chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 41 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER3612), in left arm, on 09Apr2021 as dose 2, single (Lot number: EC00162), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: 33025BD), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies:Banana, avocado" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (23Dec2022) Negative, notes: felt great and tested negative. Therapeutic measures, Paxlovid from 17Dec2022 to 21Dec2022, were taken as a result of drug ineffective, covid-19.
Numbness and paresthesia R side of neck into R side of face.  Facial drooping R side of mouth at the corner.   10/23/09 Neurology records received service date 10/21/09. Assessment: Right facial parethesias of undetermined cause. R/O Bell's Palsy? Patient reports intermittant pain and numbness proximal right arm. Facial numbness and feeling of fullness in right face. Unremarkable neurological exam.   10/23/09 Neurology records received service date 10/21/09. Assessment: Right facial parethesias of undetermined cause. R/O Bell's Palsy? Patient reports intermittant pain and numbness proximal right arm. Facial numbness and feeling of fullness in right face. Unremarkable neurological exam. /ksk
Reddish Rash on the Vaccine Site 3" Round; Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days; Diarrhea; Fatigue; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE ERYTHEMA (Reddish Rash on the Vaccine Site 3" Round) and VACCINATION SITE RASH (Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) and VITAMINS NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore Injection Site). On 18-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Reddish Rash on the Vaccine Site 3" Round) and VACCINATION SITE RASH (Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days). The patient was treated with ALLERGY MEDICATION (oral) for Vaccination site rash, at a dose of 2 allergy pills for 2 days. On 10-Mar-2021, DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore Injection Site) had resolved. On 23-Mar-2021, VACCINATION SITE RASH (Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Reddish Rash on the Vaccine Site 3" Round) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-066596 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Added patient demographics (Date of Birth, Medical history), second dose of the drug, concomitant medications. Updated the outcome of the event (Vaccination site rash) from unknown to recovered. On 07-May-2021: Follow up received on 07-MAY-2021 and does not contain any new information for first dose.
Menstrual cycle began heavily 2 days after receiving my second vaccine. It was not due to come for another 2 weeks, and I am never this early; Menstrual cycle began heavily 2 days after receiving my second vaccine; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 16:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, premenstrual dysphoric disorder (PMDD) and allergy to penicillin. Concomitant medications included citalopram hydrobromide (CELEXA) from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 04:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. 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. On 17Apr2021, 2 days after the second vaccination, the patient's menstrual cycle began heavily. It was not due to come for another 2 weeks and reported that the patient's menstruation is never this early. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual cycle began heavily and it was not due to come for another 2 weeks and is never this early was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
left hand turned red and felt swollen, pt also cleared throat a couple of times but denied any SOB.
Went home ate supper.  Had nausea and vomiting. (during the night)  Started feeling "shakey and dizzy." Donor still feels shaky.  States she took her own temp. evening of 3/13/13-101.6. Donor now hydrating with 5th bottle of H2O, with no vomiting.
Felt unsteady to walk, headache, had trouble staying awake most of day - took acetaminophen and slept - ok after about 32 hours except for headache which came back the next day
Student in class for 30 mins. Had seizure in classroom. After vaccine received became aware of recent history of prior seizures.
"Pt w/ no significant PMH. Pt was vaccinated at pharmacy @ 15:05.  Pt presented to the ED for evaluation of sudden shivering @16:50.  Patient also reports of chest pain.  He denies any fever, vomiting, shortness of breath, difficulty breathing, or abdominal pain.  Benign past medical history.  Patient is seen shivering upon arrival to the emergency department.  He is immediately roomed for further evaluation.   Physical Exam significant for a patient in acute distress.  He is diaphoretic and is noted to have a skin rash.  All other observations are WNL. Labs: Hemogram w/ diff, Panel 7, Calcium, LFTs all WNL Troponin negative x1 ECG without signs of SVTs, A. fib, or ventricular dysrhythmia.  Chest x-ray unremarkable. Pt was discharged home w/ diagnosis of allergic rxn to COVID vaccine and Atypical chest pain. Discharge medications include diphenhydramine25mg PO Q6hrs PRN itching and famotidine 40mg PO QHS PRN heartburn.  Pt was advised not to get 2nd dose.  8/28 pt presented to ED with chills and itchiness on the torso.  Pt states that he feels nervous and that the exact same thing happened after receiving the first Pfizer vaccine.  Patient denies any rashes, shortness of breath or tongue swelling.  No medications prior to arrival. Pt was administered diphenhydramine in case of allergic rxn but was ultimately diagnosed w/ anxiety and discharged home with strict return instructions.  8/29 Pt presents again to the ED.  Pt c/o left sided chest pain/pressure radiating to jaw and shoulder.  Pt denies anxiety. PMD referred to ED for EKG. Labs: Hemogram w/ diff, Panel 7, Calcium, LFTs, Lipase all WNL Troponin negative x1 BNP 38 12 lead EKG Normal Intervals                              Axis Rate:         62                       P:            73 PR:           185                      QRS:          52 QRSD:         92                       T:            58 QT:           382 QTc:          388 Chest X-Ray - No acute cardiopulmonary disease noted. Pt administered ASA 325mg PO x1 Per MD,  Differential diagnosis includes: Acute coronary syndrome, musculoskeletal pain, pneumonia, pneumothorax.  I do not suspect pulmonary embolism due to negative PERC criteria..  I do not suspect aortic dissection as the pain is not ripping/tearing, does not radiate to the back, no history of Marfan syndrome or connective tissue disorder, the patient has equal bilateral upper extremity pulses.  Finally in reference to the possibility of cardiac etiology, the patient is low risk given age/risk factors, and as such the combination of a nonischemic electrocardiogram and negative troponin are reassuring.  Advised patient to follow-up with his primary care physician. Patient given strict ER return precautions to return to ED with any worsening chest pain or shortness of breath in the next 12 to 48 hours."
Pt had MMR II/Varicella, Hib-Hep B on 8/15/06. Had febrile seizure on 9/2/06 with viral pneumonia. Hosp 9/2/06-9/4/06 with rapid improvement, RX'd with Rocephin (have on Amox). Normal exam on 9/8/06. 10/20/06 Received medical records from hospital which reveal patient admitted with fever & seizure activity lasting approx 5 min.  Patient was nonresponsive & while in ER had lateral gaze of right eye.  Temp 101.4 in ER.  Received Pb & Tylenol & symptoms resolved.  Admitted for further eval & observation from 9/2-9/4/-6.  Received IV antibiotics.  No further seizure activity noted & remained afebrile.  Dx: viral pneumonia & prolonged seizure.  D/C home on oral antibiotics./ss
PER PT STARTED GETTING ACHING AND FEVER ON 9/28/2011 AND THEN HAD A RASH ALL OVER THE BODY ON 9/29/11
Tinnitus - moderate in both ears. Did not have the condition beforehand. No treatment currently.
Sterile diluent which was intended for MMR II reconstitution was unavailable; No addtional AE; Reconstituted M-M-R II with 0.4% saline solution instead of corresponding sterile diluent; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 17-Nov-2021, The patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rha (recombinant human albumin) M-M-R II with lot# T018893 and expiration date: 06-FEB-2022 (dose, frequency, route of administration and anatomical location were not provided) for prophylaxis. The physician had reconstituted MMR II with 0.4% saline solution instead of corresponding sterile diluent since the corresponding sterile diluent which was intended for MMR II reconstitution was unavailable at that time. The patient was administered this affected 0.4% saline solution reconstituted measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rha (recombinant human albumin) M-M-R II.  No additional AE nor PQC reported.
Minutes after vaccination patient became syncopal, clinical team was nearby, patient difficult to rouse.  EMS responded.  HR was 36, BP 60/30, patient was responsive but within a few minutes had an additional syncopal episode.   Patient was responsive again, bp was 85/40,  Blood sugar was normal, EMS set up IV line and monitored patient briefly.  HR recovered to 80, and BP e179/50. 12 lead administered, but unclear.  Patient was transported by EMS to Emergency Room for further assessment.
1448- Pt presented to staff, c/o lightheadedness, redness, itching, and heat present to left deltoid, influenza injection site.  Noted 3-4 cm erythema circular area with heat around injection site.  Pt denied SOA, no voice hoarseness or labored breathing noted.  Pt lying on floor upon my arrival into room, AAOX3.   1453- RA O2: 99 %, HR: 82, BP: 150/110  Administered Benadryl 50mg PO, placed ice pack to left deltoid area.   1505- BP: 160/104, RA O2: 99%, HR: 72, Resp: 20, non labored.   1514- RA O2: 99%, HR: 71, BP: 150/100 1520- RA O2: 99%, HR: 71, BP: 140/100 1525- RA O2 99%, HR: 71, BP: 136/100, pt remained AAOX3 during entire episode, resp. non labored, no SOA reported improvement in lightheadedness.  Erythema improved to left deltoid area.  Pt returned to previous duties.
Fever chills body aches headache fatigue fibrile. Heart pain. Face rash
The patient got the Moderna vaccine and it's not fully authorized for his age group, patient mother was contacted and is aware that the vaccine wasn't fully authorized for the patient age group. The patient is feeling fine today and informed us they had minor soreness that lasted for 2 days after the injection
vials were stored in the refrigerator and thawed on same day of administration; Vaccine was expired on 04-Apr-2022 and was administered on 06-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and was administered on 06-Apr-2022) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and was administered on 06-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and was administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's weight was reported as 109.  Concomitant medications were not reported.  The patient had received booster 1. The patient had no known reactions. The vials were thawed on same day of administration. The vials did not undergo any temperature excursions.  Treatment information was not reported.
Enlarged lymph node that has scarred.  Surgery to biopsy if removal is necessary.  Removal unknown at this time.
Given a vaccine expired on 06/30/2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 26-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number XT4Z7, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired Flulaval shot. The reporter consented to follow up.
Breakthrough Case  COVID-19 (Pfizer) 1 74 Years 10 Months 03/02/2021 local Pharmacy  Pfizer EN6202   COVID-19 (Pfizer) 2 74 Years 11 Months 03/23/2021 local Pharmacy  Pfizer EN6204   COVID-19 (Pfizer) 3 75 Years 6 Months 10/05/2021 local Pharmacy  Pfizer FF2588
01/17/22 presents to Birth Center Triage for "Induction of Labor". PMHx of "Abnormal Pap smear of cervix"
Student received a "clean" needle stick while recapping a needle/syringe during vaccine prep. The needle broke the skin. However, the student did request or require medical attention.
About 2 weeks after 2nd dose blisters appeared, pain was unbearable went to Urgent Care diagnosed as shingles. They said "having had alot of cases"
Flublok was given to patient of 17 years old, who is under the age of indication, no AE; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to case 2020SA355552 (Same reporter).  This case involves a 17 years old patient who was vaccinated with 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiration date not reported) and that was under the age of indication, via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).   At the time of reports, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information on the batch number for this case.
High blood pressure, heart palpitations, unending headache, severe and continual joint pain, extreme, ongoing fatigue.
Injection site became red about an inch around,it, warm to the touch and itchy about a week after the injection
injection site is hot to touch, itching, red, and a lump can be felt still on Wednesday after injection on Monday. Monday night had itching and soreness, took Benadryl at home to relieve itching,
Client states, "about 24 hours after my vaccine I felt super sick, my arm hurt really bad, and I had a fever.  I was dizzy and just felt super super sick."  Per client she was unsure of what her fever was as her thermometer wasn't working correctly.
After receiving vaccine client states she is experiencing swelling and warm feeling on the right side of her face.  Vital signs obtained by EMS BP 119/84, HR 70, O2Sat 98%.  Client was offered to be taken to the ER.  Client declined.
I felt really tired after an hour of the shot. I woke up today sweating, but I also felt code. As of today (one day after the second shot) my right arm, shoulder, and armpit ache, my back and legs also ache.
Patient reported that she had not received any COVID vaccines in the past. She  requested a COVID-19 vaccine at the time of  visit on 4/8/21. The Pfizer covid vaccine was administered after patient signed the consent,  however when Database was update, it indicated that the  patient had already completed the 2 dose series of Pfizer covid-19 vaccine. Provider; FNP, MD on site, Manager, and patient  was made aware. Patient was supervised in the clinic for greater than 60 mins. No reaction noted. Education to the staff to follow our normal protocol, which is to check the Database system prior to injection was reiterated and stressed.
9:00pm 12/29/20 Fatigue, chills (rigors), myalgia, fever 101.5, left arm swelling, difficulty moving left arm., unable to work. Continued into 12/30/20  additional  symptom 6:45pm 12/30/20- lips tingling and rapid swelling lips and nasal passages - ER visit diagnosed with angioedema
Mom describes the under the injection site there was a huge hive or a whelt (1 inch). The site was also red.  Mom does not know when the reaction started until later in the evening when the child showed mom his arm.   Mom gave patient Benadryl and monitored the child.  Pt is doing better but arm is not completely clear yet.
Site: Pain at Injection Site-Mild, Systemic: Sore Arm for 1 day as per mom and pt has taken ibuprofen for 24 hours.-Mild, Error: Patient Too Young for Vaccine Administered-, Additional Details: Sore Arm for 1 day as per mom and pt has taken ibuprofen for 24 hours. Pharmacist has requested the immunization team to contact the patients family regarding any further notice. patient has been waiting for the call from pharmacy in order to hear anything in details. The error could have been prevented if laptops were present during the clinic and woking. we could not type a prescription as system was automatically rejecting due to age limit.
COVID arm - hot, red and purple uneven bordered reaction at injection site. 3 inches by 4 inches
8 days after vaccine developed rash on arm at injection site and below on anterior and lateral aspect of arm. It is about 4 inches long and 1 1/2 inches wide.  Very itchy on day of onset.  Itchiness is only mild if keep cortisone cream on it.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 at 17:00 as dose 3 (booster), single (Lot number: FM7553) at the age of 39 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: "Hodgkin's Lymphoma 2017-2018", start date: 2017, stop date: 2018. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (24Sep2022) Positive, notes: Positive COVID test on 24Sep2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Sep2022 to 17Sep2022.  No follow-up attempts are possible. No further information is expected.
Developed orange size swelling at injection site after vaccine dose number two. Site was red but not painful. No fever reported, no lost work or limitation of activities. Swelling began to resolve 9 days post vaccine, now not noticeable.