chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with dinner that evening anticipating some body aches (which i had for 24h after dose 1). 1/7/21: Woke in the early AM with severe arthralgia, myalgia, restlessness, mild R arm swelling.  Ate a small snack and took ibuprofen. All day 1/7/21: fatigue, myalgia, arthralgia (all of my large and small joints, my long bones, my intercostals, my large muscles stiff/ ached), and increasingly swollen R axillary lymph node(s) about the size of a large egg, extending into my upper chest.  Food aversion at breakfast - could not tolerate eating more than a few bites.  Slept almost all day except to re-dose ibuprofen and take a warm shower. Tolerating bland diet by evening.  Tmax 99.3F forehead As of now 10:30am 1/8/21, myalgias are improving.  Fatigue continues but is less. R axillary and chest lymph nodes are painful and swollen, up into my lower neck.  Continuing to take  ibuprofen with some food 3x per day
pt had 2nd injection 4/24/07 developed a rash on her face, chest, & back 3 days after the injection. Medrol dose pack was given by primary care physician
Patient was administered the above vaccinations by me, PharmD. Upon completion, patient was advised to sit in the pharmacy lobby for 10-15 minutes and I returned to the pharmacy. Instead of sitting down, patient walked over to the "patient consultation" window and requested paperwork documenting his vaccinations. Patient, then dropped to his knees and passed out. Patient was slumped against the pharmacy wall, unconscious, for aboy 10 seconds. He then regained consciousness but was pale in color and disoriented. 911 was called and patient was treated by the paramedics. Patient was able to walk out of the store on his own power accompanied by the paramedics.
This spontaneous report was received from a physician, via a company representative, referring to a 15 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by the reporter. On 19-JUL-2018, the patient was vaccinated with GARDASIL 9 first dose (dose, routes of administration, lot number and expiration date were not reported) protect against HPV. On the same vaccination date, the patient had a blood drawn, after the vaccine was administered, the patient fainted in the office. The patient was sent to an unspecified emergency room and she was found to be anemic. Then, on an unspecified date in July 2018, the patient was admitted to an unspecified hospital, for one night and the patient received 3 bags of blood. At the reporting time, patient was recovered from the aforementioned adverse events on an unknown date in July 2018. The causality between the events and the therapy with GARDASIL 9 was not reported. Upon internal review, anaemia was considered to be medically significant due to blood transfusion.
A report has been received from a Health Professional concerning a 5 year old, male subject who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 03-DEC-2014. The patient received FLUMIST Quadrivalent two doses and extra dose of FLUMIST Quadrivalent which started on 04-DEC-2014. The outcome of the event of received FLUMIST Quadrivalent two doses/extra dose of FLUMIST Quadrivalent given is unknown. The report was considered to be non-serious.
Severe diarrhea, abdominal pain, fever, stomach pain that lasted 4 weeks, swollen lymph nodes in the groin, malaise and fatigue still ongoing.
Covid-19 Infection Acute Hypoxemic Respiratory Failure, resolved -Symptom onset 7/29, presented 7/31 shortness of breath, cough, weakness -Covid-19 (+) 7/31 on presentation; vaccinated with Pfizer, last booster 1/2022 -CXR, CTPA without infiltrate/PE -S/p steroid therapy x2days, remdesivir x3days; given continued clinical improvement and respiratory stability further therapy deferred on discharge   Nonischemic Cardiomyopathy History of AICD Progressive Multiple Sclerosis Hypothyroidism GERD
Within 24 hour of the shot I had the typical symptoms, but the following night I broke out in hives while I was trying to sleep. I still currently have some bumps on me.
On January 21, 2021 at the Clinic, a PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the nurse inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The nurse then alerted the APRN, who escalated the situation to the manager. The manager then contacted Quality. The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL. After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them. Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of an abundance of caution.
Area became for red and swollen. Mother states over the weekend pt had very large area bigger than the 3in x 4in area that was present today. Today the area is still reddish purple and swollen. The area is hard to the touch. Mother has administered Tylenol and applied ice to the area.
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was Dx was metastatic pancreatic cancer in Oct 2020 and was discharged on 2/5/21 with home hospice after being hospitalized with sepsis. He had comorbidities of a recent PE, COPD and diabetes.
Received IPV and Hib in 05/2001,. One day later got hives. Received IPV and Hib in 04/2002. One day later got hives. However was on Amoxil in 05/2001 and Cefzil in 05/2002. This could be cause of allergic reaction
On 10/06/04 received influenza vaccine at 0745.  Five hours later noted tingling in injection arm-superior surface of forearm.  Noted Maculopapular pruritic rash at this site.  At HS noted generalized tingling over entire body.  Noted urticaria around R ankle.  Took cool showers and soda baths for relief.  Buzzing and tingling sensation in ears and general has continued to date.  States is sensitive to meds and has limited Benadryl use.  Denies allergy to eggs.  Has not changed laundry soaps, or sking products.  Has had varicella as child.  Is currently not sick and no children in familly are sick.  No new medications.
Last week I had a mild sore throat for a few days, then on Friday, the day before my second Moderna shot (ie one month after the first) I went to bed and turned to my right side.  My right ear made a strange pop sound and then my left ear began to ring.  The ringing was pretty loud at first and then settled into a steady low ringing.  I have had occurrences over the past couple of years of one ear ringing for a few seconds and then it going away, but never has the ringing kept going 24/7 as it has now.  My left ear (where the ringing is) feels full and my right ear drum hurts.  My head feels clogged, but I have no symptoms of a cold.
Narrative:  Per patient the first COVID vaccine, had done on right shoulder, on 1/21/21 after about 2 days, started getting "blotches around his arm". These blotches have persisted and formed a rash over right upper arm just below shoulder that still hasn't gone away. Rash has no symptoms, not itchy, not painful, not indurated, just still there since 1/21/21 and he says has progressed, getting larger. Has been applying topical astringents to cleanse the skin. Also applied OTC hydrocortisone cream - nothing seemed to help
FLU-LIKE SYMPTOMS; CHILLS; FEVER; MUSCLE SORENESS; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 12:30 vaccinated in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 20:00, the subject experienced flu-like symptoms. On 06-APR-2021 20:00, the subject experienced chills. On 06-APR-2021 20:00, the subject experienced fever. On 06-APR-2021 20:00, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, muscle soreness and flu-like symptoms was not reported. This report was non-serious.
Initial report was received from a health care professional on 24 February 2012, which also involved a case of misuse (wrong route of administration). A 53-year-old male patient had received a subcutaneous injection in the right arm below the right deltoid of ADACEL, sanofi pasteur Ltd. C4063 (sanofi pasteur Inc. lot number U4308AA) on 20 February 2012. On 21 February 2012, the patient experienced redness and swelling of an area of 3"x4" on the right arm and pain down the right side and across the chest. The patient had no illness at the time of vaccination, no medical history, took no concomitant medications and received no other vaccinations within four weeks of ADACEL. It was unknown if the patient had any adverse events to prior vaccinations. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None. Follow up information received on 4 May 2012: Illness at the time of vaccination: None. The patient recovered on 26 February 2012 and was reported that he was doing well.
I had a heart murmur prior to being vaccinated, but it was louder after being vaccinated and I seem to be having a little more palpitations now. I just had a heart study and it showed that I have some Aarrhythmia's now that I don't believe I had before.
vaginal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding) in an elderly female 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. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding) had resolved.            No Concomitant medications were reported No treatment medications were reported
Arm is extremely swollen like a baseball on her shoulder. It's very red and hot to the touch. She is complaining her entire arm itches and burn. Looks like the start of hives directly on the site.  She has a fever and complaining of all her muscles hurting.
It was reported that a 79 year old female received Fluzone SV 98-99 USP vaccine on 10/19/1998. Reportedly on 10/22/98 the pt experienced bilateral leg and arm weakness.
Vaccination given two weeks early. First shot given 3/30/21. Second shot administered 4/13/21.
Came into ED 3.17.21 with chills, cough that caused chest discomfort, fever 103, chronic SOB with exersion, sats in the low 90s at rest. Was diagnosed COVID+ on 3.17.21 and admitted to the hospital.   He had his second Moderna vaccine March 13 th.
EYE SIGHT EXTREMELY BLURRY FOR 24 HOURS STARTED ABOUT 4 HOURS AFTER SHOT HANDS WERE CURLED INTO FIST COULD NOT USE FOR ABOUT 24 HOURS STARTING ABOUT 5 HOURS AFTER SHOT  LOSE OF BALANCE STARTING ABOUT 4 HOURS AFTER SHOT - CAME BACK SLOWLY OVER SEVERAL WEEK TIME FRAME
Erythema multiforme symptoms on right forearm and right bicep.  No treatment yet except antibiotic cream
3 weeks after the vaccine I started to have an irregular heart beat. At first it was not constant but over a few more weeks it has gotten worse. Sometimes it settles but it is irregular most of the time
Patient fainted while sitting at the post-vaccination waiting area about 10 minutes after vaccination.  Immediately reached out to the patient. Positioned him properly. Other Pharmacist called 911. less than a minute, patient responded. He sat down and meantime the paramedics came in. They took him to the E.R. Called patient after 5 hours, he is still in the ER under observation. but he feels fine
Patient stated that she was not doing well after getting her shot. She complained of excessive pain in her shoulder. She was concerned that the shot was given too high on the arm and may be causing the pain. She does not believe the shot was administered into her muscle, she thinks it was too high to be her deltoid muscle.
AT 36 HOURS POST VACCINATION, CHILDS RIGHT ARM, AT THE SITE OF Dtap INJECTION BECAME VERY RED, HOT AND SWOLLEN.  CHILDS PMD WAS NOTIFIED AND DUE TO SEVERITY AND WEEKEND DAY, THE CHILD WAS ADVISED TO BE SEEN AT LOCAL ER.  PATIENT WAS SEEN AT ER. COLD COMPRESSES AND ANTIBIOTICS WERE INITIATED.  2 DAYS LATER THE REACTION RESOLVED.
Syringe malfunction.  When technician attempted to give pt the immunization the liquid went out of the syringe tip and ran down her arm.  The pharmacist came to talk to pt and pt claims she received little if any amount so we decided to repeat vaccination.
Pt. fell to floor from chair, dizziness, possible seizure activity 12 Lead, started IV, 0 meds.  Vital signs: 89/40  Pulse:60                           89/41 Pulse :55                           89/42  Pulse:56 Recorded by RN.  Pt. transported to hospital via ambulance at 11:32 A.M. with mother.
A non-serious spontaneous report of asthmatic children got H1N1 LAIV was received from registered nurse/health care professional concerning a 12-year-old child of an unknown gender. The patient had medical history of asthma. No concomitant medications have been reported for this patient. In 2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Initial report received on 04 November 2009 from a health care professional. A 54 year old male patient with no reported medical history noticed limited movement and pain in the left arm 18 hours (on 29 September 2009 at 8 PM) after receiving an initial dose of FLUZONE SV (lot number not reported) intramuscularly in the right deltoid and H1N1 (lot number UP001AA) intramuscularly in the left deltoid on 28 September 2009 at 2 PM. The patient recovered. No additional information was provided. Follow-up information received on 07 December 2009 from a health care professional. The patient has medical history of gallstones. The lot number for the FLUZONE was UT3251BA, and as a result, the product received was updated to FLUZONE (previously reported as FLUZONE SV). The FLUZONE and H1N1 vaccines were administered on 30 September 2009 (previously reported as 28 September 2009) with no change in the time administered. The onset date of the adverse events was 01 October 2009 (previously reported as 29 September 2009) without change in the time of onset and latency. The patient did not require treatment or a doctor's visit for the adverse events. Per the reporter, the patient recovered on 30 November 2009. The reporter has no additional information to add to the case. List of Documents held by Sender: none.
Tongue on left side went numb within 10min. Then weakness/numbness on whole left side of face. Weird pressure moved from left to right across my neck/chest and settled over right side of chest. When they took my blood pressure it was high (not sure what and i usually have good blood pressure). I started having trouble finding and forming the words i wanted to say. The people at the site called EMT and they took me to ER. Symptoms reminded the same but started to get heartburn and migraine. After running some tests they gave me benadryl in my IV which made my body go heavy. Benadryl did not stop the numbness of left side of face and tongue. I was released about an hour after the benadryl with same symptoms minus the right  chest pain.
Migraine type headache with first shot. Second shot: body aches, low grade fever, and fatigue
had va 845AM 12OCT92 & woke up w/hives @ 3AM 13OCT92; treated @ hosp ER w/advil; dx allergic rxn;
Pt's mother reporter to us -> pt experienced heat/warmth around head and neck went to MD-got ZPAK/pred/acyclovir, awoke next day w/left ear deafness-is still being followed by MDs.
After receiving the vaccine, I sat down to rest and gave me tachycardia with difficulty breathing, my feet were weak with tiredness and cold. Then I drank water and fluids and my heart rate stabilized. Then within 2 hours I had 4 tachycardia events but milder and then normalized.
Child exposed to shingles 2 weeks ago. Chicken pox rash appeared 02/08/04.  Child received Varicella vaccine 06/18/1999.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revaxed on 11-7-22
17-year-old Patient Received Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old Patient Received Vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old Patient Received Vaccine). On 22-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old Patient Received Vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication details was reported.   This case was linked to MOD21-065941, MOD21-069614, MOD21-069622 (E2B Linked Report).; Sender's Comments:  MOD21-065941: MOD21-069614: MOD21-069622:
pain under clavicle; limited mobility; moving her arm is very painful/pain around her triceps; cannot twist her arm back to wash her back; developed pains in her arm going downwards from the injection site; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain under clavicle), MOBILITY DECREASED (limited mobility), PAIN IN EXTREMITY (moving her arm is very painful/pain around her triceps), MOVEMENT DISORDER (cannot twist her arm back to wash her back) and VACCINATION SITE PAIN (developed pains in her arm going downwards from the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (pain under clavicle), MOBILITY DECREASED (limited mobility), PAIN IN EXTREMITY (moving her arm is very painful/pain around her triceps), MOVEMENT DISORDER (cannot twist her arm back to wash her back), VACCINATION SITE PAIN (developed pains in her arm going downwards from the injection site) and NAUSEA (nausea). The patient was treated with Physical therapy (range of motion exercises) for Mobility decreased; Physical therapy (range of motion exercises) for Pain in extremity and Physical therapy (range of motion exercises) for Movement disorder. At the time of the report, PAIN (pain under clavicle), MOVEMENT DISORDER (cannot twist her arm back to wash her back), VACCINATION SITE PAIN (developed pains in her arm going downwards from the injection site) and NAUSEA (nausea) outcome was unknown, MOBILITY DECREASED (limited mobility) had not resolved and PAIN IN EXTREMITY (moving her arm is very painful/pain around her triceps) was resolving.            No relevant concomitant medications were reported.   Treatment information was not provided.  The patient reported she had not done any strenuous activity. Arm was imperceptibly better with time although she continued to have limited mobility.   This case was linked to MOD-2021-200202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received and does not contain any new information.
Experience severe subcoconjunctival hemhorrage in right eye. As of Sunday 4/25 still severe, Cannot tell if it's still bleeding. Saw my ophthamologist who said it was severe but would take two weeks to resolve.  I think it may be ITP.
Head ache, fever 100.4 F, chest pain, body aches, arm soreness
Nausea, chills/fever, headache, foot and muscle cramps, loss of appetite, large rash on arm at injection site  Taking Ibuprofen,  resting/sleeping  Still not feeling well
Itching of left arm after administration of 2nd Pfizer vaccine.  Unclear if from Band-Aid adhesive on upper arm however with single blister with itching developed morning of 9/13/2021 after continued itching post vaccine administration.
PHARMACIST PRACTITIONER Specialty:  PRACTITIONER Progress Notes     Signed  Signed    Inpatient Pharmacy Anticoagulation Progress Note   S/O: Patient is a 83 Y male being admitted to hospital for covid/chf and being continued on Warfarin anticoagulation for Atrial fibrillation with target INR 2-3. - Patient was on Warfarin as outpatient for Atrial Fibrillation (I48.91) followed by Anticoag Clinic, goal INR 2-3 - Patient's outpatient Warfarin regimen was: Sun/Thurs = 1.5mg; ROW = 1mg (per Progress note from 8/30/23)   INR Low Range: 2 - INR High Range: 3 Warfarin Tab (MG): 1mg Pink   A/P:  Sunday (mg): 1.5 MG Monday (mg): 1 MG Tuesday (mg): 1 MG Wednesday (mg): 1 MG Thursday (mg): 1.5 MG Friday (mg): 1 MG Saturday (mg): 1 MG   Follow up date: 09/06/23    Allergies Allergen Reactions ? No Known Allergies      Recent Labs   09/14/23 0558 09/13/23 0505 09/12/23 0522 09/11/23 0519 09/10/23 0625 PT 26.6* 33.2* 31.6* 30.9* 26.9* INR 2.5 3.3 3.1 3.0 2.5      Recent Labs   09/14/23 0558 09/13/23 0505 09/12/23 0522 09/11/23 0519 09/09/23 0516 WBC 7.3 6.2 7.7 9.5 8.2 HGB 10.7* 9.1* 11.9* 12.0* 11.2* HCT 32.6* 28.6* 35.1* 35.6* 34.0* PLT 99* 90* 130* 115* 121* MCV 94 95 92 94 95     Potential DDI/DDz interaction(s) with Warfarin:  PTA methimazole    A/P: Patient is 83 Y on Warfarin for Atrial fibrillation with target INR 2-3.   1. INR is therapeutic today 2. H/H and PLT low. Monitor 3. Will give warfarin 0.5mg x1 today 4. Check PT/INR daily with AM labs           Note Details  Author File Time 9/14/2023  7:59 AM Author Type PHARMACIST PRACTITIONER Status Signed Last Editor  Specialty PRACTITIONER  Admit Date 9/5/2023  ED to Hosp-Admission (Current) on 9/5/2023  ED to Hosp-Admission (Current) on 9/5/2023   Detailed Report  Note shared with patient Care Timeline  09/06   Admitted from ED (Observation) 0419 09/08   Admitted 1430  pt in house bed