chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Male patient who to the hospital on 3/15/2021 due to 10 days of shortness of breath on exertion and right-sided chest pain.   He went to his PCP for follow-up and had a CT PE study today which was positive for right upper lobe and right lower lobe pulmonary embolism.  He notes that he received a 2nd 5 0 COVID-19 vaccination on March 6th and since then has not felt well, feeling short of breath and generally fatigued.  He notes that he has not been very active since receiving the vaccine.   CT PE study showed an increased RV to LV ratio 1.2.  He had no elevation in his troponin or BNP.  His echocardiogram showed an EF of 60% and there were no wall motion abnormalities and grade 1 diastolic dysfunction. Patient would prefer Eliquis at this time.  He will need a 6 month course of Eliquis.  Given the setting of recent COVID vaccination and recent decreased mobility as possible provoking factors, this will be treated as a provoked pulmonary embolus.  Per hospital COVID vaccine protocol, patient presentation will be reported to pharmacy for FDA reporting.
several women who experienced vaginal infections; 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 VAGINAL INFECTION (several women who experienced vaginal infections) in a female patient of an unknown age 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VAGINAL INFECTION (several women who experienced vaginal infections). At the time of the report, VAGINAL INFECTION (several women who experienced vaginal infections) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided   This case was linked to US-MODERNATX, INC.-MOD-2021-103494 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103494:Patient's Case
Possible seizure or syncope, patient wasn't able to stand for a second, then when mom picked her up she felt a little shake from patient. Spoke to mom about a hour later and next day, she said patient is fine, patient acted normal and also slept fine.
experienced a fever after her first; headache; fatigue,; achiness; This is a spontaneous report from a contactable consumer or other non hcp.   A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (age at vaccination 43 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Caller also states that she experienced a fever after her first does but it was "not that bad" and also reports "I had all the other symptoms that are listed in terms of headache, achiness, fatigue, and blah blah blah."  Caller is just concerned about the fever being this high and would like to know how long it is expected for this fever to last. Caller would like to know what medication would recommend to take to help with the fever, as far as Ibuprofen or Tylenol. Outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
4JUN96 pt exp puffy eyes bilat, rash on stomach, ears & face;pt given DPH w/resolution;pt ate but would not stand on leg-circumference 1 1/2" bigger;no breathing problems as reported by mom;sent to ER-dx probable hematoma
This case was reported by a consumer via call center representative and described the occurrence of hives in a elderly patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hives, papular rash and itchy rash. On an unknown date, the outcome of the hives, papular rash and itchy rash were unknown. It was unknown if the reporter considered the hives, papular rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for themselves. The patient stated that they just had the 2nd dose of SHINGRIX and besides the common side effects, they experienced hives, 3 small raised bumps, no colour to them, slight itch. The patient inquired whether they should see the doctor.
Fever,  chills, fatigue, malaise, soreness, stiffness, flu-like:  4 days
PAIN AT THE INJECTION SITE; BURNING AND TINGLING SENSATION ON RIGHT ARM; BODY ACHES; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS), INJECTION SITE PAIN (PAIN AT THE INJECTION SITE), ARTHRALGIA (BURNING AND TINGLING SENSATION ON RIGHT ARM) and PAIN IN EXTREMITY (BODY ACHES) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension and Stroke.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced CHILLS (CHILLS), INJECTION SITE PAIN (PAIN AT THE INJECTION SITE), ARTHRALGIA (BURNING AND TINGLING SENSATION ON RIGHT ARM) and PAIN IN EXTREMITY (BODY ACHES). At the time of the report, CHILLS (CHILLS), INJECTION SITE PAIN (PAIN AT THE INJECTION SITE), ARTHRALGIA (BURNING AND TINGLING SENSATION ON RIGHT ARM) and PAIN IN EXTREMITY (BODY ACHES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
vomiting, muscle aches, appendicitis. All symptoms started 2 days after injection
Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            No concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-427829 (Patient Link).
t103.5, vomiting, chills, ?joint, pains got 3L, iv fluids, then felt fine 36hrs; ingested 6 beers evening of 6JUL95;
Fever; very sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "very sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: On 10Sep2021 at 10:37 AM Est, about a possible side effect with their young child aged between 5-11 years. Child was in the Clinical study for the Covid vaccine at (name withheld) and got a fever and rash. Pfizer employee later clarifies that it was reported the child had got a fever and very sore arm, no rash. Pfizer employee was contacted through (withheld). Stated reporter does not provide her contact number or address in the message and he has not let her know any response or that he was providing this to Pfizer. States the message just asks how everything was going with him and informed him that she believes her child, (Name), got the vaccine because he developed a fever and a very sore arm the next day. He was to get the second dose on 22Sep2021. No further details provided.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 18SEP95 & 11APR96 11 days following known exposure to varicella, pt exp minimal itching & a rash described as 6 varicelliform, red macule typical lesions reaching a total of 20 lesions by 17APR96;no fever or constitutional sx
Grandmother reports patient developed rash on Friday 5/21/10 that they thought was poison ivy and fever/fatigue by Sunday 5/23/10. Patients feet were swollen with "knots on soles feet; hands also swollen and patient could not walk. Went to ER; diagnosed with allergic reaction with prescription given.
3/24 - day of injection: numbness tingling in fingertips (brief, several times).  4/2 - around 4pm right arm started very mild swelling (injected in left arm), 4/3 - right hand and arm mildly painful. 4/5 - wrist & finger joints a little stiff & swollen in both hands and skin feels tight. 4/7 - joints stiff & swollen in hands/arms/feet/ankles, moderate pain. Interfering with work. Tried antihistamine medications (benadryl and a zyrtac generic and aspirin on different occasions - no noticable help).  4/9 - emailed my doctor concerned. Feet and hands considerably swollen, very uncomfortable and painful. Adjusted salt intake, started hydrating more and checked vitals. 4/11 swelling down but moderate pain continues, very stiff especially in the mornings, don't have full normal joint range.  Trying ibuprofen, only a little help.  Continues to date: mornings particularly bad, unable to work until later in the day (normally a morning productivity person). 4/19 added allieve instead of ibuprofen which seems to help more but not a lot.  4/20 - Moderna booster/2nd shot. Lot 045B21A same location, 2:45pm, approximately. Same occasional numbness in 2 fingers each hand that goes away quickly same day as vaccine.  4/22 - can barely write in the mornings, and have to keep stopping every few words.  Hands fatigue quickly.
I had a headache, aching neck and shoulders, fever and chills for about a month. Then I had a seizure on 06/23/2014 and that resulted in a 5 day hospital stay. I was diagnosed aseptic meningitis. I had several other seizures while in the hospital and then seizures on 7/5/2014, 7/9/2014 and 1/14/2015. I have to take Keppra 1000 mg per say to control the seizures. I have memory loss during the hospital stay and troubles with memory in general now.
TIRED; SLEEPING A LOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced tired. On 09-MAR-2021, the subject experienced sleeping a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and sleeping a lot. This report was non-serious.
chills; headache; felt extremely tired; felt lousy and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Medical Information Team. The reporter is the patient.  An 80 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 17Feb2021 (Batch/Lot number: unknown) at the age of 80 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Congestive heart failure" (unspecified if ongoing); "COVID-19", start date: Mar2021 (unspecified if ongoing), notes: had COVID last March. Concomitant medications included: BISOPROLOL taken for cardiac failure congestive; LISINOPRIL taken for cardiac failure congestive; SPIRONOLACTONE taken for cardiac failure congestive; CALCIUM; and Vitamins.  The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "felt extremely tired"; MALAISE (non-serious), outcome "unknown", described as "felt lousy and tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
23-year-old-male presented for a Moderna COVID-19 vaccine. The patient was seated with his feet planted firmly on the floor. Immediately following vaccination, the patient had some blood running down his arm. I reached for a cotton swab to apply pressure and stop the bleeding, but the patient began to faint. I immediately positioned myself next to the patient; and held his head and arm to keep him in a sitting position. The patient regained consciousness after about twenty seconds. I began talking with the patient to ensure it was only a fainting spell. The patient was groggy but became clear-headed after about a minute. Upon further discussion, the patient stated this happens every time he sees blood, has bloodwork done or receives vaccines. The patient recounted a time when he cut his hand at work and fainted immediately. The patient was doing deep breathing exercises immediately after regaining consciousness. When asked, he said it helps him focus. I asked the patient if he wanted us to call anyone to pick him up but he refused. The patient was advised to remain seated, and we would transition him to the waiting area once he felt stable enough. After about 5 minutes the patient was helped to the waiting area (from our counseling room about 10-15 feet away). I advised him to remain in the waiting area for 30 minutes for further monitoring. The patient was offered juice, water and a snack but declined. After the 30 minute waiting period, the patient was clear-headed and appeared to be in the same state as when he arrived for the vaccine.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On 26-MAR-2019, the improperly stored and administered GARDASIL 9 intramuscularly, lot number R008163, expiry date 18-NOV-2020 (anatomical location, strength, dose and frequency were not reported) for prophylaxis, underwent a temperature excursion prior to being administered to the patient on 29-MAR-2019. The administered dose of the GARDASIL 9 experienced a temperature excursion of -28.94 degrees Celsius (C) for 30 minutes, as recorded by a data logger. With no previous reported temperature excursion. There were no known adverse effects reported. No product quality complaint was involved.
VACCINE WAS ADMINISTERED PRIOR TO PATIENT LOSING CONSCIOUSNESS. CAME ROUND AFTER A FEW SECONDS. REPORTED DIZZINESS, DENIED SHORTNESS OF BREATH, OR SWELLING. 911 WAS CALLED. EMS ATTENDED TO PATIENT.
Shoulder pain and motor deficit later definitively diagnosed as a rotator cuff tear--complete supraspinatus tear on 1/10/2014, with subacromial bursa fluid and muscle atrophy.
Pt recvd vax on 8OCT92 & 24 to 48 hrs later exp severe h/a & flu-like sx in neck & shoulders; no further details were provided;
Starting day of the shot, I had arm soreness.  Starting day January 30th I developed a rash. Its mildly annoying.
injection site pain that  got worse through the days and got resolve.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain that  got worse through the days and got resolve.) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014f21a) for COVID-19 vaccination.     The patient's past medical history included Pericarditis (hospitalized due to pericarditis from 24-DEC-2018 to 25-DEC-2018) in December 2018. Concomitant products included LIOTHYRONINE, ANAKINRA and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, the patient experienced VACCINATION SITE PAIN (injection site pain that  got worse through the days and got resolve.). At the time of the report, VACCINATION SITE PAIN (injection site pain that  got worse through the days and got resolve.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-423677 (Patient Link).
Patient states 1 week after injection right arm became painful; top of shoulder to hand. Loss of motion and weakness. Went to ER. R arm improving now.
3PM BURNING SENSATION IN THE EYES; DRY MOUTH; CHILLS/NO FEVER
Information has been received from a 65 year old retired female physician with no pertinent medical history, seasonal allergies and a history of herpes simplex who on 27-NOV-2007 was vaccinated intramuscularly into the arm with a "single vial dose" of ZOSTAVAX.  There was no concomitant medication.  On 01 FEB 2008 (also reported as 31-JAN-2008) the patient "broke out with a herpes simplex sore", (also reported as a "cold sore" and "fever blisters").  The physician prescribed the ZOSTAVAX for herself.  No other symptoms or treatments were reported other than unspecified topical ointments to "the cold sore".  On approximately 13 FEB 2008, after a two week duration, the patient had recovered.  There was no product quality complaint.  Additional information is not expected.
Arm hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR031863   Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received 2nd dose of Shingles vaccine and the  arm  hurts a good bit more but that's about it. Additional Supportive Information: The follow-up could not be possible as no contact details were available. This case had been linked with US2023AMR031863, reported by the same reporter. This case was conservatively kept valid, as per narrative.; Sender's Comments:  US-GSK-US2023AMR031863:Same reporter
5 inch welt on L side along ribs, tingling in left arm and leg x 24 hours - symptoms resolved in 24 hours.
loss of taste; loss of smell; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Aug2021 (Batch/Lot number: unknown) at the age of 65 years 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, Pfizer Covid vaccine), administration date: 21Jun2021, when the patient was 65 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; AGEUSIA (non-serious), outcome "unknown", described as "loss of taste"; ANOSMIA (non-serious), outcome "unknown", described as "loss of smell".  Additional information: Caller reported side effect of loss of taste and smell after getting the 2nd dose. Caller was asking if there is anything they can do about the side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.
no additional adverse effect reported; a patient was administered an expired dose of PNEUMOVAX 23; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 22-APR-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R002354, expiration date: 17-DEC-2019 (strength, dose number, dosing schedule and route of administration were not reported) for prophylaxis. No additional adverse effect reported.
The patient is a 23 year old female, PMHx , presents to the ER c/o intermittent L sided chest pain and arm pain/paresthesias x 3 weeks. States to become more short of breath with exertion with gradual increased swelling of extremities, and gradual weight gain.
This spontaneous report was received from a licensed practical nurse and refers to approximately 20 patients of unknown age and gender. Patient's demographics, concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot # K005958 and L018499 expiry date 09-FEB-2017 and 25-FEB-2017. No adverse effects were reported. This was one of several reports received from the same source. Additional information has been requested.
skin rash that first appeared on both ankles, then spread to feet, up the legs, back of arms and hands; This is a spontaneous report from a contactable consumer (patient). A 82-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EM9809), dose 2 via an unspecified route of administration, administered in arm left on 17Feb2021 14:00 (at the age of 82-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. No other medical history. Concomitant medications included biotin, fluoxetine, indapamide, potassium and propranolol hydrochloride taken for an unspecified indication, start and stop date were not reported. Historical vaccine of BNT162B2 (lot number: EL9262) for COVID-19 immunisation on 27Jan2021 at the age of 82 year in left arm as first dose. Prior to vaccination patient was not diagnosed with covid 19 and not tested for covid since the vaccination. On 20Feb2021 10:00 the patient was experienced skin rash that first appeared on both ankles, then spread to feet, up the legs, back of arms and hands. The treatment was not received. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Next morning, site was red and had a blister about the size of a pencil eraser.  Blister went down and then arm was red about the size of a quarter.  Arm was red and itchy.  Itchiness started spreading down entire arm by day 2.  Arm is swollen under elbow with a burning sensation from neck to lower arm.  Feels worse during bathing.
Patient presented to the ED with acute cystitis without hematuria and was subsequently hospitalized for hypokalemia within 6 weeks of receiving COVID vaccination.