chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: PT WAS WAITING AFTER GIVEN THE PFIZER VACCINE AROUND 1750. HE WAS SNORING WHEN HE SUDDENLY FELL FORWARD AND WAS UNCONSCIOUS AND UNRESPONSIVE FOR ABOUT 30 SECONDS TO 1 MINUTE. WE FLIPPED HIM TO HIS BACK AND HE WOKE UP. 911 WAS CALLED. PT REPORTED OF HX OF FAINTING WHEN DEHYRATED AND DOES NOT EAT FOR A WHILE. LAST MEAL WAS AROUND NOON  PER PT.
Red patch and it was itchy; Tender to touch injection site; Pain in my arm, sore - (left arm) vaccination site.; Redness - (left arm) vaccination site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in my arm, sore - (left arm) vaccination site.), VACCINATION SITE ERYTHEMA (Redness - (left arm) vaccination site.), RASH PRURITIC (Red patch and it was itchy) and TENDERNESS (Tender to touch injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in my arm, sore - (left arm) vaccination site.), VACCINATION SITE ERYTHEMA (Redness - (left arm) vaccination site.) and TENDERNESS (Tender to touch injection site). On an unknown date, the patient experienced RASH PRURITIC (Red patch and it was itchy). At the time of the report, VACCINATION SITE PAIN (Pain in my arm, sore - (left arm) vaccination site.), VACCINATION SITE ERYTHEMA (Redness - (left arm) vaccination site.), RASH PRURITIC (Red patch and it was itchy) and TENDERNESS (Tender to touch injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. concomitant medication was not provided.
Patient was hospitalized 15 days after receiving vaccine. Admission was not due to vaccine and was admitted for acute ascites and patient had reported fever and hypoxia. Patients admission resulted in death 7 days after being admitted to hospital.
(Rt) upper lateral thigh with 2x2 1/2 inch erythema surrounding injection site with mild warmth & induration.
Pfizer-BioNTech Bivalent COVID-19 Vaccine EUA: case resulting in invalid dose given Patient received Janssen vaccine on 3/10/21, Pfizer-BioNTech on 12/9/21, and Pfizer-BioNTech Bivalent Booster on 11/11/22. Pt received Pfizer-BioNTech Bivalent booster at 9:30AM, 12+ hours after dose was expired. Pt was monitored and no harm came to patient.
she is not feeling well; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 24Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient called to reschedule her second dose appointment tomorrow (as of 17Mar2021) because she was not feeling well. The clinical outcome of not feeling well was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
No adverse event; The dose was administered using a 5/8ths inch needle and was suspected to have been given not by intramuscular injection; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The dose was administered using a 5/8ths inch needle and was suspected to have been given not by intramuscular injection) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Dose 1), Pfizer COVID-19 vaccine (Dose 3) and Pfizer COVID-19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 17-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The dose was administered using a 5/8ths inch needle and was suspected to have been given not by intramuscular injection). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The dose was administered using a 5/8ths inch needle and was suspected to have been given not by intramuscular injection) 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 assessment was provided for INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The dose was administered using a 5/8ths inch needle and was suspected to have been given not by intramuscular injection).    No concomitant medications were provided. The patient received 4th dose of the Moderna COVID-19 vaccine on 16-Apr-2022.  No symptoms were reported. No additional doses, medications, or treatments taken at this time.
Noticed red puffy blotches on my left chest, which over the next several days increased and looked white capped and itchy. Skin in the area and on the left side was sensitive and had a warm sensation. I had an outstanding appointment to see my dermatologist, so I waited until 02/05/2010 to see him. He told me it was Shingles and prescribed an anti-viral medication. I saw him again today (02/12/2010) and the spots are diminishing but still there. Dr. said it might take another 10 days for them to completely clear. Actually getting Shingles from the shot is not on the list of possible side effects. Had I known that was a possibility I would not have taken the shot. Although the spots are diminishing, the skin remains sensitive to the touch and has a warm sensation, although it does not feel warm to the touch of someone else.
Information has been received from a licensed visiting nurse concerning her 16 year old female grandchildren with allergy to NYQUIL and no medical history who in approximately 31-DEC-2001 ("at the end of December 2001"), was vaccinated with a dose of VARIVAX (Merck). In January 2002, a classmate of the patient was diagnosed with chicken pox and was sent home on the school bus with the entire class. At some unspecified time after the patient's exposure to her classmate, the patient along with "all of the other children on the bus" developed chicken pox. The nurse was concerned about vaccine failure not transmission. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. The nurse also stated that she developed chicken pox after being exposure to the patient (WAES # 1007USA01768). This is one of several reports received from the same source. Additional information has been requested.
Hard and red around injections. High fever 103+4 crying for hours on and off. Concern about poor muscle. Holding her arms straight out behind her back when sitting or standing. Muscles twitching/body tremors. Sleep patterns disturbed. Ongoing floppy legs (loss of muscle tone). The next night - I noticed 15 minutes approx. res. onset of chronic respiratory problems/infections (seen by doc a month later for viral URI w/cough). Later, ear pain, infections/water always on ear etc. Screaming episodes lasting 15 to 30 minutes for 2-3 weeks after shots.
SM received Anthrax vaccination on 5/10/07. C/O of lump and pain upon touch.
Severe constanst pain in right arm that extends from upper shoulders to fingers. Some swelling 11 weeks pregnant at time of vaccine given Treatment of pain with lidocaine patches in addition to the tylenol. Patient also was referred to physical therapy
Myalgia, Fever FATIGUE, RIGGERS, INSOMNIA Narrative:
no adverse event---administration only. Patient needed to be 18 yrs old to receive vaccine and was only 17 at time of administration.
4 DAYS OF ACHES; 4 DAYS OF FEVER; MANY DAYS OF FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced 4 days of aches, 4 days of fever, and many days of fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 4 days of aches, and 4 days of fever, and the outcome of many days of fatigue was not reported. This report was non-serious.
Patient is reporting a knot in her left deltoid about the size of an egg at the injection site. It does not hurt or have any symptoms other than feeling like a "knot" in her arm.
I had typical side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had typical side effects) 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 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (I had typical side effects). At the time of the report, VACCINATION COMPLICATION (I had typical side effects) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-035647 (Patient Link).
This case was reported by the patient mother and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received KINRIX. In June 2014, the patient received KINRIX. In June 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX. Additional information: The patient received a dose of KINRIX vaccine when he was 4 month old. The patient mother believed that the vaccine was given in June 2014. KINRIX was recommended for children from 4 to 6 years.
Administration date of Moderna vaccine past the BUD; previously received 1 dose of a non-WHO approved vaccine (Convidecia); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and INTERCHANGE OF VACCINE PRODUCTS (previously received 1 dose of a non-WHO approved vaccine (Convidecia)) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and INTERCHANGE OF VACCINE PRODUCTS (previously received 1 dose of a non-WHO approved vaccine (Convidecia)). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and INTERCHANGE OF VACCINE PRODUCTS (previously received 1 dose of a non-WHO approved vaccine (Convidecia)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.   This case was linked to MOD-2021-320876 (Patient Link).
CHF ( Congestive Heart Failure ); cardiac myopathy; This spontaneous case was reported by a health care professional and describes the occurrence of CARDIAC FAILURE CONGESTIVE (CHF ( Congestive Heart Failure )) and CARDIOMYOPATHY (cardiac myopathy) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (CHF ( Congestive Heart Failure )) (seriousness criteria hospitalization, medically significant and life threatening) and CARDIOMYOPATHY (cardiac myopathy) (seriousness criteria hospitalization, medically significant, life threatening and intervention required). The patient was treated with CARVEDILOL for Adverse event, at a dose of 6.25 milligram; FUROSEMIDE (LASIX [FUROSEMIDE]) for Adverse event, at a dose of 40 milligram and ROSUVASTATIN CALCIUM (CRESTOR) for Adverse event, at an unspecified dose and frequency. At the time of the report, CARDIAC FAILURE CONGESTIVE (CHF ( Congestive Heart Failure )) and CARDIOMYOPATHY (cardiac myopathy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight increased: gained 19lbs (High) gained 19lbs and gained weight one month later (High) gained weight one month later. On 09-Aug-2021, Weight increased: lost 11 lbs (Low) lost 11 lbs.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter stated that shortly after the first dose (around end of June), patient experienced swelling his legs, shortness of breath and gained 19 lb. weight. Lasix was prescribed as a treatment on 09Aug2021 and patient lost 11 lb. while he was on Lasix. One month later from his office visit, when patient finished taking his Lasix, patient gained weight again and ended up in a hospital where he was diagnosed with CHF (Congestive Heart Failure) and cardiac myopathy.  Company comment: This case concerns a 57-year-old male patient with no relevant medical history, who experienced the unexpected, serious and AESI events of Cardiac failure congestive and Cardiomyopathy. Time to onset from vaccination was not reported. The rechallenge was not applicable. The benefit-risk relationship of the vaccine is not affected by this report. Further information is expected.; Sender's Comments: This case concerns a 57-year-old male patient with no relevant medical history, who experienced the unexpected, serious and AESI events of Cardiac failure congestive and Cardiomyopathy. Time to onset from vaccination was not reported. The rechallenge was not applicable. The benefit-risk relationship of the vaccine is not affected by this report. Further information is expected.
The pt complained of a red, swollen, painful to the touch, hardened area at the injection site. No other symptoms.
LOCALIZED ERUPTION ON LEFT UPPER ARM ABOUT 4 DAYS AFTER VARICELLA VACCINE.  BLISTER LIKE LESION WITH SEVERAL SMALL RAISED LESIONS AROUND IT.
Employee developed numbness and tingling in the right arm down to her fingertips. She continues to have this on and off daily.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Negative, notes: Tested negative on day 5 of Paxlovid treatment; (28Jul2022) Positive, notes: Tested positive 5 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 19Jul2022 till 23Jul2022. Clinical course: No known allergies. Patient received paxlovid for Treatment of COVID-19. Patient tested negative on day 5 of Paxlovid treatment and tested positive 5 days later. Patient did not had any other medication in 2 weeks. Patient was on day 3 of rebound case experiencing very mild symptoms: some sinus pressure and runny nose.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache Pain at sige for one day, fatigue, chills for day 2-3. Narrative:  Other Relevant History:
30 minutes after receiving vaccine my arms abdominal and legs began itching and had red patches like hives. I ignored this and continued working. Then insides of my ears began itching. I told the pharmacy techs that were qt my place of work administering the vaccine. They gave me 50mg of benadryl, at that time my eyes had begun to itch and started coughing. Pulse rate was 160. No shortness of breath and no tongue swelling. They offered an epipen but as a nurse myself I declined and wanted to wait to see if benadryl would be effective. I was monitored for an hour. By the end of the hour I was not coughing, my eyes and inner ears had stopped itching and my pulse was back below 100. I still had hives and moderate itching to my body which resolved about 2 hours after taking benadryl.
High blood pressure; Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure) and TACHYCARDIA (Rapid heart rate) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced HYPERTENSION (High blood pressure) and TACHYCARDIA (Rapid heart rate). At the time of the report, HYPERTENSION (High blood pressure) and TACHYCARDIA (Rapid heart rate) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.
Patient complains of pain upon receiving vaccine.  Called the next day stating she could not sleep or move her left arm, stabbing pain.
Mild to moderate nausea for a couple of days; fatigue for a week; belly pain and diarrhea for a few days; and increased joint pain for a few days.
Covid symptoms and positive covid test 3 weeks after having received 3rd booster.  Symptoms cleared in 2 1/2 weeks but then developed bronchitis during last week of Oct. 2022.
Suspect an allergic reaction; Rash; Shortness of breath; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 38-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: unspecified) via unspecified route in the left arm, as 1ST DOSE, SINGLE DOSE on 05May2021 for COVID-19 immunization (at the age of 38-years). The due date for the next shot was 02Jun2021. The patient medical history was not reported. Concomitant medication(s) included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient stated that he suspects an allergic reaction, he was not sure if it was. The patient also experienced rash and shortness of breath on an unspecified date. The patient did not receive any treatment for the events. The clinical outcome for the events was unknown.  No follow-up attempts are needed. Information on lot/batch number has been requested.
Severe itching; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe itching/pruritus.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) severe itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), severe itching was unknown.
COULDN'T SLEEP AT NIGHT; ACHES; CHILLS; FEVER; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical conditions, not on any medications. no history of irregular heart beat.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced irregular heart beat. On an unspecified date, the subject experienced couldn't sleep at night, aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and fever, had not recovered from irregular heart beat, and the outcome of couldn't sleep at night was not reported. This report was non-serious.
Employee states that within 15-20 minutes after receiving the vaccine, she began experiencing dizziness. The next day she experienced nausea, vomiting, vertigo and weakness and low blood pressure. These symptoms continued for approx. 3 days.
Patient reported feeling dizzy 10 minutes post-administration of first Pfizer dose. Had patient sit down and take off mask to make sure patient is breathing adequately. Took patient's blood pressure twice; both WNL 5 minutes apart. Provided patient with some water and snacks while he was waiting in our facility for 30 minutes. Then patient and his sisters decided to leave afterwards.
Patient waited 15 min after vaccine administration with no signs or symptoms. Patient was cleared and left clinic. Patient returned to clinic 15 min after leaving with complaints of headache, nausea, chills, cold sweats. Patient also had an elevated blood pressure of 147/87. Patient was transported to hospital via EMS at 0910.