chrisvoncsefalvay/vaers-outcomes huggingface dataset:
03/13/2023 administered 3 vaccinations. HPV and MCV4 in the right deltoid and Men B in left deltoid. Pt. c/o red, raised, hard to the touch, 4-5 cm diameter circle area. It was there approximately 2 months.  4-5 weeks after vaccination, pt. went to see her PCP regarding issue. FNP did not think it was an allergic reaction to vaccine but a local reaction.  No concerns regarding not finishing up series.  Pt. said the area resolved a few weeks after that.  When I saw pt. on 05/23/23, no knot or local reaction evident.  Administered the HPV in left deltoid and Men B in right deltoid. I called family on 05/26/23- no reaction thus far on either arm.
administered improperly stored PROQUAD; This spontaneous report as received from a medical assistant and refers to a female patient of unknown age. On 24-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T005406 has been verified to be a valid lot number, expiration date: 12-AUG-2021, subcutaneously (formulation, strength, exact dose and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  Administered dose of vaccine experienced the temperature excursion of (-9 to 8 degrees Celsius) (-6.1) (multiple excursions). Time frame was unknown by reporter. Data logger was involved. There were no previous excursions reported. No additional information provided.  Multiple temperature excursion: Improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T005406 has been verified to be a valid lot number, expiration date: 12-AUG-2021 (formulation, strength, exact dose, route of administration and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of (-14 to -10 degrees Celsius) for 116 hours and (-9 to 8 degrees Celsius) (-6.1) for 13 hours. Time frame for 129 hours. Data logger was involved. There were no previous excursions reported.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-DEC-2016, the patient was subcutaneously vaccinated with an expired dose of ZOSTAVAX lot # L028279, expiration date 28-OCT-2016. No adverse effects were reported. Additional information has been requested.
palpitations; heaviness in his heart.; patient received his third dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (palpitations), CHEST DISCOMFORT (heaviness in his heart.) and EXTRA DOSE ADMINISTERED (patient received his third dose of the vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Brain disorder NOS and Memory impairment.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PALPITATIONS (palpitations), CHEST DISCOMFORT (heaviness in his heart.) and EXTRA DOSE ADMINISTERED (patient received his third dose of the vaccine). On 17-Mar-2021, PALPITATIONS (palpitations), CHEST DISCOMFORT (heaviness in his heart.) and EXTRA DOSE ADMINISTERED (patient received his third dose of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An ambulance was called and an EKG was taken but the caller has no information on its results. The patient was able to keep up a conversation throughout this situation. Eventually, his feelings resolved and he was stable and released from the vaccination site. Concomitant product use was not provided by the reporter. Treatment information was not provided.
seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid.  I had a headache and chills while in the ER.  Went home and felt fine that night other than mild headache.
Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            No concomitant medications were reported.  The patient asked that was it necessary to get another dose, was the test of COVID free and could he still get a booster.  No treatment information was reported.
Had varicella vaccine on 04/19/2005. On 04/30/2005 developed rash on face, arms, legs, trunk, head, and groin. No fever. Seen in our office on 05/02/05 by CRNP and diagnosed with varicella. Several crops of papules and pustules with confluence on face, some crusting.
Hospitalized 11/22/2021; COVID-19 positive 11/22/2021; fully vaccinated  BRIEF OVERVIEW: Admission Date: 11/22/2021 Discharge Date: 11/24/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 62-year-old male who presented to the emergency department with shortness of breath and fatigue.  Patient with known COVID-19.  In the emergency department, patient was found to be hypoxemic on room air and placed on supplemental oxygen.  Chest x-ray was performed and concerning for COVID-19 pneumonia.  He was admitted and started on Decadron and remdesivir.  Patient did improve during his stay and felt well on the day of discharge.  Pulmonary rehab was consulted and patient was set up with home oxygen.  He is to wear 3 L nasal cannula at all times.  He was also enrolled in the COVID at home program.  He was recommended to follow up with his primary care physician.  He was discharged home in stable condition.
The pt developed redness, swelling, edematous area at the injection site 24 hrs post vaccination.
Information has been received from a physician concerning a 17 year old female with no drug allergy and no medical history who on 06-JUL-2009 was vaccinated with a first dose of GARDASIL (therapy route and lot # not provided). On 21-APR-2011 the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (lot # 667194/1081Z, expired date unspecified). There was no concomitant medication. 48 hours after the patient received her second dose of GARDASIL, on 23-APR-2011, the patient experienced severe abdominal pain. Patient stated that the abdominal pain was a 10 on a scale of 1 to 10 and 10 was the worst pain she could have experienced. It was also reported that the patient experienced a headache as well. "Today", on 25-APR-2011, patient was feeling better and was recovered. No lab diagnostics studies were performed. Patient had sought unspecified medical attention. Additional information has been requested.
second dose of Moderna was administered sooner than the recommended minimum timeframe of 28days.  It was administered on day 15.  Dose 1 given on 9/14/2021 Dose 2 given on 9/30/2021
severe difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  The patient received the first dose of PFIZER BIONTECH COVID-19 VACCINE on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunization and had vomiting on unknown date. Then, received the 2nd dose on unknown date. The patient experienced severe difficulty breathing on unknown date with unknown outcome.   Information regarding the lot/batch has been requested.
Information has been received from a healthcare worker referring to an unspecified number of patients. On unknown dates, the patients were vaccinated with PEDVAXHIB (lot # M032147, expiration date 14-APR-2019; M020100, expiration date 07-MAR-2019), which was improperly stored at 50.9 F for 10 hours. No adverse effect reported. No data logger was involved. There was no previous excursion. This is one of several reports received from the same source. Additional information has been requested.
My arm was red from my shoulder to my elbow and very hot. My arm was also swollen. I had a headache and was not hungry for dinner. My arm was very sore for 3 days.
N/V; N/V; lightheaded; abdominal discomfort; general weakness; SOB; increased high blood pressure and heart rate; increased high blood pressure and heart rate; This is a spontaneous report from a contactable HCP consumer. This HCP consumer (patient) reported that:  A 47-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW01150 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm left on 06Apr2021 12:00 AM (age at vaccination was 47-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had allergies to medications, food, or other products: penicillin and iodide. Medical history included Migraine and high lipid panel from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications received within 2 weeks of vaccination was omega-3-acid ethyl ester (LOVAZA), rosuvastatin calcium (CRESTOR), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP7534, and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 16Mar2021 12:00 PM as DOSE 1, SINGLE for covid-19 immunisation. On 12Apr2021 15:00 the patient experienced N/V, lightheaded, dizzy, abdominal discomfort, general weakness, SOB, increased high blood pressure and heart rate, weakness. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 12Jan2021 by nasal Swab. Treatment received for the events was unknown. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Vaccination of Moderna Booster #2 on April 14, 2022.  Onset of Urticaria 12 days later on April 26, 2022.  Urticaria started to resolve after approx. two weeks but did not completely resolve until three weeks after onset.
Pfizer 12+ Bivalent vaccine given when child not yet 12 years old
Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 003K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2022 at 2:25 PM, the patient received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .25 milliliter. On 26-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    Concomitant medications were not reported. Patient race was reported as other. Patient received Moderna covid 19 vaccine Dose 3 on 23 Nov 2021 on 8 47 am with batch lot number 077C21B, intramuscular as 025 ml dose. The event did not cause the patient to seek medical care. It was unknown if there was any other potential cause. It was unknown if the patient experienced a similar event in the past. Vial was initially stored in refrigerator on 21Jan2022 and the used vial was again stored in refrigerator on 7jun2022. Treatment information was not reported.
She was due Pediarix and we gave Kinrix per guidelines if vaccine was given "inadvertently administered the dose should be counted as valid and does not need to be repeated provided minimum interval requirements have been met."
Shortly after receiving the vaccine I felt dizzy, lightheaded, and had a slight headache. About an hour after receiving the vaccine, I began to feel as though I couldn?t fully form my words, as if  I was tripping on my words. I also mixed up my words a couple of times. I did not have any swelling of the  tongue or mouth so this was not the reason for my difficulty.
Hives covering arms, legs and torso - lasting for about 45 minutes once or twice per day. They went away on their own. Happened for a few days, and then started happening less frequently - once every few days, once every week, and now (months later) not happening anymore.
Shoulder pain. Pain started at injection site, that evening, pain level increased to a 9 by next afternoon. I had held it idle as much as possible, during this times as it was sore. But when I went to move my shoulder, I felt a rubbing noise, it felt like fluid in my joint, felt like things were scraping, and if felt like my shoulder was popping/slipping out of joint when I moved it. Arm? shoulder felt weak, like it was weighed 150#, felt swollen, and achy, and and numb like. Could not raise my arm. It felt like the weight of my arm was pulling the joint out of place. Lots of excruciating pain.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data).  Patient interested in revaccination following our recommendation to do so. Not yet scheduled.
Nausea, Dizziness, Vomiting.  Bp 107/59, HR 73, RR 16.  Pt stable and released from the vaccination site.
Twelve hours after injection I experienced 18 hours of symptoms making me bedridden. Fever, Severe Muscle Aches, Severe Joint Pain, Headache, Weakness, Difficulty concentrating. I took no medication for these symptoms. They subsided after 18 hours, gone.
arm pain; This spontaneous report was received from a female patient who was reporting on herself. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On approximately 11-SEP-2020 (reported as 2 or 3 weeks ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection as a booster shot (prophylaxis) (lot #, expiration date, exact dose, dose #, route of administration and anatomical location were not provided ). On an unknown date in September 2020, the patient experienced arm pain for about a week after the injection. The outcome of the event was unknown.  The causality assessment was not provided.
Right shoulder and  upper arm  weakness, decreased strength since receiving vaccine.  Full range of motion still intact.  No pain but some discomfort when arm is raised above shoulder height and  when arm is outstretched and rotated anteriorly.   Unsure of exact notice of onset; at first just thought that the area was still sore post-injection but has not gotten any better and, in fact, the weakness is slightly more pronounced as time progresses.   No official medical diagnostics completed, just symptom assessment.  I am a 20+ year RN (and am actually contracted with the local health department to be giving Covid vaccines).   I am doing some range of motion exercises with that joint/area  and some light strength exercising to prevent further weakness.   ***Of important note, the vaccine was not administered 2 finger-widths below my acromion process with good placement in the deltoid - it was given very high toward my shoulder.***
delays in my period; muscular pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0151) at the age of 36 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset Apr2021, outcome "unknown", described as "delays in my period"; MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "muscular pains".  Additional information: Vaccination Facility Type: Workplace Clinic, Vaccine was not Administered at Military Facility. No Relevant Tests, No Specific Relevant Test for Thromboembolic Events with Thrombocytopenia. Since the first dose of the vaccine, patient started having delays in her period. The fists delays were of 1 or 2 weeks. After the second dose, the delays increased to months. For that reason, patient decided not to administer any more vaccines on herself. Currently, patient had 5 months without my period. It was regular and now patient have this problem. Regarding the muscular pains, they are really strong. she can't sleep well due to them. The biggest one is on the back.
a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 27-NOV-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637642, expiration date 28-MAY-2022, 0.5 milliliter; route was not reported) for prophylaxis (product storage error). There was previous temperature excursion. Data logger was involved. 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: 1637642; expirationdate: 28-MAY-2022; 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
cannot lift arm without pain; pain in left arm where she got the shot; joint/elbow hurts; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (cannot lift arm without pain), VACCINATION SITE PAIN (pain in left arm where she got the shot) and ARTHRALGIA (joint/elbow hurts) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (cannot lift arm without pain), VACCINATION SITE PAIN (pain in left arm where she got the shot) and ARTHRALGIA (joint/elbow hurts). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (cannot lift arm without pain), VACCINATION SITE PAIN (pain in left arm where she got the shot) and ARTHRALGIA (joint/elbow hurts) had not resolved. Not Provided          No concomitant medications were provided to the patient.  The reporter stated that the pain was aggravated.  Action taken with mRNA-1273 in response to the event was Not Applicable     Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Additional information was received form the initial reporter: Patient reported that the event pain in arm is still ongoing. It has gotten better, but continues to be a problem, especially above the elbow; Sender's Comments:
59 yo BF  c/o dizziness ten minutes after receiving 2nd dose of Pfizer vaccine. Staff member notified EMS and NP of the incident   PT was evaluated by on-site EMS and NP.  VS, BS and EKG initiated. Patient has a medical Hx of Diabetes. Patient stated that she had not eaten since breakfast. After 1 hour, patient stated he was feeling and will allow her daughter to drive her home.
Had a seizure at school on 10/18/21 around 2:50 pm and was taken to local ER where he had another seizure around 3:45 pm. We were transferred via ambulance to the Hospital. Numerous test were conducted,,,Cat Scan ,EEG, lots of blood work  and even a drug screen. All test came back normal. No explanation why a healthy 17 year old athlete all of a suddden had 2 seizures with no family history or them on either mother or father' s side of family.
Child has had shingles 3 times (02/21/02 approx 4 days, 04/25/02 approx 3 days, 06/18/02 approx 3 days). RT check all three times. Given Acyclovir topical for control every 2 hr appliation. Episodes lasting. Short term recovery.
Very low energy, body aches, headache. Took Tylenol, symptoms persist.
This spontaneous prospective pregnancy report as received from a register nurse refers to a 17 year old female patient. Medical history and concurrent conditions were not provided. In approximately December 2014, the pregnant patient was accidentally vaccinated with a dose of GARDASIL lot number K006095, expiry date 02-FEB-2017 (dose and route were not provided). There was no concomitant medication reported. On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not known. The pregnancy outcome was outcome pending. Additional information has been requested.
Patient experienced itching on 2-28-15. It started with mild itching. It got worse as time progressed. On 3-1-15 patient experienced severe itching on both extremities and chest. Patient also develop redness and rash on both arms.