chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1-10-09 11am stiff neck, tight jaw muscles. 13:30 Left arm bottom itched, 1"x4" hard lump w. red edges sprayed w/ bactine and took anti-histimine. 16:30 lump now 2"x6". 22:30 lump 3"x7" and shoulder joints very sore. 1-11-09 9:30 lump is all pink now 5"x9" and sore. 101 Fever. took Tylonol and anti-histimine. 13:30 102 fever. muscles, joints, bones, fingers, legs, hips, groin glandsextremely sore (much worse than the flu) more tylenol. 17:00 Pain worse, fever 101 and lump 5"x10". 1-12 8:30 fever 101. pain less but extremities and hips & shoulders still bad.  Edge of lup not as distinct but larger area of original lump yellowish and the other site 1.5"  sore red lump. 1-13 pain less. Fever 99.5 left side of neck and head painful, large lump not as obvious but more yellow. Other lump still red 1.5"
Usual symptoms on day 2 sore arm, achy joints. Day 5 sore throat, achy joints and fatigue. Day 6 extreme dizziness/vertigo, nausea, diarrhea, chills, achy joints and fatigue.
3RD DOSE COVID VACCINE, PFIZER, GIVEN 1/13/22, #FJ1614; pt had a positive COVID test at home on 9/29/22; family found pt unresponsive on 9/30/22 and called EMS; EMS confirmed asystole; pt passed away in his home
Sore arm where injection was given, limited range of motion, shooting pain, unable to sleep on left arm.
6 pm c/o sore throat, then something stuck in throat. At 11 pm wheezing noted-Mom administered her own Rx Albuterol 2 puffs to patient with subsequent relief of Sx. No return of wheezing.
10 days post injection, 3/4 inch by 1/2 inch bullae formed at injection site with surrounding erythema.
Malaise beginning ~10 hours after injection. Finally able to sleep at 8:00 next morning. Woke at 11:00 disoriented, blurred vision. EMT took me to stroke center. They determined probably not a stroke, sent me to the Hospital (cardiac) area. I was told the MRI there showed no evidence of stroke. I do not know the results of the other scans/tests. Felt better after 24 hours. Mostly recovered after 72 hours. Now (28 days later), have some residual problems with right eye, become out of breath after moderate exertion (%SpO2 95 or above). Health Department administers vaccinations at a local convention center but has no permanent offices/staff there.
I received my COVID19 vaccines on 12/31/2020 and 1/21/2021. On 2/3/2021 I woke up with pain, swelling, redness, and decreased range of motion in my R elbow at the site where I had hardware (wires, pins, tension band) placed during a surgical repair of my olecranon process in 2013. I have never had any issues with this elbow since the surgery, and no illnesses/dental work/medication changes in the months before this. The only change was getting my COVID vaccine. I went to see my PCP Dr. who advised me to go to the ER due to fear of a potential infection based on these symptoms. I went to the ER and after extensive testing they ruled out this being an infectious cause, though I was put on PO doxycycline as a precaution. An orthopedic specialist came to see me and determined that my body is essentially rejecting the hardware and I need to have surgery to have it removed. Since then, the swelling has decreased, however I still have persistent pain in my elbow along the site where the hardware is inserted and limited mobility due to pain with certain movements that put tension on this joint. I will need to have surgery eventually to have the hardware removed but am hoping to wait a couple months so that I can complete nursing school. I was advised to report any potential side effects from this vaccine and am choosing to do so as I do not know of any other reason this could be happening.
A month or two later I started to become itchy, mainly in the vaginal area.  After seeing my gynecologist who could find no reason (infection or otherwise) as to why I was itchy, he sent me to a dermatologist who then sent me to an allergist.  No doctor could find a reason for the itching or why it was worse some times than others.  Two years later I determined that the itching got worse with the more gluten I ate.  I have never had an issue with gluten (no sensitivity at all) or any other food in my life.  Ever since I got my first Johnson & Johnson Covid vaccine, this issue started shortly after with no other changes in my life to potentially cause it.
Three days, post vax, extreme pain and weakness in bother lower legs and forearms. The fatigue and weakness has improved somewhat over the past year, but still unable to do physical activities that she did before (like climbing, skiing and workouts). Has been to chiropractor,rolfar, acupuncturist, alternative medicine and now seeing a regular MD and receiving Elavil-chronic pain switching to Prozac. Has been in the military. Dx: peripheral neuropathy.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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 aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No relevant concomitant medications were reported. Vaccine was moved from freezer to refrigerator on 12/02/22. Of the ten vials in question 43 injections were given and 7 doses were wasted. No treatment medication reported.  This case contains information for the 7th of 43 adult patients described by the reporter.; Sender's Comments:  master case
all the symptoms associated with the flu; 99.6 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (all the symptoms associated with the flu) and PYREXIA (99.6 degree fever) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INFLUENZA (all the symptoms associated with the flu) and PYREXIA (99.6 degree fever). At the time of the report, INFLUENZA (all the symptoms associated with the flu) and PYREXIA (99.6 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 99.6 degree (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient felt pretty bad. Concomitant medications were not provided. Treatment information was not reported.; 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.
We received the following literature report on 15 JUN 2009. 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1709 and MA2009-1712 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?).  Request was sent on 22 JUN 2009, no follow-up information received.
Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: Patient got nauseous and sweaty while in post vaccination area.  I had him lay down and put his feet up for about 15 minutes.  After a few minutes of laying down he drank some orange juice he had with him.  Felt better/back to normal after.
Fever Dose 1: day 2/3 c/o of mild pain/soreness at injection site, fevers 2nd day post vacc. Narrative:  Dose 1: Day 2/3 c/o of mild pain/soreness at injection site, fevers 2nd day post vacc.
Nausea, brain fog, headache, lethargy, chills, fever, weakness, local inflammation, pain
Seizures, Slurred speech, Dizziness, muffled hearing, blurred vision, involuntary joint movement, easily frustrated, muscle spasms, taste and memory disturbances, loss of sleep, extreme stress and anxiety related to symptoms and treatments.  7/23/09 Consultant records received DOS 7/31/07 to 7/13/09. Assessment: Partial seizure emanating from the left hemisphere. Patient "felt like something would happen" Then unable to speak appropriately, jumbled words, could not speak properly. Right arm made involuntary movements, felt like she was out of her body. Make loud noises. Hearing felt muffled. Felt on edge and not as sharp for 24 hours. Slightly mumbles, tired at times. Recurrent episode. Blotches in vision, headache. Agitated, irritability - Keppra.  ICD-9 Code: 345.11, 780.39, 784.0   7/28/09 Medical records received DOS 5/30/07 to 1/29/09. Patient requests Gardasil vaccine. 1st dose of Gardasil given. Oral contraceptive changed from Desogen to Seasonique. Has had two seizures, on Keppra. 2nd, 3rd doses of Gardasil given.  Denies any side effects from this medication (Gardasil).
12 hrs post injection: stiff shoulders/neck/arm (at injection site) and headache  18 hrs: migraine, muscle pain, chills 24-36 hrs: fever (100-102 Fahrenheit), migraine, muscle pain/fatigue, joint pain, increased skin sensitivity/pain to the touch, chills/sweats, shortness of breath, nausea 37-48 hrs: fever broke, continued headache/muscle pain and fatigue, exhaustion at 51 hrs: headache, muscle stiffness, pain at injection site
Patient hospitalized for Diverticulitis of intestine with abscess within 6 weeks of receiving COVID vaccination.
Shingles; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (at the age of 55-years-old), administered in Arm Right on 12Mar2021 21:00 (Lot Number: EN6207) as 1st dose, single for COVID-19 immunization. Medical history included rheumatoid arthritis from Apr2020 and ongoing, immune suppressed. The patient does take other unspecified concomitant medications. The patient experienced shingles on 21Mar2021. She received the first dose of the vaccine on 12Mar2021. The pain didn't get bad until the weekend. She is unsure if the shingles were brewing the prior week. The patient developed shingles one week after receiving the Pfizer Covid-19 vaccine. She didn't see her doctor. She showed him pictures from her phone. She went to the hospital because of the pain being so bad. The pain was really bad and she went to the emergency room on 21Mar2021. She was diagnosed with shingles while at the emergency room. They gave her medication and told her to follow up with her doctor. She had nerve pain from the left side of her back to the front. She had pain 3-4 days before she went the hospital. She was going out of her mind. Shingles are awful. She was not admitted to the hospital. Therapeutic measures were taken as a result of the event. The outcome of the event was recovering. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). She received the second dose on 03Apr2021 (Lot: EP7533) in her right arm.
S/p vaccination c/o feeling dizzy w/associated nausea; reports did not eat breakfast this am Vitals assessed/ wnl; BP 120/77 P59  O2sat 95 Rest,  po hydration tolerated w/cookies, and some juice Monitored x 30 minutes, reports "feeling better"  Released from facility to home
This spontaneous report as received from a healthcare worker refers to a 4 month old patient. On 17-SEP-2015, the 4 month old patient was vaccinated with doses of MMR II, (Merck) VARIVAX, VAQTA, poliovirus vaccine inactivated (unspecified) and DTAP. No adverse effects were reported. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of SARS-CoV-2 positive test (tested positive for COVID-19) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On 1Mar 19, 2021, patient experienced SARS-CoV-2 positive test (tested positive for COVID-19). At the time of the report, SARS-CoV-2 positive test (tested positive for COVID-19) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Violent total body shaking.  all evening.  Dr. Recommended 2 Tylenol.   Symptoms eventually subsided. Unable to sleep the rest of the evening.
Pt was given a Pfizer Bivalent dose in his left glute intramuscularly. No adverse reactions reported.
At site-rapid heart rate, slight swelling of tongue abs slight throat ?swelling? (as though mistakenly ate nuts allergy trigger foods) -brief Fri 5/218pm severe body aches throughout the night. Slight fever. Aches not highly responsive to ibuprofen. Severe body aches stopped after valerian root was used 5/22 evening. 5/22 1:28 pm left Eye swollen. Ache on skull.  Pain even when hair touched later in the day.Swelling gone following day.  5/ 24 Palpitations on left chest top. Palpitations gone by evening. 5/25 Brain fog and lethargy but no other symptoms.
This case was reported by a nurse and described the occurrence of fever in an adult female pt who received hep A vaccine inactivated (Havrix). The nurse reported that approx 15 pt, experienced fever, facial pain and fatigue following the administration of Havrix, however, pt identifiers were not provided. On an unspecified date in May 2004, the pt received a dose of Havrix in her arm (dose number not specified). Approx 48 hrs after the admin of Havrix, on an unspecified date in May04, the pt experienced fever, facial pain and fatigue. The outcome of the events is unk.
Top lip started hurting like she was hit in the mouth; Red dot on top lip; Swollen lip; Numb lip; Bruised lip; Whole body started with a itchy tingling sensation; Skin itching; Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (Top lip started hurting like she was hit in the mouth), RASH MACULAR (Red dot on top lip), LIP SWELLING (Swollen lip), HYPOAESTHESIA ORAL (Numb lip) and ORAL CONTUSION (Bruised lip) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced LIP PAIN (Top lip started hurting like she was hit in the mouth), RASH MACULAR (Red dot on top lip), LIP SWELLING (Swollen lip), HYPOAESTHESIA ORAL (Numb lip), ORAL CONTUSION (Bruised lip), PARAESTHESIA (Whole body started with a itchy tingling sensation), PRURITUS (Skin itching), PAIN (Achy) and FATIGUE (Tired). At the time of the report, LIP PAIN (Top lip started hurting like she was hit in the mouth), RASH MACULAR (Red dot on top lip), LIP SWELLING (Swollen lip), HYPOAESTHESIA ORAL (Numb lip), ORAL CONTUSION (Bruised lip), PARAESTHESIA (Whole body started with a itchy tingling sensation), PRURITUS (Skin itching), PAIN (Achy) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided
No adverse event; Patient received monovalent Moderna COVID19 vaccine as a booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID19 vaccine (1st dose Pfizer COVID19 vaccine 30Dec2020) on 30-Dec-2020, Pfizer COVID19 vaccine (2nd dose Pfizer COVID19 vaccine 20Jan 2021) on 20-Jan-2021 and Pfizer COVID19 vaccine (3rd dose Pfizer COVID19 vaccine11Oct2021) on 11-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID19 vaccine, Pfizer COVID19 vaccine and Pfizer COVID19 vaccine.   On 26-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent Moderna COVID19 vaccine as a booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent Moderna COVID19 vaccine as a booster).    No concomitant information provided No treatment information provided
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 15-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 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.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Administration error/Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error/Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administration error/Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error/Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.) 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 ACCIDENTAL UNDERDOSE (Administration error/Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.).    No concomitant product use was reported.   No treatment information was provided.  This case contains information for the 05th patient out of 09 patients as described by the reporter.
Manufacture date of expiry 3-apr-2022 ,  Vial stored in the refrigerator 15-Apr-2022 .; I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.) and PRODUCT STORAGE ERROR (Manufacture date of expiry 3-apr-2022 ,  Vial stored in the refrigerator 15-Apr-2022 .) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Manufacture date of expiry 3-apr-2022 ,  Vial stored in the refrigerator 15-Apr-2022 .). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.) and PRODUCT STORAGE ERROR (Manufacture date of expiry 3-apr-2022 ,  Vial stored in the refrigerator 15-Apr-2022 .) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided. The vial did not undergo any temperature excursion.