chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle/body ache; muscle/body ache; achy joints; chills; tiredness; headache; feeling unwell; decreased appetite; arm pain; administration_date=06Jan2023/dose_number=5/other_vaccine_same_date_dose_number=4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 06Jan2023 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "Asthma" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "allergies" (unspecified if ongoing), notes: allergies; "bronchialstasis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Oxycodone, reaction(s): "known allergies: Oxycodeine", notes: known allergies: Oxycodeine. Vaccination history included: Covid 19 vaccine (Dose 1; MANUFACTURER UNKNOWN); Covid 19 vaccine (Dose 2; MANUFACTURER UNKNOWN); Covid 19 vaccine (Dose 3; MANUFACTURER UNKNOWN). The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Jan2023 at 15:00, outcome "unknown", described as "administration_date=06Jan2023/dose_number=5/other_vaccine_same_date_dose_number=4"; PAIN IN EXTREMITY (non-serious) with onset 07Jan2023, outcome "recovering", described as "arm pain"; ARTHRALGIA (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering", described as "achy joints"; CHILLS (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering"; MALAISE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering", described as "feeling unwell"; HEADACHE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering"; MYALGIA (non-serious), PAIN (non-serious) all with onset 07Jan2023 at 04:00, outcome "recovering" and all described as "muscle/body ache"; FATIGUE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering", described as "tiredness". Therapeutic measures were taken as a result of myalgia, pain, arthralgia, chills, fatigue, headache, malaise, decreased appetite, pain in extremity.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt presented to ED w/2 week hx of malaise, myalgias, weight loss associated w/dyspnea and dry cough. Found to be hypoxic, in which she responded well with 2L O2. Labs confirmed COVID-19 positive w/elevated inflammotory markers (lactic acid). Pt had received Janssen vaccine (3/31/21). Was admitted for additional management of her acute hypoxemic respiratory failure w/COVID-19 on 4/23/21. Was treated with dexamethasone, remdesivir and empiric antibiotics which were stopped early. Pt ultimately discharged 3 days later w/follow-up scheduled in 3-5 days.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-OCT-2014"), an unspecified number of patients received ZOSTAVAX (doses, routes of administration, lot # and expiration dates were not reported) stored for 8F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Swelling at injection site, golf ball size, severe arm pain, high fever, weakness and hypoglycemia.
ER admit for CP and Jaw pain, exhaustion, Aortic arteritis normal SED rate found on CT scan hospital admit IV medications required Solumedrol and Actemra questionable how much medications received d/t IV's not working. Released from care on 2/19 with prednisone . Symptoms still present off and on. 2/21 922pm CP Jaw Pain severe EMT's called EKG done reported no heart attack, pain better, EMTs left. 10/15 severe Pain collapsed with no pulse and no breathing, EMTs returned unable to obtain a shock-able rhythm time of death pronounced. reason for death on certificate Aortitis - hospitalist thinks aortic dissection d/t severe inflammation
Redness at injection site; Soreness at injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 014B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. Not Provided        Concomitant product use was not provided by the reporter.  Treatment for the event included acetylsalicylic acid.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-077195, MOD-2021-070988, MOD-2021-072067, MOD-2021-070997 (Patient Link).; 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.
devel high fever-104+, severe h/a, chills, gen achiness, dizzy when getting up;was flat in bed for 3 days;also pain @ inj site & in armpit;
No adverse event; Administered Moderna Covid-19 bivalent dose) that later determined to be expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 bivalent dose) that later determined to be expired) and NO ADVERSE EVENT (No adverse event) in a 52-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 06-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 bivalent dose) that later determined to be expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 bivalent dose) that later determined to be expired) 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 EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 bivalent dose) that later determined to be expired).    No concomitant medications were reported.  No treatment information was provided.
Spontaneous nosebleed upon awakening, temporary. This is unusual for me.  There was also some slight blood in nose mucus soon after first dose.
I have developed blood clots in my lungs; I get my first shot that when I developed; I can not get my breath; I started coughing the blood; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, in Feb2021 (reported as 07Feb2021 or 17Feb2021), as dose 1, single, for COVID-19 immunisation. The patient had no medical history and no concomitant medications. After first COVID shot in February, the patient developed blood clots in lungs. The patient could not get breath and started coughing the blood. The patient was hospitalized due to the events. It was reported that, the patient was going through so much problem. Before COVID shot the patient was in real good state. The patient was put on a blood thinner, Eliquis due to blood clot in lungs he was still sick, and a team of doctors got together 2 weeks ago and determined that it was from the Pfizer vaccine. It was also reported that, the patient was given a test in hospital, the result was not reported. The outcome for blood clots in lungs was not recovered while for other events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Jaw ache/pain - unable to sleep due to it; Jaw ache/pain - unable to sleep due to it; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ES1686) in a hospital, via an unspecified route of administration at the left arm on 08Jan2021 at 11:00 AM at single dose for COVID-19 immunization. The patient's medical history included birth control. No other medical history and has no known drug allergies. The patient had no COVID prior to vaccination. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL) birth control pills. The patient experienced jaw ache/pain - unable to sleep due to it on 10Jan2021 at 18:00 (06:00 PM) and these were not relived by Advil. The patient has not been tested for COVID post-vaccination. The clinical outcome of the events was not recovered.
Rash is on his legs, arms, and back; It also itches and itches.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleeping pill" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE taken for insomnia (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, 1st dose: , Date: 01Feb2021, Time: Unknown , Anatomical Site of injection: Administered in right arm, Route of Administration: Not provided, Batch/Lot number: EL3248), administration date: 01Feb2021, when the patient was 75-year-old, for Covid-19 Immunization; bnt162b2 (DOSE 2, SINGLE, 2nd dose: , Date: 20Mar2021, Time: Unknown , Anatomical Site of injection: Administered in arm, unknown which arm ., Batch/Lot number:EN6200), administration date: 20Mar2021, when the patient was 75-year-old, for Covid-19 Immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 01Oct2021, outcome "not recovered", described as "It also itches and itches."; RASH (non-serious) with onset 01Oct2021, outcome "not recovered", described as "Rash is on his legs, arms, and back". The events "rash is on his legs, arms, and back" and "it also itches and itches." required physician office visit. Therapeutic measures were taken as a result of rash, rash pruritic.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362828 Same patient, same drug/different dose, different event;US-PFIZER INC-202300362835 Same reporter/drug/event, different patient;
PT WAS GIVEN MODERNA MOVOVALET BOOSTER INSTEAD OF BIVALENT BOOSTER. NO ADVERSE EVENTS KNOWN ABOUT.
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a 16-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 18-Dec-2011. On 21-Dec-2011, expired FLUMIST was administered to the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 04-Apr-2012. The patient did not develop any late occurring adverse events.
Non consolable high pitch crying x 3 hrs; MD wrote order for pt to recvd DT only from now on;
Pt was seen not at a pharmacy clinic, but at at pharmacy inside store and was administered the vaccine and she stated she screamed because of the pain of injection. She denied any pain like this receiving her other 4 covid vaccines. She reports the pharmacist apologized and she left, but the pain did not go away. She has since developed right shoulder edema, pain with ROM that is still there 7 days later.
Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) that was properly stored. On 20-SEP-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N009777, expiration date on 04-MAR-2018 (strenght, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccine had a temperature excursion of 78 Fahrenheit (F) during a time frame of 3 days. It was reported that no previous temperature excursions ocurred and a digital data logger was involved.
Patient was given bivalent booster rather than monovalent booster for their 2nd dose. Spoke with Pfizer, per CDC recommendations, patient is to not repeat the dose and to continue with recommended regimen. Patient is also aware of the vaccine mix-up and did not state of any ADR.
Narrative: Pt presented to ED 12/2/21 with BP 175/108. Pt states his BP has been more difficult to control since receiving the COVID vaccine 1st dose 1/27/21. He subsequently received a second dose 2/24/21. HOWEVER, looking at the trend of BP readings taken at facility, the patient's BP was already trending up in October and December 2020; patient states it became worse after the vaccine. It is higher on facility measurements since that time.
Patient received extra dose of HPV; first dose was given 10/22/2020 and second dose on 09/24/22. Patient's vaccine record was not properly abstracted into the chart, so she received an extra dose on 11/06/22.
Left arm started swelling getting red, painful to touch and is itchy all started on 11-1-14 in the morning as the day progress the redddness started spreading up to neck and down arm. Patient instructed to start taking benadrly for itching to arm and ibuprofen for pain to left arm and can apply a cold compress to site to help easy swelling.
a little hurt in the arm; This is a spontaneous report from a contactable consumer via medical information team.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date as a dose 2, single and dose 1, single for COVID-19 immunization. The patient had medical history of dialysis and concomitant medication were not reported. On an unspecified date the patient mentioned that she received the 2nd dose on Saturday at 9am. Patient reported that she had no symptoms other than the "normal ones" like a little hurt in the arm. Patient had experienced this with the 1st dose as well. Patient had gone for dialysis on Monday at 7am and queried if this will affect the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Itch and redness at injection site Soreness at injection site after initial soreness resolved (unclear if sore from injection or from other source)
Body aches starting around noon on left side, 02/03/21 6:00am left arm sore and swollen at injection site, increasing redness warmth and itching at site, max size to 3cm diameter and firm till 02/05/21, decreasing size and minimal discomfort
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concomitant medications ant concurrent conditions were not reported. On unknown dates, the unspecified number of improperly stored doses of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported) were administered to the patients. No adverse effects have been reported. On unknown dates, the doses were stored in the temperatures between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 336 hours. Information about previous temperature excursion was not provided. Digital data logger and product quality complaint were not involved. Additional information has been requested.
pt stated that she noticed a red spot on her left arm around the injection site.  She stated it kept growing.  It went from the injection site to the elbow and was red, hard, swollen and warm to the touch.  She went to see her PCP 2/9/2021 and was prescribed antibiotic cephalexin.  Pt was told to come back if the antibiotic did not work that she would need to be put on a steroid.  Pt stated her arm is not as red today and was instructed not to get the second dose.
02/15/22 presents to ED for "gait ataxia, intractable nausea and vomiting and a fall". PMHx of "HTN and a brain mass"
This case was reported by a nurse via call center representative and described the occurrence of fever in a 57-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, several hours after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, myalgia, fatigue and lower extremities weakness of. On an unknown date, the outcome of the fever, influenza-like symptoms, myalgia, fatigue and lower extremities weakness of were recovered/resolved. It was unknown if the reporter considered the fever, influenza-like symptoms, myalgia, fatigue and lower extremities weakness of to be related to SHINGRIX. Additional details were reported as follows: The patient experineced fever, flu like symptoms, myalgia, fatigue and weak in the knees within a matter of hours after SHINGRIX vaccine. The myalgia and fatigue were extreme within 12 hours.   The patient did not plan to get the 2nd shot at this time. The issues lasted for 1 week. The reporter did not consent to follow up.
Left arm red swollen at the site of injection. Reaction started 6 to 7 days after first injection.
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient was allergic to BENADRYL. The patient did not have any pertinent medical history and did not take any concomitant medications. On approximately 17-APR-2017, the patient was vaccinated with ZOSTAVAX a single dose, subcutaneously, lot # M039453, expiration date: 19-DEC-2017 to prevent shingles. The vaccine was reconstituted in sterile diluent. On 18-APR-2017 (reported as "one day after the injection"), the patient developed a rash on the left arm. On 21-APR-2017 (reported as "three days later"), the patient's rash expanded to a size of a grapefruit and a hardened knot appeared in the center of it. The patient sought medical attention. No treatment was given for the event and no laboratory studies were performed. The outcome of the adverse events was reported as recovering. The causality between the events and suspect therapies was not provided. Additional information has been requested.
Swelling, erythema (R) upper thigh. Symptoms occurred 48 hours later. Parents used BENADRYL.
Within 24 hours he reports to have experienced marked chills, fever, and marked weakness, dizziness, and body aches.
Covid returned after 5 days; Covid returned after 5 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6206), in right arm, on 30Mar2021 as dose 2, single (Lot number: ER8733), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: MYRBETRIQ, start date: 15Dec2021; AMLODIPINE, start date: Jan2011; TAMSULOSIN, start date: Jan2011; EZETIMIBE, start date: Jan2011, stop date: Mar2022; ROSUVASTATIN, start date: Jan2011, stop date: 22Apr2022; QUINAPRIL/HYDROCHLOROTHIAZIDE, start date: Jan2011; FINASTERIDE, start date: Jan2011; CLOPIDOGREL, start date: Jan2011; ELIQUIS, start date: Aug2020; LITHIUM OROTATE, start date: Apr2017. Past drug history included: Peg3350, reaction(s): "Known allergies: PEG3350". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid returned after 5 days". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  If Vaccine received: Yes, Other medication in 2weeks: Yes. Product=COVID 19 Treatment, Brand= Paxlovid; Treatment start date=22Apr2022, Treatment stop date=26Apr2022, Indication=Treatment of COVID-19. Other medication in 2weeks product= Q-urol, Other medication in 2weeks brand= Farr labs, Other medication in 2weeks start date= Nov2021.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, suspected COVID 19, Drug Ineffective and BNT162B2 is considered possible.
severe tinnitus,  happened a few days after the second shot. had mild tinnitus previous to shots.  Much worse than ever before. No other factors  I know of. My stress level overall is low.
Developed Shingles for the first time in my adult life 6 weeks after vaccine,  I am NOT blaming the vaccine, it could be a coincidence,  just providing a datum point in case a pattern develops.
Left leg swelled very badly. Lasted for 24 hrs, 8 hrs at its worse.
Since he received the Pfizer vaccine, he's incurred fatigue, bleeding where he's had to receive several units of blood/hemoglobin four times. He was admitted into the hospital for these treatments. To beat it all, he developed jaundice and is now getting ready to undergo treatment for pancreatic cancer.
Arthralgia, CHILLS, shivering, fatigue. swollen lymph nodes in armpit of injection site Narrative:
pt recvd vax & devel raised rash on face & neck & swelling of face & eyes on 0JUL; mom brought pt to clinic 9JUL93; MD gave DPH;
Mother stated daughter's deltoid was more swollen yesterday, today it is small and tender to touch. No other problems noted.