chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient broke right arm between elbow and wrist; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of UPPER LIMB FRACTURE (patient broke right arm between elbow and wrist) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced UPPER LIMB FRACTURE (patient broke right arm between elbow and wrist) (seriousness criterion medically significant). In 2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, UPPER LIMB FRACTURE (patient broke right arm between elbow and wrist) was resolving. Not Provided          No concomitant medication was provided. Treatment medication was not provided by the reporter.  The patient had broke her right arm between elbow and wrist. They did surgery after setting two bones that broke. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  the reporter's causality for Humira for the event(s) of patient broke right arm between elbow and wrist and flu symptoms after second covid19 vaccine with humira(adalimumab) was no reasonable possibility.  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  Company Comment: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Upper limb fracture (patient broke right arm between elbow and wrist), after receiving the second dose of mRNA-1273 vaccine. The patient underwent surgery. Exact onset date of the event, clinical course and diagnostic tests were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-622861 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Upper limb fracture (patient broke right arm between elbow and wrist), after receiving the second dose of mRNA-1273 vaccine. The patient underwent surgery. Exact onset date of the event, clinical course and diagnostic tests were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 27-Apr-2022); Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 27-Apr-2022)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 27-Apr-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 27-Apr-2022)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vaccine provider removed the vaccine from the fridge, thawed it if needed and administered it on the same day of removal. The expired vaccine was kept it in the fridge and only removed to administer the patients.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-569375 (Patient Link).
rt arm began swelling w/some redness progressively worsened to large red area on rt arm;warm to touch;skin tight;has not changed in the last 12hr;child says it doesn't hurt;no rash elsewhere on body;child has not had fever or illness;
SEVERE JOINT PAIN, HEADACHE, NUMBNESS TINGLING IN LEFT ARM THRU HAND,FATIGUE  LASTED THRU 72 HOURS, BUT STILL FATIGUED
vial was in the refrigerator for 33 days; we gave 3 doses from a vial that was in the refrigerator for 33 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (vial was in the refrigerator for 33 days) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was in the refrigerator for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (vial was in the refrigerator for 33 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions No treatment information was provided by the reporter.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted shortly after receiving Pfizer booster today. She was alert after 1-2 minutes. Her mother was with her and stated she faints after every immunization she receives due to needle phobia. Patient stayed longer than 15 mins and was fine. She was advised to drink lots of water today and to take it easy
This patient first received the Pfizer COVID vaccination in April of 2021. In May of 2021, he developed a scaly rash on the elbows that was diagnosed by his PCP as psoriasis. He was unable to achieve clearance of his psoriasis with topical steroids alone, and had to be put on IV steroids for worsening symptoms such as swelling in the lips and tightness in the throat. He then saw our office for discussion and management of psoriasis, which  we explained to him that psoriasis is an autoimmune condition that can flare with various stressors or infections, and that it is not certain whether a COVID infection or the COVID vaccine could have induced a dermal autoimmune hypersensitivity response, however, it is possible that the COVID vaccine could have induced this autoimmune response. He was started on narrow band UVB light therapy for treatment and he has a history of immunosuppressive drug use for psoriasis management with CellCept.
On 06/15/99 pt had a fever which was not unusual after receiving his vaccinations. I cannot say an exact date we noticed pt changing. It was so very gradual. Pt was diagnosed with pervasive developmental disorder in February of 2000. follow up information received 10/16/02 stated, " (the child) will not be recovering from autism"
Left Arm/Shoulder/Bicep/Tricep/Front and Rear Delt, Neck and Trap no mobility without severe pain. Went to Doctor 3/29/18 very concerned deep down in pain. Gave Steroids and MRI. Joint pain is very deep.
Pt to ED 10/16 for weakness, rigors. Pt lethargic, difficulty keeping eyes open while talking. Lungs sound coarse throughout. Pt COVID+ 10/16. 10/17 Patient is lethargic, VSS and no S/S of acute distress noted at this time, denies SOB/chest pain. Congested cough noted with thick, yellow sputum. Upper/lower coarse crackles noted. 10/18 Patient received alert and oriented x4, currently on oxygen via NC, no distress noted. 10/20 pt discharged.
Right arm discomfort at muscle / injection site within 12 hours. Within 18 hours joint discomfort throughout body. Discomfort level on scale of 3 out of 10 (10 being SEVERE). Discomfort disappeared within 36 -48 hours.
Reports rash at injection site, itching, and nausea.  Instructed to follow- up with PCP or go to ED if symptoms worsened. Patient states she's ok, just has some itching.
In March of 2023, I saw the doctor for an ear infection and a white dot on my tongue. The following week I saw my primary doctor for my ear infection. On March 29, 2023, I started to get diarrhea, a cough and my head hurt. I tested positive for COVID-19 and called the doctor. I was prescribed PAXLOVID and began taking it on the same day. I felt miserable for several days. I was very tired and not hungry. I was very thirsty. I had a bit of hallucinations. I had horrible dreams.
Rash on the left upper arm 2cm/3cm red rash round noted left upper arm tender to touch.
temperature excursion; No other AE; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # U015845, expiration date 19-MAY-2023, 1 time dose (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 17 degree Fahrenheit (°F) for 30 minutes. There was no previous temperature excursion reported.
Right Arm Pain at Injection site; whole body was pulsating; chest was super tight/chest tighten/chest tightness; lack of hunger; sinking feeling; heart speed up /heart is trying to pump really hard; like the feeling of the fear response feeling; chest pain on the left side of his chest and it radiated down his arm; stinging feeling of his stomach/was kind of painful/weird stinging feeling in the middle of his stomach,; chest was tight; This is a spontaneous report from a contactable consumer (patient).   A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485, administered in Arm right on 27Jul2021 (at the age of 24-year-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. After first dose of vaccine patient experienced, chest pain on the left side of his chest and it radiated down his arm, stinging feeling of his stomach/was kind of painful/weird stinging feeling in the middle of his stomach, chest was tight, whole body was pulsating, chest was super tight/chest tighten/chest tightness, lack of hunger, sinking feeling, heart speed up /heart is trying to pump really hard, like the feeling of the fear response feeling. On 29Jul2021, patient experienced Right Arm Pain at Injection site. Treatment received for the event. The treatment was not reported for event like the feeling of the fear response feeling and others events the patient was received the treatment. On an unspecified date in 2021, lab data included, heart speed up /heart is trying to pump really hard. The Outcome of all events was not resolved.  Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 05-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012659 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
No additional AE or PQC reported; HCP reported VARIVAX was administered after the expiry date.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 20-MAR-2023, the patient was administered with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), dose of 0.5 mL, lot number: U008180, expiration date: 12-MAR-2023 (dose number, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The reporter confirmed that the varicella virus vaccine live (Oka/Merck) (VARIVAX) did not have a history of temperature excursions. No additional adverse event (AE) or product quality complaint (PQC) was reported (no adverse event).
I had the Moderna vaccine at 7 p.m. on January 7th 2021. I awoke at 3 am with a severe headache which lasted the entire day. In addition I woke at about 10 in the morning with extreme ringing in my ears that has not stopped as of today January 11th 2021. Symptoms include constant ringing  day and night, a feeling of fullness in ears ,throbbing in ears and some mild pain.
I was in perfect health prior to injections.   10/1/2021 - Drove to another state for 1st injection.  My dog was sitting in my lap the entire way.  Upon return, she would not lay in my lap and continues to not lay in my lap in the car or at home.   Same day about 3-4 hours later,  numbness in R hand and B LE leg feeling of  ?shaking? but not visibly.  Sudden increase swelling of R hand middle finger at metacarpals w/ pain at joint.  Continue to have pain and swelling in R middle finger with pain.  No pain or swelling prior to injection.  B LE ?shaking? continued into the night and continues to happen when sleeping and wakes me up w/ R>L in ?shaking?.  The shaking almost feels electrical w/ feet feeling like they?re hot.  I feel more sensitive to hot water of feet and hands than before injections, again R>L in sensitivity, and ?shaking? feeling.  Sleeping has been more difficult than before injections.     3/1/2021  Pain at the injection site, heavy arm feeling, and dizziness for 20-30 minutes.   Immediate numbness in R hand after, and 20 min later, R forefoot and toes had numbness.   1 hour later, B LE feeling of ?shaking? increased and L foot numbness.   By evening, B LE ?shaking? feels increased than before w/  difficulty falling asleep and wakes me up w/ R>L in ?shaking?.  Still the shaking almost feels electrical w/ feet feeling like they?re hot.  I feel even more sensitive to hot water of feet and hands than before injections, again R>L in sensitivity, and ?shaking? feeling.  Sleeping has been more difficult than before injections.     3/7/21 -  L sided chest pain (at heart) and tightness that lasted approximately 1 hour.  No medical treatment sought.  Rested and went away.
This spontaneous report was received from a physician referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates between 31-MAY-2017 and 21-JUN-2017, these patients were administered improperly stored PEDVAXHIB (lot# L035878 with expiration date 11-AUG-2018, lot# L004738 with expiration date 10-NOV-2017, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 34 Fahrenheit (F) for 90 minutes and 49 Fahrenheit (F) for 30 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005365: US-009507513-1708USA010784.
Abdominal pain; Feeling sore; Vomited three time Thursday and Friday; A Spontaneous case was received from consumer , concerning a male patient  of age 30, who received Moderna's COVID-19 vaccine experienced Myalgia/ Feeling sore, Vomiting/ Vomited three time Thursday and Friday , Abdominal pain.  The patient's medical history was not provided. The Patient's concomitant medications was not provided.  On  17Feb2021 , prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number : unknown) via unspecified route for COVID-19 infection prophylaxis.  On 18Feb2021, the patient woke up feeling sore, he vomited three times on Thursday, and Friday, he is complaining of abdominal pain.  The action taken in response to the events, Myalgia, Vomiting, Abdominal pain was unknown.  The outcome of the events, Myalgia, Vomiting, Abdominal pain was considered to be unknown.  The treatment medications reported to be taken by the patient were not provided.
mom reports 11MAY96 pt c/o soreness & itchiness on lt thigh;observed red area, raised, about mosquito bite size;12MAY96 pt c/o itchiness site was golf ball size, red & raised;13MAY96 mom noted no c/o soreness or itchiness
This spontaneous report was received from a medical assistant/office manager regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # R013572 and expiry date 21-MAR-2021) (strength, dose were not reported) and VAQTA (lot # R018935 and expiry date 05-SEP-2019) (strength, dose were not reported), both for prophylaxis. No adverse effects were reported. The reporter reported first excursion occurred on 21-DEC-2018. The product was stored at 1.6 degrees Celsius for 26 minutes and previous excursion was reported as 1.1 degrees Celsius for 1 hour 35 minutes. This case was due to digital data logger. No product quality complaint was filed. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1902USA003534: US-009507513-1902USA004942.
My daughter received the second dose of the Pfizer vaccine for COVID-19 on 6/9/2022. On 7/20/2022, she was exposed to COVID-19. The entire family got sick, though she didn't really display many symptoms. One day over the weekend of 7/23/2022-7/24/2022, she took a long nap, and that was probably the only sign that something was different. She took a home antigen test, and the result was positive. She never needed medicine, though, and she was isolated for about a week. After that, everything was fine.
Patient has redness at injection site; looks almost like an insect bite; no muscle pain or soreness
extreme soreness of injection site, followed by body aches, fever, and fatigue lasting until 3 days later
12/06/2006 Complain of right arm starting 3 hours after receiving flu vaccine on 11/30/06. Positive pain with movement of arm, occasional pain to shoulder and arm. Took Tylenol and Advil with improvement. 12/7/06 pain decrease, now only at  injection site denies redness/swelling advised to call PCP.
1st had jaw pain, eye pain that progressed to nose/throat pain. Eye began to droop, notched pupil on affected side much smaller than other side. Saw MD which started Amoxicillin ant Valacyclovir 1mg TID. Symptoms have not worsened but not lessened- Remain the same.
This is report # 3 of 3, one for each Gardisil administered.  Mother stated to me on 05/18/07, that 24 hours after Gardisil vaccines, patient had fever, and then developed flu-like symptoms.  Mother feels that after Gardisil administration, patient seemed much more susceptible to flu-like illness and various infections, e.g. sinusitis.
Pain at site of injection - dull, annoying pain - persisted for 3 days. Pain with range of motion that patient describes as sharp stabbing pain. Started approx 2 weeks ago.
Right away, arm was a little puffy, and had red circle around it. By 1am bones were aching bad. Patient felt like she was going to throw up and stomach was crampy.  Patient reports problems breathing, left breast hurt really bad, and the entire left side hurt. Patient called doctor at 3am and told to take a Benadryl. Patient just rested and aching would come and go. In the morning, patient woke up and had diarrhea and then 2 hours later vomited. Patient reports having diarrhea since.  Patient called doctor again and  took Imodium, take Benadryl as needed and stay on a bread diet.  Patient told to call back on Tuesday if not feeling better and continue to drink plenty of fluids.
arm swelled up and very sore. Still sore. Saturday night got flu like symptoms: chills, fever, sweats, aches. Same Sunday night. Felt like hit by a truck Sunday day. Tired, weak, sore, fatigued. Same as Monday day. Felt little better Monday Night
Pt reports that immediately after receiving the flu vaccine she began coughing and having difficulty breathing. She returned to the ED where the vaccine had been administered to receive treatment.
Patient had significant bruising on arm in area of vaccine administration. It was her right arm, which is the one her flu shot was given in.
Patient received both doses of the Pfizer COVID-19 vaccine. On 6/24/21 the patient developed symptoms consistent with COVID-19. Per Hospital policy the patient, who is an employee was tested on 6/25/21 and the test was positive. The patient was tested for COVID-19 via a PCR test. The patient was considered fully vaccinated at the time of the positive test and is a breakthrough case.
This spontaneous report was received from Registered Nurse regarding to multiple unspecified patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date multiple unspecified patients received improperly stored (Merck) VARIVAX (lot # L005300, expiry date 17-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccines were subjected to temperature excursion of 9.3 degree C for a time frame of 8 hours and 2 minutes. It was reported there were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.