chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(R) arm started aching 3 PM 10/25/10 - by 4PM same day could not lift arm in front or to side of her. 10/25/10 PM woke pt. from sleep with throbbing pain. 10/26/10 - Continue with throbbing pain - as day progressed pain not as severe. 10/27/10 = Fine pain went away. 10/31/10 Normal activity - 4 PM pain, problems lifting arm - Applied heat (which made worse) & took MOTRIN. 10/31/10 pain woke pt. up - 11-1-10 AM unable to lift arm up in front or to side. At times pain & throbbing less severe with movement. 11-1-10 Still with throbbing pain in (R) arm - Advised to seek medical treatment.
Nausea, vomiting, severe headaches, chest pain, SOB (only occuring at night), slight leg pain, and upper back pain
severe arm pain and fatigue. possible low grade fever for 24 hours. Overall flu like symptoms that have since subsided in about 48 hours, but pt does not want to finish the series.
pt recv vax 3MAY95 & 25MAY95 exp h/a, low grade fever, unspecified lesions & a hot arm @ inj site; No further details were provided;
11/14/2022   I had a headache, stuff and runny nose, sneezing , it just seemed like I had a bad cold.  I had a negative at home COVID test. The next day , I had the same symptoms and was still negative for COVID with an at home COVID test.  11/16/22 I felt the same. I took an at Home COVID test and it was positive. I called the doctor?s office and she told me I did not need to take drugs unless I had very bad symptoms or trouble breathing.  Since I just had symptoms of a cold, I did not need to go in to see them.  I tested negative on 11/30/22.  By then I felt pretty good. I have recovered.
Fever that started shortly after receiving immunizations up to 102 degrees. Rash present along entire body. Decreased activity and unsteady on his feet.
Patient developed numbness and tingling in her feet. It came on suddenly and has progressed up her legs to below the knees. She has sensitivity and discomfort. No weakness. Nothing makes it worse or better. No treatment. No abnormal physical exam findings-no abnormal weakness, sensation intact, normal vibratory sensation, and reflexes intact. Symptoms are persistent.
Patient mother called in 7/10/17 with the following information (Patient is in college) he received 6/2/17 went back to college the week of 6/12-6/16 not feeling well S/B a Dr and on antibiotics for ? UTI. Returned home and taken to ER by mother 7/1/17, blood work increased WBC and enlarged inguinal glands, treated with antibiotics for ? STD.-Mother thinks symptoms are related to vaccine given 6-2-17.
This spontaneous report was received from a registered nurse refers to an unspecified amount of patients of unknown age and gender. Nurse stated that on an unknown date in 2014 within the past 2 weeks an unspecified amount of patients were vaccinated with a dose of RECOMBIVAX HB which was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
"After about 3 days of a sore arm ( I know this is normal) I started to get the feeling of flushing with minimal change in color to my face. My brain was telling me my skin felt hot but if you touched it or looked at it you would think maybe my cheeks were a little pink.  I could feel this hot sensation on all of my skin on the top half of my body.  This happened regularly for about 8 days. I have not felt the hot sensation since 1/3/21."
Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose; Heart rate between 120-130; A fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) 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, the patient experienced HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102). At the time of the report, HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) A fever of 102. On an unknown date, Heart rate: 120-130 (High) 120-130. On an unknown date, Oxygen saturation: low (Low) Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose.         No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-311180 (Patient Link).   Reporter did not allow further contact; 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.  Event of hypoxemia was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious. No further information is expected since consent for follow up has been denied.
Patient states she has noticed these bilateral arm lesions for about 2 months after getting injections. The lesions are located on bilateral deltoids. Patient reports erythema and tenderness. Rates bilateral upper extremity pain 7/10. Patient got vaccination injections and bilateral arms on 10/3/18. Patient had pneumonia and influenza vaccination in right arm and hepatitis A vaccination in left arm. Shortly after getting these injections, patient noticed erythema surrounding injection sites and states she had feverish symptoms. Patient states she has taken 3 antibiotics, and states that I and D has been done on both lesions. States the lesions began to improve, but healing has recently plateaued. Patient reports headaches, nausea, loose stools. Denies fever, chills, sweats, vomiting. Patient states she has had the influenza vaccine before and has never had a reaction like this.
PT RECD VACCINE 5/6, HAVING CHEST TIGHTNESS ON 5/7 WHILE WORKING. CODE GREEN CALLED. TRANSPORTED TO HOSPITAL
Pt given flu vaccine approx. 2:15 pm 9-15-11 approximately 15-20 min later pt c/o "itching and bumps". Observed papules 2-3 mm in size to area of injection site 1-2 same on legs not on chest, back or abd. Pt stated "I feel ok". "I just itch". CNM instructed to ER if worsened.
Tested positive for COVID-19; Flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and COVID-19 (Tested positive for COVID-19) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 02-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and COVID-19 (Tested positive for COVID-19) outcome was unknown.
I had a light head cold. My husband was experiencing covid symptoms and he is not vaccinated. The next day December 6th we went to an urgent care clinic to be tested and my husband came back positive and I came back negative for covid. We were prescribed azithromycin for 5 days. I was feeling ok. On December 8th I lost my taste and smell. At 9:30 in the morning I became short of breath and it was hard to breathe. I did an at home covid test that was positive. I drove back to urgent care clinic. They did another test that was positive. I was still having a hard time breathing. I was getting light headed. They said I had inflammation in my airways in my lungs. The doctor at the urgent care called my oncologist and told them to immediately send me for the monoclonal antibodies which I had on December 8th. On December 9th I didn't feel good but my breathing was better. December 10th I had no more breathing issues and my taste and smell returned. December 11th I felt completely over the covid.
Mild maculopapular rash across arms and facial and neck flushing. Rash did not itch; facial and neck flushing; other vaccine same date vaccine date on 17Dec2020; This is a spontaneous report from a non-contactable consumer (patient).   A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 17Dec2020 at 07:30 on Right Deltoid at single dose for COVID-19 immunization. Other vaccine was received on the same date on 17Dec2020 Right Deltoid. The patient medical history included Hypertension. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medication included Lisinopril (strength: 20 mg). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tramadol and experienced allergy. The patient experienced mild maculopapular rash across arms and facial and neck flushing on 18Dec2020 at 13:30. Rash did not itch and resolved spontaneously in 24 hours. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events "mild maculopapular rash across arms and facial and neck flushing" was recovered in Dec2020 in 24 hours. The report was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
3 DAYS OF MILD SYMPTOMS PRIOR TO ADMISSION, SOB, HYPOXIA, COUGH, FEVER, HEADACHE, AND BODY ACHES
pt recv vax 12SEP97 & 3DEC97 & p/vax pt exp some patchy hair loss;
Patient first developed spots to the right side of her face on 02/21/2015 sometime in the afternoon. Patient boarded a flight.  When patient arrived home rash began to spread from cheek to rest of body, entire body was covered except palms and soles of feet. Mom reports by 2/22/2015 patient was covered with rash. Patient also had slight runny nose and low grade fever. Patient came to our office on 2/24/2015 reporting rash was not as bad as it had been two days ago. Patient presented in office with rash to body from head to toe zero rash to palms or soles of feet. Rash to arms and legs redder, flat, blanching.
Mild symptoms began around 4:30pm (nausea, chills, headache, fever of 101). I took a nap around 7:00pm and when I got up around 8:30 my fever was 102. It continued to go up until it hit 104.6 around 9:00. My chills were gone, I was a little achy and had a headache, and was unconsciously crying even though I was experiencing very little pain. I took some Tylenol, and it went down to about 101 at 10:00pm. It stayed around 101 for most of the night and was back to normal by morning. We had called the hospital and they said there's nothing they can do for vaccine symptoms, but I thought I should report the high temperature.
pain in left arm all the way town to finger tips, bad headache and tightening of chest. Contacted medical office who said to monitor and make sure they do not worsen.
Swollen arm where injection was given - two inch round diameter hard and raised injection site.  Diarrhea- stomach pain and loss of appitite.  Headache- Fever- lethargic - Rash Headache - 9/17 11:00am Fever 9/17 12:00 Muscle pain in arm  9/17 2:00 Redness and swelling on site 9/17 2:00 Raised and hard injection site 9/18 9am Loss of Appitite 9/18 1:00 pm Continued pain in arm and swelling 3pm Fever and lethargic 4pm Stomachs ache 6pm.   Diarrhea 9/19   7am Rash on chest and back of left arm. 830am     diarrhea- muscle pain-
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ANGIOEDEMA, INIT ANGIOEDEMA, SUBSEQ ANGIOEDEMA, SEQUELA
"COVID arm" redness in upside down teardrop shape at the site of immunization with a bruise under it  that showed up 8 days after the immunization, rash on chest, back, buttocks, groin, upper thighs, different type of rash on front and back of both hands,  all over and between fingers, inner wrists, left ankle and 2nd and 3rd left toes (this rash looked like "COVID toes"), given a course of Prednisone taper 20mg 3 tab x3 days, 2 tab x3 days, 1 tab x3 days, 1/2 tab x3 days, triamcinolone 1% cream topical, Benadryl 50mg q6hr, Allegra once/day, "COVID arm" redness lasted 7 days, rash on chest, back, thighs, buttocks cleared after 5 days of Prednisone and above medications, rash on hands, fingers, toes, wrists and ankles persist at 9 days, incredibly itchy several times/day, sensitive when washing hands, paresthesia feeling at times on areas that spots are present on hands
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.  The patient had no adverse events.   This case was linked to MOD-2021-395985 (Patient Link).
No adverse event; Vaccine administered beyond use date 07Jul2022; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not provided. Vaccine received on 07-Jun-2022. Treatment medication information was not provided by the reporter.
Father called on 7/19 stating his daughter had a reaction to her last set of shots given on 6/18/07.  On 6/20/07 10:30pm, hard area of enduration on the inner aspect of left arm where both DTaP and IPV were administered. Also large reddened area over the left deltoid.  Father denied any fever or systemic symptoms.  No treatment was sought for the redness/swelling.
tested positive for Covid-19 virus; tested positive for Covid-19 virus; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable female consumer(patient).  A female patient of an unspecified age received first dose BNT162B2, via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient receive 1st dose 11Jan2021, then experienced tested positive for covid-19 virus on Jan2021 with outcome of unknown.     Information on the lot/batch number has been requested.
I started getting symptoms of sore throat, sinus symptoms, fatigue, and tiredness. It was like a sinus infection. I got a positive COVID-19 test. These symptoms lasted for 5 days.
Sudden neurosensory hearing loss - At 11 AM on 10/29/21 episode started with ringing in the ears.  At 2 PM I had loss 50% of my hearing.  At 6 PM I was totally deaf in my left ear.  I went to the emergency room and received 60 mg Prednisone and started dose at 7 PM.  I was placed on 60 mg Prednisone for 9 days.  I am currently tapering 10mg every two days and will complete the taper on 11/16/21.  I had a direct injection of steroid into my middle ear on 11/10/21.  To date (2 weeks after adverse event), there has been no improvement.  I cannot hear.
p/vax pt recv vax & immed became unconscious for a few seconds;mad snoring sounds & had some jerking movements of head;ammonia inhalant to nose;pt already conscious & talking;walked to exam table & reclined;ice pack to forehead;
Patient received 4th dose of pediarix for 15 month immunization. No adverse reactions occurred.
R arm pain, R sided facial pain, after second shot, R sided leg pain/parasthesia. Unable to walk.
Breakthrough COVID infection, ICU admission. Recieved Pfizer COVID 19 vaccines on 1/11/2021 and 2/1/20221
I was feeling really run down and tired which is not like me. I started cough and feeling like I do when I need a breathing treatment. My wife suggested that I use a home COVID-19 test, I did, and it came back positive immediately. I called and had a telehealth visit. I was prescribed PAXLOVID that I started taking as soon I got it from the pharmacy. I took me two weeks before I felt like was back to normal.
The patient said he came down with a sore throat, cough, fever.  He presented a prescription for an antibiotic today 5/31/16, saying that the dr. gave it to him because he still wasn't better.  We tried to explain that the symptoms probably weren't related to the immunization, but the patient insists they were.
Necrotic ulceration at Injection site - 4 cm. Large eschar developed. Treated with Bacitracin Ointment.
Approximately 12 hours after the vaccine I developed a headache and became VERY tired. Approximately 14 hours after the vaccine I developed a fever. As of 9:00 am everything is back to normal.
FLUBLOK by accident or the staff administered one to a 4 year old with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2022SA381569(CLUSTER).  This case involves a 4 years old and unknown gender patient to whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] dose was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date flublok dose was administered to a4 years old with no adverse event (product administered to patient of inappropriate age) (same day latency). Physician said they received FLUBLOK by accident or they didn't order it but his staff is clearing that up. He wanted to know about safety issues and if it needs to be repeated.  Action taken: Not applicable.  Outcome: Unknown.    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 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.
Case number PHEH2015US026639, is a combined spontaneous report initially received from a physician on 17 Dec 2015 and follow up report from Quality assurance department on 21 Dec 2015. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medications were not reported. The physician opened a new bottle of FLUVIRIN and when he popped the orange lid off a small portion of an orange plastic remained on the lid. The patient received FLUVIRIN (batch number: not reported) intramuscularly on 17 Dec 2015. The physician reported that, the liquid was clear and there was no particles in it. The physician did not push through the plastic part and only the rubber portion. No adverse event was reported following this administration error. Following an internal review on 30 Dec 2015 for the information received on 17 Dec 2015: Following correction was dose to the case: An additional event syringe issue was added in the case.
Slight light colored erythemic ring, flesh colored middle with center where DTAP was given on left deltoid. Slight swelling.
It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)).    This case contains information of 3rd out of 6th patient reported by reporter. Concomitant medication use information was not provided by reporter. Vaccine expired on 08 June 2023 (30th day). 6 doses of Moderna Covid-19 bivalent were administered. Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729005:Master case
Pain,  localized swelling, warmth, and redness at injection site. Fever of 102 degrees for 2 days. Body aches, chills, and loss of appetite for 2 days