chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/13/21 hx of Anxiety, DM2, HLD, Depression, Hypothyroidism, and Sarcoidosis, psoriatic arthritis on MTX, and GERD who presents w/chief complaint of SOB, fatigue, and cough
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The batch number was not reported. The patient received SHINGRIX vaccine on left arm and only experienced a slight bump at the injection site which resolved within a few days. The reporter consented to follow up. For tolerance of 2nd dose refer linked case US2019GSK065616.
Accumulation of mucus in her chest/Lot of mucus/The mucus goes away and comes right back; keeps her up at night and can't even sleep; Little bit of cough; Keeps having to clear her throat; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Accumulation of mucus in her chest/Lot of mucus/The mucus goes away and comes right back), MIDDLE INSOMNIA (keeps her up at night and can't even sleep), COUGH (Little bit of cough) and THROAT CLEARING (Keeps having to clear her throat) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE and HYDROCHLOROTHIAZIDE for Blood pressure.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Accumulation of mucus in her chest/Lot of mucus/The mucus goes away and comes right back), MIDDLE INSOMNIA (keeps her up at night and can't even sleep), COUGH (Little bit of cough) and THROAT CLEARING (Keeps having to clear her throat). The patient was treated with PREDNISONE at an unspecified dose and frequency; AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) in March 2021 at an unspecified dose and frequency. At the time of the report, PRODUCTIVE COUGH (Accumulation of mucus in her chest/Lot of mucus/The mucus goes away and comes right back), MIDDLE INSOMNIA (keeps her up at night and can't even sleep), COUGH (Little bit of cough) and THROAT CLEARING (Keeps having to clear her throat) outcome was unknown.
Started feeling sick day of 2nd dose of the Moderna vaccine.   never felt good.   personal journal entries testify of this.  never felt good before she died.   Had a massive thrombophlebotic stroke 10 days later causing death.
Throat closing, tightness on chest. Shortness of breath. EPIPEN 0.3 mg given. 15 mins to recovery.
It started in the morning on 10/30/2021 and lasted until 09/04/2021. It was the heaviest menstrual period I have ever had. When I woke up on Sunday, I had my underwear, my pad, my pajamas, sheets, and mattress cover, and I bled through all of those. All the way to the mattress cover. I have never bled that much ever in my period. I have had heavy periods for 2 days the most, but this lasted several days, and it was heavy until the last day. My period would last 5 days usually with one day of heavy flow, but this was heavy bleeding until the last day. It was odd how quickly it stopped. I had heavy discharge with that. I had to use a tampon and a pad and change it several times a day. I was worried a blood thinner would make it worse. I had intense cramps, I had to stay 2-3 days in bed, I could not really eat or drink anything. I forced myself to do it. I was afraid I was going to become anemic. I called the hospital and they suggested me to go to the ER, but I thought by the time I would get there I would be waiting there for 5 hours so I decided to stay at home comfortable. I worked through the pain. I have an appointment this week to see a gynecologist, but I am experiencing post COVID symptoms which are debilitating. I had COVID-19 on 2020 but I still experience post symptoms. I do not know if I have COVID-19 right now to be honest. I was also having mood swings, very unusual, something I have never had before. I am starting to feel like myself again, but not quite completely.
Little dizzied; Recieved Epidural Steroid Injection just a few days prior to my first shot,; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Little dizzied) and VACCINATION FAILURE (Recieved Epidural Steroid Injection just a few days prior to my first shot,) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Little dizzied) and VACCINATION FAILURE (Recieved Epidural Steroid Injection just a few days prior to my first shot,). At the time of the report, DIZZINESS (Little dizzied) and VACCINATION FAILURE (Recieved Epidural Steroid Injection just a few days prior to my first shot,) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Epidural Steroid Injection. No treatment information was provided.  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. However, the medical history of Epidural Steroid Injection could be a contributory factor.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non- Significant follow up: Reporter's contact information has updated On 16-Jul-2021: Significant FU. Added event  Epidural Steroid Injection just a few days prior to my first shot outcome unknown. Added Epidural Steroid Injection as concomitant medicine.; Sender'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. However, the medical history of Epidural Steroid Injection could be a contributory factor.
Patient received Moderna Vaccine 04/05/2021, and left the country, he came into the clinic today and asked for a Pfizer Covid-19 vaccine. He stated that since he missed his return date for Moderna of 05/05/2021. He would like to get the Pfizer Covid-19 vaccine. He stated that he had discussed it with his PCP.
Tested positive for covid-19; Tested positive for covid-19; Booster; Location of injection for vaccine received same date: Flu Vaccine; Location of injection for vaccine received same date: Flu Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Oct2021 09:00 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 15Feb2021 09:00 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 25Jan2021 09:00 (Lot number: EL3247) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 27Oct2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (medically significant) all with onset 27Oct2021, outcome "unknown" and all described as "Location of injection for vaccine received same date: Flu Vaccine"; IMMUNISATION (medically significant) with onset 27Oct2021 09:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 07:00, outcome "unknown" and all described as "Tested positive for covid-19". The event "tested positive for covid-19" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive; (29Dec2021) positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course:  Reported Event: Tested positive for covid-19 on 29Dec2021.  Woke up with a sore throat, took a at home rapid antigen test and it was positive. Later that day took a pcr test and it was also positive. Had mild symptoms for 4 days including headache, sore throat, and cough.   The lot number for bnt162b2 was not provided and will be requested during follow up.
MINIMAL SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. 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 (Dose number in series: 1) (suspension for injection, route of admin not reported, and batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced minimal side effects. (Dose number in series: 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minimal side effects was not reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, and batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The reporter had not reported any adverse events following vaccination. This report was non-serious.
pt recvd vax 27SEP95 & 15NOV95 pt devel approx 5 to 10 papulovesicular lesions on the trunk & chin;next day was seen by MD & dx w/a breakthrough case of chickenpox;
Rash at injection site/and around arm area. Primary care physician diagnosed that vaccination caused shingles outbreak valacyclovir TID x 7 days.
Hives covering body; Felt like on fire; Redness on arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 14Oct2021 17:00, outcome "recovered" (Oct2021), described as "Hives covering body"; FEELING ABNORMAL (non-serious) with onset 14Oct2021 17:00, outcome "recovered" (Oct2021), described as "Felt like on fire"; ERYTHEMA (non-serious) with onset 14Oct2021 17:00, outcome "recovered" (Oct2021), described as "Redness on arm". The events "hives covering body", "felt like on fire" and "redness on arm" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of urticaria, feeling abnormal, erythema.  Additional information: The events were reported as non-serious. The patient was treated with Antihistamines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown, if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks were reported as unknown.   Follow-up attempts are completed. No further information is expected.
A month later I had gone out for a walk at 9 AM 07/14/2021 and I came back in and I got lightheaded and fainted and stumbled and hit my head really hard. I went to the hospital and I was checked in for a couple of days with a really low sodium level and so they sent me to see a cardiologist to see what was causing the fainting and they diagnosed me with pericardial effusion which I don't have a history with that. I had low white blood cells and neutrophils and I've had both before but not at the same time. I see Dr. tomorrow 08/24/2021 to follow up for the next steps. I'm having Nausea, Dizziness, and having cognitive problems from the fall and I'm working with a neurologist. This is still ongoing and hasn't been resolved.
Knot on thigh of both legs the day after immunizations. No redness or edema. Used warm compresses.
None currently.  He did not know that he had a previous pnuemoccal vaccine in 04/02.
Red; Warm; Itchy; soreness at the injection site; A spontaneous report was received from a consumer concerning, a 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events warm, itchy, red, and sore at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, the patient experienced warmth, itchiness, redness at the injection site. The patient later developed soreness at the injection site. The redness at the injection site was still growing.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   On an unknown date, the outcome of events, warm, itchy, and sore at the injection site were considered unknown.  On an unknown date, the outcome of the event, red at the injection site was considered not resolved.
Information has been received from a nurse, for GARDASIL a Pregnancy Registry product concerning a 25 year old female patient who on 28-APR-2010 was vaccinated with the first dose of GARDASIL (Lot# 665607/1332Y exp date unknown) and on 01-JUL-2010 with the second dose of GARDASIL (Lot#665768/1354Y exp date unknown). The nurse reported that after receiving the 2 doses of GARDASIL the patient did two home pregnancy tests that were both positive. The patient's last menstrual period (LMP) was 13-JUN-2010 and her estimated date of delivery (EDD) was 20-MAR-2011. It was unknown if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. Follow-up information has been received from a registered nurse concerning the 25 year old female with no illness at time of vaccination who on 01-JUL-2010 was vaccinated intramuscularly at right deltoid with the second dose of GARDASIL (Lot#665768/1354Y). Secondary suspected vaccination included the first dose of BOOSTRIX (Lot# AC52B061BA) which received intramuscularly at left deltoid on 01-JUL-2010. The registered nurse stated that the patient was pregnant at that time but did not know of the pregnancy. Follow-up information has been received from a registered nurse who reported that the patient "miscarried about 1 month after GARDASIL was given" as disclosed (to her office) via verbal report. The source of this verbal report was unknown at time of return call. The reporter did not have on record any name of OB/GYN or general care physicians following patient. There was no record of fetal viability. Upon internal review, miscarried was considered to be an other important medical event. No further information is available.
indication=Treatment of COVID-19; indication=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 56-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 3 (booster), single (Lot number: EL0142), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Antibiotics, reaction(s): "some antibiotics get a rash", notes: some antibiotics get a rash. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts possible. No further information expected.
Information has been received from a registered nurse concerning a 45 year old female with asthma, rhinitis allergic, chronic sinusitis, food allergy, sulfonamide allergy and KEFLEX allergies who on 07-APR-2010 at 2-3 PM was vaccinated with a dose of PNEUMOVAX 23 (lot # 662270/1135Y, IM) into her left deltoid. Concomitant therapy included ADVAIR, RHINOCORT AQUA, PROVNETIL HFA and EPIPEN. On 08-APR-2010 at 4 AM, the patient awoke with joint problems. She couldn't move her left arm. The patient went to the hospital and was admitted for 2-3 days. The hospital removed fluid from the left shoulder and also gave vancomycin. On 11-APR-2010, the office called the patient and discovered that she had better mobility in her left shoulder. At the time of reporting, the patient was recovering. Joint problems and couldn't move her left arm were considered to be disabling and other important medical events. Additional information has been requested.
Received vaccine 12/23/20. No issues. Sore arm noticed while working  out on 12/30/20. When looked at area, had several raised red spots on arm over site where injection was given. After 12 hours - being one confluent spot. Slightly tender. Not itching. Does not otherwise appear to be spreading.   5 weeks 6 days pregnant at time vaccine given 6 weeks 7 days pregnant at time rash appeared EDD 8/19/2021
Information has been received from a patient who on an unknown date was vaccinated with VARIVAX (Oka/Merck). On an unknown date, the patient developed a breakthrough of chickenpox after getting the VARIVAX (Oka/Merck). Additional information has been requested.
COVID positive. It started with a cough and extreme fatigue and sinus headache and occasionally lose the voice. They told me to take aspirin and get lots of sleep and told me to take Flovent to prevent COVID pneumonia. I'm still having the sinus headaches and extreme fatigue and the cough is very occasional now. Quarantine for 11 days and that was up this past Sunday. Scheduled for another COVID test tomorrow 01/04/2021.
Patient stated that she had history of dizziness after she received birth control shot ( six years) ago, but she has been getting flu shots and felt fine.  No known drug allergies per patient.  On 04/04/2021, patient received her first J&J covid vaccine from one of our technician, her skin stated turn crimson. The technician reported to the on duty pharmacist. The pharmacist then found patient sat on a chair sideway and was unresponsive. A immediate 911 call was made. In the meantime, Patient sat up and was able to answer questions appropriately. Patient declined to call ambulance. Patient's BP was 135/86 and P was 48.  We observed patient for an additional half hour until her ride came. Pharmacist also counseled patient to have some benadyl at home and seek PCP for medical evaluation.  The pharmacist checked back patient twice after she left and she felt fine.
I basically had all of the symptoms of Covid. I exp nausea, diarrhea, 103. temp, chills(got fever under control was gone in a day), body ache,congestion lasted 3 days. I went to the ER twice first time discharged to go home rest and second time told it might of been food poisoning,
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted 5 minutes after injection. after recovery, felt like he was going to faint again. pt had covid several months ago, if that matters as a statistic for fainting reaction
Chills, Nausea, Dizzy, Gastro Issues, Weakness, Gas   Diarrheas bouts 6 to 7 times a day and 2 to 3 times at night. Dran a lot of water but could not keep food in. Followed bland foods per list.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A.) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported. No treatment medications were reported This case was linked to MOD-2021-310991 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunization; 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. 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 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. The patient received treatment with Paxlovid from 12Jul2023 to 16Jul2023. Patient experienced return of Covid symptoms and positive test result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful  slightly raised splotchy rash , about two inches below injection site, no irritation at injection site
SYSTEMIC: MOM STATED THAT PATIENT FELT TIRED AND "NOT FEELING WELL" AND DECREASED APPETITE. HE DEVELOPED A FEVER OF 101F IN THE MIDDLE OF THE NIGHT. FEVER FLUCTUATED FROM MIDNIGHT UNTIL 6AM OF 11/27, WITH THE HIGHEST TEMPERATURE AT 103.5. MOM ADMINISTERED 100 MG OF IBUPROFEN AT 4:30AM. BY THURSDAY MORNING TEMPERATURE STAYED AT 100-101.5F, AND DECREASED TO 99F ON FRIDAY. PATIENT HAD TROUBLE SLEEPING ON THE NIGHT OF 11/26 AND 11/27. ON THE NIGHT OF 11/28, PATIENT SLEPT THROUGH THE NIGHT. LOCAL: MOM NOTICED THAT THE INJECTION SITE WAS "DEEP RED," INFLAMED, AND FELT "HOT TO TOUCH." MOM STATED THE ERYTHEMATOUS AREA WAS 3inX1.5in. MOM STATED PATIENT COMPLAINED OF HIS ARM HURTING WHEN HE MOVED IT.
Patient was requesting an influenza vaccine and was instead administered a COVID-19 vaccine. Her original series was completed over 6 months ago with the Moderna vaccine.