chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right Ankle Fracture; Wound Infection from a Right Ankle Fracture; Delayed Second Vaccine (Not received yet); This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (Right Ankle Fracture) and WOUND INFECTION (Wound Infection from a Right Ankle Fracture) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ANKLE FRACTURE (Right Ankle Fracture) (seriousness criteria hospitalization and medically significant) and WOUND INFECTION (Wound Infection from a Right Ankle Fracture) (seriousness criteria hospitalization and medically significant). On 22-Apr-2021, the patient experienced OFF LABEL USE (Delayed Second Vaccine (Not received yet)). The patient was hospitalized on 30-Mar-2021 due to ANKLE FRACTURE and WOUND INFECTION. At the time of the report, ANKLE FRACTURE (Right Ankle Fracture), WOUND INFECTION (Wound Infection from a Right Ankle Fracture) and OFF LABEL USE (Delayed Second Vaccine (Not received yet)) outcome was unknown.        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.   The Hospital did not have Moderna Vaccine and they refused to allow the Nursing home to send someone to the hospital to vaccinate her. Agent provided the case# and instructed the caller to update Moderna, If and when the patient is vaccinated with the second dose, the date and the lot# for both doses of Moderna COVID-19 Vaccine.  Company comment: Based on the current available information, and not knowing the circumstances that resulted in the ankle injury, a causal relationship with the events cannot be excluded.; Sender's Comments: Based on the current available information, and not knowing the circumstances that resulted in the ankle injury, a causal relationship with the events cannot be excluded.
Patient experienced chest pain immediately after receiving vaccine.  Chest pain lasted about 2 hrs.  Vaccine left a large bruise on right deltoid about 1-2 inches in diameter.
Extended local reaction to flu shot in left deltoid. Itching, erythema, pain, swelling extending into shoulder.
temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 08-APR-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  with dose reported as 1 administered subcutaneously  (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
allergy like symptoms; Excessive sneezing; Eyes itching; Throat not closing up; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration in the left arm on 20Jan2021 23:30 at a single dose for COVID-19 immunization. The patient's medical history included hypertension and seasonal allergy. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications were not reported. It's winter and patient have self-isolated for 2 1/2 months. On22Jan2021, the patient experienced allergy like symptoms such as excessive sneezing, eyes itching, and throat not closing up. Throat not closing up and sneezing lessened with nasal spray. The patient did not receive treatment for the rest of the events. She didn't checked her temperature. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
patient developed symptoms starting on 7/25/2021, including runny nose, fatigue, and loss of smell / taste.  She tested positive for COVID on 7/27/2021.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache), FATIGUE (feeling tired), CHILLS (chilly) and MUSCULOSKELETAL STIFFNESS (stiff arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included Thyroid disorder NOS, Heartburn, COPD and Heart rate abnormal. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, ATENOLOL for Heart rate, FAMOTIDINE for Heartburn, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ACETYLSALICYLIC ACID (BABY ASPIRIN) for unk. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced FATIGUE (feeling tired). On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 18-Jan-2021, the patient experienced CHILLS (chilly) and MUSCULOSKELETAL STIFFNESS (stiff arm). On 25-Jan-2021, PAIN IN EXTREMITY (sore arm), HEADACHE (headache), FATIGUE (feeling tired), CHILLS (chilly) and MUSCULOSKELETAL STIFFNESS (stiff arm) had resolved.    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. Patient was treated with Tylenol and using heating pads to warm up. Concomitant products included vitamins. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No specific follow-up information recorded.
Received vaccinations approx. 345pm. Approx 650pm baby woke up screaming, high pitched scream for several hours (until approx 10pm). Nothing would calm my baby that normally would. Called MD spoke with nurse. Told to give TYLENOL. She cried to the point that she had to catch her breath. I was told she had a reaction, most likely DTaP part of vaccine (per MD).
Patient had severe right arm pain within a few hours after injection resulting in an emergency room visit. Patient was also nauseous and lightheaded after vaccine.
No adverse event; Patient received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .2 milliliter. On 28-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine).    No concomitant medications were reported.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-724187 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724187:same reporter
closing of the throat; This is a spontaneous report from a contactable consumer. A 91-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date (at the age of 91-year-old) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient has been tested for COVID-19. On an unspecified date after second dose, the patient experienced a sensation of the closing of the throat. The patient called 911 and EMTs came to assist. She declined going to the hospital and stayed with her daughter that night for observation. The symptoms subsided by the next day. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
swelled up, his hands, feet and legs; He had issues with arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: He had issues with arthritis; "Car accidents" (unspecified if ongoing), notes: he played ball, football and baseball and had been in a couple of car accidents. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelled up, his hands, feet and legs"; ARTHRITIS (non-serious), outcome "unknown", described as "He had issues with arthritis".  Additional information: Caller states that her son had the Pfizer shot and he swelled up, his hands, feet and legs. He had issues with arthritis and he played ball, football and baseball and had been in a couple of car accidents. Caller declined to proceed with report on her son.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Patient received Pfizer COVID vaccine on 2/17/21 (out of state), 3/10/21 (out of state), and 9/8/21. Patient was initially diagnosed with COVID in May 2022 and had been hospitalized at an outside hospital several times since then. He had persistent acute on chronic hypoxic respiratory failure of unclear etiology in the setting of persistent COVID-positive testing. On 8/13/22, patient admitted to our inpatient facility CCU with acute on chronic hypoxic respiratory failure due to long COVID-19 and pulmonary fibrosis. Patient expired on 8/17/22.
improper product storage; No adverse event; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown. On 20-FEB-2020, the patient received a dose of improperly stored (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose with lot # 1660112, expiration date 18-OCT-2020 (anatomical location, route of administration was unknown) for prophylaxis. The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at multiple temperature excursions of below 2 degrees Celsius (1.28 degree Celsius) for a time frame of 2 hours and 30 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Tested positive on 11/04/21.  Feels "fine"  tested because we had two residents test positive.  All residents had to be tested.
Lightheaded 20 minutes after the vaccine, no other symptoms. BP 144/70, pulse 68, O2 sat 100%. Patient offered water/juice, refused. Stable to go home.
Patient received her 1st Pfizer booster shot and started experiencing anxiety and reported high blood pressure in observation. Vital signs were as follows: 142/90 blood pressure, heart rate 65, respirations 15, SPO2 97%. She did not report any other symptoms at this time. Taken to ambulance truck via paramedics. Next set of vital signs: 190/109 blood pressure, heart rate 63, respirations 18, SPO2 96%. Per patient daughter, she does not have history of high blood pressure. Patient did not look to be in distress, shortness of breath or any chest pain. She had slight discoloring of lips, but talking without distress. Next set of vital signs: 173/86 blood pressure, heart rate 65, respirations 18, SPO2 97%. Educated by patient still sitting without distress and talking to paramedics and her daughter. Next set of vital signs: 164/86 blood pressure, heart rate 65, respirations 18, SPO2 97%. On back of paramedics paper, safety officer listed when family should take her to the ER based on vital signs, if feeling shortness of breath, chest pain or difficulty breathing. Next set of vital signs were: 154/90 blood pressure, heart rate 61, respirations 18, SPO2 97%. Cleared by safety officer to go home and rest over the weekend. Patient left site without any symptoms and feeling safe to go home. Safety officer called patient's daughter on 1/11/2022 to check up on patient and was told family took patient to the ER over the weekend for blood pressure 130/90 but told to go home. She has a PCP appointment this week and will take list of vital signs to MD for review.
Patient vomited and fainted. We already had EMS here for his sibling. He was also fine after resting and calming down.
Moderna vaccine was administered - reported by patient.  G40.901 STATUS EPILEPTICUS, GRAND MAL 8/22/2022 FEMALE BREAST CANCER, UNSPECIFIED SITE OF RIGHT BREAST G40.909 GENERALIZED EPILEPSY 7/21/2022 FEMALE BREAST CANCER, UNSPECIFIED SITE OF RIGHT BREAST G40.901 STATUS EPILEPTICUS, GRAND MAL 8/22/2022 CANCER METASTATIC TO BRAIN G40.909 GENERALIZED EPILEPSY 7/21/2022 CANCER METASTATIC TO BRAIN G40.901 STATUS EPILEPTICUS, GRAND MAL 8/22/2022 SEIZURE, UNSPECIFIED G40.909 GENERALIZED EPILEPSY 7/21/2022 SEIZURE, UNSPECIFIED
Extreme fatigue , hypothermic 1 week 97.2 . Low grade fever today 99.7 . Nausea . Multiple joint pain .
Information has been received from a registered nurse concerning a 31 month old male child with no past medical history, no known drug allergies, and no illness at the time of vaccination, who on 01/19/2000 was vaccinated with the first dose of varicella vaccine SC in the right leg. There were no concomitant medications. On 06/29/2001, the child developed 25-50 vesicles on the abdome, chest and extremities and a temp of 99.7 deg. F. The pt sought unspecified medical attention. It was noted that the child was treated with Benadryl and calamine lotion. Tylenol and oatmeal baths were given as the occasion required. It was reported that the pt recovered. No further info is available.
Feel throat difficulty swallowing.  Recommended by EMS to contact primary care or call 911.  Understanding verbalized.  176/96, HR 76, BS 187, O2Sat 98%, 183/102, P 70. 197/93 11:10am Refusing transport, prefers to go home and will call 911 from home.  Accompanied by husband.
On May 5, 2021 went to work exp a fever. I woke up felt lightheaded as if I was going to faint on May 13, 2021 went to hospital at Hospital. I was hospitalized for 6 days doctors stated it was vertigo. The neurologist seen me while in the hospital told him felt as if I was going to fall out of bed. I went to see my doctor on Jun 22, 2021 had a EKG my heart rate was 43. She so worried about me informed me to go to the Hospital observed with a heart monitor and given lots of fluid. The nurse told me my heart rate went down to 38 while sleeping. I was in the hospital from June 22-23, 2021 then discharged to follow up with Cardiologist. Since October the Cardiologist stated maybe the vaccine has affected my heart. This has caused me to have a hard time performing job duties and I'm constantly in the hospital.
chills; nausea; low grade fever (99-100 F); This is a spontaneous report from a non-contactable e consumer (patient).  A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 09:30 (Batch/Lot Number: EL3247), age at vaccination of 42-years-old, as single dose, for covid-19 immunisation.  The patient medical history was not reported. The patient had no allergy. The patient was not pregnant and was not pregnant at the time of vaccination.There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced chills, nausea, low grade fever (99-100F), all on 24Feb2021 at 11:00 AM. No treatments were given. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant, refers to a currently 8 month old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ per oral, (which had a lot # of N030366 and an expiration date of 13-MAR-2019; however, dosage number was not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Body aches, chills, high fever 102.5 ..  on the 3rd day after vaccine started seeing flashes and floaters in the right eye.  Never had  eyes problem before  vaccine.  I still see flashes from the same eye  and both eyes feel weakened.  Also feel more muscle and joints pains.
Patient received last HPV 12/12/14 - was second dose. 1st dose was 10/6/14. Seen on 1/12/15 2pm for 3 wks of fatigue and intermittent episodes of right eye drooping, lip drooping on (R) and right arm and leg tremors. Also balance issues and slurring of speech which is intermittent.
having aches in my right shoulder, neck, and leg/shoulder pain/joint pain; having aches in my right shoulder, neck, and leg/neck pain; having aches in my right shoulder, neck, and leg/her right leg from her feet to her thigh, it feels like a muscle ache or a little pain; muscle aches; arthritis has gotten worse; muscle pain; This is a spontaneous report received from a contactable consumer. This consumer reported for herself (patient) that the 63-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2) for covid-19 immunization. The patient experienced having aches in my right shoulder, neck, and leg/shoulder pain on an unspecified date with outcome of unknown, having aches in my right shoulder, neck, and leg/neck pain on an unspecified date with outcome of unknown, having aches in my right shoulder, neck, and leg/her right leg from her feet to her thigh, it feels like a muscle ache or a little pain on an unspecified date with outcome of unknown, muscle aches on an unspecified date with outcome of unknown, arthritis has gotten worse on an unspecified date with outcome of unknown, joint pain on an unspecified date with outcome of unknown, muscle pain on an unspecified date with outcome of unknown.    The clinical course was reported as follows: I had the first shot either March 1st or the next Monday nd my last one was on the 29th of March. In between I didn't think nothing about it but I've been having aches in my right shoulder, neck, and leg. It's mostly at night. I put cream on it for muscle aches but this is not going away. It's not all the time just mostly at night. She was having symptoms after getting the Covid 19 vaccine and she is asking if anyone else is having these symptoms. She has neck pain and shoulder pain and her right leg from her feet to her thigh, it feels like a muscle ache or a little pain. She puts some cream on it and it goes away. It doesn't hurt all the time, mostly at night. She told the lady yesterday that she spoke with she had these symptoms. She does report she has arthritis but it has never affected her every day. She thinks maybe her arthritis has gotten worse. She was reading over the paper that has side effects from the Covid 19 vaccine and it talks about muscle pain and joint pain. She has questions. She reports the facility kept her vaccine card after she received her second dose. She thinks she received her first dose on 01Mar2021 or 08Mar2021 and she received her second dose on 29Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Day after receiving flu vaccine, I broke out in hives and had uncomfortable itching.  The following day I took an Alavert tablet, and the itching stopped in about 45 minutes.  Itching did not return.