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 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient has not received any other medication in 2 weeks.
HEAVY BREATHING EVEN IF JUST TALKING/SHORTNESS OF BREATH; HEADACHES; HEAVINESS IN CHEST/FEELS LIKE SOMEONE IS SITTING ON MY CHEST; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced heaviness in chest/feels like someone is sitting on my chest. On 02-APR-2021, the subject experienced heavy breathing even if im just talking/shortness of breath. On 02-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy breathing even if  just talking/shortness of breath, and the outcome of headaches and heaviness in chest/feels like someone is sitting on my chest was not reported. This report was non-serious.
After first Moderna vaccine had spotting and hotflashes. Three days after second moderna vaccine had vaginal bleeding for 21 days
This spontaneous report as received from a pharmacist refers to a 73 year old male patient. No medical history or drug reactions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # J001700, exp. date: 08-MAY-2014) (Dose and route not reported) in the left deltoid. On 20-JUL-2013, the patient experienced swelling around the injection site and fever after receiving ZOSTAVAX. The patient spoke to the pharmacist. The events were treated with Ibuprofen (manufacturer unknown) and BENADRYL. The outcome of swelling around the injection site and fever after receiving ZOSTAVAX was unknown. Additional information is not expected.
Tingle sensation in the index finger all up to the middle finger; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Tingle sensation in the index finger all up to the middle finger) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced PARAESTHESIA (Tingle sensation in the index finger all up to the middle finger). At the time of the report, PARAESTHESIA (Tingle sensation in the index finger all up to the middle finger) outcome was unknown.        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 information was provided by the reporter. No concomitant medication  information was provided by the reporter.
Pt came to ER c/o cough, congestion, headache, SOB, and fever x 4 days.
(L) arm pain, swelling (site of injection). Mild wheezing noted. Flu like symptoms, fever x 24 hours.
pt recv vax 23MAY97 & that same day  exp swelling the size of an egg & warmth @ the inj site;no erythema was noted @ the inj site;
Sweating; it's hurting; Enitre body ache; A spontaneous report was received from a consumer concerning a 29-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced left arm hurting(pain in extremity), entire body ache (pain) and sweating (hyperhidrosis).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Meloxicam and Buspirone Hydrochloride.   On 05 Jan 2021, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient's husband reported that she received the Moderna vaccine on 05 Jan 2021.  That day, he stated that her arm hurt and that she was having generalized aching.  The next morning, 06 Jan 2021, he reported that she was sweating.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, left arm hurting, entire body ache and sweating, was not provided.   The seriousness criteria for all event was not reported.  The outcome of the events, left arm hurting, entire body ache and sweating was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
I had a partial hysterectomy because of endometriosis in June of 2020. I was pain free without any major complications until May 16th when I had crippling abdominal pain on both sides requiring an ambulance ride to the emergency room. Pain started around noon that day and was extremely intense. Scans were done, labs were run and meds were given. Nothing major to report except for endometriomas on each ovary. The only explanation is that my endo had come back and to follow up with my GYN. I did follow up with him and it was confirmed they indeed it was back and we needed to do another surgery to alleviate the pain. Once he got inside he found more endo growing in the areas that he had already excised during my hysterectomy. He removed the endometriomas, a cyst and burned what he could see of the endo. I am now approx 8 weeks post op and my pain is still extremely bad. I am going to a specialist for an additional surgery consult in 3 weeks. The only thing that had changed is the COVID injection.
Information has been received from a nurse practitioner concerning a female who on 18-JUN-2007 was vaccinated IM with Gardasil and fainted after receiving the injection. No further information is available.
Feeling weak; Ill; Temp of 100.2; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak), ILLNESS (Ill) and PYREXIA (Temp of 100.2) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Organizing pneumonia. Concurrent medical conditions included COPD.    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 ASTHENIA (Feeling weak), ILLNESS (Ill) and PYREXIA (Temp of 100.2). At the time of the report, ASTHENIA (Feeling weak), ILLNESS (Ill) and PYREXIA (Temp of 100.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) high.         No concomitant medication was provided.  No treatment medication was provided.
Per Nurse documentation in pt chart on 6/10/15: Wife said husband has had a fever that evening and the next morning after receiving a vaccine. Wife said PRC told her the vaccine was PCV13. Wife said he had had a fever all week, could hardly walk, he was struggling to breathe. She said she did not take him to the ER. Wife said today he is resting, is a tad bit better. She said his breathing is a little bit better today. Wife spoke to daughter in the background and she said breathing is about the same. She said she knows to call 911 if needed. Advised wife that husband to be evaluated in ER now. Daughter got on phone she said dad has COPD. Daughter said SATs down to 90 percent on room air yesterday, and SATs better today. She said they will bring him in to ER.
ACUTE STROKE OF BASAL GANGLIA, UNSPECIFIED TYPE AND ARTERY 4/11/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE RESPIRATORY FAILURE 4/11/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
PATINET HAD BLISTERS ON LEFT ARM,NECK AND ON THE BACK.INJECTION SITE WAS SWALLEN RED AND INFLAMMED.PATIENT DIDNT TOOK ANY MEDICATION FOR THE TREATMENT.PATIENT STILL HAVE ITCHING ON LEFT SIDE.WE CALL HER DR AND THEY OFFER HER TO COME TO SEE A DOCTOR.
after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after expiration date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 023M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (after expiration date). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-406176 (Patient Link).
One of her grandchildren also got the vaccine and mentioned that she got "hit by a mad truck" but was okay in a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "One of her grandchildren also got the vaccine and mentioned that she got "hit by a mad truck" but was okay in a few days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 person died after regular shots; 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 DEATH (1 person died after regular shots) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were provided by the reporter.  No treatment information details was provided by the reporter.  It was reported that one person died after regular shots and reporter thinks it was moderna vaccine but was not sure about it.  This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the expected fatal event of Death, with no cause of death provided. The event occurred at an unknown date after a dose of Spikevax (unknown dose). The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-332581 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the expected fatal event of Death, with no cause of death provided. The event occurred at an unknown date after a dose of Spikevax (unknown dose). The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Arm is warm; Arm is painful to the touch; Had a blister on arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm is warm), PAIN IN EXTREMITY (Arm is painful to the touch) and BLISTER (Had a blister on arm) 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 FEELING HOT (Arm is warm), PAIN IN EXTREMITY (Arm is painful to the touch) and BLISTER (Had a blister on arm). At the time of the report, FEELING HOT (Arm is warm) and PAIN IN EXTREMITY (Arm is painful to the touch) had not resolved and BLISTER (Had a blister on arm) was resolving.            No concomitant medication was reported by the reporter.  Patient received the booster dose on Saturday and by Sunday patient had bister on arm.  No treatment medication was reported by the reporter.
ill-defined disorder; shingles; Information has been received from a lawyer, regarding a case in litigation, and referred to a elderly male patient (pt) of unknown age.  No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 29-APR-2014, the pt was inoculated, by a pharmacist, with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.On an unknown date (reported as "subsequently"), the pt experienced shingles and other zoster-related condition (Ill-defined disorder); and was treated by a healthcare provider (unspecified).  The outcome of the events was not reported. The reporter consider the events to be related to zoster vaccine live (ZOSTAVAX).
A 17 Year old boy, received his first dose of COVID -vaccine, Pfizer. He walked out of the health room feeling fine. Stood outside in  the waiting room talking to his mom during his 15 min observatory period.  within 10 mins, he fainted and fell on his face on  the floor. Till the pharmacist came out to him, the pharmacist kept tapping his shoulder and called his name out loud, he recovered and woke up. pharmacist checked his BP and was 121/71 and 68 HR. 911 was called , and paramedics came in,  checked his vitals and all were normal . He just hit his chin when he fell, and bled from his gum, no loose teeth reported and  a chin wound that might  need glue stitches per paramedics. Patient was fine and talking when paramedics transported him to the hospital.
10.5 erythema and induration , with 11 mm ulceration centrally. Robitussin Taken.
This spontaneous report was received from an other health professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (dose and lot number not reported) were administered by a clinic. No adverse effects were reported. Additional information has been requested.
PATIENT SAID FELT LIKE FAINTING AND STARTED SHAKING.  SINCE NOT FEELING BETTER WE CALLED EMS.
fever to 101.4, arm pain, swelling 10 days  p/vax;devel rash 14 days out;resolved 16 days out;
Starting itching on both arms and both legs. After itching noticed fine rash to arms, lower extremities and inner thighs.
Pt fainted when checking out from the office after vaccination, she started to fall towards her mother, who gently lowered her to the floor. Pt awakened within 5-10 seconds and was alert within a few seconds. She remained supine for another 1-2 minutes and drank some water. Pt stated she had not eaten anything since awakening that day. She subsequently was able to get up to sitting for a few minutes, then standing and left the building ambulating on her own without any further symptoms.
On day 2 I developed an immune response which included, headache, chills, fatigue, myalgias.  In addition to that the entire deltoid area was red, itchy, and swollen with intermittent pain that radiated to the wrist and lasted through the week.
Below and above normal temperature, headache, lower back ache, general body ache, nausea, insomnia.
Information has been received from a nurse practitioner concerning a 16 year old female with a sulfonamide and NSAID allergy and a history of osteomyelitis who on 17-DEC-2006 was vaccinated with a first dose of Gardasil (lot # 654389/0961F) 0.5mL IM. On 19-FEB-2007 the patient was vaccinated with a second dose of Gardasil (lot # 656049/0187U) 0.5mL IM. Concomitant therapy included hormonal contraceptives (unspecified). On both occasions the patient experienced throat closing sensation, neck stiffness and a burning sensation down her arm. Medical attention was sought. All symptoms lasted several hours and at the time of reporting the patient had recovered on both occasions. The patient has not received the third dose yet. No further information is available. Addition information has been requested.
Generalized vaccinia starting Day #10 following vaccination (major 1 hour reaction). 3 lesions noted. F/U visit 9/12/03 (Day #18) showed resolution of lesions.
Slightly sore arm- (3-4days); This is a spontaneous report from a contactable consumer (patient) received from a regulatory authority. A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, lot number: EM9809), intramuscular on 25Feb2021 as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, lot number: EN5318), via an intramuscular on 04Feb2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experience slightly sore arm- (3-4days). The outcome of event was unknown.  No follow up attempts are needed; information on Lot/batch cannot be requested.  Follow-up (09Apr2021): This is a follow-up spontaneous report received from a contactable consumer. Updated information included patient's age, second dose information, route of administration, new event added as slightly sore arm, missed dose event deleted, vaccine facility information, lot numbers for both doses,   No follow-up attempts are possible. No further information is expected.
Mild pain at injection side; Chills; fatigue; muscle aches; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 11Feb2021 15:15 (at the age of 37-years-old) as dose 2, single for covid-19 immunization at workplace clinic. The patient medical history was not reported. Concomitant medication included valacyclovir [valaciclovir] taken for an unspecified indication, from an unknown date. Other medications received in two weeks included valacyclovir. The patient historical vaccine included first dose of BNT162B2 (lot number: EL3247, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 21Jan2021 03:15 PM (at the age of 37-years-old) as dose 1, single for covid-19 immunization. The patient does not have any allergies. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 12Feb2021 11:45 AM the patient experienced mild pain at injection side. Chills, fatigue, muscle aches the day after the second dose. Patient did not receive any treatment for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Starting about 2 weeks after the second shot, I experienced intense episodic vertigo.  Most of the time I had the sensation of spinning on my long axis.  Triggering vertigo was somewhat random at first. Frequency and intensity gradually decreased, and then triggering of vertigo seemed to correlate with major changes in position. Eventually it occurred only when I was lying down and switched position from lying on one side to lying on the other (i.e., from left decubitus to right decubitus, or vice versa). Symptoms finally stopped in early May, so duration of symptoms was about 3 months.  Very similar symptoms happened when I think I had COVID infection in February 2020 (not confirmed by a test, but the symptoms were consistent)--at that time, about 2 weeks after my initial symptoms, when the infection symptoms were almost gone, I started having similar intense vertigo.  The difference the first time around was that the symptoms lasted only about a month.   In addition to what I have described above, I had the more expected symptoms of fever, anorexia, intense migraine, intense migrating arthralgias, fatigue, and muscle pain in the neck and shoulder area. That started 12 hours after the shot and went on for 3-4 days. I experienced similar symptoms of lesser intensity and duration following my first COVID shot (12/30/20).
Headache, Chills, Nausea, Diarrhea, Malaise