chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. In October 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, the patient experienced WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine). Concomitant medications were not reported. They were not aware of any adverse event after the vaccines were given. Treatment medications were not reported. This case contains information for the 20th of 26 adult patients described by the reporter.
After 2nd covid vaccine  on 3-6-20-21, next day developed pain at site then developed erythematous rash on wrist and severe arm pain starting at elbow and extending to fingers. On 3-12-21 he developed paresthesia and 2-3rd digit sensitivity and papulopustuar rash overlying thenar eminence . These symptoms have now persisted 11 days and seem to be worsening. Patient denies fever or any systemic symptoms. All symptoms are isolated to shot arm and hand. Patient has remote history of varicella zoster during childhood, but rash itself is not painful and pain although predominantly over median nerve distribution does extend beyond that.
"When I woke up, I felt sick to my stomach, experiencing nausea, sharp pain in my back towards my right shoulder. I felt dizzy, and feeling in my head, detached fatigued, feeling like I kind of had a head cold, but didn't. Dull ache in my head on the (R) side. Strange transient pains in my body. My heart felt like it was racing, and I felt like someone had punched me in my lower stomach".
experiencing diarrhea that is a little bit on the loose side; This is a spontaneous report from a non-contactable consumer (patient herself).  A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 also known as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date not reported), via an unspecified route of administration on 13Jan2021 at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhea that she was a little bit on the loose side on an unspecified date in Jan2021. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
FEVER HIGHEST AT 99.8 VIA EXERGEN, ACHE ALL OVER BODY,  IN BED FOR 11 STRAIGHT HOURS,  SEVERE SHOULDER PAIN
expiration date of the box was different than the vials inside. Based on the expiration date on the box, it was not expired at the time, however the vials did.; expiration date of the box was different than the vials inside. Based on the expiration date on the box, it was not expired at the time, however the vials did.; received an expired dose / expired on Nov 30, 2020; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 54-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA207A, expiry date 30th November 2020) for prophylaxis. This case was associated with a product complaint.   On 18th June 2021, the patient received Menveo. On 18th June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the patient experienced product packaging confusion and product expiration date issue. On an unknown date, the outcome of the expired vaccine used, product packaging confusion and product expiration date issue were unknown.  Additional details were provided as follows: The patient received expired dose of Menveo which expired on 30th November 2020 which led to expired vaccine used.  Healthcare professional mentioned that, the expiration date of the box was different than the vials inside which led to product packaging confusion.  Based on the expiration date on the box, it was not expired at the time, however the vials did which led to product expiration date issue. The reporter consented to follow up.  This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152086:Same reporter US-GLAXOSMITHKLINE-US2021152084:Same reporter
Patient came into the pharmacy and recieved VARIVAX around 415-430p. According the patient, she went home and developed a purple and red rash about 7 hours later around 11pm. At that time she took a benedryl and the rash went away. However, the next day she developed a very painful, red rash around the injection site. She is still experiencing dizziness. It was recommended for her to go to the doctor after the patient called the pharmacy.
Sore throat; This is a spontaneous report from a contactable consumer. A 25-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Jun2021 as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a bad sore throat in morning on 15Jun2021. It was asked if it was common effect of the vaccine. Treatment was not received for adverse event. The outcome of the event was unknown.  Follow-up attempts are needed. Information about lot/batch number has been requested.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt sycope most likely due to fear of needles. ems called and evaluated pt. pt declined visit to hospital. pt released after ems eval.
02/25/21:  Slightly accelerated heart rate; sore arm, tender nodule above left clavicle. 12/26/21: severe chills, heart face and head, stiff neck, general weakness, sore arm.  Severe symptoms lasted approximately four hours but continue to a lesser degree for several more hours. Throughout the day, weakness, feeling cold, sore arm and nodule is still there and still tender.
red rash on the face; Weakness after first shot; Chills after first shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (red rash on the face), ASTHENIA (Weakness after first shot) and CHILLS (Chills after first shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Cholesterol (Generic Lipitor for cholesterol) and Seasonal allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (Weakness after first shot) and CHILLS (Chills after first shot). On 22-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash on the face). The patient was treated with DOXYCYCLINE for Red rash, at a dose of 100 milligram twice a day. On 10-Mar-2021, ASTHENIA (Weakness after first shot) and CHILLS (Chills after first shot) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash on the face) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was also taking Generic Lipitor as concomitant medication for cholesterol. Patient's dermatologists had given an unspecified steroid shot for red rash.  For allergies, the doctor did not do a biopsy.  Patient took 2nd vaccine on 05-Apr-2021 in left arm and Batch number - 013B21A and Booster dose on 03-Dec-2021 in left arm, Batch number - 0031A21A.   This case was linked to MOD-2022-482209, MOD-2022-482235 (Patient Link).
Headache, Fever, Diarrhea, fatigue Headache, diarrhea, fatigued-slept for 3 days, fever 100.1; tylenol; resolved 2/2/21.
Red, swollen, hot circle raised around injection site - 2 in diameter painful to touch.
"Really bad diarrhea ever since she had the flu shot today." Mom reports patient is not eating, difficulty drinking, appears to have "a little trouble breathing." Per mom, these are all changes since being seen in office today at 1315. Mom advised if patient is experiencing any change in respiratory status she should be taken to ER immediately.
Multidisciplinary Note  Hem/Onc. Pt. in today for sick visit, c/o fevers.  Pt. arrived to clinic with fever of 38.3.  Pt had labs including blood cultures sent.  Received pt into the infusion center with fever 38.4.  Pt. received 400ml NS bolus IVx1 over 80 minutes without event.  Pt. received Zofran IVx1 as ordered over 20 minutes.  Pt. 'perked up' after receiving NS bolus.  Spoke with Dr. and as per the conversation, pt. ok for discharge to home.  PAC flushed with NS and Heparin 100unit/ml and deaccessed without complication.  Pt. left in care of mom and dad in stable condition.
pt became pale w/circumoral cyanosis, limp;rr dec 16-14, HR 128 few min p/vax;extremities cold & paler occasional cough
Patient had seizure and fell flat on her back, stiffly.  Arms and legs shook (not violently); eyes stayed open and did not roll back.  Patient reports seeing everything go blurry and does not remember what happened.  At the time, she was also experiencing either a bad cold or mild virus with slight fever.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "Moderate to severe asthma" (unspecified if ongoing); "significant small nerve fiber damage" (unspecified if ongoing), notes: significant small nerve fiber damage; "Dysautonomia" (unspecified if ongoing); "Executive dysfunction" (unspecified if ongoing); "Eosinophilic esophagitis" (unspecified if ongoing); "PTSD" (unspecified if ongoing). Concomitant medication(s) included: PROZAC, start date: 01Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test rebound 7 days after last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment included Paxlovid (Treatment start date: 01Sep2022, Treatment stop date: 06Sep2022). Adverse event included symptoms and positive test rebound 7 days after last dose of 5 days course of Paxlovid and the patient had long Covid that led to disability and PTSD and this rebound was traumatic (adverse start date: 12Sep2022 15:00 PM).  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if  and when received.
Information has been received from a medical assistant concerning a 32 month old white male pt with no medical history who on 10/09/01 was vaccinated in the left upper arm with a first dose of varicella virus vaccine live (Lot # 638242/0563L) (Lot #  for diluent: 640357/0832L). There was no illness at the time of vaccination.  On 05/16/03 (previously reported as 05/14/03) the pt developed a "chickenpox outbreak" described as "small, red, vesicular bumps on entire body". There was no relevant diagnostic lab data completed. Subsequently the pt recovered in June 2003.  No further information is expected.
On 3/24/00, the pt received the first Lymerix vax by mistake. The physician asked for a blood draw to test for Lyme antibody, instead Lymerix was given. At the time of the event, the pt was pregnant approximately 8 months with an estimated delivery date of April 2000.
Client received 2nd Moderna COVID vaccine (lot # 026B21A and expiration date 4/29/21) at 9:37AM. Nurse administered vaccine and after she walked client over to observation station and gave report to EMTs. PHN  asked RN  after she returned why client was walked over and RN informed lead of history of reaction to first moderna. PHN went to observation room, EMT had taken baseline vitals when she arrived at 942: blood pressure 126/82, pulse 84, oxygen 94%. PHN spoke with client who stated at this time feeling well. Per client first dose was given at location, client stated headache , throat itchiness, metal taste, flushing, blurry vision, and high blood pressure. That time she was given Benadryl and stayed 2hrs post vaccine for monitoring. Per client had spoken with primary doctor who recommended she still receive second dose. EMTs stayed with client. At 1002 client informed EMTs of flushed feeling and metallic taste. PHN informed and joined EMTs. Vitals: blood pressure 116/70, pulse 85, oxygen 97%. Client stated same symptoms as last time returning. Alert and oriented. Client denied shortness of breath. Face and hands flushed. PHN offered client Benadryl and client accepted, wanted PO only. Benadryl 50mg given PO. Client's sister was present, client was not driving. Allergies to Vit B. Medical history of hypertension, client did not take medication this morning. Vitals 1016: blood pressure 124/88, pulse 92, oxygen 98%. Client stated headache to frontal are, metallic taste, flushing in face and hands. 1021 vitals: blood pressure: 120/78, pulse 85, oxygen 98%. Client stated symptoms improving. Face flushing improving. Client alert and oriented. At 1026 client stated feeling hands were swelling, specifically right index finger. Client able to move hands, denied pain or tingling. Vitals: blood pressure: 116/78, pulse 85, oxygen 98%. At 1030 client wanted to use restroom, sister and EMT accompanied client. Client walked with steady gait there are back. After sitting down client stated feeling dizzy again. Vitals 1034: blood pressure: 126/82, pulse 80, oxygen 97%. No headache, no metallic taste, right index finger swollen and palms flushed. Client stated feeling tired. 1039 vitals: blood pressure: 120/80, pulse 79, oxygen 98%. 1044 vitals: blood pressure 122/80, pulse 81, oxygen 98%. Symptoms improved, swelling of right had same. Vitals 1053: blood pressure 124/82, pulse 82, oxygen 98%. Vitals 1109: blood pressure 126/100, pulse 85, oxygen 97%. Alert and oriented, per client feeling better. No headache, metallic taste, shortness of breath, headache, or flushed face. Swelling improved. Per client blood pressure higher since she did not take blood pressure medication this morning. Denied chest pain, blurry vision, or dizziness. 1114 vitals: blood pressure 118/90, pulse 84, oxygen 99%. Client stated all symptoms had resolved. ER precautions given to client. Last vitals at 1130: blood pressure 136/94, pulse 84, oxygen 98%. Client aware blood pressure diastolic high, still wanted to leave. Able to stand from chair with no dizziness. Client left facility with steady gait at 1131.
swelling and itching at site of injection, fever 101.6, body aches; tylenol x 3 (500mg); resolved in 24 hours
Within 2 weeks after each of her three vaccinations for hep B, she had a GI episode similar to diverticulitis or colitis.  None of the episodes have received a definitive diagnosis.  She has given a stool sample, which showed nothing except a lack of GI flora.  She has been referred to Dr. for a colonoscopy, not yet scheduled.  She has no history of this type of incident prior to these three--all of which developed 2 weeks after receiving the hep B vaccine.
In November 2022, I missed my menstrual cycle. The premenstrual symptoms I normally get appeared that month, but the period never came. I experienced premenstrual symptoms for three months, during which I never had a period. I went to my gynecologist on 1/31/2023. She did lab work. The results did not indicate any abnormalities, but we agreed that if I did not get my period within the following two weeks, she would prescribe me progesterone to induce a period. In February 2023, I finally got my period, and progesterone use was unnecessary. During the time of my premenstrual symptoms, I experienced hyperactive bowels, which led me to follow up with a gastroenterologist, with whom I had a telehealth consult. The gastroenterologist took stool samples and did lab tests, and the results were mostly normal, except the calprotectin fecal test indicated elevated inflammation. I am currently waiting to undergo a colonoscopy next month. Although I got my period in February, my menstrual cycles are still irregular. I had another period in March 2023, but I have not had another since then.
A non-serious spontaneous report of felt kind of crummy has been received from a non health professional concerning a 15-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. The patient received FLUMIST on 02-Sep-2011. On 02-Sep-2011, the patient felt kind of crummy. The outcome of the event was not resolved.
temperature excursion "over the weekend" with no adverse event; 1 dose of FLUZONE QUAD was administered with no adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA374787, 2022SA375305, 2022SA377972, 2022SA377654, 2022SA378232, 2022SA377654, 2022SA376599 and 2022SA378232.  This case involves an unknown age and unknown gender patient where temperature excursion "over the weekend" with no adverse event and 1 dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 07-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at an unknown dose (lot UJ882AE, expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunisation.  On an unknown date there was temperature excursion "over the weekend" with no adverse event (product storage error) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On 07-Sep-2022, 1 dose of fluzone quad was administered with no adverse event (poor quality product administered) same day latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported that the refrigerator reached the lowest temperature of 31.3 degrees F for 1 and a half hours before returning to recommended storage conditions. The pharmacist reported that he had called yesterday to obtain stability information and was calling back to gather additional stability information. Alternate temperatures were initially reported therefore the pharmacist confirmed the following temperature readings with the system for verification: MAXIMUM TEMP REACHED: 46.4 degrees F/ 8 degrees C MINIMUM TEMP REACHED: 31.3 degrees F / Below 0 degrees C MAXIMUM TIME PERIOD EXPOSED: 1 hour and 30.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01May2021 as dose 2, single (Batch/Lot number: unknown) and on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2022, outcome "not recovered" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2022) positive, notes: still positive per home antigen test today 29Oct2022; (17Oct2022) positive, notes: Patient diagnosed with Covid 19 on 17Oct2022; (27Oct2022) positive, notes: She tested positive for covid on 27Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient was diagnosed with Covid 19 on 17Oct2022, took paxlovid standard dosing 18Oct2022 through 23Oct2022 and felt recovered. Then on 27Oct2022 developed covid symptoms with significant congestion, symptoms more significant than initial illness episode per pt. She tested positive for covid on 27Oct2022 and is still positive per home antigen test today 29Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event tested positive for covid cannot be excluded based on temporal association and available information.
5x5 for one day. Right arm red, swollen, warm, painful; rates pain at "7", couldn't sleep because of pain, positive itchy. Instructed patient to apply ice; patient given Clarinex.
Bright red maculo papular rash to face, neck, arms, chest, abdomen, back and groin blanching and non vesicular. Not itchy, afebrile, No V, No D. Posterior pharynx redness, tonsils grade 2+. (10 days after MMR)
Moderna COVID-19 Vaccine EUA.  After about 4 days from my second COVID shot, my left leg begin to feel uncomfortable when walking.  I try and walk 3 miles every day, but began to notice left leg discomfort and slight pain from my hip to my ankle when walking.  Do not notice this discomfort when sleeping or if my leg is propped up.  Feet are both fine and my right leg is fine, no pain.   Also notice that it is harder and slower getting out of bed in the morning and I get drowsy earlier at night than I used to.  By 9 PM I feel like I want to go to bed.
Patient accidentally given Pfizer dose 2 in covid vaccine series instead of Moderna which is what he should have gotten. MD has provided guidance on potential sx to look for and when to report to PCP or ED.
swelling, redness, to left arm. This reaction happen status post one day after vaccine. Also, prior to vaccine  mother applied ice pack to left arm and broke and leaked out onto the  left arm.