chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced epistaxis 2-3 x daily  for approx 3 weeks, self ordered platelet count and it dropped significantly since 12-31-2020 and last blood work.   Currently the frequency has slowed down.
Pain in arm. Body and joint aches on day 2, fever 100.6F; chills. Symptoms diminished on day 3. However, painful lump has appeared in armpit of the arm where I received the vaccination.
According to  patient , 6  hours after she had the vaccine, her temperature went up to 100.9 F .  On Monday patient had headache in the morning around 5am. Tuesday 8:30pm, patient had red raised rash on the arm below the injection site
This spontaneous report was received from a pharmacist and refers to a 83-year-old male patient. The patient's pertinent medical history included atrial fibrillation. Concomitant medications included SINGULAIR, BETAPACE, VITAMIN K and COUMADIN. The patient did not have any drug reactions or allergies. On 17-JAN-2017, the patient was vaccinated with PNEUMOVAX 23 injection intramuscularly, lot # L033707, expiration date: 18-MAY-2017 (dose was not provided) for prevention of pneumococcal disease. On 17-JAN-2017, the patient experienced swelling/soreness at the injection site that extended to the elbow, stomach ache, fatigue, fever, chills and vision changes. The reporter stated that the patient's vision was affected by the patient looking at the color white and the white object would look amber in color. The patient did not receive any treatment for the events, however, he sought medical attention by contacting an unspecified physician by phone. The outcome of the events and the causality assessment were not provided. Additional information has been requested.
This spontaneous report was received from a physician referring to a 19 months old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fahrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768.
Pins and needles beginning in my lower legs and feet followed by weakness and sometimes pain. 4 days later also in my fore arms and hands. Eventually ascending up my body. Residual weakness and loss of strength with pins and needles in my extremities and sometimes pain.
a 70 y.o. male admitted with pna due to covid-19 / acute resp failure with hypoxemia. Pt completed 5 days of treatment. Also appears to have had a bacterial infection and met Regulatory Authority criteria on admission. Unfortunately, unable to isolate an organism. Possibly due to uti that was not tested for initially as pt described dysuria several days into hospital stay. Will complete extended course abx. Procal downtrending suggesting improvement. Also found to have a PE on admission. Subsegmental, unilateral. Gave pt options of different anticoagulation strategies. Pt electing to receive free month of eliquis and attempt to search for alternative meds or cost reducing programs outpatient with pcp. Currently eliquis after first month would cost >$500 and pt is aware of this issue.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Swollen, red left thigh. Fever 103 and crying for 2 days. Observed at ER for 3 hours on day of vaccination.
Day after vaccines (4/25/20) mom noticed redness and swelling of left thigh erythema covering about half of left thigh around the area of injection, mild erythema on right.
Left upper arm around the site where injected is covered in a red rash, hot to touch, and very sore.
A knot formed at injection site immediately as I pulled the needle out of her arm. It was raised, but not warm to the touch. I gave her an ice pack to place on the site right away. She held it to the site for approximately 5 minutes. Then she removed it and I removed her band aid and cleaned the area, At this point, the knot had gone down in size. She said it was not painful. I offered her some Benadryl, she said she felt ok. I also offered her to take the ice pack home to ice it on the way home. She insisted she was ok, and would ice as soon as she got home (does not live far from pharmacy). Her husband was with her and said he would watch her as well, but said she was fine. I called and spoke with her at 5:20pm (3 hours after the shot), and she stated it was still a little knot, but no pain. I advised her to call if any further issues.
Case number PHEH2016US023427, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 22 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into left arm on 04 Mar 2016. On 04 Mar 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse.
Patient presented with altered mental status and acute respiratory distress several hours after receiving monoclonal antibody infusion for recent diagnosis of COVID-19. Vital signs showed the patient has a fever. He has a new oxygen requirement of 2-4 L by nasal cannula. He is slightly tachypneic. Pfizer vaccine given 9/28/2021.
Pt exp erythema, edema, warmth @ inject site p/receiving Td following laceration injury; exp achiness & malaise; Ice was applied to inject site area & APAP was given;
acute hypoxic respiratory failure, severe sepsis, acute COPD exacerbation, secondary to COVID-19 pneumonia.  remdesivir  Solu-Medrol 40 mg IV
I had my first dose on 1/11 I had dizziness and rapid heartbeat and light Flu-like symptoms  On2/8 I had my second dose and the injection site got very sore. I experienced flu like symptoms of achiness, fever, chills. I also had diarrhea and I felt like my intestines were on fire. my arm turned red and was incredibly itchy
Focal seizure x 3 minutes no significant fever not postictal also pink, indurated, tender left thigh.
My 6 week old newborn got a fever and had oxygen saturation in the 80s 30 hours after I was vaccinated and had breastfed. Baby was not hospitalized and fever went away and oxygen returned to normal after a couple hours
Caller reports that his Therapist received a Covid-19 vaccine series and booster and caught Covid-19 anyway.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller reports that his Therapist received a Covid-19 vaccine series and booster and caught Covid-19 anyway.) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller reports that his Therapist received a Covid-19 vaccine series and booster and caught Covid-19 anyway.). At the time of the report, COVID-19 (Caller reports that his Therapist received a Covid-19 vaccine series and booster and caught Covid-19 anyway.) outcome was unknown.            Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious AESI COVID-19, after receiving the booster dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medication reported No treatment medication reported The reporter was not sure which Covid-19 vaccine that the patient received.; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious AESI COVID-19, after receiving the booster dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt. states after receiving 2nd Phizer 04/01/2021 started experiencing pins and needles in the feet advancing to the arms and head 06/01/2021. ER visit 06/292/2021 resulted in recommendation for a Neurologist visit. Appt. set for 07/20/2021
Facility I had shot was an authorized Covid-19 vaccine facility at undisclosed location, which is different than location I was seen at for side effects.  24 hours after vaccine/ Day2: fatigue and muscle soreness, chills, ear ringing (more like I had large shells covering my ears and sound you hear). Fatigue lasted two days.  Ear ringing lasted 5 days then resolved.
Patient called back stating she experienced dizziness, headache, runny nose and fever, "like a cold". Symptoms resolved 9/30/15. Patient states she did not see a physician and received no treatment or medications for her symptoms.
Administered MODERNA 6MO-11YR  2023-24 SARS-COV-2 (COVID) VACCINE. The manufacture provided 0.5mL per 1vial instead of 0.25 per 1 vials.
Started feeling bad; Unable to function; Double vision; Memory loss; confused; Headaches; chills; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 08Apr2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Patient had unspecified medical history. Patient had no known allergies. The patient received other medications within two weeks of vaccination, names were unspecified. 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 10Apr2021, the patient experienced started feeling bad, had memory loss, was confused, unable to function. Headaches, double vision, chills. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events started feeling bad, had memory loss, was confused, unable to function. Headaches, double vision, chills was not recovered.  No follow-up attempts are needed. No further information is expected.
Client passed out at checkout window, fell backwards and bumped his head on a closed door, opened eyes when on floor and was covered in sweat, BP:80/60 P:96 regular. Legs where elevated and patient was monitored for 30 minutes. Followed up next morning by phone, and he stated that he was doing fine. No headache, bleeding or bruising.
Patient called week of 9/30 to report was not feeling well day after receiving vaccine (flu-like symptoms, muscle aches, jaw hurting, fever, right arm swollen, rash at site, warm to touch). Patient advised to take ibuprofen and call Dr. Pharmacist followed up again 10/5, and per patient symptoms were improving but advised seeing her Dr even so. 10/6/18 patient called to say she saw Dr and Dr advised more ibuprofen and BENADRYL and that she should improve after another 3 days. Dr stated she is in the 2% of the population that they see have this hyperresponsive reaction. Dr still advised patient get 2nd dose in series but to "load up on ibuprofen and BENADRYL prior".
Patient had the flu vaccine on 10/23/08 and was admitted to the hospital on 10/25/08 with bleeding on the brain though the patient was on medication COUMADIN which is a blood thinner. Patient had called with questions about if his symptoms could be a reaction to the flu vaccine, his symptoms were headache, vomited twice last night and feeling achy. The correct dose and route of the flu vaccine was given. patient was given the information sheet and consent to read about the flu vaccine prior to the injection.  1/23/09 MR received fro multiple admissions 10/26-11/14/2008 with DX: Large chronic subdural hematoma, 11/14-12/1/2008 with DX: Poor neurological status due to bilateral subdural hematoma and 12/1-3/2008 with D/C DX: Chronic bilaterally subdural hematomas with poor neurologic recovery. Initially presented following a seizure preceeded by 2 day hx of H/A. Subdural hematomas noted on CT and taken emergently to OR for evacuation. Pt in guarded condition, intubated with decreased LOC following procedure. Unresponsive and posturing, reflexes depressed.Was to be d/c to palliative care 11/14/08, but began to awaken and was speaking albeit confused, lasted only briefly. Little improvement from 11/14/-12/1/08 so transferred to trasitional care unit. Developed Acute Renal Failure. D/C to hospice care.
101.5 fever started at 3am for 24 hours.  Also severe body aches and flu like symptoms.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. Previously administered products included Influenza vaccine with an associated reaction of influenza like illness (over past 2 decades receiving Flu vaccine, refer case US2018GSK135676). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site swelling, injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the influenza-like symptoms, injection site swelling, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In the next morning of vaccination, the patient experienced flu-like symptoms. Less than a year after vaccination, the patient experienced redness, swelling and pain at the injection site. The patient did not provide any additional details. The patient did not wish to provide any contact information and ended the call before any additional details could be obtained.
Headache, Myalgia, after 1st dose - HA, fatigue & muscle pain. After 2nd - HA. Then 14 days out cough and nasal congestion- CEPHID test NEG. Related??
Spreading raised papular vesicular clustered rash down. Right upper arm from right trapezius area over 12 hours started 2/25/07. Pt seen 2/26/07 started on Zovirax-labs enclosed. Pictures enclosed.
Information has been received from a pharmacist via a company representative referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates (reported as each on a separate unspecified date), the patient was vaccinated with two doses of ZOSTAVAX (lot #, frequency and route were not reported). No adverse effect was reported. The reporter wanted to know what the ramification was when a patient received more than one dose of ZOSTAVAX. Additional information has been requested.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment medication were reported.   This case was linked to MOD-2022-644983, MOD-2022-644996 (Patient Link).   Reporter did not allow further contact
No reported adverse events.  Reporting the utilization of Sterile Water for Injection as diluent for Pfizer BioNTech COVID-19 vaccination recognized on 12/29/2021.  It was discovered that SWFI was used for reconsitution of vaccine for the date range 12/6/2021 through 12/28/2021.  These vaccines were utilized for vaccination of a total of 219 patients.  There have been no reported adverse events from any vaccinated patient.
About five minutes after receiving the vaccine, the patient started to turn very pale and his heart rate increased. He drank some water which made him feel better His heart rate was 60 and BP 110/80. After about 20 minutes of monitoring, the patient left the facility feeling fine. He did report that he had a similar vasovagal response to the MMR vaccine.
chills; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
On December 8, 2022, a mother brought her child to the Immunization Clinic to be vaccinated.  The nurse in the back of the clinic received the orders from Triage and vaccinated him.  However, one of the vaccines ordered was a combination drug that has diluent.  Mistakenly, the RN diluted the vaccine with the wrong diluent.  She realized her error only when one of her peers told her; she called the mother and informed her.   She did not want to return to the clinic the same day and stated he would get revaccinated when he had to return to the clinic in six months for additional vaccines.       This incident was the nurses' first time preparing this combination vaccine.  When she pulled the drug, she noticed the two different colored tops on the vials in the box but proceeded to dilute the powered vaccine with a dilute other than what was in the box.  The manager informed.
legs were so weak she had to  crawl to the bathroom; freezing to death; dizziness; deathly ill; ached all over; fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (legs were so weak she had to  crawl to the bathroom), FEELING COLD (freezing to death), DIZZINESS (dizziness), ILLNESS (deathly ill) and MYALGIA (ached all over) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Diabetes.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULAR WEAKNESS (legs were so weak she had to  crawl to the bathroom), FEELING COLD (freezing to death), DIZZINESS (dizziness), ILLNESS (deathly ill), MYALGIA (ached all over) and PYREXIA (fever of 102 ). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (legs were so weak she had to  crawl to the bathroom), FEELING COLD (freezing to death), DIZZINESS (dizziness), ILLNESS (deathly ill), MYALGIA (ached all over) and PYREXIA (fever of 102 ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 102 (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Chills; Joint pain; Muscle pain; I just feel like I have been run over by a truck today; tiredness; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date in Mar2021 the patient experienced chills, joint pain, muscle pain, i just feel like i have been run over by a truck today, tiredness. The clinical course was reported as he had the vaccine yesterday about 24 hours ago, he saw the symptoms and side effects, he basically knows the tiredness, joint pain. Muscle pain and last night he had very bad chills and he just feel like he had been run over by a truck today. He talked to some other family their experience any side effects he was pretty healthy guy, but he was experiencing. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.