chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented to the Clinic on 8/3/06 with c/o rash over entire body times 3 days. Pox like lesions scattered all about chest, neck, back, arms, legs times 2-3 days. Diagnosed as Pox dermatitis. RX: Feldene and Allegra, f/u in one week, sooner if rash worsens. Light duty restrictions given. F/U visit on 8/9/06 notes improvement in pustular rash with most areas having resolved without developing further except for 2 lesions on the ulnar wrist both 7mm in diameter with 2mm central excoriation or eschar. Diagnosed as probably mild disseminated vaccinia with no significant residuals.
Every time I get a flu shot, I get the flu , and an excuse why the shot never worked; Every time I get a flu shot, I get the flu , and an excuse why the shot never worked; Initial information received on 24-Feb-2022 regarding an unsolicited valid social media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who experienced every time i get a flu shot, i get the flu , and an excuse why the shot never worked while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect Influenza vaccine produced by unknown manufacturer (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested. On an unknown date the patient developed a non-serious event every time i get a flu shot, i get the flu, and an excuse why the shot never worked (influenza) (drug ineffective) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both events.
This spontaneous report was received from a medical assistant, concerning a 15 months old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 07-JUL-2017, the patient was vaccinated with an expired dose of MMRII lot number L024268 and expiration date of 01-JUL-2017 for prophylaxis (dose and route of administration were not reported) reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). No adverse effects were reported. This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1707USA006499:
Low blood pressure of 75/49, racing heartbeat, nausea, backache, hives over whole body, temperature
PATIENT RECEIVED SHINGRIX VACCINE ON 1/13/2021 IN THE MORNING WENT HOME FELT SLIGHTLY FEVERISH AND LETHARGIC. THESE SYMPTOMS GOT PROGRESSIVELY WORSE THE NEXT DAY AND PATIENT HAD A FINE RASH. ON 1/15/2021 HE SAW A MORE PRONOUNCED RASH AND PAIN ON THE BODY AND SATURDAY1/16/2021 HE WAS DIAGNOSED WITH SHINGLES AND GIVEN A COURSE OF ACYCLOVIR. HE HAS RECOVERED BUT TOOK APPROXIMATELY 2 WEEKS TO GET OVER THE BLISTERING AND PAIN.
No adverse event; Moderna bivalent administered after 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna bivalent administered after 30 day beyond use date).    The vial was initially stored in the refrigerator on 25-Sep-2022. The vials were from unbroken cartons. The doses were administered after a beyond use date of 25-Oct-2022.  The vial had undergone no temperature excursions. The concomitant and treatment medication was not reported.
Patient experiences left sided neck/clavicular swelling 2 days after vaccine. No lymphadenopathy. No pain. No dysphagia or issues with breathing.
have livedo reticularis on both my legs; my left leg is worse and it goes from the inside of my groin all the way down to my ankle and my right one goes up to my knee on the inside; pain in both her legs; minor itching at injection site, like a bug bite; bruising appeared down her legs, down from her groin to her ankle on her left leg and then on her right leg it went only to her knee; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 31Mar2021 10:00 (at the age of 36-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received no other vaccinations on the same day or in the 4 weeks prior to getting the COVID-19 vaccine. The patient had started no new medications. The patient reported that, "I have livedo reticularis on both my legs, my left leg is worse and it goes from the inside of my groin all the way down to my ankle and my right one goes up to my knee on the inside" this began about 5-6 days after she received the first vaccine dose, on an unspecified date in Apr2021. She said at first all she had was "minor itching at injection site, like a bug bite" on an unspecified date in Apr2021. She said 5-6 days after vaccine (on an unspecified date in Apr2021) then the "bruising appeared down her legs, down from her groin to her ankle on her left leg and then on her right leg it went only to her knee", in the same lattice like pattern. She said she had done no treatment for the itching. She said with the bruising on her legs, this caused "pain in both her legs" (on an unspecified date in Apr2021), and it was not really getting better, not yet. She said that she had done no treatment for the pain or the bruising. She said she had been trying to contact her doctor but had not been able to yet. She said, the second dose was scheduled for the 22Apr2021, and her provider had advised her that getting it might not be a good idea. She said she have pictures of reaction she could send if requested. The outcome of events was unknown.  No Follow-up attempts are needed. No further information is expected.
Redness,swelling,blistering,hard induration,fever,arm stiffness, warm to the touch after 1.5 hr of having administered.
Patient stated that she was feeling dizzy, and she broke out in hives, and high heart rate. Treatment that was given by Dr. was a Depo 80 injejection, and Benadryl 50 mg and stated to patient to take benadryly 25 mg q4hrs.
Pain-went away in 5 days  Rash-severe itching, started spreading down arm. By day 7 also on hip
Patient was given regular dose of adult flu vaccine instead of the high dose of flu vaccine that is appropriate for her age of 67. No known adverse events.
Information has been received from a nurse referring to a patient of unknown age and gender. On 18-SEP-2014 the patient was vaccinated with the first dose of VAQTA, 25/0.5 injection, lot# and expiration date not reported, 0.5ml/ 1 dose, intramuscular. Nurse reported that the patient inadvertently received their second dose of VAQTA on 05-MAR-2015, thirteen days earlier than the recommended schedule. No adverse effects reported. Additional information has been requested.
Patient received one of these vx after excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Menveo, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Menveo, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's comment: The nurse reported that the following vaccines were exposed to freezing temperatures included Bexsero, Boostrix, Engerix B, Infanrix, Kinrix, Menveo, Pediarix. On 22nd July 2022, vaccines were exposed to a lowest temperature of minus 10.7 Degree Celsius for 1 hour and 9 minutes.  The health care professional believed that there was patient that received one of these vaccines after this excursion.  The health care professional was trying to figure out who was the patient involved as well as the vaccine. The reporter consented to follow up by email. Additional Supportive Information: The nurse reported that the Bexsero, Boostrix, Engerix B, Infanrix, Kinrix, Menveo, Pediarix vaccines were exposed to temperature excursion which led to incorrect storage of drug.
Body Aches, Headache and distinct lump/swelling under armpit on the same side as injection site.
Initial report was received from a health care professional on 06 April 2012. The reporter also reported two other adverse events for two other patients which were captured in case numbers 2012-03759 and 2012-037. A 12-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd. lot number C3940 (sanofi pasteur Inc. lot number U4046AA) on 04 April 2012, the patient experienced a site reaction that included redness, swelling and a red ring around the injection site. The patient also experienced nausea, abdominal pain and flushing of the skin. The patient's parent stated the patient was showing signs of increased sensitivity to medications. The patient was prescribed ice packs and TYLENOL. The patient had a history of multiple allergies, a latex allergy and is underweight. The patient's last Dtap was seven years ago. The patient's concomitant medication included BENADRYL as needed. The site reaction was improving per patient. The patient's outcome was unknown. Documents held by sender: None.
Moderna COVID-19 Vaccine EUA  Fever, chills, stomach cramping, headache, muscle and join aches and
This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN JAW (Jaw pain), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Positive COVID test the evening of 3/2/22) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 002A21A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). 02-Mar-2022, the patient experienced COVID-19 (Positive COVID test the evening of 3/2/22). On 03-Mar-2022, the patient experienced PAIN IN JAW (Jaw pain). At the time of the report, PAIN IN JAW (Jaw pain) and COVID-19 (Positive COVID test the evening of 3/2/22) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2022, SARS-CoV-2 test positive: positive (Positive) Positive Covid test. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter. On 01-Mar-2022 patient had sore throat. On 02-Mar-2022 patient had nasal congestion, runny nose and post nasal drip. On 03-Mar-2022 patient had headache and jaw pain. All symptoms ongoing. Company comment: This is a case concerning a 43-year-old female patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. Drug ineffective is considered as the patient had a proper time interval between first and second doses of the vaccine. The event occurred approximately 3 months after receiving the third dose of mRNA-1273 vaccine. The clinical course and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a case concerning a 43-year-old female patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. Drug ineffective is considered as the patient had a proper time interval between first and second doses of the vaccine. The event occurred approximately 3 months after receiving the third dose of mRNA-1273 vaccine. The clinical course and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt woke up next day with large 4x2 area that was beet red & stated it hurt badly - swollen too. Started getting better after day 4 & at day 10 still red 2x2 area.
SOB, TACHYPNEA, CHEST PAIN; FLU A AND COVID POSITIVE
Mental confusion the next morning; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Mental confusion the next morning) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 014M20A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021 at 9:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONFUSIONAL STATE (Mental confusion the next morning). At the time of the report, CONFUSIONAL STATE (Mental confusion the next morning) outcome was unknown.      No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-402971 (Patient Link).
patient sitting in chair for injection. approximately 30 seconds after injection, observed color (pale) on face,patient lost consciousness for a moment and than regained consciousness.  no other injury, patient did not fall from chair. placed patient on bed. patient alert and oriented.  Mother states client has not had any breakfast or drinks that morning. gave orange juice and breakfast bar to cleint. after color returning to his face and after eating and drinking, patient states feels better. no further dizzeness or loss of consciouness.
head hurts; feels like vertigo; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head hurts) and VERTIGO (feels like vertigo) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (head hurts) and VERTIGO (feels like vertigo). At the time of the report, HEADACHE (head hurts) and VERTIGO (feels like vertigo) outcome was unknown.            No concomitant medications were reported by reporter Treatment information was not provided by reporter
1 hr after vaccine - laid down, cried, hoarse. Mild stridor noted in office.
w/in 24hr pt ran fever of 100.4, inj site was extremely hot, hard & red;the redness, heat & local tenderness spread to the entire upper lt arm;pt taken to MD & dx w/local cellulitis @ inj site;
Patient was given TDAP twice during pregnancy. Once on 12/15/2020 and again on 2/12/2021. Patient did not have any unusual side effects. Currently 37w pregnant.
After the booster I received on 04/11/2022, I had a sore upper arm, headache, diarrhea, loose bowls, fatigue, achiness in my mouth, difficulty breathing, and an upset stomach. In previous vaccines I've had, I've noticed soreness in my kidneys. I have a reaction to sulfates and sulfites which are often used as preservatives in vaccinations. One of the reactions I have is that it kicks off kidney stones in my kidneys. I first figured this out the help of a nutritionists based on my reactions to certain medications. So, each of the COVID-19 vaccines I've had, I've had a similar reaction. I didn't see anything in the ingredients that appeared to be sulfate or sulfites, but I still had that same type of reaction. In August, I went to see my urologist who sent me for an x-ray, and I had a three-millimeter kidney stone. On 09/25/2022, I received my fifth dose of Pfizer. In November, I went for additional x-rays and the kidney stone was still there. After that, the kidney stone started moving before a procedure I was going to have and it moved to a place they could not see it, this was around Christmas time. It started moving around on 12/16/2022. I went in for an x-ray on 12/20/2022 and that is when they could not find it. The did find several small kidney stones at that time. Based on that x-ray, the lithotripsy that I was scheduled to have on 12/21/2022 was cancelled. The kidney stone shifted again on 12/24/2022. I have not been in contact with the doctor since that happened.
extra dose of vaccination; inappropriate schedule; This spontaneous report has been received from a lawyer and physician, via a memo and medical records from a case in litigation for quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (2302USA008667), concerning a 9-month-old female patient. Her historical conditions included pharyngitis, gastroenteritis, viral syndrome, ear infections, allergic rhinitis, upper respiratory infection, abdominal pain and eczema. Family history of mixed hyperlipidemia. family history included: add/adhs (brother), fibromyalgia (maternal aunt), irritable bowel syndrome (mother and maternal grandmother), allergies (mother).  On 07-SEP-2001, the patient was vaccinated with haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (reported as HiB) (dose, route of vaccination, vaccination site, lot # and expiration date were not reported) for prophylaxis. On the same day, the pt was also vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP), pneumococcal conjugate vaccine and polio unspecified vaccine.  On 07-NOV-2001, the pt was vaccinated with the second dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (reported as HiB) (dose, route of administration, vaccination site, lot # and expiration date were not provided) for prophylaxis. On the same day, the pt was also vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP), pneumococcal conjugate vaccine and polio unspecified vaccine.  On 04-JAN-2002, the pt was vaccinated with the third dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (reported as HiB) (dose, route of administration, vaccination site, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). On the same day, the pt was also vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP) and pneumococcal conjugate vaccine. On 08-OCT-2002, the pt was vaccinated with the fourth dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (reported as HiB) (dose, route of administration, vaccination site, lot # and expiration date were not provided) for prophylaxis (extra dose administered). Other vaccines included: quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL), hepatitis A vaccine, inactivated (VAQTA), hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as Hep B, unspecified), measles vaccine, mumps vaccine, rubella vaccine (MMR), meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO), meningococcal vaccine a/c/y/w conj (DIP TOX) (MENACTRA), pneumococcal conjugate vaccine, polio unspecified vaccine, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Tdap) and varicella virus vaccine live (Oka/Merck) (VARIVAX).  This is one of the three reports received from the same reporter, concerning the same patient.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 11 days post expiry) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 11 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 11 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.   This case was linked to MOD-2021-395985 (Patient Link).