chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling in my hand on the same arm of the injection; sore arm; Body ache; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in my hand on the same arm of the injection), PAIN IN EXTREMITY (sore arm), PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling in my hand on the same arm of the injection), PAIN IN EXTREMITY (sore arm), PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PARAESTHESIA (Tingling in my hand on the same arm of the injection), PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.   Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 12May2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "Sulfa antibiotics." (unspecified if ongoing), notes: Known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Had 2 doses about 1 month apart in error; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he/she recently had received 2 Shingrix vaccines about 1 month apart in error, which led to drug dose administration interval too short. The reporter enquired if that was going to harm him/her and whether he/she would need another one in 3 months.
4/7/21 Chills, Body Ache 4/12/21 Cough , Blood Tinged Sputum 4/16/21 Chest Pain (seen in emergency room - admitted to hospital)
No adverse effects initially.  On second day after the vaccine, I woke up feeling like I had sustained some kind of shoulder injury:   significant reduction in motion, weakness, pain. So far it has lasted two days.
pt recvd vax 22nov94, mom reported rash, "sl raised, almost looked liked hives" noted on pt's belly, arms, & neck; denies oth sxs; rash lasted about 2 days;
a dose of Fluzone High-Dose Quadrivalent was administered to a patient, who had already received a high-dose flu shot this season at a pharmacy/ no AE; Initial information was received on 09-Nov-2021 regarding an unsolicited valid non-serious case from a physician via Global Media Information (under reference- 00850127) and transmitted to Sanofi on 09-Nov-2021.   This case involves a 69-year-old female patient who administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and she had already received a high-dose flu shot this season at a pharmacy, with no adverse event (Inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 08-Nov-2021, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ715AB and expiry date 30-Jun-2022] via intramuscular route in unknown administration site for prophylactic vaccination.  It was reported " Caller reporting patient is unsure of the exact date she received the flu shot, but it was in September 2021".  It was a case of actual medication error due to Inappropriate schedule of vaccine administered (latency was on same day).  At the time of reporting, patient had no adverse 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 by the regulatory authority. 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.
It was reported that a 53 year old female patient received a Yellow Fever vaccination, lot # UB077AA, vaccination date not specified. Her arm at the injection site became red, swollen, and painful. Patient called the doctor's office and reported this event on 10/29/01, she will be coming in for medical evaluation tomorrow 10/30/01.
Patient's arm become red with a hot and thick rash. She also had a 99 degree fever and the site was itchy. She also reported joint pain and diarrhea. Pt was referred to her primary care where she will possible get a steroid/anti-inflammatory
lt deltoid, swollen, tender, hot x 3hr p/vax;no fever, chills;
Light headed, chills, increased blood pressure, nausea.  Cold compress, Patient advised to lie on floor and elevate legs, sips of apple juice, blood pressure taken with patient sitting  upright x3.  Blood pressure remained elevated so we called EMT assistance. They arrived and took her to their ambulance to further monitor her blood pressure.  Patient stated that she did not experience this following the first vaccination.  She also said she had covid-19 several months ago and was quite sick for 3 weeks.
devel Hepatoblastoma (liver cancer); dx by biopsy on 17AUG94, condition present 30-45 days a/biopsy; 42 days a/biopsy was vaccinated; recv 5 rounds of chemotherapy & died 1JAN95;
Local title: Outpatient progress noted date of note: FEB 26, 2004 at 13:00 HISTORY OF PRESENT ILLNESS: Patient presents with his wife for evaluation of swelling of his left arm, S/P PNEUMOVAX earlier this a.m. He has had PNEUMOVAX in the past, approximately seven years ago and had no adverse reaction. He states that he started noting swelling of his left arm, approximately two hours after the PNEUMOVAX was given and he became dizzy. He denies any difficulty breathing, shortness of breath, chest pain, swelling of the lips and tongue. Ice was placed on the area which relieved the pain somewhat. IMPRESSION: Local reaction to PNEUMOVAX. PLAN: 1. Continue ice to the area 2. Patient will purchase BENADRYL OTC and take two every six hours PHYSICAL EXAM: VS: BP: 156/110 with repeat blood pressure of 150/90 BP earlier today was 118/83. P: 80 R: 98.4 Pain 0 GENERAL: Well Developed, well-nourished and does not appear to be in any acute distress. Speech is fluent. Tongue and lips are not swollen. LUNGS: CTA x 4, (-) Wheezing, (-) Rales, (-) Rhonchi CARDIAC: RRR, (-) Murmur, (-) Rub EXT: Left arm is swollen and tender to palpation with area of induration and no increased warmth and no erythema.
Took a week before the soreness to go away. In the beginning of June she woke up one morning in serious pain in her left shoulder. She went to doctor and was diagnosed with inflammation in the tenders and build up of fluid.
pt devel redness @ the site p/vax; 1wk post vax pt had a 5 to 6 large area of purple discoloration;also an area of blanching where the needle went in;MD felt rxn was r/t vasculitis rather than ecchymosis;
SUSPECTED COVID-19 INFECTION; RASH; ITCHING ON SCALP, ARMS AND STOMACH; HOARSENESS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, ibsd, and penicillin allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. 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 APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 53 years old. No concomitant medications were reported. On 09-OCT-2022, the patient experienced rash, itching on scalp, arms and stomach, and hoarseness. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, itching on scalp, arms and stomach, and hoarseness, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Patient presented to ED with nonproductive cough, dyspnea, especially on exertion and orthopnea that had been ongoing for 1 week.  D. Dimer >20.00
RAISED RASH FROM ABOVE ELBOW BEND TO ABOVE WRISTS OVER BOTH ARMS.
Tired, achy all over within three hours of shot, soreness at injection location, fever of 100.6 within first 24 hours.
Hypotonic, Hyporesponsive episode, Infant died: Reyes text Syndrome.  Vaccine given for routine immunizations.
Left upper arm there is a rough,fine papular rash without erythema or edema. Almost eczematous appearing.  About 3 inches by 1/2 inch
Just under 5 hrs. after injection, my heart suddenly started racing rapidly and my abdomen started swelling up. I immediately took Benedryl and after 20min. passed, my heart rate returned to normal. I have been continuing Benedryl daily ever since the event.
Initial unsolicited report received from a non-health care professional on 28 Sep 2016. This case involves an 80-year-old male patient who was vaccinated with third dose of Fluzone HD (Batch number: UI636AB, expiration date: 27 Mar 2017, dose and route of administration were not reported) in the left deltoid on 19 Sep 2016. Illness at the time of vaccination was also reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was hypertension. Concomitant medications were reported as patient was on PLAVIX. Any other vaccinations within four weeks of vaccinations were also reported as none. On 21 Sep 2016, approximately two days following the vaccination, the patient experienced left arm soreness. on an unspecified date, following vaccination, the patient was unable to fully reach arm over his head, his range of motion was limited. He did not want to go to personal physician for this situation. It was reported that the patient was vaccinated twice with Fluzone HD in previous years. Laboratory investigations were reported as none. Corrective treatment was not reported. The patient recovered from left arm soreness on an unknown date (reported as no complaints of pain or soreness now). The patient was not recovered from other events (reported as just concerned with his lack of arm movement). List of documents held by sender: none.
LEFT SIDE FACE PAIN; BLISTERS ON THE FACE; FEVER; This spontaneous report received from a consumer concerned a 28-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included benzylpenicillin. On 03-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38 C. On 05-APR-2021, the subject experienced left side face pain. On 05-APR-2021, the subject experienced blisters on the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 04-APR-2021, and had not recovered from left side face pain, and blisters on the face. This report was non-serious.
?Moderna COVID-19 Vaccine EUA? fever of 102.2, extreme chills - unable to get warm for a couple of hours, shaking, difficulty breathing, extreme fatigue, all over body aches, headache, weak. Symptoms lasted from 8:30 am-6:30pm. A first only chills, by 9:30 fever, chills, and shakes started, by 10:30 all symptoms were present and lasted until 3:00. By 4:30 only the fatigue and headache and low grade fever of 99.9 were present. By 6:30 all symptoms were gone except a slight headache and still a little tired. I slept all night and woke ok. I was completely back to normal by 10:00 am on 4/15/21.
55yo F reported immediate mid back pain, non-radiating and stabbing in nature. Denied history of similar pain or back injuries. Pt was evaluated by medical staff and ems. She was midly hypertensive to 150s systolic that improved after 30min. Pt was unable to find a position of comfort and reported waxing and waving of pain while be observed. Pt was released with instructions on nsaid use, heat therapy, stretching, and return precautions.
Swelling and redness around inject site that spread down the arm. Felt sick the day following the immunizations with flu like symptoms.
Significant pain and redness at injection site.   Arm pit area very sore and tender to touch
sight injection - hot to touch,  abdominal cramping, loose stool,   abdominal bloating,  fatigue
Polymyalgia Romatica - joint aches on both sides ( hips, shoulders arms, wrists. Successfully treated with Prednisone over a long period.
Her doctor said she may have possible leukemia; Soreness; Redness the size of a quarter, Redness was 2 inches round, Redness is 4.5 inches in length and 3.5 inches in width; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Rash; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Terrible pain on her arm; A spontaneous report was received from a consumer who was also a 81-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced soreness, pain at the injection site, couldn't sleep, vaccination site pain,  redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width. Patient's doctor suspecting leukemia.    The patient's medical history included COVID 19 infection on 13 Oct 2020. Products known to have been used by the patient, within two weeks prior to the event, included hydroxyurea nonspecific.  On 13 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection.  On 13 Feb 2021 at night 11pm, patient began to feel pain at the injection site. Patient reported that patient couldn't sleep all of Saturday night, every time patient turned, it was painful. By Monday, the pain turned into just soreness, however, patient developed redness the size of a quarter at the injection site. Two days before reporting, the redness was 2 inches round and currently the redness is 4.5 inches in length and 3.5 inches in width, which indicates that it was spreading. Patient reached out to patient's doctor. Patient also reported some itching at the injection site last night. The patient also reported Rash, terrible pain on arm, and COVID-arm reaction. Patient's also reported that her doctor is suspecting a leukemia.  Treatment for the event included ice on the area 3 times a day, 15 minutes at a time.  Action taken with mRNA-1273 in response to the events was not provided.  The events,  soreness, pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash, were considered recovered on an unspecified date and The outcome of  the event leukemia is unknown.  Addition information Additional information received on 01 Mar 2021 included outcome of the events , pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash and reported patient was suspecting leukemia.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
"This patient seen by facility on 1/13/21 after reaction to her first dose was told that she needed PEG/polysorbate skin testing prior to her second dose.  For unknown reason the patient arrived to vaccine clinic on 2/9/21 without allergy skin testing or follow up. She reportedly told them that she was ""cleared by Occ health"" after her first reaction and the administering RN said that there was no flag on her chart so she was given the vaccine.  Unfortunately, immediately after she got it, she developed throat tightening and got zyrtec. The reaction progressed very quickly (minutes) to diaphoresis, panic, grabbing at throat saying she was suffocating, nausea, and difficulty verbalizing. She was diffusely red but no hives. They couldn't get a BP and O2 sat and temp were normal but they put her on a non-rebreather and gave her Epi. Rapid response was called and she was taken to the ED.
patient admitted through the ED with general fatigue , extreme weakness n/v and synocal epidsode
Within 5 minutes of vaccination, patient developed throat tightness.  Patients vital signs and symptoms monitored, diphenhydramine 25mg po x 1, diphenydramine 37.5mg IM  x1  and subsequently Epi-pen was administered (no progression of symptoms but incomplete resolution of throat discomfort led to decision to administer Epi. ) Monitored x 5 hours total in office;patient discharged home stable with epi-pen and plan of care.
Mild affects began 1st night with cold sweats, wild dreams, waking up gasping for air.  Very tired the next day, just felt lousy.  2nd night was same, not feeling great the next day either.  Really hoping to feel better tomorrow, and get a normal nights rest tonight.
On the day after I got my vaccination, I experienced low levels of tenderness on the injection site. On the next day, I had low grade fever, more intense pain on the injection site, severe headache, body malaise. On the 3rd day, I noticed a lump under my left armpit about the size of half of a tennis ball (as of this writing).
Patient developed ocular migraine 8 days post second vaccine.  Seen in pediatrician's office on 12/09/21; recommended Motrin and neuro referral.
Around 3:45pm, patient was given the pediatric Engerix-B dose (10 mcg) instead of the adult Engerix-B dose (20mcg). When the error was discovered around 4pm, patient was called and informed of the error, and she came back around 4:15pm and received the correct adult Engerix-B dose.
Arm and shoulder pain in left arm. Difficulty lifting arm, aching in shoulder and arm. No treatment but it's been going on for 3 weeks since the vaccine.  Today it seemed a lot better but this is 25 days later. Definitely still some achiness there though so the outcome is unknown.  My concern is if the vaccine went into the muscle and was it effective?  I am supposed to get my second dose later this week and I want to make sure the first dose was injected properly and effectively.  I can live with the pain although it is frustrating.  I just want to be sure I'm protected with the first dose and am ok to move on to second dose. Hoping someone can help me with this.
pt recvd vax & had red raised rash all over body; questionable rxn to VAx; seen in er; tx w/ epi, DPH, pred;
Information has been received from a medical assistant concerning a 69 year old female with hypertension and increased high density lipoprotein and drug hypersensitivity to lisinopril (ZESTRIL) and valdecoxib (BEXTRA) who on 13-DEC-2007 was vaccinated with ZOSTAVAX 0.65mL SQ (Lot #658396/0967U).  Concomitant therapy included atenolol, hydrochlorothiazide, losartan potassium (MSD) and lovastatin (MSD).  On 14-DEC-2007 the patient developed a warm and itchy rash at the injection site.  The patient sought medical attention and contacted the physician's office.  The medical assistant reported the "rash started out small and progressed to the size of a golf ball."  The patient's warm and itchy rash at the injection site persisted.  Additional information received from the physician confirmed that the patient developed redness and itching to the right triceps area after receiving ZOSTAVAX on 13-DEC-2007.  The physician advised the patient to treat the symptoms with diphenhydramine (BENADRYL) PRN.  The symptoms persisted for two weeks.  Subsequently, the patient recovered from the redness and itching to right triceps area.  Additional information is not expected.