chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium
Information has been received from a healthcare professional concerning a 66 year old white male with high cholesterol, high blood pressure, and allergies to metroprolol tartrate, Indapamide, Caroxlyn, enalapril maleate, potassium bicarbonate(+)potassium citrate, guanfacine HCl, and nifedipine who on 6/2/04 was vaccinated SC in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 647657/0947N). Concomitant therapy included atenolol, aspirin, valsartan, simvastatin, and finasteride. The healthcare professional reported that on 6/2/04, the patient developed a swollen arm which was hard to the touch. There was swelling and redness of arm 33cm around. On 6/4/04, unspecified medical attention was sought and the patient was given an unspecified medication to treat his arm. The patient subsequently recovered. The reporter felt that the patient's swelling and redness of the arm were other important medical events (OMIC). No additional information is expected.
This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # N005274, expiration date 03-APR-2018, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.4 degrees Fahrenheit) and 32 degrees Fahrenheit to 35 degrees Fahrenheit (35 degrees Fahrenheit) for unknown duration. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA012210: US-009507513-1708USA012211: US-009507513-1708USA012212: US-009507513-1708USA012213: US-009507513-1708USA012214.
pt lives at facility; pt had a positive COVID test on 1/21/22 in the facility; pt recovered from COVID; DNR; pt's overall condition continued to decline; hospice referral; pt passed away in the facility on 3/11/22
Family member reported patient deceased.  Was found on 3/21/21.  She had told a friend she wasn't feeling well on the night of 3/19/21.
Left arm extremely sore, full body aches, joint pain all over, nausea, fever, headache, extreme fatigue. Lasting 36 plus hours. Left arm still extremely painful 3 days later. About 24 hours later I also noticed a very sore left armpit and sort of lump., probably a lymph node..still sore 48 plus hours later.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 13-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)0.5 ml  in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
Wrong vaccine (GARDASIL) was given to patient. Patient had no adverse reaction to the vaccine.
Within 30 minutes of injection of all 3 vaccines, pt returned wheezing (mild) and facial hives. Wheezing reversed with Albuterol.
Approximately 2 hrs after injection, had fever of 104.5, pallor, abd pain, vomiting, some delirium. Seen in office 01-25-2017 with persistent fever, pallor, decreased energy, appetite. Fever. Maximum temperature is 104.50 F. Relieving factors include acetaminophen. Associated symptoms include nausea and vomiting. Pertinent negatives include cough, diarrhea and rash. Additional information: Patient had bad reaction to Flu shot which he received 1/24/2017. Patient had glossy eyes, pale skin and was seeing things that weren't there. HA and abd pain and fever. Had flu shot yesterday am and felt sick shortly after that. Fever 104.5. TYLNEOL helped vomited x 2 last night. Perioral rash. Rash around mouth for months tried mupirocin with not much help. Now using Hydrocortisone and Aquaphor. Has not been truly compliant with anything.
16 year old patient accidentally received the moderna covid-19 vaccine; A spontaneous report  was received from a HCP  concerning a 16-years-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a 16-year-old patient accidentally received the Moderna Covid-19 vaccine (Product administered to patient of inappropriate age).   The patient's medical history was not reported. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection.    On unknown date, the patient experienced product administered to patient of inappropriate age.  Laboratory details not provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the event was not reported.     The outcome of the event is unknown.; Reporter's Comments: This case concerns a 16-year-old patient of unknown gender who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
pt recvd vax 2MAR92 & 16MAR92 pt devel a defuse rash over entire body which described as being erythematous; devel nose bleeds, photophobia, low grade temp 99, achiness, BP elevated 160/100;
pt recvd vax & devel sudden right leg pain & refused to walk 7oct94; fever 102.9; red macules peri orally;
Information has been received from a registered nurse referring to patient of unknown age and gender. Information about concomitant medication, pertinent medical history, drug reactions/allergies was not provided. On 30-NOV-2018, the patient was inadvertently vaccinated with VAQTA (lot #:N026997, expiration date: 10-NOV-2018, 25/0.5 unspecified dose in series, frequency were not reported) intramuscular for prophylaxis (expired product administered). No adverse effects reported. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided.
Ct. reports great soreness in arm, esp. at site with decreased range of motion, and pain with use X 2 wks; continued soreness with use in shoulder joint.
Patient seen in ER. HCP reported difficulty swallowing and breathing. IV steroids given.
Information has been received from a nurse concerning a 17 year old female patient who was vaccinated with a first and second dose of Gardasil.  Concomitant therapy included another vaccination (unspecified) at the time when she received the first injection.  The nurse reported that the patient fainted after receiving the second dose of Gardasil.  She indicated that the patient lost consciousness for about twenty seconds within an hour of receiving her second injection.  She reported that the patient woke up then and was fine before leaving the physician's office.  She mentioned that the patient fainted after receiving the first dose of Gardasil.  Additional information has been requested.
immed itching @ site w/accompanying c/o dry mouth/dizziness/sensation feeling hot;BP 102/64;AP 64 sit pinkish in color per family MD was called 14min p/initial c/o instructed epi;
patient was given undiluted vaccine... day 1  arm was sore..am of day 2 sore arm..afternoon day 2 headache and sore arm
also after its beyond use date; No Adverse Event; HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster - to 2 adult patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (also after its beyond use date), WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster - to 2 adult patients) and NO ADVERSE EVENT (No Adverse Event) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster - to 2 adult patients). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (also after its beyond use date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (also after its beyond use date), WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster - to 2 adult patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (also after its beyond use date) and WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster - to 2 adult patients).    No concomitant medications were reported. No treatment medications were reported.
Pt recvd 3 doses of Engerix-B & was determined to be weakly reactive for HBSAB; pt recvd 4th dose of Engerix-B on 2JAN92;
Right arm swollen around injection site approximately 2inches in diameter, red, warm, itchy, painful to touch. 2 days since vaccine. Noticed the morning after vaccination. No other symptoms.
Received third dose of Hepatitis B vaccine 1/21/03 given in rt. deltoid.  No reactions to previous doses. Returned to clinic next day with pain and erythema at injection site.  Returned following day with worsening symptoms - 5cm circular induration.  No evidence of cellulitis. Evaluated by MD in clinic.  Returned following day with improvement in symptoms, which appear to be resolving.
Diarrhea,vomits, several body pain, fever over 40 degrees, limphatic nodules inflammation , nausea chills dizziness, cellulitis in the left arm
Nausea (within an hour) for 3 hours. Fever (within an hour) for 12 hours. Bruising at injection site - 4/3/07 - lasting two weeks - softball size. Swelling at injection site - 4/2/07 lasting two weeks at injection site - 4/2/07 - lasting two weeks - softball size - non-responsive to Ibuprofen.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced high fever on an unspecified date with outcome of unknown. No follow up attempts are possible. No further information is expected.
Rash on neck and chest; Rash on my face across my nose and cheeks; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for herself. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EK5730) via an unspecified route of administration on 28Dec2020 at 15:00 (at the age of 58-years-old) as a single dose in the right arm for COVID-19 immunization.  Medical history included arthritis, hypothyroidism and chronic back pain and arthritis in back; all from unspecified dates and unspecified if ongoing. It was reported that the patient did not have any allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications (taken in two weeks) included duloxetine hydrochloride, levothyroxine, nortriptyline and methocarbamol (ROBAXIN); all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Dec2020 at 19:00 the patient experienced a "rash on my face across my nose and cheeks" and on 30Dec2020 the patient experienced "rash on neck and chest". It was reported that "the evening after my vaccine I developed a rash on my face across my nose and cheeks. The next day I developed a rash on my neck and chest and the rash on my face was gone. I still have a rash on my neck and chest. No fever or other symptoms." It was reported that the adverse events were non-serious and did not require treatment nor hospitalization. The clinical outcome of the event "rash on my face across my nose and cheeks" was recovered/resolved on an unspecified date and the outcome of the event "rash on neck and chest" was not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Felt dizzy and "heart racing", elevated BP noted with Afix on monitor.  Patient felt "symptoms" at 15 minutes with periods of Afix and normal sinus on the monitor.  Vitals and on going monitoring completed.  Patient verbalized history of chronic Afib.  No other symptoms and no distress noted otherwise.  Patient and family declined ER treatment or further medical evaluation.
Presented with SOB, fever x 7 days; +Covid PTA 7 days PTA; dx with Covid PNA; Treated with steroids, antibiotics, zinc, supplemental O2; discharged home with O2 (not on PTA)
Severe muscle ache, fatigue, weakness, swelling and redness at injection site about the size of an orange. Patient took ibuprofen to help with pain. Swelling at injection site lessened over the course of a week, but not completely dissipated.
fever, lethargy, fever to 102 ax on 19NOV92, lethargy, fever to 103 ax on 20NOV92; 20&21NOV92 seen by MD;
pt recv vax 9MAY95 & 9MAY95 pt turned white & passed out;pt did not respond for 20min & was unaware;pt then open eyes & completely recovered p/20min;
Got Janssen Vaccine from Outside source - Housing complex... reported by patient 4/06/2021 - ACUTE RESPIRATORY FAILURE
Reported feeling light headed unwell and weak post vaccine, difficulty breathing and chills , hands were cold and clamy. DId not pass out, was alert and oriented at all time, took vitals until EMS arrived. Once EMS arrived and he was feeling better he declined to be transported to hospital. Left with wife who took him home.
Pt c/o dizziness. Pt placed on yoga mat. Pt drank some juice and ate some cheetos. Pt states that he is diabetic and did not eat breakfast. Pt reports that his blood glucose monitoring kit is at home.  BP=162/96, HR=92. Ice pack placed on forehead. After laying down for approximately 10 minutes, pt states that he felt better and was ready to go home.
CLIENTS STATES SHE BROKE OUT IN HIVES ON HER ARMS AND TORSO. HIVES WERE RELIEVED AFTER TAKING OTC BENADRYL 50 MG FOLLOWED AT BEDTIME BY BENADRYL 100 MG. NO SYMPTOMS AT TIME OF THIS REPORT.
Information has been received from a health professional concerning an 8 year old male, with no medical history and no allergies, who on 07-FEB-1998 was vaccinated with a 0.5 ml subcutaneous dose of Varivax (Lot# 624441/1105E). There was no concomitant medication. It was reported by the patient's mother to the reporter that the patient had a rash of erythematous papules in the past, on an unspecified date. The patient presented on 11-MAY-2006 to the practice with a similar rash of erythematous papules on his trunk and head, beginning on 10-MAY-2006. It was noted that there was some crusting of the papules, but they were not fluid filled. The patient was also experiencing a mild fever and congestion. At the time of the report the patient was recovering. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient came in for a covid vaccine appointment, writer administered the moderna bivalent booster to the patient, patient noted to not have any previous covid vaccines done.
pain at injection site; fever; This is a spontaneous report from a non-contactable consumer.  An adult male patient received BNT162B2 (lot not available/provided) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced pain at injection site and fever on unspecified dates. It was noted that it was forgotten if it was pain at injection site or fever the day after. The events were non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt began to feel flush, overhot with tingling in neck & throat area within 10 minutes of FLUZONE administration asked pt to self-monitor for changes in condition that could not be observed & per pt description/complaint. Admin EPIPEN 0.3mg approximately 12:25pm & contact E-svcs.
Late reporting per patient:  Localized redness/swelling and arm soreness; reported n 04.11.22 per pt.  Apparent reaction from 01.12.22 Shingrix #1; no medical tx at that time; lasting 2-3 days. Pt used ice only.
Convulsions; Patient is experiencing a possible vaccine reaction; This spontaneous case was reported by a nurse and describes the occurrence of SEIZURE (Convulsions) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant). 25-Jun-2021, the patient experienced VACCINATION COMPLICATION (Patient is experiencing a possible vaccine reaction). The patient was treated with LORAZEPAM (ATIVAN) 25-Jun-2021 for Convulsion, at a dose of 2 mg. At the time of the report, SEIZURE (Convulsions) was resolving and VACCINATION COMPLICATION (Patient is experiencing a possible vaccine reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Lab Data: results pending. It was reported that in the emergency room they have treated the patient with 2mg of Ativan, with improving results, from convulsing to subtle shakes.  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.; 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.
This is a 64-year-old male with significant past medical history of sarcoidosis of the lung, DVT and massive PE that presented to the hospital with chief complaint of progressive worsening dyspnea for about a week.  Patient states he started feeling sick about a week ago and his breathing progressively got worse.  The patient had fevers but no chills.  The patient has had a poor appetite has not been eating and drinking very well.  The patient has been feeling weak, fatigue malaise and other viral symptoms.  The patient denies significant chest pain.  The patient has been using his inhalers and taking his Eliquis.  The patient denied any abdominal pain, nausea or vomiting.  He did have some intermittent diarrhea.  Denied any dysuria, hematuria urinary frequency.  The patient denied any significant lightheadedness or dizziness.  The patient did get the COVID-19 vaccine, Johnson & Johnson.  The patient could not breathe so he had to come to the hospital today.  He does have a history of lung sarcoidosis and is on prednisone daily.
Injection site pain, Swelling, Lymph node swelling/tenderness Fatigue, headache, general muscle pain, slight nausea, sinus pressure/tenderness, sore throat, insomnia
45 minutes, post vax, she had hives in both legs, lasted a few hours and was gone by morning. Told us about rash on 1/27/01.
Gave vaccine to 17 year old; A spontaneous report  was received from a nurse concerning a 17-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event, gave vaccine to a 17-year-old/inappropriate age of dose of administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient received the vaccine resulting in the event of inappropriate age of dose of administration.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, gave vaccine to a 17-year-old, was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 013M20A with no associated AEs.
pt recv vax &  began to exp an alteration in smell;still exp diminution in ability to smell;also reports sense of taste has also been sl diminished;has alterations in smell, diminished smell, & taste discrimination & sensation;
That evening patient stated that she was having body aches and chills. Patient passed out. Patient had fever. 911 was called. When patient stood up her heartrate increased. Headache was constant for nine days. Head felt funny. Patient experienced a high level of fatigue.