chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 75-year-old male with history of obesity hypoventilation syndrome, memory impairment, venous insufficiency, hyperglycemia, hyperlipidemia, hypertension who presents to the emergency room with shortness of breath.  Patient was actually at the immediate care center earlier today for shortness of breath and was diagnosed with COVID-19, he had sats 88-89 on room air and was dyspneic with exertion so they recommended him come to the emergency room for further evaluation.  Patient is fully vaccinated against COVID-19, however he did tell the emergency room provider that he was not vaccinated, his vaccinations are seen in epic.  He does have history of memory impairment, and seems to be a somewhat poor historian and changes his story about onset of symptoms.  In review of the note from immediate care center he did then that his wife had COVID and his symptoms have been ongoing for a few days.  He tell me that he was not aware of any exposure but he has had symptoms for 2 days with shortness of breath and cough.  She denies any fever, no nausea or vomiting although he has had a poor appetite the last few days.  He states he feels much better since being put on oxygen, at this time he has no complaints.
Approx 5 minutes following shots, fainted fell & hit lt side of forehead; @ the time pt was @ the cashier's office; carried back to clinic & examined; diaphoretic; MD examined; parents took pt to ER;
Warm to the touch; Tenderness; Itchy is getting worse, looks like pink points at the injection site; Swollen; Red; Minor reaction to the vaccine; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minor reaction to the vaccine), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Tenderness) and VACCINATION SITE DISCOLOURATION (Itchy is getting worse, looks like pink points at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BERBERINE, ACETYLSALICYLIC ACID (ASPIRIN 81), CHOLESTEROL and AMLODIPINE for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced VACCINATION COMPLICATION (Minor reaction to the vaccine), VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Tenderness), VACCINATION SITE DISCOLOURATION (Itchy is getting worse, looks like pink points at the injection site), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION COMPLICATION (Minor reaction to the vaccine), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Tenderness), VACCINATION SITE DISCOLOURATION (Itchy is getting worse, looks like pink points at the injection site), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was provided blood pressure pills but not coded No laboratory was provided by the reporter. Treatment information not available.   This case was linked to MOD-2021-240189 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received on 29-JUN-2021 and it does not contain any new information.
Initial misuse case was received from a healthcare professional on 16 SEP 2013. Cases were received on 21 March 2014. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE HD vaccine on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received expired vaccine. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
2 cm area of induration in a 4 cm patch of erythema. Pain is improving, rash appears to be fading.
arm swollen and sore at injection site. Other symptoms include fever (100.5-100.8), body aches, chills, fatigue, nausea. ibuprofen taken at 12 am and 10:30 am on 1/31/21.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No pertinent medical history or concurrent condition were reported. On 22-JUL-2015, the patient was vaccinated with improperly stored VAQTA, strength 25/0.5 (units not specified), lot # K012457, expiration date 04-JUN-2017, through an unknown route. No adverse effects reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
First 48 hours: sore arm, muscle aching, headache: treated with ibuprofen for 48 hours.  7 days out blood sugar elevation with occasional severe hypoglycemic events
Rash on arms and legs - raised, itches, no relief from over the counter medication.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot number M041768 with an expiration date of 25-JUN-2018 and lot number N004946 with an expiration date of 05-OCT-2018 orally for prophylaxis (dose was not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1709USA011980: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
pt recv vax 12MAY95 & 22MAY95 pt exp rash & fever; rash consisted of more than 30 bumps & vesicles; No further details were provided;
This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash), VACCINATION SITE WARMTH (warm to the touch at the injection site) and FATIGUE (fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FATIGUE (fatigue). On 28-Jan-2021, the patient experienced RASH PRURITIC (itchy rash) and VACCINATION SITE WARMTH (warm to the touch at the injection site). At the time of the report, RASH PRURITIC (itchy rash) outcome was unknown and VACCINATION SITE WARMTH (warm to the touch at the injection site) and FATIGUE (fatigue) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. Treatment details included medicated lotion. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: NNI: Reporter refused to give her Email ID/Fax number and took the call back number 1-866-663-3762; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
HPV vaccination (R) deltoid IM - immediately upon administration patient c/o heavy arm, then became pale/diaphoretic-moved patient to supine position with legs elevated. Patient took approx 10 minutes to return to baseline. 7/23/15.
Heat, slight swelling, and some redness near injection site that occurred about one day after shot was administered, still present when pt appeared at pharmacy to report.
Case number PHEH2013US022650 is an initial spontaneous report received from a pharmacist on 28 OCT 2013. This report refers to a 12-year-old female patient who was vaccinated with FLUCELVAX 2013/2014 (batch number: 006011A) intramuscularly on 26 OCT 2013. No adverse event was reported following medication error (inappropriate age at vaccine administration).
Information has been received from a physician concerning a female "in her mid to late 60's" who on an unspecified date was vaccinated with a "single dose" of zoster vaccine live (Oka/Merk). "Within the last few weeks" prior to reporting, in approximately January 2008, the patient developed a severe varicella rash which was cultured and positively identified as shingles. At the time of reporting the patient was recovering. Unspecified medical attention was sought.  There was no product quality complaint.
Rapid heartbeat, sweating, a little heaviness in chest. Sat back down with the dr that was there until my heart rate went down. Next day, today, chills a little achy. Tired
bleeding; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2), first dose on 16Apr2021 (lot no.: ER8735) and second dose administered in left arm on 07May2021 14:00 (Lot Number: EW0167); at the age 44-year-old both via an unspecified route of administration single dose for COVID-19 immunization. Medical history included Diabetes type 2. Concomitant medications included metformin; sitagliptin (JANUVIA); and multivitamins. The patient previously took acetylsalicylic (ASPIRIN) and experienced allergy. On 18Apr2021 at 12:00, the patient started bleeding 2 days after the first dose but did not think anything of it because she was due to start her period. After her period ended, she continued spotting for 3 weeks some days more than others. She received her 2nd dose on 07May2021 and started bleeding again like a period. And it has not stop as of today (16May2021). There was no treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Received vaccine to Left arm on 1/23/19 and felt sore the rest of the day. On 1/24/19 pt still C/O tenderness to arm and a large area of upper arm red and swollen about the size of grapefruit. By that same evening, Mother reported area at injection site appearing purple. Today, 1/25/19, arm is still a little sore and with an area of 3.25" in diameter of pink color. Area is not raised, or draining. Injection site a little sore.
Within 5 min of receiving vaccine pt had anaphylactic reaction and was given oral BENADRYL, 2 EPIPENS, went to ER and was given IV BENADRYL and steroids. Flu vaccine given due to hospital employee rules.
Redness, swelling, pain in entire left arm.  Feeling unwell.  Arm so painful patient unable to sleep.
Diagnosed with diabetes January 2006, started on oral meds.  Found GAD65 antibodies around June 2006, indicating autoimmune-induced diabetes and thereafter taking injected insulin.  Tests showed lots FAV038 and FAV041 contained squalene adjuvant. 7/18/07-records received from patient. 1/10/06 seen in ED with DX of new onset Diabetes. C/O polydypsia, polyuria and loss of vision. Followup 3/30/2010. Insulin-dependent diabete, expected to continue for life.
Side effects have continued for 3 days and have not resolved: nausea, emesis, low fever 99.8, chills, body aches, joint pain, diarrhea, large bruise at injection site about the size of a half-dollar
Tingling and numbness in extremeties which has moved upward. Achy wrists. Some weakness in hands
PT left arm got swollen and a large rash developed down the whole arm. PT felt pain and stiffness. No shortness of breath, fever.
Seizure within 24 hours of vaccination. No history of seizures prior to this episode. None since.  1/19/09 Reviewed hospital medical records of 01/01-01/05/2009. FINAL DX: seizure disorder suspected; child abuse suspected; overfeeding; GERD Records reveal patient experienced shaking of arms, fists clenched, arching of back x 1 day after being dropped & striking head day before episode.  No further episodes while hospitalized & d/c to home.
In December of 2021, I went for my wellness check-up, and while my PCP was listening to my heart, he didn't like what he heard. He ordered an EKG right away in his office. He contacted a local hospital to schedule a cardiologist for me. I never heard back from anyone, but I made some calls and was finally able to see a doctor. I wasn't feeling that bad, but when I saw the doctor, he ordered a heart monitor. I wore that for a week, but during that time, I was contacting their RN with concerns of shortness of breath and they told me that I needed to come in earlier than they thought. I had an echocardiogram and they did not like the results. They did a heart catheter, hoping they could fix the valves, but noticed that my valves were severely damaged. They did a TEE. Everything came on super quick with how quickly it progressed. I was ordered to have surgery today 05/09/2022, but I got COVID-19 on 05/06/2022.  I have to have my mitral and aortic valves replaced. My mitral valve has always seemed mild and my aortic valve was mild/moderate. I am now on the waiting for the surgery again.
Complained of red mark, hot area of upper arm, area is black and blue and swollen the size of a fist.
Patient received booster dose of Moderna. At the end of the 15 minute observation period patient stated he felt dizzy. Staff had patient sit back down for awhile to see if he felt better. Patient complained of the "room spinning," he felt warm and his hands felt clammy. We started a fan to help cool him off. After a few minutes he said he felt cold and a little nauseous. Patient was coherent and could speak. He said he ate earlier in the day. He denied any previous reactions after a vaccine. After another 20 minutes or so, he still reported he felt dizzy and it wasn't going away. He was not accompanied by anyone. He requested paramedics be called. They came to the pharmacy, checked him out and chose to transport him to a hospital. I did not receive any information or vitals from the paramedics.
This spontaneous report as received from a nurse refers to a 04-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Today the redness has come down to my arm, it's spreading.; Yesterday I looked at it and there was a red area there; my shoulder started itching.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Today the redness has come down to my arm, it's spreading.), VACCINATION SITE PRURITUS (my shoulder started itching.) and VACCINATION SITE ERYTHEMA (Yesterday I looked at it and there was a red area there) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal (Patient takes unspecified blood pressure medicine every morning) and Macular degeneration (Patient mentioned she uses vitamins for macular degeneration). Concomitant products included VITAMINS NOS for Macular degeneration.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (my shoulder started itching.). On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Yesterday I looked at it and there was a red area there). On 04-Feb-2021, the patient experienced ERYTHEMA (Today the redness has come down to my arm, it's spreading.). At the time of the report, ERYTHEMA (Today the redness has come down to my arm, it's spreading.), VACCINATION SITE PRURITUS (my shoulder started itching.) and VACCINATION SITE ERYTHEMA (Yesterday I looked at it and there was a red area there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In addition to taking vitamins for macular degeneration as noted above, the patient reported taking an unspecified blood pressure medication every morning per source document.   Treatment for the events included use of hydrocortisone cream and diphenhydramine (Benadryl) cream as prescribed by the patient's doctor.
unable to get up, stand or walk; unable to get up, stand or walk; This is a spontaneous report from a contactable non-healthcare professional reporting for a patient.   An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EN5318 and expiry date unknown) on 06Feb2021 13:30 at single does via an unspecified route of administration into her right arm for COVID-19 immunization.  Medical history included asthma, chronic obstructive pulmonary disease (COPD), osteoarthritis, marginal zone lymphoma (stable not treated at this time), prior ductal carcinoma in situ (DCIS). Known allergies: Sulfa Drugs, Macrobid. The patient had not had COVID prior to the vaccination, COVID not tested post the vaccination.  Concomitant medications in two weeks: fluticasone propionate/salmeterol xinafoate (ADVAIR), ipratropium bromide/salbutamol sulfate (COMBIVENT), losartan (LOSARTAN), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), meloxicam (MELOXICAM), tamoxifen (TAMOXIFEN), acetylsalicylic acid (ASPIRIN) low dose, ascorbic acid/biotin/ calcium/calcium phosphate dibasic/chromic chloride/cupric oxide/cyanocobalamin/ferrous fumarate/folic acid/magnesium oxide/manganese sulfate/nickel sulfate/nicotinamide/pantothenic acid/ phytomenadione/ potassium chloride/potassium iodide/pyridoxine hydrochloride/retinol/riboflavin/sodium metasilicate/sodium molybdate/ sodium selenate/hiamine mononitrate/ tocopheryl acetate/vitamin d nos/zinc oxide (CENTRUM SILVER), ascorbic acid (VITAMIN C). No other vaccine received in four weeks.  On 06Feb2021 at 19:00, approximately 5.5 hours after the vaccination, the patient sat down and was unable to get up, stand or walk, was leaning to side in chair, which lasted for at least 1.5 - 2 hours. The events resulted in emergency room/department or urgent care and hospitalization for 1 day. Bloodwork and CT scan were done; the patient was observed overnight. The event was resolved on an unspecified date in Feb2021.
Fever Tmax 101.1, mild cough, (L) deltoid bruise and itching at injection site starting day 1 and still present at day 4 - improving. No rash or SOB.
This is a spontaneous report obtained from a contactable consumer. A 66 year-old female patient received, on an unspecified date, intramuscular PREVNAR 13 single dose. Relevant medical history included high blood pressure and potassium low. Concomitant medications included NORVASC, losartan, PREMARIN, tablet and trazodone. The patient mentioned that she experienced the side effects, in February 2nd (unspecified year), when she received PREVNAR 13. After the vaccination, her left arm got hurt at injection site and possibly like cellulitis, and she had pain at injection site also. The patient was put on antibiotic cephalexin. She was feeling sick like she had the flu, she was hot, had nausea, her blood pressure was abnormal ("she can't control her blood pressure") and her potassium value raised up. The patient did not recover from the events at time of this report. The patient mentioned that her doctor recommended her to take the shots as she had strains of pneumonia.
Skin sensitivity on right side upper chest and upper back/shoulder blade area (same side of body). Mild burning sensation, persistent over a number of days. It has not yet gone away.
After the second dose, within hours (4-5) left shoulder was in pain. 4 Months later, patient went to see orthopedic and was told to take a Cortisone shot and do an MRI.  To this day pain I still within the left shoulder, nothing has helped.
Shingles in the occipital nerve; Other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unspecified age and gender. The pt's concurrent conditions, concomitant medications and medical history were unknown. On or about November 2011 (at approximately 61 years old), the pt was administered the zoster vaccine live(ZOSTAVAX) vaccine (strength, dose, rout of administration, lot# and expire date were not reported) by a doctor in a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently (unspecified date), the pt was treated by healthcare providers (HCP) at urgent care for the following injuries resulting from the zoster vaccine live(ZOSTAVAX) use: shingles in the occipital nerve and other zoster-related conditions (ill-defined disorder). The outcome of the events was not provided. The events were assessed as related to zoster vaccine live(ZOSTAVAX) by the lawyer.  Upon internal review, shingles in the occipital nerve was considered to be medically significant.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 17-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.