chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On April 12  I got MEDERNA vaccine in the LEFT arm and had the usually reported soreness at the injection site that lasted almost a week with stretching and active use of that arm.  On April 21 I awoke  with an itchy  LEFT arm and assumed it was a mosquito or spider bite.  The diamater was about the size of a walnut. The  area was red, hot and bumpy itchy rash.  As the week continued the area grew to L8" x W4" welt almost banding the circomfrence of my arm. It was extremely HOT TO THE TOUCH, and there was swelling in the entire arm.  Ice was applied, Tylinol/Advill were administered as well as Arnica Montanna in a  gel solution.  Welt went away after 7 days
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Heart palpitations) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 23) for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations). At the time of the report, PALPITATIONS (Heart palpitations) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications provided by the reporter.
77 year male with hx HTN, HLP, PAF, CKD, MV repair/annuloplasty 8/2020, GERD, BPH, PTx, recurrent heart failure, last Echo was a year ago with presrved EF, normal coronaries per LHC, last year, presents to ED tonite for weight gain of 12 pounds x 1 week, and decrease in urine output. He reports to occasional use of diuretics but does no take regularly. Recently he was positive for COVID 19 on 8/25/21, presented to ED for monoclonal antiboidies-Regeneron on 8/26, had the infusion and went home. ***Patient was noted to be on ivermectin by his PMD.
Vaccine administered. Patient .  Sheturned to bare left arm for 2 more immunizations and she leaned down.  She then leaned back in chair by  and starting seizing and  foaming at mouth. for about 30 seconds.  She came too and was white,clamy and sweating.  She also urinated on herself during that time.  Once she came too she was weak.  I asked her husband who was with her whole time did she have seizure disorder.  He said no but she was deathly afraid of needles.  She then said she has history of doing this since a little girl.  She said she has to take anxiety med before goes to Dr so she will not pass out from extreme anxiety. She said she only did this because of her anxiety to needles.  She has done this numerous times in past.  We called 911 but she refused and was feeling better in about 10 minutes and walked out on her on accord.  I called her Dr to report and his nurse informed me that she has done this in their office before due to anxiety.
Site of vaccine was 2 inches in diameter, red, warm to touch , painful. Client was instructed to apply cold compress and use analgesic as needed.
no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported). No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-MAR-2020 at 09:56 hours, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB with a valid lot # S023645 and expiration date on 10-MAR-2022 ( at a dose of 0.5 mL intramuscularly (IM) on the right thigh (RT) and with an improperly stored dose of ROTARIX oral route and lot # Y5CN5, diphtheria toxoid, and an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # AT8585; for prophylaxis, however no adverse effects reported.   Administered dose of LIQUID PEDVAXHIB experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was split and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008875: US-009507513-2008USA008885: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008890: US-009507513-2008USA008889: US-009507513-2003USA002275: US-009507513-2008USA008877: US-009507513-2008USA008879: US-009507513-2008USA008883: US-009507513-2008USA008886: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008876: US-009507513-2008USA008917: US-009507513-2008USA008904: US-009507513-2008USA008904: US-009507513-2008USA008932: US-009507513-2008USA008901: US-009507513-2008USA008930: US-009507513-2008USA008900: US-009507513-2008USA008899: US-009507513-2008USA008929: US-009507513-2008USA008928: US-009507513-2008USA008898: US-009507513-2008USA008927: US-009507513-2008USA008926: US-009507513-2008USA008925: US-009507513-2008USA008896: US-009507513-2008USA008923:
At the time I received the 2nd Dose, I was experiencing some sore muscles as an effect of physical therapy exercises and massages.  Specifically, I have deep pain in both buttocks, my side of my left hip and thigh, both sides of my left knee and lower calve.  After I received the 2nd Dose, the muscle pain never went away.  I have been on pain management regiment of Morphine 15 mg and Cymbalta 60 mg with Hydromorphone 2 mg as backup when needed daily for 17 years to treat acute neuropathy pain from surgery that resulted in removal of the top lobe of my right lung, as well as bone and nodes.  To handle the additional pain caused from the 2nd shot, I have had to add more medication at bedtime so I can sleep consisting of Advil 400 mg, Flexeril 10 mg, and Hydromorphone 2 mgs.  In addition, I use Advil 200 mg, CBD 20mg to 400mg creams and lidocaine 4 mg patches during the day and night.
No adverse reaction until March 1st 2021 Rytuxin Infusion plus (Bendadryl Decadron Zofran) Tues March 2nd 2021 Redness Swelling @injection site  Wed March 3rd 2021 Prevagen Infusion plus (Benadryl Zofran)  Vitamin B12 injection Thursday March 4th 2021 Nerve Block with local anesthesia Saturday March 6th 2021 Headache Cough Sweats Chills Body Aches Monday March 8th Internal Medicine Telehealth Appointment NP Covid Test Rapid & PCR Negative results given for both March 10th Telehealth Appointment with Internal Medicine Dr. cough medicine & antibiotics given at this time
arm pain, axillary pain, chills in the evening ~ 6 hours after vaccine administration. Vomiting x 2 at night. Talked to patient in evening and advised advil 400 mg (no tylenol available). In the morning - patient felt better - still took another 400 mg of advil
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment with paxlovid from 13Jul2022 to 20Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient fainted while waiting in the seating area after the vaccine was administered. Paramedics were called and took patient to hospital for further testing and evaluation
RASH NECK 4 INCHES FROM SITE OF FLU SHOT INJECTION.
DIFFICULT TO SLEEP; SHORTNESS OF BREATH; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 60 year old female. 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: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced flu-like symptoms. On an unspecified date, the subject experienced difficult to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, and shortness of breath, and the outcome of difficult to sleep was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
This case was reported by a consumer via sales rep and described the occurrence of influenza in a 13-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent). On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. In December 2017, less than a month after receiving Influenza vaccine Quadrivalent, the patient experienced influenza. In December 2017, the outcome of the influenza was recovered/resolved. It was unknown if the reporter considered the influenza to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient received an unknown flu vaccine within the last 2 weeks before the date of reporting and caught the flu afterwards. The patient was fine and had recovered.
This spontaneous report as received from a healthcare worker refers to a patient of unknown current age and gender. Medical history and current conditions were not reported. In approximately 2011 (also reported as at 1 year old) the patient received their first dose of M-M-R II (subcutaneous injection, strength, route, dosage, lot # and expiration date not reported). On 10-JUN-2014 the patient received their second dose of M-M-R II (subcutaneous injection, strength, route, dosage, lot # and expiration date not reported), when the patient was 4 years old. It was reported that the patient inadvertently received a third dose of M-M-R II (subcutaneous injection, strength, route, dosage, lot # and expiration date not reported) on 23-JUL-2014. No adverse effect was reported. Additional information has been requested.
Pt vaccinated /w DTP & developed a fever of 101, given Tylenol; convulsing arms & legs eyes closed no crying, mouth open with drooling. Taken to ER - temp 103, alert, active, lungs-clear, lungs clear, neuro - CNII, TM's- lt inflammed, rt ok
Within a short time after receiving my COVID vaccination, I experienced a burst of energy, pretty severe abdominal cramping, and vaginal bleeding (small amount; very close location-wise to being internal but was external). Bleeding lasted until bedtime and was gone, along with the abdominal cramping and burst of energy by the next morning and has never returned.  Vaccine #2 was on 2/9/21 and the only difference I felt after that one was tiredness; took a 3 hour nap shortly after I returned home and never noticed anything else since.  (Not sure if this helps to know...I had a hysterectomy mid-October, 2020.)
Vaccine were stored more than 30 days in a refrigerator; The patient administered the vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine were stored more than 30 days in a refrigerator) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-May-2022 at 11:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-May-2022 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine were stored more than 30 days in a refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine were stored more than 30 days in a refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had no known allergy. No concomitant medications were reported. The patient had not ever tested positive for COVID-19, and had not taken any prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination and also not had any acute illness at the time of vaccination and up to 1 month before. Six (6) vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022. The vials did not undergo any temperature excursions. The patients had not reported symptoms.  No additional doses, medications, or treatments had been administered.   This case was linked to MOD-2022-583062 (Patient Link).
On May 11, 1999, the pt received her first (IM-Right Arm) dose of Lymerix for prevention of Lyme disease. 1 - 1 1/2 hours later, on May 11, 1999, she experienced cold sweats, vomiting and severe pain over her entire body (muscles and joints). Her pain was so intense that she had difficulty driving. Her MD instructed her to go to the ER, but she did not get there. The vomiting and cold sweats subsided five hours later, leaving her with joint pains and muscle pains throughout her body. She was seen by he MD on 7/6/99 who ordered a rheumatoid test and sed rate. On 7/5/99 she was prescribed Trilisate which she took for a few days and then stopped because it was not helping her joint and muscle pain. She was seen by a different MD on 7/15/99. He prescribed prednisone which was started on 7/16/99. She was also prescribed Arthrotec. The most recent information received on 7/16/99, reports the condition of the pt is ongoing.
On the night reported, I started to not feel well and my pulse jumped abruptly (125-135 range) when sitting on the floor, I felt palpitations and I felt very unwell.  I felt like I needed to take big, deliberate breaths and I had tingling in part of my left arm (elbow down to ring and pinky finger) and I felt dizzy and unsteady on my feet.   I almost went to the ER thinking I was having a heart attack, but things calmed down enough to wait until today (12/16/21) to go to my primary care doctor to be checked out.   During the adverse event on 12/15/21, my pulse eventually went back down to 90-105 range and my blood oxygen was at 98-100% and my blood pressure was around 115/78.  Tonight (12/16/21), I am out of breath when going up and down the stairs and my pulse spikes up to the 130-140 range when exerting energy.
Ringing in the ears that varied in intensity but usually mild; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 17Apr2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high which was normal with medicines and high cholesterol from unknown dates. Concomitant medications included atorvastatin calcium (LIPITOR), esomeprazole (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 26Mar2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19. On 19Apr2021 at 00:00, the patient experienced ringing in the ears that varied in intensity but usually was mild. It was constant and the patient, could hear it through ambient noise (tinnitus). This started only after the second dose. The patient's hearing was still normal otherwise and could hear every sound. The clinical outcome of the event ringing in the ears that varied in intensity but usually mild was not resolved.   No follow-up attempts are needed. No further information is expected.
Never even felt the shot No adverse effects - not even sore at the site Today (10 after receiving the shot) the arm has red blotches at the site, is itching, hot, there is a hard lump Otherwise I feel fine
pt stated became delirious approx 6hr p/vax (MFR unk);
Swelling of Lymph Nodes in right arm pit about the size of a cupped hand.
I woke up in the morning extremely tired and weak with difficulty getting out of bed, shortness of breath (went down to 89%). Coughing a lot continuously with no temp. I did not loose my sense of test and did an at home COVID test that came back positive. I continued with the symptoms for almost 2 weeks. I spent a couple of days in bed only getting up to get something drink.
PATIENT'S DAUGHTER REFERS THAT HER MOTHER DEVELOPED PAIN IN THE LEFT UPPER EXTREMITY APROXIMATELY 2 HRS AFTER VACCINATION.
Information has been received from an employee at a physician's office concerning an 8 year old girl with allergic rhinitis who on 26-AUG-1999 was vaccinated with VARIVAX (Oka/Merck) and COMVAX. Other concomitant therapy included POLIO vaccine (manufacturer unknown). On 06-APR-2007 the patient developed zoster around left leg and thigh. The patient was treated with Acyclovir 400 mg. The symptoms lasted for 6 days. A strep screen was performed (results not reported). The patient's outcome was not reported. Additional information has been requested.
Initial report recei9ved from a health care professional on 20 June 2013. A 26-year-old female patient had received an intramuscular dose 1 of ADACEL vaccine (batch number: U4612AA, site of administration was not reported) on 20 June 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 08 November 2012. The estimated date of delivery was 15 August 2013. The patient's health during pregnancy, risk factors, concomitant medications, treatment for infertility and medical history were not reported. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none.
5-12-2006 Friday Child's grandmother called and stated that the child's right arm began with redness, swelling, and warmth around 7:30 pm on 5-11-2006 and had received vaccinations on 5-10-2006. Instructed grandmother she would need to have it evaluated by doctor and to obtain copy of follow up notes for our records. 5-15-2006 Monday Spoke with child's grandmother about follow up with MD and she stated she has appointment tomorrow afternoon. 5-17-2006 Wednesday Spoke with grandmother and she stated MD had no further recommendations for treatment and she also stated that all symptoms had resolved except for a small knot on right arm. Reminded to get follow up from MD if able.
Information has been received from a medical assistant referring to a 5 month and 14 day old patient of unknown gender. There was no medical history or drug reaction/allergies reported. On 20-AUG-2015 the patient was vaccinated with a dose of VARIVAX (lot# K015994 with expired date 23-SEP-2016, 0.5 ml, subcutaneous). No concomitant therapy was provided. No adverse effects were reported. Follow up information has been received from the medical assistant on 30-NOV-2015 referring to the female patient. She had 8 siblings and had no illness at time of vaccination. On 20-AUG-2015, at 5:33 pm, the patient was vaccinated her first dose of VARIVAX intramuscularly (previously reported as subcutaneous) in left thigh in public health clinic/hospital with public funds. Additional information is not expected as all required correspondence was received. Patient's information, product, event and narrative were updated.
I have had loud ringing in my ears 14 hrs after vaccine.  its now 5 days later and the ringing is driving me insane
Got dropped foot within 10 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERONEAL NERVE PALSY (non-serious), outcome "unknown", described as "Got dropped foot within 10 days".  Additional information: When the reporter was asked if there is any other people who got the vaccine (Pfizer COVID-19 Vaccine) and experienced the same issues, reporter stated, "Yes, because I know 2 girls they got dropped foot within 10 days". The reporter also stated, "That is not my place to report about their medical information but I will give them this number for them to call because I don't know the total exact."  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300396841 same drug/event, different patients;
Mild itching in circular area about 2 inches in diameter, treated with antihistamine for about 5 days
I started getting bruises in at the end of October so I had a blood test done by a  specialist in rare diseases and was given a referral to Dr. prescribed prednisone in case I have a bleed. I was then told to be careful not to get injured.
pt was given wrong 2nd dose of the Moderna Covid Vax at a pharmacy on 5/10/21.  His 1st dose was Pfizer given on  4/14/21.  The patient completed the consent form correctly but pharmacist gave him the Moderna vax in error.  That is the only vaccine they had in the store.
36 y.o. male who presents with chest pain that began receiving the Pfizer vaccine. The patient reports that he received his second dose of the Pfizer COVID vaccine three days ago and began to develop fever, body aches, diaphoresis, and dizziness later that night. States that he had a fever recorded to be 102 until it broke yesterday morning. Shortly after the fever broke he began to notice chest pain that radiates to the left side of his chest and into his arm pit. Patient states that the pain is intermittent and describes it as being uncomfortable and tight. He also notes that it feels like his heart is beating much faster.