chrisvoncsefalvay/vaers-outcomes huggingface dataset:
consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported.  Treatment information was not reported.
Anterior scleritis of left eye treated by opthalmologist.  Treatment not finished yet.
About 45 minutes after receiving vaccination patient return and stated that her arm was swelling and she had a pins and needles feeling. The said the injection site was a little tinder. Upon checking there was no redness or warmth of the site. Check with the patient at 12:40pm and she state that if felt about the same. Attempted to contact patient at 8pm without success.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
Passed out; Fell; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032230) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and FALL (Fell). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) and FALL (Fell) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) event of loss of consciousness (passed out) and non serious event of fall. The events occurred on unknown date. Temporal association with a dose of SPIKEVAX 2023-2024 PFS is unclear. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750490, US-MODERNATX, INC.-MOD-2023-750486, US-MODERNATX, INC.-MOD-2023-750249, US-MODERNATX, INC.-MOD-2023-750485 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750490:Same Reporter US-MODERNATX, INC.-MOD-2023-750486:Same Reporter US-MODERNATX, INC.-MOD-2023-750249:Same Reporter US-MODERNATX, INC.-MOD-2023-750485:Same Reporter
Shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified date in 2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider (HCP) for long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's inoculation, she was treated by an HCP for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX), she had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was reported as not resolved. The causal relationship of herpes zoster was reported as related to zoster vaccine live (ZOSTAVAX).
took just 1 pill of Valaciclovir 500mg on the morning of January 20th for his Herpes outbreak; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (took just 1 pill of Valaciclovir 500mg on the morning of January 20th for his Herpes outbreak) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unnown) for COVID-19 vaccination.     Concomitant products included VALACICLOVIR HCL from 20-Jan-2021 to an unknown date for Herpes infection.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Jan-2021, the patient experienced DRUG INTERACTION (took just 1 pill of Valaciclovir 500mg on the morning of January 20th for his Herpes outbreak). At the time of the report, DRUG INTERACTION (took just 1 pill of Valaciclovir 500mg on the morning of January 20th for his Herpes outbreak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
5 Days after vaccine - red rash down arm site of vaccination. Severe muscle soreness weakness. Rash spread from upper arm down to hand. Turned colors lasted 2 more wks.
Lesion on left outer thigh began 4 days before presentation. Patient reports noting a red pustule 2 days before presenting. Upon clinical eval, a 3 cm erythemaous pustule with central eschar area. Area was smaller than 2 days previously.
Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt reported to feeling pain and complained for experiencing buring feeling in hand
Ten minutes after receiving the vaccine, my tongue felt like it was swelling and then went numb and I had difficulty swallowing.  I was given two doses of Benadryl and was observed for another 45 minutes. My symptoms began to improve enough that I felt like I could drive home.
The patient experienced rash all over her body and no other symptoms. Her primary doctor prescribed VALTREX 1 gram to be taken twice a day.
get a serious case of the flu; Initial information regarding an unsolicited valid serious case received from a consumer (patient) via social media on 27-Oct-2020.  This case is linked to case 2020SA305230. (Same reporter media)  This case involves a patient of unknown demographics who got a serious case of the flu (Influenza), while patient received INFLUENZA VACCINE.  Past vaccination included flu shot (INFLUENZA VACCINE) which did not contain the strain H1N1.  Medical history, medical treatment, family history and concomitant medication were not provided.  On an unknown date in 2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiration date unknown) not reported via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2020, the patient developed serious case of the flu (Influenza) (unknown latency) after the administration of INFLUENZA VACCINE. As a reason of developing the flu, the patient explained that the last flu that was received did not contain the strain H1N1 which was there in the current INFLUENZA VACCCINE that was received. Thee patient also said that even if the new strain had been added to the current INFLUENZA VACCCINE, the patient was always immuned to the older strains and that she highly recommended of getting the flu shot as it helps the symptoms to keep milder.   The event flu was assessed as medically significant as per reporter.   No laboratory test was 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 on the batch number for this case.; Sender's Comments: Sanofi company comment dated 18-Dec-2020: This case concerns a patient of unknown demographics who had presented Influenza after vaccination with company suspect INFLUENZA VACCINE. The time to onset was unknown. However, patient's medical condition, concomitant medication and laboratory tests ruling out alternate etiologies were not reported. Moreover, one vaccination preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.
This spontaneous report as received from a nurse practitioner refers to an adult patient of unknown age and gender. On an unknown date the patient was vaccinated with (Merck) VARIVAX (lot number and expiration date unknown), dose, route and anatomical location unspecified. Concomitant medications were not reported. It was reported that the patient with (Merck) VARIVAX at the age of 1 and developed shingles at the age of 8. Nurse practitioner reported that the patient is an adult now. The outcome of shingles at the age of 8 was unknown. Additional information is not expected.
- Soreness at injection site, congestion and headache for 2-3 days. - Piercing pain/headache and light sensitivity originating in both eyes for 6-8 weeks gradually getting better. - Ringing in both ears, intermittent at first but now it is constant and seems to get worse.  Currently and continuing side effect.
Next day - redness, warmth, swelling - to ER. MD put on Ibuprofen - back to school next day.
Runny nose; Coughing; her throat is irritated/scratchy; feels like she flu like symptoms; feels like she is getting a cold; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration on 13Jul2021 as dose 1, single for covid-19 immunization. Medical history included diabetes and hypertension. The patient's concomitant medication included unspecified medication for her high blood pressure. The patient reported that, she took the shot on Tuesday 13Jul2021 and yesterday (as reported) on an unknown date in Jul2021 she started having a runny nose and has been coughing. She was not really sick. Her nose has been running a lot and she was coughing a lot. She feels like her throat is irritated/ scratchy and flu-like symptoms. On an unknown date in Jul2021, she felt like she is getting a cold. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Pain in right shoulder with decrease ROM and Pain with abduction and radiation of pain to right hand. Symptoms lasted four weeks.
I had dry cough for a couple of days, severe sore throat for a couple of days. I had the chills, feverish for 1 day. A couple of days later the symptoms disappeared. At first I thought it was symptoms from the flu vaccine so I was taking DAYQUIL. Then I got tested and it was positive so I took PAXLOVID. I only took it for 3 days because I started developing side effects from it. I started getting hives on my legs, nausea, and very bitter taste in my mouth and then developed acid reflux.
Fever; This is a spontaneous report from a Pfizer sponsored study  from a contactable consumer. The patient was the reporter's daughter. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) dose 2, via an unspecified route of administration, on 09Mar2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received dose 1 of BNT162b2 on an unspecified date, for COVID-19 immunization. The patient experienced fever on an unspecified date. The clinical outcome of the event fever was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
04/13/2022 Tested positive for COVID-19 with at home test. I had a telehealth visit with my doctor. The doctor prescribed Paxlovid symptoms are gone.
36 hours after injection: full body rash, chest pain, shortness of breath  slowly worsened throughout the day
pt c/o stuffy head, h/a, stomach ache, but no soreness @ inject site; pt was seen by MD dx cold & high blood sugar;
Client was vaccinated at 1539 and was being observed for 15 minutes. After 13 minutes, client stated that she took off her bandaid and looked at the vaccination site and it made her feel faint.  Client was noted be slumping out of chair and was moved into Trendelenburg position on the floor. Vital signs were taken at 1553- 115/72, 75, 18.   Once responsive and interacting with mother, she was moved into chair and @ 1603, a second set of vitals taken: 118/77,70, 18.  Client remained in observation and noted to be chatting with mother.  Final set of vitals were obtained @ 1415: 121/75, 70, 16.  Client left on own accord accompanied by mother.
Patient presented to Hospital on 01/02/2022  via EMS in supraventricular tachycardia that was symptomatic.  Vagal maneuvers were unsuccessful.  Patient received 2 boluses of adenosine, and started on amiodarone bolus plus drip.  Chest Xray alveolar airspace disease in the left lower lobe, small effusion has developed in the right lung base and right minor fissure.  Covid returned positive.  Patient was started on dexamethasone, bronchodilators.  Patient was admitted to ICU and required intubation.   She develop PEA arrest.  She was pronounced dead on 01/04/2022.
Pfizer covid vaccine administered to a 15-year old when it was indicated for 16-year olds and above. This occurred on 4/9/2021 for the first dose (left deltoid) and on 5/6/2021 for the second dose (left deltoid). The legal guardian was made aware. The facility medical director was made aware. No adverse effects noted on either dose.
Initial and follow up information has been received from a nurse at the physician's office concerning a 21 year old female patient who on 18-MAY-2007 was vaccinated with a first dose of Gardasil and on 17-JUL-2007 was vaccinated with a second dose of Gardasil. She had no pertinent medical history and there were no concomitant medications. In follow up it was indicated that her symptoms started on 18-JUL-2007 in the early morning the next day of second vaccination. She had a fever, dizziness, nausea, vomiting, body aches, and headaches. She was rushed to the emergency room (ER)/acute care, and she was not admitted to the hospital. Acute care felt that the patient's symptoms were a probable side effect from her Gardasil vaccination. The patient recovered at this time and was doing fine. The nurse reported that the patient did not have a similar event after her first injection. The reporter felt that the nausea and vomiting were considered serious as another medical event. Additional information has been requested. In follow-up information the reporter indicated that the patient went to emergency room for fever, dizziness, nausea, vomiting x6, severe headache, body aches since early AM. Nausea and vomiting started during night. The patient took TYLENOL for muscle aches. She vomited twice and had low grade temperature in AM (99.2 0F). In the medical record it was indicated that se was treated with IM 12.5 mg of promethazine hydrochloride. she was given prescription for 25 mg promethazine hydrochloride tablet ass needed and acetaminophen for headache by mouth. The urine analysis showed trace of ketones. The serum pregnancy test was negative. On 20-JUL-2007 the patient recovered. The reporter felt the nausea, vomiting and headache was probably related to therapy with GARDASIL. The reporter felt that the patient requiring visit to the emergency room was to prevent patient from being serious and considered as a serious other medical event. Additional information is not expected.
A little soreness on my left arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: ER8727), via an unspecified route of administration, in arm left on 24Mar2021, as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a little soreness on left arm. The outcome of the event was unknown.  The second dose was taken on 14Apr2021 PFIZER EW0151. Information on lot/batch number was available. Additional information has been requested.
Received Twinrix on February 8th, 2005. States that on February 11 or 12th she started with some itching and by the 23rd of February she now has hives covering from her neck to her knees. States that on the 15th of February she also noted a blue streak, appeared like a bruise, that was approximately 2 inches long that started at the injection site of her left arm. This site is slowly fading.
12/29/21 @ 4:42PM  As pt. was being assessed , I was notified by Nurse, RN regarding  administering moderna booster 0.25mL IM to 17 y/o pt.  I informed the father and pt that I have given moderna to his 17 y/o daughter. I explained to parent that moderna should not be given to 17 y/o. Father and pt acknowledged and is aware. Pt will  monitored for 30 minutes from 4:30 pm to 5:00 pm.
Fluid around heart, symptoms of myocarditis, ventricle wall thickening, large trivial pericardial fusion, mitrial valve has trivial regurgitation, tricuspid valve moderate regurgitation, aortic valve leaflet is leaking, runs of svt's and pvc's
shortness of breath; temperature; I had edema and swelling in my lower extremities, my feet and my legs; soreness in my arm; diarrhea/ frequent and loose bowels; body aches and pains; a bit gastro intestinal upset, distress; This is a spontaneous report from a contactable consumer (patient). A 62-year-old patient of an unspecified gender received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: ER873U) as a single dose in the Left arm/ left shoulder (at 62 years of age) for COVID-19 immunization and dexamethasone sodium phosphate (DEXAMETASON), unspecified route, dates, dose and indication. Medical history included gastrointestinal (GI) bleed, ulcer, glaucoma and allergies. Concomitant medications included enteric coated acetylsalicylic acid (BABY ASPIRIN) 81mg, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), cetirizine hydrochloride (ZYRTEC ALLERGY) and 3 medications for glaucoma. The patient had significant soreness in the arm later that evening, initially they had nothing. About nighttime, it was very sore and they had body aches and pains. The patient did not take anything for it. The patient had quite a bit GI upset and distress right after taking the vaccine. They had diarrhea and some frequent and loose bowels. The GI upset started before the patient even left the pharmacy. They stayed there for a good hour. The patient had was shortness of breath that was intermittent. On 28Apr2021, they had edema and swelling in the lower extremities, feet and legs. The patient's legs started swelling when they had edema, food retention and swelling after having taken the vaccine. Although the patient did not have a temperature, they went to the ER. Because of their history of GI bleed, they were not able to take anything so they were administered an IV infusion of Dexamethasone on 28Apr2021. They tested and the patient's heart was fine. The patient was concerned whether taking the dexamethasone after the first dose would diminish the efficacy of the vaccine or the efficacy of the second dose and will that interfere with the upcoming administration. The patient was not going to take another dose of the Dexamethasone. It had to be given because they could not take aspirin for temperature so they had an infusion of dexamethasone. The outcome of soreness in the arm, body aches and pains, GI upset/ distress, diarrhea/ frequent and loose bowels, shortness of breath, edema lowere extremities, feet, legs, food retention and temperature was unknown.  No follow-up attempts are needed. No further information is expected.
slight nausea, tiredness, fuzzy thinking, headache, very strong shivers first night.  This just after the first day, and still  some fuzzy headedness, and tiredness.  No more shivers. And this is an odd thing... related to the headache -- the roots of my hair or the scalp is sensitive.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (vaccine given 6 days post expiry) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A and 011J20A) for COVID-19  immunization. No medical history reported. On Dec 21, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient administered expired product (vaccine given 6 days post expiry). On Nov 12, 2021, administered expired product (vaccine given 6 days post expiry) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-395985 (patient link).
Loss of speech, regression from previous milestones, a light went out from child's eyes, fever, lethargy, refusing to eat, encephalopathy.
Heartache; sharp, pulsing pain in the left side of my chest; Muscle pain; This is a spontaneous report from a Non-contactable consumer (patient). A 38-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Jun2021 (Batch/Lot Number: EW0168) at the age of 38-years-old as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unknown date for covid-19 immunisation. 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. The patient experienced heartache, sharp, pulsing pain in the left side of her chest, and muscle pain on an unknown date in Jul2021. The clinical course as following: Heartache started about a week after getting 2nd shot of Pfizer. Never had heart issues before in her life. She had noticed sharp, pulsing pain in the left side of her chest while in store. There pain pulses lasted for about a minute, then subsided. Since it subsided, she though it might have been muscle pain. However, she had the same pain happening 2 days later. Now it has been 2 weeks since her 2nd shot of Pfizer and she continue to get pulsing pain in heart area almost daily. It usually last anywhere from 1-3 minutes and then subsides. The pain was sharp, but tolerable. The outcome of the events was not recovered. Since the vaccination, the patient was not been tested for COVID-19.   No follow-up attempts are Possible. No further information is expected.