chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; FATIGUE; MILD HEADACHE; LOW FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On an unspecified date, the subject experienced chills, fatigue, mild headache, and low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, mild headache and low fever was not reported. This report was non-serious.
Information has been received from a medical assistant concerning a 72 year old male with hypercholesterolaemia and diabetes and no drug reactions or allergies who on 13-NOV-2006 was vaccinated intramuscularly into the right deltoid with a third dose of Pneumovax 23 (lot #655500/1005F). Concomitant therapy included omega-3 marine triglycerides, FLOMAX, metformin, lovastatin, multivitamins and aspirin. Later that evening the patient experienced chills with a fever, and the arm in which he was vaccinated was red, painful and warm to the touch. The patient also experienced increased fatigue. The next day, he had redness in the right bicep, right upper extremity and right chest wall that resolved by the time he was seen on 16-NOV-2006. He also experienced ecchymosis in the mid to lower right bicepand distal right upper extremity. No hematoma was noted. Unspecified medical attention was sought. No labs were performed. At the time of report, the patient was recovered from the events but did not recover from ecchymosis. No product quality complaint was involved. Additional information is not expected.
My upper arm surrounding the injection site got swollen. My arm became hard, hot, and red. It was sore like someone had punched me in the shoulder. It lasted for ~2 days. The first day it was swollen, I felt like I was starting to get sick with a mild headache, and I felt feverish even though I checked my temperature and it was 97 degrees. The second day I no longer felt like I was getting sick and the arm pain was decreasing although it was still swollen, hard, and hot to the touch.
Patient called today to let us know she began yesterday with a shingles like rash on her chest area described as red, burning sensation with blisters (as if she was burned) and in her back area as well (although not as severe) along with the other typical reactions of fever, headache and arm pain. The typical side effects she said she felt the same day of administration, however the shingles type rash began yesterday 3-2-23. She has been taking tylenol for fever and placing cold towels over the rash for relief. I told her to see her physician and she stated she has an appointment on 3-9-23 and will discuss with her then. Also advised her to continue the cold towels for relief and tylenol if needed.
Just a little pain in the arm the next day. But today 01/18/21 it feels like a hard red lump and itches
This spontaneous report as received from 73 year old male (72 was also reported) with thyroid disease reporting on himself who 2-3 years ago on approximately 30-JAN-2010 was vaccinated with dose 1 live ZOSTAVAX (dose, route and lot # not provided). No other co-suspects were reported. Concomitant medications included acyclovir and gabapentin. The consumer stated that on 24-JAN-2013; he noticed red spots on his chest and left abdominal area that in a band that went around to his back in a horizontal type pattern. They did not itch, burn, or were painful initially but now he says they are very painful causing him to not sleep. He went to doctor today and was diagnosed with shingles. There was prescribed pain medicine and an antiviral pill acyclovir and gabapentin were given as a treatment. Labs were performed no results provided. The outcome of shingles was unknown. The relatedness for shingles was unknown for live ZOSTAVAX. Additional information has been requested.
Left upper arm local reaction. Swelling of 7x8 cm, itching. On Benadryl and Cephalaxin 500 mg.
Information has been received from a pharmacist referring to unknown number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, 3 doses of improperly stored RECOMBIVAX HB (lot # L048848, dose, route and expiration date not reported) had been administered to patients. The doses of vaccine were improperly stored at 35 degree Fahrenheit for 1 hour. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker (Medical Assistant) refers to unspecified patients of unknown age and gender. Since December 2014 these patients were administered improperly stored VARIVAX (Merck) (lot#, dose, route not reported). Concomitant medications were not provided. No adverse events were reported. Additional information is not expected as the physician did not want to be contacted.
day followimg shot: i awoke to extreme pain in all muscles and joints, profuse sweating, blurred vision, headache just behind my eyes muscle/joint pain lasted approx 24 hours; ibuprofen offered some relief. sweating lasted 3 days and resulted in dehydration to the point where my kidneys ached; i drank as much water as i could but my urine remained dark headaches/blurry vision lasted 2 days 5 days after the shot, the soles of my feet began to feel itchy, and the itchiness has been ongoing even up to now (7 days after shot) 7 days after shot, itchiness has also begun affecting the palms of my hands
Unable to provide me a second dose of vaccine due to a mismanagement of doses; This spontaneous case was reported by a consumer and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Unable to provide me a second dose of vaccine due to a mismanagement of doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Unable to provide me a second dose of vaccine due to a mismanagement of doses). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Unable to provide me a second dose of vaccine due to a mismanagement of doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # unknown  with no associated AEs
Pt was given 0.5ml dose instead of 0.25ml booster dose.
started 5FEB97 w/erythema, warmth 2 1/4 x 3 1/2) tenderness & edema @ inj site rt deltoid;
pt recv vax; T of 103; fever; screaming all night; could not really touch; called MD who saw pt but told mom to report to hlth dept;
FULMINANT MYOCARDITIS; PEA ARREST; SUSPECTED COVID 19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report was received from a literature. This report concerned a 26 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 01 total, administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced PEA (Pulseless electrical activity) arrest, suspected covid-19 infection, suspected clinical vaccination failure and was hospitalized (date unspecified). On an unspecified date, six months after taking the vaccine the patient had fulminant myocarditis and was hospitalized (date unspecified). The patient was hospitalized for 50 days and had an Intensive care unit (ICU) stay of 34 days and was on venoarterial extracorporeal membrane oxygenation (VA-ECMO) for nine days. The patient had survival to discharge. The patient visited an emergency room for the events. The patient was taking steroids as a treatment for COVID-19. Laboratory data (dates unspecified) included: C-reactive protein (NR: not provided) was at 2.1 mg/dL, Erythrocyte sedimentation rate (NR: not provided) 2 mm/h, LVEF (Left ventricular ejection fraction) was at 10 percent and post ECMO (extracorporeal membrane oxygenation) LVEF (NR: not provided) it was at 55 percent and Troponin (NR: not provided) was at 1.34 ng/mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the PEA arrest, fulminant myocarditis, suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0:20220551032-Covid-19 vaccine ad26.cov2.s- Fulminant Myocarditis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220551032-Covid-19 vaccine ad26.cov2.s- PEA arrest, suspected covid 19 infection. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220551032-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Subsequent to IM injection on deltoid, patient had minor bleeding which soon stopped. As patient was rising from chair, he fainted and fell from chair. His mother caught him as he fell. It did not appear to be a bad fall. Patient regained consciousness right away. The fainting was brief. Patient was monitored for about 30 minutes during which time he was stable with no complaints.
When band aid over injection site removed about 24 hrs later, longitudinal blister noted 1" x 1/8", intact skin and no induration or erythema. Also noted 1/16" round blister approx. 2" away and lateral to main site. Denies any pain, fever, HA, N, V or other s/s.
The case was received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 18 September 2013. A 06-month-old patient had received 0.5 ml dose of FLUZONE QIV instead of 0.25 ml on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Seizure-type activity. Acting "startled", tensing up, "in a daze", then went into seizures. Lab and test done- sent to neuro. W/ sequelae/on Phenobarb.
very sore left injection site arm; patient was very tired after his second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (very sore left injection site arm) and FATIGUE (patient was very tired after his second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (very sore left injection site arm) and FATIGUE (patient was very tired after his second shot). At the time of the report, VACCINATION SITE PAIN (very sore left injection site arm) and FATIGUE (patient was very tired after his second shot) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
About 4 hours after vaccination, he developed fatigue and headache, mild arm soreness. He slept off and on for the next 16 hours. Was seen in clinic on 4/16 at 0900 and still had fatigue and frontal headache, but normal neurologic exam, vital signs. No injection site swelling or redness.
while standing next to mom 15-20 mins p/finger prick for hemoglobin & DTP in school-fell back to floor & had jerky sz, eyes rolled back for 10 seconds then woke up c/o h/a;
This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic GN) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Glomerular disease in temporal association with SARS-CoV-2 vaccination: a series of 29 cases. Kidney360;2(11):1770. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic GN) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic GN) outcome was unknown. Related. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: proven glomerular disease proven glomerular disease. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic GN) to be related. No concomitant and treatment medications were reported. 28 patients were reported of de novo GN within native kidney biopsies and one disease flare in an allograft. Company comment: This literature non-study case concerns a 76yearold, female patient with no medical history reported, who experienced the unexpected, serious medically significant event of glomerulonephritis rapidly progressive. The event occurred after the administration of the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination dates. The report stated that the patient experienced Crescentic glomerulonephritis. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539885, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903 (Patient Link). Sender's Comments: This literature non-study case concerns a 76yearold, female patient with no medical history reported, who experienced the unexpected, serious medically significant event of glomerulonephritis rapidly progressive. The event occurred after the administration of the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination dates. The report stated that the patient experienced Crescentic glomerulonephritis. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Rheumatoid arthritis flare up; This is a Solicited report from a non-contactable consumer (patient) based on information received by Pfizer from AbbVie, Inc. (Manufacturer Control No: 21K-163-4055854-00).  Solicited report from the USA by a consumer of an adult female (58-year-old) with an event of non-serious rheumatoid arthritis flare up with upadacitinib (RINVOQ). The route of administration for upadacitinib was oral. There was no reported medical history and concomitant medications. On an unknown date, the patient experienced rheumatoid arthritis flare up. Tozinameran (PFIZER BIONTECH COVID-19 VACCINE) was also considered suspect. The patient was having rheumatoid arthritis flare up a little due to not taking upadacitinib. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech lot number and expiration date were unknown. On unknown date, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number and expiration date were unknown. The route of administration for COVID-19 Vaccine manufactured by Pfizer/BioNTech was intramuscular, both for COVID-19 immunization. The action taken in response to the event for upadacitinib was not applicable. The outcome of the event was unknow.    The reporter considered there was a reasonable possibility that the event was related to upadacitinib, there was a possible causal relationship for the event with tozinameran.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  event Rheumatoid arthritis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1st day Thursday night after the shot - swollen nodes, pain in the shot area 2nd day Friday cold chills, fever, body pain, dizziness,  5th day Monday hives, itchiness, rash all over body 7th day Wednesday head throbbing in the afternoon, sleepy 12th Monday day muscle pain, weakness, stomach ache 13th & 14th day Tues & Wed vertigo, black stool, ulcer, back pain 15th day Thurs soar throat
Left upper thigh red, swollen area 9 1/2cm x 5cm, warm to touch, firm, tender, T 99.7 this morning at home.
LARGE LUMP IN LEFT ARM PIT AFTER FIRST DOSE OF MODERNA VACCINATION; SEVERE FATIGUE; INSOMNIA; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (INSOMNIA), AXILLARY MASS (LARGE LUMP IN LEFT ARM PIT AFTER FIRST DOSE OF MODERNA VACCINATION) and FATIGUE (SEVERE FATIGUE) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported medical history.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 21-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced INSOMNIA (INSOMNIA) and FATIGUE (SEVERE FATIGUE). On an unknown date, the patient experienced AXILLARY MASS (LARGE LUMP IN LEFT ARM PIT AFTER FIRST DOSE OF MODERNA VACCINATION). At the time of the report, INSOMNIA (INSOMNIA), AXILLARY MASS (LARGE LUMP IN LEFT ARM PIT AFTER FIRST DOSE OF MODERNA VACCINATION) and FATIGUE (SEVERE FATIGUE) had not resolved.            Concomitant medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient received booster dose of Moderna COVID-19 vaccine.   Action taken was reported as dose not changed for the events with respect to HUMIRA (ADALIMUMAB).  Reporter causality was reported as probable for the event fatigue extreme and not related for other events with respect to HUMIRA (ADALIMUMAB).  Treatment information was not provided by the reporter.
Cellulitis - Evening at 9-25-17. Pt. stated arm hurt and difficult to move. Come into office 9-27-17 - red and sore below injection site, warm to touch.
I started getting symptoms of sore throat, runny nose, and fever. I was in bed all day. The next day, I took a COVID-19 test at home that was positive. My symptoms progressed to cough, congestion, and loss of appetite. I did a virtual visit with my doctor and was advised to take Mucinex. My symptoms are still lingering today.
when pt returned to office 23APR97 for 2nd dose of vax pt had been itching since 1st inj;pt was given claritan;
pt recvd vax & had severe h/a for 2 days; 1 mo later, no vision during a h/a; h/a persisting as of 20AUG92; tx w/APAP;
Headache, Diarrhea, NauseaVomiting, "lightheaded", redness and swelling at injection site, warm to touch.
I?m not sure if they are adverse or not.  My arm is swollen.  Severe joint pain.  My bones hurt in shoulder, arm , down to fingers (like arthritis) in the arm of injection.  Severe fatigue,  feels more like exhaustion, slight fever, chills,, kind of feels like the flu.  I?m not sure if this is normal for the 1st dose of the vaccine
Three weeks after my second dose, which was given on 3/10/21, Lot #EN6204, I suddenly began having numbness and tingling in both feet as well as in the left lower leg. The left was much worse than the right.
Facial swelling (orbital swelling, lips swollen, mud drooling).  10:45AM shots given, approximately 10:55AM cinaphylactic.  Treatment noted.  (No fever, no seizure, no respiratory distress).
Patient presented with her brother (who is developmentally disabled) to vaccine clinic today 11/6/21. Both patient and her brother had appointments for booster doses of vaccine. Patient was scheduled for Pfizer booster, and brother was scheduled for Moderna booster. Due to brother's condition, it was necessary for him to remain with patient during their appointments. The seating at the clinic for patients is divided into rows by vaccine type. Because patient and brother needed to remain together, they were both seated in  the "Pfizer row". When approached to begin vaccination encounter, I and my scribe verified patient name and DOB. Scribe then asked the patient if she is here for the Moderna booster and she responded "yes". After preparing the vaccine and cleaning the site, I asked the patient "and you are getting the Moderna booster, correct?" and patient answered "yes". After administering the vaccine patient stated (paraphrasing here) and he is getting the Moderna. This led me to question the administration on the Moderna booster to this patient. I then administered the Moderna booster to patient's brother.  I did not question the patient directly at this time.  All seating is in close proximity to other patients, and I wanted to verify with the second RN in question that the patient had indeed stated yes when asked if she is getting the Moderna booster. I reviewed what had happened with the second RN that was present at the time and he confirmed that patient responded affirmatively when asked if she is receiving the Moderna booster.  Accompanying staff advised me on next steps including contacting the patient to notify her that she has received the Moderna vaccine, filing an incident report, entering report into VAERS. Manager on site was made aware of the situation as well. Patient was called and was notified that she received Moderna booster.