chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Pfizer / BioNTech May2022/ Moderna Bivalent Sep2022; Pfizer / BioNTech May2022/ Moderna Bivalent Sep2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), OFF LABEL USE (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech May2022/ Moderna Bivalent Sep2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Extreme sore throat and eventual sores/ulcers in back/top of throat. (May be Paxlovid, may be covid) Night sweats. (May be Paxlovid, may be covid) No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
got flu within hours of shot both times; Initial information was received on 27-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer (Patient).  This case involves patient of unknown demographics who got flu within hours of shot both times (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu both times (influenza) (within hours) following the administration of INFLUENZA VACCINE.  It was reported that, patient take flu shot twice.   Details of laboratory data not reported.      It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Diarrhea, NauseaVomiting, reported runny & itchy nose lasting approximately 4 hours post-immunization Narrative:
Sore throat, fever, severe headache, severe stomach cramps, bloating, rash
Patient did not have vaccine card. Patient states COVID shot approximately 2 weeks prior, Flu shot approximate 4 weeks prior, cold prior to flu shot. Shingles shot prior to flu shot.   For past 2 weeks patient had weakness to legs to point could no longer walk without help today. Decreased tendon reflexes on exam. CT head, Thoracic spine, lumbar spine negative. Labs only with slightly low sodium. Lumbar puncture unremarkable other than markedly elevated protein. Concern for Guillian Barre Syndrome. Transferred for Neurology.
Patient received ZOSTAVAX vaccine in (L) SQ arm on 6.9.10 at approx 6:30pm. Injection site rash, itch, redness and swelling manifested on Friday AM 06.11.10. Patient says it has not worsened but warm to touch.
Sore arm, fever started on the day of vaccine 1/19/2021,body aches started on the day of vaccine  until today 02/25/2021, joint ache started at the time of vaccine up to now 02/25/2021, lingering fever 99.9 to 100 mostly at night .lingering headache, fatigue easily, short of breath on exertion started 2/02/2021 until now.
Systemic: Patient fainted while she was seated waiting for 15 minutes-Mild.
Blood Clot in Leg; A spontaneous report was received from consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in leg.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included blood thinners for blood clot.   On 21-Jan-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route on left upper arm for prophylaxis of COVID-19 infection.  On 18-Feb-2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013M20A) through intramuscular route at right upper arm for prophylaxis of COVID-19 infection.  On 23-Jan-2021, after the first dose patient developed leg pain. The patient reported of having the leg pain linger for about 2 weeks before seeing a healthcare professional. The healthcare professional had later found that the leg pain was related to the development of a blood clot.   Relevant Treatment  for the event was with blood thinner.   The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of event, blood clot in leg was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Tylenol given after shots. Woke up this am with Temp of 103 degrees. Arms and legs warm and sore
body aches, fever, sweating, shaking, chest pressure, anxiety, shortness of breath, muscle pain
Shortly after immunizations, began sneezing and then complaining of abdominal pain. Then he began vomiting for about 45 minutes. Vomiting up thick clear phlegm. Also, developed a rash mainly over knees, elbows, stomach, hands, ears, chest, and on thighs where given injections. Became lethargic and non-responsive to voice. Admitted to PICU; given 30mg Solumedrol and a IVS bolus of 300ml.
Starting on the late afternoon after injection, I started to get light flu like symptoms (warmish, aches, tiredness).  Had lack of appetite.   Overnight the symptoms got worse quickly and lasted over 36 hour period.  Restlessness at night from feverish, aches and pains, headache, ear pain, sinus pain... just like a server sinus infection, but with only minor nasal congestion.  Neckache.  Cough.  Sever tiredness and lightheadedness.  Second night I got out bed at night I took my mouth piece out I have for sleep apnea because my teeth were unusually uncomfortable and in pain.  Conditions got better thru the day on Sunday, but still had lightheadedness.  Have been able to eat a little.   Had an onset of great discomfort and swelling under armpits making Sunday-to-Monday sleep uncomfortable.  And also periodic headaches.    Monday morning the armpit discomfort was much better, but still lightheaded.  As day progressed the armpit discomfort got a little worse, but not as bad as the night before.  Ears bothering me again a little.  I had the same manufacture and does amounts for shot #1 and #2 previously with feverish results, but not as bad as this.  This time felt like being run through the meatgrinder and being tortured.  Treatment:  took severe cold/flu meds and liquids
WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; Coat hanger neck/ shoulder pain; Coat hanger neck/ shoulder pain; flushed; felt uncomfortable; couldn't sit still; feeling clammy; saw spots; BP dropped to 60s/30s; felt like throat was closing; couldn't breathe well; hands were numb; lips were white/ blue; This is a spontaneous report from a contactable nurse (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via an unspecified route of administration in right arm on 07Jan2021 13:30 at first single dose for COVID-19 immunization. Medical history included asthma, fibromyalgia, idiopathic hypersomnia, seasonal allergies (dust, ragweed, pollen, dander), covid-19. Concomitant medication in two weeks included duloxetine hydrochloride (CYMBALTA), modafinil, montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D). No other vaccine in four weeks. 1-2 min after shot the patient became flushed and felt uncomfortable/ couldn't sit still, began feeling clammy, saw spots, BP dropped to 60s/30s, all other vitals stable, felt like throat was closing and couldn't breathe well, hands were numb, lips were white/ blue. No itching or hives. Resolved with trendelenburg and rest, fluids given in ED. WBCs and neutrophils and platelets elevated 3 hours later. Coat hanger neck/ shoulder pain for the next few days. Adverse event start date was 07Jan2021 01:30. Event resulted in emergency room/department or urgent care. Covid was not tested post vaccination. Outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Within 5 minutes of receiving the vaccine, patient stared to feel warm, and clammy. He was assessed by EMS in the Observation Areas. He was assessed by EMS. He did have low BP. Initial was 114/77, and lowest was 58/38. No dizziness or loss of consciousness.
Breakthrough case admission after three vaccines Moderna 3/17/21 Lot# 040A21A;  Moderna 4/14/21 Lot# 037A21B;  Moderna 7/18/22 Lot# 014B22A;
Swelling around neck; Body aches; Swelling at injection site; Severe headache; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling around neck), PAIN (Body aches), VACCINATION SITE SWELLING (Swelling at injection site), HEADACHE (Severe headache) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020 and Migraine (Reported as cluster migraine  headaches..). Concurrent medical conditions included Drug allergy (Allergic to codeine.), Drug allergy (Allergic to sulfa drugs.), Allergy to nuts, Fruit allergy and Drug allergy (Patient Is allergic to any pain medicine.). Concomitant products included VERAPAMIL HYDROCHLORIDE (CALAN [VERAPAMIL HYDROCHLORIDE]) and ALPRAZOLAM (XANAX) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Body aches), VACCINATION SITE SWELLING (Swelling at injection site), HEADACHE (Severe headache), PYREXIA (Fever) and NAUSEA (Nausea). On 15-Mar-2021, the patient experienced SWELLING (Swelling around neck). At the time of the report, SWELLING (Swelling around neck) outcome was unknown and PAIN (Body aches), VACCINATION SITE SWELLING (Swelling at injection site), HEADACHE (Severe headache), PYREXIA (Fever) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, COVID-19: postive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Treatment medication includes steroid injection.
Sore throat, fever, headaches, fatigue about two weeks after getting the second COVID-19 shot.
mild hallucinations; nauseated; extremely fatigued; eyes heavy with a slight burning sensation; eyes heavy with a slight burning sensation; in a head fog state; mild headache; sick; chills; nose run; sneezing; that were so cold it; This is a spontaneous report from a contactable consumer(patient). A 31-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0176), via an unspecified route of administration at Arm Left on 06-MAY-2021 12:45 at the 31 years old at single dose for COVID-19 immunization.  The medical history was not reported. The concomitant medication was ethinylestradiol, ferrous fumarate, norethisterone acetate(JUNEL FE)  The patient previously took steroids and experienced known allergies Tendency. After the initial dose, the patient began to feel nauseated on 06May2021 14:00. The patient waited for the 15min period on site and then proceeded home. By time the patient arrived home, the patient was extremely fatigued and her eyes heavy with a slight burning sensation on 06May2021 14:00. The patient spoke to her mom briefly and she recalls that the patient told her that she got the vaccine. She also stated that the patient rambled off some strange vaccine name and statics on it which the patient have no memory of. During this time the patient had mild hallucinations on 06May2021 14:00. The patient saw her walk by and asked her where she went and she had never moved from her chair. The patient went to her room to rest/sleep immediately after where the patient remember hearing someone come in and lay down but there was no one. The patient also vividly remember waking up and checking the time which was incorrect as well.  The patient was in a head fog state on 06May2021 14:00. The patient had a mild headache on 06May2021 14:00. Later that night the patient ate some food and was sick after.  While going to bed, the patient had chills that were so cold it made my nose run and the patient was sneezing excessively on 06May2021 14:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for all of events. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Dizziness; This non-serious case was reported by a physician via sales rep and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness). The outcome of the dizziness was not reported.   It was unknown if the reporter considered the dizziness to be related to Shingrix.     It was unknown if the company considered the dizziness to be related to Shingrix.   Additional Information: GSK receipt date: 12-JUL-2023 It was reported that patient experienced dizziness especially when standing up after receiving 1st dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
A nurse reported that a female patient received an injection of Flu Shield (2001-2002 formula) from a syringe that had been stored at a temperature higher than recommended. Subsequently, the patient developed a "large" amount of bleeding at the injection site.
Lt thigh all red & swollen up, hard as rock, size of stone-very fussy-sl warm, area of hardness approx 1in x 1in not sore to touch today, has been very sore last 2 days;
Presented via EMS w/ worsening SOB X2 wks, generalized body aches, rt. hip pain (prev. fx 1/6) and hypoxia. Tx for Covid+ pneumonia, PE, pleural effusion. Decadron, O2, expired d/t acute hypoxic resp. failure secondary to Covid pneumonia.
Fever, chills, redness at injection site and glands swollen at bottom of left side of neck. All started within 24 hours of injection but have since subsided or gone away
Patient reported an outbreak of SHINGRIX approximately 7-10 days after pharmacy administered the initial dose of SHINGRIX.
Information has been received from a literature article concerning a 12 year old female patient developed uveitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median ag was 17 (range 12 - 29). The median time from vaccination to onset of ADRs was 30 days (range 0 - 476 days); time to onset was unknown in 1 case; the time to onset in this case was of 49 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional; information has been requested.
Pt reported feeling a warm on lower left arm distal to vaccination site. Feeling quickly dissipated after a few minutes, no signs of a reaction at the vaccination site.
HEARING LOSS; VERTIGO; This spontaneous report was received from literature. The objective of this study was to describe cases of tinnitus after COVID-19 vaccination mainly to raise awareness of this possibility and prompt referral for audiology and otolaryngology evaluation for possible concurrent sudden sensorineural hearing loss and treatment as appropriate. The patient's weight, height, and medical history were not reported. This study involved 27 patients out of which 4 patients received JANSSEN COVID-19 VACCINE. The patients ranged in age from 41 to 84 years old including seven male and twenty female patients. Patients were included if they are having possible covid vaccine related tinnitus and reported tinnitus onset within four weeks of any COVID-19 vaccine dose, no other attributable cause was identified, had an audiogram after onset of symptoms and at least one visit with our Otolaryngologists. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, within four weeks after vaccination, the patient experienced hearing loss, and vertigo (dizziness and tinnitus experienced by the patient were subsumed under vertigo). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo and hearing loss was not reported. The authors concluded that there is no definite correlation could be established between COVID-19 vaccine and tinnitus with this retrospective study with such few cases. However, patients will still present to their medical providers with tinnitus with and without hearing loss after a COVID-19 vaccination. In cases of sudden hearing loss, treatment with oral and/or intratympanic steroids within the recommended time frame should be considered based on prior clinical practice guidelines as causation by COVID-19 vaccination has not been proven. Improvement in tinnitus after steroids is not clearly shown and providers should use their discretion in each individual case. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20230410678, 20230427728 and 20230424648.; Sender's Comments: V0: 20230424639-Hearing loss. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 61.74.  No concomitant medications were reported.  Vial was moved to fridge on 09-Mar-2021. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. Product moved to clinic on 20-Mar-2021. Beyond use date for the vial was reported as 08-Apr-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).