chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 days post 2nd COVID-19 Pfizer dose,  developed a high fever, chills, very rapid heart rate at rest accompanied by chest pain.  She was taken to the ER for evaluation.  Initial EKG showed SVT. She was treated with IV fluids and Acetaminophen.  All tests, including blood work-up, chest X-ray, COVID-19 test, strep , Flu and RSV done came back normal or negative. A repeat EKG was normal. She was discharged and has since recovered.
6 month infant received Moderna COVID Bivalent 6m-5yr pink cap/yellow  border as a first dose.  No side effects noted by parents.
"Dime sized" bump under skin in area where shot #3 was administered. Site is tender to touch.
FEW MINS AFTER VACCINE, FELT COLD, DIZZY, "UNDER WATER" FEELING, TUNNEL VISION, ASSISTED TO GROUND FEET PLACED UP ON CHAIR. FELT SOME RELIEF. BROUGHT TO OBS VIA WHEELCHAIR, PLACED IN TRENDELENBERG, FELT BETTER. SAT UP FOR SNACK AND WATER, HELPED BUT STATES TOOK BENADRYL PRIOR TO COMING PER PCP INSTRUCTION DUE TO FOOD ALLERGIES, SO GROGGINESS THATS REMAINING PROBABLY RELATED TO THIS. SOME DIZZINESS REMAINS SITTING UP BUT MUCH IMPROVED PER PATIENT. STANDING UP PATIENT STATES STILL FEELS BETTER, JUST GROGGY FROM BENADRYL. ESCORTED WITH SIG OTHER VIA WHEELCHAIR TO EXIT WITH NO FURTHER ISSUES AT 1228. 1155 INITIAL BP 125/86 HR 114 RR 18 SATS 98% RA (SITTING, AND PATIENT STATES HR USUALLY OVER 100 WITH ANXIETY) 1210 BP 130/82 HR 110 RR 20 SATS 99% RA 1225 STANDING BP 145/94 HR 106 RR 20 SATS 99% RA
Pruritis; Arthralgia; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 30 days after receiving Shingrix, the patient experienced pruritus and arthralgia. On an unknown date, the outcome of the pruritus and arthralgia were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and arthralgia to be related to Shingrix.  Additional details were provided as follows: The reporter indicated that a consumer came into his pharmacy on 29th July 2019, and reported that he began to experience pruritus and arthralgia in both hands approximately 1month after receiving the 1st dose of the Shingrix vaccine. The reporter was unable to provide additional information.
hiccups & crying approx 2 1/2 hrs @ inject; nl exam 5 hrs p/inject; 7 hrs p/inject, temp spike to 104; pt given APAP & sponge bath;
Hive type rash to arms, chest, face. BENADRYL 50 mg PO with improvement.
Administered only the liquid component; Administered only the liquid component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA687A, expiry date 31st October 2022) for prophylaxis.   On 9th May 2022, the patient received Menveo. On 9th May 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments:  The nurse was called in to inquire any recommendations if patient should be revaccinated. The reporter reported they inadvertently administered only the Menveo liquid component without powder to a patient. The reporter did not consent to follow up. Additional Supportive Information: The patient inadvertently administered only the Menveo liquid component without powder, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Pt, received a shingrix vaccine 4/22/23 around 9:58am. Pt was instructed to wait 15 mins post vaccination to monitor for potential side effects.  Upon processing vaccines for another patient, I walked past the waiting room and asked how she was feeling.  She appeared uncomfortable/unwell but reported she was fine, just "feeling funny." Pt stated that she needed to sit and we were fine to continue business. At 10:10am, the pt was still sitting in the waiting room. At 15 mins post vaccination the pt reported that she was not dizzy but wanted to close her eyes. After prying it was determined that she did not feel well to stand as she was having visual disturbances and lightheadedness.  Upon questioning, the pt did not report chest pain, SOB, difficulty breathing, n/v, and no hx of vaccine related AEs.  Pt reported that she was struggling with menopause which made her "heart weak" and caused "spells" of dizziness/lightheadness.  Pt had no medical hx at Pharmacy, but reported taking a low dose beta blocker herbal SL supplement for dizziness. At 1030am the pt was still unwell, she was transferred from a chair to a blanket on the floor, to prevent possible syncope related injuries. Pts blood pressure taken 154/99.  Pt husband is out of the town and she only had potential friends able to help.  Suggested calling the squad for continued monitoring since pt had never loss consciousness but event was ongoing. Squad called at 10:37am, briefed on arrival, pt transferred to stretcher with minimal assistance.
I had a fever the day after but more concerning is the allergic reaction I am having at the injection site that seems to be getting worse. Large panful bulge in my arm and a red itchy rash that is spreading.
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 01-JUN-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Patient is fully vaccinated and boosted.  COVID positive 2/21/2022 on admission to the hospital. 63y.o. male with history of diffuse large B cell lymphoma on active chemotherapy, CVA (12/2021), hypertension, hyperlipidemia, who presented as a stroke code with slurred speech.  CT head stroke protocol was negative for acute hemorrhage, territorial infarct or mass effect. Labs revealed severe pancytopenia including WBC<0.1, severe neutropenia with ANC <0.1, thrombocytopenia with PLT 51, and acute on chronic anemia with Hgb 6.3. Cultures were drawn and broad spectrum antibiotics cefepime and vancomycin were initiated. One unit of pRBCs was ordered. Does not require oxygen for COVID.  Positive for mental status changes, malaise/fatigue, speech change (slurred) and weakness.  + fever 103.2; Neutropenic fever. Discharged home.
Pt has history of fainting and dizziness from blood drawn and vaccines. It was answered and documented on the screening questionnaire. Pt felt dizzy and then fainted for approximately 10-20 seconds in the chair as she was being held and regained consciousness. She was given cold compresses which helped tremendously and waited a total of 30-45 minutes to ensure no further adverse reactions. There were none and pt went home. Will follow up and call patient.
Guillain barre syn. weakness in extremities received IVIg. Diarrhea. He experienced stomach flu, vomiting on Dec 17.
Pt received his vaccine at 12:57 PM and around 1PM he started feeling light headed and became sweating.  Pt remained oriented x 4.  Able to answer questions.  Pt was laid down on his back, feet elevated higher than his head.  Vitals were taken at 13:05.  BP 132/80, HR 67, RR 20, T 95.5 (temporal) OxSat 96% RA.  Pt stated he has had these type of episodes before.  He is not taking any of the OTC medications.  Ha has an allergy reaction to PCN in the past.  No vaccine in the last 14 days.  Pt stated he feels better @1320 pt was able to sit up and drank 100% of his water.  Pt was assisted out to his car where his wife was waiting.  Pt laid down in the back.  Advised to call 911 if his symptoms get worse.  He agreed
Bad headache and spiking fevers 103.7 deg F through Tylenol and Ibuprofen for 3 days.  On and off low grade temps with headaches without meds for 4 days. Then 101.7 deg F temps with significant headaches for 3 more days.  Occasional headache with low grade temps no meds for 2 more days. CXR, UA, WBC normal.  CRP elevated.
Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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 Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was patient's mother. The age at vaccination was not reported. The patient had arm soreness for two days after after receiving Bexsero. The reporter did not want to file report, hence information was very limited as she was reluctant to file report. The reporter did not consent to follow-up.
About 24 hours after the administration of the vaccine, patient developed a rash that was warm to the touch on left deltoid, below the injection site. The rash spanned all the way down to just above the elbow. It did not span the circumference of the arm, it only appeared on the outside of the deltoid, below the injection site. The patient did not experience any hives or itching. As of early week of 10/08/17, the rash was starting to disappear.
Genital herpes outbreaks; Increased genital herpes outbreaks after both doses; This case was reported by a nurse via call center representative and described the occurrence of genital herpes in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of genital herpes (1st dose received on an unknown date and experienced increased genital herpes outbreaks). Concurrent medical conditions included genital herpes.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced genital herpes and condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the genital herpes and condition aggravated were unknown.   It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient experienced increased genital herpes outbreaks after receiving the dose of Shingrix vaccine. The reporter did not have any other information except patient's gender. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176130:Same reporter. US-GLAXOSMITHKLINE-US2021AMR177309:Same reporter. Pt2 - 1st dose. US-GLAXOSMITHKLINE-US2021AMR177313:Same reporter. Pt2 - 2nd dose.
Muscle and  joint aches; Muscle and  joint aches; headache; soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 10:00 (Lot number: BA30145) at the age of 71 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "HSVII" (unspecified if ongoing); "known_allergies: lactose" (unspecified if ongoing); "known_allergies: wheat intolerant" (unspecified if ongoing); "Depression" (ongoing); "Vt D Density" (ongoing), notes: Vitamin D Density; "Low Bone Density" (ongoing); "Mixed type lipidemic" (ongoing), notes: Mixed type lipidemic. Concomitant medication(s) included: FLUOXETINE; VIT D3 taken for bone density abnormal (ongoing); PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; PROZAC taken for depression (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date (dd-Mmm-yyyy): 06Jan2021, Pfizer/BioNTech COVID-19 Vaccine Details), administration date: 06Jan2021, when the patient was 71 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2nd , Date (dd-Mmm-yyyy): 29Jan2021, Pfizer/BioNTech COVID-19 Vaccine Details), administration date: 29Jan2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 28Sep2021 06:00, outcome "recovered" (29Sep2021) and all described as "Muscle and joint aches"; HEADACHE (non-serious) with onset 28Sep2021 06:00, outcome "recovered" (29Sep2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 28Sep2021 06:00, outcome "recovered" (29Sep2021), described as "soreness at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, arthralgia, headache, vaccination site pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Muscle & joint aches, headache, soreness at injection site, 8 on a scale of 1-10, 10. Prior to and since the vaccination, was the patient was not diagnosed with COVID-19. Patient received Booster (Pfizer covid vaccine) 29Sep2021 called 29Sep2021 to report she had indexes HA misled it pain 08/10 touch typical receiving 29Sep2021.  No follow-up attempts are possible. No further information is expected.
Vomiting off and on; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting off and on ) in a male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting off and on ). At the time of the report, VOMITING (Vomiting off and on ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
PT c/o runny nose, congestion, slight fever (unknown temperature), cold sweats, headaches (rating 7/10 on numeric pain scale), non productive cough, fatigue x 1 day. Has been taking OTC  benadryl, ibuprofen  .
I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/5/21 after the completion of a full Pfizer vaccine series (Dose 1 on 12/28/20 and Dose 2 on 1/18/21). The patient later died on 4/9/21. Cause of Death is listed as ?Metastatic Rectal cancer?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION, DIABETES MELLITUS  Comments: Spoke to the case adult daughter. She informed that the case resides at a rehabilitation center. The case's daughter stated that her mother is not having any symptoms and was fully vaccinated. The daughter did not have all the information on dates of vaccine. called center spoke to the administrator who provided the information. The case was at the hospital from 3/27-4/1. Rehab requires a (-) test result to return and a (-) test four days after returning. The case test (+) on her 4th day 4/5.nnn
swollen; super itchy; red; Injection site swelling; Injection site pain; redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swollen), PRURITUS (super itchy), ERYTHEMA (red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PAIN (Injection site pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE ERYTHEMA (redness). On 28-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen), PRURITUS (super itchy) and ERYTHEMA (red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) for Itching, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Swelling, at an unspecified dose and frequency. On 24-Jan-2021, INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE ERYTHEMA (redness) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen), PRURITUS (super itchy) and ERYTHEMA (red) was resolving.        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.
feels lousy today; Patient received third dose of bnt162b2 vaccine; Patient received third dose of bnt162b2 vaccine; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Oct2021 (age at vaccination was 52 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization; palbociclib (IBRANCE, Film coated tablet, Batch/Lot number was not reported), via an unspecified route of administration from 02Oct2021 to an unspecified date, at 125 mg for malignant neoplasm of overlap sites of right female breast. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and DOSE 2, SINGLE for covid-19 immunization. Patient wants to take ibuprofen and per facts and clinical pharm. On 23Oct2021 (1 day after vaccination), reported as today, the patient felt lousy. The outcome of the event was unknown. The action taken in response to the event for palbociclib was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
The first Vaccine on January 30th- February 4th was covid arm Second Vaccine on Feb 27th,  Very sore body and very sore arm the next day
PASSED AWAY PEACEFULLY ON HOSPICE SERVICES, COMFORT CARE ON 11/28/2021
c/o numbness or heavy feeling in arm, lightheaded, joint pain, swelling;(immed following infect) daycare ctr director took pt to see pvt MD;
Patient received 1st dose pfizer vaccine. About 10 minutes later, patient said she was feeling unwell. Pharmacist went over to check her vitals. Pulse oximeter showed her to be at 151bpm. She complained that she was not feeling well. Looked distressed. She complained that her left arm where she received the injection, was feeling numb/heavy and tingling.  Patient also complained that she was feeling very thirsty and asked for water, which we refused to give her in the fear of her choking if she was to pass out.  Paramedics were called to the scene and she was taken to hospital by ambulance.
HCP called too report that expired dose of GARDASIL 9 ( EXP: 04-SEP-2022 ) was given; No additional AE/PQC.; This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date, the patient was vaccinated with an expired dose (expired product administered) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 mL, with expiration date 04-SEP-2022 (route, anatomical location, and lot number were not reported) for prophylaxis. No additional adverse events were reported.
Information has been received from a women in a physician's office concerning a 42 month old male who on 04/24/01 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Lot # 637975/1897K).  There was no illness at the time of vaccination. On 11/10/03 the pt broke out with chickenpox. It was noted that this was a very mild case. Subsequently, the pt recovered. No labs or diagnostic tests were done.  Additional information has been requested.
This spontaneous report has been received from the medical assistant refers to a 12 months old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (MRK) used to reconstitute the VARIVAX was properly stored. On 09-JUL-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
Listless following 1 hr p/shot; t103 won't eat, won't drink, can't walk; jerking all over;
Information has been received from a nurse referring to a 11 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On day before the patient turned 12 months of age which was outside the recommended age according to the prescribing information, the patient was administered Oka/Merck VARIVAX (strength, dose, route, frequency were not reported, lot # 1702Y and expiration date 04-DEC-2011) and (wistar ra 27-3) M-M-R II  (strength, dose, route, frequency were not reported, therapy type: rHA, lot # 1367Y and expiration date 25-SEP-2011) for prophylaxis. No adverse effects were reported.
Approx 5 min after receiving 1st dose of Pfizer vaccine patient was noted to be slumping over in chair.  2 RN's prevented him from falling him.  Pt's eye's remained open but he was non responsive.  After about 30 seconds patient regained consciousness.  He was moved to a wheelchair and then stretcher.  BP 135/77, O2:100% pulse 80.
22 hours later I got chills, goosebumps, I felt terrible. I felt fatigue, a headache and muscle aches and chest pain. I Went home and laid down. My temp read 102.9. Called a nurse and she was concerned because of my heart condition. come in to the hospital if the chest pain lasts longer than 5 minutes. I didn't go in because I figured I could use a nitroglycerin pill if it got too bad.  The following day I had chest pain every few hours or so. the waves of chest pain only lasted about 5 minutes a piece.