chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.; No adverse event; Expired vaccine administered to patients; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.).    Total 7 doses were given 1 vial. The reporter did not knowhow vial was stored but stated that vaccines are usually put in refrigerator a week before administration. The vial did not undergo any temperature excursions. Patient was given 1st booster dose. No concomitant medications were reported. No treatment  medications were reported.
Maculopapular rash on chest, back, and left arm, non-itchy, started 2 days after vaccination
When I recieved the injection, my arm burned and ached at the injection site immediately after the shot. By the time I got to the car, my top lip was tingling, then numb. Seconds later, I could taste a medicinal taste on my tongue that lasted about a minute.  About a minute after that sensation, I had more burning across my face, around behind my ears and what seemed to be burning in my brain;  sure felt a deep hard tingling burn.  In about 45 seconds the sensation was over and I was left with a temporary head ache; as far as I know nothing else has happened.
This patient received a Pfizer booster that had a higher dose administered due to only 1.3 mL of NaCl mixed instead of 1.8 mL. Per reference, no dose is needed to be repeated, just an increase in side effects locally and systemically with a sore arm. Patient has already been notified and is aware.
Child was given a 2nd dose of FluMist, and only should had received 1 dose due to age. Child is 10 years of age. No treatment. Per mother, no signs or symptoms noted after adverse event. Adverse event was reported to staff.
2nd shot (first shot was fine) :Round lesion about 4 inches in diameter around injection site.  Area was swollen and hot to the touch . It was also very sore and itchy.  This did not happen with the first shot. About 12 hours after 2nd shot, I woke up with chills and body aches. Neck and shoulders were so painful. Headache  was a 7 out of 10 on pain level. Felt like I had a fever and had the flu. Took 4 Advil. Helped with aches and pains. Also kept hydrated with Pedialyte.  Slept on and off for 24 hrs. Woke up  on the third day and felt much better. All aches and pains were gone with the exception of the round lesion on arm. Also was still a bit tired. Overall main flu like symptoms only lasted a full day. Covid arm is still sticking around as of day 4. But it?s not as red and swelling has gone down.
Immediately after injection, the injection site started profusely bleeding. The area of the injection immediately swelled and became hard and turned a purplish color. The patient said they were not experiencing pain. It is assumed that a vein was hit when injecting the vaccine.
Started with a light headache , Left are sore and tired and swallon glands in jaw line. As the day progressed, symptoms worsen. By evening, started to run low fever with chills, aching all over and extremely tired. I could hardly stay awake.  I felt so bad with the chills and aching I went to bed early after taking 2 extra strenght Tylenol. I woke up crying around 2:00 am hurting so bad, I felt like someone beat me with a 2x4 board, so I took a Percocet 325 and went back to bed. When I woke up I had chills, severe pain all over, very weak and could hardly move my left arm which was red and swallon.  Then my skin was burning and itching in different places. I laid in my recliner and couldn't stay awake. Slept most of the day.  Fever stayed under 101 and finally stopped by Sunday morning, weakness stayed till Monday morning. Swallon glands in jaw line got better each day afterwards.
PT GOT VACCINATED ON 5/28/2018 AND CAME ON 5/30/2018 AND HER BOTH HANDS ARE SWOLLEN AND REDNESS, WE RECOMMENDED HER TO GO TO DR AND SHE CAME WITH RX FOR ANTIBIOTICS AND STEROIDS.
This spontaneous report as received from a registered nurse refers to unspecified number of patients (age and gender unknown). He reported that GARDASIL (dose, route, indication unknown) injection 120 Y which was exposed to 22F for 3 months might have been administered to an unspecified number of patients during that period in time. No adverse effects reported. Additional information has been requested.
After the MMR Shot, the pt quit communicating and regressed into autism.The 60 day follow-up report states autism. Per annual follow-up: "We believe vaccinations have contributed to his autism in conjuction to his weak immune system".
Fever, fatique, muscle aches, headache, abdominal pain. Was treated with Tylenol and resolved.
Patient was admitted to facility May 7 2021 with hemolytic anemia.  Recent surgery for lung cancer but had not started adjuvant chemotherapy.  No antecedent hematologist or autoimmune problems.  Had Moderna Covid vaccine at facility 02/24/2021.  I am inclined to think we need to report to FDA.  Please advise.
arm hurt a lot for three days, it bothered him when trying to lift it and he had to shower with only one hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a lot for three days, it bothered him when trying to lift it and he had to shower with only one hand) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a lot for three days, it bothered him when trying to lift it and he had to shower with only one hand). At the time of the report, PAIN IN EXTREMITY (arm hurt a lot for three days, it bothered him when trying to lift it and he had to shower with only one hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.  Patient gave consent to safety for Follow-up.   This case was linked to US-MODERNATX, INC.-MOD-2021-067513 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067513:
fever, muscle pain extreme, chills , in bed for  33 hours. could not walk with pain, dizzy . No food only water
Janssen COVID-19 Vaccine EUA Following the shot was the expected soreness. Then pain throughout my arms like pins and needles  began about 8 hours later. I self treated with Tylenol. After going to bed, I woke at 5am nauseous and in pain. I was freezing  even though I would normally be fine. I was shaking which made the pain in all of my limbs and back hurt more. The day following the injection, the pain and nausea didn't go away. It hurt to pick up and hold things. It is now two days after injection and I keep fighting nausea after eating. I keep stretching and it barely keeps the soreness in my arm at bay. I can feel my hands starting to cramp just from typing this even though I would normally be fine.
Chills, shakes, fever, badly aching muscle and joints, headache, soreness at injection site, raised BP and HR, 12 hour duration of symptoms
It started with sore arms and chest pains on my left side, and I went to my doctor because I had shortness of breath and chest pain, Swollen lymph nodes of the left. Friday it got worst, all on my left breast area, got lab work done.  Last week it came back really bad on Wednesday, Went to ER, chest tight and pain -sharp pain, tightening in chest.  Did labs and test acute carditis and was given meds. Sunday went back in ER tingling and numbness on right foot. Carditis was the same but had confirmed that it was a reaction to the med that was given. I was advised to stop taking these meds.  These were Colchicine, Indomethacin, Pantoprazole.  Still having chest pains and hard to breath with inflammation of the heart.  ER visit was twice.
On January 28, 2014, patient informed me that he developed redness, swelling and a pus filled boil at injection site approximately a week after his influenza vaccine on November 1,2013.
Patient described having an extremely sore arm. The soreness is still present as of 6/25/18.  Unknown treatment, if any.
pain at injection site that has lasted 19 days. Fatigue, elevated CRP and Sed rate. Increased resting heart rate, headaches.
Donor has approx 4 inch bruise and small decubitus ulcer at injection site.
Case number PHEH2015US021097, is an initial spontaneous report received from a healthcare professional  on 19 Oct 2015. This report refers to an 11 years old male patient. Medical history and concomitant medication were reported as unknown. The patient was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly at a dose of 0.5 ml on 16 Oct 2015. It was reported that the patient was under the age of 18 years and received the vaccine inadvertently. No adverse event was reported following this medication error.
a little bit cough now; lump under the armpit and it hurts; it hurts; Swollen Lymph node between the armpit and breast; chills; The anatomical location where she got the vaccine, its sore there too on the arm; Fever; feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: 30135BA) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Diabetes Type 2" (unspecified if ongoing); "sinus" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY taken for hypersensitivity; DAYQUIL taken for sinus disorder. Vaccination history included: Bnt162b2 (Dose Number :1, Batch/lot No: EL9269, Location of injection: Arm left), administration date: 03Feb2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Dose Number :2, Batch/lot No: EN6202, Location of injection: Arm left), administration date: 26Feb2021, when the patient was 50 years old, for Covid-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Nov2021, outcome "not recovered", described as "The anatomical location where she got the vaccine, its sore there too on the arm"; PYREXIA (non-serious) with onset 13Nov2021, outcome "recovered" (14Nov2021), described as "Fever"; LYMPHADENOPATHY (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Swollen Lymph node between the armpit and breast"; CHILLS (non-serious) with onset 13Nov2021, outcome "recovered" (13Nov2021), described as "chills"; AXILLARY MASS (non-serious) with onset 15Nov2021, outcome "unknown", described as "lump under the armpit and it hurts"; PAIN (non-serious) with onset 15Nov2021, outcome "unknown", described as "it hurts"; MALAISE (non-serious) with onset 13Nov2021, outcome "unknown", described as "feeling sick"; COUGH (non-serious), outcome "unknown", described as "a little bit cough now".  Additional information: The chills stopped on the 13Nov2021, when she got under the heating blanket. She got over heated and then got off, that was her body telling her that she is warm. Expiry Date of Covid Vaccine: Unknown. Reporter states that she is a caregiver, and takes care of a disabled person. Reporter stated that she was feeling sick for 2 days, on the 13Nov2021 and 14Nov2021. If she touches where she got the vaccination, its still sore.  Follow-Up (22Nov2021): Follow-up attempts are completed. No further information is expected.
During a community vaccine clinic,  a Registered Nurse forgot to add diluent prior to administering the vaccine in the patient's right arm.
Within 2 weeks of second dose of Pfizer COVID-19 vaccine (dose 1 date: 05/28/2021; dose 2 date: 6/18/2021; dose 1 lot: EW0179; dose 2 lot: EW0177) the patient first experienced symptoms of Amyotrophic Lateral Sclerosis (ALS), a diagnosis which was confirmed 12/2021.  Prior to the administration of the second dose of the COVID vaccine, the patient had experienced no symptoms of ALS. The patient passed away 08/25/2022.  The patient first began experiencing instability and need to walk slowly by the end of 06/2021, on or around 06/30/2021. The patient began having difficulty with walking and moving the right foot, or foot drop. By early 07/2021, the patient felt unbalanced when trying to walk with the right leg's quickly becoming unresponsive and the right foot's dragging. The patient's first fall occurred the first week of 08/2021; a second fall occurred the first week of 09/2021. The patient began using a cane soon after; on 11/18/2021 the patient needed to use a walker. Positive diagnosis of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease, occurred 12/16/2021. The patient's condition rapidly worsened, and the patient passed away 08/25/2022.
Seen in am for Health Assessment - given DPT - IPV and PCV 13 - within - 12 hrs - while sound asleep - repetitive jerking of left leg > right - seen in ER - normal exam  - no sequelae - fine within 24 hrs.
Fully vaccinated, asymptomatic COVID breakthrough infection upon admit for delivery.   Full term baby with no complications delievered.    Requires interpreter, Male- born Vaginal, Spontaneous delivery on 1/8/2022 at 10:55 AM  Gestational Age: 41w0d  Apgars:  8  , 9   Birth Weight (GM): 3.81 kg (8 lb 6.4 oz)
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 13-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient fainted and appeared to have a seizure - lost bladder control and seemed to be convulsing on the floor.  Her mother said she was just shaking because she was so scared of needles, and that she didn't have a seizure.  She was pale and lethargic for about 10 minutes, then vomited.  She drank water and rested about 30 minutes, then said she felt better (and looked better) and left with her family.  Her mother didn't want me to call 911 for an ambulance.
chest pain; diagnosed with myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and MYOCARDITIS (diagnosed with myocarditis) in a 31-year-old male 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, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization) and MYOCARDITIS (diagnosed with myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to CHEST PAIN and MYOCARDITIS. At the time of the report, CHEST PAIN (chest pain) and MYOCARDITIS (diagnosed with myocarditis) outcome was unknown.            No concomitant medication details was reported.  No treatment medication details was reported.  For mRNA-1273 (COVID 19 Vaccine) (unknown route), the reporter did not provide any causality assessments.   On an unknown date the patient was diagnosed with myocarditis 3-4 days after getting the second dose of the Moderna vaccine and was hospitalized for 2 days.  Company comment:  This case concerns a 31-year-old male patient with no previous medical history, who experienced the unexpected serious event of Chest pain and the serious expected event of Myocarditis (AESI). The events reportedly, occurred 3-4 days after the patient received the second dose of the mRNA-1273 vaccine. The exact dates of vaccination and the start dates of the events were not provided. The patient was hospitalized. The outcome of the reported events remained unknown at the time of this report and no further information regarding the clinical course of the events was provided. The reported event of Chest pain could have been occurred in the setting of Myocarditis. The re-challenge is not applicable having in mind that the events developed after the second dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 31-year-old male patient with no previous medical history, who experienced the unexpected serious event of Chest pain and the serious expected event of Myocarditis (AESI). The events reportedly, occurred 3-4 days after the patient received the second dose of the mRNA-1273 vaccine. The exact dates of vaccination and the start dates of the events were not provided. The patient was hospitalized. The outcome of the reported events remained unknown at the time of this report and no further information regarding the clinical course of the events was provided. The reported event of Chest pain could have been occurred in the setting of Myocarditis. The re-challenge is not applicable having in mind that the events developed after the second dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
the symptoms continued so I took an at-home COVID (antigen) test which revealed a positive result.; the symptoms continued so I took an at-home COVID (antigen) test which revealed a positive result.; cough; sore throat; body aches; nasal congestion; fatigue; low grade fever (99.5 F at its highest); This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 at 08:00 as dose 1, single (Lot number: EL9266), in right arm, on 14Mar2021 at 08:00 as dose 2, single (Lot number: EN6206), in right arm, on 30Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FF2593), in right arm and on 02Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Mellitus Type 2" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Stroke", start date: 2017 (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "macular edema" (unspecified if ongoing); "cataracts" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; FARXIGA; JANUVIA; TOUJEO; AMLODIPINE. The following information was reported: PAIN (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered", described as "body aches"; COUGH (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered"; FATIGUE (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered"; PYREXIA (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered", described as "low grade fever (99.5 F at its highest)"; NASAL CONGESTION (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered", described as "sore throat"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Jun2022, outcome "unknown" and all described as "the symptoms continued so I took an at-home COVID (antigen) test which revealed a positive result.". The patient underwent the following laboratory tests and procedures: Body temperature: (06Jun2022) 99.5 Fahrenheit, notes: low grade at its highest; SARS-CoV-2 test: (07Jun2022) Positive, notes: Nasal Swab; (unspecified date) Negative. Therapeutic measures were taken as a result of cough, oropharyngeal pain, pain, nasal congestion, fatigue, pyrexia.  Clinical course: No other vaccine in four weeks, No covid prior vaccination, tested positive post vaccination. I took Advil and guaifenesin/dextromethorphan to treat the symptoms.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and suspected Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
This spontaneous report as received from a consumer of 64 year old with penicillin allergy, autoimmune disease unspecified concerning herself. On an unknown date in 1995, patient had shingles and the pain lasted for one month. On an unknown date patient developed allergic reaction to penicillin (unspecified) (dosage/ frequency/ manufacturer unknown. On 21-FEB-2014 the patient was vaccinated with ZOSTAVAX vial injection, (strength, dose unit, route, and lot # and expiry date unknown). Concomitant therapies included prednisone (manufacturer unknown) and diltiazem hydrochloride (manufacturer unknown). On 28-FEB-2014, patient experienced rash, pain and watering of the left eye, stiffness and phantom itching. Patient visited doctor for medical attention and no treatment was provided. On an unknown date, unspecified blood work was performed and result was unknown. The outcome of rash, pain and watering of the left eye, stiffness and phantom itching was reported as not recovered/not resolved. No further AE information was provided. Additional information has been requested.
Patient came to pharmacy with red patches that were swollen and irritated on upper left deltoid and wrapping around arm.