chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a 66 year old male patient. Concurrent conditions or pertinent medical history were not reported and the patient had no allergies or reactions to drugs. On 05-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # K023624 - Expiration date: 19-FEB-2016), 0.65 ml, subcutaneously. Concomitant therapies were not reported. On 05-MAY-2015, the patient experienced injection site erythema and injection site swelling after the administration of ZOSTAVAX. The pharmacist stated that the male patient did not experience a rash. The patient did not received treatment for the adverse events. On 08-MAY-2015, the patient sought for medical attention with the pharmacist to report the reaction. At the time of the report, the outcome of infusion site erythema and injection site swelling was reported as not recovered; and the causality between ZOSTAVAX and injection site erythema and injection site swelling was not reported. Additional information has been requested.
inadvertently administered ActHib when ordered to received a Hepatitis B vaccine; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a patient (with unknown demographics) who was inadvertently administered HIB (PRP/T) VACCINE [ACT-HIB] instead of HEPATITIS B VACCINE lot number not reported via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  It was reported that HCP inadvertently administered ActHib, NDC 42981-547-48, when the patient was ordered to received a Hepatitis B vaccine.  It was unknown whether patient experienced any adverse reaction.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 30-NOV-2015 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. This is one of the many reports from the same source. Additional information has been requested.
Post vax, the pt developed swelling of left arm over 10 cm area. Itchy and non-tender.
Swelling and erythema/warmth to injection site. Patient is retired RN and described this as "severe" - she had to ice her arm.
I received my second dose of Moderna COVID19 vaccine on 1/21/2021. On 1/22/2021, the arm in which I received the injection was much more sore than with the first shot. On 1/24/2021, my injection arm was still sore. I glanced in the mirror at my arm and noticed it was red at the injectin site. The area was also warm to touch.
Within 24 hours of the 2nd vaccination, I suffered severe flu-like symptoms; joint aches and headache for about 2 weeks. Then I had severe joint problems and muscle aches which became worse as time went by. This developed into arthritis in all my joints and neck and shoulders. I can't lift or walk without severe pain. I can't sleep more than 1 hour at a time without waking up in pain.
Patient received Moderna 3/26/2021 and they told us they received Pfizer. No symptoms they talked to the nurse practitioner
Positive for COVID-19; Positive for COVID-19; MARKETING PROGRAM NAME NOT AVALIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4499107-00.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Batch/Lot number: unknown), on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 31May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, all intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Lot number: 1164825) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter considered "positive for covid-19" related to BNT162b2.  Clinical course:The reporter's causality for the event(s) of POSITIVE FOR COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19,Vaccination failure.
This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, she felt "really sick, kidney damage, blood in her urine, her stomach is "really bad on 2021. Reported as, Patient got the first dose of Pfizer vaccine 2 weeks ago, does not remember exact day. She felt "really sick", it looks like she had kidney damage, she had blood in her urine, she had a "very bad" reaction. The last two weeks she has been to 5 different hospitals, because they know nothing about the vaccine o how to help her. She was prescribed antibiotics, her stomach was "really bad", she still has kidney problems. On Wednesday, she was scheduled for the second dose. Treatment were given for the adverse event. Outcome of the event kidney damage was not recovered and unknown for other events. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Patient became pale and unresponsive in post vaccine waiting area within 3 or 4 minutes while waiting 15 minutes with mother. When assessed patient was breathing and had pulse but was only responding partially to verbal stimuli. Placed cold compress on neck and once alert and fully responsive gave glucose tablets. EMS responded and checked vitals but did not share results. Patient fully recovered and left with mother after we verified contact info.
32 hours after patient obtained the 2nd vaccine, he began to seriously decline and died the next day. He was on hospice and his death was eventually inevitable due to his lung cancer, but I am reporting this event as his death occurred so close to administration of the vaccine.
Several hours after vaccine #2, developed severe headache, myalgias and vomiting. Seen in ED on 2/3/21 and admitted to hospital for pain and nausea control.
symptom: increased heart rate, flushed skin, difficulty breathing.  Client stated that it felt as if her heart was coming out of her chest.
No signs or symptoms reported.; temperature excursion on VARlVAX - VAQTA that was administered; Information has been received from a medical assistant reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 22-APR-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#T017687, expiration date 21-MAY-2022 (dose and route of administration were not reported) and with hepatitis A vaccine, inactivated (VAQTA) lot#T023913, expiration date 31-MAR-2022 (dose and route of administration were not reported). Both vaccines for prophylaxis.   On an unknown date, varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent a temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 1 hour and 45 minutes; between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 2 hours and 30 minutes. On an unknown date, hepatitis A vaccine, inactivated (VAQTA) underwent a temperature excursion above 47 degrees Fahrenheit for 2 hours. No previous temperature excursion. The call was not placed due to a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007341: US-009507513-2104USA007215:
Moderna COVID-19 Vaccine EUA Soreness at injection site immediately following injection through 4/5/2021 Redness on arm surrounding the injection site that was initially noticed around 2pm on 4/3/2021 Headache that started around 10pm on 4/2/2021 Tiredness that started around 12pm on 4/3/2021 Body aches that started around 12pm on 4/3/2021 Fever that started around 4pm on 4/3/2021
Information has been received from a physician referring to an adult patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with PROQUAD (dose, route, lot # and expiration date were not reported) for prophylaxis by an unknown "technician" in the office (Drug administered to patient of inappropriate age). No adverse effects were reported.
A Moderna first dose COVID vaccine was given this morning without realizing before that the expiration was yesterday; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A Moderna first dose COVID vaccine was given this morning without realizing before that the expiration was yesterday) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A Moderna first dose COVID vaccine was given this morning without realizing before that the expiration was yesterday). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A Moderna first dose COVID vaccine was given this morning without realizing before that the expiration was yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information were reported.   Reporter did not allow further contact
1998, pt devel numbness, tingling, loss of sensation, loss of mobility in lower extremities; progressively worsening w/ each of 3 anthrax shot, pt didn't report d/t fear of separation from service, missed 20 days duty p/ 3rd vax, 80% recove
When the nurse went to draw up last dose for patient only 0.3 ml was in the vial. Emailed the Department of Public Health Immunization Branch, was directed to the regional preparedness and informed to complete VAERS report. Another facility contacted in hopes to get the booster dose for the patient. Currently, awaiting call.
This spontaneous report as received from a nurse refers to a 7 month old male patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 06-FEB-2019, the patient was vaccinated with improperly stored RECOMBIVAX HB injection 5/0.5 mcrg/ml (frequency, route of administration was not reported; lot # R012001, expiration date 06-NOV-2020) for prophylaxis. The temperature of excursion with RECOMBIVAX HB was above 9 Celsius degrees for 1 hour and 36 minutes. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1902USA007125: US-009507513-1902USA007126.
Systemic: Weakness-Mild, Additional Details: Patient reported that he was experiencing off and on fatigue nearly three weeks after receiving his third dose of Moderna's mRNA COVID-19 vaccine.
PATIENT WOKE FROM HER NAP IRRITABLE APPROXIMATELY 4 HRS AFTER RECEIVING VACCINES. SHE HAS ONE EPISODE OF EMESIS, AND HAD PURPLE COLORATION TO HER RIGHT LEG BELOW THE KNEE THE LASTED 5-10 MINUTES SO PARENT TOOK PATIENT TO ER. PATIENT WAS AFEBRILE, WELL APPEARING, TOLERING FEEDS, AND NO DISCOLORATION TO THE LEG WITH BRISK CAP REFILL. PATIENT WAS GIVEN TYLENOL IN THE ER. NO LAB WORK WAS DONE. EXTREME FUSSINESS AND CRYING LASTED 45 MINUTES. LEFT LEG WAS THE SITE WHERE VACCINES WERE GIVEN.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On 12-JUL-2016 the patients were vaccinated with improperly stored GARDASIL 9 (lot # M005714, expiration date 30-OCT-2017, dose and route were not reported). There was no previous temperature excursion. The vaccine was stored under temperature of 1 degree Celsius for 48 hours. No adverse effects were reported. Additional information is not expected as the reporter did not consent to be contact.
Pt was given Moderna vaccine at age 17. No adverse reactions noted. Mother consented to completing dose #2 even though not FDA approved for under 18. Mother's name.
Cold sores on nose and mouth Tingling nerve sensation on face, scalp, and neck Minor first outbreak of shingles (painful bumps under right armpit) Tinnitus (from a 1 out of 10, to a 2 out of 10)
72 y/o woman with history of  gout, hypertension, T2DM (last HgA1c of 7.2) and arthritis, vaccinated with Pfizer/21 but no booster, who presented to the Emergency Department on 12/10 with worsening shortness of breath. She was tested positive for covid on 12/2/2021. She was admitted for acute hypoxemic respiratory failure due to covid pneumonia.    Hospital course:       COVID Pneumonia with acute hypoxemic respiratory failure: Symptom onset on 12/5, COVID positive on 12/2. Last fever on unknown. She is s/p 5 days of Remdesivir ended on 12/15 and on D7/10 of decadron 6 mg daily. Now on RA and needs 1-2L on ambulation to keep O2 sat above 92%. Liver enzymes stable, mild elevated ALP 33, CRP down trended to 1.8, she received lovenox for DVT PPx and pepcid for GI ppx. She will be discharged on home O2 only with ambulation. Booster when she is feeling better, within a month. She will be in isolation 20 days from started on symptoms which was 12/5.    EKG on admission with new afib, continued to remain in for >48 hours. CHA2DS2VASC score of 4. She was started on pradaxa by Doctor. She has converted to SR and remains in SR with HR 50-60s on atenolol 50 mg daily. PTA was atenolol 100 mg daily but HR drops to 48-50s during sleep and her blood pressure is well controlled on atenolol 50 mg daily and cozaar 25 mg daily. Please adjust her blood pressure medication.   AKI : resolved  Cr 2.01 on admission. Suspect pre-renal. S/p IVF resuscitation and good PO intake with normalization of Cr.     AGMA due to  lactic acidosis (5.9) which resolved after IVF resuscitation. Suspect due to hypovolemia and concomitant metformin use at home.    T2DM:  Resume PTA metformin/glipizide   history of gout: continue PTA allopurinol   History of HTN/HLD: on much lower meds here even on steroids. I am only resuming cozaar at 25 mg daily and atenolol 50 mg daily. Holding PTA Norvasc 10 mg daily, Losartan 100 mg daily since tenuous blood pressure. Advised daughter to monitor her diet and blood pressure.    Primary Procedures:  none   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  Lactic acidosis and Hypoxemia
Strong dizziness for three days. Then intermittent dizziness and unwell feeling in head for the next five weeks up to present.  Unwell feeling in head  interferes with mental processing.   Noticed faint ringing in ears approximately a few weeks ago. Then  two days ago 3/28 (1 1/2 weeks following 2nd shot on 3/19), tinnitus became very noticeable. Volume was 4/10. And last couple days has ranged in volume between two and four.  Have contacted doctor, but not been seen.
Patient received 2 doses of Moderna, last in March, at distribution site.  In July came down with severe covid requiring admission and high flow oxygen in the ICU.  Was discharged home after a week.
Moderna COVID-19 Vaccine  Had normal sore arm and fatigue for two days after vaccine.  On 1/15/2021, work up to a rash to bilateral elbows with itching and discomfort.  By 1700 on 1/15/2021, joint pain started to bilateral elbows, fingers, wrists, hips, ankles, right toe.  Joints to hands swollen with red, raised, and bluish/purple tinted areas over the finger joints.
Pt. described feeling "bubble in chest."  States he has had previous heart attacks in the past.  Pt. sat down for additional 15 min and states he feels better. Pt refused hospital for further evaluation.  Pt. D/C 1425
Redness, firmness and soft pain when touching around the area of the shot after a week of the first dose
Local induration 5.5 X 5 cm, Arm tenderness, SC nodule, Vaccine given 03/20/00, Noticed 03/22/00
Severe reaction; This case was reported by a other health professional and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient had a severe reaction to the Shingrix vaccination and thought that the reporter should be aware of.
Headache and chills in first 24 hours then after 48 hours and large red  skin rash appeared below injection site.
2 wks after first vaccine experienced chest pain along L breast and radiated to sternum and L neck.  Pressure below the sternum. itching/aching in random areas of body.
Vomiting; slept entire second day; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 15:00 (Lot number: FJ8762) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression", start date: 2018 (ongoing), notes: was taking 125 mg at the time of 2nd dose. Concomitant medication(s) included: ZOLOFT taken for depression, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date: 29Mar2021, Time (24hr): 09:00 AM ET, Anatomical site of Injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 29Mar2021, when the patient was 18 years old, for COVID-19 immunisation; Bnt162b2 (Dose: 2nd , Date: 19Apr2021, Time (24hr): 09:00 AM ET, Anatomical site of Injection: Left Arm, Batch/Lot number: EP6955, Route of administration: Intramuscular), administration date: 19Apr2021, when the patient was 18 years old, for COVID-19 immunisation, reaction(s): "he started not feeling well at night", "sick", "vomiting", "Nauseous". The following information was reported: NAUSEA (non-serious) with onset Dec2021, outcome "unknown", described as "nauseous"; VOMITING (non-serious) with onset 21Dec2021 06:00, outcome "recovered" (Dec2021), described as "Vomiting"; HYPERSOMNIA (non-serious) with onset Dec2021, outcome "recovered" (2021), described as "slept entire second day".  Additional information: Patient had similar reaction to that he had to his second dose where he was just nauseous. His booster dose he had a similar reaction. For the booster, (name withheld) received the booster at 03:00 PM in the afternoon and was vomiting at 06:00 AM the next morning. So about the same 15 hour window after getting the shot. Similar recovery- slept entire second day and resumed normal activities within 48 hours. Specific Relevant Test for thromboembolic events with thrombocytopenia was reported as None. Prior vaccination (within 4 weeks)was None.  No follow-up attempts are possible. No further information is expected.
Nauseas the day of the shot and the next day. Red hard warm bump at injection site. Arm pit pain on the injection arm.
Swelling on front and back of shoulder, bicep, tricep.  5 in by 5 in.  Redness and warm to touch on entire area.  Pain with movement and tingling and in forearm and hand- radiating to fingers.  Skin leathery- 4 in height by 5 in.