chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breathing Problem      states pt had DIB 2 hours pta. Initially 76% on RA./ FD administered 125 mg Solumedrol and 1x breathing tx en route, were able to get SPO2 up to 90%.     HPI    Patient is a 74-year-old male with past medical history of A. fib, COPD, GI bleed, hypertension, CAD with complete occlusion of RCA, and who presents to the ED for shortness of breath that started last night. Acutely worsened this morning. Patient arrived via EMS from home. On EMS arrival, patient was found to be 70% on room air. He was placed on CPAP with improvement to 90%. Wife states that patient had started a cough last night. Patient is currently still smoking.   Review of Systems  Constitutional: Negative for chills and fever.  HENT: Negative for congestion, rhinorrhea and sore throat.   Eyes: Negative for pain and visual disturbance.  Respiratory: Positive for cough and shortness of breath.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain, constipation, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria, flank pain and hematuria.  Musculoskeletal: Negative for back pain and neck pain.  Skin: Negative for rash and wound.  Neurological: Negative for dizziness, syncope, light-headedness and headaches.  Psychiatric/Behavioral: Negative for confusion and hallucinations.
Patient received Pfizer COVID vaccine on 3/20/21 (lot # ER2613), 4/27/21 (lot # ER8731), and 8/25/21 (lot # FC31836). On 2/9/22, patient admitted to our inpatient facility with COVID19 pneumonia, acute hypoxic respiratory failure, and reported melena. As of today (2/10/22), patient is still admitted in our med/surg unit.
Poor ROM to right shoulder, pain difficultly performing ADLs. Ibuprofen/Acetamiophen, diclofenac gel, and heating pad
OBSTRUCTIVE SLEEP APNEA 12/16/2022 ANEMIA
Patient had a low grade fever the next day and the site of injection was red, circular, hot, and painful.
swollen lump size of baseball with red rash. Lymph nodes under arm swollen. Moderate pain.
After 12-13 hours of 2nd dose it was 3 am (early morning) next day. I was having headache and did not understand that fever is getting higher too. In the morning around 6.30/7 am i figured out that there is fever and i measured it. It was 103.5 Fahrenheit.  Then took ibuprofen 600 mg for every 6-8 hours. Weakness was lasted for 48-72 hours. Soreness at injection site was there for 2-3 days.
After my stroke, I am currently going to rehab and also have had steroid shots in June 2021. I received my third dose on 08-23-2021. When I first woke up on 08-24-2021 I felt very dizzy. I told my wife how I felt. She then told me to sit down in the toilet seat so I would not fall. My BP was taken by my wife and it was 84/62. My wife gave me the Medridine medication and my BP was 117/77, oxygen level was 76. We then sat down at the kitchen table. And I felt dizzy again and my wife got the BP cuff and she took my BP and it was 100/80. My wife then rechecked my BP in 30 minutes and it was 113/77 and it did not drop again. My wife then called the pharmacist since she knows I have these chronic issues and also to tell her how I was feeling and she recommended for my wife to take me to the Clinic where a doctor saw me there and he took my BP and it was 130 over something and my oxygen level was 98. The doctor at the clinic could not say it was an episode of the vaccine or that just his BP was dropping. My wife does not know if this is coincidental or if the vaccine caused my symptoms. On 08-24-21 at about 1:00AM, I experienced severe abdominal pain but by the later morning I felt fine.
The pt came to the clinic because of left upper arm redness, swelling, tenderness and hot to touch. Treated with compresses, Tylenol, Benadryl for itch.
Pt reported feeling a little dizzy immediately following vaccine. Feet elevated. Within a few minutes also  felt mildly nauseous and looked pale. Pt put into reclined position and color immediately improved. provided with white soda which pt sipped and nausea improved very quickly. Confirms she did have breakfast and that  always feels this way with vaccines and blood draws. Informed that for the second vaccine we will elevate her feet before injection and will likely recline her immediately after. Pt verbalized understanding and was agreeable to plan. Staged return to upright position in increments and at each stage pt pt was given time to see how she felt and reported feeling fine at each point. Pt was able to leave appt at the end of the 15 minute wailt. Time.
pt stated feeling anxious with paresthesia and was unable to sleep night of vaccine due to symptoms. pt feels it will go away in a day or so on its own.
woke up with my mouth on fire like it had been dipped in jalapeno oil; Eyes then  started to burn same way; This is a spontaneous report from a contactable Health care professional (Patient).  A 56-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 03Feb2021 09:30 at SINGLE DOSE for covid-19 immunisation. Facility where the COVID-19 vaccine was administered: Nursing Home. The patient's medical history included Antiphospholipid antibody syndrome, arthritis, allergic to Sulpha. Concomitant medication (list of any other medications the patient received within 2 weeks of vaccination) included warfarin, eplerenone, furosemide, oxycodone hydrochloride.  On 04Feb2021 02:00, the patient reported that, I felt fine, went to bed, woke up with my mouth on fire like it had been dipped in jalapeno oil.  Eyes then started to burn same way. Called advice nurse, she recommended benadryl.  Followed up with pcp at noon next day.  Advised against 2nd shot. The patient has received treatment with antihistamine. Outcome of the events were not recovered. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers 065K21A and 045L21A had undergone temperature excursion.   Maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medication were reported.   This case was linked to MOD-2022-591989 (Patient Link).
2 weeks after receiving immunization patient complained of site pain, only when stretching or moving her arm
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 07-AUG-2018, the patient was vaccinated with a improperly stored PROQUAD recombinant Human Albumin (rHA) (which had a lot # of R006747 and an expiration date of 03-SEP-2019; however, dosage number and route of administration were not reported), for prophylaxis and was reconstituted with properly stored sterile diluent (MERCK). Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: 6° F to 14°F for 6 minutes. Reportedly, there had been no previous temperature excusions and the aformentioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter; Sender's Comments: US-009507513-1809USA006757: US-009507513-1809USA006756.
Patient started experiencing tingling in his left arm. Sensation was going down to his fingers. Per Dr. patient has equal strength and moving hand appropriately. Sensation continued for 25 mins. Sensation was worse with utilization of the arm. No rash. No shortness of breath. No other sypmtoms. Triage nurse (RN) spoke with mom on 07/24/2020 who reported that the patient's symptoms resolved. Patient is active and alert. Denies tingling is present in the left arm.
Left upper arm swelling and redness warm to touch; no fever. Treated with Augmentin.
Nausea (24 hours), chills (24 hours), sore throat (1.5 weeks, ongoing), thick bloody mucus (1.5 weeks, ongoing), dry cough (1.5 weeks, ongoing), loss of voice (1.5 weeks, ongoing)
3 hrs after - pain, tenderness, redness, swelling. 12 hrs after - entire upper arm swollen, red and hard, pain. 12-24 hrs - fever 100 degree; fatigue, nausea, headache, swelling. 24-48 hrs - treated w/antibiotics for cellulitis - hospital admission, intravenous antibiotics and fluid. Physician determined 4 days later it was not cellulitis but an adverse reaction. 01/22/10 2:30 p.m. received vaccine at physician's office. 5:30 p.m. noticed pain, swelling and difficulty raising arm. 7:30 p.m. phone call to physician; possibly a local reaction - wait 24 hrs. 01/23/10 symptoms worsened during day. Symptoms included fever, fatigue, nausea, loss of appetite, headache and malaise as well as increasing redness, heat, pain and tenderness and swelling of entire upper arm from shoulder to elbow. 7:00 p.m. phone call to physician: go to emergency room. 8:00 p.m. examined in the emergency room -tentative diagnosis: cellulitis. Provided with oral antibiotics and antihistamine. Symptoms worsened during night. Redness, heat and swelling increased and spread. Pain, agitation and restlessness prevented sleep. 01/24/10 9:30 a.m. returned to emergency room and was admitted to hospital for intravenous antibiotics and fluids. All symptoms continues but did not worsen. 01/25/20 3:00 p.m. released from hospital with oral antibiotic. Symptoms slightly decreased in intensity. 01/26/10 Symptoms slowly decreasing. Fatigue, malaise and headache continue but not as intense as well as swelling, redness and pain in upper arm. Notes some edema down to wrist on injection arm as well as behind shoulder and in lymph area in opposite (mastectomy) arm. 5:30 p.m. Follow-up visit to physician. Her diagnosis: severe adverse reaction to vaccine rather than cellulitis.
1 -2 days after the first dose he started getting confused . 3rd day we admitted him to the hospital . At one point they thought or were testing about his brain bleeding . Roughly after 4 days in the hopsital his body crashed he was in a coma and then died roughly 14 days after the injection on March 24, 2021. He died of an acute intracerebral hemorrhage which we were told he had a blood clot then stroke
I am feeling like I have a sinus infection; This is a spontaneous report from a contactable consumer (patient).  A patient of an unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route, 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced feeling like I had a sinus infection. The outcome of event was unknown.  Information on the lot/ batch number has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of INITIAL INSOMNIA (Could not fall asleep), ABDOMINAL PAIN UPPER (Stomach hurts), PAIN IN EXTREMITY (Arms hurt) and CHILLS (Chill all night long) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INITIAL INSOMNIA (Could not fall asleep), ABDOMINAL PAIN UPPER (Stomach hurts), PAIN IN EXTREMITY (Arms hurt) and CHILLS (Chill all night long). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INITIAL INSOMNIA (Could not fall asleep), ABDOMINAL PAIN UPPER (Stomach hurts), PAIN IN EXTREMITY (Arms hurt) and CHILLS (Chill all night long) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Chills, mild fever, aches, loss of taste, I feel like I have the flu. Extremely sore arm
no other symptoms or other AE reported; doses of VARIVAX were given following temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.    On 18-MAR-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U022732, expiration date: 20-JUL-2023; strength, dose, and route were not reported) for prophylaxis (product storage error).    It was reported that the suspect vaccine was exposed to a temperature of 7.4 Fahrenheit (F) for a time frame of 10 minutes (on 01-MAR-2022). There were no previous temperature excursion. No other symptoms or other adverse event was reported.  This is one of the several cases reported by the same reporter.; Sender's Comments:  US-009507513-2203USA010326:
fever; muscle spasms; felt really cold; chest pain; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administration date 08Dec2021 (Lot number: EW0187) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: The patient was also on high blood pressure medication, she did not provide details.; "Abdominal pain" (unspecified if ongoing). Concomitant medication(s) included: DOXYCILLIN taken for abdominal pain (ongoing). Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0187), administration date: 01Jun2021, when the patient was 60 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0170), administration date: 11May2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 09Dec2021, outcome "recovered" (Dec2021), described as "fever"; MUSCLE SPASMS (non-serious) with onset 09Dec2021, outcome "recovering", described as "muscle spasms"; FEELING COLD (non-serious) with onset 09Dec2021, outcome "recovering", described as "felt really cold"; CHEST PAIN (non-serious) with onset 09Dec2021, outcome "recovering", described as "chest pain". Therapeutic measures were taken as a result of pyrexia, muscle spasms, feeling cold, chest pain.  Additional information: The patient stated she was on high blood pressure medication, did not provide details. A week age (as reported), the patient received the concomitant drug doxycycline hydrochloride. The patient stated she got the shot on 08Dec2021. On 09Dec2021, the patient felt really cold, it was 75 degrees in her house but she felt like it was 20 degrees in there, had a little fever that was gone at the time of reporting, had muscle spasms, took some pills for that and it was  just a little bit there, a little chest pain, and the patient stated it was improving but was still there. The investigation assessment was none.   No follow-up attempts are needed. No further information is expected.
Started antibiotics the day after finishing the Vivotif course; Spontaneous report received on 10MAR2020.  A nurse reported that a consumer "started antibiotics the day after finishing the Vivotif course" (PT: Labelled drug-drug interaction medication error). The consumer was receiving Vivotif for immunisation. The consumer had completed a course of Vivotif on Thursday. On the following day, the consumer initiated a five day course of unidentified antibiotics for a dental procedure that was also conducted on Thursday. No complications were reported. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer started antibiotics the day after finishing the Vivotif course (Labelled drug-drug interaction medication error). This consumer had a dental procedure on the day he took the last dose of Vivotif and the next day, the consumer started unknown antibiotic course without any complications. Antibiotics should not be started for at least three days of completing the Vivotif course. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer started antibiotics the day after finishing the Vivotif course (Labelled drug-drug interaction medication error). This consumer had a dental procedure on the day he took the last dose of Vivotif and the next day, the consumer started unknown antibiotic course without any complications. Antibiotics should not be started for at least three days of completing the Vivotif course. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.
Body feverishness, nausea, racing heart, large swollen lump-very hot to the touch (approx. 2inches x 1 inch), condition existed for just over 48 hrs. followed by extreme lethargy. Ice was applied often to relieve pain and swelling.
acute deep vein thrombosis (DVT) and pulmonary embolus (PE)
seen in office for appointment by Dr. on 3/22/21: arthritis of hand (Bilateral) bilateral hand swelling and MCP joint swelling  symptoms worsening each day per patient  suspect rheumatoid arthritis even with negative rheumatoid factor  will recheck labs today and refer patient to rheumatology for further work up  patient to start prednisone 7.5 mg every day x 30 days  used in the decision making process  Send for rheumatology referral Check ANA multiplex w/reflex 11 Ab cascade Check cyclic citrullinated peptide (ccp) Ab (IgG) Check rheumatoid factor Check C-reactive protein Check sed rate  Start predniSONE 5 mg tablet 1.5 tablets every day for 30 days tendonitis of left shoulder limited range of motion, tenderness  pain since administration of Pfizer covid vaccine in January  patient agrees to steroid injection to area  patient reports improvement post injection  used in the decision making process  Start Kenalog 40 mg/mL suspension for injection 1 cc kenalog and 2 cc xylocaine to L shoulder Send for physical therapy referral hypothyroidism denies worsening symptoms or side effects  will check lab today  continue current treatment  used in the decision making process  Check TSH hypertensive disorder blood pressure within normal limits patient denies side effects continue current treatment used in the decision making process  hyperlipidemia denies side effects  continue current treatment  used in the decision making process  celiac disease denies worsening symptoms  continue current treatment  neoplasm of prostate followed by oncology--reviewed records  congestive heart failure followed by cardiology--records reviewed  overweight BMI 27.8 + hypertension, hyperlipidemia, CHF  weight maintained since last visit  continue current efforts--diet and exercise  History of Present Illness pt is here for pain to hands pt states he is having pain to left arm where he had covid vaccine. pt thinks that pain and swelling to hands begin after he got the covid vaccine. pain level is 10/10 pt finds swelling is worse in the mornings pt is also having trouble walking   established pt  pain in right hand pain of left shoulder joint Kenalog 40 mg/mL suspension for injection hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight   pain in right hand ketorolac 60 mg/2 mL intramuscular solution ANA screen, ifa, w/refl titer and pattern C-reactive protein cyclic citrullinated peptide (ccp) Ab (IgG) rheumatoid factor hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight intolerant of cold CBC (includes diff/plt) comprehensive metabolic panel TSH w/reflex to FT4 T3, free
Information has been received from a RN concerning a 38 y/o female employee with mild asthma and no known drug allergies who on 23Jun2003 was vaccinated SC with a dose of varicella virus vaccine live. Concomitant therapy included albuterol prn. On 08Jul2003 the pt developed a breakthrough rash all over her trunk and down one let. The vesicles were reported as painful, but not itchy. No other information was provided. No laboratory data or diagnostic studies were done. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Pt had an red rash in her arm, bruising, fatigue, diarrhea, abdominal pain.
a bottle of moderna was used for vaccination after it was supposed to be pulled from the fridge and discarded.  12 days "expired"  per manufacturer recommendations for storage and handling. manufacturer recommends re-vaccination for proven efficacy in opposite arm.  pt. wants to wait, she is still having minor skin irritation.  will contact us if she decides to get 3rd shot. strongly recommended re-vaccination.
Arm pain at injection site,  headache,  fever,  fatigue.   Affects began about 15 hrs. after receiving the shot  and  lasted about 12 hrs.   Experienced the same affects, minus the fever, after the first shot, but this time the affects were more severe then the first time.  Did not require or seek medical or doctor  assistance,  simply  stayed hydrated and rested.
After receiving Hep B#2 and Rabies/Imovax #5, pt. complained of flu like symptoms, with fever vomiting, malaise.  Also developed rash on her arms day after dose.  Unable to return to work until 3rd day post vaccination.