chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness, Headache, Myalgia, Fever, Rash, Sweats and chills Narrative:  With first shot 12/24/2020 pt had headache and myalgias that lasted 24 hours. With 2nd injection 01/20/21 pt had fever, sweats and chills x 2 days. Pt attempted to come to work 1/22/21 but felt lightheaded and dizzy. Temp did not break until 1/22/21 despite taking medication. Had a rash on her arm-looked like hives on edge of bicep area up towards deltoid injection site. Headache lasted until 1/25/21. Had some arm pain at injection site with both injections. Missed work x 2 days. No known prior covid infection.  Other Relevant History:
This spontaneous report received from a patient via a company representative concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had not COVID till now. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced tired for 3 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired for 3 days on 2021. This report was non-serious. This case, involving the same patient is linked to 20220719927.
Patient received Pfizer COVID vaccine on 3/6/21 and 3/26/21.  On 10/23/21, patient admitted for acute hypoxemic respiratory failure due to COVID-19 pneumonia with bilateral pleural effusions. During admission, patient also developed MRSA LLE osteomyelitis and sepsis, AKI, pyelonephritis in transplanted kidney. Patient expired on 10/25/21.
So a month after the vaccine, on 06/26/2021, I noticed my anxiety and it progressively got worse. At 1st I thought it was because I was cooped up in the house for so long, I was working from home since 03/2020. I did return back to the office 09/20/2021 for 3 days a week, but I could not go back because of my anxiety. After July I developed extreme depression. I reached out to an online app to a doctor and he diagnosed me with ADHD and I received online consultations. On 09/29/2021 I saw my doctor, because the anxiety became worse. He referred me to a neurologist and psychiatrist. Dr. mentioned he could not rule out the vaccine, but it could be that it is an after affect of having COVID-19.
UrticariaPruritus localized erythema, edema, and itching  Narrative:
Within 10 minutes started with lump in throat chest discomfort.  Progressed to coming, rash and hives.     Given zofran, Epi, benadryl, Pepcid and solumedrol. All iv
The new Pfizer COVID-19 vaccine is intended to be given intramuscularly with a 1 inch needle. Instead, a shorter needle was used, only 1/2 inch, which the immunizer uses to draw up the dose and therefore, it is uncertain if it was properly injected into a muscle. Immediately following administration, a red welt appeared on the left arm and it felt hot and bumpy. A superficial bump under the skin is more indicative of an intradermal or a subcutaneous injection, not an intramuscular one.
Influenza vaccine administered 10/21/11 - Lt. deltoid. Severe swelling, itching, redness; warmth within 24h. Swelling involved entire Lt. upper arm. No s/o anaphylaxis, hives or eczema. Rx: BENADRYL 12.5mg - q 6 h x 24h then added KEFLEX 250/5 tid x 5d.
Injection site rash with swelling and hot to touch. Muscle soreness in arm and left side of neck. Some tingling in fingers at times.
pt recvd vax & 9 days post vax exp erythema multiforme & was hospitalized for 2-3 days;tx Duricef bid x 7 days;
Patient presented to urgent care with abdominal pain, intractable vomiting x 4 days on 4/2/23. +sore throat.
Congestion or runny nose  Contacts   Type Contact Phone User 05/08/2021 09:59 AM Phone (Outgoing) (Self) RN Care Coordination Progress Note RN (Registered Nurse)    COVID 19 MAB Infusion Navigator Post Infusion Outreach #1   Infusion Date: 5/7/21    Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab       Tell me how you are feeling today? Feeling fine, no reported side effects from infusion. O2 reported as 94%. No reported fevers. Eating and drinking okay. Navigator reviewed isolation guidelines and protocols. Patient with no further questions or concerns at this time.    We recommend that you have a follow-up with your family doctor, especially if your symptoms are not improving. This can be by video/telephone or in person, dependent on the office preference. Inform the office that you have received a COVID monoclonal antibody infusion. The office will let you know when and how to follow-up.  Please call your provider/physician to schedule a follow-up appointment.    I will be calling you in another couple of days on 5/17.   Please continue to monitor your temperature and pulse ox (oxygen level). If everything is going well, we will plan for you to graduate from monitoring around day 10 after your infusion.   Reminder: There is a possible risk of reduced immune response to the COVID vaccine. COVID vaccination should be delayed for at least 90 days after you receive the infusion.
lip swelling/tingling/numbness, tongue numbness, tightness in throat, tightness in chest Symptoms started around 5-10 mins after the injection in the initial 15 min observation. Was observed for additional 15-20 mins, on-site nurse took vitals. Blood pressure was a little high, heart rate a little escalated, but oxygen saturation 99%. After the total 45-60 mins, symptoms did not lessen, but did not get much worse. Opted to take Benadryl tablet over epinephrine. Patient found some relief of symptoms from the Benadryl.
PNEUMOVAX and MENACTRA given 5/19/14. Patient developed swelling and redness at site and up arm.
I had a scratchy throat that got progressively worse. I had some fatigue and felt a bit tired. I completed an at-home COVID-19 test on 02/07/2022 and the result came back positive. I called my physician's office the same day to let them know that I just tested positive for COVID-19 and they prescribed me an anti-viral medication.
Within seconds of receiving the vaccination, patient stated she was starting to feel lightheaded, vision splotchy. After roughly 20 seconds she had a full syncope episode including losing consciousness for ~5 seconds. During this time she moved her arms in a way that seemed like her muscles tensed and became rigid. She recovered within seconds complaining of sweating, splotchy vision, ringing in ears. I gave her orange juice and monitored her at least 15 minutes. She stated her symptoms were improving at that time.
Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication information was provided. Patient states she had fatigue and sore arm after her moderna covid-19 vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Symptoms began around 5:00 p.m. the day of vaccination with sore arm, not feeling well. By 11:00 p.m., body aches and nausea.  Around 2 a.m. the next morning vomiting started accompanied by teeth-chattering chills, body aches, fatigue, and fever,  all of which persisted through the entire day. Fever peaked at 101.7 around 6 p.m., then continued to dissipate until gone by 8:30 p.m. Body aches, along with injection site pain and stiffness,  persisted for approximately 5 days. Long-covid symptoms of fatigue and myalgia increased following injection, and as of today, 11/9/21, fatigue is still significantly high and leg myalgia persists.
There was no adverse event reported by the patient. The provider gave the RSV vaccine to a patient 59 years of age. The vaccine is given to those age 60+.
Rash, burning skin, skin crawling. Rash lasted about 1 week and covered arms and thighs, stomach. Burning sensation of the skin happened during the night about 3 times. Skin crawling sensation occurred twice during the night as well. Consistent itchy skin.
When MA administered vaccine, the syringe "popped" off the needle and the vaccine spilled out.  The MA was able to remove the needle from the patient's arm, but unable to ascertain if the patient received any of the vaccine dose.  This was to be the patient's booster dose.  Provider advised pt to return in one month to repeat vaccination.
Received 2nd set of immunizations on Thursday. Friday am, child was covered with hives. No dyspnea of fever. By Saturday hives became worse and child was taken to ER. No other distress noted. Given Benadryl 12.5 mg and sent home.  By Tuesday, hives began to disappear and Friday- completely gone.
"possible varicella body rash" that may be "chicken pox" acquired from a parent; This spontaneous report was received from a Physician and refers to a 7-month-old female infant. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (also reported as vaccination) (formulation, strength, lot # and expiration date were not reported).  On an unknown date, the patient developed "possible varicella body rash" that may be "chickenpox" acquired from a parent. The patient saw medical attention and treatment was given for the adverse event. However, no lab diagnostics or studies were performed. The physician report that the patient has only been administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and have not received varicella virus vaccine live (Oka/Merck) (VARIVAX), measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3), varicella virus vaccine live (Oka/Merck) (PROQUAD) or zoster vaccine live (Oka/Merck) (ZOSTAVAX). At the moment of this report the patient was recovering from "possible varicella body rash" that may be "chicken pox" acquired from a parent.  The relatedness between the event occurrence and rotavirus vaccine, live, oral, pentavalent (ROTATEQ administration was not reported.
Pt's mother stated pt threw up approximately 12 hrs post vax. She had no further problems.
Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm.  States she was lightheaded 1st, then headache, feels like someone is pressing down on head and neck- temples and note- feels like a band around head. Pain is 2/10, progessed to 6/10. States muscles are starting to get sore around trapezius region. Stated she had feeling of euphoria initially,  BP 128/76, HR 66, 98% RA.  Nausea, but no emesis. Metallic taste to mouth- pins and needles when drinking water.
NAUSEA, VOMITING, DIZZINESS, BODY ACHES, DRY MOUTH FOR TWO DAYS.
Fever 101, required 4L of oxygen, Lungs sounded coarse. Administered oxygen and started weaning down on 2/4 to 3L. Fever resolved after administering tylenol and ibuprofen last night. However, resident is in a home that has had recent covid positive employees and residents so this may simply be related to actual covid 19. She was tested yesterday and we are awaiting the lab results.
RA flares; General body pain; Swelling; Jawpain; Tiredness; Swelling of feet; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA flares), PAIN (General body pain), SWELLING (Swelling), PAIN IN JAW (Jawpain), FATIGUE (Tiredness) and PERIPHERAL SWELLING (Swelling of feet) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product SARILUMAB (KEVZARA) solution for injection for Rheumatoid arthritis.    No medical history was reported.  Concomitant products included PREDNISONE for an unknown indication.   On 15-Jul-2019, the patient started SARILUMAB (KEVZARA) (Subcutaneous) 200 mg. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced RHEUMATOID ARTHRITIS (RA flares) (seriousness criterion medically significant), PAIN (General body pain) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), PAIN IN JAW (Jawpain) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of feet) (seriousness criterion medically significant). The patient was treated with PREDNISONE at a dose of 20 mg, 4 pills for 3 days; PREDNISONE at a dose of 3 pills for 3 days; PREDNISONE at a dose of 2 pills for 3 days and PREDNISONE at a dose of 1 pill for 3 days. On 14-Jun-2021, RHEUMATOID ARTHRITIS (RA flares), PAIN (General body pain), SWELLING (Swelling), PAIN IN JAW (Jawpain), FATIGUE (Tiredness) and PERIPHERAL SWELLING (Swelling of feet) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-219927 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
SICK 11-10-2021 WITH 101.6 FEVER, COUGH, SHAKINESS, ADOBOMINAL CHEST PAIN, SOB, UTI FROM CHRONICALLY DWELLING FOLEY TESTED + FOR COVID-19 11-10-2021,  ADMITTED 11-10-2021,  DISMISSED 11-14-2021
A 17 year old female reported feeling blurred vision and dizziness after administration of the vaccine. Evaluation is preformed and S/V is taken. Consultation with Doctor is carried out, which indicates that she be placed on a stretcher and monitored for 30 minutes and her vitals are reassessed. After 30 minutes, the patients vitals are reassessed and she reports having improved her symptoms and feeling well. To which she withdraws from the center under her own feet.
Swelling and pain at injection site, generalized malaise, chills, aches, lymphadenopathy, left axilla
On 11/7/2021 at about 5:00 PM, I began to feel stuffy. I decided that I wanted to eat something spicy, because I thought it would clear up my sinuses, so I went out to eat. The following day, on 11/8/2021, I had a runny nose and a dry cough. On 11/9/2021, I still had a runny nose and a dry cough, but I was coughing more often. I decided to get tested for COVID-19, so I went to a drive-thru for a PCR test. I was going to have to wait for 3 days for the results of the test, so I decided to also get a home COVID-19 test. I tested myself at home, and the results were positive. I tested myself again 36 hours later, and I still had a positive result. I also got the results from the PCR test, which were also positive. I informed my doctor of my diagnosis, and he prescribed me Keflex. I was told by my employers I could return to work on 11/18/2021 if I was symptom-free. I took another PCR test on 11/17/2021, and I got a positive result back on 11/20/2021. By then, I had already returned to work. Since I was symptom-free and over 10 days had elapsed since the onset of my symptoms, though, my employers were still fine with my being back to work.
No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     The information of allergies to medication, food and other products were unknown.     On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant product use was not provided by the reporter. The information was unknown whether the patient had ever been diagnosed with/tested positive with COVID-19. The information of acute illness at the time of vaccination and up to one month before was unknown. Expired Moderna vaccine was given to the patient. The vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo temperature excursion. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-648572 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received with updated reporter's address; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648572:Master case
patient stated vaccine  hurt going in and then he was unable to lift his arm up and it is still very painful lost range of motion
Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: 6 days after dose patient had a syncopal attack and severe palpitations. Daughter called ambulance after finding mother had fainted.
received the fluzone hd qiv to 59 years old with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 59 years old female patient who received the fluzone hd qiv (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ924AD, expiration date: 30-Jun-2023 via intramuscular route in the left deltoid as Immunization  On 17-OCT-2022 the patient who was 59 years old received the fluzone hd qiv with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event     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 the guidelines. 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.
Sharp chest pains when inhaling, shortness of breath, and  mild fever. They lasted for about 5 days, but I never went to the doctor because I was unaware of Myocarditis as a side effect prior to taking the shot.
Period stopped for 4 months and her period resumed 3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Period stopped for 4 months and her period resumed 3 weeks ago) in a 51-year-old female 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 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 an unknown date, the patient experienced MENSTRUATION IRREGULAR (Period stopped for 4 months and her period resumed 3 weeks ago). At the time of the report, MENSTRUATION IRREGULAR (Period stopped for 4 months and her period resumed 3 weeks ago) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.
I have frozen shoulder; Swollen lymph nodes in neck and under arm.; Stiffness on whole left upper shoulder, side of breast; arm pain; It took two months for swelling to go away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 10:00 (Lot number: ER8734) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ENALAPRIL. Vaccination history included: Bnt162b2 (dose 1, single, lot number=EN6206,, administration time=09:00 AM, vaccine location=Left arm), administration date: 11Mar2021, when the patient was 61 years old, for Covid-19 Immunization, reaction(s): "First shot had very sore arm for few days.".The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Mar2021 13:00, outcome "unknown", described as "Swollen lymph nodes in neck and under arm."; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 31Mar2021 13:00, outcome "unknown", described as "Stiffness on whole left upper shoulder, side of breast"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 13:00, outcome "unknown", described as "arm pain"; SWELLING (non-serious) with onset 31Mar2021 13:00, outcome "recovered" (2021), described as "It took two months for swelling to go away"; PERIARTHRITIS (non-serious) with onset Jun2021, outcome "unknown", described as "I have frozen shoulder". Therapeutic measures were not taken as a result of lymphadenopathy, musculoskeletal stiffness, pain in extremity, swelling, periarthritis.  Additional information :patient did not receive any treatment for AE,Patient not receive any other vaccine in four weeks ,patient receive other medications Levothyroxine, enalapril in two weeks .patient not tested covid positive prior vaccination. patient not tested covid positive post vaccination. No known allergies  No follow-up attempts are possible. No further information is expected.
Fever 1/26.  Also altered mental status  but was present prior to episode  Fever resolved.  Continued altered mental status but unclear etiology.  Did result in additional workup for infection, arthrocentesis, etc that may not have been done otherwise