chrisvoncsefalvay/vaers-outcomes huggingface dataset:
KIDNEY STONE; WEAKNESS IN BOTH LEGS, LOWER BACK AND PELVIC AREA; MORE FATIGUE/TIRED; MORE WEAKNESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included right hip replacement, and concurrent conditions included hypertension, penicillin allergy, and sulfur allergy, weakness and fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: Unknown) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 2020, Laboratory data included: Arthroscopy (NR: not provided) Not reported. The patient stated that she had been experiencing more weakness and fatigue than usual since Apr-2021 three weeks after taking vaccine. Further, the patient reported that in APR-2021, the pain intensified along with the weakness in both legs, pelvic area, and lower back 2-3 weeks after vaccination. On 20-MAY-2021, she went to emergency room for kidney stone. The patient was referred to pain specialist and stated that she felt about the same and wanted her leg to work. The patient was tired and fatigued. Laboratory data included: CAT scan (NR: not provided) Kidney stone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more fatigue/tired, weakness in both legs, lower back and pelvic area, and more weakness, and the outcome of kidney stone was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210727924-Ccovid-19 vaccine ad26.cov2.s-kidney stone. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pt developed vomiting, diarrhea, decreased appetite, cramping, abdominal pain. Positive for rotavirus after full series of rotavirus vaccine.
Flushing, diaphoresis, lightheadedness, Itch at vaccine sight, redness at sight, Induration of 30mm.
Fully vaccinated.  COVID breakthrough with inpatient hospital stay  Vaccine 1 Lot #  EN6208 Vaccine 2 Lot #   EW0150
now I feel like I have a cold with an off and on low grade fever; now I feel like I have a cold with an off and on low grade fever; This is a spontaneous report from a contactable consumer.  A female consumer of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient reported now she felt like she had a cold with an off and on low grade fever on 26Mar2021 with outcome of unknown. She stated that if she calls her doctor all they are going to tell her to take some Mucinex.  No follow up attempts are possible. No further information is expected.
Swollen glands in neck came first.  Headache was added as well as night fever resulting in loss of sleep. Leg pain. Had to take the next day off work due to lack of sleep and headache which did not go until 3 pm after using a prescription strength pain pill.
erythematous rash 4 cm below injection site occured 4 days after administration.  The rash is a flat erythematous base around 10 cm x 5 cm with overlying cluster of clear vesicles/bullae around 1cmx0.5 largest and several which are 3-6mm diameter
ADMINISTRATION ERROR We had our drive through influenza clinic at our hall.  We utilize volunteers throughout, including volunteer nurses. We administered the High Dose influenza vaccine meant for 65 and older to this 61 year old.
pt received Td on 5/14/04, then on 5/16/04 had increased leg pain, redness, warmth, swelling at site of injection in left deltoid.
previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer; previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer; patient did not experienced any AEs; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer), COVID-19 IMMUNISATION (previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer) and NO ADVERSE EVENT (patient did not experienced any AEs) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer), COVID-19 IMMUNISATION (previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer) and NO ADVERSE EVENT (patient did not experienced any AEs). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer), COVID-19 IMMUNISATION (previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer) and NO ADVERSE EVENT (patient did not experienced any AEs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (patient did not experienced any AEs) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer) and COVID-19 IMMUNISATION (previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer).    No concomitant medications were reported. It was reported that a 3 year old patient who previously received 2 doses of Moderna COVID-19 Vaccine accidentally received a 3rd dose of the primary series from Pfizer instead of receiving 1 bivalent booster from Moderna. Pfizer third dose was given to immunocompromised individuals. No treatment information was provided.   Reporter did not allow further contact
Message taken by other staff and passed on to this RN: "Patient called and states that she got her COVID vaccine today and is now on her way to indigo urgent care due to her lips swelling and hives under her eyes. "
Aunt gave patient Advil 400mg at 9am. Eye and gum swelling started around 12:30pm, around 1:30pm aunt gave Benadryl 40mg capsule and eye drops. Swelling on eyes reduced 6pm gum swelling cleared by next day.
Redness, swelling, Bruising, and blister-like rash near area where varicilla was administered.
(Bells Palsy) 11/4/09 left facial palsy - weakness left eyelid, nose mouth on left side, ringing left ear began 24 hours after vaccine. Treated 11/01 with ZITHROMAX administered for strep throat, appeared resolved 11/3/09. 11/20/09 Medical records received for DOS 11/03/09- 11/13/09. Final DX: Bell's Palsy Facial weakness s/p flu nasal mist vaccine and Gardasil #1.  Buzzing in L ear. L eye not closed, weakness mouth and nasal L side. DX strep throat 2 days prior to vaccine.
unable to eat; stomach feels like its swelling; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (unable to eat) and ABDOMINAL DISCOMFORT (stomach feels like its swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FEEDING DISORDER (unable to eat) and ABDOMINAL DISCOMFORT (stomach feels like its swelling). At the time of the report, FEEDING DISORDER (unable to eat) and ABDOMINAL DISCOMFORT (stomach feels like its swelling) outcome was unknown. 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.
5 patients received the expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received the expired) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received the expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received the expired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. It was reported that vaccine that shows on Moderna tx.com as expired August 14, 2021 but also expired on October 14, 2022. No Treatment information was reported.
Redness, edema, pain to upper left arm - Cellulitis, symptomatic treatment and Keflex by mouth.
she had "just a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she had "just a sore arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (she had "just a sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (she had "just a sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use included "Noutral .5".
Headache, fever, chills, body ache, cramping, diehreah, nausea from 9-21-21 and ongoing as of 9-30-21
Altered dosing schedule; No adverse effect; This spontaneous report was received from a Registered nurse refers to a male patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies. On an unknown date in 2016 (approximately 3 years ago), the patient was administered his first dose of hepatitis a vaccine, inactivated (VAQTA) 1 dosage form for prophylaxis. (strength, dose, frequency, route, lot number, expiry date unspecified). On 26-SEP-2019, the patient was in office to receive booster dose of hepatitis a vaccine, inactivated (VAQTA) (inappropriate schedule of product administration). No adverse effect reported. No PQC involved.
36 yo man with BMI 28.8, current smoker, presented with 2 days of waxing and waning chest pain/pressure radiating to his left arm.  His pain improved with ASA, but then later recurred.  He has one younger sister with no known history of premature CAD.  His EKG showed inferior ischemic changes, but no STEMI and his troponin rose to 5.2.  Given concern for ongoing ischemia, he was taken to the cath lab where he underwent PCI with a DES to the RCA.  He required temporary pacing during the procedure.  There was also clot that likely embolized distally, so he was started on Tirofiban.  He is now chest pain free and hemodynamically stable.
shortness of breath, wheezing, cough, chest pain, nausea and vomiting
"I have another nurse in my office now that is telling me that when she went to put the needle on the syringe she heard a click. Because she had just read my email below she checked the integrity and did not find a leak but when she went to administer the med the med sprayed out of the syringe area. These are not novice nurses they have done these for years, and they are both surprised by these issues. I am looking at the syringe and I think they plastic leur lock device may be the culprit."
She was fine until she started taking the Moderma vaccines. The she started with numbness in her legs and after she took the booster shot she wasnt able to walk at all.
his finger pain and finger joint pain started off the 2nd dose of his Pfizer covid vaccine that was administered on 19Jan2021; his finger pain and finger joint pain started off the 2nd dose of his Pfizer covid vaccine that was administered on 19Jan2021.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 2, single (Lot number: EK9231) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose Pfizer Covid vaccine was, administered on 28Dec2020 with lot if he can read it and the lot is EH9Y99 and is handwritten on the card), administration date: 28Dec2020, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "his finger pain and finger joint pain started off the 2nd dose of his Pfizer covid vaccine that was administered on 19Jan2021"; ARTHRALGIA (non-serious) with onset Jan2021, outcome "unknown", described as "his finger pain and finger joint pain started off the 2nd dose of his Pfizer covid vaccine that was administered on 19Jan2021.". Additional information: A medical doctor on the line calling and stated his wife called yesterday several times and she filed an adverse event on his behalf that soon after his 2nd Pfizer booster dose (as reported), he experienced pain in his fingers and finger joints of both hands. He was calling to provide the lot number from the vaccine he had. He was a 74 year old male. His 1st dose Pfizer Covid vaccine was administered on 28Dec2020 with lot if he can read it and the lot was EH9Y99 and was handwritten on the card; 2nd dose was on 19Jan2021 for the Pfizer Covid vaccine with lot EK9231; 3rd dose Pfizer Covid vaccine on 16Sept2021 with lot FC3183; 4th dose is Moderna vaccine administered on 14May2022 with the lot 048L21A but can't tell due to handwriting and the first digit may be the letter O; 5th dose Moderna on 12Sep2022 with lot AS7144B. It was clarified that his finger pain and finger joint pain started off the 2nd dose of his Pfizer covid vaccine that was administered on 19Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200475581 Same reporter and patient, different dose/events;
Immediately after first dose,  maybe within 1-2 minutes, my lips became numb and tingly. Similar to when oral anesthesia at dentist wears off.   After second dose, about 7 days later I started hearing a loud ringing in my ears, tinitus. It was very disturbing for the first 2-3 weeks, but continues to improve luckily.
Information has been received from a nurse concerning a "21 year" old female who "about a year ago", was vaccinated with the first dose of GARDASIL (0.5ml, IM). The patient fainting about 20 to 35 minutes after the shot and was surrounded by nurses. The patient received the shot at a hospital and the patient had not been seen since the adverse events. Who administered the shot was unknown. Therapy with human papillomavirus vaccine was discontinued "about a year ago". The outcome was unspecified. Additional information has been requested.
Discharge Provider: Medical doctor Primary Care Provider : Medical doctor    Admission Date: 7/26/2022 Discharge Date: 07/30/2022  PRESENTING PROBLEM:  Acute hyponatremia Hypochromic microcytic anemia Hyponatremia Paroxysmal atrial fibrillation Acute cystitis without hematuria   HOSPITAL COURSE:   Patient is a 85 y.o. female with past medical history significant for pancreatic cancer, status post chemo and radiation, atrial fibrillation, on Xarelto who presented to the emergency department for severe fatigue, and dyspnea with exertion, lightheadedness and weakness. She had a hgb of 6 on arrival. She had no symptoms of GI bleeding.  She had a positive COVID-19 PCR, did not require any oxygen, treated with supportive care.  She was found to be hyponatremic and denied diarrhea, nausea or vomiting. Na+ 121 on admission with Cr 1.15.  Sodium level gradually improved with gentle IV hydration, sodium level upon discharge was 136  Urine chemistry showed low urine osmolality and low urine sodium.  Her home med of hydrochlorothiazide /triamterene was discontinued, started on losartan 25 mg daily.  Hemoglobin remained relatively stable after 1 unit PRBC transfusion, GI did not plan for EGD, recommended Protonix 2 times a day and resuming back Xarelto, hemoglobin upon discharge was 7.6  Was also treated with empiric Rocephin for 3 days for urinary tract infection.  PT and OT recommended home with assist.  Eventually discharged on 07/30/2022 in stable condition, recommended follow-up with PCP in 1 week to get hemoglobin and sodium level checked.  Instructions discussed in detail with patient and husband, they verbalized understanding.
Information has been received from a physician concerning a female with no prior history of fainting who in approximately April 2007, "about six months ago, " was vaccinated IM with the first dose of Gardasil. It was reported that after receiving her first dose of Gardasil the patient fainted and has fainted several times since the injection. On one occasion the patient developed a concussion. The patient's outcome was unknown. Additional information has been requested.
Progressive ascending paralysis consistent with Guillain-Barre Syndrome.  At time of hospitalization, patient was unable to walk.  Diagnosis confirmed by spinal tap.  IV IG therapy administered for 5 days post diagnosis with significant alleviation of symptoms.  As of the date of this filing patient is near completion of at-home PT and has regained the ability to walk using a cane, but recovery is ongoing.
Day 1-3 Entire muscle very sore starting 2 hours after injection. Almost felt muscle was clenched the entire time. Day 6 Swollen Lymph Nodes under armpit.  No other symptoms
Covid booster shot unknown which kind.  Pt had a syncopal episode with elevated troponins requiring hospital admission
Case number PHEH2014US022803, is a combined initial and follow-up spontaneous report from a consumer (patient) and pharmacist received on 10 Nov 2014 and 11 Nov 2014. This report refers to a 57-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145224) intramuscularly into left arm on 16 Oct 2014. Three days later she experienced partial paralysis which started at the injection site and spread down to left side of the body. The reaction started on 19 Oct 2014 and by 20 Oct 2014 it was horrible. On 20 Oct 2014, she went to the pharmacist as her arm was stiffening up with pain and could hardly move it. On the same day night, while on bed she screamed as her arm and shoulder felt like they were on fire; it was inflamed. She had a rash covering her arm and shoulder. On 21 Oct 2014, she went to medical center where it was stated that the vaccine triggered an autoimmune attack of her upper arm and was diagnosed with myositis. She was treated with ibuprofen every 4 hours, pain medications, immune suppressant and steroid as prescribed. On 22 Oct 2014, she was still in misery and attempted to work. By 23 Oct 2014, she could barely walk and paralysis was spreading. On 23 Oct 2014 and 24 Oct 2014, she was unable to leave the house or walk across the house. She was unable to open car doors, hold anything, difficulty to do her work and was unable to lift her arm up as it was frozen in there. She was unable to put on clothes or anything over her head; it's like having a stroke. She started physical therapy three times a week which helped her to regain mobility in her affected arm. As of 10 Nov 2014, paralysis was isolated to left arm and shoulder. Outcome of the events was reported as improving. Seriousness and causality of the events was not reported. Seriousness assessment of myositis and paralysis was upgraded based on the NVD key event list; stiffness, inflammation, burning sensation, difficulty in walking, pain in arm, injected limb mobility decreased based on the information in source document.
Returned 48 hrs after vaccination (influenza) to inform us of a rxn. Her arm had a 2 1/2 inch x 2 1/2 inch induration and was warm to t he touch. Instructed to take BENADRYL.
GI bleed has happened three times in three weeks. Still in hospital for third GI bleed.