chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 17-FEB-2016, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Pt. c/o feeling dizzy/ light headed. She was verbal  A& o x 4. Paramedic team was present to assess her condition. V/S obtained was bp 158/105, h r114, res 16,temp 98.3, o2 99% RA . Pt. refused ambulance services to the ER. Apple juice and a bottle of 500ml water offered. She finished the liquids and verbalized feeling well. At 4:24 p m Pt walked out of the recovery hall unassisted, to the parking lot where she said her mom was waiting to drive her home.
Booster 0.25ml given too soon (not 6 months since last dose).  3 full doses, last full dose was on 8/13/2021
pt recv vax 1MAY95 & 1FEB97 pt devel moderate breakthrough chickenpox;
Scar; MAJOR PSORIASIS OUTBREAK; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (Scar) and PSORIASIS (MAJOR PSORIASIS OUTBREAK) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   In 2013, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SCAR (Scar) and PSORIASIS (MAJOR PSORIASIS OUTBREAK). At the time of the report, SCAR (Scar) outcome was unknown and PSORIASIS (MAJOR PSORIASIS OUTBREAK) was resolving.            It was unknown if patient was enrolled in COVID-19 vaccine trial. Causality for the Humira (Adalimumab): The reporter's causality for the event of Scar and MAJOR PSORIASIS OUTBREAK was not provided. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 3/19/21 and 4/16/21. Presented to ED 2/22/22 Covid+ in PEA arrest 2/2 septic shock due to polymicrobial PNA and bacteremia 2/2 Streptococcus viridans. Upon arrival to ED he has found to be unresponsive, apnic, and pulseless within vehicle. Rec'd epi x6, bicarb x2 & calcium 1g w/ROSC achieved. Became hypertensive and received Cardizem w/subsequent bradycardia and PEA arrest. ROSC after Epi x 1. Labs significant for BG 299, SrCr 3.4 up from 2.4 in 12/21, AST 168, ALT 104, CRP 11.5, Lactate 7.1 initially 6.1 on recheck, procal 0.17 BNP 1408, Ddimer > 20,  WBC 18.2. Tx'd w/cefepime, vanc and therapeutic cooling, during rewarming he did not have meaningful neurologic activity.  For 24 hours, all sedation was discontinued and he remained in a persistently vegetative state. Transitioned to comfort care, expired 2/25/21.
Patient was have difficulty breathing after getting to vaccine. Unable to take in breath. Gave EPI-PEN 0.3mg in Rt thigh. Improvement. 911 called and sent to ER.
SUSPECTED CLINICAL VACCINATION FAILURE; GOT COVID; This spontaneous report received from a male patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown, expiry: unknown) 1 total, frequency, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient tested positive to Covid-19 (got Covid and suspected clinical vaccination failure). No further information provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got covid and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210841128-Covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive 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: SPECIAL SITUATIONS
Sore arm, warm to the touch but then a blister formed on 4/9 and busted and a sticky fluid oozed out.
2 days later i woulnd up getting a severe rash in my eyes both eyes that i still have to this date. swelling and itchyness.  i have been placed on many medicines antihistimenes and creams for my eyes. i was sent to dermatologist who did 8 patch(88) chemical testing) and confirmed i was allergic to nothing.
RASH NOTED IN BILAERAL AXILLARY REGIONS. NOTICED THIS MORNING. CONCERNED BECAUSE JUST RECEIVED 1ST COVID INJECTION 5 DAYS AGO. RASH DOES ITCH AT TIMES. DENIES ANY OTHER AREAS OF BODY INVOLVEMENT. RASH COMES AND GOES. DENIES NIEW SOPAS OR ALLERGENS. NO SHORTNESS OF BREATH, SENSATION OF TONGUE OR THROAT SWELLING.
Developed a dark rough patch on my inner right arm near the elbow and a second smaller patch farther up on the inner right arm.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0164) via an unspecified route of administration in the left arm on 22Apr2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 03May2021 at 20:00, the patient developed a dark rough patch on inner right arm near the elbow and a second smaller patch farther up on the inner right arm. The clinical outcome of the dark rough patch on inner right arm near the elbow and a second smaller patch farther up on the inner right arm was not resolved.  No follow-up attempts are needed. No further information is expected.
Had no mobility; Fell to the floor; Very weak; Little confused; No apetite; High blood sugar; Agitated; Restless; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Had no mobility), FALL (Fell to the floor), ASTHENIA (Very weak), CONFUSIONAL STATE (Little confused) and DECREASED APPETITE (No apetite) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL (ZESTRIL), METFORMIN HYDROCHLORIDE (METFORMIN ER), GLIMEPIRIDE (AMARYL), GABAPENTIN 100MG (GABARONE), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), LEUPROLIDE [LEUPRORELIN], ENZALUTAMIDE (XTANDI), ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced MOBILITY DECREASED (Had no mobility), FALL (Fell to the floor), ASTHENIA (Very weak), CONFUSIONAL STATE (Little confused), DECREASED APPETITE (No apetite), BLOOD GLUCOSE INCREASED (High blood sugar), AGITATION (Agitated) and RESTLESSNESS (Restless). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Had no mobility), FALL (Fell to the floor), ASTHENIA (Very weak), CONFUSIONAL STATE (Little confused), DECREASED APPETITE (No apetite), BLOOD GLUCOSE INCREASED (High blood sugar), AGITATION (Agitated), RESTLESSNESS (Restless) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included hot and cold compresses.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: No specific follow-up information recorded.
Vaccine placed into fridge on 12/1/21 and administered on 1/6/22
pt recv vax & c/o itchy watery eyes & c/o feeling strange & hives;soon appeared on face & arms w/SOB developing w/tongue swelling;pt was coherent but agitated;911 called & responded;02 applied;
Individual is a physician who presented for vaccination , completed the consent vaccine form and was given the vaccine.  Later upon entering the vaccine into the system for the state - it seems he has already been vaccinated with the 2 dose Pfizer series
I had no noticed issues for about 18 hours after the injection Tuesday evening.  Sometime early Wednesday afternoon I began to experience body aches, a low-grade fever, and extreme tiredness.  I slept most of the rest of the day and night and felt better when I woke up Thursday morning, well enough to go about a normal day.  It is now late Thursday afternoon and I am still a little tired and mildly achy with no fever but otherwise much improved.    One other thing to report, initially there was no pain or tenderness to the injection site but that started changing about 24 hours after the injection.  Now about 46 hours after injection the site has a constant noticeable soreness even if I am not moving my arm.
Patient received Pfizer vaccine and began to feel itchiness within 5 minutes. Two cold compresses were given to patient and was followed with 2 benadryl 25mg after the patient began to fell hot and increased itchiness. EMS arrived shortly, blood pressure was taken, and patient denied transport to emergency room. EMS recommended self transport if needed.
Approximately 8hrs after receiving vaccine I developed itchy eyes, hives around my eyes, itchy throat. I took 2 benadryl capsules. The symptoms resolved in approximately 2 hours. I woke up the next day with some itching and 2 hives on my abdomen (approximately 21 hrs after injection). Nothing was taken and symptoms resolved on their own.
This spontaneous report was received from a physician refers to a 59 week old male patient. The patient was possibly allergic to nuts. On 19-JAN-2015 the patient was vaccinated with VARIVAX (Merck) (lot # K010438, expiration date: 22-JUL-2016), 0.5 ml, subcutaneous. Concomitant medications were not reported. On 29-JAN-2015, the patient experienced rash papular as he developed a papular rash on his trunk and legs. The patient sought medical attention and his parents called the physician's office. The reporting physician reported that she will be seeing the patient in her office later on the same day regarding the rash. No treatment was given for the adverse event. No product quality complaint (PQC) was reported. Outcome of the event, rash papular was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Pt received vaccine on 10/25/21. Went to hosp on 10/26; c/o painful arm/ couldn/t move/ thought arm was out of socket. Was sent home from hosp, told to take APAP. Pt reported being fine next day.
PATIENT STATED RASH STARTED 2 DAYS AFTER DOSE. RASH MIMICKED TRUE SHINGLES
Parents noticed discomfort, fever upon pts return home from school Afternoon of vaccination pt experienced hives and lethargy.  Talked to MD on Saturday, ans was advised continued treatment of symptons with tylenol.
Nauseous; I got a really strong headache; Really intense headache right no/ headache was on her left side of her head; something weird going on with right eye/ very blurry for like 3 minutes/ really blurred up/ blurriness was the right corner of her right eye; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Saturday 19Dec2020, the patient had something weird going on with her right eye. It was very blurry for like 3 minutes, she kind of let it go. But she got a headache afterwards on 19Dec2020. And it happened again at night, same night around 10 o' clock. Not on 20Dec2020, but 21Dec2020, she just got it really blurred up again and she got a really strong headache. But the headache was on her left side of her head whereas the blurriness was the right corner of her right eye. And she just came on very hard headache and she was just very nauseous on an unspecified date. The patient just was in a really intense, she didn't know why she was having such trouble. She just had a little trouble. The patient just wanted to know if this was something normal to get a bad headache like this. The headache outcome was not recovered, of the other evens was unknown.  The information on the batch number has been requested.
MODERNA COVID VACCINE #3 GIVEN 11/12/21, LOT #065F21A; 1/25/22 pt to ED from Rehab for acute on chronic AMS, Nausea, vomiting, diarrhea, RUQ abdominal pain; admitted; 1/26/22 pt had a positive COVID test; not hypoxic; acute on chronic pancreatitis;  suffers from depression in the nursing home; dehydrated; pt did not make improvements while in the hospital; DNR; transitioned to comfort measures; passed away in the hospital
Administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was reported that vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
? 0940-Child vaccinated with 1st dose Pediatric Pfizer COVID 19 Vaccine(6 months-4years) in right vastus lateralis by RN. Child extremely agitated before and during vaccination.   ? 1000-Dad noticed rash on thighs and SO notified by OBS staff.  ?  Non-raised rash noted by SO on bilateral thighs and anterior/posterior trunk.  ?  No swelling of lips, no hives, color pink, child in NAD, bilateral BS nl, no wheezing, moving air bilaterally without difficulty, awake and alert. "Acting normal" per dad.  ?  Dad declined EMS activation. SO requested dad to stay additional OBS time for total of 30 minutes and to notify OBS staff of any change in child's condition.    ? 1015-Dad ready to leave OBS.   ? SO assessment at this time: rash-no change.   ? Child in NAD, color nl, no swelling noted, no hives, bilateral BS nl, no wheezing, moving air bilaterally without difficulty.   ?  Instructed father in s/s anaphylactic rxn and potential latent rxn, contact 911 if s/s respiratory distress/swelling of lips/tongue, contact PCP with any other concerns post-vaccination. Dad verbalized understanding of all instructions and says he would like to continue to monitor child at home at this time.   ? Child awake and alert, carried by dad from vaccination clinic @1020.
I have had numbness/tingling in both of my legs and R arm since the vaccination. The symptoms started the next day and has lasted for 3 weeks now.
menactra was given subcutaneously in the right upper arm to a patient instead of intramuscularly, no reported adverse event; Initial information was received on 12-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who experienced menactra was given subcutaneously in the right upper arm to a patient instead of intramuscularly, no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 07-Jul-2022, the patient received 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7299AB) (formulation, strength and expiry date: unknown) via subcutaneous route in the right upper arm for routine prophylactic vaccination.    On 07-JUL-2022 the patient developed a non-serious menactra was given subcutaneously in the right upper arm to a patient instead of intramuscularly, no reported adverse event (incorrect route of product administration) (Latency same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event menactra was given subcutaneously in the right upper arm to a patient instead of intramuscularly, no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The patient was a family member of a staff member who came in with his mom and dad.. the three of them received Janssen. After they were vaccinated the staff member realized the patient was 17 and not 18.
Pt reports left arm swelling, pain, tenderness, red streaks, fever. Placed on Amox, Augmentin.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, single (Lot number: EP7534) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: LOSARTAN taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: BNT162b2 (Dose: 1, Site of administration: Consumer stated, "Left arms."), administration date: 06Mar2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "I have a very high fever temperature after each one", "Chills", "Achy all over for approximately 24 hours on each of those". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Achy all over for approximately 24 hours on each of those"; CHILLS (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I have a very high fever temperature after each one". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, pain. Additional Information: Therapeutic measures was with Tylenol 100 milligram. No Follow-up attempts are possible No further information is expected.
pt recv vax & later that noc pt started getting flu sx;arm stayed sore for 2wk;flu sx went away next day;
Immmediatly post vaccination at 1824 patient reported feeling lightheadedness and faint. Team proceed to lay patient down on the floor and legs elevated. Set of VS were iniciated.
6NOV92 3PM trouble swallowing, very cold, shaking; 4PM MD gave DPH @ clinic; 9NOV92 pt recovered;
Patient received Booster Dose of 0.3ml Pfizer vaccine, she currently does not qualify under the EUA as her age is 17. Notified parents, patient, and physician.
Swollen lips, itchy throat and ear canals; inspiratory wheezing per auscultation (pt not aware) bloodshot eyes. ER 50 mg Prednisone PO; BENADRYL 50 PO in ER x 3 days
Bowels closed  I've to take lizzness daily to have a bowel movement.  Stomach cramps and several pain  Got to take Aleve or Tylenol daily
Flu vaccine 0.5 ml given to 20 month old. Discovered during vaccine audit. State Epidemiologist notified. No ill effects.
Pt c/o feeling light-headed... stated that he didn't eat breakfast today. Pt admin OJ & monitored for an additional 15 mins. BP-130/70, P-86, R-24, O2 Sat-96, @ 11:35a... Pt feeling better, advised to call PCP is anything changes. Pt left in stable condition. BP-128/70, P-78, R-16, O2 Sat 98, @ 1150a...
No adverse reactions reports. In November 2022 our Immunization program did our every-other-year audits in Both our offices. It was discovered at that time, that some covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the state.)
This spontaneous report was received from a consumer via social media, referring to an adolescent male patient of unknown age.  Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On an unknown date, the patient was vaccinated with a dose of vaccinated with a dose of an unidentified hpv vaccine (name and lot number not provided) for prophylaxis. The reporter stated that "the drug it's bad and it's paralyzed a teen boy". Upon internal review, the event "Paralysis" was considered to be medically significant. This is one of several reports received from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004850: US-009507513-1701USA005334.
Pain in right shoulder in October, then pain and progressive weakness in left shoulder in February, diagnosed with Parsons-Turner Syndrome in March.
Approximately 4 to 5 hours later, patient developed pain in joints throughout body; upper arm where vaccines were administered was red, warm (looked like blotchy rash).