chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVId Vaccine Breakthrough CAse  Pfizer Dose 1 3/11/21 (EN6205) Pfizer Dose 2 4/1/21 (EP7533) COVID Positive 12/3/21  12/3/21: History is obtained from patient as well as by personal review of records.  Patient is 75-year-old gentleman with known history of coronary artery disease, congestive heart failure, AICD, COPD, chronic kidney disease and other medical problems. Presented to emergency department with generalized muscle pain, neck pain, left lower chest pain radiating to flank, and feeling of being unwell for 1 week following a gathering.  Denied subjective fevers.  Denied shortness of air or hemoptysis.  Denied firing of pacemaker.  Denied recent weight gain or weight loss. Denied orthopnea or paroxysmal nocturnal dyspnea.  EKG showed paced rhythm.  He tested positive for  SARS-CoV-2.  12/7/21: Patient is a 75 year old male with a history of CKD, CAD, CHF, and AFib on AC.  He was admitted on 12/4/2021 with left lower lobe community-acquired pneumonia, COVID positivity, AKI on CKD, hypokalemia, hypomagnesemia, and elevated cardiac enzymes.  Cardiology was consulted.  And they ruled out ACS.  They did make some cardiac med changes to control bursts of tachycardia.  His electrolytes were repleted.  He was started on courses of Azithromycin, Rocephin, and remdesivir.  He has not required any supplemental oxygen.  His vitals have been grossly stable over the last 48 hours his kidney injury has resolved.  He is back to his baseline renal function.  He has not had a fever or cough.  Reports that he feels great today.  Wants to go home.  We discussed the benefits of staying to complete his 5th dose of remdesivir, and the patient opted to go home today after his 4th.  He denies shortness of breath at rest, dyspnea on exertion, chest pain, palpitations.  He was evaluated by Physical therapy, and they felt the patient would benefit from visiting nurse services. The patient was agreeable. Patient is being discharged home with visiting nurse services for nursing and physical therapy.  He also enrolled in a safe at home program.  Those nurses will follow-up with him at discharge.  He should discontinue Coreg.  He should continue Toprol XL 100 mg p.o. b.i.d. and Azithromycin 250 g p.o. daily x4 days.  He should continue to self-quarantine x7 days.  He should follow-up with his primary care provider in 1-2 weeks.  He should follow-up with his primary cardiologist in 2 weeks. He has been provided patient education for community-acquired pneumonia, acute kidney injury, hypokalemia, COVID, Azithromycin, and Toprol XL.  I have answered all of his questions and addressed all of his concerns.  The patient is being discharged in improved and stable condition.
Pt had vaccines admin at 12:30pm at pharmacy. Around 2 am, pt experienced vomiting, diarrhea, nausea, weakness. Pt fell and suffered black eye while trying to get out of bed to get to bathroom.
1 day after COVID vaccine, patient developed a pruritic, painful maculopapular rash that started on her ankles and hips then spread to the rest of her body.
Arm hurt - could barely lift the arm Nausea Fever 100.6 with Tylenol and/or Advil (or generic versions) Headache (which have been consistent since first vaccine) - Not prone to headaches prior Tired Sore Throat
c/o itching 25 mins after Influenza vaccine given. Itching at left deltoid. No rash or breathing difficulty. Influenza vaccine given at 3:30pm. Benadryl 50mg po at 3:45. Vital signs checked and monitored by RN. Discharged from medical dept at 4:45pm. Ice packed applied left deltoid. Pusle Ox checked at 100 % B/P and heart rate and respiratory normal.
Diarrhea - Surely non bloody stool with each feeding starting 24 hour after Rotavirus.
Fever of about 101. Chills, nausea, sore muscles, headache.
8 days p/vax pt exp gen sz which lasted 1min;pt noted to have ax temp 104 immed w/sz;tx w/APAP, tepid bath;pt was seen in peds 4 days later;
A report was received from a health care professional on 25 November 2003, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 05 November 2003. On 05 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.
Within 48 hours patient showed redness and hypersensitivity to Band-Aids.  She has never shown any sensitivity to Band-Aids before.  Within 72 hours her left shoulder was covered in hives and was red and swollen.   Blisters and hives were showing up all over the body on the torso and legs.  Some went away and some stayed for a few days.   Redness, blisters, irritation and itching are worsening still after 5 days on the shoulder and arm of the injection site.     This is the second of 10 required catchup vaccines patient is required to get this year.  She has only had one vaccine prior to this (polio) and we are concerned that if this is an allergic reaction she may have more severe reactions to the next shots.
Could not move arm, couldn't stand pain; upper extremity dysfunction; Big pain at the injection site; Redness at the injection site; Pregnant patient received first dose of vaccine; swollen arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of vaccine), PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (Could not move arm, couldn't stand pain), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Big pain at the injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0272AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. The patient's last menstrual period was on 29-Sep-2020 and the estimated date of delivery was 07-Jul-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of vaccine), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Big pain at the injection site) and MUSCULOSKELETAL DISORDER (upper extremity dysfunction). On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Could not move arm, couldn't stand pain). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 09-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of vaccine) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (Could not move arm, couldn't stand pain), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Big pain at the injection site) and MUSCULOSKELETAL DISORDER (upper extremity dysfunction) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided was muscle rub cream in the injection side; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
use of vaccines after being involved in temperature excursion with no reported adverse event; vaccine out of range since 08DEC2021 with the temperature range of 0.61 degrees C up to 12 degrees C; temperature excursion with no reported adverse event; Initial information received regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA180455(CLUSTER).  This case involves an unknown age and unknown gender patients who administered vaccine which was out of range since 08dec2021 with the temperature range of 0.61 degrees c up to 12 degrees c; temperature excursion with no reported adverse event and use of vaccines after being involved in temperature excursion with no reported adverse event while receiving vaccine influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Dec-2021, the patient received a  dose of suspect influenza quadrival a-b vaccine (formulation, strength, route, lot number, expiry date : unknown) unknown administration site for prophylactic vaccination.  Vaccine was out of range since 08-Dec-2021 with the temperature range of 0.61 degrees c up to 12 degrees c; temperature excursion with no reported adverse event (product temperature excursion issue) and on an unknown date the patient had use of vaccines after being involved in temperature excursion with no reported adverse event (poor quality product administered) (unknown latency). Clinic staff as unaware that there was a recommended temperature the products must be kept in.   Action taken: Not applicable for both the events  Outcome: Unknown for both the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01098962:
Intense pain in hips, lower back and legs (lasted 18 hours); tremors and intermittent teeth chattering (lasted 1 hour); nausea (lasted 12 hours)
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 61-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 10-SEP-2013, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis. On an unspecified date in September 2013, the patient suffered shingles (herpes zoster). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles (herpes zoster) was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).
Muscle weakness of arms for 1 wk followed by muscle soreness in trunk & neck Sore to touch & "achy"; muscle weakness gone by 7JAN91, but soreness remains spoke w/MD 8OCT + 28DEC90; seen by MD 4JAN91 had repeat HBV vax w/out effects.
Ever since I got the vaccine I have headaches which increased to near migraine level on 12/29, then yesterday 12/31 at 330pm while painting my left face became paralyzed and numb.  Went to ER Had CT/CTA of head EKG, chest Xray and multiple labs including Lyme test which will not be resulted for 5-7 days.  ER started me on taper prednisone and doxycycline.  Diagnose with significant Bell's Palsy
NO ADVERSE REACTION REPORTED BUT PATIENT WAS ONLY 15 AND SHOULD NOT OF RECEIVED MODERNA VACCINE
DEVELOPED A RED, WARM, HARD AREA AT INJECNTION SITE ON RIGHT ARM.
I began to feel dizzy, even while sitting. I got up to get a drink of water, but had great difficulty maintaining my balance, both while standing and trying to walk. I got the water and sat again for a while, but the dizziness returned. I then went to bed and as soon as I laid down on my back I started to experience the same sensation as when I suffered vertigo - the room began spinning. This went on a short while and I eventually went to sleep. I got up several times during the night and my balance was better when walking to the bathroom. By morning I felt mostly normal, except for the muscle pains I had experience with previous vaccinations.
Pt stated that about 10 minutes after receiving vaccine she felt like she was "hit in the back of the head", and had developed a severe headache.  Pt also c/o numbness and tingling on the L side of her face.  Checked for signs of a stroke, none noted.  Vitals- B/P- 148/90; P- 108; R-14; SpO2- 94-96% on RA.  Lung sounds clear.  Pt denies any itching, difficulty breathing, or chest heaviness.  No rash noted.  Pt called her PMD who told her to have her husband bring her over to his office for evaluation.   PHN called pt on 3/3/21 to check on status.  States she still has a headache and some numbness on her face.  States she is also having trouble finding words when she is talking.  Encouraged to f/u with PMD again today.
Pt has an 8 hour period of inconsoleable crying. Mom TX with ibuprofen ever 8 hours. Pt recovered after 8 hours.
Severe muscle aches. Couldn't lift arms or legs, couldn't get out of chair, couldn't walk without help. Needed help getting dressed, bathing and any common movements, went on for 3 months before diagnosed as polymyalgia rheumatica, caused by the shingles shot.
2 days after getting flu vaccine and PENTACEL, child got 3-4mm "bumps" scattered over whole body & came & went x 48 hours before stopping ? urticaria - not brought for evaluation.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     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.    This case was linked to MOD-2021-242280 (Patient Link).
This spontaneous report was received from a physician via company representative referring to a 3 year old male patient who on 2013 (exact date unspecified), was vaccinated with a dose of VARIVAX (Merck), (lot number not reported). The physician reported that the patient developed chicken pox after receiving VARIVAX (Merck) in August 2013 (exact date unspecified). The patients parent spoke with the physician. The outcome of chickenpox was reported as recovered/resolved. Additional information has been requested.
Rash which developed approximately 7 days after receiving 2nd dose of Pediatric Pfizer vaccine.  Rash was localized to buttocks and groin area and has improved with hydrocortisone, but not resolved
I was having cold symptoms, I thought it was allergies', I had fatigue, tired, no sore throat, low fever, for 1-2 days (99.9), mainly congestion and running nose and sneezing but I had 2 episodes of diarrhea and my appetize was not as hungry.; the next day I made the appointment with the doctor, I was not a candidate for Paxlovid. I took Tylenol. This is the 2nd time I have COVID-19, this time mild than the first time. No memory lost this time.
pt recvd vax & lt leg appeared erythematous & had a welt on the lt thigh; pt had few scattered urticarial lesions; poss allergic reaction;
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm), feeling abnormal (felt "spacey"), somnolence (slept for a longer period of time), fatigue and tiredness in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016B21A) for COVID-19 immunization. No medical history reported. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Apr 2, 2021, patient experienced pain in extremity (sore arm). On Apr 4, 2021, patient experienced feeling abnormal (felt "spacey"). On Apr 5, 2021, patient experienced somnolence (slept for a longer period of time), fatigue and tiredness. On Apr 5, 2021, somnolence (slept for a longer period of time), fatigue and tiredness resolved. On Apr 6, 2021, pain in extremity (sore arm) and feeling abnormal (felt "spacey") resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant product use or treatment medication.
Patient is a 86 y.o. male with a history of dementia, atrial fibrillation (Eliquis) and sHFrEF who presented to Hospital 3/3/2023 with dizziness and low BP's at home. Found to be in atrial fibrillation RVR and COVID positive. Blood pressure and symptoms improved with IV fluids CXR showed suspected right basilar infiltrate.   1. Acute hypoxemic respiratory failure: due to COVID. CXR showed bronchial wall thickening with right basilar infiltrate. Required 2 L nasal cannula on admit, weaned to room air at time of discharge. 2. COVID-19 pneumonia: Unvaccinated. Tested (+) 3/3/23. Mild headache and generalized weakness without cough or dyspnea. Dexamethasone prescribed at discharge. 3. Sepsis without shock: Tachycardic, tachypneic and hypotensive on admission secondary to acute viral pneumonia and arrhythmia. BP responsive to IV fluids. No signs of end-organ damage. Did not warrant IV antibiotics or blood cultures.  4. Atrial fibrillation with RVR: First diagnosed in 2/2022 and converted to sinus rhythm spontaneously. Potentially triggered but not being on home metoprolol and COVID. Metoprolol prescribed at discharge, DOAC cost prohibitive and pt unable to do coumadin. Pt to follow up with cardiology outpatient  5. Cardiomyopathy: Follows with Dr. (also intended f/u at facility?). TTE 2/2022 EF 25% with severe LA enlargement. LHC 3/2/22 mild non-obstructive disease felt discordant to degree of myopathy. Remains clinically compensated (suspect elevated BNP related to COVID). Home lasix prescribed as PRN given pt's improvement with IV fluids  6. Elevated troponin: Troponin 51, repeat 51. Not consistent with acute coronary syndrome. 7. Hypertension: per history, Held home losartan at discharge and prescribed lasix as PRN 8. Mood disorder: No longer taking zoloft as pt prefers not to take many medications and per son will maximize medical therapy with required cardiology medications  9. Dementia: No longer on home donepezil  10. Code status: DNR-CCA/DNI
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not provided. Treatment medication was not provided   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Heartbeats irregular; palpitation; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported; NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 24Apr2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization. The patient reported that since she got the second dose, she noticed her heartbeat was irregular. Before it was not that reason but later she felt it almost daily specially in the afternoon time, even during late night-time and sometimes a whole day. She never felt this type of heartbeat irregularly and she felt strong, stronger, and weaker and the timing between was longer. She said it was palpitation. She never had this issue before as she could barely feel her heart beating, it was obvious. She and her husband took the vaccine at the same day and her husband felt the same thing and reported it was not as strong. She had a strong suspect that the events were caused by Pfizer vaccine, so she planned to visit her physician. She wanted to know if the events were reported by lot of people. She asked how to deal with the events. She thinks that she had never contacted covid, and she had never gone through the test. She was wondering as it had been over one month ago. She just felt bothered and nervous. The outcome of both the events was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021640539 same reporter/different patient
This spontaneous report was received from a nurse practitioner referring to a patient of 3 years and 9 months and unknown gender. There was no information about the patient's concurrent conditions, medical history, allergies or concomitant medications. On an unknown date, reported as "recent", the patient was vaccinated with M-M-R II dose 2, for prophylaxis, lot # N004433 (expiration date 07-FEB-2019) (frequency, anatomical location and route of administration were not provided). According to the report, the patient received the second dose of the vaccine at age 3 years and 9 months (administered early). No adverse effects were reported.