chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  An elderly male patient received BNT162b2 (BNT162B2), on 26Feb2022 as dose 4 (booster), single (Lot number: FL3209), in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypercholersterolemia" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN oral, start date: 01Jan2022, stop date: 24May2022; ROSUVASTATIN oral, start date: 01Jan2022, stop date: 06May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: COVID relapse, notes: low cycle threshold  on PCR testing. Therapeutic measures were taken as a result of covid-19. Clinical Course: Anti-viral details, covid-19 Treatment was Paxlovid started on 07May2022 to 11May2022. Covid relapse 5 d after d/c Paxlovid with low cycle threshold on PCR testing.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
PT RECEIVED MODERNA FIRST DOSE AND PFIZER SECOND DOSE ON 5/13/21
Heart palpitations/racing heart rate when not active; Heart palpitations/racing heart rate when not active; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0179) via an unspecified route of administration in the left arm on 29Apr2021 at 09:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. 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. On 08May2021 at 20:00, the patient experienced heart palpitations/racing heart rate when not active. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with unknown medications and also monitoring heart activity with wearable device. The clinical outcome of the events heart palpitations/racing heart rate when not active was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Initial and gradual onset of normal symptoms began 12 hours after receiving the vaccine and included fever, chills and aches during day one. On day two the aches intensified, particularly on my left side, deep in my glute and calf muscles. My head and ears throbbed with each heartbeat. On day three the "normal" symptoms subsided, except for lingering deep muscle aches, light numbness in my cheeks, numbness, lack of dexterity in my left hand, and an intense, almost deafening ringing in my ears. Although I seemed to have full facial control, I drooled when I tried to eat. I immediately sought medical care at the local clinic about the...numbness and loss of dexterity.  The PA on duty found no signs of DVT and recommended I give a little more time for the symptoms to subside.  Over the next two days, all symptoms except the tinnitus subsided. The tinnitus is sometimes accompanied by vertigo, especially when I'm driving, and continues to this day (7 weeks). The ringing sensation is intense and interferes with my sleep and concentration. Occasionally there is a strange crackling, static-like "sound" (it's not really a sound - if I plug my ears it's still in my head), or an increase in volume of these "sounds" to the point where it's difficult to hear.   I have no prior health or hearing issues. I do not have above average stress at work or home. I do not suffer from anxiety or fear of needles or vaccines. The onset of tinnitus happened within 12 hours of receiving the vaccine and there has been no relief.   I visited an MD on 11/23/21. My doctor ordered an MRI to evaluate cause of vertigo and has referred me to an ENT.  She advised that I report this incident to VAERS.  On December 16, 2021 I visited the ENT,.  The audiology tests show my hearing is excellent and the tinnitus is not a result of damage to my ears. The audiologist was able to match the tone and verify the existence of the tinnitus and my inability to hear sounds in that same tonal range.  Since my inner and middle ears appear undamaged and my hearing is excellent, Dr. stated that nerve damage could be the cause of the intense tinnitus.
Dose one resulted in immediate hives, as the days and weeks went by the worse and more frequent hives occurred.  The second dose resulted in HR and BP issues with hives/rash.
Right upper arm where she received the vaccine was red; Right upper arm where she received the vaccine was swollen and puffy; Muscle aching; Right upper arm where she received the vaccine began to itch; Cramping in her feet and back of thighs; Mild soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping in her feet and back of thighs), PAIN (Mild soreness), VACCINATION SITE PRURITUS (Right upper arm where she received the vaccine began to itch), VACCINATION SITE ERYTHEMA (Right upper arm where she received the vaccine was red) and VACCINATION SITE SWELLING (Right upper arm where she received the vaccine was swollen and puffy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN (Mild soreness). On 05-Jan-2021, the patient experienced MUSCLE SPASMS (Cramping in her feet and back of thighs). On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Right upper arm where she received the vaccine began to itch) and MYALGIA (Muscle aching). On 10-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Right upper arm where she received the vaccine was red) and VACCINATION SITE SWELLING (Right upper arm where she received the vaccine was swollen and puffy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 10-Jan-2021 at an unspecified dose and frequency. On 11-Jan-2021, MUSCLE SPASMS (Cramping in her feet and back of thighs) and PAIN (Mild soreness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Right upper arm where she received the vaccine began to itch), VACCINATION SITE ERYTHEMA (Right upper arm where she received the vaccine was red) and VACCINATION SITE SWELLING (Right upper arm where she received the vaccine was swollen and puffy) was resolving and MYALGIA (Muscle aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: No new information, denied further follow-up; 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.
fever >102;vomited x 2;rash around mouth-mom states purple;antiemetic;
Myalgia, Fever,  Drowsy, pain injection site, low strength, Narrative:
pt recvd flu vax & pt devel nausea, headache, & diarrhea & reported moderate soreness @ inject site;
Pt recvd vax 8OCT92 & 22OCT92 exp pain, stiffness & swelling in wrists, hands & fingers; awakened several times; PE was unremarkable x/ swelling of fingers; lab eval revealed a pos ANA of 1:160; It was felt pt had delayed reaction to vax;
Myalgia, Fever & Nausea Vomiting  Narrative: Approx 12 hours after vaccine administration began to feel chills,  myalgias, nausea. Vomited overnight. Tmax reported as 105 at home (home oral  thermometer, digital). Headache as well. Out of work xl day at this point.  Managing at home with motrin and conservative therapy.
Incorrect route of drug administration PROQUAD vaccine, given IM not subcutaneous. No adverse reaction/event. Reported to Merck 8/26/15. Merck aware, MARRS#1508USA012135.
Pfizer COVID-19 Vaccine EUA  Patient received dose#1 Pfizer vaccine on 3/9/2021. Patient received dose #2 of Pfizer Vaccine on 4/6/2021. Approximately 25 minutes after dose #2, patients reported facial swelling, tongue swelling, burning, swelling lips, and stated difficulty swallowing.  Raspy voice was noted, as well. Epinephrine 0.3 mg IM administered, and patient subsequently transferred to Emergency Department. Upon arrival, patient was AAOx4, respirations were even and unlabored and patient was speaking in clear and complete sentences. No facial swelling noted and patient was maintaining airway and secretions.  Troponin was noted to be within normal limits, EKG without changes from prior.  Patient observed in ED for 4 hours without concerning symptoms.  Patient discharged home in stable condition.
only the adjuvant of Arexvy was administered to a patient; the adjuvant of Arexvy was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: only the adjuvant of Arexvy was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: the adjuvant of Arexvy was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The pharmacist reported only the adjuvant of Arexvy was administered to a patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Arm soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Headache (had headache prior to vaccine).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN on 12-Apr-2021 for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) outcome was unknown.            No relevant concomitant medications were provided.  Reportedly, the patient took ibuprofen 90 minutes after the vaccine for a headache which he had prior to the vaccine. No treatment information (for the events) was provided.
Heart rate went from my resting heart rate to 160 very quickly in about 2 mins. Noticed on apple watch.
PT COMPLAINED OF FEELING SICK, SWEATING, ACHES, AND PAIN AT INJECTION SITE.
Fully vaccinated patient admitted to hospital and tested positive for COVID.  Admitted for intoxication to ICU.  History of unmedicated schizophrenia.  No s/s of COVID.
Information has been received from a RN concerning an adult (age and gender unk) pt who within the last six months, on an unk date was vaccinated (route unk) with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot650329/0747P). Subsequently, within the last six months on an unspecified date, the pt developed an injection site reaction which included pain, redness, swelling and local heat. Unspecified medical attention was sought. Subsequently, on an unspecified date the pt recovered. No product quality complaint was involved. A lot check has been requested. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. Additional information has been requested.
High fever and rash. Pt was seen by Dr on 3/31/06 with high fever and rash.
2/9/22 pt found on the ground in the cold by his brother; brought to ED; states was diagnosed with COVID ON 2/4/22 by Clinic; hypothermic; dysphagia, has PEG tube but has pulled it out; severe protein calorie malnutrition with recent 30# weight loss; confused at times; family decided to transition pt to hospice and comfort care; pt expired in the hospital
After the shot I had soreness at the site for about two days. Approximately a week after the shot, I am experiencing an itchy rash that is circular, on inspection sort of like ringworm. Have not sought medical treatment at this time. Continues to itch.
pt recv vax & 20min p/vax c/o blurred vision, h/a, weakness in rt leg;BP 210/110;
projectile vomiting starting 6/9/22 after rotavirus vaccination, bilious vomiting starting 6/11/22, Intussusception  diagnosed 6/11/22
Weakness/heaviness of the right side of the body, headache only on the right side of the head - lasted ~30 mins. Flulike symptoms, fever, general headache - lasted 24 hours. Extreme fatigue - lasted 4 days.
A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. N adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment.  Update 1, 12/1/03: Follow up information received from a health care professional indicated that a 14 month old male vaccinee inadvertently received Fluvirin on 10/18/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400017, PJP200400018, PJP200400019, PJP200400020, PJP200400021, PJP200400022, PJP200400023, PJP200400024.
he tested positive for covid-19. The first dose was given last March 21and his2nd schedule is on April 11.; he tested positive for covid-19. The first dose was given last March 21and his2nd schedule is on April 11.; This is a spontaneous report from a contactable consumer (reporting on himself). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not provided), first dose via an unspecified route of administration, on 21Mar2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that, the patient received his first dose on 21Mar2021 and tested positive for Covid-19 on an unspecified date. And, the patient was enquiring if he can take the second dose, since he tested positive for covid-19. The patient underwent lab test and procedure Covid-19 positive. The outcome for the event was unknown.  No follow-up attempts are needed. No further information is expected.
Immediate pain at injection site.  Then subsequent pain down arm that extended to fingers.  There was also a cramping sensation in her shoulder.  She treated with ice/heat/tylenol/ibuprofen/tramadol.  She started PT on 11.9.22.
Swollen painful arm, armpit swelling, aches, chills, fever, nausea
Information has been received from a consumer concerning her friends' 15 month old male child who on unspecified dates were vaccinated with the first and second doses of MMR II (LOT#s not reported). The child experienced autism after the second dose of the vaccine at the 15 months old. With intensive diet and therapy there has been some improvement. Unspecified medical attention was sought. No other information was provided. Upon internal review, autism was considered to be an other important medical event. This is the first of two reports which was received from same source. No further information is available.
Red rash (2"RD) 2" from vaccine site; some discomfort -> lunch (#5). Soreness muscular at site at triceps (#3); Thurs (6/23): Head pain (#3); stom. disc & triceps soreness (#3); Fri (6/24) Headache (#0); stom. disc (#3); soreness (#2); (6/25) Head pain (#2), stom. disc & soreness (#3) rash still there (#2) - All symptoms gone (6/29 = 9 days) except rash/redness (95% gone) (7/5) rash 96% gone!
tested Covid positive 6 weeks after 2nd dose of Pfizer vaccine; tested Covid positive 6 weeks after 2nd dose of Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (batch/lot number and expiration date were not reported) as the 1st dose, single, and then via an unspecified route of administration on an unspecified date (batch/lot number and expiration date were not reported) as the 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested Covid positive 6 weeks after 2nd dose of Pfizer vaccine on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Shingles pain (mild to moderate) in the upper back and torso; Redness; shingles pain (mild to moderate) in theupper back and torso; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8730) via an unspecified route od administration on 01Apr2021 at 17:00 in the left arm (at the age of 52-years-old) as single dose for COVID-19 immunisation. Medical history included autoimmune NOS, shingles event April 2020 and environmental allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks prior to COVID vaccine. Concomitant medication included colecalciferol (VITAMIN D3), CENTRUM WOMEN and vitamin b complex (B-COMPLEX); all for unspecified indication and start date. On 03Apr2021, started with 48 hours post vaccine, the patient experienced shingles pain (mild to moderate) in the upper back and torso, redness and had no visible rash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events with unspecified topical cream and otc acetaminophen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of shingles pain (mild to moderate) in the upper back and torso and redness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 15:30 (Lot number: EP7533) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Celiac" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Apr2021 16:00, outcome "recovering", described as "soreness at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient had no Allergies to medications food or other products.  No follow-up attempts are possible. No further information is expected.
pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart; weak; feels discomfort in the chest; feels discomfort in the chest like if he is lack of breath; fatigue; pain on L arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart), ASTHENIA (weak), CHEST DISCOMFORT (feels discomfort in the chest), DYSPNOEA (feels discomfort in the chest like if he is lack of breath) and FATIGUE (fatigue ) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Iron overload. Concurrent medical conditions included Hemochromatosis (The patient referred he suffers from Inherit Hemochromatosis diagnose it on 2016 that caused cirrhosis hepatic, diabetes, heart issues.) in 2016, Cirrhosis liver, Diabetes, Osteoporosis, Heart disorder (heart issues: he has inflammation on the left ventricle) and Arthritis. Concomitant products included ENALAPRIL for Heart disorder, INSULIN, OMEPRAZOLE, FUROSEMIDE and SPIRONOLACTONE (SPIRONOLACTONA) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart), ASTHENIA (weak), CHEST DISCOMFORT (feels discomfort in the chest), DYSPNOEA (feels discomfort in the chest like if he is lack of breath), FATIGUE (fatigue ) and VACCINATION SITE PAIN (pain on L arm of injection). At the time of the report, HYPOAESTHESIA (pain on L arm of injection, like numbness, like inside of the arm and it goes to the heart), ASTHENIA (weak), CHEST DISCOMFORT (feels discomfort in the chest), DYSPNOEA (feels discomfort in the chest like if he is lack of breath) and FATIGUE (fatigue ) outcome was unknown and VACCINATION SITE PAIN (pain on L arm of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient described chest discomfort  like anguish and it´s located on the left side of his heart. Treatment information was not provided by the reporter.
PT WENT TO THE EMERGENCY ROOM  ON 6/20/2022 FOR "PAIN AND ARMPIT SWELLING" PT. C/O PAIN FROM SHOULDER "ALL THE WAY DOWN" MOTRIN  600 Q 6 RXED.DX AXILLARY LYMPHADENOPATHY. SEEN IN CLINIC HERE 7/6/2022  WITH RESOLUTION.