chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse via field employee, referring to a 17 year old male patient. The patient had multiple allergies to unspecified medication. Information of concomitant therapy and medical history was not provided. On 19-SEP-2018, the patient was vaccinated with a dose of MENACTRA, and then the second dose of GARDASIL 9 (dose unknown; lot # R002344 and expiration date 16-NOV-2020) intramuscularly for prophylaxis around 04:10pm.  In the 30 minutes after the dose of GARDASIL 9 was administered, the patient was fine. About 30 minutes later after the vaccination, the patient then turned gray (pallor), stated he couldn't see (blindness transient), his eyes became dilated (mydriasis) and his blood pressure dropped (blood pressure decreased).  The reporter worried he might have a seizure and called an ambulance who took the patient to the emergency room in a hospital, where he was admitted and had a magnetic resonance imaging (MRI) performed.  Results of the MRI were not known. In the following evening, the patient felt better and was discharged from the facility. The outcome of the events was reported as recovered. The causality between the events and GARDASIL 9 was not reported. Upon internal review, Blindness transient was determined to be medically significant.
Expired vaccine administered to infant. DPH notified, VAERS form filled out, parents notified. Recommend revaccination of Hep B #1.
Patient reporting arm pain that is keeping him from fully lifting arm. Vaccine location of administration confirmed as correct in deltoid.
Shortly after injection patient had syncopal episode lasting approx 10 seconds. Had hypotension and bradycardia for several minutes. BP prior to vaccine 118/80, HR 74.
Caller reports administration of ROTATEQ after temperature excursion; This spontaneous report has been received from a consumer concerning  a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 11-JAN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml,  Lot # 1691141, expiration date 01-NOV-2021 for prophylaxis (dosage regimen was not reported). The storage temperature was reported to had been at 1.3 °C for 19 minutes.           There was digital data logger involved, no previous temperature excursion was reported and no other information was available.
Onset of erythema noted by mom 24 hours after vaccine administration.  Erythema site is 14cm x 12cm.  Child reports it is tender.  Child is active, no other complaints, stable.  Zyrtec orally 1 tsp.  Conservative monitor.
I had a heart scare attack and it was months after the shot however I feel that it relevant to the vaccine. I had to wear a Holter monitor for 24hrs.
A 50-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this age group), lot number C26300AA, on 18 August 2006. This product was administered instead of Adacel. The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours. The reporter in this case is the same as the reporter in cases 2006-02409, 2006-03043, 2006-03044, 2006-03045, 2006-03046, 2006-03047, 2006-03048, 2006-03050, and 2006-03051.
The patient began feeling weak and slight malaise within 45 minutes of receiving the vaccine. The feeling of near faintness, weakness and dizziness progressed. Ringing ears and vomiting followed after. The patient reported feeling unsteady throughout. Water nor food could be consumed without violent regurgitating. Symptoms resolved after approximately 8 hours.
Blood pressure increased; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL SODIUM for Pulmonary arterial hypertension, TADALAFIL for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED. At the time of the report, BLOOD PRESSURE INCREASED outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact.
Itchy rash began 22NOV91; hives on chest, under arms & @ inject site occurred on 24NOV91; relieved w/DPH;
Patient stated she was nervous about getting vaccine due to fear of needles, but she got herself this far, so she wanted to proceed with the vaccine. Vaccine was administered, she seemed somewhat relieved that it was over. I asked her to stay sitting for at least 15 minutes to see if she had any reaction. I walked away from her, but about 2 minutes later I heard her calling me. I ran over to her and she was ready to faint. I held her onto the chair so that she wouldn't hurt herself by falling, I called a pharmacy tech over to help me, and we both eased her off the chair and onto the floor. She was breathing rapidly and had a strong pulse. We asked her if she wanted us to call anyone, she asked us to call her fiancé, pharmacy tech called him, he asked us to call 911, which pharmacy tech did. Police arrived within minutes and administered oxygen, EMS and fiancé also arrived later. EMS evaluated her and eventually allowed her to leave when they were satisfied that she was ok. I called her around 5 pm to check up on her, she said she was doing fine, simply a reaction due to her fear of needles.
Narrative:  54 yo male with lung cancer died during home hospice care on 1/31/2021. Pt had received covid vaccines on 4/1/21 & 4/30/21. This death is not related to covid vaccines. Pt died of metastatic lung adenocarcinoma with mets to pelvic bone and brain.
Fatigue, chills, nausea, throwing up, body aches - persisted 2 days after 2nd dose shot
Information has been received from a register nurse referring to a female patient of unknown age. The patient was vaccinated with her first dose and second dose of VARIVAX (Merck) (lot#, expiration date, route, dose unknown) for pre-employment vaccination on 20-NOV-2014 and 06-JAN-2015, respectively. On 03-FEB-2015, the patient returned to the office of the nurse and stated she was pregnant. Pregnancy was determined by the patient at home with a home pregnancy test. None lab diagnostics studied performed. The last menstrual period (LMP) was estimated date of delivery (EDD) were unknown. Additional information has been requested.
Fever, fatigue, nausea, sore muscles, that same evening and then adrenal failure a few months later
4/12/04 given DTaP 0.5 cc left deltoid, MMR 0.5 cc right deltoid, PPD 0.1 cc left arm. 4/14/04 9x9 swelling, no redness left arm. Treated with Benadryl.
15yo patient was given flublok. Pt's mother stated on 12/3/2020 that the patient has not experienced any adverse effects from receiving the Flublok vaccine.
Fever 101.5 on Fri; fever 104.2 Sat-Sun; No appetite Sat-Mon; Irritable/clingy Sat-Tue.
Patient initially presented with a seizure after a soccer game, then proceeded to have 3 more seizures, followed by aphasia, difficulty using right hand. Initial MRI showed a 0.8 mm deep white matter lesion, likely demyelinating.
Today my blood pressure was 144/82; i am  having nose bleeds; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Today my blood pressure was 144/82) and EPISTAXIS (i am  having nose bleeds) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HYPERTENSION (Today my blood pressure was 144/82) and EPISTAXIS (i am  having nose bleeds). At the time of the report, HYPERTENSION (Today my blood pressure was 144/82) and EPISTAXIS (i am  having nose bleeds) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hypertension: 144/82 (Inconclusive) 144/82.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
DEVELOPED A RED SWOLLEN HOT AREA AT THE SITE OF INJECTION. THE AREA WAS LARGE EXTENDING HALF OF HER UPPER ARM. NEXT DAY HAD FEVER, HEADACHE AND ACHES.
Patient reported severe pain racing up and down arm that received vaccine.  The pain caused her to not be able to mover her arm.  She also experienced swelling around sight of injection but no redness.
10/30 received vaccine. 11/2 tongue was numb. 11/5 Bell's Palsy symptoms L side of face. 11/6 to MD, medications initiated, diagnosis of Bell's Palsy.
Client reported to Clinic around 10:00 AM 3/21/2018. Significant swelling redness and warmth at the injection site and below down to 5 inches below elbow joint. Client reports no other symptoms. Educated patient PCP to rule out cellulitis. Patient does not have PCP referred her to NP. Requested patient to contact Health Department with further questions and after she is seen by NP. Patient may wait until tomorrow to see NP despite being encouraged to call today.
Pt felt light headed, shallow breathing, he sat down, we gave him coldpack and had him wait additional 15 minutes. He feels better, and is able to leave on his own.
Patient had previously received a Moderna Vaccine possibly on 4/4/21 as reported by patient or on 4/23/21 as stated.  Patient recieved Johnson and Johnson vaccine due to oversight and miscommunication because they thought he signed up for Moderna vaccine but our site only has Johnson and Johnson.
Pt experienced site swelling/redness/irritation/pain/discomfort that spread throughout her upper arm starting Saturday. She "didn't feel well", had a headache and was fatigued. Her symptoms decreased by 1/11 when she came into the pharmacy to show us her reaction. She had taken a single dose of 25 mg Benadryl but nothing else to alleviate symptoms.
got the shingles vaccine - not in the drop down menu Literally couldn't get out of a chair severe pain in shoulders and legs
Day 1: Common symptoms: Fatigue, chills, headache. Day 2-Day14: Began experience upper gastrointestinal symptoms.  Pain, Bloating, Feeling of extreme fullness, Nausea, constant gurgling of the stomach.  This lasted for approximately ~ 2 weeks.  These symptoms have not fully resolved but have improved 85-90%. Day 3-current: Twitching and muscle spasms began in the arm that I got the shot in.  Shoulder, bicep, and into the forearm were CONTINUOUSLY twitching all day long.  Sleep became difficult for a period of a few days due to this.   This muscle twitching then began to occur in all other parts of the body.  Eye lids, arms, legs, torso.  Everywhere.  The rate of the twitches at worst was approximately 30 twitches per minute bouncing around from one area of the body to another.  I am currently 3 weeks post vaccination and although I have seen significant improvement in the twitching, I am still currently experience this symptom.
I received a pneumonia vaccine in the left arm and lost the use of the arm. It has been extremely painful and I could not use it for a week. Had a fever of 101.1 on Tuesday.
My arm started hurting and now my hand; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm started hurting and now my hand".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A spontaneous report was received from a consumer who was a 64-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced patient did not receive second dose within allowed dosing window/inappropriate schedule of product administration. The patient's medical history was not provided by the reporter. Concomitant medications were not reported. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:004M20A) intramuscularly for prophylaxis of COVID-19 infection. As of 11 Mar 2021, the patient stated that he still had not received the second dose of vaccine and was now outside of the recommended dosing window.  Treatment for the events were not reported. Action taken with mRNA-1273 in response to the event was not reported. The event, inappropriate schedule of product administration, was considered recovered/resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 1:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:39 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.49.  Concomitant products were not provided.  On 27-Oct-2021, Excursion time was 09 AM and 10 AM, temperature was 29 and 32, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 5-Oct-2021, vial was moved to clinic on 27-Oct-2021. 1 and 4 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021 and 4-Nov-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA. The patient was treated with TYLENOL at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, MYALGIA had resolved.            Concomitant product use was not provided.  Treatment included Tylenol and Motrin.   This case was linked to US-MODERNATX, INC.-MOD-2021-056534. Sender's Comments:  US-MODERNATX, INC MOD-2021-056534: Second dose of vaccine.
Discharge Provider:  MD Primary Care Provider at Discharge: NP Admission Date: 9/4/2022 Discharge Date: 9/7/2022  PRESENTING PROBLEM: AKI (acute kidney injury) Acute respiratory failure with hypoxia Sepsis due to pneumonia Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung COVID-19 Severe sepsis COVID-19 virus infection   HOSPITAL COURSE: Patient is a 60 y.o. female who presented to the emergency department with complaints of shortness of breath and wheezing.  Patient has past medical history of chronic obstructive pulmonary disease, hyperlipidemia, hypertension, hypothyroidism, metastatic renal cell carcinoma, obesity, tobacco abuse, and chronic respiratory failure. Patient had complaints of shortness of breath and wheezing that had been going on for approximately 1 day and presented to the emergency department via EMS for evaluation.  In the emergency department, patient was febrile, tachycardic, tachypneic, and was on BiPAP to me oxygen demands.  This was subsequently weaned to her baseline oxygen requirement of 4 liters/minute via nasal cannula.  Complete blood count was unremarkable.  CMP showed acute kidney injury, hyponatremia.  Lactic acidosis was also observed.  Troponin was indeterminate at 70 and a repeat was 66. COVID-19 was positive.  Chest x-ray showed increased airspace disease in both lungs consistent with pneumonia.  Procalcitonin was 1.28.  IV fluid boluses and antibiotic therapy  was initiated in the emergency department.  Upon arrival to the unit, patient was very lethargic and hypotensive.  ABG revealed metabolic acidosis.  Since patient remains hypotensive, despite hydration, she was moved to the intensive care unit for vasopressor therapy.  Suspect lethargy is secondary to metabolic processes.  Suspicion of bilateral bacterial pneumonia superimposed on COVID-19 resulting in septic shock and COVID-19 pneumonia.   Patient's hyponatremia resolved with further IV fluid resuscitation and she was able to be weaned off Levophed drip. She was treated with IV Azithromycin and Cefepime and transitioned to oral Ceftin and Doxycycline to complete a 7-day course of antibiotics, as recommended by the antibiotic stewardship team. She received dexamethasone and aggressive pulmonary toilet while inpatient. She remained stable on her 3-4L 02 per nasal cannula, shortness of breath and wheezing beyond her baseline resolved.   Her blood pressure remained stable off of her blood pressure medications; so losartan and amlodipine were discontinued at discharge, hydrochlorothiazide will be continued. The patient understands she is to keep a blood pressure log and follow up with her PCP as soon as possible for continued monitoring of blood pressure.   PT and OT evaluated the patient while in the hospital and recommended that same care services she had prior to admission, home health OT and RN to continue management of pressure wounds on buttocks.  The patient was discharged home in stable condition with the above mentioned care plan in place.
I woke up at 0230 6 hours after the vaccine was administered with indigestion, sulfur burps, vomiting and liquid stool. These symptoms continued for about 2 hours. I still had liquid stool when I woke up at 0800, but I felt better. I did not seek treatment.
8 hours after the injection I became fatigued 11 hours after the injection I had body aches and chills, Temp-99.1; Tylenol 500mg. 2 tabs was taken 16 hours after the injection I had extreme body aches, chills and a headache with a very sore arm around the injection site, Temp 100.;Tylenol 500mg. 2 tabs was taken 22 hours after the injection  I continued with body aches, Temp 101.1; Tylenol 500mg. 2 tabs was taken 24 hours after the injection my Temp was 99., body aches and chills were subsiding 26 hours after the injection Tylenol 500mg. 2 tabs was taken 34 hours after the injection the fatigue resolved along with my arm aching around the injection site.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on left side of neck) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.  No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node on left side of neck). At the time of the report, LYMPHADENOPATHY (Swollen lymph node on left side of neck) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: normal (normal) No infection present.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment information was unknown.
30 April 2003 at 1800, redness, pain, swelling, around injection site, and swollen lymph nodes under left arm. On morning of 01 May 2003 noticed increased swelling, redness, and pain. Pt was seen by MD on 01 May 2003. Was given Motrin, Tylenol, and Levofloxacin.
ear infection; ear problem; This is a spontaneous report from a Pfizer (CEP 159558). A contactable consumer reported that, a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that, she received first dose of covid-19 vaccine. Patient had second dose scheduled 4Mar2021. Patient wanted to know if it is okay to take Antibodies if provided, for her ear problem or ear infection (date unspecified). Outcome of both the events were unknown.    Information on lot number/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
(R) red area 10 cm slightly tender (Patient received Pneumovax 1 yr ago dose)
Vaccine expired on 04/06/2022, vaccine was given on 04/06/2022. Moderna was contacted once we were made aware that the vaccine had expired. Moderna concluded that the vaccine had maintained viability and no reimmunization was needed.