chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admission Date: 8/15/2022 Discharge Date: Aug 24, 2022  PRESENTING PROBLEM: Weakness SOB (shortness of breath) COVID   HOSPITAL COURSE: Patient is a 26 y.o. male with history of muscular dystrophy, hypertension and anxiety who presents to the ER with generalized weakness due to COVID 19 infection. Patient did not have any respiratory issues.  He did not require any oxygen therapy.  He was not started on remdesivir or Decadron.  However, patient continued to have weakness during his stay related to this infection.  Physical therapy recommended inpatient rehab.  PMNR was consulted and he was accepted. Patient was discharged in medically stable condition.   Patient is a 26 y.o. male, right handed, with past medical history of congenital myopathy (SMA/distal myopathy) followed by SH neurology and hypertension who presented initially to the ED with chief complaint of generalized weakness.  Patient with positive home COVID test.  Patient does have history of full vaccination booster with visor COVID vaccine.  Patient apparently developed dry cough, shortness of breath, increased weakness with poor appetite.  He had been exposed family members over the weekend that did test positive for COVID-19.  Patient was noted to be tachycardic and hypertensive in the emergency department.  O2 sats stable.  CT angiogram thorax negative for pulmonary embolism.  Was not given dexamethasone around the severe due to no hypoxia.  Patient was evaluated by Rehabilitation deemed a good candidate for acute inpatient rehabilitation.  Patient was admitted to in patient rehab unit on 08/20/2022 where following medical issues addressed as noted below:   Patient seen on day of admission.  Patient seen in no apparent stress sitting up in wheelchair.  Denies any pain currently.  Denies any fevers, chills, nausea, vomiting, headache, chest pain, shortness of breath, difficulty spelling, abdominal pain, dysuria, paresthesias, depression.  Patient does report he is weaker than his at baseline.  Last bowel was yesterday.  Lives alone in a 1st floor apartment with 0 steps to enter.  Uses a power wheelchair at baseline.  Patient does not drive but had been modified independent to independent for ADLs.   Functional and mobility deficits due to COVID 19, with hx of Spinal muscular atrophy This patient is noted with decreased independence with transfers, ambulation, ADLs, IADLs, decreased endurance.  We will continue PT and OT to evaluate and treat regarding these deficits.  They will continue 3 hours per day, 5 days per week.
Blisters; degrees of erythema 2 inch x 2.5 inches.  Redness 3.5 x 4 3/4 in.  Hot to touch.
2/18/21 - Eight days after initial dose  of Moderna  vaccine developed redness, itching and swelling approximately one inch below injection sight.    Redness spread  to cover a 3 x 3 inch area of the right arm.    Applied Benadryl cream to  affected area  and  symptoms seem to be improving.
Upon 7 hours after receiving both smallpox and Anthrax booster one after the other, most of my body became covered in red raised bumps that both itched, and fevered which lasted for approximately seven days. Only a topical ointment was used to relieve the itching.
fever on day of vaccination that lasted for 2 days. Periocular rash that developed 3 days after vaccination and developed a vesicle.
vaccination site inflammation; vaccination site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (vaccination site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (vaccination site redness). At the time of the report, INJECTION SITE ERYTHEMA (vaccination site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
pain and tenderness in the arm; tiredness; shivering; achy feeling; slight nausea; symptoms began within 1-2 hours of receiving the vaccine and abated by 60 hours post-vaccine.
3/9/21 Received vaccine around 3:53 pm.   3/10/21 12:30 am - awoke feeling hot and sweaty and having a slight headache and muscle aches.  Went back to sleep but awoke two or three more times throughout the night, each time feeling a little worse. 3/10/21 5:30 am - Got up to try to go to work: Had significant vertigo, headache was now much worse (felt like a migraine), nausea and severe body aches.  Still felt very hot.  3/10/21 8:00 am - Went to work. Temperature was 100.7.  Went directly home. 3/10/21 8:15 am - Back at home.  3/10/21 8:15 am - 3/11/21 6:00 am - Headache was very severe.  Vomited.  Went to bed to try to sleep.  Headache and nausea kept waking me up.  I didn't have a thermometer at home but I continued to feel extremely hot and sweaty.  I'm usually very cold.  Could not even sip liquids or it caused vomiting.   3/11/21 6:00 am - 6 pm - vision was impaired.  It looked like my room was filled with smoke.  Nausea continued.  Slept most of this time 3/11/21 6:30 pm - Woke up.  Nausea was much less.  I was able sip liquids.  Headache was less.   3/12/21 6:30 am - Woke up.  Nausea only slight.  Headache only slight 3/13/21 6:30 am - Much better
Extremely heavy menses with clots for a month. Ultrasound showed no ovulation for this cycle which is abnormal for me.  Oral Progesteron was needed to stop the bleeding.
The patient received a dose of Moderna before they have turned 18 years old. No adverse side effects were witnessed while they were on site for their shot or during their 15 minute waiting period after receiving the shot.
A terrible case of tinnitus (ringing in the ear); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (A terrible case of tinnitus (ringing in the ear)) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 experienced TINNITUS (A terrible case of tinnitus (ringing in the ear)). At the time of the report, TINNITUS (A terrible case of tinnitus (ringing in the ear)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The action taken with mRNA-1273 with the events was considered as not applicable
itching; swollen; very red; 5 inches long; 3 inches wide; A spontaneous report was received from a consumer concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, itching , swollen, very red , 5 inches long, 3 inches wide.  The patient's medical history was not provided. Concomitant medications was not reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:011M20A ) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb  2021, the patient experienced the events, itching, swollen, very red, 5 inches long, 3 inches wide.  Treatment details was not included.  Action taken with mRNA-1273 in response to the events was unknown.  Outcomes of the events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema, injection site swelling and injection site itching are consistent with the known safety profile of mRNA-1273.
Patient states he went home and fainted from sitting position about 45 minutes after his immunization. Wife revived him after about 10 seconds by calling his name.
Narrative:  88yo male patient died in hospice care at hospice facility on 10/11/2021. Pt had received covid vaccines on 1/15/2021 & 2/12/2021. Death is not related to vaccines.
Unknown adverse reaction.  This event is being reported because a patient neglected to inform us that he had already received a first dose of the Pfizer vaccine and was given what we thought was a first dose of the Moderna vaccine.  No complaints of any adverse reaction from the patient.
RN from public health clinic went to local nursing home to provide 2nd doses of Moderna to nursing home residents.  Nursing home staff escorted health department nurse to resident rooms based on a list the director of the nursing home had provided. Health department nurse realized multiple residents had recieved 3rd doses of Moderna inadvertently after returning back to the health department and enteriing vaccine information into state registry. Nursing home staff notified of event.
The patient experienced no symptoms.; The patient administered a first dose of GARD ASIL 9 on 27-SEP-2017 and second dose on 16-DEC-2019; This spontaneous report was received from a Pharmacy intern referring to a 23 year old patient, of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.    On 16-DEC-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were unknown) at age 21 years old and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly with lot 1621929, and expiration date 6-DEC-2021 on 16-DEC-2019. The patient experienced no symptoms.
After the first vaccine, the only thing that I experienced right away was pain at the injection site and then ten days later I started experiencing headaches, pains, fatigue, fever, sore throat, loss of taste and smell. January 21, 2021 I had a covid test and was positive.
Employee received COVID-19 vaccine on 12/28/20.  Reports doing well until this morning.  Woke up feeling itchy around injection site (left upper arm).  Reports area feels tender and with mild burning to touch.  Arm is sore at injection site but able to perform daily normal activities.   RN observed a red, raised, localized rash to left upper arm.  Rash extends about 10 centimeters below injection site.  Rash is localized and no other concerns at this time. RN advised to avoid touching or scratching the area.  Cold compresses and OTC cortisone cream if it gets itchy again. Instructed to monitor and report any new or worsening symptoms.  Instructed to seek immediate medical care if any hives or breathing issues develop. Patient voiced understanding and agreement with plan.
Extremely lethargic, sore throat, chills, achiness, nausea, dizziness, congestion, runny nose, burning sensation in lungs, coughing, asthma attack, swollen lymph node under arm with injection
The day after the second dose I had extreme fatigue and muscle aches. I felt better after two days and I just had some soreness in my arm. I am pregnant with twins and I experienced vaginal bleeding on 05/07/2021. It was determined that it was due to Placenta Previa. I was 14 weeks pregnant at the time.  At the moment I have been advised to take it easy and the babies are fine.  Due Date-10/30/2021 Pregnancy-Second
Left deltoid where Tdap was given was red and swollen about 3 inches around site, warm to touch - no fevers; no drainage (started the next day after imms received). Pt states site smaller now.
Patient signed up to receive Pfizer COVID vaccine and was given Moderna 0.25ml booster vaccine instead
Experienced some adverse effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experienced some adverse effects) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced some adverse effects). At the time of the report, VACCINATION COMPLICATION (Experienced some adverse effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  Treatment information was not provided
pt stated that exp pain in center of chest, deltoid of appetite opposite arm for an inj site lt & rt elbow;few ways p/vax lasting for 1 1/2 days;muscles pain;relief w/Ibuprofen;
Pt stated that she "blacked out, could not see". Vitals: 16:03 101/61, 71 -- > 16:09 97/60, 70 -- > 16:13 105/65, 68 -- > 16:16 110/71, 63 -- > 16:26 113/82, 62 lifted pt's feet up to inc BP.  Pt given water.  Pt A&O x4 since laying down and BP inc Pt stable and released from the vaccination site
Paresthesia for 1 hour, headaches- sharp shooting/pressure off and on ever since. Never had headaches before. Still get them most days ever since.
No adverse event; Moderna Bivalent booster dose was inadvertently administered on 17-Feb-2023, instead of second Monovalent primary series dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster dose was inadvertently administered on 17-Feb-2023, instead of second Monovalent primary series dose) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     It was reported that patient had no known allergies and did not had any COVID test. It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (1st Monovalent primary series) on 25-Jan-2023. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 17-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Feb-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 (Moderna Bivalent booster dose was inadvertently administered on 17-Feb-2023, instead of second Monovalent primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster dose was inadvertently administered on 17-Feb-2023, instead of second Monovalent primary series dose) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster dose was inadvertently administered on 17-Feb-2023, instead of second Monovalent primary series dose).    It was reported that patient received 1st Monovalent primary series dose on 25-Jan-2023 lot number 074B22A on the same facility. No adverse reaction was reported by the patient with administration error. No concomitant information was reported. No treatment information was provided.
I started to get excessively itching in my both ears and throat; I started to get excessively itching in my both ears and throat; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 09:58 at 61 years old (Lot Number: EW0164; Expiration Date: 31Aug2021) at single dose for covid-19 immunisation. Medical history included she had to get her glasses to read the handwritten information. The patient's concomitant medications were none. No other vaccines were administered on the same date or within 4 weeks prior to vaccination. Patient received it at 9:58am and stayed there for 15 minutes and went about her day. Everything went fine. Sometimes many hours later, say 6:00 in the evening, she started to get excessively itching in her both ears and throat on 19Apr2021. She didn't even think about getting the vaccine that day or if the reported event had something to do with that. She was talking with someone and they said maybe she shouldn't get the 2nd dose, would the 2nd reaction be more severe? And by the time she went to bed at 11pm it had subsided. The symptoms had subsisted by then. She spoke with her PCP and at first she said maybe she should hold off. Let her call you back and said the more she looked into it was not a severe reaction it wasn't within the first hour and she recommended do get the 2nd one but before she did that, she had 21 days, to refer her to an allergist just in case. Patient asked if there was any information on changing vaccines, like getting the Moderna one for her 2nd dose. She would follow up with an allergist. Stated somebody told her to call her primary care physician and she was wondering if she should get the 2nd dose of the Pfizer COVID Vaccine. The events didn't require a visit to ER or MD office. Caller stated she did not require treatment and the itching in her throat and ears is better. There were no relevant tests. The outcome of the events was recovering. Serious criteria was non-serious.  No follow-up attempts are needed. No further information is expected.
This patient was given this vaccine as a booster because her blood titers came back negative for Hepatitis B and an hour and half after the injection she became dizzy and her heart was racing.  Patient tried to sit and relax and ate food but symptoms did not improve so she was recommended to go to the nearest emergency room to be evaluated because  she had returned to her work in a dental office.
15 min p/shots given pt c/o body pruritis; Benadryl 25MG given;
High fever >102 F. Pulse Rate >115 BBP. Physical chills, and shakes.
blood clot; pain in leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) and PAIN IN EXTREMITY (pain in leg) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced THROMBOSIS (blood clot) (seriousness criteria death and medically significant) and PAIN IN EXTREMITY (pain in leg) (seriousness criterion death). The reported cause of death was Pain in leg. An autopsy was performed. The autopsy-determined cause of death was blood clot.            Concomitant medications were not reported. treatment medications were not reported.  Company comment: This case concerns a 62-year-old male patient with no medical history reported, who experienced the fatal events of thrombosis and in in extremity. The events occurred an unknown time after the second dose of mRNA-1273. Autopsy report states cause of death as thrombosis. This case report has been submitted by a consumer who knew the patient, though limited information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 62-year-old male patient with no medical history reported, who experienced the fatal events of thrombosis and in in extremity. The events occurred an unknown time after the second dose of mRNA-1273. Autopsy report states cause of death as thrombosis. This case report has been submitted by a consumer who knew the patient, though limited information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Pain in leg; Autopsy-determined Cause(s) of Death: Blood clot
This spontaneous report was received from an office manager concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot# and expiration date were unknown) for prophylaxis, which had a temperature excursion 27°F for 10 minutes and 28°F for 14 hours. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008645: US-009507513-1702USA009059: US-009507513-1702USA009057.
ED to hospital admission on 1/2 for lower abdominal pain. Acute left renal colic, caused by the above + yeast encrusted left lower pole stent/ left upper and lower pole hydronephrosis, improved post urology intervention, stent replaced, cleared by urology to dc. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Fever 101.7 initially. Seen in clinic next day. Fever 103.2 T. Fever lasted for 3 days. Had rash to legs only from 03/23/2012 continuing through 3/27/2012.
4 months after vaccination, I woke up and had swollen tonsils and white buildup on them as well. I felt I had sinus pressure from the neck up. I had a telemedicine visit in the month of May and they said it was probably strep and gave me an antibiotic called Augmentin. The symptoms did subside after that medication. On 6-20, the symptoms came back and they were much worse this time. The tonsils again had buildup and were swollen as well as fatigue, fever up to 103, a full body rash, nausea off and on for 2 weeks, body sweats and lymph nodes behind neck were incredibly swollen. On 6-20, I had another telemedicine visit and they wanted me to have a COVID-19 PCR test and gave me a prescription for penicillin.  I was diagnosed with acute pharyngitis. I took 2 home COVID-19 tests on this day and they were both negative. I also took 2 home COVID-19 tests on 6-21 with negative results as well. On 6-23, I went to a community center that was set up to do testing and had the COVID-19 PCR test done with negative results. On 6-27, I went to my primary care physicians office and she gave me a rapid strep test that had negative results. I had bloodwork done to test for mono. She told me to stop the penicillin and put me on Cephalexin. She told me that the vaccine could have lowered my immune system and that is why I was susceptible to other viruses. I received the results on 7-1 that my mono was positive.  She told me to finish out the antibiotics and to wait it out. I was told to come back if symptoms are longer than 4 weeks. My symptoms are still ongoing and I went for bloodwork on 7-21 and my Lymph absolute results were abnormal. I have another doctors appointment today with my primary care physicians office.
pt recv vax early MAY96 & w/in 24hr exp exacerbation of ulcerative colitis & was hosp;lab eval @ that time revealed hematocrit 40 & a scope revealed a GI bleed;repeat lab eval 3wk later revealed hematocrit 26;