chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was feeling great until day 9 after the injection.  I could not sleep, was very warm and arm was sore.  I woke next morning to find my left arm at the injection site very swollen, hard, red, rashy, and extremely hot to the touch.  I advised with the nurses at work that morning, and I was told it was a common side affect, but I was still uneasy since I had no reaction until day 9.  I was prompted to call my doctor, which was out of the office, was advised to go to prompt care.  I was treated with a prescription of steriods and antibiotics.  Slept better that night, less hot, hard, rashy, and red next morning.  Still used ice packs during the work day.
RED ARM FROM TOP OF SHOULDER TO ELBOW. RECEIVED VACCINE ON TUESDAY AND RASH DIDN'T APPEAR UNTIL SATURDAY. I WAS NOTIFIED SUNDAY.
THE PATIENT PASSED OUT AND FELL OUT OF HIS CHAIR ABOUT 5 MINUTES AFTER RECEIVING THE VACCINE. IT WAS REPORTED THAT HIS HANDS WERE SHAKING AS HE WAS FALLING
ACHY JOINTS BACKACHE, VERY TIRED, HEADACHE AND RASH ON COLLAR BONE TAKING IB, AND BENADRYL FOR THE RASH, DID TAKE THERA FLU ON 10/3/2010 BEFORE GOING TO BED--TODAY FEEL BETTER BUT NOT 100%
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender.The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 08-SEP-2016, 20-MAR-2017 and 13-AUG-2018 the patient received the three GARDASIL 9 or GARDASIL because it was unknown which vaccine was administered (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. On 26-OCT-2018, the patient was vaccinated with GARDASIL 9 as a fourth dose after 3 previous HPV vaccinations. No adverse effects were reported
This literature marketed report as received from a other health professional refers to a 20 year old male patient with smoking. This is case 3 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown). Both the vaccination were received in the same arm. Patient's concomitant medication was not reported. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth) (hospitalization), fever (hospitalization), leucocytosis (hospitalization), rigors (hospitalization), presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 22.8K/microliter and Maximum temperature 103 degree F. The patient sought care within 2-3 d of vaccination and was admitted to the hospital for observation, with or without treatment of presumed cellulitis. Patient received full courses of antibiotics to cover for common skin flora as well as methicillin-resistant staphylococcus aureus. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. In one patient, the local swelling and erythema at the injection site lasted about 2 weeks. The outcome of the events localized inflammation, injection site erythema, warmth and swelling and presumed cellulitis was considered resolving and outcome of fever, leucocytosis, rigors and vomiting was considered as resolved. The reporter considered the events to be not related to influenza virus vaccine (manufacturer unknown). The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The author stated that "the 5 patients in this series all had leucocytosis, fever and large local inflammatory reactions following influenza vaccine (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Based on the known side effects of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), the lack of similar findings in patients who receive the influenza vaccine (manufacturer unknown) and the patient 2's lack of influenza vaccine (manufacturer unknown) associated local symptoms we believe these reactions were due to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)". This case is linked to case # 1405USA008573, 1405USA007995, 1405USA008575 and 1405USA008576.
A report received from a health professional. The report concerns a female patient of an unknown age and ethnicity. Concomitant medications, concurrent disease and relevant history were not reported. The patient received nasal FLUMIST started on an unknown date. During the administration of FLUMIST, the patient flinched during administration in the second nostril, and some vaccine may have sprayed into the eye. Action taken with FLUMIST was not applicable. At the time of reporting, the outcome of the event inadvertent administration in the eye was unknown. The reporter assessed the event inadvertent administration in the eye as non serious. The reporting health professional considered the causality between the event of inadvertent administration in the eye to be unrelated to the suspect drug of FLUMIST and the company physician agreed with that.
Severe ulcerative colitis with pain in lower abdomen..  He's in the hospital at this time, for a week so far.  Diarrhea, gas and pain in abdomen started about 3 weeks after 2nd covid vaccine shot and become worse to the point where he was dehydrated and had to go to the emergency room for fluids.  They assumed it was something common like a virus or bacterial infection but less than a week after the ER visit, he was admitted due to the bloody diarrhea and dehydration along with the fact that they didn't know what was wrong.  Colonoscopy performed at the hospital confirmed  it was ulcerative colitis and one of the worst cases the doctors have ever seen.  They treated with steroids which didn't improve the situation.  Now they've treated with REMICADE (given via IV) and they say it's not having the effect they want (not helping to improve his severe ulcerative colitis) so they will evaluate again today (8-6-2021) and try another infusion  of REMICADE on 8-7-2021 if they don't see improvement today (8-6-2021).
Presented to the clinic with rashes / lesions to the trunk which started about 4/9/10. See attached notes.
Swelling of throat; lightheaded; right arm injection site arm pain; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730 expiry date: unknown), via an unspecified route of administration on the right arm on 19Dec2020 09:30 at single dose for immunization. Medical history included cervical spine disc herniations. Concomitant medications included sulfamethoxazole and bisacodyl (DULCOLAX [BISACODYL]). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 19Dec2020 10:00, the patient experienced Swelling of throat, needing to keep clearing my throat, lightheaded, right arm injection site arm pain. The event was considered as non-serious. The patient received BENADRYL as treatment for the events swelling of throat, lightheaded, right arm injection site arm pain. Outcome of the events swelling of throat, lightheaded, right arm injection site arm pain was not recovered.
I began to experience left eye pain shortly after receiving the first COVID-19 vaccine (Moderna) on 12/28/20. I still experience pain when blinking.
Member was getting up after 15 minutes post vaccine and felt left sided chest/lower rib pain radiating to back with diaphoresis.
After I got home I didn't feel sore. The next morning I developed a fever so I took a Tylenol. About 4 or 5 hours later I felt fine since then. I felt a little stiffness in my left arm, but after 3rd day I was fine. I started feeling uncomfortable with my tummy. I had chronic constipation on December 7th. On December 9th I took a laxative for it, and I started to feel better.
Narrative:  Covid infection after Covid vaccine 02/09: COVID infection #1 03/09: COVID infection #2 09/20: Chills, Cough, Runny nose (Rhinorrhea) 09/21: mild Cough 09/22: productive cough, "heavy cold", congestion 09/23: improved
LOST 60 POUNDS DUE TO A DEPRESSED APPETITE; CAN NOT WALK VERY FAR; CAN NOT STAND FOR LONG PERIODS; DEPRESSED APPETITE; SEVERE RASH OVER THE ENTIRE TRUNK OF HIS BODY; HE WAS TIRED ALL THE TIME; HE HAS NO ENERGY; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced lost 60 pounds due to a depressed appetite, can not walk very far, can not stand for long periods, depressed appetite, severe rash over the entire trunk of his body, he was tired all the time, and he has no energy. Laboratory data (dates unspecified) included: Weight loss lost 60 pounds due to a depressed appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the he was tired all the time, severe rash over the entire trunk of his body, he has no energy, lost 60 pounds due to a depressed appetite, can not walk very far, can not stand for long periods and depressed appetite was not reported. This report was non-serious.
Arm is so sore; Arm is red/ Red skin; Arm with a little tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm is red/ Red skin), TENDERNESS (Arm with a little tenderness) and PAIN IN EXTREMITY (Arm is so sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ERYTHEMA (Arm is red/ Red skin) and TENDERNESS (Arm with a little tenderness). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is so sore). At the time of the report, ERYTHEMA (Arm is red/ Red skin), TENDERNESS (Arm with a little tenderness) and PAIN IN EXTREMITY (Arm is so sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Extreme chills/sweating. Fatigue. Severe aches in most joints. Some joint swelling. No nausea. Bedridden 6 days. Headache. Intermittent fever 101.
Approximately ten minutes post injection patient experienced a vasovagel syncope episode. Hit head on floor. Lost consciousness for approximately 3 seconds.  BP and heart rate monitored by nursing staff. Ambulance was called.  Patient evaluated by EMS and released to mother.  Will follow up with MD
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   Previously administered products included steroid shot (received in the patients neck).   On 21st June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The pharmacist on the chat reporting that, 3 weeks before the reporting the patient went to pain management to get a steroid shot in the back and they noticed a shingles rash on her back. At the time of reporting, the rash seems to have cleared and dried up. Not bothering or itching the patient. The reporter consented to follow up. All details as provided.
Blood pressure has been running inordinately high.  Typically 185/90. I have blood pressure issues but has been controlled by prescriptions. The time coincidence has prompted me to think it could be related to the covid vaccine.
May have received a higher dose of vaccine due to insufficient diluent being inserted into the vial. A total of two doses were able to be drawn from the vial instead of five. The individual was notified by phone that day and a report was made in our city immunization information system. No side effects were identified during the time in clinic or reported by the patient during the call.
I started feeling vertigo a few times on 4/28. Since then (today is the 3rd day) I've been feeling dizzy at times even when sitting. I only had the first shot 2 weeks ago and haven't had the 2nd shot yet.
Pt. in tent 4 at 2:31 at observation lane was reporting throat tightness and headache.  Paramedics assessed vitals.  Bp 210/115.  Paramedics and Pt. wanted her to go to the hospital.  Emergency services was called.  She was transported.
Doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. No adverse event reported.  It was reported that the vials did not undergo any temperature excursions.
This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 14-JUL-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
I was 38 weeks, 2 days pregnant. I got induced at 39 weeks, 1 day pregnant & gave birth to a healthy baby boy weighing 8 lbs 3 oz. There were no adverse reactions with the birth or the baby. However, one of my HIV screenings came back as reactive twice without having been exposed to HIV or taken part in any risk factors for developing HIV throughout this pregnancy (or my whole life); the same is true for my partner. We had an RNA test completed, which was negative, but the screening feels potentially related to the vaccine.
Thursday night shortly after the vaccine I was exhausted and headed home to go lay down. While driving, I developed a severe headache. I went home and went to sleep really early. Friday morning, woke up, went to work. Extreme lethargy and severe headache. Left work early (2 ish) with joint pain, headache, lethargy. In the evening (still Friday) I went to the grocery store and walking in the parking lot to the store my joints hurt with every step. I sent my partner in and I went back to the car. I could not do it. Went to sleep soon thereafter. Saturday morning, we woke up and had planned to go to the cabin. We were trying to run errands (coffee shop, post office, bank...simple errands) and I was exhausted and feeling bad. Still headache, lethargy, achy. Assumed it was flu like which was a side effect, so I continued to press on through the discomfort. Left for the mountains. less than 1 mile from home, started to feel tingling and "buzzing" throughout my body, like a vibration sort of. Stayed quiet and thought about this. Another block or two and the feeling was in my tongue. Then I felt it in each tooth root and spoke up. I asked to go home and rest for 30 minutes before going to the cabin. At this point, I could not move my hands. We got to the house and I could not open my car door or take off my seatbelt. I had hand paralysis for about 10 minutes. Made it in the house. Got to the couch and laid down for about 60 seconds. Got up had to use the restroom. Solid, not diarrhea, but took 45 minutes. Apparently, I was pale like a piece of paper. I do not remember being in the bathroom for 45 minutes, I felt like it was 5 minutes, partner said 45 minutes. Made it back to couch, laid down, freezing! Under 2 blankets, one of them was an electric blanket on high. Began throwing up, clear bile. Had not eaten anything yet. Stayed on couch, also lost track of time, was there for 5 ish hours. Tried to eat something so I could take Tylenol for the headache. Barely ate anything, so I never took the Tylenol. It lessened. Cabin trip cancelled. Still lethargy and dizzy yesterday but no joint pain, no nausea. Now, Monday morning, still dizzy/lightheaded. Symptoms are subsiding, but not gone.
Patient stated that he began vomiting and having diarrhea approximately 30 minutes after receiving the Fluzone vaccine.  The following day, the patient was still vomiting/having diarrhea and I told him to see a physician.  I tried contacting the patient since, but have been unable to talk to him since 10/08/2010.
expired dose of DAPTACEL was given to a patient an 11 month old patient/no AE; Initial information regarding an unsolicited valid non-serious case via Agency (Reference number- 00420720) was received from a nurse and transmitted to Sanofi on 07-Jan-2021.  This case involved an 11 month old male patient who received an expired dose of 0.5 ml of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5367AA and Expiry date: 30-Jan-2021) on 07-Jan-2021 via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency same day).   At the time of reporting, no adverse event was reported.  Nurse stated another staff member couldn't put the product lot into the computer after she gave the dose. Also stated the employee was new and fortunately this was the first dose out of this box but didn't know how it slipped by and stayed in the refrigerator so long.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a physician and described the occurrence of anaphylaxis in a child subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline).  Concurrent vaccination included live attenuated oral poliomyelitis vaccine (manufacturer unspecified) given in 2001.  In 2001 the subject received unspecified dose of INFANRIX (unknown).  At an unspecified time after vaccination with INFANRIX, the subject experienced anaphylaxis and generalized rash.  This case was assessed as medically serious by GSK.  At the time of reporting the events were resolved.  The physician considered the events were probably related to vaccination with INFANRIX.  This event was reported as the reporting physician (an allergist) wanted to give BOOSTRIX to this child subject that is allergic to gelatin.  In the course of conversation, the allergist mentioned the events above in response to INFANRIX.
Information has been received from a nurse concerning a 21 year old female with ovarian cyst and no drug allergies reported who on 09-SEP-2008 was vaccinated with the first and only dose of GARDASIL IM and experienced nausea, chills and stomach pain right after receiving vaccination.  There was no concomitant medication.  The symptoms disappeared one hour after the vaccination.  The patient did not seek medical attention.  Additional information has been requested.
Sick; Psoriasis flare up; Joint pain; Fever; Fatigue; Extreme nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PSORIASIS (Psoriasis flare up), ARTHRALGIA (Joint pain), PYREXIA (Fever) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriasis.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), PSORIASIS (Psoriasis flare up), ARTHRALGIA (Joint pain), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Extreme nausea). At the time of the report, ILLNESS (Sick), PSORIASIS (Psoriasis flare up), ARTHRALGIA (Joint pain), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Extreme nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-021756, US-MODERNATX, INC.-MOD-2021-021756 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-021756: US-MODERNATX, INC.-MOD-2021-021756:Crosslinked (MOD21-021976)
Vaccine administered on 9-22-2009. Patient called pharmacy at 9:20am 9-29-2009 and stated that her arm was still sore after vaccination. She has never experienced such soreness following previous flu vaccines. She stated her arm was sore when she moved it and it was not as bad if she was sitting still. She did mention use of heating pad and capzasin cream on arm. She also stated that pain did seem lessened compared to a few days ago, but was still sore.
Large/Severe local reaction at site of Menveo vaccine: Erythema and edema extending entire upper arm (7x5in), warm and tender to touch. No presence of system symptoms (hives, SOB, CP, throat closing).
pt stated the day of the injection he started having pain in neck, knees, ankles, and shoulders.  Pt stated he started having joint pain and bronchial tube pain along w/ headache and slight fever and then congestion started that lasted through the night and next day.  Pt contacted PCP which told him to go the ER if symptoms did not subside.
Localized swelling at injection site ongoing  for 5days Nausea with vomiting 48 hours after vaccine
Patient previously given 2 Moderna COVID immunizations. Dose #3 bivalent COVID-19 Pfizer on 4/3/23. No treatment provided. No adverse clinical outcome aside from Pfizer bivalent 3rd dose given to patient with 2 previous COVID-19 immunizations from Moderna.