chrisvoncsefalvay/vaers-outcomes huggingface dataset:
really sick, pretty sick; had severe aches; cold; fever; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick, pretty sick), PAIN (had severe aches), NASOPHARYNGITIS (cold), PYREXIA (fever) and CHILLS (chills) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick, pretty sick), PAIN (had severe aches), NASOPHARYNGITIS (cold), PYREXIA (fever) and CHILLS (chills). At the time of the report, ILLNESS (really sick, pretty sick), PAIN (had severe aches), NASOPHARYNGITIS (cold), PYREXIA (fever) and CHILLS (chills) had not resolved.            No Concomitant use were reported  Patient got really sick, had severe aches, fever and cold chills. Has been like this for 3 days and was not getting better.  No Treatment were reported
Hives/rash, mostly on left arm but also right upper arm, right thigh, some just red and slightly raised, some scaly in texture, the latter of which were itchy
Fever; Chills; Nausea; Tiredness; Injection site pain; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 19Apr2021 at 15:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included iodine contrast media allergy, adhesive tape allergy, allergic to codeine and sulfur. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included hydrochlorothiazide/triamterene (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and unspecified vitamin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 29Mar2021 at 15:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 04:30, the patient experienced fever, chills, nausea, tiredness, injection site pain and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, nausea, tiredness, injection site pain and feeling unwell were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever over 102 for one day while on Tylenol. Swollen lymph nodes above right clavicle. Chills and cold sweats lasting with the fever. Full body aches. Extreme fatigue lasting 3 days.
Burning sensation on left forearm; This is a Spontaneous report from a contactable nurse (patient). A 57-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9261, expiry date was unknown), via intramuscular, administered in Arm Right on 28Jan2021 12:00 (at the age of 57-year-old) as dose 1, single for covid-19 immunization. Medical history included High Cholesterol from an unknown date and unknown if ongoing. The patient previously took hepatitis b vaccine and experienced allergies. Prior to the vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications within 2 weeks of vaccination. On 31Jan2021 15:00 the patient experienced burning sensation on left forearm. The patient underwent lab tests and procedures which included cholesterol: high on an unspecified date. Therapeutic measures were taken as a result of burning sen-sation on left forearm with triamcinolone cream and using caladryl cream. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
injection site reaction the size of a half-dollar that was itchy warm  and swollen; Bump that was size of half-dollar; Injection site warm; Injection site itchy; Extremely exhausted; Injection site swollen; Only slightly tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reaction the size of a half-dollar that was itchy warm  and swollen), VACCINATION SITE MASS (Bump that was size of half-dollar), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itchy) and FATIGUE (Extremely exhausted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), DEXLANSOPRAZOLE (DEXILANT), DULOXETINE HYDROCHLORIDE (CYMBALTA), ALPRAZOLAM (XANAX), UBROGEPANT (UBRELVY), SALBUTAMOL SULFATE (PROVENTIL [SALBUTAMOL SULFATE]) and LORATADINE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE REACTION (injection site reaction the size of a half-dollar that was itchy warm  and swollen), VACCINATION SITE MASS (Bump that was size of half-dollar), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itchy), FATIGUE (Extremely exhausted) and VACCINATION SITE SWELLING (Injection site swollen). In April 2021, the patient experienced VACCINATION SITE PAIN (Only slightly tender). On 09-Apr-2021, FATIGUE (Extremely exhausted) had resolved. On 12-Apr-2021, VACCINATION SITE REACTION (injection site reaction the size of a half-dollar that was itchy warm  and swollen), VACCINATION SITE MASS (Bump that was size of half-dollar), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) had resolved. At the time of the report, VACCINATION SITE PAIN (Only slightly tender) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included application of ice to the area.
Low fever 0.5 F above the normal,  heart rate increased from 75/min to 110/min.  Blood pressure 15 above the normal daily reading.  coughs 3 to 4 times. Then, after 30 hours of the shot of vaccine, felt headaches.   At that time,  heart rate was closed to the normal.  But had a couple of coughs. Just felt having a light flu at the beginning and tired. Pain on the shot area in the arm was not a concern.  After 60 hours of the shot, feel good. Just report what I had.
received the first dose of the vaccine on 05Feb2021 and the second dose on 27Mar2021/ 50 days in between 1st and 2nd; slight chills; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), administration date: 05Feb2021, for COVID-19 immunisation, reactions: "blood pressure high", "heart rate high", "rash", "shingles", "lung infection". The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "slight chills"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Mar2021, outcome "unknown", described as "received the first dose of the vaccine on 05Feb2021 and the second dose on 27Mar2021/ 50 days in between 1st and 2nd".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11/10/2021 - Vertigo (dizziness, unable to stand up for short periods of time).  Still continuing on as of 11/14/2021  11/14/2021 - still experiencing vertigo and a new symptom of neck and back pain  Will be making an appointment to see the doctor on 11/15/2021
Patients head tilted back and eyes were rolled up, towards the top. She appeared clammy and remained conscious. Patient did not want to discuss past medical history but stated this has happened before when she received previous vaccines. Patient quickly returned to normal state. Vital signs were taken and she was offered water.
Information has been received from a physician concerning a 3 year old female with no known medical history or allergies who on 23-APR-2004 was vaccinated with a 0.5 mL SC dose of Varivax (lot # 647087/0851N). There was no concomitant medication. In February 2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023; No adverse event; HCP explained they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) 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 EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported.  The vial was initially stored in the refrigerator on 02-MAR-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
Information has been received from a physician assistant concerning a 22 year old female patient with sexually transmitted disease in 2007, kidney stone in 2008 and VICODIN and PERCOCET allergies who on 14-FEB-2011 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 666948/0886Z). There were no concomitant therapies or vaccines. On 14-FEB-2011 the patient experienced dizziness, vomiting and sweating 30 minutes after vaccination. The patient was sent to emergency room and was treated with BENADRYL (not known if oral or parenteral), ZOFRAN intravenously fluids and MEDROL pack orally were administered/prescribed. Patient was not admitted to hospital. The physician assistant was not sure which emergency room the patient was taken. Patient fully recovered and would not receive the rest of the GARDASIL series. No further information is available.
Patient had been experiencing diarrhea for the past 5 days and wasn't  feeling well. He had not been taking his furosemide for past 2 days. Wife indicates  that patient has dizziness spells in the past. Patient with hx of Atrial fib, coronary  artherosclerosis, CVA, HTN, Aortic Stenosis, s/p aortic valve replacement 2015.  Pt reports feeling unwell for 3 days prior. He did not give this information prior to  the Covid Vaccination #2.
tingling in his right pinky/tingling in certain parts of my legs saying "it'll flash then stop/Tingling in my fingers; My arm felt stiff; A loss of sensation stating "I really haven't had any sense of sharp pain; He states that the sensation is more warm or burning; that it was a "swelling/numbing effect".Swell little bit; I could feel things were swelling; He reports that immediately after he received the dose (in his right arm) he "could feel it throughout my body" and that it was a "swelling/numbing effect".; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 12May2021 (Age at time of vaccination 47-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Patient stated that I took the Ibuprofen because when I first got the shot I could feel things were swelling (further details unknown), I could feel some like, I took pills at the time like a it was swelling like some pain initially and then I heard from other that to prevent the headaches and to prevent the soreness of the arm, to took Ibuprofen, so that I took it as a preventive measure that, I would not get sore but I didn't have any of those, my arm felt stiff but I never felt the pain, and I never feel any headache at the time, like I said, I kind of lost sense of acuteness, loratadine taken for hypersensitivity, start and stop date were not reported. Patient reports that immediately after he received the dose (12May2021) (in his right arm) he "could feel it throughout my body" and that it was a "swelling/numbing effect". He has since been experiencing neurologic symptoms that include:  tingling in his right pinky, a loss of sensation stating "I really haven't had any sense of sharp pain. I can feel pressure but can't determine actual point of pressure."  He also reports "tingling down [his] left arm while laying down last night" and tingling in certain parts of my legs saying "it'll flash then stop" and is most notable in the calf/shin of his right leg. He states that the sensation is more warm or burning, "not sharp pain" and that it will be a "small burst in a certain area, then go away". On an unknown date Patient also experienced that ,I kind of noticed that I can't feel thing I will say go numb as if kind of feeling through my body,Swell little bit; I could feel things were swelling,I don't have like feeling like touch like when I touch something I feel pressure but I don't have that huge sense of feeling,Tingling in my fingers, its practically I lost my left arm The  outcome of events was unknown.  Information on the lot/ batch number has been requested.
Chills, fever, aching body "Covid arm" - swelling, itchy, redness, hardness  Treatment: Betamethasone Dipropionate Topical Cream and only two Publix Brand Antihistamine tablets taken
This spontaneous report was received from a pharmacist and refers to a 66-year-old male patient with no pertinent medical history, drug reactions or allergies. On 15-MAR-2017, the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX lot # M036613, expiration date: 19-NOV-2017. Concomitant therapies included LIPTOR, hydrochlorothiazide and atenolol. On 17-MAR-2017, the patient experienced itching, swelling, redness and warmth at the injection site. The patient was not treated for the events. He sought medical attention by calling the pharmacy on 17-MAR-2017. The outcome of the adverse events was reported as not recovered. The causality between the adverse events and ZOSTAVAX was not provided. Additional information has been requested.
2 weeks after taking the vaccine she broke out in hives all over her body. It was sensitive to the touch. Went to ER due to closing of the throat and went into anaphylactic shock.
My arm is red; having arthritis in the arms and legs; I couldn't get up from the bed, my legs and arms couldn't move; feeling a little whizzy; I fall in my family room and couldn't get up; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (feeling a little whizzy), HYPOKINESIA (I couldn't get up from the bed, my legs and arms couldn't move), ERYTHEMA (My arm is red), FALL (I fall in my family room and couldn't get up) and ARTHRITIS (having arthritis in the arms and legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included HYDROXYCARBAMIDE (HYDROXYUREA), PRAVASTATIN, DOXEPIN and LEVOTHYROXINE for an unknown indication.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced WHEEZING (feeling a little whizzy) and FALL (I fall in my family room and couldn't get up). On 22-Aug-2021, the patient experienced HYPOKINESIA (I couldn't get up from the bed, my legs and arms couldn't move). On an unknown date, the patient experienced ERYTHEMA (My arm is red) and ARTHRITIS (having arthritis in the arms and legs). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, WHEEZING (feeling a little whizzy), HYPOKINESIA (I couldn't get up from the bed, my legs and arms couldn't move), ERYTHEMA (My arm is red), FALL (I fall in my family room and couldn't get up) and ARTHRITIS (having arthritis in the arms and legs) outcome was unknown.            Patient was taking an unspecified medication for arthritis.
Redness at injection site; Swelling at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age group was captured as adult as per vaccine indication. The reporter did not consent to follow-up. There was no vaccination date, injection site, patient's identifiers, lot number nor expiration date provided.
Left deltoid reddened, tender and slightly swollen Pt. reports worsened overnight. Erythema to upper left arm that extends to inner aspect arm halfway toward elbow. Advised to elevate and take ibuprofen for pain.
Pt. was admitted to hospital on 1/6/21 with fatigue, weakness. Pt. was Covid positive in November of 2020. Impression upon admission was fatigue may be due to her aortic stenosis and some hypertensive issues with blood pressure changes. She was anemic. WBC was elevated to 19.2, HBG 10.5, NA-131, K+ - 3.1, Rule out bacterial infection. Potential source could be her heart valve. Also noted to have acute renal failure with BUN of 47 and Creatinine of 2.2 noted. Pt. was transferred to Hospital on 1/8/2021 with dx of aortic stenosis, bacteremia, ARF, Dehydration and anemia. Discharged with dx. of sepsis. Pt. expired on 1/18/21 with dx. of severe sepsis, complete heart block, staphylococcus epidermidis bacteremia.
Pt developed immediate sore joints, extreme cognitive decline and depression. Within 1 week, he developed extreme fatigue. Within 1 month he had tingling of his arm, facial tics and an inflamed elbow with extreme pain. Poor cognitive function, no memory, joints hurt. Constantly "sick" since receiving the lyme vaccine. In April, May and June of 1999. Brain swelling. Cannot work.
Swelling a redness noted same evening.  There was no sleep disturbance.  Next day, hard & red thigh Seen 27 hr after the shot: large red area created on site of shot- entire thigh swollen & hard.  Walting with slight temp
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.    This case was linked to MOD-2021-364943 (Patient Link).
APPOINTMENT MADE AND CONSENT / QUESTIONNAIRE FILLED OUT BY PARENT USING A DATE OF BIRTH. INSURANCE DID NOT REJECT FOR INCORRECT DOB AND COVID VACCINE WAS ADMINISTERED TO 11 YEAR OLD PT.