chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site burning/Pain during injection; Vaccination site pain, Injection site burning, Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain, Injection site burning, Injection site pain) and VACCINATION SITE PAIN (Injection site burning/Pain during injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous). On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain, Injection site burning, Injection site pain). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site burning/Pain during injection). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain, Injection site burning, Injection site pain) and VACCINATION SITE PAIN (Injection site burning/Pain during injection) had resolved.            No concomitant medications were reported.   On unknown dates, the patient experienced burning on injection and hurting on injection. In 2021, the patient experienced sore arm from covid-19 vaccine. On unknown dates, sore arm from covid-19 vaccine, burning on injection and hurting on injection resolved. Moderna was also considered suspect.  It was unknown if patient was enrolled in covid-19 clinical trial  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
excruciating pain in the back/lower back pain; spasming when she was trying to sit down or stand up; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (excruciating pain in the back/lower back pain) and MUSCLE SPASMS (spasming when she was trying to sit down or stand up) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No medical history provided by the reporter.     On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced BACK PAIN (excruciating pain in the back/lower back pain) and MUSCLE SPASMS (spasming when she was trying to sit down or stand up). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BACK PAIN (excruciating pain in the back/lower back pain) and MUSCLE SPASMS (spasming when she was trying to sit down or stand up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20-JUL-2021 and contains non-significant information.
Called and stated injection site was "big as a dinner plate" and hot and painful. Recommended ice and to be seen by physician.
fever x 48 hrs w/3 min febrile sz on 1NOV92 brought to ER by ambulance concurrent OM noted & treated;
Patient received 3 vaccines. Approximately 5-10 minutes post administration, friend noticed patient began to have rash. Pt brought back into immunization space by staff who observed patient with urticaria to face, neck, chest and upper back. Patient denied shortness of breath. Noted with clear and equal LS bilaterally. Patient denied tingling / itching in throat, feeling of throat closing or heavy tongue. Did state felt mouth was dry. Mild anxiety noted. Patient initially hypertensive with normal HR. Oxygen saturation 96%. Patient observed for 30 minutes with diminishing urticaria and dry mouth. Blood pressure decreased to normotensive range with HR remaining stable and oxygen saturation at 99%. Patient reported feeling much better. Sent home and instructed to take 50 mg benadryl PO (per Dr. instruction) follow up with physician and educated on symptoms that required emergency department visit. Verbalized understanding and all question s/ concerns answered. Noted to be without urticaria and dry mouth upon departure. Denied any other sign and symptoms.
Tingling and numbness in left arm that extended to fingertips. Tingling and numbness had resolved by the morning of 9/29/2017. At that time patient complained of residual weakness and soreness in left arm. Mom says that the symptoms lasted a total of 24 hours.
Sensitivity in the skin, irritation in the right eye, doctors did not find and infection and with treatment it has not improved.
pt has had 3 doses of Covid 19 Moderna in the past. Got Pfizer Bivalent. Has right axillary lymph swelling and pain.
Local rxn evening of receiving shot 24MAY91; Area large red, hot & swollen T103 given APAP & warm compresses; Seen in office 28MAY91- area discolored, soft, not inflamed; no fever; PE normal;
This case was considered medically important. Additional information provided updated event details and laboratory results. Information regarding PREVNAR vaccine was received from a healthcare professional regarding a female child (between 2 and 3 years of age), who experienced pneumococcal bacteremia/drug ineffective. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date in 2010, the patient went to the physician's office appearing ill and very sick. The patient's white blood cell count was 15.4 and her blood culture was pneumococcal positive. The patient was not hospitalized. Treatment included 2 injection of Rocephin. As of 16 Jul 2010, the patient recovered. A repeat blood culture (date unspecified) showed negative results. In 2010 test results were: white blood cell count (results: 15.4); physical examination (results: physical growth and development normal); blood culture (results: repeat negative); and blood culture (results: positive for pneumococcal). No additional information was available at the time of this report.
Initial and follow information has been received from a physician concerning a 17 year old white male who on 21-JUL-2007 at 1:00 PM was inadvertently vaccinated IM with a first dose of GARDASIL (Lot # 655205/1426F) instead of MENACTRA. On 31-JUL-2007, the patient was seen in the office and he was healthy, and had to adverse event at all. No further information is expected.
This is a spontaneous report from contactable nurse via a Pfizer Sales Representative. A patient of unspecified age, race, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at the injection site on an unspecified date. The patient recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
Soreness around area where shot was given (Day 1) soreness of right arm; severe lethargy and rash developed in mid-section on both sides as well as left-hand wrist (Day 2) Continued soreness of right arm; severe lethargy and rash grew from mid-section up part of back (Day 3) Continued soreness of right arm; severe lethargy and rash continued to grow up back and increase to go below waist (Day 4) - contacted medical unit to report as symptoms were not subsiding. Med Unit doctor referred me to see a dermatologist on day 5 Soreness in right arm and lethargy continued; rash continued to give off heat and itch.  Visited dermatologist who examined rash and determined it was a reaction to the flu shot.  Prescribed a steroid shot, antihistamine, and cream for the rash  (Day 5) Lethargy subsided and rash stopped expanding up back and below waist (Day 6) Rash started going away and lethargy subsided (Day 7) Rash was gone (Day 8)
I had chest discomfort later that night. I have a 101.8  fever Saturday and bad chest pain. Went to ER and they found large lymph nodes and I had surgery to remove them. Currently awaiting results and will see surgeon tomorrow.
At approximately, 9:30PM on 03/05/2021 patient reported having injection site/arm pain, dizziness, muscle spasms that alternated between shoulder blades, neck, thighs, nausea, chills, "heart racing and shortness of breath after climbing stairs to bedroom" . Patient stated symptoms lasted through 03/06/2021 and started to improve on 03/07/2021. Injection site continues to be sore.
Pt received Menactra (2/21/07) in the afternoon and within 6 hours had developed hives all over his body.  Pt came into the office (2/22/07) 8:45am-given prescription for Zyrtec.
She said she got the Fluzone  65+ vaccine and not the Fluzone Quadrivalent with no adverse event; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a female patient of unknown age she said she got the fluzone  65+ vaccine and not the influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] (product dispensing error) (formulation, strength, dose, frequency, batch number, expiration date and route of administration were unknown) for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to inappropriate schedule of vaccine administered (latency unknown).  At the time of reporting, no adverse event was reported.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
INR last month was 2.5 and it now went up to 3.9.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient (husband) of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced INR (international normalized ratio) last month was 2.5 and it now went up to 3.9 in Jan2021. No patient identifiers were provided but the reporter had firsthand knowledge of the patient and was reporting on a specific patient. Her husband got the 1st Covid vaccine yesterday and his INR last month was 2.5 and it now went up to 3.9. She stated he was on blood thinner's. She wanted to know if that was because of the Covid vaccine. Provided PMI number and cold transferred to PSCC for AE, since caller's husband INR test results went up after getting the 1st Covid vaccine. The patient underwent lab tests and procedures which included INR: 2.5 in Dec2020, INR: 3.9 in Jan2021. The outcome of event was unknown. Information on the lot/batch number has been requested.
On the morning of 3/24 I began to feel pain in my armpit on the side that I received my 1st dose injection. On the evening of 3/24 the injection site began to feel slightly itchy and warm. In the morning of 3/25 a rash began to form around the injection site and the pain in my left armpit persisted along with a warmth and itchiness at the injection site. After taking a bath the evening of 3/25 the rash appeared larger and more raised. In the morning of 3/26 the pain in the left armpit has mostly subsided but the rash is still present around injection site. The rash appears to have because more connected to have formed one large welt on my arm. It is still warm and itchy.
Daughter has just had first pap smear and it is "abnormal and positive for HPV"; This spontaneous report was received from the patient's mother and concerns an 18-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On unknown date in May 2011 at the age of 11, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis.  On unknown date in July 2011, the patient was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis.  On unknown date in November 2011, the patient was vaccinated with the third dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported for 3 doses) for prophylaxis.  On an unknown date after the vaccination cycle, the patient had her first pap smear. Result was reported as abnormal and positive for human papilloma virus (HPV) (smear cervix abnormal). Outcome of the event and causality assessment between the event and suspect drug was not reported.
I have an IUD (I've had it for 3 years - no trouble) for controlling my fibroids and have not had a period or any bleeding for 3 years. 3 days after my first dose of the Pfizer vaccine, I experienced very heavy bleeding which was a bright red color. The next day, (4 days after my first dose), I experienced very strong (the strongest I've ever felt) cramping and a very large piece of uterine lining expelled from my body. Again, very bright red color. I just received my 2nd dose on 4/22/21 and am waiting to see if I have bleeding and/or cramping again.
I was asked to make this report because I contracted Covid, not because of issues with the shot.  I reported those through vsafe back when I had the various.  I started having allergy symptoms on May 4 and since they got worse and I had traveled on a plane I did a home test on May 5 that was positive.  Positive was confirmed on May 6 st an urgent care.
The patient came from traveling. She visited our office for COVID 19 vaccination on 8/6/21. She did not tell us that she already got the full Astrazeneca vaccines from abroad before being given the Pfizer vaccine. After she got the Pfizer vaccine, her husband told us that they got the full Astrazeneca vaccines and they were in our office for booster shots. No adverse reaction during 15 mins observation.
pt recvd vax & devel overt flu like symptoms including fever, achiness, dry cough; reporter suspected lack of vax effectiveness;
Shingles flare up. Started with itching about 2 days after vaccine. Continued with bumps, blisters, pain on left side of body around abdomen. Had shingles previously in 1988.
Heart palpations; confusion; legs and abdomen shaking; injection site soreness; voice shaking; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart palpations), CONFUSIONAL STATE (confusion), TREMOR (legs and abdomen shaking), VACCINATION SITE PAIN (injection site soreness) and DYSPHONIA (voice shaking) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEART RATE INCREASED (Heart palpations), CONFUSIONAL STATE (confusion), TREMOR (legs and abdomen shaking), VACCINATION SITE PAIN (injection site soreness) and DYSPHONIA (voice shaking). At the time of the report, HEART RATE INCREASED (Heart palpations), CONFUSIONAL STATE (confusion), TREMOR (legs and abdomen shaking), VACCINATION SITE PAIN (injection site soreness) and DYSPHONIA (voice shaking) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history was reported. On 25-MAR-2013, the patient was inadvertently vaccinated with a 0.5 ml dose of PEDVAXHIB (Lot #1246Z), intramuscularly that had expired on 22-OCT-2012. No concomitant medications were reported. No adverse effects reported. Additional information is not expected.
Child initially had a sore arm after vaccination. Mom states child woke early in morning with a fever (warm to touch). Mother had given MOTRIN to reduce fever and for comfort. Mom states on 4-27-10 that arm (left) was red and swollen. On 4-28-10, mom states that childs left arm was "worse" with redness from shoulder down to elbow. Mom will monitor and call doctor if necessary (increased redness).
Nausea; Vomiting; low grade fever of 99.6; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (low grade fever of 99.6) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (low grade fever of 99.6). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (low grade fever of 99.6) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided. Patient treatment information was not provided.
Three days post vax, this pt developed a high fever for 12-24 hours followed by a febrile seizure. On 08/13, CBC was conducted. Eight days later on approximately 08/20, the pt developed a maculopapular rash described by the reporter as "similar to roseola." The pt was noted by reporter to have subsequently recovered.
skin was rough to the touch; injection site hot; redness and itchiness spread almost to elbowand to chest; redness and itchiness spread almost to elbowand to chest; injection site itching; rounded lump around injection site; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (skin was rough to the touch), VACCINATION SITE WARMTH (injection site hot), PRURITUS (redness and itchiness spread almost to elbowand to chest), ERYTHEMA (redness and itchiness spread almost to elbowand to chest) and VACCINATION SITE PRURITUS (injection site itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (injection site hot), PRURITUS (redness and itchiness spread almost to elbowand to chest), ERYTHEMA (redness and itchiness spread almost to elbowand to chest), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE MASS (rounded lump around injection site) and VACCINATION SITE ERYTHEMA (injection site red). On an unknown date, the patient experienced DRY SKIN (skin was rough to the touch). At the time of the report, DRY SKIN (skin was rough to the touch) outcome was unknown and VACCINATION SITE WARMTH (injection site hot), PRURITUS (redness and itchiness spread almost to elbowand to chest), ERYTHEMA (redness and itchiness spread almost to elbowand to chest), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE MASS (rounded lump around injection site) and VACCINATION SITE ERYTHEMA (injection site red) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  3 to 4 days after receiving her first dose of the Moderna COVID 19 vaccine she experienced itching and a rounded red hot lump around her injection site. This redness and itchiness spread almost to her elbow and to her chest. Patient called her dermatologist who recommended antihistamines which did not help very much but she slowly started to heal after about 1 month. The symptoms were alarming to her and she was concerned about anaphylaxis. She consulted an allergist who encouraged her to get a second dose. Patient has never previously been diagnosed with COVID 19.   This case was linked to MOD-2022-483265, MOD-2022-481671 (Patient Link).
Covid infection after full vaccination. /positive COVID-19 cases for individuals who have been fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid infection after full vaccination. /positive COVID-19 cases for individuals who have been fully vaccinated) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid infection after full vaccination. /positive COVID-19 cases for individuals who have been fully vaccinated). At the time of the report, COVID-19 (Covid infection after full vaccination. /positive COVID-19 cases for individuals who have been fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         No concomitant product use was provided. No treatment information was provided.; Sender's Comments: This case concerns a female patient with no age and  medical history reported  who experienced the unexpected event of COVID-19.  The time that this event happened from the time of vaccination with the 2nd dose of Moderna is unknown , no details were reported. The benefit-risk relationship of Moderna  is not affected by this report.
4-13-22 I received dose 4 covid 19 vaccine   No major issues or reactions the first 2-3 days following the vaccination. My vision began to become blurry & then developed into double vision.  I had my annual eye exam in March of 2022,  eyes were healthy, got new glasses on 3-24-22.   No eye issues until 4-16-22 when the double vision started