chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient became diaphoretic and light headed following vaccine. Skin pale and Bp 108/60 with pulse 68. No respiratory distress noted. Patient transported to cot via wheelchair where they were monitored for 60 minutes. Bp improved to 118/60 before leaving.
Started with back pain, went to arm numbness, chest pain started after about a half hour of back pain. went to ER, diagnosed with pericarditis, myocarditis
headache; dizziness; nausea; This is a spontaneous report from a contactable other health professional.  A 56-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced headache, dizziness and nausea on an unspecified date with outcome of not recovered. The patient received the vaccine in the emergency department. The reporter stated that the symptoms began immediately after getting the vaccine and are persisting. Information about batch/lot number has been requested.
I had my vaccination on 04/27/2023. On 05/05/2023 I started to have double vision. It started to have intermittent double vision and it made my anxiety very high. I put in message to my optometrist as my eye was tracking inward and it was affecting my daily life. It has not resolved on 05/22/2023. I was referred to urgent care and had blood panel performed with an MRI. The results have not found any abnormalities. They think its 6th cranial nerve palsy. No course of treatment has been provided at this time except alternative eye patching. I have follow up appointment with ophthalmologist in 06/2023 and possible neurologist referral.
Just learned of this reaction today 10-19-06.  Guardian reported adverse reaction to 3rd DtaP given 9/11/06.  Fever 103-104 - muscle aches and lethargy.  Was taken to ER 9-12-06.  Guardian was adament that her reactions were d/t the immunizations not the sore throat seen in the E.R.
Dose administered  greater than 12 hours post puncture; vial exposed to room temperature for Just over 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered  greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial exposed to room temperature for Just over 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2022 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered  greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial exposed to room temperature for Just over 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered  greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial exposed to room temperature for Just over 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  It was reported that patient received Moderna COVID-19 booster vaccination that was expired past 12 hours use date. Vial was initially stored in the refrigerator on 07 Jun 2022 and was first punctured on 10 Jun 2022 at 11 00 AM approximation. Vial was stored post puncture in room temperature and did not undergo any temperature excursions. Total amount of time vial was exposed to room temperature range (8 degree to 25 degree C was equal to 46 degree to 77 degree F) was unknown and was exposed to room temperature for just over 24 hours.  No treatment medications were provided.
Patient was happy and healthy no sign of illness when we arrived at the clinic approx 10 am May 7th 2018.. Within 30-45 min she was complaining of not feeling well and became very sleepy... She felt hot to the touch.. Thinking this was a normal reaction as we were told we went on to get lunch... patient has not napped in 2 years... She became glassy-eyed and then fell asleep at the table. We took her home where she continued to sleep so deep that I had to shake her to wake her. She refused food and water for 24 hours. About 6 pm I woke her to try to record her as I was getting worried. She then went back to sleep and continued to sleep through the night a total of 24 hours. She wet herself in the night and for weeks after (she has been fully potty trained without accidents since age 2). Out of fear of backlash I did not take her to the Dr. I should have. Patient continued to show signs of diabetic reaction, extreme thirst, upset stomach, lethargic etc for a few months after. Her eyes returned to normal about a month later no longer glazed over. I did take her to the Dr later and explained what we had been through and my fears and asked that they document it. Dr decided not to test her sugars.... I showed the physician the video and photos I had taken from her. I suspect it got ignored and was not reported or documented.
Cannot go up and downstair; Both hands pain; Both hands weakness; Pain similar to arthritis; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (Cannot go up and downstair), PAIN IN EXTREMITY (Both hands pain), MUSCULAR WEAKNESS (Both hands weakness) and ARTHRALGIA (Pain similar to arthritis) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Cannot go up and downstair), PAIN IN EXTREMITY (Both hands pain), MUSCULAR WEAKNESS (Both hands weakness) and ARTHRALGIA (Pain similar to arthritis). The patient was treated with PARACETAMOL (TYLENOL) for Arthritic pains, at an unspecified dose and frequency and IBUPROFEN for Arthritic pains, at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (Cannot go up and downstair), PAIN IN EXTREMITY (Both hands pain), MUSCULAR WEAKNESS (Both hands weakness) and ARTHRALGIA (Pain similar to arthritis) outcome was unknown.            The action taken with mRNA-1273 in response to the event is not applicable.  It was reported that Tylenol and Ibuprofen did not help relieve the symptoms.
ED to Hosp-Admission Discharged  8/25/2021 - 8/29/2021 (4 days)  COVID-19 virus infection  Respiratory insufficiency  Presenting Problem/History of Present Illness/Reason for Admission Shortness of breath [R06.02] COVID-19 virus infection [U07.1]     Hospital Course   This is a 49-year-old male with essential hypertension and type 2 diabetes on oral medications who got his first Covid vaccine (moderna)-2 days later started getting sick coughing fever chills and ultimately presented to the hospital with acute hypoxic respiratory insufficiency requiring supplemental oxygen he was admitted to the hospital and had convalescent plasma for COVID-19, CT scan showing infiltrates but negative for PE, his COVID-19 pneumonia responded to the combination of convalescent plasma, remdesivir, dexamethasone and time   He had hyperglycemia secondary to steroids and was treated with insulin Blood pressure medications were adjusted for lower blood pressures however at the time of discharge his blood pressure is 130/84
Patient presents for Covid-19 vaccine booster. Patient reports having received second dose of original Moderna series on 3/10/21 and vaccine card is reviewed; date of vaccination verified and confirmed. Patient passes CDC pre-vaccination checklist for Covid-19 vaccination. Denies being immunocompromised and reports feeling well today. Denies having allergic reaction to any vaccine in the past. Temp is measured at 97.5. Vaccine is given in left deltoid. Patient tolerated well and is monitored for 15 minutes following vaccination. No signs/symptoms of adverse or allergic reaction. Patient profile is accessed (immunization registry) in order to document vaccine administration. When reviewed, it is discovered that patient has already received 3 vaccines. The third (Pfizer) dose was documented as administered on 8/18/21. Patient is asked about this and states "Oh no, I forgot about receiving the third dose in August. We (my husband and I) were going on a trip and our doctor friend told us to get it. Sorry, I forgot about that." Patient is educated that the CDC guidelines require at least 6 months from the time of the second dose to receiving the Covid-19 booster vaccine. Patient verbalizes understanding. No obvious signs or symptoms of adverse effects noted at this time.
A non-serious report of vomited twice has been received from a nurse concerning a four-year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST for the first time on 25-Nov-2008. One hour after the dose of FLUMIST, the patient experienced two episodes of vomiting. Per the child's parents, there were no other problems and the patient was doing well. The events resolved on 26-Nov-2008.
Patient experienced 103 fever the night after immunization.  Continuing to 101 for another 24 hours and then all resolved.  No other symptoms.  No other signs of illness
mom called @ stated that pt was shaking & that hands & feet were of bluish color;pt became limp;911 called pt seen @ ER discharged w/dx of febrile sz;
GI changes; she doesn't have a taste for decaf coffee; uncomfortableness in my stomach /stomach upset; she hasn't been tolerating spicy foods; stomach ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  An 83 year-old female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "idiopathic immunosuppression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "GI changes"; TASTE DISORDER (non-serious), outcome "unknown", described as "she doesn't have a taste for decaf coffee"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortableness in my stomach /stomach upset"; ABDOMINAL PAIN UPPER (non-serious) with onset 18Mar2021, outcome "unknown", described as "stomach ache"; FOOD INTOLERANCE (non-serious), outcome "unknown", described as "she hasn't been tolerating spicy foods". Clinical course: The patient received both doses of her Pfizer-BioNTech Covid19 vaccine (last dose 07Mar2021). Since that time, she started noticing GI changes, she doesn't have a taste for decaf coffee (usually has 1 cup caffeinated and 1 cup decaf daily) and she hasn't been tolerating spicy foods, either. She describes it as "an uncomfortableness" in her stomach and because of her stomach upset she cannot enjoy her normal activities, stating that she had to stop her exercises, yesterday because her stomach was so upset. She also stated they symptoms occurred about 1 hour after eating her breakfast. Her other medical history includes idiopathic immunosuppression. She does not know if this was related to vaccination, but wanted to ask, "out of an abundance of caution".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A 12 months old who received both PROQUAD and VARIVAX; This spontaneous report was received from a nurse concerning a 12 month old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 17-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (inappropriate schedule of product administration), both for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided) .
Eleven days post vax, this pt experienced an allergic reaction consisting of generalized erythematous rash around the trunk and extremities with scattered, raised, circumscribed patches over the trunk and extremities. The pt was seen by physician and subsequently recovered.
The patient states that he had flushing, red spots, hives, itching, and felt mentally unclear 30 minutes immediately after the vaccine.
Chills, fever, rash and redness to injection site; swelling and erythema to injection site measuring 5x4 inches on left deltoid area, warm to touch and hard. Patient given steroid injection of Decadron 8mg.
I have severe muscle and joint aches constantly that keep me from walking, sleeping, and taking care of myself. It gets worse every day instead of better. I feel like my body is breaking down in my lower extremities and back.
"covid arm"/REACTION; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("covid arm"/REACTION) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3005287 and 3004225) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION ("covid arm"/REACTION). At the time of the report, VACCINATION SITE REACTION ("covid arm"/REACTION) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-AUG-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 2 times with the following lowest recorded temperatures: 34F (1.111 Celsius degrees) for 64 hours and 33 F (0.555 Celsius degrees) for 16 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Injection site became itchy, red, and hot to the touch 8 days after vaccine. The area has remained red with a circular ring shape and warm to the touch since then.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from Office Staff. This case involves a 6 months old female patient who experienced thigh was red at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; ACT HIB for Immunisation; PREVNAR for Immunisation; and ROTATEQ for Immunisation. On 30-Oct-2018, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ042AB, expiry date-19-MAY-2019, via intramuscular route in the right thigh. On an unknown date, the patient developed a non-serious thigh was red at the injection site (vaccination site erythema) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also the case of actual medication error due to overdose and inappropriate age at vaccine administration. Other relevant tests included no lab data. Final diagnosis was thigh was red at the injection site. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient presented to off-site vaccine clinic with parent. Had signed consent to receive Moderna vaccine. RN administered Moderna vaccine (1st dose) before verifying patient was over 18 years of age. Patient is only 17 years old. Contacted Moderna and they deemed this as off-label use and advised patient could get second dose at routine interval. Patient waited for 15 minutes after administration without any adverse reactions noted.
L arm-sore next morning. Induration 15mm x 20mm, erythema 25-30mm
On cell phone at approximately 1120AM in monitoring area; per volunteer MD and volunteer RN, pt voice louder, was observed leaning forward in chair. Pt stated not feeling well and noted to have moist pale skin. Assisted to floor at approx. 1123, feet elevated. Pt had full body seizure with oral secretions at approximately 1125; O2 applied, airway/limbs and head were protected. VS at 1125 160/100, HR 93, O2 sat 99%. EMS called at 1127, pt seizure approx. 1 minute. Pt aroused, oriented to name, place, requested mom be called. Mom called at, she denied seizure hx. Pt VS monitored at 1130 99% sat, 96 HR, 160/115, EMS arrived at 1135 sat 99%, HR 81, transported to ED with EMS.
Covid-19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and DRUG INEFFECTIVE (lack of drug effect) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (Covid-19) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, COVID-19 (Covid-19) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Fever of 103-104 p/vaxs; screaming & crying 6-8 hrs; large red knots & rash down to knees on both legs; vomiting; rash & swelling lasted about 1 week;
received 3 Pfizer inoculations; 3 Pfizer inoculations / daughter-in-law becoming infected with Omicron; 3 Pfizer inoculations / daughter-in-law becoming infected with Omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "received 3 Pfizer inoculations"; DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "3 Pfizer inoculations / daughter-in-law becoming infected with Omicron". Clinical course: The reporter's daughter-in-law (patient) became infected with Omicron despite having the vaccine. She had moderate infection but was fortunate to have gotten a PAXLOVID prescription before the pharmacy sold out. The patient was reported to had received 3 Pfizer inoculations. She was recovering.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a certified medical assistant and refers to 3 patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) lot # L029466, expiration date 06-AUG-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as 3 doses of improperly stored VARIVAX (Merck) were administered to unspecified patients. The temperature was  14.3 F during 8 hours and 45 minutes and there was no previous excursion. No adverse event was reported. The patient's status was unknown. Additional information has been requested.
After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious event after the vaccines lost temperature they were administered (Product storage error, out of specification product use) for mRNA-1273, lot # 027L20A), Exp date-unknown. There were no reported AEs associated with the event lost temperature they were administered.
Information has been received from a physician concerning a 62 year old male who on 25-FEB-2009 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX  (Merck). On 02-MAR-2009 the patient developed shingles even though he had been given ZOSTAVAX (Merck). A couple of days after he got shingles, he recovered. The patient sought unspecified medical attention. Additional information has been requested.
Patient received her flu vaccine at a Flu Clinic by our organization. She went home and then at noon felt very tired. She laid down and fell asleep. She felt this was unusual. In the afternoon she got up to get ready for a benefit. She went to the benefit early evening. Symptoms happended within 30 minutes of arriving. She ate something then vomited and passed out. They transported her via ambulance to ER. She was evaluated and released. She called me on Thursday. I interviewed her on Friday and she felt fine. I told her I would submit the report to you and she may be called for more information. She has received flu vaccines in the past with no problems.
several hr p/vax pt devel an inj site rxn characterized by swelling, redness, warmth & a rash which extended to elbow;pt was treated w/ice & APAP & recovered w/in 3-4 days;