her vaccinations triggered her systems & an early diagnosis was made.  She wouldn't have shown until puberty with this type of tumor.  After all our research we strongly believe there is a link with vaccines and Austism, etc.  Our 21 month old has not been vaccinated.
Patient took the flu vaccine syringe out of pharmacist's hand and gave himself an injection in his left thigh.
On the 2nd day, I got chills, exhaustion, headaches, dizziness & weakness in the legs and coordination walking.
This spontaneous prospective pregnancy report as received from a 36 year old female pharmacist refers her. The patient did not have any pertinent medical history and did not have any drug allergy. The patient was pregnant with last menstrual period (LMP) of 08-AUG-2014 and estimated date of delivery (EDD) of 15-MAY-2015. Initial exposure to ZOSTAVAX was at 21 weeks. On 02-JAN-2015, the patient was administering vaccine with ZOSTAVAX vial (strength, dose, route, location, lot and expiry date not reported). No concomitant medication was reported. On 02-JAN-2015, while preparing the vaccine for administration she inadvertently splashed reconstituted ZOSTAVAX on her face and lip. She stated that the needle slipped out of the vaccine vial as she was withdrawing the dose of ZOSTAVAX. No adverse effects were reported. The patient did not receive any treatment and did not seek medical attention. The outcome of the event was unknown. No further information provided. A product quality complaint (PQC) was not reported. Additional information has been requested.
arm felt burning gradually more inflammed 6x5cc local rxn, erythema, hot to touch, tiny blister on opposite wrist & knee;
Incorrectly administered intradermal vaccine to patient's right forearm. Patient had a mild reaction to the vaccine at the injection site.
on/ off Jitteriness; injection site was hot; Injection site was sore, painful, tender; Fatigue; nausea but no vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING JITTERY (on/ off Jitteriness), INJECTION SITE WARMTH (injection site was hot), INJECTION SITE PAIN (Injection site was sore, painful, tender), FATIGUE (Fatigue) and NAUSEA (nausea but no vomiting) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FEELING JITTERY (on/ off Jitteriness), INJECTION SITE WARMTH (injection site was hot), INJECTION SITE PAIN (Injection site was sore, painful, tender), FATIGUE (Fatigue) and NAUSEA (nausea but no vomiting). At the time of the report, FEELING JITTERY (on/ off Jitteriness), INJECTION SITE WARMTH (injection site was hot), INJECTION SITE PAIN (Injection site was sore, painful, tender), FATIGUE (Fatigue) and NAUSEA (nausea but no vomiting) outcome was unknown.            No concomitant medications were provided.  No treatment medication was provided.
I received the NOVAVAX Booster on October 27, 2022.  Around the  20th of November, fatigue, upper respiratory symptoms, fever, sore throat, and severe pain in the throat were felt.  Some of the symptoms were not so problematic at first, but around end of Dec holiday time, I was rushed to the emergency room due to severe pain in the throat, on-and-off fever, fatigue,  severe coughing, and dizziness.
Patient came in the pharmacy today to report that she had soreness, bruising, and scabbing from her Shingrix vaccine that she received on 4/17/2023. She stated the reaction lasted about 1 week and the scabbing got better after applying moisturizer to the area.
Moderate pain left shoulder to elbow, fever 101.5, chills, nausea and vomiting, Took 2 regular ASA, but did not help pain. Ice did not help the pain. Saturday 2 days later he awoke with pain in upper left arm and other sx resolved, except for limited hearing in right ear. At 10am he took 2 caplets to decrease fever and help pain. Recommended warm compresses and monitor. On Saturday 10/2/17 patient had edema and erythema of upper left arm, deltoid area and below. Next day persistent soreness even with moist compresses. Still with limited hearing in right ear. After 3 months of complete hearing loss in right ear, hearing fully returned on 12/31/17 after ear popped.
Mom started giving APAP immed p/vax & cont q 4 hrs; appox 15 hrs p/vax pt devel t105 that lasted the next 48 hrs; APAP brought fever down to 103;
Redness, swelling at injection site - treatment: prednisone 10 mg.
BEGAN FEELING CHEST PAIN AND LIGHTHEADEDNESS BEGINNING 3/14, THE DAY AFTER GETTING THE VACCINE.  HE PRESENTED TO THE EMERGENCY ROOM ON 3/17 WITH WORSENING OF CP THAT WOULD NOT GET BETTER WITH NSAIDS, PAIN RADIATING DOWN LEFT ARM.  TROPONINS NOTED TO BE ELEVATED, PT ADMITTED TO INPATIENT ROOM FOR CARE ON 3/17.  TESTING DONE AND PT TREATED FOR  MYOCARDITIS POSSIBLY SECONDARY TO COVID 19 VACCINATION.  DC'D HOME ON 3/24 WITH LISINOPRIL AND PREDNISONE.  ORDERS TO FOLLOW UP WITH DR.
Patient called the office today than since yesterday (10/11/15) his right arm is painful, red, warm and swollen. A 4:30PM seen per Dr. No treatment necessary appears as local reaction.
Redness and swelling of the site (R) deltoid, fever 103 degrees, chills x 5 days and pain of the site.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-APR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 168, 32 and R; 920, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & 7 days p/vax pt exp fever & rash;no further details were provided;
no adverse event; vaccine used which were beyond the 30-Day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date).    Concomitant products were not reported.  It was reported that patient received monovalent dose that was administered beyond 30 day beyond use date. The use by date of lot 042J21A was reported as 17-Feb-2022.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Significant Live Follow up received use by date of the vaccine was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Pediatric Havrix and Engerix to adult pt; Pediatric Havrix and Engerix to adult pt; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 61-year-old female patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis.   On 11th April 2022, the patient received Havrix pediatric and Engerix B pediatric. On 11th April 2022, unknown after receiving Havrix pediatric and 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: 13-Apr-2022 Reporter's Comments: Pharmacist reported an adult patient (61 years old) had been vaccinated with a pediatric dose of Havrix and one of Engerix on Monday ( 11th April 2022). The Healthcare professional had no information about lot numbers of the vaccines. The reporter consented to follow up. Additional Supportive Information: The adult patient received pediatric dose of Havrix and Engerix B, which led to underdose and adult use of a child product. Note: The formulation of suspect products was captured as solution for injection, as the reporter had no information regarding the formulation.
Was fine the day of receiving vaccine. The next morning when woke up, was unable to move legs. Stated could not get out of bed, could not walk, has severe weakness. flank pain, nausea, headache, fever, and chills
Patient received first Moderna covid vaccine at 1210pm.  At 1215pm, patient was feeling light-headed and disoriented.  Patient's blood pressure was normal, but pulse was 90.  Patient was alert, but became disoriented for about 30 seconds and didn't respond, however, but still breathing.  After that episode patient was more alert and talking, at that time the ambulance arrived and did BP, pulse, and oxygen check.  Patient was feeling fine.
Per mother states it's a size of a quarter as well as redness and warmth on the R thigh where the Prevnar 13 was given mother stated now the bump has improved and it's no longer there.
2/7 NOTE:  PATIENT'S ARM IS SWOLLEN AND RED - ABOUT THE SIZE OF A BASEBALL LAST NIGHT. TODAY AT 1:15P, IT IS ABOUT THE SIZE OF A GRAPEFRUIT AND LOOKS LIKE A RED RASH BUT IS NOT SWOLLEN
On the day of the vaccine, that evening, I started was feverish but I didn't think too much of it, but my back hurt and all my joints hurt, I was not well at all over the weekend. I maintained a low fever all week. My heart rate was elevated even at rest, I wear a health monitor and it told me it was at 150 even when sitting and resting.   I used deep breathing to try and bring that down so I went to urgent care to see if I had covid. I had joint stiffness and could no longer maintain my prior level of physical activity. My knees were hurting terribly bad. I ended up going to a chiropractor of which I currently see for the same problems. My brother got his second Moderna shot and he called me on April 18th and he told me he had heart racing since and he had never had heart issues before. He ended up passing away on May 3rd and it has me concerned since I did not have any health issues before this.
Started with fatigue, headache, muscle pain, joint pain, and chills in the morning on 1/23/21. This resolved on 1/24/21
Janssen COVID-19 Vaccine EUA On Oct 13 Vaccinated at 12:45. Swelling and hot skin around injection site beginning late afternoon on first day. Super tired and went to sleep around 7 pm. Increasing body aches through the night.  On Oct 14 Discovered a rash had formed a few inches around the injection location at 6 am. Extremely tired, severe muscle aches in torso, arms, & legs. Low grade headache all day, and vision became blurred for several hours in late afternoon. Slept most of the day due to fatigue. Alternating chills and sweating starting late afternoon, and throughout the night. On Oct 15 at 6 am the rash, swelling, headache were gone. Aches subsiding and no chills since 8 am.
having a bad case of the flu; light headed; chills; effected his vision; Kind of clammy today too; feels horrible, feels like he got hit by a truck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient of an unspecified age (Age: 59 Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "light headed", "his Right arm hurt where the injection was".  The following information was reported: DIZZINESS (non-serious) with onset 24Mar2021, outcome "unknown", described as "light headed"; CHILLS (non-serious) with onset 24Mar2021, outcome "unknown", described as "chills"; VISUAL IMPAIRMENT (non-serious) with onset 24Mar2021, outcome "unknown", described as "effected his vision"; INFLUENZA (non-serious) with onset 25Mar2021, outcome "unknown", described as "having a bad case of the flu"; COLD SWEAT (non-serious) with onset Mar2021, outcome "unknown", described as "Kind of clammy today too"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "feels horrible, feels like he got hit by a truck".  Additional information: The patient would like to know how long would side effects last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 3 days the patient developed widesread rash covering the breasts the abdomen and the back. Very pruritic