chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 38 patient's symptoms improved after Moderna vaccine; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine).    Concomitant medications were not reported.  Reporter stated she had been administering the 65+ bivalent dose to her patients who have symptoms of "long-haul COVID" (non-indicated use of vaccine) and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reaction reported. Treatment medications were not reported.  This case contains information for patient 16 out of 42.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Patient 16 out of 42 patients
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
anaphylactic reaction; Information has been received from a physical assistant who was also the patient's mother referring to a 9 months old (also reported as 10 months old) female patient. The patient's pertinent medical history included food allergies (sesame, egg, cow milk, peanuts). She had anaphylactic reaction to food once. The patient's historical vaccines included hepatitis B virus vaccine rHBsAg (yeast) (ENGERIX-B) (reported as "Emgcrix B") and an unknown non-company hepatitis B vaccine (the patient did not have reactions to both doses). The patient did not have concomitant medication.  On 07-DEC-2020 in the evening, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (0.5 ml x 1 dose, intramuscular; lot number and expiration date were not provided; reported as the third dose in series of hepatitis B vaccine; therapy type was not specified) for prevention of hepatitis B at her pediatrician's office.   On the same day at night, the patient went to bed and woke up with hives which progressed into an anaphylactic reaction over a 16-hour time frame. The patient was given an epinephrine hydrochloride (EPIPEN) by the reporter which they had at home due to the patient having multiple allergies. The patient was then taken to the hospital for medical attention and monitored overnight. Other treatment for the event included diphenhydramine hydrochloride (BENADRYL). No lab diagnostics or studies were performed. On 12-DEC-2020 (also reported as after 5 days of rash), the patient was fully recovered. The reporter stated that this was the only hepatitis b vaccine (recombinant)(RECOMBIVAX HB) the patient received. No product quality complaint (PQC) was reported. The vaccine was not available for retrieval as it was disposed of after administration at doctor's office. The causality assessment was not reported.  Upon internal review, anaphylactic reaction was determined to be medically significant. According to the reporter, the event was considered serious because of intervention to prevent serious criteria, significant disability or incapacity, life threatening and hospitalization.
lymph nodes in under arm both sides swollen; Tired for 2 days; swelling left arm where shot given; Knot at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 10:00 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "obese" (unspecified if ongoing); "veinous insufficiency" (unspecified if ongoing); "known allergies: Strawberries, fresh caught fish" (unspecified if ongoing); "known allergies: straw materials" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE]; SINGULAIR. Vaccination history included: Bnt162b2 (Dose 2, Single, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 12Mar2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Single, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 19Feb2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 13Oct2021 13:00, outcome "not recovered", described as "lymph nodes in under arm both sides swollen"; FATIGUE (non-serious) with onset 13Oct2021 13:00, outcome "not recovered", described as "Tired for 2 days"; VACCINATION SITE SWELLING (non-serious) with onset 13Oct2021 13:00, outcome "not recovered", described as "swelling left arm where shot given"; VACCINATION SITE NODULE (non-serious) with onset 13Oct2021 13:00, outcome "not recovered", described as "Knot at injection site". Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, vaccination site swelling, vaccination site nodule.  Additional information: Other medications in two weeks included Claritin, albuterol , steroid inhaler, singular. No other vaccine in four weeks. Patient had no Covid prior vaccination and Covid not tested post vaccination.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Severe pain in both knees, could not walk. Symptoms lessened with cold compresses and Naprosyn, but stayed in bed most of the day.  Chronic knee pain, pain in hands, more so than usual.
Got vaccine around noon on 9/19/18 and by the next morning (9/20/18) her arm and armpit area were very swollen, red, warm, and very itchy. She also reported a slight fever. Today is 1 week later and most symptoms have resolved, but the site is still very itchy.
Shortly after arriving in observation area, patient reported tightness in her throat and hot flashes.  She had a hx of anaphylactic reaction to peanuts.  Patient was observed for 45 to 60 minutes.  Vital signs remained stable 0956 Pulse 98, 0xygen sat 99%, BP 124/82 1004 Pulse 88 O sat 98%, BP 111/82 Benadryl 50mg given orally, tight feeling in throat and chest feeling much better 1013 Pulse 84, O sat 98% BP 104/78 1025 Pulse 76, O at 100% BP 111/83 Patient stated she felt she returned to baseline, with expected drowsiness from benadryl and felt well enough to proceed home.  Patient had her own EpiPen for previously stated allergy and her and her husband confirmed competency in its usage.
Wrong dose of COVID  vaccine administered to patient.  Patient is 3 years old and received a COVID vaccine dose for 5-11 years. No adverse reaction. Nurse immediately informed mother of error. Mother had no concerns.
I was coughing and had chest congestion. I had tested myself several times with home COVID-19 test that came back negative. I made an appointment with my doctor and had a telehealth visit. We discussed my symptoms; she prescribed a Z-PAK and an inhaler to help me to get over what I was going through. After getting the medication it took me four days to get over everything and I am feeling much better.
10 days after vaccination, my left arm was hot and there was a large (grapefruit) sized red ring at the site of the injection. The 'ring' and heat dissipated on day 15.
Adverse reaction to PREVNAR. Patient reported flu-like symptoms and red, swollen, black/blue at site of injection.
Narrative:  Patient reported chest tightness following administration of Janssen covid vaccine. Patient was advised to seek medical care. Unclear whether patient did and if additional intervention was needed.
This spontaneous report was received from a doctor of pharmacy concerning unknown number of patients (age and gender unspecified). On an unknown date in 2012 (reported as from August of 2012 through September 2012) (exact dates unspecified), the patients were vaccinated with a dose of an improperly stored MMR II (lot number, expiry date, dose and route unspecified) at a clinic associated with a hospital. No adverse event was reported. This is one of the three reports from the same source. Additional information has been requested.
At approximately 11:00 PM, 13 hours after receiving the vaccine, I began to feel cold and have chills. I also experienced achiness at this time. This progressively worsened throughout the night, resulting in my struggling to sleep, until about 4:00 am, when I noticed that I did not feel the feverish coldness symptoms as intensely. From this point on however, I experienced a substantial headache, coming and going all morning. Until now (12:45 PM) when I still feel a slight headache.
1/1/21 thru 1/3/21  body chills fever  101-102 temp     1/3/21 @ 4am fainted with temp of 101.5
Rash on arm around injection site that is red, warm to the touch, and slightly swollen. Arm is also sore at sight of rash.
Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021; Patient Received vaccine beyond Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) in a 41-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 23-Feb-2022 at 4:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient  ethnicity was reported as Black or African American. No concomitant medication was reported by reporter. Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. No treatment medication was reported by reporter.
This spontaneous case, initially received from other non-health professional on 27-Oct-2018, concerns a 67-year-old elderly female patient. The patient's current conditions included Crohn's disease, diabetes and kidney cancer (reported as medical history). The concomitant medications included VOTRIENT, ENTYVIO, Cyanocobalamin, FERATE, Flax Seed Oil, Furosemide, Ginger root, Glipizide, Glucosamine, Lisinopril, Melatonin, Metformin HCL, Metoprolol, Nifedipine, Probiotics, Simvastatin, Turmeric, Vitamin D3. On an unspecified date in Oct-2018 (reported as last week), the patient was administered Influenza vaccine (batch number: 8ZP9087 (as reported), dose, route of administration, anatomical location, trade name, manufacturer and expiry date: not reported). On 23-Oct-2018 after vaccination, the patient experienced cold symptoms which lasted for about four days. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: pt complained of lower back pain-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: EMS was called , symptoms seemed to go away after about 20 minutes of injection
started 2 January - shortness of breath getting worse over 3 days - no coughing, wheezing or chest tightness
Patient passed out a few aisles away from the pharmacy and fell to floor. Came back to full alertness quickly, lips lost coloring but regained coloring quickly.
Subsequent to receiving vax, the pt became increasingly lethargic. Three days post vax, the pt experienced a seizure like activity, eyes rolling back, tongue twitching, vomited and fell into a deep sleep and was unable to be awakened.  She was pale, limp and non-responsive. Pt was taken to the ER and still did not wake up for the triage nurse. Her heart rate was quite variable from 120 - 180. She finally did awaken about one hour after becoming non-responsive and was seen by the physician. Pt remained groggy and the following day she experienced another seizure like episode, eyes rolling, unable to focus, and then a deep sleep with rhythmic leg jerking. Pt remained groggy/lethargic until 03/26. Pt went from 15-16 hours of sleep per to day to 20-21 hours of sleep per day. The pt had trouble staying awake for more than a few minutes at a time.
There was a spill and a patient may not have received the full dose; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, there was a spill and a patient may not have received the full dose.  The patient's medical history was not provided. Concomitant product use was not provided.  On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 12 Jan 2021, during vaccine administration, there was a spill and the patient did not received the full dose. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The event, there was a spill and a patient may not have received the full dose, was considered resolved on 12 Jan 2021.; Reporter's Comments: This spontaneous report refers to a case of a patient who experienced a non-serious event of there was a spill and a patient may not have received the full dose (Incomplete dose administered) for mRNA-1273, lot # unknown), Exp date unknown. There were no reported AEs associated with this case of there was a spill and a patient may not have received the full dose.
Began with ringing in the ear, over time developed into severe dizziness and nausea and pressure in the ear and loss of hearing in right ear.   Dizziness was so severe that I could not walk or stand.  After MRI a sinus infection was revealed.  After a month of antibiotics, still dealing with loss of earrings, stuffy ear and dizziness.  I have never experienced this before.
Pt broke out with a fluid-filled rash. He was seen in the office the next afternoon, and the rash was confirmed to be varicella by MD.
During the night the patient woke up with nausea and gagging. Called the on call Pediatric triage nurse who gave her supportive therapy. Called the office in the am and there was no vomiting or any other symptoms. PCP was not sure if this was related to the vaccines but wanted to file a VAERS report just in case.
5 days s/p vax pt was sleeping w/mom; pt presented to the ED in asystole; pt had been sleeping w/mom on couch; pt had blood from both nares in field; possible SIDS (pt expired); investigation ongoing;
Pt received vaccine immediately complained of being "dizzy and hot" became pale and diaphoretic.  Wheeled to recovery cot to lie down,   elevated feet, placed ice pack to back of neck. - LOC - SOB - N/V.   MD evaluated  surmised Vasovagal response to getting vaccine. Pt stated, " I was nervous about getting vaccine"   VS taken  BP 102/72,  HR 80 reg strong, resps 16 regular non-labored,  SpO2 98%.   Husband at side.   After 10 min of lying down with feet elevated,  sat pt up provided water for hydration, pallor, diaphoresis and dizziness subsided. Left deltoid site benign, pt stated "I did OK with 1st vaccine. " Provided reassurance.  Monitored for 30 min for observation  Pt stated "I feel fine" left recovery with husband.   Ok'd to exit  RN
COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4504309-00.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), on 20May2021 as dose 2, single (Batch/Lot number: unknown) and on 03Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 0740020), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was dosage not changed. clinical course: Solicited report by a consumer of an adult male with an event of non-serious covid-19 with Humira (Adalimumab). On an unknown date, the patient experienced covid-19. Pfizer Biontech covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of covid-19 with Humira (Adalimumab) Was a reasonable possibility. Causality: COVID-19 (COVID-19). Causality as per reporter (Drug/Vaccine): Possible.  The reporter considered "covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162b2 cannot be excluded. ,Linked Report(s) : US-PFIZER INC-202201065448 Same Patient, different drug/AE;
I had swelling and redness and severe itching of the injection site.  I did contact my doctor sooner and they prescribed me a steroid.  I took that a few days and it started to clear up.
>10cm inject site rxn characterized by erythema & edema; Temp 101 & vomiting; resolved w/in 48 hrs onset;
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Patient was given MMRV vaccine instead of MMR vaccine. RN spoke with patient about 2 hr following vaccine administration; no adverse events reported; pt stated he felt "fine."
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (details not reported) who was vaccinated with PENTACEL (batch number, expiration date, dose, route and site of administration was not reported) and one of their offices reconstituted the ACTHIB portion of PENTACEL with sterile water, on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was unknown whether the patient had any 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 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. List of documents held by sender: none.
burning pain 20sec p/vax; p/1hr hard, red, swollen & hot area fromed larger than 2nd shot;reddened area increased in size w/ each successive shot;reddened area max size p/3 days 4" x 4";itching cont;
ADMINISTRATION ERROR VAERS.  NO ADVERSE EVEN REPORTED. PATIENT WAS GIVEN AN INCORRECT FULL DOSE MODERNA VACCINE AS A BOOSTER.  PATIENT IS NOT IMMUNOCOMPROMISED.
Headache, Chills, Fever and Faint throughout the night.  Fever reached at least 100.7 degrees. Low grade fever part of next morning.