chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From the History and Physical Exam on 11/05: Patient is a 58-year-old female with history of type 1 diabetes mellitus, CAD status post CABG 2012 PCI x5 most recently June 2021, HTN, fibromyalgia, current everyday smoker who quit 3 days ago presented in via EMS early this morning after her husband found her talking to herself walking around her kitchen and then falling into bed. This is strange and abnormal behavior for her. Denies any head injury or loss of consciousness. Patient's reports of the events leading up to this episode are somewhat confusing - seemingly has a pan positive ROS. Patient states she is headed to month history of diarrhea approximately 3 loose stools daily. She denies any abdominal pain, nausea, loss of taste or smell. Most recently she had developed chills and incontinence over the last 2 days. Denies fever, headache. She denies feeling short of breath. Complains of a 2 month history of dry cough. Cough recently has not changed in character, no sputum production, chest pain. Husband has been dealing with fevers, myalgias, shortness of breath for the last week and a half. Patient also informs me of one-week history of blood sugar readings of 600+. Taking her insulin as prescribed. In the emergency department, the patient was found to be COVID positive. Lab workup remarkable for CRP of 13.4, creatinine 1.77 (baseline 0.8), procal 1.2. D-dimer 2400. CTA chest negative for pulmonary emboli. Chest x-ray revealing mild subtle patchy ground-glass infiltrates of both lower lung fields. Patient was slightly hypotensive and tachycardia upon arrival but this improved with 1 L of fluids. O2 sats ranging from 94-98% on room air. Patient admitted to hospital for management of AKI and further evaluation.
I had a chills and fever all night and the next morning, Sore body and armpits is majorly sore.
Left arm itching, red, warm to touch and slightly swollen at vaccination sight.  Occurred one week after vaccine administration and not before.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe
p/vax pt devel fever, lasted 4 days; fever as high as 104; had cough; coryza & conjunctivitis along w/fever; devel raised red bumps on most of body; fever returned w/rash;8/31 pt feels fine
Pt had redness and swelling noted, starting on 11/15/01 PM. It was less red in the office on 11/16/01 AM. The left upper arm and lower deltoid area was red 7cm X 10cm, with induration which had more intense redness in the center of this area (4cm X 6cm). Pt was given Benadryl, po.
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 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 9:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:53 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced 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). 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.   Age of patient was reported as 32.62 and 32.71   Concomitant products were not provided.  On 20 Mar 2021, Excursion time was 09 AM, 10 AM temperature was 34,37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09 Mar 2021, vial was moved to clinic on 20 Mar 2021. 19 vials were sent to clinic. Vaccine BUD date was 08 Apr 2021 On 13 Feb 2021, Excursion time was 09 AM, temperature was 32 , total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09 Feb 2021, vial was moved to clinic on 13 Jan 2021. 30 vials were sent to clinic. Vaccine BUD date was 10 Mar 2021    On 20 Mar 2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 00, 9 AM: 30, 10 AM: 41, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.   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 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
Dizziness, Myalgia, First light headeness, next day dizziness,soreness and  weakness; all symptoms resolved with tylenol Narrative:
Patient developed jerky movement on 12/22/2011 after vaccination. He also c/o dizziness, nausea and mild abdominal pain.
8 days after my first vaccine my arm was red, swollen, fevered and spread to cover a large area of my arm. I started to itch on the left side of my neck and around my lip/mouth area.  I also felt my heart beat faster and heart fluttering or skipping a beat.  This lasted 4-5 days.
Sores in mouth. Started about a week after 2nd shot. Still experiencing. Have had 4 sores so far a new one keeps popping up as soon as I get rid of one.  I also have a rash on my right leg that started a week or two ago. So it would?ve shown up 2 weeks after 2nd shot.
After 2 Days a very sore shoulder. After a month the pain remained, described as worse. Post a doctor appointment it was diagnosed as SIRVA.
arm was sore at the injection site; my right leg, from my hip down to foot, went completely numb; felt pins & needles in my right leg; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (my right leg, from my hip down to foot, went completely numb), PAIN (felt pins & needles in my right leg) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0U7A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HYPOAESTHESIA (my right leg, from my hip down to foot, went completely numb) and PAIN (felt pins & needles in my right leg). On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the injection site). On 18-Mar-2021, HYPOAESTHESIA (my right leg, from my hip down to foot, went completely numb) had resolved. At the time of the report, PAIN (felt pins & needles in my right leg) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
1.28.2021  Dad began having hallucinations the morning of January 28. He seemed not to have them in the afternoon.  1.29.2021 Dad had hallucinations all day and was very distressed by them.  1.30.2021         The hallucinations stopped.
had the shot still gets shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via Shingrix  interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the shot still gets shingles. The reporter asked are there any studies that might help. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
This case was reported by a other health professional and described the occurrence of injection site reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site reaction and shingles. On an unknown date, the outcome of the injection site reaction and shingles were unknown. It was unknown if the reporter considered the injection site reaction and shingles to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the healthcare professional who himself was the patient. The age at vaccination was not reported. After the injection the patient had a bad reaction in the injection site, and within 10 days had a bad case of shingles. Now the patient was concerned with the upcoming second dose of SHINGRIX, regarding what would happen if he skipped this dosage. He asked what were the chances of another shingles attack if he receive 2nd dose. This was a very bad occurrence as per the patient, he further asked what he should do. The patient wanted advice, as he had not decided on what to do and did not want a bunch of grief from the physician. The patient gave details of vaccination administration (VAERS).
Tongue tingling and swelling; Tongue tingling and swelling; Immediate headache; Tingling in arms/hands; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the arm right on 05Apr2021 at 10:00 (at the age of 35-years-old) as a single dose for COVID-19 immunization. The patient had no known allergies to medications, food or other products. Concomitant medications included sambucus nigra (ELDERBERRY), multivitamins, paracetamol (TYLENOL), birth control (unspecified); all from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced immediate headache and tingling in arms/hands on 05Apr2021,at 10:00 and tongue tingling and swelling on 05Apr2021,at 10:30. Details were as follows: on 05Apr2021 at 10:00, the patient experienced immediate headache, within 2 minutes, tingling in arms/hands, which subsided and returned throughout the day, also within 30 minutes, the patient had tongue tingling and swelling. At 24h mark, tongue was still slightly tingly and slightly swollen but had subsided some. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The clinical outcomes of immediate headache, tingling in arms/hands and tongue tingling and swelling were recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored GARDASIL (lot #K023432 with expire date of 18-JUN-2017, dosage and route not provided). The temperature/time frame was Cumulative "-4.7 C" for 513 hours. The call was because of a "date logger". There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
No adverse event; The patient received 0.15 ml dose of the Moderna COVID-19 vaccine instead of 0.25 ml dose; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (The patient received 0.15 ml dose of the Moderna COVID-19 vaccine instead of 0.25 ml dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .15 milliliter. On 16-Aug-2022, the patient experienced UNDERDOSE (The patient received 0.15 ml dose of the Moderna COVID-19 vaccine instead of 0.25 ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (The patient received 0.15 ml dose of the Moderna COVID-19 vaccine instead of 0.25 ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (The patient received 0.15 ml dose of the Moderna COVID-19 vaccine instead of 0.25 ml dose).    Concomitant drugs were not reported.  It was reported that they had an issue and they incorrectly drawled up the doses. The patient had received lower-than-authorized doses.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2022: Follow up received included significant information: Case report type was updated, reporter first name was updated, patient details were added, Suspect vaccine dose number was added, dose description was updated and narrative updated.
Delayed reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of SKIN REACTION (Delayed reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported.     On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN REACTION (Delayed reaction). At the time of the report, SKIN REACTION (Delayed reaction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medicines were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received, no new was updated. On 15-Jul-2021: Follow-up received, no new information was updated.
C/O itchy red rash B/L arms, chest, back Benadryl one hour prior to injection and continue every 6 hours for 2 days after injection.
given just the Shingrix adjuvant only (unreconstituted Shingrix); given just the Shingrix adjuvant only (unreconstituted Shingrix); This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 44DX9, expiry date 28th October 2022) for prophylaxis.   On 12th June 2021, the patient received the 1st dose of Shingrix. On 12th June 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacist reported that a female patient was given just the Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.   No symptoms reported. The reporter consented to follow up.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 78 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016.  As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Terrible headache came on suddenly that was severe pressure or vise like squeezing in the whole back half of head; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 12May2021 at 16:00 (at the age of 49-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic pain and depression, since unknown date. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included antidepressants (MANUFACTURER UNKNOWN), muscle relaxers (MANUFACTURER UNKNOWN) and pain medications (MANUFACTURER UNKNOWN), all on unknown date for unknown indication and unknown if ongoing. On 01Jun2021 at 19:00, the patient had a terrible headache came on suddenly that was severe pressure or vise like squeezing in the whole back half of head, this came on suddenly during sexual activities and had never happened to before and the headache had lasted over a week and the same exact pain comes and goes throughout the day app day every day. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event terrible headache came on suddenly that was severe pressure or vise like squeezing in the whole back half of head was not recovered at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 02Jun2021 at 16:00 (at the age of 49-year-old), as a single dose for COVID-19 immunisation  The lot number for the vaccine BNT162b2 was not provided and will be requested during follow up.
Myalgia Chills Narrative:  Missed one day work following first dose due to above symptoms
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Pt first developed rash bilaterally to flank, abdomen and legs two days after covid vaccine administration. Then developed pain, marked swelling and redness to bilateral knees and elbows with difficulty ambulating and pain with movement. Pt had a low grade fever and skin was sensitive and hot to touch near knees and elbows.
Injection site: pain/tenderness  General side effects: Nausea, weakness (full body), nearly fainting multiple times, headache, some confusion, dehydration, some difficulty breathing, tired even with rest, low fever
Shots given noon a couple hours later arm felt burning that evening arm developed red rashy areas. Applied cortisone cream next morning blackened areas appeared on left arm and (L) lateral torso.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patent's concurrent conditions, concomitant allergies or medical history provided. On 06-OCT-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscularly, batch# reported as M023460 for prophylaxis (anatomical location, dose and expiration date were not reported). On 16-NOV-2016, the patient was vaccinated with another dose of PNEUMOVAX23 intramuscularly (dose, anatomical location, lot # and expiration date were not provided) in error. No adverse events were reported. Additional information has been requested.