chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore muscles (not to touch) left arm; could not raise above head; fever 100 degrees; chills; weakness in legs; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in left arm on 05Mar2021 at 10:00 (at the age 64-years-old) as 2nd single dose for COVID-19 immunization. Patient's medical history included known allergy of sulfa. The patient's concomitant medication was not reported. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in left arm on 12Feb2021 at 12:00 PM. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the nursing home/senior living facility. Patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine and other medications in two weeks. The patient had not been tested for COVID19 nor before neither since the vaccination. The patient experienced after 23 hours later, sore muscles (not to touch) left arm, could not raise above head; fever 100 degrees, chills and weakness in legs on 06Mar2021 at 09:00. The patient underwent lab tests and procedures which included body temperature was 100 degrees. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Left arm became inflamed at site of injection one week after the first dose. This is a very mild reaction. My arm is simply red around the the site and a little itchy. Just trying to add to the data on reactions to the Moderna vaccine. I am fine!
Initial unsolicited report received from a Consumer on 11 May 2016. This case involves a 52-year-old female patient who was vaccinated with a dose of Tetanus vaccine (batch number, expiry date not reported) intramuscularly in left arm on 10 May 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included reflex sympathetic dystrophy syndrome on right leg and seasonal allergies and illness at time of vaccination included pain and swelling in leg and right arm. Concomitant medications were not reported. On 10 May 2016 (by the evening), same day following the vaccination, the patient had experienced soreness at the injection site. Patient's left arm, above the injection site was swollen and the swelling wraps around to the back of the arm and the shoulder. Patient could not approximate the size of the swelling and pain when she lifts the left arm. No redness noted by patient. No other symptoms reported. Relevant diagnostic tests/laboratory data included blood work was done in the office, result was pending. Corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none.
Heavy night sweats; Joint pain; Sore injection site; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Oct2021 at 19:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergies to yeast and penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Sep2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation and received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 04Oct2021, the patient experienced heavy night sweats, joint pain and sore injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heavy night sweats, joint pain and sore injection site was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Developed throbbing headache, high fever, severe pain at injection site, and extreme body pain.  Symptoms began approximately 10 hours after vaccine and lasted about 24 hours.
Heart went into Atrial fibrillation causing blood clotting. He has no prior heart condition.  A blood clot traveled to his brain causing a Posterior Cerebral Artery Stroke. He has been in ICU since 04/22/2021.
Moderna COVID-19 Vaccine EUA For a couple of days after injection had the usual tenderness at site. Then nothing.  Nine days later itching at site and some redness.  This has continued through today with redness being very light colored now but still some itching.
really affects my coagulation; This spontaneous case was reported by a patient and describes the occurrence of COAGULATION FACTOR DECREASED (Coagulation factor decreased) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination.     Concomitant products included PRAMIPEXOLE for Restless leg syndrome, WARFARIN SODIUM, METOPROLOL, PRAVASTATIN, TAMSULOSIN, DIGOXIN, MULTIVITAMIN [VITAMINS NOS] and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced COAGULATION FACTOR DECREASED (Coagulation factor decreased). At the time of the report, COAGULATION FACTOR DECREASED (Coagulation factor decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prothrombin time (2.0-3.0): 1.4 (Low) decreased.         The patient's concomitant medicines also include  Dorzolamide eye drops in both eyes thrice daily.  The patient enquired if the Moderna vaccine have had any effect on the prothrombin time. But there was no information available in US FAQs to answer the query. When agent placed a call back to the patient, the call had ended. Agent attempted to callback several times, without success.  There is no product complaint associated with this case. Treatment medication information was not provided.
Parents noticed large, red area on left deltoid area 6/14/07 11:00 a.m approx. 5 inches x 6 inches, hard, red, hot.  Painful with movement and touch.  Low grad fever 100.5.  No other symptoms.  Ice applied.  Recommended Motrin, ice.  Drew line around redness.  Advised if no improvement by tomorrow 6/16/07 go to provider (DR.)Seen in our office 6/15/07.
I started to feel pressure build up on the inside of my body & almost started to blackout.  It seemed like Heat Inflammation.
4:00 PM arm hurt a little bit. At midnight was freezing like nobody's business and this lasted 4 hours. Chilling. Arm pain and whole body hurts. From toe nails to hair. All joints hurt. Could not sleep.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, Fatigue, sore arm, Narrative:  Fatigue, headache, sore arm, fever 101.7, myalgia, N/D.
This spontaneous report was received from a nurse via Poison and Drug Center (PDC) refers to a patient of unknown gender between the age of 2 years and 5 years old child. The patient's relevant medical history, past drug history and concomitant medications were unknown. On 26-MAY-2015, the single dose vial of PROQUAD (Merck) underwent temperature excursions 5.3 degrees Celsius for 2 hours and 8 minutes. On 02-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K014798 and expiration date 12-MAR-2016) via injection (dose, frequency and indication were unknown). The patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. As of 05-AUG-2015, it was unknown if the patient continues on PROQUAD (Merck). This is one of the eight reports received from the same source. Additional information has been requested.
Patient developed a 2.5 cm hematoma and stated it was itchy.  Inspection and light palpation showed lump under skin with redness, no rash.
Had symptoms that night but went away by morning except for the muscle pain that targeted an untreated vehicle accident injuries until the following night. Friday night and all of Saturday (almost 2 months later) I've been having a cough, headache, fever, muscle pain, runny/stuffy nose, irritability, and loss of appetite, smell, and changed tastes. I've self-isolated until I can get tested but it feels like the flu. But it's late June.
- Pain in palm of left hand immediately after receiving the injection - Left shoulder/trap pain starting a few hours after injection that continued throughout the night. Couldn?t sleep on left side.  Full pain by left shoulder blade too. Symptoms lasted for about a day or two.  - On eighth day after the injection I noticed stinging pain in the palm of my left hand, and also pain in my left elbow going down to center of my palm, pinky finger, and ring finger.  Fingers/hand felt weak like I couldn?t grasp anything.  Elbow felt like I hit my ?funny bone? with shooting pain down by forearm.  Upper shoulder felt okay.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 36.31 for dose administered on 15-Apr-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00AM. This vial was moved to fridge 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Inflammatory reaction/ inflammation; Nodules/ granulomatous nodules; Swelling and lumpiness; This spontaneous case was reported by a health care professional and describes the occurrence of INFLAMMATION (Inflammatory reaction/ inflammation), NODULE (Nodules/ granulomatous nodules ) and SWELLING (Swelling and lumpiness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient was injected with Restylane Defyne around the jawline in September 2020.  The patient's past medical history included Anxiety, Depression and Dermal filler injection. Concurrent medical conditions included Sulfonamide allergy and Restless legs. Concomitant products included Restylane Defyne for an unknown indication.    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 INFLAMMATION (Inflammatory reaction/ inflammation), NODULE (Nodules/ granulomatous nodules ) and SWELLING (Swelling and lumpiness). At the time of the report, INFLAMMATION (Inflammatory reaction/ inflammation) outcome was unknown and NODULE (Nodules/ granulomatous nodules ) and SWELLING (Swelling and lumpiness) was resolving.        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.   Patient was injected with Restylane Defyne around the jawline in September 2020.  Follow up: Treatment provided was several rounds of injectable treatments to help reduce the inflammation in the area.  The patient had had a COVID-19 vaccine 7 to 8 weeks prior to seeing reporter on April 20 of 2021. A couple of weeks after  patients vaccine  developed swelling and lumpiness consistent with granulomatous nodules in the area where  had facial fillers placed which was below the oral commisure.The patient  has had a dramatic improvement, the reporter expect that this will resolve with further treatment. There should be no long lasting deformity or problems from this.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updated reporter information. Updated patient information i.e age, race, sex  and medical history.Added events swelling and lumpiness,  granulomatous nodules both outcome recovering.Updated all events outcome to recovering.
Narrative:  74yo male patient with diagnosis of end stage renal disease on dialysis with history of noncompliance with dialysis visits and has missed up to 1-2 weeks at a time even though has been educated on the importance of routine dialysis has died on 8/11/2021 with no hospitalizations and no notes regarding pt's death. Pt had covid vaccines on 5/28/21 & 3/31/21. Pt's PROBLEM LIST: Diabetes HTN Hyperlipidemia CKD 5 COPD BPH PTSD Anemia Restless legs Gout Low back pain This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Facial twitching that began about 1-2 hours after injection. The facial twitching lasted about 24 hours.
Administered DTAP to a 7 yr old. Client behind on all shots. Gave DTAP in lieu of Td in error. No complications. No adverse event.
This is a prospective pregnancy case. This female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX .5 ml on an unknown date. On unknown date, an unknown time after receiving BOOSTRIX the subject developed drug exposure during pregnancy (Non-serious). The outcome of drug exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: Gestational age was unknown. Estimated date of delivery is unknown. No other adverse events were reported.
His entire arm from clavicle to wrist is red, swollen, and itchy.
Dizzyness, nausea, flushed, tingling in the legs. VR reported typical reaction to all vaccines minus leg tingling.
Shortness of breath, X-ray on chest - slightly enlarged heart, hands tremor, hard time walking, unable to stand straight.
presented with R side weakness and fall Dx  CVA, Covid PNA; Labs D dimer 2.0, CRP 1.33 ferritin 194; Tx: Decadron, Remdesivir (start 2/6), lovenox, Initially on 2 LPM O2, up to 4 LPM max and back to room air by d/c; going to rehab at d/c
entered room  drooling .  right sided neglect  BP elevated  .  not following command  send to ER   Admited to hospital with CVA                                                                                               PCP Note upon return - Patient is a 67-year-old female with past medical history of hypertension, MS, dementia, CHF, chronic kidney disease and hyperlipidemia who was sent from the facility to the emergency room for altered mental status and possible CVA.  In the emergency room,  blood pressure was elevated at 170/100 and she was noted with more pronounced weakness in left upper extremity and lower extremity and left gaze. Neurosurgery was consulted and deemed patient a poor candidate for TPA due to recent GI bleed. Stroke workup was negative for acute findings and a brain MRI ×2 was negative. EEG was ordered to rule out seizure and it was normal and neurologist recommended to start patient on Keppra.  Patient was initially started on aspirin which was stopped due to drop in H&H.  Patient was also noted with low-grade fever and infectious workup including blood cultures, UA and extensive imaging did not have evidence of infection and COVID-19 was negative.  Social services spoke to patient's sister who is the POA regarding advanced directives and she requested to change advanced directives to DNR/DNI/no PEG and orders noted in chart. Patient's symptoms progressively improved and discharged back to the facility and resting in bed comfortably in no acute distress
Generalized redness, throat tightening given oxygen, Benadryl 50 mg IM prednisone increased to 40 mg BID for 5 days
blood sugar fluctuated and became unmanageable; flu like symptoms; headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE FLUCTUATION (blood sugar fluctuated and became unmanageable), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31A21A) for COVID-19 vaccination.    Co-suspect product included non-company product OXYCODONE for an unknown indication.    Concurrent medical conditions included Diabetes mellitus. Concomitant products included INSULIN for Blood sugar level fluctuation.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started OXYCODONE (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE FLUCTUATION (blood sugar fluctuated and became unmanageable), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache). The patient was treated with IBUPROFEN for Headache, at a dose of 1 dosage form. At the time of the report, BLOOD GLUCOSE FLUCTUATION (blood sugar fluctuated and became unmanageable), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (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.   .
This spontaneous report as received from a physician via field employee refers to unspecified patients of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL injection (dose, frequency and indication were not reported). Other suspect therapy was GARDASIL 9 (dose, frequency and indication were not reported). Patients who started the HPV series with GARDASIL vaccine were administered either 1 or 2 doses of GARDASIL 9 to complete the series. No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
When we came home from the doctor, I fed her lunch and put her down for a nap. Then she woke up crying and threw up five times over the course of two hours. After that, I tried giving her some water, but she threw up a sixth time. She seemed tired, uncomfortable, and unfocused. After three hours, she suddenly seemed completely back to normal and was able to hold down clear fluids and eventually food.
Woke up next day with 100.1 fever, vomiting, headache, fatigue, sore arm Sent email to Dr. to notify him and make note in  file.
intense swelling in hands and feet making it difficult to walk/grasp; intense swelling in hands and feet making it difficult to walk/grasp; intense swelling in hands and feet making it difficult to walk/grasp; hives on legs/hives covered most all of body to include face and neck; mild fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248; Expiration Date: Apr2021), via an unspecified route of administration on 23Mar2021 08:00 as dose 2, single for COVID-19 immunization. Medical history included ongoing Scalp disorder. Concomitant medication included ongoing topical steroid for scalp. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced mild fatigue and headache on an unspecified date in Mar2021, hives on legs/hives covered most all of body to include face and neck on 26Mar2021 and intense swelling in hands and feet making it difficult to walk/grasp on 27Mar2021. It was reported that morning of 26Mar2021, began to notice hives on legs. By end of day 26Mar2021, hives covered most all of body, went to urgent care, and began taking Benadryl to no effect. By morning 27Mar2021, hives covered all of body to include face and neck, intense swelling in hands and feet making it difficult to walk/grasp. Returned to urgent care, no life-threatening danger, received prescription strength antihistamine which helped reduce symptoms. Morning 29Mar2021, back to regular fatigue and mild swelling, no hives. Outcome of event mild fatigue was not resolved; Outcome headache was unknown. Event hives on legs/hives covered most all of body to include face and neck was resolved on 29Mar2021; intense swelling in hands and feet making it difficult to walk/grasp was resolving.  No follow-up attempts are possible. No further information is expected.
Redness, soreness, swelling at the site of injection, diarrhea, dizziness, headache, neck pain, fatigue, fever, chills - Pt referred to Urgent care or ER for further evaluation of symptoms on 5/5/2021 at 12:50pm
Flu shot was administered on 11/7/11. Patient's arm (left) got swollen on 11/8/11.
Seizure. Lasted approximately 10 sec. Entire body was shaking. Pt was transported via ambulance to the ER where w/u was performed, and pt was admitted for obs. He was released after 2 days with no further Sx.
I have been having heaviness of the chest when leaning forward. And concerning amounts of heart rhythm issues during my normal exercises that I have been doing for years. I thought my heart was going to stop I had my finger over 911 ready to call if it did.