chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site redness; Swollen injection site; Fever of 101 Degrees Fahrenheit/Fever of 103 Degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Swollen injection site) and PYREXIA (Fever of 101 Degrees Fahrenheit/Fever of 103 Degrees Fahrenheit) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included IBUPROFEN for an unknown indication.   On 02-Feb-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) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Swollen injection site) and PYREXIA (Fever of 101 Degrees Fahrenheit/Fever of 103 Degrees Fahrenheit). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Swollen injection site) and PYREXIA (Fever of 101 Degrees Fahrenheit/Fever of 103 Degrees Fahrenheit) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 103 (High) 103 degree Fahrenheit.   mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up included medical history added, contact information was added
Fever for 2 - 3 days starting day of vaccine; developed hives 6-14-06 - still present.
Chief Complaint  Reports cough and SOA x2 days. Positive covid test this morning. Pt reports increased weight gain and unable to take diuretics d/t being tired. Reports hx of diabetes and CHF.  History of Present Illness  89-year-old female with past medical history significant for atrial fibrillation, sick sinus syndrome (s/p pacemaker), chronic diastolic heart failure, sleep apnea, presented with worsening cough, shortness of breath, concerning for heart failure.  Patient reports developing a nonproductive cough shortness of breath on 11/23.  She reports having a mild headache, but no fevers.  She reports taking all of her medications as directed.  She went to see her cardiologist on 11/24, and at that time patient was on room air, weight was up 4 kg from October 2021.  No significant medication changes were made at that time, although there was discussion about possible referral for AV nodal ablation.  There is also documentation that patient may be a appropriate candidate for hospice given her decompensated heart failure and advanced age and multiple medical comorbidities.  Patient with back to her assisted living center.  Patient awoke on the morning of November 25 more short of breath, had a cough productive of clear sputum.  Patient was also tachycardic with heart rate in the 120s.  She presented to the emergency department for evaluation.  In the ER, patient had crackles on her lungs, and chest x-ray revealed evidence of worsening heart failure with central pulmonary hypertension and basilar pulmonary congestion and small dependent effusions on both sides.  Radiology read as a right upper lobe mediastinal airspace infiltrate with some lobar consolidation, potentially representing ammonia.  Patient was also found to be Covid positive.  Patient initially required no oxygen in ER, but then desaturated to 88% and was placed on 2 L of oxygen.  Patient had blood cultures obtained and started on Rocephin for possible pneumonia coverage.  Patient admitted to hospitalist service for management.   On my interview, patient reports feeling tired, denies chest pain.  She does report shortness of breath and difficulty breathing with exertion.  She reports taking her medications daily except for the morning of November 25.  Reports receiving a flu shot this year, but has not yet received booster.  She denies known sick contacts with Covid.  I spoke with patient's son, who confirmed her DNR status.   Patient has history of episodes of hypertensive emergency and flash pulmonary edema.  Blood pressure in ER stable in the 120s-140s, no severe hypertension noted.  Admission BNP 8188, baseline BNP 3000.  Patient was last hospitalized at from 10/16 through 10/19 for heart failure.
Chills; Headache; Nausea; Arm pain; Felt some burning; Subtherapeutic response; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient also received salicylic acid (GOLD BOND ULTIMATE MULTI SYMPTOM PSORIASIS RELIEF)(Lot Number: 218107) from an unknown date, via an unspecified route of administration at three times per day for an unspecified indication. Medical history included vertigo and the patient had an injury on her back and could only move her arms to a certain point, having arthritis on her hand and had surgery as well. The patient's concomitant medications were not reported. The patient shared her experience with the Pfizer vaccine and had really terrible side effects. On an unknown date, the patient experienced non-serious chills, headache and nausea, arm pain, also felt some burning and sub therapeutic response. The patient stated she had the problem all day long. She said she was in pain but she didn't take any pain killers. she also had the Gold bond ultimate firming neck and chest but it only worked on her neck, doesn't help her chest. It was not reported if the patient received a corrective treatment for the events. Action taken with salicylic acid was unknown. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
03.11.21  Thursday Day 1:  Arm sore and swollen by bedtime, c. 2:00 am Friday. 03.12.21  Friday      Day 2:  Arm remains sore and more swollen than yesterday.  Mild nausea all day.  Moderate ?acidity? all day.  Mild muscle aches all day but now seem to be lessening (8:43 pm).  Started feeling unusually tired around 6 pm.   03.13.21  Saturday   Day 3:  Arm sore at vaccine site only. Nausea stronger.  Acidity stronger ? feels like undilute sulfuric acid is burning a hole in my stomach.  Extremely unpleasant.  Less fatigued than yesterday.   Very mild muscle aches.   03.14.21   Sunday     Day 4:  Nausea mild.  Acidity mild.  Unpleasant.  More energy than any day since vaccine. 03.15.21   Monday    Day 5:  Very mild nausea and acidity, but still unpleasant.  Slept too late but good energy level otherwise.
some of the shot leaked out and some went in the patient; the needle might have failed or was not on correctly, Leakage appear to come from the between the syringe tip and needle port; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 66 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that some of the shot leaked out and some went in the patient (vaccine underdose) and the needle might have failed or was not on correctly, leakage appear to come from the between the syringe tip and needle port (syringe issue).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ311AB and expiry date: 30-Jun-2020 via unknown route in unknown administration site.  It was a case of actual medication error case due to vaccine underdose.  It was also a case of syringe issue.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial report received on 11 February 2009 from a healthcare professional.  A 17-year-old female patient, with an allergy to penicillin, received a first left deltoid intramuscular injection of MENACTRA (lot number U2660BA) on 10 February 2009 at 11:00.  The patient had no medical conditions, no concomitant drugs or illness at the time of vaccination.  Six hours after vaccination, at 17:00, the patient returned to the physician's office and was observed to have bilateral leg tremors.  The patient was sent home and was to be reassessed by the physician the following day.  No other information was reported.  The patient's recovery status was reported as unknown. Follow-up information received 16 March 2009 from a healthcare provider who reviewed the case and had no new relevant medically significant information to provide at the time of the report.   Follow-up information received 03 April 2009 from a health care provider who reviewed the case and had no new relevant medically significant information to provide at the time of the report. Documents held by sender: None.
red mark one inch wide, by 4 inches long,  intense pain in injection side, armpit pain, body aches, headache
Pt was here today for well visit. At visit she received two vaccines (tdap & menactra). Pt went to the waiting room to check out & while mom was checking out Pt slid down the chair she was sitting in. Front Desk called MA's for help. Pt c/o of dizziness, tingling down (R) arm, trouble swallowing, Diaphoretic, shaking & weak. MA obtained vital sign while other MA got the PCP. PCP gave benadryl, listened to lung sounds & assessed pt. Called for Ambulance per PCP request to have pts muscle swallowing monitored at ER. Ambulance arrive-gave report to staff & turned care over the EMT/medic.
I ended up with hypothermia, it lasted until the next day. I was covered in blankets and my fiancé laid with me to keep me warm. By the next morning my temperature was back to normal.
2nd shot was painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Jul-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient had the full dosage, the 2nd shot was painful but from what he/she heard about Shingles, rather the shots The follow-up would not possible as no contact details were available.
This spontaneous report was received from a medical assistant refers to a 14 year old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dose, units, frequency and route not reported) (lot# N020353, expiration date: 28-APR-2020 and lot # N017686, expiration date: 02-FEB-2020) at a temperature from 47 Fahrenheit (F) to 77 F for 21 hours 45 minutes. No adverse effects were reported. No previous temperature excursion was occurred to the vaccine GARDASIL 9. Data logger was involved. No product quality complaint was involved. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1803USA004556: US-009507513-1803USA005947: US-009507513-1803USA005946.
sore injection site right arm; did not receive second vaccine dose within 35 days of first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site right arm) and PRODUCT DOSE OMISSION ISSUE (did not receive second vaccine dose within 35 days of first dose) 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.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site right arm) and PRODUCT DOSE OMISSION ISSUE (did not receive second vaccine dose within 35 days of first dose). At the time of the report, VACCINATION SITE PAIN (sore injection site right arm) and PRODUCT DOSE OMISSION ISSUE (did not receive second vaccine dose within 35 days of first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
bruising above the knees and on his lower legs; fall; Pain as if he had the flu; This is a spontaneous report from a non-contactable consumer (patient). This male patient of unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unknown route of administration on 13Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After his second dose the patient reported bruising above the knees and on his lower legs; the patient also mentioned a fall. He stated he had pain as if he had the flu. The patient was most worried about the pain and bruising in his legs; he inquired if that was normal/reported nearly two weeks after a dose, and what he should do. He reported that he called his physician and if it's not better by "this." The patient was also looking for information that he could be sent. The clinical outcomes of bruising above the knees and on his lower legs, fall, and pain as if he had the flu were unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 2:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 2:29 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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 reported as 45.15 on 28-Feb-2021 and 45.23 on 28-Mar-2021. Concomitant products were not provided.  On 29-Mar-2021, Excursion time was 10 AM temperature was 35 total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021 and vial was moved to clinic on 29-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. On 28-Feb-2021, Excursion time and temperature was 09 AM:27 and 01 Pm :26 respectively total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021 and vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 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.
Initial misuse report received from medical assistant on 13 December 2013. An unknown age and gender had received ACT-HIB (no information was provided regarding the patient). Reporter stated that patient reconstituted with sterile water and administered. List of documents held by sender: none.
On 3/31/2021, it was noticed that she was jaundiced.  Labs were drawn which confirmed jaundice (bilirubin of 4.4 - unconjugated) due to a new Hemolytic Anemia (HGB 9.3).  The HGB was 11.7 on 2/28/2021.
pt recv vax & in 1995 pt began to exp the sx of resistant polymyalgia rheumatica for which pt has been treated w/pred since AUG96;pt had to stop running & was not able to perform many activities;AUG97 pt exp inc severity of arthralgia;
Darkening of skin at injection site for over one month.  Darkened area did eventually fade.  Unlike a bruise which turns various purples, greens, or yellows, this spot remained the same color and dark throughout the time period.
On 7/5/22 I noticed mild scratchy throat and that was it. I tested because people we had been around tested positive. I took the COVID-19 home test on 7/5/22 and it was positive. I contacted my doctor they connected me with their COVID-19 representative. They prescribed PAXLOVID. It took about 7 days before I was symptom free after taking PAXLOVID.
Fever of 100.6 for 12 hours. Now fever has been at 99 for another 12 hours; Arm was immovable; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 14Apr2021 at 10:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date in 2021 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. 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. On 15Apr2021 at 18:00, the patient experienced fever of 100.6 for 12 hours, now fever has been at 99 for another 12 hours and arm was immovable until 11:00 this morning since yesterday the day of vaccine at 6. The patient had no reaction to the first dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 15Apr2021 at 18:00, the patient underwent lab test and procedure which included body temperature and result was shown as 100.6 (units unspecified). On 16Apr2021, the patient underwent lab test and procedure which included body temperature and result was shown as 99 (units unspecified). The clinical outcome of the events fever of 100.6 for 12 hours, now fever has been at 99 for another 12 hours was resolving and the clinical outcome of arm was immovable was resolved on 16Apr2021 at 11:00.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache, body aches, fever for 5 days ever since Menactra vaccination.
Nausea, vomiting and diarrhea, subjective fever and hematoma to site.
mom noticed temp of 101 @ 4PM same day; gave APAP; no other sx until next day when pt vomitted; treated w/clear room temp liquids; temp & vomitting resolved by following day;
headache; nausea; joint pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself that a female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 27Feb2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the vaccine on Saturday (27Feb2021), and after getting the first dose she was experiencing headache, nausea, and joint pain. patient asked if that's normal. The outcome of events was unknown.  Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: Yes  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
bilat paracervical muscle spasm-sustained c/w a bilat torticollis; began 30 hrs p/vax & persisted almost 4 days; no toxicity or sign of encephalopathy;
On 09/05/2023, one dose of Pfizer-BioNtech Covid-19 vaccine, Bivalent Ages 5 to <12y , 0.2mL was administered intramuscularly to the patient who turned 12 years old  on 08/30/2023.   Patient did not exhibit signs and symptoms of an adverse reaction.
Pt described red and inflamed axillary lymph nodes, having received Fluvirin in L deltoid.  When went to MD, the pt (who is an experienced RN) received antibiotics for a suspected cellulitis of the axilla, but pt states swelling and pain did not quickly respond to antibiotic treatment and that she still suspects the vaccine.
LEFT ARM SWELLING, REDNESS, ITCHING, HOT TO TOUCH, BURNING SENSATION AT AND AROUND INJECTION SITE, ALONG WITH HEADACHE. PATIENT ADVISED TO TAKE ZYRTEC 10ML DAILY AND PRESCRIBED PREDNISOLONE 15ML/5ML ORAL SOLUTION 10ML BY MOUTH EVERY DAY X 3 DAYS