chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Lot number: EW0171) and on 19May2021 as dose 2, single (Lot number: EW0182) at the age of 49 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: O60H21A), on 22Apr2022 as dose 4 (booster), single (Lot number: O48L21A) and on 28Sep2022 as dose 5 (booster), single (Lot number: AS7163B) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Nuts" (unspecified if ongoing), notes: known allergies: Nuts. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID 19 Treatment Brand=Pfizer Paxlovid. Treatment start date=03Dec2022, Treatment stop date=03Dec2022, Lot number=GE3010, Indication=Treatment of COVID-19.
After shot, later in the evening started experiencing shortness of breath. Due to pharmacy side effects warnings that was one of them so I thought it'd go away after awhile. Unfortunately for me it began to progress so on May 11, 2023 I went to ER where I was admitted immediately for respiratory failure, two days later on May 13, 2023 I went into cardiac arrest with multiple organ failures. When the doctors brought me back to life I was intubated and placed in ICU until May 22, 2023. My breathing and feeding tubes were removed once my organs woke up and began functioning again and was moved to the PCU (progressive critical unit). On May 24, 2023 I went home to Home Healthcare Services and continue receiving physical therapy, Registered nurse care, and on oxygen. My lungs failed, my heart failed, my kidneys failed, and do not remember anything.
Arm swelling pain moved into base of neck like something moving inside veins. Then pain moved to heart causing to clutch at heart from pain. Pain faded after 3 days. Felt like something was wrapped around heart near bottom of it. Then hard pain that felt like size of coin then size of smaller coin in a centralized spot.
pt became irritable p/vax & the next day reported to be fine;2 days p/vax pt was seen by MD hosp & dx w/hemolytic uremic synd;
After vaccine had a "hot flash" but went away, same evening of injection at 6 pm felt general malaise went to bed early, woke up next day very ill, woke up to go to the bathroom and almost passed out, severe vertigo, nausea, double vision, headache, chills and lower leg muscle twitching that would not subside, taken to ER that am, received 1 liter of fluids and medication for vertigo, multiple labs and EKG done, DX serum sickness. It lasted total of 10 days, a few days after ER, returned to ER as I developed what was dx as local reaction in addition to the systemic one right trapezius inflammation that tracked to right side of neck with pocket of edema, I had some intermit left sided mainly, paresthesia legs arm and facial may have been due to migraine that was triggered. I am an RN and was deeply concerned over my hypersensitivity reaction to this injection. Very scary!! I am not happy about it nor the medical bills that have resulted.
painful wrist/ right hand was hurting very bad/joint is swollen with severe pain; joint is swollen with severe pain; felt very cold; arm hurt at the injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 30Mar2021 (at the age of 66-years-old) as dose 2, single for covid-19 immunization.  Medical history included acid reflux. The patient had no concomitant medications. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration on 09Mar2021 (at the age of 66-years-old) as dose 1, single for covid-19 immunization. The patient had a little pain in arm where the vaccine was injected on the day of vaccination. On the second night the patient felt very cold. This morning when he woke up his right hand was hurting very bad where he had put his watch and the joint was swollen with severe pain.  The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID injection. Diagnosis was acute pulmonary embolism.
patient fainted on 1st dose (Pfizer) she was aware that she was going to faint for 2nd dose and had mom with her. Once shot administered she became pale and fainted, later started to convulse and we called 911. Pt left with EMS
So, for the 1st dose it started early morning of 12/24 maybe even on the 23rd I had a kind of chills, a pain sensation in my arm, temp on 12/24/20 was 100.3F I also developed a pain on my right breast - developed mastitis. I started antibiotics (Dycoclocilin)that afternoon after contacting my PCP. I am a breastfeeding mother. There was redness on the right breast and pain. Some muscle aches.  Fatigue. It lasted about 3 days or so.
I have not taken dose 2 of moderna yet; It is very irritating; Chills feeling inside my body which did not go away/sometimes it happens my chest, sometimes inside my back, hips/so the chills feeling is running around inside my body like a current; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (It is very irritating), CHILLS (Chills feeling inside my body which did not go away/sometimes it happens my chest, sometimes inside my back, hips/so the chills feeling is running around inside my body like a current) and INTENTIONAL DOSE OMISSION (I have not taken dose 2 of moderna yet) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced IRRITABILITY (It is very irritating) and CHILLS (Chills feeling inside my body which did not go away/sometimes it happens my chest, sometimes inside my back, hips/so the chills feeling is running around inside my body like a current). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (I have not taken dose 2 of moderna yet). At the time of the report, IRRITABILITY (It is very irritating) and CHILLS (Chills feeling inside my body which did not go away/sometimes it happens my chest, sometimes inside my back, hips/so the chills feeling is running around inside my body like a current) had not resolved and INTENTIONAL DOSE OMISSION (I have not taken dose 2 of moderna yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) All the results are normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Eight months later the patient still had the same chills feeling. The chills feeling was not very serious, the patient do not feel cold and do not need to add cloths, but it ws very irritating. The chills feeling was not a full body one but localized. Sometime it happens inside body like a current. At each location of my body, the chills feeling remain for ten, twenty minutes each times and then moves to other location. Because of this situation, the patient have not taken second dose of moderna yet. No treatment medications were reported.
pt recv vax 17SEP97 father reports pt devel hives the next day;did not seek med attention or given any meds;cont until 21SEP97 then gen elevated pin point rash over day 22SEP97 & fever;very irritable;CBC,UA nl;given DPH, APAP;
Pain and lump in right arm. ART and ASTYM treatments-ongoing to this date.
Initial information received from a consumer who is also the patient on 26 October 2012 and follow up received on 01 November 2012. A 61-year-old male patient, whose medical history included ADHD and concomitantly received antibiotics; had received intramuscular dose of ADACEL (Lot number and doses not reported) on left deltoid on unspecified date. The reporter stated that after 5 days of vaccination the patient had a temperature of 100.1, which was lasted for 24 hours, patient became achy and had stiffness throughout his body. Patient had difficulty to get up and moving in the AM, walked hunched over. Patient's pain and stiffness were improved, but are still present. The patient had diarrhea since he received the vaccine. Further the reporter stated that he went to doctor on 14 October, 19 October, 21 October and then on 26 October. On 31 October, the pain in the right hip and knee got worse in the evening. That night his temp went up to 99.4 F and then temp went down in the morning. The patient went to the doctor who told him he never saw the symptoms of a swollen knee cap and spasms as he was having. It hurts to sleep and urinate. His neck was stiff and left knee hurts. Laboratory details were not reported. Corrective treatment included LIDODERM patch 5 percent, hydrocodone and a muscle relaxer Tizanidine. Patient's outcome was not recovered. Documents held by sender: None.
no adverse event; patient received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml doses; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml doses) and NO ADVERSE EVENT (no adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .15 milliliter. On 16-Aug-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml doses). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml doses) 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 ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml doses).    Concomitant medication list was not provided. It was reported that 5 patients received 0.15 ml doses of the Moderna COVID-19 vaccine instead of 0.25 ml doses from the same vial lot. The reporter stated they had an issue and they incorrectly drew up the doses. Treatment information was not provided.
Pfizer COVID-19 vaccines received on 03/13/2021 and 04/03/2021. Hospitalized on 10/31/2021 Diagnosis: COVID-19 pneumonia, hypoxia and hyperglycemia. Treatment: CTA of chest, oxygen support, Remdesivir, dexamethasone, insulin sliding scale, metformin and glipizide.
passed out and collapsed to the floor in his apartment's bathroom; passed out and collapsed to the floor in his apartment's bathroom; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 12:00 (Batch/Lot number was not reported) as dose 2, single (at age of 35-years-old) for covid-19 immunisation. Medical history was none. Known allergies: none. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 12:00 administered in Arm Right (at age of 35-years-old) for COVID-19 immunization. On 26Mar2021 23:00, later that evening on the date he got the second shot, he passed out and collapsed to the floor in his apartment's bathroom. This incident occurred as he was in the process of urinating. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. Outcome of the events was recovered with sequelae.    The lot number for BNT162B2 was not provided and will be requested during follow-up.
Patient vaccinated by EMS on 3/29/21,  EMS notified clinic that patient was taken to the Hospital for a stroke on 4/1/21
I have a sore throat, cough, and body aches. I am taking an antibiotic, cough medicine, and Advil.
This non-serious spontaneous case, initially received from other non-health professional on 25-Sep-2018, concerns a pregnant female patient of an unspecified age. On an unspecified date, the pregnant patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number and expiry date: not reported]. At the time of the report, no adverse event was reported.
On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the saline solutuon diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the DOH reported there was a diluent shortage at the time. Under the direction of the DOH the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the DOH, as they later questioned their original desecion. The were 30 to 36 doses drawn this solution and this person is 1 of 72 others who may have had a dose of this mix
Rapid heart rate, atrial fibrillation episode after both first and second dose.  I have occasional/rare atrial fibrillation.  This episode was directly after each dose.  Heart rate elevated to 140 bpm; Rapid heart rate, atrial fibrillation episode after both first and second dose.  I have occasional/rare atrial fibrillation.  This episode was directly after each dose.  Heart rate elevated to 140 bpm; This is a spontaneous report from a contactable pharmacist (patient). A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 16:30 (the first dose, lot number: EL3249) at single dose; via an unspecified route of administration on 03Feb2021 (the second dose, lot number: EL9264) at single dose, both in left arm for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM) and the patient had myectomy surgery for Hypertrophic Obstruction Cardiomyopathy in 1993. Concomitant medications included paracetamol (TYLENOL), verapamil hcl, simvastatin, apixaban (ELIQUIS). No covid prior vaccination and no covid tested post vaccination. The patient had no known allergies. The patient had rapid heart rate, atrial fibrillation episode after both first and second dose. The patient had occasional/rare atrial fibrillation. This episode was directly after each dose. Heart rate elevated to 140 bpm, lasting 12 hours after 1st dose, 17 hours after 2nd dose.  The patient underwent lab tests and procedures which included heart rate was elevated to 140 bpm in Jan2021 and Feb2021. No treatment was received. The outcome of the events was recovered in Jan2021 after first dose and recovered in Feb2021 after second dose.; Sender's Comments: Based on available information, a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported events Atrial fibrillation and Heart rate high. 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.
Itchy, hot, raised, red, blotchy, hard fist size area at injection site.
5:30 am. -Mind "cloudy", tightness in lower esophageal area, minor swallowing difficulty, fatigue. 9:00 am. - progression of previous symptoms with addition of discomfort on chest area, severe acid reflux. 1:00 pm. - further progression of previous symptoms with addition of pain in neck and jaw area and headache, occasional feeling of shortness of breath. 7:00 pm - all symptoms began to progressively decrease in mostly the same order of onset.  11:00 pm - Continued decrease in symptom severity. 1/24 @ 8:00 am - Symptoms subsided with exception of minor degree of swallowing difficulty and reflux.
Woke up with flu like symptoms. Diarrhea, throwing up, sweating  Lasted for about one hour then gone
Rec'd shot in L arm and states feel "sick" lightheaded-protected on chair lowered head & knees -encouraged to take deep deep breaths- Mom @side. Stated this always happens "she'll be fine" assisted to BR per request. Mom @ side helped to  toilet seat, voided, cool cloths to back if sick. "I want to go home"- Mom went to get car stayed with pt. assisted safely to car encouraged to call prn for assist 1330 called LMom if any questions call prn. a take to family dr. a ER if concerns.
This spontaneous report as received from a consumer (mother of the patient) refers to an approximately 13 year old female patient, who was also a school athlete. The patient's pertinent medical history included asthma and drug allergies were none. On an unknown date in August 2014, the patient was vaccinated with first dose of GARDASIL. Concomitant medications were none. On an unknown date in 2014 since 1 week after the administration of 1st dose of vaccine, the patient experienced episodes of stomach pian, nausea, paleness, weakness and dizziness. These episodes are associated with exercise and resolve with food and rest, without requiring medical intervention. The patient was evaluated by an unspecified provider at medical Center. An unspecified blood work was negative. The patient was referred to an unspecified cardiologist. A cardiac stress test and electrocardiogram were normal. The second dose of GARDASIL was administered an unknown date in October 2014. The outcome of the events, stomach pain, nausea, paleness, weakness and dizziness was reported as recovered/resolved. The relatedness of the events with GARDASIL was not reported. No product quality complaint was reported for GARDASIL. Additional information has been requested.
Pt experienced chickenpox with multiple lesions described as a pretty nasty case. Pt was seen in physician's office on 12/22/99 and the lesion were noted as dry and mostly desquamatous. Pt was treated with Benadryl, Aveeno and Tylenol. On an unspecified date the pt recovered. It was noted that the pt's sister also developed chickenpox following vaccination. No further information is available.
According to patient, soft lump developed on upper left arm at injection site and and moved down arm over the course of several days to below the elbow.  Tender but no heat or redness.
thrush; oral thrush; body aches; tongue is still brown and white and it's pretty thick; tongue is still brown and white and it's pretty thick; sore throat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (Comirnaty COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration on 12Apr2021 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Comirnaty COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration on 22Mar2021 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. On an unspecified date May2021, the patient experienced Sore throat; and on an unspecified date thrush, oral thrush, body aches, tongue is still brown and white and it's pretty thick. On an unspecified date, the patient underwent lab tests and procedures which included laboratory test: Unknown, this time she had other side effects with it, so she thought that she had COVID, and she had a test done. Patient stated, she has gone to the doctor and they gave her a mouth rinse and she has been taking Tylenol for the body aches and that sort of thing, but she doesn't know if that has anything to do with the COVID vaccine or if she should just look elsewhere. The outcome of the event Sore throat was recovered on an unspecified date 2021; and others event was unknown.  Follow-up (09Sep2021): This is a follow-up spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported that which included: weight of the patient, adverse events, and outcome was updated in narrative.  Follow-up (14Sep2021): Follow-up attempts are completed. No further information is expected.
Reported that experienced the onset of dizziness, "full feeling in head" at 30 minute discharge time- stated that these symptoms had started @ 2 minutes after Covid-19 vaccine was administered but was not reported until discharge ( did have multiple  check-ins in waiting area) "hoping it would go away" no SOB, no urticaria, no facial swelling
Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (other). This case involves a 5 months old female patient who received vaccine PENTACEL. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR 13 and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). On 04-Feb-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5427BA, expiry date 31-Oct-2019 via intramuscular route in the right thigh. The DTap/IPV Lot: C5427BA, Expiration Date: 13Oct2019, ACTHIB Lot: C5575AA, Expiration Date: 13Oct2019. PENTACEL Box Lot: C5575AA, Expiration Date: 13Oct2019. It was an actual medication error due to inappropriate reconstitution technique and incorrect product storage. It was reported that patient was given today the DTaP/IPV and not the ActHIB. The ACTHIB was left out an hour. Cumulative excursions up to 72 hours at 46 degree F through 77 degree F (8.1 degree C through 25 degree C). Half of the Pentacel, the liquid portion, was administered It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.