chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (nurse) and described the occurrence of rapid heart rate in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2012 the subject received a dose of FLULAVAL (.5 ml, unknown details). On 4 October 2012, about 5 to 10 minutes after vaccination with FLULAVAL, the subject experienced rapid heart rate, high blood pressure, nausea, dizziness and lightheadedness, and flushing. A pharmaceutical product complaint has been reported. The nurse "suspects she has a bad batch of FLULAVAL" since this dose was one of the first injections used out of a new vial. At the time of reporting the outcome of the rapid heart rate, dizziness and lightheadedness and flushing had resolved. At the time of reporting, the outcome of the high blood pressure and nausea was unknown. The healthcare professional (nurse) reported that the events of rapid heart rate, dizziness, lightheadedness and flushing were probably related to vaccination with FLULAVAL. It was unknown if the nurse considered high blood pressure and nausea related to vaccination with FLULAVAL. The nurse reported another subject who received FLULAVAL and experienced events. See case A0999481A for details on the other subject. This case was associated with a product quality complaint for FLULAVAL. "A registered nurse reports that she received a suspect batch of FLULAVAL. She notes that she opened a new vial, and the very first 2 patients who received the injection had systemic side effects. Vials were stored under recommended conditions. Nothing looked out of normal when the product was visibly inspected." Quality Assurance (QA) results received on 19 November 2012. Based on the fact that no precise technical problem was reported, and based on the conforming results of the Quality Control visual appearance test, performed on the returned samples, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.
Daptacel that has been expired for 9 hours was administered with no reported adverse event; Initial information received on 27-Feb-2023 and live follow up was processed on the same day regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a patient of unknown age and gender and it was reported that diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] that has been expired for 9 hours was administered with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 27-Feb-2023 at 09:00 hours, 0.5 mL of the suspect diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] suspension for injection (batch/lot number: c5816aa and expiry date: 26-Feb-2023; strength, route: unknown) in unknown administration site for prophylactic vaccination (immunization) that has been expired for 9 hours was administered with no reported adverse event (expired product administered) (latency: same day).   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the guidelines. 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.
Injection site reaction. Hot to touch, itchy, painful, red, raised, rash about 6 inches in diameter. Developed approximately 2 days after injection. Went to Emeg. Room diag. of cellulitis. BACTRIM DS x 10 and PERCOCET.
Narrative:  reports edema, itching, TTP and erythema at injection site (right proximal tricep area) RUE (right proximal tricep) 7x5 cm area of erythema/edema/TTP. Apply ice to affected area 4-6 times per day. DIPHENHYDRAMINE HCL as needed for itching. Apply HYDROCORTISONE 1% OINTMENT for redness and swelling.
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 02-NOV-2015 the patient was vaccinated with a dose of M-M-R II (lot# reported as 1002873, expiration date: 27-JAN-2017, route and dose were unknown) which was improperly stored. There was no previous temperature excursion. No adverse reaction was reported. Lot number 100287 has been verified to be a non-valid lot number for MMR vaccine. This is one of several reports received form the same reporter. Additional information has been requested.
it is documented that pt received 2 Pfizer vaccines and then had a Moderna booster on 11/17/21. on 11/17/21 or 11/18/21 it is documented that pt had a bit of ringing in her ears. on 11/22/21 while on vacation at lunch, she developed sudden vertigo and called emergency number. Her MRI showed "large acute/subacute infarct involving medial inferior right cerebellum. Minimal nonspecific periventricular white matter changes adjacent posterior horn lateral ventricles."
pt recv vax 2DEC97 & 16DEC97 pt devel a papular erythematous rash on face;the rash was described as red, raised, clustered, bumps & w/o itching;23DEC97 pt recovered;
Pt. reported to pharmacy with rash around upper arm around the area of injection site. Rash was red and spotty - localized to right arm only.
After receiving  vaccine in the left deltoid, patient fell face down on to the floor.  Patient was noted with what appeared to be two seizures lasting 10-15 seconds in duration. Patient received immediate attention, contacting EMS and recording vital signs. Blood pressure noted at 105/64, heart rate 55, 02 saturation noted at 99%.  EMS arrived and provided immediate attention. Parental guardian (Mother) refused transportation to the emergency room. Mother was provided patient education in the risk of refusing medical care. Mother signed AMA form and stated she would take patient to the hospital.
Expired vaccine administered to 26 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  Vaccine was administered on 19-Aug-2021, 2-Feb-2022, 2-Mar-2022  The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022.  No treatment medications was provided by the reporter.
Severe sepsis with septic shock - ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
angina; difficulty breathing; throat closing; funny taste in mouth; shooting pain in jaw; hotness; joint pain; redness and raised area at injection site; redness and raised area at injection site; pain in arm; A spontaneous report was received from a consumer, a 74 years old female patient who experienced  difficulty breathing/ dyspnea, throat closing / throat tightness, funny taste in mouth / taste disorder, pain in arm / pain in extremity, shooting pain in jaw/ pain in jaw, angina / angina pectoris, joint pain / arthralgia, injection site redness / injection site erythema and raised area at injection site / injection site swelling, and injection site hotness / injection site warmth.  The patient's medical history not included. Products known to have been used by the patient, within two weeks prior to the event, included nitroglycerine.     On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient experienced difficulty breathing, throat closing, funny taste in mouth, pain in arm, shooting pain in jaw, angina, joint pain, redness and raised area at injection site and hotness. Treatment for the events included Benadryl, liquid nitro, aspirin, and inhaler.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events, difficulty breathing, throat closing, pain in arm, angina, joint pain, redness, raised area at injection site, and hotness, were considered recovered. The outcomes of the events, funny taste in mouth and shooting pain in jaw, were considered not recovered.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Arthralgia, Injection site redness and injection site swelling are consistent with the known safety profile of the vaccine
One week post vax neck seemed stiff and went to chiropractic who stated that neck was weak and the vax affected that weakness. Pt was stiff for 2 months.
Swollen Lips; Swollen Mouth; Swollen Nose; Hard to Breathe; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen Lips), MOUTH SWELLING (Swollen Mouth), SWELLING (Swollen Nose) and DYSPNOEA (Hard to Breathe) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced LIP SWELLING (Swollen Lips), MOUTH SWELLING (Swollen Mouth), SWELLING (Swollen Nose) and DYSPNOEA (Hard to Breathe). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, LIP SWELLING (Swollen Lips), MOUTH SWELLING (Swollen Mouth), SWELLING (Swollen Nose) and DYSPNOEA (Hard to Breathe) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other treatment medications included Steroids Injection Concomitant product information, if any, was not provided by the reporter.
0-4 hrs felt great 4-18 hrs mild headache & mild fever 18-28 hrs Heavy Kidney pain 28-38 hrs Facial numbness, light headed when I stand up, Shivering chills and sweating , Kidney pain not as bad. Had a fever 4 out of 7 days. 8th day mild fever. No symptoms after that.
Edema with induration, heat to left thigh 8.5 x 12.5 cm no pus, fever, chills, wheezes etc.
The patient swatted at the syringe and the needle scrapped the patients leg; The nurse then administered the dose to the patient from that same syringe that had some of the dose leak out and that the patient received a less than recommended dose / she is unsure of how much of the dose the patient received.; some of the PROQUAD leaked out of the syringe.; the nurse then administered the dose to the patient from that same syringe that had some of the dose leak out; This spontaneous report has been received from a nurse referring a 4-year-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 21-MAR-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), subcutaneous injection ,at a dose of 0,5 milliliter, lot number W030849 that has been verified to be a valid lot number with expiration date 26-MAR-2024, administered subcutaneously for prophylaxis (strength, vaccination scheme, anatomical site of application were not provided).  On that same day, the patient swatted at the syringe, the needle scrapped the patients leg (limb injury) and some of the with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (recombinant Human albumin (rHA), leaked out of the syringe (syringe issue), then the nurse then administered the dose to the patient from that same syringe that had some of the dose leak out, she was unsure of how much of the dose the patient received or if received a less than recommended dose (underdose) (poor quality product administered).   The outcome and the action taken with suspect therapy was not provided.   The causal relationship between the events and (PROQUAD) was not reported.
Fever of 101, diarrhea, vomiting, fatigue, nauseous, no appetite, arm red and swollen at injection site.
?Moderna COVID- 19 Vaccine EUA? - Patient received Moderna vaccine 12/23/20, developed rigor and low grade temperature 99.8 degrees F, pain at injection site same day as injection. 12/27/2020 developed worst headache of life for 5-6 hours, vomiting, welts and hives on face, bruising of upper thighs, itching of legs. Patient considered going to emergency department due to severe headache and vomiting but improved after 5-6 hours. As of 1/5/2021, patient still has welts and hives on face and healing bruises on thighs, has been taking diphenhydramine with little improvement.
Fast pulse; No energy; achiness; Severe headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast pulse), ASTHENIA (No energy), PAIN (achiness), HEADACHE (Severe headache) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEART RATE INCREASED (Fast pulse), ASTHENIA (No energy), PAIN (achiness), HEADACHE (Severe headache), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Fast pulse), ASTHENIA (No energy), PAIN (achiness), CHILLS (Chills) and NAUSEA (Nausea) had resolved and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details was not reported by the reporter.
Hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a patient of an unknown age and gender 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. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Information has been received from a physician concerning a 15 week old female who was vaccinated with a first and second 2 ml oral dose of Rotateq (Lot# 655864/1082F) on 20-FEB-2007 and 20-APR-2007, respectively. It was reported that there were no problems after the first dose of Rotateq. On 28-APR-2007 the patient was lifting her legs in discomfort, and crying in pain and there was abdominal distension with pain after a feeding. Two ultrasounds were performed and neither showed any signs of intussusception. Intussusception was suspected but was never formally diagnosed. Subsequently, the patient recovered. It was noted that the physician did not want to give the third dose of Rotateq. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. 08/31/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 15 week old female, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of ROTATEQ (Lot# 655864/1082F) on 20-FEB-2007 and 20-APR-2007, respectively. It was reported that there were no problems after the first dose of ROTATEQ. Concomitant vaccines administered on 20-APR-2007 included a second intramuscular dose in the right upper leg of PEDIARIX (Lot# AC21B07AB) and a second intramuscular dose in the left lower leg of ACTHIB (Lot# UF119AA). There was no illness at the time of vaccination. On 28-APR-2007 the patient was lifting her legs in discomfort, and crying in pain and there was abdominal distension with pain after a feeding. Two ultrasounds were performed and neither showed any signs of intussusception. Intussusception was suspected but was never formally diagnosed. Subsequently, the patient recovered. It was noted that the physician did not want to give the third dose of ROTATEQ. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that the patient had abdominal pain for 2-3 days and then recovered. Additional information has been requested.
Orange-ish yellow color appeared on hands (color of iodine)  was noticed on Saturday  Night 2/20/21 and lump developed above left clavicle noticed Sunday Morning 2/21/21. No treatment was performed.
Taste Aversions, a lot of things taste spoiled and there is a very odd smell I get randomly.
Shoulder and neck ache, headache, nausea, stomach pain, tiredness, redness of site, stomach upset.
PT c/o dizziness and waves of tightness in chest 20 minutes after receiving #2/2 Pfizer vaccine to left deltoid.  Skin noted to be cold and clammy.  No c/o pain, no shortness of breath, PT alert, oriented & talking.  PT cooperative and answers questions.  PT stated he had a history of bradycardia & seen by a doctor.  PT stated that he continued to feel fine up till current time.  No medication given, no long term health conditions reported. VS at start of reaction... 2:40pm HR 66, O2 sat 98%, BP 126/75, RR 20, 2:50pm HR 60, O2 sat 98%, BP 155/65, RR 24 EMT called at 2:50pm and arrived 3:10pm  VS at 3:00pm HR 60, O2 sat 98%, BP 140/60, RR 20 VS at 3:05pm HR 61, O2 sat 98%, BP 135/55, RR 24  PT assessed by EMT, PT refused transport to medical facility, PT stated he felt better but stated he continued to feel light tightness in chest without dizziness.  PT left vaccination room and returned to office in same building.  PT encouraged to call for medical attention if further dizziness is noted.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) positive. Therapeutic measures were taken as a result of covid-19.  Additional information: Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating and Seriousness criteria-Congenital anomaly/birth defect: No; Relevant past drug history: Name of Drug as Reported: No/ Reaction: Allergy. If vaccine received: Yes; other medication in 2weeks: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.