chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 64-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients. The reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  No treatment medications were reported.
pt recvd vax 6JUN95 & was presented to hosp on 11SEP95 w/high fever & szs; culture of CSF fluid grew H influenzae type B; pt was treated w/IV Claforan & Dilantin; Pt had addlt szs on 14SEP95;
This spontaneous report was received from the patient's father, referring to his daughter, a 18 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In March 2016, at her 18 years old, the patient received her first dose of GARDASIL 9 for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). However, after getting that first dose, the patient ended up experiencing headache. Then, the patient's father explained that his daughter's physician still recommended the patient get the second dose of the GARDASIL 9 vaccine, which the patient received in November 2017. Although, it was very late since it was outside of the recommended 2 months dosing schedule period for the second dose administration in the series per the official Prescribing Information. At the reporting time, reported as "currently", the patient's father said that his daughter, at her 20 year-old, still had not received the third and final dose in the series; thus, the third dose had not been administered. The outcome of headache was unknown. The causality assessment between the headache and GARDASIL 9 was not provided.
This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown dates in April 2016 (also reported as from 05-APR-2016), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L028645, expiry date 25-MAY-2017; lot # L008059, expiry date 18-DEC-2016 and lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Pfizer/BioNTech-Dose Number: 4/Moderna-Dose Number: 1,2,3,5; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 56 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 037K20A), on 09Feb2021 as dose 2, single (Lot number: 012M20A), on 24Oct2021 as dose 3 (booster), single (Lot number: 091D21A) and on 09Sep2022 as dose 5 (booster), single (Lot number: AS7143C) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Indomethacin, reaction(s): "Known allergies: Allergic to Indomethacin", notes: Known allergies: Allergic to Indomethacin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Mar2022, outcome "unknown", described as "Pfizer/BioNTech-Dose Number: 4/Moderna-Dose Number: 1,2,3,5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative; (22Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Paxlovid was taken as an treatment for Covid-19 started from 21-NOV-2022 .; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective, Interchange of vaccine products and COVID-19 cannot be ruled out.
Pt received vaccine on 1/7. Started having symptoms of fever, body aches, fatigue, headache, sore/dry throat, diarrhea, and vomiting.
sore arm; 25 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) and MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to codeine).    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 21-May-2021 and the estimated date of delivery was 25-Feb-2022. On 05-Nov-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant). On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 05-Nov-2021, MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant) had resolved. At the time of the report, INJECTION SITE PAIN (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided Company Comment : This spontaneous case of maternal exposure during pregnancy concerns a 37-year-old female patient with no relevant medical history who experienced non-serious expected event of injection site pain. The patient did not experience any adverse events associated with maternal exposure during pregnancy. The event injection site pain- occurred unspecified time after the third, booster dose of the Moderna COVID-19 vaccine . The patient was 25 weeks pregnant at the time of vaccination. Rechallenge was not applicable since  the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case of maternal exposure during pregnancy concerns a 37-year-old female patient with no relevant medical history who experienced non-serious expected event of injection site pain. The patient did not experience any adverse events associated with maternal exposure during pregnancy. The event injection site pain- occurred unspecified time after the third, booster dose of the Moderna COVID-19 vaccine . The patient was 25 weeks pregnant at the time of vaccination. Rechallenge was not applicable since  the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
painful arm that received the vaccine, gas and cramping, headache, fatigue, stiffness
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included squamous cell carcinoma (named head, neck and shoulder cancer and required chemo and radiation 10-15 years ago), thyroidectomy and cancer surgery. Concurrent medical conditions included muscle atrophy (muscle loss in his left arm from cancer surgery done 10 to 15 years ago). Concomitant products included Baking Soda, Levothyroxine, Magnesium, morphine, MUCINEX, PERCOCET and Potassium. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. The reporter considered the injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The SHINGRIX vaccine was administered in the right arm and pain presented in his right arm 2 to 3 hours after receiving the SHINGRIX vaccine and resolved after 3 days although was so severe at the time it was immobilizing. The patient was not certain of the exact date of the first shot but assumed it was 2 months ago because his pharmacy called him to remind him to come in to get the second shot. This case was linked with US2018GSK107452, reported for same patient for 2nd dose of SHINGRIX.
Muscle discomfort; Muscle pain; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle discomfort in both arms and muscle pain (Myalgia).  The patient's medical history was not provided. Concomitant medication was not provided by the reporter.  On an unspecified date in Jan 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   Post receiving the vaccine, the patient experienced muscle discomfort in both arms. The patient wanted to know if there is anything the patient could take to relief the muscle pain.  Treatment information was not provided by the reporter.   Action taken with mRNA-1273 in response to the events were unknown.   The outcome of the event, muscle discomfort in both arms and muscle pain, were considered unknown on an unknown date.
lip swelling approx 26 hours following vaccination. No other s/s of anaphylaxis. 50 mg of benadryl  taken with no improvement
Patient developed severe rash on upper portion of body with severe itching six days after the vaccination.  As of this report, rash continues to spread.  Patient has been seen by a nurse and prescribed Methylprednisolone for treatment.
Chest pain; Atrial Fibrillation; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 02Oct2021 at 15:30 (Lot Number: 30155BA, unknown expiration) as dose 1, single at the age of 50 years old for COVID-19 immunization.  Medical history included COVID (If COVID prior vaccination: Yes). No known allergies. No other medical history. No other vaccine in four weeks. Concomitant medication included omeprazole. On 04Oct2021 at 22:00, the patient experienced chest pain and atrial fibrillation. The patient was tested for COVID-19 post vaccination via nasal swab on 07Oct2021 with negative result. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient received treatment for chest pain and atrial fibrillation. The patient has not yet recovered from the events. The events were assessed as serious (hospitalization for 1 day).   Information on the lot/batch number has been requested.
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All     COVID VACCINE CLINIC 3/16/2021    Patient                                                        Date:  3/16/2021                                                                              Subjective Patient is a 44 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience headache.  She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness and facial swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain and rapid progression of symptoms.   PMH includes htn Currently taking lisinopril and hctz.   ALLERGY REVIEW OF SYSTEMS:  Patient complains of headaches   Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain and dizziness       Previous Reactions: none    Objective    Vitals Vitals:   03/16/21 1103 BP: 120/88 Pulse: 71 SpO2: 100%      Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is not diaphoretic.  HENT:     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Eyes:     Extraocular Movements: Extraocular movements intact.     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.     Gait: Gait normal.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: water, snacks and tylenol Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns)   Headache   VS stable. Exam unremarkable. Monitor at home. Follow up with pcp. Pt walked out with son w/o assistance.    APRN Electronically Signed 3/16/2021 11:02 AM
Numb left hand and tightness in jaw left side on 3rd day after vaccine booster lasting a week. Pain in side of neck left side possibly lymph nodes.
2 hours after receiving immunization, client reports that she had difficulty breathing, chills, sweating and chills. Client was transported by EMS to Pauls Valley General Hospital. Client received O2 2L nasal cannula, IV of Normal Saline, Benadryl 25mg and solumedrol 125mg in ambulance.  At emergency room client received epinephrine .3 sub-q, xopenex 1 amp via nebulizer, pepcid 20mg IV.
Initially I had experienced the standard adverse effects of drowsiness, a little difficulty sleeping, minor chills. The next day following my Dose 1 of the Moderna Vaccine, I started noticed chest pains on both sides of the chest. It wasn't from breathing and not very consistent or something I could re-create on command. It seemed to happen every hour for a few seconds and was a sudden, sharp pain. That was a concern for me so I did some basic internet searches and found that Chest pains are a symptom of the vaccine. I didn't think too much of it after that but It was a concern I kept in my head. My timeline gets a little foggy here but either that same day or the following day, the chest pains were still happening and I wasn't feeling 100%. One evening I went to take a bath. As I was laying in the water, my heart rate felt off, almost as if it was skipping a beat or not in the right rhythm. I remember laying in the bathtub, trying to count my pulse or seeing if I could "catch" the incorrect beat.  Rather than one normal heartbeat it felt like there was 2 beats very closely timed with each other. My heart rate felt faster than normal considering I was only laying down in water and didn't do any exercises the past few days. Unfortunately I never was able to find a good way to track the pulse and timing, but I was sure that something was wrong. I had difficulty sleeping that night because I kept feeling something wrong with my heart rhythm.  I got worried that I would need to go to the emergency room, but I told myself to sleep it off and if the chest pains and awkward heart beat continues for 5 days, I would go see a doctor. As for an outcome, thankfully I stopped noticing it around day 4 and haven't had chest pains since.  I am extremely worried as to how my body will react to Dose #2.
Started about 3 days after second dose. (First dose was 4/1/21). Constant, low volume hissing/buzzing/whistling in my head. Hard to describe.  No other symptoms.  It is not painful, just slightly annoying. Has not changed in frequency or intensity as of this reporting. Hopefully it will resolve? I have never had this sensation  before other than short term side effect of certain OTC pain meds meds. No hx of tinnitus.
Cough; Sore throat; Stuffy nose; Dry heaving; Fever; Muscle pain; Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 20Jul2022 at 14:00 as dose 1, 0.3 ml single (Lot number: FM0173, Expiration Date: 06Dec2022) at the age of 29 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 26Jul2022, outcome "recovered" (27Jul2022), described as "Fever"; MYALGIA (non-serious) with onset 26Jul2022, outcome "unknown", described as "Muscle pain"; HEADACHE (non-serious) with onset 26Jul2022, outcome "not recovered", described as "Severe headache"; COUGH (non-serious) with onset 27Jul2022, outcome "not recovered"; RETCHING (non-serious) with onset 27Jul2022, outcome "not recovered", described as "Dry heaving"; OROPHARYNGEAL PAIN (non-serious) with onset 27Jul2022, outcome "not recovered", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 27Jul2022, outcome "unknown", described as "Stuffy nose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got first vaccine on 20Jul2022 and had really bad reactions the day before this report. The patient spent most of the day before this report from 4am-12 pm with a 102 fever and was in so much pain from muscle pain and headache.The fever started at 4am in the morning and broke the day before this report about 1 pm and then got another one that started last night and broke about 4am this morning. Still had headache and the fever broke around 2am in the morning on the day of reporting. The patient worked in animal medicine.There was no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. There were no AEs following prior vaccinations. No family history relevant to AEs. There were no relevant lab tests. The events did not result in emergency room/physician visit.
Lightheaded  briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
Patient was given a dose of Pfizer 5y-<12y vaccine on 10/5/2022. After administration, it was realized that vaccine had expired on 9/30/2022.
pt broke out in greater than 100 pox marks treated w/supportive measures & DPH;
Leg Pains Unable to sleep due to pains Hot spots on legs Difficulty walking Fever
Patient came in today. Stated approximately 6-7-8pm on the evening of shot given face became swollen, had blisters from chest up, and headache, followed by difficulty breathing and lip swelling two days later up to this past weekend. States he did not call 911 or go to the ER until this past weekend. Dr. aware, and patient was seen today.
Multiple Pulmonary Embolisms, chest pain and difficulty breathing, xeralto for approx 6 months
blotchy erythema around the injection site, pain, tenderness and itching MD advised rest, cold compress, oral antihistamine like Zyrtec for itching and follow up if worsening.
This report was received from the investigator on 20 May 2010. A 22 year-old male subject with a history of palpitations/pounding heart without exercise, chest pain, chest pressure, pericarditis and abnormal electrocardiogram, received ACAM2000 (lot number not reported) on 05 August 2009. The subject had previously received anthrax vaccine (other manufacturer and lot number not reported) on 23 July 2009. On Day 7 (12 August 2009), the subject had a normal Troponin I level and an abnormal electrocardiogram. Eight days after receipt of smallpox vaccine, the subject was diagnosed with unspecified disease of the pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of document held by sender: None.