chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A vaccine dose was taken out of a vial that had been pierced/opened 13 hours earlier. The vial in question was set to be discarded this morning, however it had not been discarded yet. The vial has been refrigerated since it was opened and is now being quarantined until I receive guidance from Janssen who has already been contacted.  The Pt. was also contacted and advised of the situation along with let know of this report and the call to Janssen for guidance. I advised him that I contact him back as soon as follow-up information has been received from Janssen.
Breakthrough case admission after 2 vaccines pfizer 12/21/20 lot# EL0140;  Pfizer 1/11/21 Lot# EK9231
21 y/o M who presented to the ER with c/o left shoulder pain worsening over the last 3 1/2 weeks. Pain initially began after patient received anthrax vaccination. Located over the left shoulder/trapezius, described as "sharp" and "shooting" radiating to the neck and down the left arm and spine, rated as a 9/10 with paroxysms of pain. Over the last 3-4 days he notes shaking, numbness/tingling in the left arm below the shoulder. Patient was initially seen at his facility and treated for shoulder pain with NSAIDs and recommended PT however continued to worsen. On follow up case was discussed with Neurology and thought that symptoms were consistent with a neuralgic amyotrophy, patient was started on a 5 day prednisone burst. However again without any improvement and patient has now been seen in the ER and was started on Gabapentin. Patient reports finishing the steroids yesterday and ran out of Gabapentin this morning so hasn't taken any today. Xray left shoulder and C-spine series both normal. Denies any recent illnesses, F/C/N/V, SOB, chest pain.
COVID-19; COVID-19; Interchange of vaccine product; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2021 at 15:00 as dose 1, single (Lot number: EW0185), in right arm and on 02Jul2021 at 14:00 as dose 2, single (Lot number: EW0198) at the age of 36 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Jan2022 at 16:00 as dose 3 (booster), single (Lot number: 084J21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE, start date: 01Sep2022, stop date: 15Mar2023; LAMOTRIGINE, start date: 01Dec2022, stop date: 15Mar2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Jan2022, outcome "unknown", described as "Interchange of vaccine product"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course:  Oral contraceptive from 01Nov2022 to 15Mar2023.
The pt experienced a seizure 9 hours post vax. Taken by ambulance to the hospital where a sepsis work up was done. Mother states that the doctor's did not think seizure was caused by vaccines.
Chills and subjective fever which began 10 hours after administration. During; 5 hours.
8 days after receiving the vaccine, I started to develop a red rash in the arm the vaccine was given in. Over the course of 3 days, it was covering over 1/3 of my upper arm. There was mild swelling, mild pain, and itching. I put cortizone cream on it which seemed to make it worse. I took a couple doses of benedryl and within a couple more days, the rash was gone.
I hadn't performed any strenous activity for three weeks following the vaccine, yet within less than a month, I began feeing symptoms of sciatica.
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Previously administered products included ZOSTAVAX (received in 2014). On 22nd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). .5 ml. On 22nd March 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, injection site lump, nausea, appetite absent, headache and fever. On 26th March 2018, the outcome of the nausea, appetite absent, headache and fever were recovered/resolved. On an unknown date, the outcome of the pain in arm and injection site lump were recovering/resolving. It was unknown if the reporter considered the pain in arm, injection site lump, nausea, appetite absent, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The patient was only on maintenance medications and did not have anything in their medical history that was pertinent to this case. The patient was administered SHINGRIX in the left arm in the morning and later that day after lunch, they presented with all the symptoms. Everything resolved by 26th March 2018 except for the arm soreness (felt like there was a knot in the arm where the patient got the vaccine). The patient's body temperature was recorded as 103 F. It was getting better but had not fully resolved till the time of reporting. The health care professional was certain it was due to the vaccine because the patient was a pharmacist as well. The patient stayed in bed for the whole weekend that this happened.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 09-JAN-2020, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Therapy type: Digital Data Logger), lot number  S014948 and expiration date 12-APR-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
In 11/00, the pt was hospitalized due to leucocytoclastic vasculitis affecting skin and kidneys. Ovarian cancer was dx'd while in the hospital and the pt had a good response to chemotherapy (pallilative). The event resolved in 4/01 and the pt recovered. There was insufficient information to determine the reporter's causality assessment.
Client had appointment for 2nd Adult Hep B dose. Also due for MMR. Vaccination admin error and Hep A admin'd in error. Client waited  15 minutes in lobby after administration and then left. Nurse contacted client to have them return for proper, 2nd Hep B dose
Exp. Date 12MAR2023, the vial was initially stored in the refrigerator 10APR2023; No adverse event; administered a first primary dose of Moderna COVID-19 vaccine, After she administered the dose she noticed that it expired in March and not in May; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a first primary dose of Moderna COVID-19 vaccine, After she administered the dose she noticed that it expired in March and not in May), PRODUCT STORAGE ERROR (Exp. Date 12MAR2023, the vial was initially stored in the refrigerator 10APR2023) and NO ADVERSE EVENT (No adverse event) in a 21-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a first primary dose of Moderna COVID-19 vaccine, After she administered the dose she noticed that it expired in March and not in May). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Exp. Date 12MAR2023, the vial was initially stored in the refrigerator 10APR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a first primary dose of Moderna COVID-19 vaccine, After she administered the dose she noticed that it expired in March and not in May), PRODUCT STORAGE ERROR (Exp. Date 12MAR2023, the vial was initially stored in the refrigerator 10APR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered a first primary dose of Moderna COVID-19 vaccine, After she administered the dose she noticed that it expired in March and not in May) and PRODUCT STORAGE ERROR (Exp. Date 12MAR2023, the vial was initially stored in the refrigerator 10APR2023).    No concomitant medication were reported.  Nurse called to report that She wrote expiration date of 12-MAY-2023 on the vial by mistake. After she administered the dose she noticed that it expired in March and not in May. Individual vials with vial size of 5.5 ml Red Cap. The vial was initially stored in the refrigerator on 10-APR-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
This case was reported by a consumer and described the occurrence of ill-defined disorder in a child patient who received INFANRIX. On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced ill-defined disorder (serious criteria hospitalization). On an unknown date, the outcome of the ill-defined disorder was unknown. It was unknown if the reporter considered the ill-defined disorder to be related to INFANRIX. Additional information was provided: The mother of the child mentioned that the child was hospitalised due to a bad reaction to DTP vaccination. On further questioning, she confirmed that it was INFANRIX that was given, but she did seem sure which variant (Penta or Hexa). When asked about further detail about the reaction, the mother did not want to provide any further information.
This spontaneous report was received from a Registered Nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with improperly stored VARIVAX, lot # R002054 and expiration date on 22-JAN-2018, for prophylaxis (route of administration and anatomical location were not reported). It was reported that the vaccine was reconstituted with properly stored sterile diluent. The administered dose of the vaccine experienced a temperature excursion of -9 to 8 degrees Celsius for 2 hours and 47 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA012082; US-009507513-1810USA012268; US-009507513-1810USA012269.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX for prophylaxis.  On 19th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, fatigue, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site pain were recovering/resolving and the outcome of the fatigue, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, fatigue, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: At 13:00, the patient received SHINGRIX on an unknown arm. About 12 hours after receiving the SHINGRIX, she had redness and swelling at the injection site, about the size of a baseball. It was also hot to the touch and it was sore when she used her arm, though not to touch. She also had some fatigue. The patient still had some of the redness, though it had improved, and her arm still hurts when used, though it was minor. The patient had denied permission to contact their physician. This case has been linked with the case US2018GSK181021, reported by the same reporter.
Caused QUANTIFERON-TB GOLD PLUS  test to be positive.  Secondary test a week later came back as negative.
Tinnitus started or intensified a couple of weeks after the 2nd dose of the vaccine.  I have some hearing loss and tinnitus off and on prior, but now the tinnitus seems amplified and more frequent & constant in a quiet environment.  I have not reported this to my doctor as of this date.  Just started doing some research on it.
Patient received adult dose instead of pediatric dose of Pfizer.  1 day before 12th birthday.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. 01-DEC-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 15-FEB-2016, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient with generalized weakness since immunization. Two days after vaccination became dysarthric. Three days after vaccination became minimally responsive and brought to emergency department (ED) by ambulance. On arrival patient had right lower extremity weakness, right upper extremity mild drift, and severe dysarthria. Patient underwent thrombectomy and did not have residual neurologic deficits. Initiated on antiplatelet agent, anticoagulation, and cholesterol-lowering agent. Patient also experienced NSTEMI and newly diagnosed with heart failure and initiated medications for management. Patient discharged medically stable. Three days later patient admitted for atrial fibrillation with rapid ventricular response and worsening ischemia: initiated antiarrhythmic medications and patient improved and discharged medically stable.
Large red lump that was very sore to the touch, the site is warm and 7 days later a bruise has formed. Lump appears to be very slowly getting smaller.
19SEPp96 early AM t101 R, vomiting 1x;20SEP96: t103 R, runny nose & eyes & very cranky;attempted to dec temp w/sponge bath w/o success;to ER approx 6PM;dx tonsillitis;rx erythromycin;
I started having fever and sore throat I did a home test, and I was negative and then I went to a pharmacy and did a PCR test that was positive for COVID-19. I had a virtual consult with my doctor and was given PAXLOVID, azelastine hydrochloride nasal spray, TESSALON PERLES and albuterol. Within a few days of the results I started having headache, runny nose, congestion, body aches, chills, coughing, loss of smell and fatigue. These symptoms lasted for two weeks in total. Although I am still having cough, fatigue and my sines of smell is off (smelling smoke for some reason).
Severe itching in the muscle involved in the injection site. Feels like an internal itch.
Woke up around midnight, vomiting, hot & flushed, coughing & dyspnea. Symptoms subsided when went outside in cold air. Cough lingered into the next day.
Headache; Body aches; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Batch/Lot No: Unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; Batch/Lot No: Unknown), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 29Nov2022, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset 29Nov2022, outcome "not recovered", described as "Headache ". Therapeutic measures were taken as a result of headache, pain.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore arm; little triredness after getting the vaccines; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (little triredness after getting the vaccines) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Dec-2022, the patient received fifth 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 PAIN IN EXTREMITY (sore arm) and FATIGUE (little triredness after getting the vaccines). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (little triredness after getting the vaccines) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient has tolerated the vaccines well. No treatment drug details was reported.   This case was linked to MOD-2023-716296 (Patient Link).   Reporter did not allow further contact
Hospitalized with COVID 12/14/2021 and deceased 12/29/2021 multiple subsegmental pulmonary embolism.
Around 5:00 pm the day after the shot, I began experiencing some sharp aches/pains in my upper chest and lower abdomen, both on my left-side. Breathing was a little more difficult due to these pains. The symptoms have persisted since that time, although they have been more subdued. Experienced a peak again around noon on 4/30/2021, but is milder again as I submit this.
Red swollen injection site, Warm to the touch where injection was administered, headache, severe body ache, hot/cold flashes.
Diagnosed with Atrial Fibrillation; Heart started going strange; felt funny; Severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with Atrial Fibrillation) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0S(5)8F0IA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation in 2006.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced NAUSEA (Severe nausea). On 03-Nov-2021, the patient experienced HEART RATE ABNORMAL (Heart started going strange) and FEELING ABNORMAL (felt funny). On 08-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (Diagnosed with Atrial Fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with Atrial Fibrillation), HEART RATE ABNORMAL (Heart started going strange), FEELING ABNORMAL (felt funny) and NAUSEA (Severe nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2021, Electrocardiogram: abnormal (abnormal) Atrial Fibrillation.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company comment: This case concerns a 76-year-old female patient with relevant medical history of Atrial fibrillation in 2006, who experienced the unexpected event of Atrial Fibrillation. The event occurred 6 days after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Atrial fibrillation in 2006 remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 76-year-old female patient with relevant medical history of Atrial fibrillation in 2006, who experienced the unexpected event of Atrial Fibrillation. The event occurred 6 days after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Atrial fibrillation in 2006 remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Mother states redness on right thigh. Temperature of 103 on 3/4/00. Mother states the pt's symptoms were caused by the Hib vax but did not seek medical assistance.