chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) in a 17-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     The relevant medical history/conditions, allergy, concomitant diseases and risk factor reported as unknown.    On 29-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)).    Patient did not received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case contains for patient 8 out of 12.   This case was linked to US-MODERNATX, INC.-MOD-2023-737216 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737216:Master case
Initial report was received from a health care professional on 25 September 2012. A 33-year-old male patient who had no concurrent illness and no medical history, had received an intramuscular left deltoid injection of FLUZONE, lot number UH711AB on 22 September 2012 and within minutes of receiving the vaccine, he became dizzy with numbness and tingling of his hands and around his mouth. His blood pressure was 180/111 and heart rate was >100. He was transported to the emergency room by ambulance, treated and released. Outcome was recovered. Documents held by sender: None.
MUSCLE ACHES, DIZZINESS, FEVER, FATIGUE. THIS ALL LASTED TILL TODAY, 08/31/2011. FEVER WAS 101F AT WORST POINT. I WAS ALMOST DEBILITATED AND UNABLE TO FUNCTION. I WAS IN BED FOR MOST OF THE LAST 3 DAYS.
atrial fibrillation; tachycardia/ fast heart rate; sore arm; knot/ large knot on arm; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain in extremity (for tolerance, refer linked case) and Tetanus vaccine with an associated reaction of pain in extremity.   On 22nd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 25th June 2019, 3 days after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria hospitalization and GSK medically significant) and tachycardia (serious criteria hospitalization). On an unknown date, the patient experienced pain in arm and skin mass. On an unknown date, the outcome of the atrial fibrillation and tachycardia were recovered/resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the skin mass was unknown.   It was unknown if the reporter considered the atrial fibrillation, tachycardia, pain in arm and skin mass to be related to Shingrix.  Additional details were provided as follows: The patient provided only his first name and would not provide his last name or any contact information. The patient stated that, in the evening of Saturday, he received the Shingrix vaccine in left deltoid.  On Tuesday morning, he started experiencing a very fast heart rate, over 200. The patient went to the emergency room and was admitted to the hospital for atrial fibrillation. The patient never had atrial fibrillation.  He was shocked 3 times while at the hospital but he did not go back into normal rhythm. He finally went back into normal rhythm on his own. The patient had a few periods of tachycardia since this experience, but they did not last long enough to need treatment. The patient's heart tests were performed and it showed he was clear of blockages. He also noted that, less than a month after Shingrix vaccination, he had a large knot on his arm after the injection and his arm was very sore for 3.5 to 4 months and was a little sore till the reporting date. The patient mentioned his arm often hurts for 2 weeks after getting the flu shot (refer case ) and sometimes he would get that after the tetanus vaccine. The patient did not consent to follow-up.
The patient received Pfizer COVID19 vaccine on 1/15/2021 followed by Moderna COVID19 vaccine 2/8/21 as his second dose.
Pt. reported by phone and email had arm pain at time of injection and shoulder pain since. Referred to her primary care provider. Not seen by vaccine facility.
In about a week my shoulders, back around my shoulder blades, my arms down to my elbows and my elbows are constantly aching. I take ibuprofen for it.
Pt had not previous reported symptoms with dose 1.  Patient fainted after receiving dose 2. Feet elevated bed and some juice and water offer. Patient verbalized was fine and no report any dizziness. Patient was directed to observation area to complete monitoring time by a nurse. Patient left in stable condition
Patient received the monovalent Pfizer COVID-19 vaccine as their booster dose instead of the intended bivalent Pfizer COVID-19 vaccine
tested positive on 01Apr2021; tested positive on 01Apr2021; This is a spontaneous report from a contactable consumer (himself). A 69-years-old male patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution of injection) via an unspecified route of administration on 19Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Apr2021, the patient had tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Apr2021. The timeframe between vaccination and starting of symptoms was 13 days. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Patient complained of swelling, erythema, and pain to right deltoid after receiving TD injection onset of above signs and symptoms day 2 after injection.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 26-MAY-2010, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 16-OCT-2012, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
I received my 1st dose 12/31/20 and my second dose twenty something days later.; massive hair loss/Beginning in Feb 2021 I noticed increased hair shedding/FF to now and I've lost at least 1/3 of my volume and have massive, massive breakage throughout; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 1st dose 12/31/20 and my second dose twenty something days later.) and ALOPECIA (massive hair loss/Beginning in Feb 2021 I noticed increased hair shedding/FF to now and I've lost at least 1/3 of my volume and have massive, massive breakage throughout) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 1st dose 12/31/20 and my second dose twenty something days later.) and ALOPECIA (massive hair loss/Beginning in Feb 2021 I noticed increased hair shedding/FF to now and I've lost at least 1/3 of my volume and have massive, massive breakage throughout). The patient was treated with MULTIVITAMINS [VITAMINS NOS] for Hair loss, at an unspecified dose and frequency; VITAMIN B COMPLEX for Hair loss, at an unspecified dose and frequency; COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Hair loss, at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] for Hair loss, at an unspecified dose and frequency and COLLAGEN at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 1st dose 12/31/20 and my second dose twenty something days later.) had resolved and ALOPECIA (massive hair loss/Beginning in Feb 2021 I noticed increased hair shedding/FF to now and I've lost at least 1/3 of my volume and have massive, massive breakage throughout) outcome was unknown.            No concomitant medication reported. Patient stated that events started from beginning of Feb-2021.Patient stated that she had lost at least 1/3 of her volume and had massive  breakage throughout. She stated that she had  very long and healthy hair before vaccine. Patient stated that she had no genetic conditions or predisposition to alopecia or hair loss.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Chills; Body aches; Headache; Night sweats; Dizziness; Upset stomach; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 09:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) and ascorbic acid, pyridoxine hydrochloride, biotin, folic acid, colecalciferol, cyanocobalamin, retinol palmitate, choline bitartrate, inositol, calcium pantothenate, zinc citrate, potassium iodide, dl-alpha tocopheryl acetate (VITAMINS). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 16Apr2021 at 21:00, the patient experienced chills, body aches, headache, night sweats, dizziness, stomach upset and fatigue. The events did not result in doctor or other healthcare professional office or clinic, emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, body aches, headache, night sweats, dizziness, stomach upset and fatigue were resolved on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Redness, swelling, warmth to left leg from hip to knee.  Child was also fussy, crying.  This lasted through the night but was resolved in the morning.  Parents state they did give Tylenol after speaking with a nurse about these symptoms.
BRIEF OVERVIEW: Admission Date: 8/29/2023 Discharge Date: 9/3/2023 Discharge Disposition:  home health care svc  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 80y/o male with a past medical history of BH. CAD, dilantin toxicity, epilepsy, dilantin toxicity, neuropathy, and sleep apnea who presented for increasing weakness.   Patients symptoms began 3 days prior to admission with increasing weakness and confusion, intermittent fevers, balance issues, and a fall  without LOC or head injury. Patient additionally began to develop a cough prior to presentation to the ED. With patient' s change from baseline, family called EMS to bring patient in. Upon evaluation, patient was put on 2L of oxygen on the way to the ED. Patient did not wear oxygen at baseline. In the Emergency Department, patient presented with a fever of 101.8, tachypnea, and SpO2 at 91% on 2L NC. Basic labs were ordered and revealed a mild normocytic anemia with hgb 13.2, elevated CRP of 24.1, and a mild hyponatremia 133 but were otherwise benign. 4-plex was completed and came back COVID positive. Patient was placed in respiratory precautions. EKG findings demonstrated increased PR interval from known first degree AV block, PACs, and T wave abnormality, but not significantly different from previous findings. CXR revealed mild pulmonary vascular congestion but no signs of pneumonia. D-dimer was slightly elevated at 660. Hospitalist team was contacted for further evaluation.    Upon admission patient was started on remdesivir and lasix. Patient was placed in seizure precautions with his history of having seizures 1-2 times weekly. PT/OT evaluation recommending SAR, but on day 2 of admission noting that pt is improving and could potentially progress to home. Pt had a controlled fall on the morning of 9/1/2023 where he misstepped from the practice stairs, and PT was able to lower him to the ground. He sustained no injuries. On reevaluation on day of dc felt safe for dc home with HHC physical therapy . Rec on dc 2 person assist with stairs and standby assist with other ambulation.  Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days. Patient voiced understanding was agreeable with plan of care discharge
Headache, Myalgia, Arthralgia, Developed chills HA,sweats, myalgias, arthralgias , fatigue and arm soreness later in the day of vaccine administration of 2nd COVID 19 vaccine. Narrative:  Developed chills, HA, sweats, myalgias, arthralgias , fatigue, and arm soreness later in the day of vaccine administration of 2nd COVID 19 vaccine
Low grade temp of 99 for 24 hours. "Not himself", irritable. Extremely hyper active day after vaccinations which she has never been before. Nonstop moving her arms/legs, jabbering nonstop, unable to sit still. Randomly will scream for no reason. Headaches. Defiant. Decreased po. On 18th reported chicken pox like rash. That showed up 10 days post immunizations. Itchy raised red spots, no blisters. Mom believes vaccines caused wheat intolerance and milk intolerance and the above sx and would like events reported.
She started swelling in the deltoid, supraclavicular and axilla, likely lymph swelling.
Took the vaccine and still got the shingles/Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took the vaccine and still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
I had the vaccine and got shingles./Suspected vaccination failure; I had the vaccine and got shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, it was not 100 percent because he/she had the shingles vaccine and got shingles.  It was a very mild case and was gone in 2 weeks. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible as no contact details were available.
At 10:00 pm I started with a stomach ache (12 hrs after my vaccine). By 10:05 pm I was experiencing nausea, vomiting and diarrhea. Within 10 minutes, my face had swollen up, my eyes were swollen and red, and my hands, feet and chest had hives.   Paramedics were called and arrived 5 minutes later. At this time I was barely able to walk, was still vomiting and having diarrhea, and was shaking. They put me in the ambulance and took me to a 24hr emergency clinic.   In the ambulance, I was given saline, epinephrine, Benadryl and nausea meds. I stayed under observation until 3 am. I was released to go home at that time. Since then I have only experienced weakness and nausea.
Discomfort in site for several weeks then finally left.  Since then trouble with arm right arm lifting, exercising doing household  chores. I am right handed.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, muscle pain, influenza like illness, exhaustion and feeling abnormal. On an unknown date, the outcome of the pain in arm, influenza like illness, exhaustion and feeling abnormal were recovering/resolving and the outcome of the muscle pain was unknown. It was unknown if the reporter considered the pain in arm, muscle pain, influenza like illness, exhaustion and feeling abnormal to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Friday, the patient received a dose of SHINGRIX correctly in the deltoid. Within a few hours after vaccination, the patient experienced arm soreness in the vaccinated arm. At that night, the patient's arms ached and she had difficulty in sleeping due to not being able to get comfortable. On Saturday (the day following vaccination), the patient had muscle aches, felt like flu-without the fever, exhausted and just felt eh. On Sunday the patient felt better and was pretty much back to normal on Monday. The reporter agreed to follow up from the GlaxoSmithKline. This case has been linked with case US2019GSK014100 (husband's case), reported by the same reporter.
received j&j vaccine on 3/11; dx w/ DVT on 3/26.
Patient presented with lupus and needed a surgical wound check. Patient was positive for COVID and is COVID+
Headache, Myalgia, Fever, CoughWheeze & NauseaVomiting Narrative: -Day 1- tireness, muscle aches and chills, Day 2-L arm weakness and tingling, Fever 100.5 headache and joint pain. day 3-Chills, headache, Day 4-6 fatique Day 9 Developed cough-went PCP 4/17/2021 Day 18-developed shortness of breath-went to ED-elevated dimer (2.3) Reports: Still have issues with being short of breath with minimal exertion
Dyspnea, wheezing, dizziness, started approx 1930 was taken to ED via 911 ambulance.
At 6 pm it started to feel like I had been ran over by a car everything hurt,. After that I was vomiting violently 7 hours straight. Now I can?t lift my arm and my body hurts really bad.