chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/06/2022- The patient presents with allergic reaction. 60 yr old male with HX of HTN, cholesterol, DM, ESRD on dialysis (Tu-Thur.-Sat), recent amputation of all left toes (on 12/20/21) presents to ED for swelling of his entire body onset last night. States he went to receive dialysis treatment this morning but was advised to come to the ER by his nephrologist. Patient had IV infusion of antibiotics started yesterday. Patient was receiving vancomycin while admitted after surgery on 12/20/21 but sent home on Cubicin. The onset was last night. The course/duration of symptoms is worsening. Location: Diffuse face upper extremity lower extremity but not mouth or not throat. The character of symptoms is swelling. The degree at onset was minimal. The degree at present is moderate. Potential allergen(s) to medication(s). Risk factors consist of recent antibiotic use and ESRD on dialysis, recent surgery. Prior episodes: none. Therapy today: none. Associated symptoms: denies dyspnea, denies wheezing and denies difficulty swallowing.
rt arm became very sore approx 2 hrs p/inj w/pneumo vax-hard to lift arm;area became swollen, hives appeared more towards inside of arm about 2" x 4" in size with a knot underneath arm; pt was very tired as if was coming sown w/something;
Patient reported symptoms started about a week to a week and a half ago from 11/18/2023 patient vaccinated on 10/25/2023 patient reported red dots or spots, gets a few bumps per day, they blister and scab over, they itch like crazy, no fever, no muscle aches, no breathing problems, they appear on patients chin, chest, cheeks, neck, inner part of arms
Cough; sore throat; Felt like I had a hangover; Felt terrible/I felt like was going to die; Nodule in lung; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), FEELING DRUNK (Felt like I had a hangover), FEELING ABNORMAL (Felt terrible/I felt like was going to die) and PULMONARY MASS (Nodule in lung) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement (3 stents). Concurrent medical conditions included Blood pressure high, Cholesterol and Heart valve replacement NOS (Valve replacement issue in May/June). Concomitant products included METOPROLOL for Blood pressure high, ATORVASTATIN CALCIUM ANHYDROUS for Cholesterol.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), FEELING DRUNK (Felt like I had a hangover), FEELING ABNORMAL (Felt terrible/I felt like was going to die) and PULMONARY MASS (Nodule in lung). The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) for Surgery, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), FEELING DRUNK (Felt like I had a hangover) and FEELING ABNORMAL (Felt terrible/I felt like was going to die) had resolved and PULMONARY MASS (Nodule in lung) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Lozenges for sore throat. Other than nodule in lungs, patient's other symptoms lasted an hour or two. Patient didn't have any side effects for the second dose. Patient has taken the second dose on 25-FEB-2021 in left non-dominant arm, lot no- 001A21A   This case was linked to MOD-2021-023991 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up information was received. Reporter's address was added. Patient's relevant medical history ,concomitant medication, treatment and an additional event were updated.
Sore arm; Fever; A report was received from a consumer concerning a 26-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and developed sore arm and fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT or BATCH  number 011320A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced sore arm that lasted about 1 day, and fever which lasted about 5 hours. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The events, sore arm and fever, were considered resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My onset of symptom was 20MAR2023 I began to feel an itch sensation in my throat, during that day and through the next several days I experienced a fever of one hundred and one degrees. An on and off not consistently but an unusual headache chills coming and going muscular and joint body aches sinus congestion, chest congestion, my chest felt uncomfortable and heavy with a bad cough, I coughed up mucous especially when lying and I felt very tired. On 21MAR2023  I called my PCP she was out of town her office did not want to see me and instead called in a prescription for Paxlovid.  I started that 22MAR2023 I took all as prescribed on schedule, I took all of them. I had acute symptoms for three of four days and after ward began feeling better quickly, my only lingering symptom was cough especially in the morning that lasted three weeks and then stopped.
no additional adverse effect reported; a patient was administered a dose of improperly stored Varivax; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 29-JAN-2020, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection, subcutaneously, lot # S024364, expiration date 06-AUG-2021(exact dose and anatomical location were not reported) for prophylaxis. The vaccine was diluted with a properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion of - 14 degrees Celsius to - 10 degrees Celsius (-12.6 degrees Celsius) for 9 hours and 53 minutes. Digital Data Logger was involved. The vaccine underwent previous temperature excursion of - 14 to - 10 degrees Celsius (- 13 degrees Celsius) for 14 hours and 22 minutes. No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA001486: US-009507513-2002USA001480: US-009507513-2002USA001517: US-009507513-2002USA001358: US-009507513-2002USA001459:
This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine for the first dose in the patients primary series) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine for the first dose in the patients primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine for the first dose in the patients primary series) 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 WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine for the first dose in the patients primary series).    No concomitant medications were reported.  No treatment information was provided.
Apprehension, lightheadedness BP 146/96 pulse 100 resp 18
Child developed left thigh redness extending approx. 4 cm in diameter across anterior left thigh, pruritus, and tenderness 2 hours after injection of QUADRACEL. Child presented to our office 2 days after the injection. Mom has been treating the pain with TYLENOL but has not tried anything else. Child was given 5 milliliters of BENADRYL oral syrup in office for pruritus, and instructed to apply cool compresses, and hydrocortisone cream to affected area three times daily.
12-29-20 approx 2:00pm. Very flushed . Temp 97.3 Lasted for about 3 hours
Pt recv vax on 3/9/99; 1/2 hr post vax pt exp sore arm, warm vax site, upset stomach
12/18  1500 onset of nausea 1730 onset of chills (temp not recorded) 1800 onset of extreme fatigue 2000 temperature measured at 100.7  12/19 0145 onset of vomiting (3x over 2 hours) 0155 onset of diarrhea (>10x over 12 hours) 0220 lightheadedness/feeling faint 0245 temperature measured at 100.3 0900 admitted to ER (local HCF) IV fluids and zofran administered CT scan More zofran Discharged from ER
pt recvd vax & 1/2 hr post vax exp numbness of the lt side of the face; still has intermittent numbness; no treatment; pt spoke w/MD;
Pt devel upper resp sx, tightness in chest, cough, bronchitis; no fever, chills;
Pt went in to Dr's office back on November 2012 to get a Flu shot, when Pt came out she felt her arm in bad pain but she thought it was normal because of the shot. Now shes been having really sharp pain in her left shoulder all the way down to her elbow or sometimes down to her wrist.
Employee reports shortness of breath approximately 4 hours post vaccine with little relief from inhaler and continued to report shortness of breath the next day (though milder than the day of the vaccine).
Passed out; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program.  A male patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization.  The patient medical history was not reported. Concomitant medications were not reported. On an unspecified date, the patient experienced: passed out (hospitalization, medically significant). The patient's mother called-in on-behalf of her son who passed out in a restaurant and was taken into the hospital due to this emergency. The patient's mother was worried saying that her son was due for the second dose of the COVID-19 vaccine. The patient's mother was unable to identify when her son received the first shot of the vaccine. The patient's mother was also unable to identify why her son passed out. The mother's concern was that her son already missed the second dose. The clinical outcome of the event, passed out, was unknown.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
A report was received from a healthcare professional on 10/09/2003, concerning a 30 year old female vaccinee who developed large erythema at the injection site and experienced fever, headache, and joint pain on 10/09/2003 after receiving Fluvirin vaccine on 10/08/2003. On 10/09/2003 at 9:00 the vaccinee developed large erythema at the injection site and experienced fever, headache and joint pain after receiving Fluvirin in her left deltoid muscle on 10/08/2003.  The vaccinee was administered diphenhydramine hydrochloride and ibuprofen for her symptoms.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/10/2003: Further information received from a healthcare professional on 11/10/2003 indicated that the vaccinee received Fluvirin on 10/09/2003.  The vaccinee also experienced vomiting on the night of 10/09/2003.  The vaccinee was out of work for 2 days.  The fever, joint pain and vomiting resolved 2 days later. No follow up pending.
Pt recvd 1st dose of Hep B vax on 20FEB92 & on 27FEB92 devel rectal bleeding w/ a bloody mucous discharge from rectum; c/o mild diarrhea; p/2nd dose exp cramping;
18MAR92 devel sl dry small bumps near diaper area; 27MAR92 fever 250PM 102.4 450PM sz; taken to hosp seen by MD in ER given tranquilizer & antibiotic; found pt to have URI w/febrile seizure;
Per patient presented with a low grade fever 3/26/20 of 99.1.  Temperature was taking with the highest temperature documented at 100.9.  Pt presented with no other symptoms other than elevated temperature.  After hospital visit patient was diagnosed with pneumonia.r
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 46-year-old, adult patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 12-Oct-2018, the adult patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2020 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805487 was crossed linked to original cases 201804863 due to same reporter.
After testing positive for Covid on 10Jun2022; After testing positive for Covid on 10Jun2022; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 2, single (Lot number: ER7523), in left arm, on 24Aug2021 as dose 3 (booster), single (Lot number: FA7485), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypopituitarism" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "not recovered" and all described as "After testing positive for Covid on 10Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (10Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: After testing positive for Covid on 10Jun2022 took by the drug, Paxlovid  for five days following which I tested negative.  Then, 3 days I began I became symptomatic And tested positive again for Covid. I continue to be very ill with symptoms including fever cough congestion.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
This spontaneous report as received from company representative from a physician. It was reported that the physician stated that anytime he or his staff administer GARDASIL, or GARDASIL 9, to an unspecified number of patients, the patients immediately complain of burning or tingling at the onset of administration up to two minutes after. Even if the patients are getting other vaccines they can identify that it is GARDASIL being administered, due to the burning. No further information was provided. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that she was aware of two other patients that got the shingles after getting the SHINGRIX, the same day that she received the SHINGRIX. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. Consent to follow up was given. Limited information was provided. This was 1 of 3 cases reported by same reporter.
Information was received from a registered nurse concerning a male patient of unknown age who was vaccinated with his first dose of GARDASIL (lot number, expiration date, and dosage not provided), intramuscularly, on an unspecified date. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient's second dose of GARDASIL (lot number L040459, expiration date 06-APR-2017), was administered approximately 2 years after his first dose, intramuscularly (dosage not provided). No side effects to report. No further information reported. Additional information has been requested.
pt recv vax 10AM;@ 3AM the following morning pt @ first became limp, eyes rolled back & all extremities began to jerk according to father;sx occurred intermittently for approx 1hr;father took child to PMD who prescribed APAP, robituss
Patient vomited and then became lethargic for 5 minutes.  Did not lose conciousness.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 21Aug2023 to 25Aug2023.  Clinical course: On day 3 after completing paxlovid, I feel worse. Headache, nausea, and fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Anaphylactic reaction; Initial information was received on 18-Jun-2020 regarding an unsolicited valid serious case received from a physician.  This case is linked to case 2020SA159441 (same reporter).  This case involves patient of unknown demographics who experienced anaphylactic reaction, when received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. At the time of the event, the patient had ongoing severe milk allergy.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date not reported) via unknown route and administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious anaphylactic reaction unknown latency following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  Case detail : Physician wanted to know why the company had not included history of anaphylaxis to milk protein in the warnings section and stated that he received a letter about the milk contents for Adacel, DIPHTHERIA TETANUS (DT), and Menactra and requests another letter with all 5 products.  Details of laboratory data were not reported.  Final diagnosis was anaphylactic reaction.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of anaphylactic reaction.  Information on the batch number was requested.; Sender's Comments: This case involves patient of unknown demographics who developed serious anaphylactic reaction on an unknown latency following the vaccination with DAPTACEL vaccines. Time to onset was unknown. Patient had history of severe milk allergy. However, detail additional information of past medical treatments, concomitant therapies, past vaccination and tolerance were not reported. Based upon the reported information, the role of the vaccine cannot be assessed. Missing data needed for further assessment of the case.
short interval between the 2 doses/ 1st dose 29Dec2020; 2nd dose 11Jan2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (short interval between the 2 doses/ 1st dose 29Dec2020; 2nd dose 11Jan2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (short interval between the 2 doses/ 1st dose 29Dec2020; 2nd dose 11Jan2021). On 11-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (short interval between the 2 doses/ 1st dose 29Dec2020; 2nd dose 11Jan2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Significant FU: Reporter city added, Patient race added, Vaccination full details added for dose 1 and dose 2, vaccination record provided.