chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given expired FLUZONE, with no AE; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 39-year-old female patient given expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 07-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7073LA, expiry date unknown) via an intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error expired vaccine used (same day).  It was reported, "caller stated that she needs guidance on if they need to revaccinate a patient that was given EXPIRED FLUZONE on 07Sep2021".  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 9/23/2021, I experienced redness, itching and a rash near the injection site. The rash was on the shoulder area and spread to right underarm. Benedryl gel was applied. The reaction appeared on the 3rd day after the vaccination and lasted 1.5 days. I did not gave this type of allergic reaction with the previous 2 injections.
This spontaneous report was received from the office manager referring to a currently 88 year old female patient. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with a single dose of PNEUMOVAX23 (lot # L008664; expiration date 03-MOV-2016) in the arm (dose was not reported). Concomitant medication was not reported. On an unknown date, the patient complained of pain and swelling. The patient was seen on 12-OCT-2015. The outcome and causality of pain and swelling was unknown. Additional information has been requested.
Mom heard child heaving over her baby monitor. Entered room to find child having a seizure noted foam in mouth, witnessed for approx. 1 minute then child was post tictal. Mom called 911 and went to ER.
About 12 hrs after immunization, patient developed redness, induration and swelling around injection site. No fever. Area tender and warm to the touch. Evaluated to have injection site reaction and recommended treatment with warm compresses and ibuprofen q6h.
The pt is an orthopedic surgeon. He was reportedly "healthy". "Tests performed before and during the study showed no signs that the participants had Lyme disease." The pt received 2 doses of Lymerix on unspecified dates. Within 24 hours of the 2nd injection, he developed "severe swelling, redness and pain in his fingers". He also developed "acute disabling small and large joint symmetrical synovitis". A dx of "arthritis in his hands" was made. He also experienced flu-like symptoms, achiness, swelling in his toes, myalgia, and "severe pain in his shoulders." He was treated with "moderate doses of NSAIDS (NOS)" and recovered without sequelae, within 4 or 5 days. The guest physician stated, "And we have no reason to believe that it was anything but the vaccine involved in the development of the arthritis." He further stated, "We believe that the immune response to OspA is resulting in an auto reactive response."
Localized redness, swelling, tenderness, muscle soreness, very hot to touch. No systemic symptoms. No other signs of infection. Better today (less red/tender/warm) per patient.
Diarrhea; Migraine; Fever of 101.7F; Headache or something; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MIGRAINE (Migraine), PYREXIA (Fever of 101.7F) and HEADACHE (Headache or something) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009J212A, 045B21A and 019B21A) 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) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced MIGRAINE (Migraine), PYREXIA (Fever of 101.7F) and HEADACHE (Headache or something). On 11-Jan-2022, the patient experienced DIARRHOEA (Diarrhea). In January 2022, MIGRAINE (Migraine), PYREXIA (Fever of 101.7F) and HEADACHE (Headache or something) had resolved. At the time of the report, DIARRHOEA (Diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2022, Body temperature: 101.7 (High) Fever of 101.7F.         No concomitant medications were reported. No treatment medications were reported.  Patient reported that the first and second doses were given through an off site health care facility.
Agent reports caller said she has tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Agent reports caller said she has tinnitus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Golf ball sized raised lump with fever, pain that radiates into armpit and up into the neck. Occurred approximately 3 days after injection. Includes swollen lymph nodes in neck and armpit area. Seen by ED physician, Dr.
Patient stated he was experiencing numbness in the right side of his face the day after receiving his vaccine.  He came to the pharmacy a few days later saying he is fine and the numbness went away after a day.
pt complained of a rash that started the day after the shot and was still a problem on date of reporting.  itchy, raised, red at area of injection
This spontaneous report was received from a healthcare worker referring to two infant patients of unknown age and gender. The patients did not have pertinent medical history, drug reactions or allergies and were not taking any concomitant medication. On 16-AUG-2018 and on 07-SEP-2018, respectively, the patients received the first dose, in the vaccination series, of ROTATEQ, orally, lot # N032569 with expiration date 18-JUN-2019, as "wellness visit" (prophylaxis). On an unspecified date in 2018, reported as shortly after receiving ROTATEQ, both patients were admitted to the hospital and both were diagnosed with salmonella with symptoms of bloody stools and dehydration. The patients sought medical attention and treatment was given for the adverse event. No laboratory diagnostics or studies were performed. At the time of reporting, the outcome of the patients was unknown. The causality assessment between ROTATEQ and the event was not reported. The reporter considered the salmonellosis to be life threatening and that caused the patients' significant disability, because both patients were hospitalized. Upon internal review, salmonellosis was determined to be medically significant.
Seriousness criteria other medically significant (OMIC). Initial report received from a physician on 5/19/2006. A four year old male patient, with a past medical history of hay fever, had received a left arm, fifth dose injection of Daptacel, lot number  C2396AA, and a right arm, fourth dose injection of IPOL,lot number Y1051, on 5/11/2006. The next day, the patient had redness at the IPOL vaccination site. Three days post vaccination, the patient developed red raised dime half dollar sized rash on his face, extremities and trunk. He was examined by a physician on 5/17/2006 and 5/18/2006 and treated with prednisolone. At the time of this report, the symptoms were persisting.
Received vaccine in LA on 12/15/10. And on evening of 12/16/10 began to get red and swollen. On 12/17/10 swelling bigger. Size of quarter and raised and redness extending down arm about 2 inches.
Chills, headache, tired, night sweat 2 nights and 1 day
Administered shingrix and flu shot to patient. Shortly after, patient stated that she felt light headed. I stayed by her side throughout whole incident. She kept saying she was light headed in the chair. She exhibited no signs of allergic reactions like difficulty breathing or hives. She passed in chair for a few seconds. We positioned her on the ground and we called 911 for assistance. EMTs were sent. I went into the pharmacy to get epinephrine and benadryl. I came back out and she was sitting up. She was breathing fine with no symptoms of anaphylaxis. She was speaking to me throughout the rest of the duration. She was breathing fine and I asked her to verify. She stated that she was breathing fine and that she still felt light headed. I gave her a single dose of liquid benadryl and monitored her to see if I would need to use epinephrine. I did need to use epinephrine. I relayed info. to EMTS when they arrived. EMTs stated patient had low bp and took her to hospital.
no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    The case contains the information regarding patient 3 of 16 reported.  Concomitant products were not reported.  No adverse event was reported from any of the patients involved.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Information was received on 28-OCT-2016 from a pharmacist regarding a 66 year old female consumer. Medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016 the female patient received an injection of PNEUMOVAX 23 (lot # M020521, expiration 17-NOV-2017) in her left arm. The pharmacist reported that the patient reported to her that she developed a warm red raised rash on the back of her arm behind the injection site approximately one day after receiving the PNEUMOVAX 23 injection. The patient went to an urgent care center and was given a prescription for an unnamed antibiotic, which she filled on 27-OCT-2016. The patient reported to the pharmacist that she missed a couple days of work due to the reaction. The outcome of warm red rash on the back of her arm behind the injection site was unknown. The pharmacist did not rate the causal relationship between warm red rash on the back of her arm behind the injection site and PNEUMOVAX 23. No additional information was available. No further information is expected.
heart attacks; blood clots from vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (heart attacks) and THROMBOSIS (blood clots from vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attacks) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (blood clots from vaccine) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attacks) and THROMBOSIS (blood clots from vaccine) outcome was unknown.            No concomitant medication information was mentioned. No treatment medication information was mentioned  Additional information was mentioned patient had a vitals and internal bleeding  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.  Thrombosis is an adverse event of special  interest.  Further information is expected.; 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.  Thrombosis is an adverse event of special  interest.  Further information is expected.
Laparoscopic Appendectomy 2/27/2021  (Miniperforation) Never had any previous trouble with appendix symptoms came on (mild) 1 week after first Moderna vaccination, to ER for CT scan following evening: surgery 1:30am. No idea I?d this is related. Only reaction to first vaccination was sore arm.
5-4-05 to present: "Acid reflux like", "Pain-Back-Midsection", "Nausea", and "Heartburn".
Patient fainted several minutes after receiving the J&J vaccine.  Patient stated that he had fainted before but not to vaccines.  While the patient was being checked by  paramedics, the patient stated that they had been feeling dizzy at home in the morning with chest discomfort.
Significant full facial/sinus pressure. No visible swelling. Sudafed and ibuprofen did not alleviate symptoms. Claritin helped. Symptoms resolved in 24 hours.
Feeling shaky 30 to 45 minutes after vaccine administration. Two to three hours after face pale and clammy.
loss of vision in Rt eye for 15 minutes  Narrative:  When pt presented to COVID VACCINE CLINIC for 2nd dose he reported that a few days after his 1st dose (2 or 3 days later- he was not sure), he experienced loss of vision in his right eye lasting 15 minutes which returned to normal ever since then so he attributed it to the vaccine. Information was forwarded to pt's Primary Care Provider to determine if further medical evaluation recommended.
Medical proffesional (tech) administered vaccination to 17 yo outside of guidelines.  Forms were given to pharmacist after administration.
swollen; redness; left arm started itching last night; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (left arm started itching last night), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025J20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (left arm started itching last night). On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (left arm started itching last night), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Instead of receiving the Pfizer 12+ Bivalent booster like they were supposed to, they received the Pfizer 12+ Monovalent vaccine. The medical assistant accidentally pulled the wrong type of Pfizer Covid vaccine. Patient's PCP is aware of the situation.
COVID?19 Vaccine EUA- 30 minutes after injection, I had a rapid heart rate, felt jittery and had trouble concentrating for about 2 hours. My arm was sore for the next 3 days.  14 days after, the site began to itch and on day 16 a large rash also appeared on that arm surrounding the injection site.
Dizziness; Vomiting; could not get the second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness) and VOMITING (Vomiting) in an 81-year-old female patient who received mRNA-1273 (batch no. 0136204) 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 23-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (could not get the second dose). At the time of the report, DIZZINESS (Dizziness), VOMITING (Vomiting) and PRODUCT DOSE OMISSION ISSUE (could not get the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       Limited information regarding the dizziness and vomiting has been provided at this time and a causal relationship cannot be excluded.  It is not clear if the patient was hospitalized as the report only states they were taken to hospital. This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error; Sender's Comments: Limited information regarding the dizziness and vomiting has been provided at this time and a causal relationship cannot be excluded.  It is not clear if the patient was hospitalized as the report only states they were taken to hospital. This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error
pain, redness, heat at injection site.  applied ice several times throughout the day for 20 minutes, ongoing at this point but improving. Fever ranging up to 100.3 degrees, chills, headache, general weakness.  drank plenty of fluids, ate chicken soup with garlic, rested.  Symptoms mostly resolved after 24 hours.
DPT - Tetnus Shot Extreme pain in upper right arm (vaccine site) and numbness and pain up and down entire arm.  Later and to this day, a hard lump at the vaccine site and continuing pain.
3 weeks after getting the vaccine i developed breast tenderness along with my period. I have been in menopause for a year and a half with my last period at age 51. The same thing happened identically to my sister. She did receive the Pfizer vaccine.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out 30 seconds after vaccine while walking away. 911 called and first responders took her to hospital. Patient in early 20's. Parents were notified or incident and trip to hospital.
5 days after taking the vaccine he was running a high temp. 101. He started having COVID symptoms and his temp kept going up. After a few days of chills and sweats the fever finally broke.
Received influenza vaccine on 11-21-16. 11-29-16 I began to feel numbness and tingling in both feet. 12-2-16 I began to have difficulty walking. 12-20-16 IV/IG treatment began.
As described above, about 13 hours after the vaccine I woke up at 3 am with a severe pounding and constant headache. I was also extremely fatigued so much so that I did not get out of bed or do anything all day 4/11 and didn't start feeling better until the following Monday. Then I hear in the news about the 6 adverse reactions and the J&J vaccine shutdown, possibility for blood clots etc. and to keep an eye out for various symptoms over next 2-3 weeks! It was stressful enough registering and not being able to secure the Moderna or Pfizer so I just said ok and got the J&J. Now I have something else to worry about. Heart and blood clot issues are in my family. I do not take any blood thinners and don't plan to. But now am questioning whether I should have gotten the vaccine at all. I have had enough chronic illness in my life. In fact, December 2019 I was in another town taking care of my mother and her subsequent death when I caught someone's cough. Urgent care diagnosed me with pneumonia, fluid in the lungs, put me on course of antibiotics. I couldn't breathe, needed a nebulizer etc. They called me and said it was not pneumonia or flu a or b (I get the shot every year) and to go to the ER if it got worse. I couldn't eat or move much for three weeks and breathing was extremely difficult. I had to get a nebulizer. Eventually went away. Then in March Covid 19 became official. When I tested for Covid 19 here at a state site in 2021, I tested negative.
slightly itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (slightly itchy) and RASH (Rash) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Jan-2021, the patient experienced RASH PRURITIC (slightly itchy) and RASH (Rash). At the time of the report, RASH PRURITIC (slightly itchy) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.