chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022); 2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) and PRODUCT STORAGE ERROR (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 014F21A, 030A21A and 031M20A) for COVID-19 vaccination.     No medical history and allergic conditions were reported.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 27-Jul-2020 to an unknown date, DIGOXIN from 18-Dec-2020 to an unknown date, AMLODIPINE from 21-Sep-2021 to an unknown date and ALENDRONATE SODIUM (ALENDRONATE) from 24-Nov-2021 to an unknown date for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-May-2022 at 8:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) and PRODUCT STORAGE ERROR (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that after getting the vaccine it was discovered later in the day that the vial had expired on 03-May-2022 but had not been pulled for disposal.  No treatment medications were reported  It was unknown if the patient ever been diagnosed with or tested positive for COVID-19.  It was unknown if the patient took any other vaccines within one month prior to any dose of Moderna COVID-19 vaccine.  The vial was initially stored in the refrigerator on 05-May-2022. The vial did not undergo any temperature excursion.
received Quadracel instead of a flu vaccination, with no reported adverse event; Initial information received on 10-May-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 10 years old female patient who experienced received quadracel instead of a flu vaccination, with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [quadracel].  The patient's past vaccination(s) included DTAP in MAY-2016 and IPV in MAY-2016. The patient's past medical history and family history were not provided.  Concomitant medications included Influenza vaccine inact split 4v (fluzone quadrivalent) for Prophylactic vaccination.  On 09-May-2022, the patient received a  dose of suspect Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine suspension of injection 0.5ml of lot C5862BA and unknown expiration date via intramuscular route in the right deltoid for immunization.  On 09-MAY-2022 the patient developed a non-serious received quadracel instead of a flu vaccination, with no reported adverse event (wrong product administered) following the administration of Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken with Diphtheria, tetanus, ac pertussis and ipv vaccine (quadracel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received Quadracel instead of a flu vaccination, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received quadracel instead of a flu vaccination, with no reported adverse event.  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.
Angiosarcoma of the spleen. ED Visit, Surgery and hospitalization. This visit was within 6 weeks of receiving COVID vaccine.
PATIENT RECIEVED THE FIRST DOSE OF MODERNA VACCINE AT HOSPITAL, COVID CLINIC. RN OBSERVING NOTICE THE PATIENT STARTED GETTING ANXIOUS AND WANTED TO MOVE AROUND AND LAY ON THE FLOOR. PATIENT STARTED TO TURN PALE AND WAS COMPLAINING OF BEING WARM. RAPID RESPONSE WAS CALLED. PATIENT STARTED TO LEAN BACK IN THE CHAIR BUT WAS CONSCIOUS THE WHOLE TIME. RAPID RESPONSE TOOK THE PATIENT TO THE ER.
T38.5C, head rash, adenopathy in the inject area & generalized;
Patient is 17yo here for COVID 19  Pfizer Vaccine; Within 15 minutes of the shot, she developed unresponsiveness.   She has snoring, seizure disorders, OSA, hypertension, developmental delay, elective mutism. Her mother called us to the room Per mother , She was unresponsive, her lips were blue and she was pale She has had no recent seizure; compliant with Keppra She was very anxious prior to the vaccine. She was at baseline this am per mom prior to the shot.
This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 69-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On 25th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th November 2018, immediately after receiving SHINGRIX, the patient experienced localized erythema, pain in arm and radiating pain. On an unknown date, the patient experienced local swelling. On an unknown date, the outcome of the localized erythema, local swelling and radiating pain were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the localized erythema, local swelling, pain in arm and radiating pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced localized redness, swelling, and pain which radiated down her arm to her elbow after receiving SHINGRIX. The redness and soreness started right away. The redness went away but patient still had soreness. The swelling started a couple days after receiving SHINGRIX and had since gone away. The reporter gave consent to follow up.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced fever, malaise, chills and injection site pain. On an unknown date, the outcome of the fever, malaise, chills and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, malaise, chills and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient reported that his wife planned to follow up with her physician on an unknown date.
This spontaneous report as received from a pharmacist refers to a 74 year old female patient. On 11-OCT-2014 the patient was vaccinated with ZOSTAVAX (vial 19400 PFU) in the arm (dose and route was unknown). Other suspect therapies included influenza virus vaccine (manufacturer unknown) administered on 11-OCT-2014 (on the opposite arm) (dose and route was unknown). On 11-OCT-2014, the patient experienced tiredness. On 14-OCT-2014 the patient experienced ZOSTAVAX arm red and blotchy and some areas on the patient's arm were darker red. It was reported that there was no pain, raised areas or rash present. Patient sought medical attention, came back to pharmacy. No product quality complaint was involved. On an unknown date in October 2014 ( reporter spoke to the patient on 17-OCT-2014) the outcome of tiredness, some areas on the patient's arm were darker red and ZOSTAVAX injection arm was red and blotchy was reported as recovered. The reporter considered tiredness to be related to Influenza Virus Vaccine (manufacturer unknown) and the relatedness of the events some areas on the patient's arm were darker red and ZOSTAVAX injection arm was red and blotchy with the therapy Influenza Virus Vaccine (manufacturer unknown) was not provided. The relatedness of the events with the therapy ZOSTAVAX was not provided. Additional information has been requested.
Swelling, inflamed, sore, itching, spreading rash. Treated at ER on 8/2/14. Discharge diagnosis: Allergic Reaction (unclear if cellulitis) IV antibiotic administered. Prescribed Keflex 500mg 4/day for 7 days. Prescribed Prednisone 40mg for 4 days.
had the shot, still had shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had the Shingles shot but still had the shingles but not bad. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
He was sitting after receiving vaccinations (maybe 5 minutes) and then fell over onto floor in a plank position and was slightly shaking. regained consciousness after less than 30 seconds. Taken by ambulance for further treatment/testing
redness; a circular bubble in the middle, itching; swelling, a circular bubble in the middle; itching; hot to touch; Initial information with live follow up regarding an unsolicited valid non-serious case from a physician via Agency (Reference number- 00618846) and transmitted to Sanofi on 27-May-2021.  This case is linked to cases 2021SA179435 and 2021SA179389 (same reporter).  This case involves a 01-year old male patient who had redness (vaccination site erythema), circular bubble in the middle (vaccination site mass), swelling (vaccination site swelling), itching (vaccination site pruritus) and hot to touch (vaccination site warmth), while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On 25-May-2021, the patient received 0.5 ml once (total) dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5765BA and expiration date: 28-Aug-2022) via unknown route in unknown administration site for prophylactic vaccination.  On 26-May-2021, the patient developed a non-serious, redness (vaccination site erythema),  circular bubble in the middle (vaccination site mass), swelling (vaccination site swelling),  itching (vaccination site pruritus) and hot to touch (vaccination site warmth), 1 day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the events was resolved.
Information has been received from a physician concerning a female who on approximately 05-JUL-2007 was vaccinated with a dose of Gardasil. On approximately 05-JUL-2007, the "patient fainted while still in the office". Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:27 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 1:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna COVID 19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer or refrigerator, otherwise it was maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported.   This case was linked to MOD-2021-402935 (Patient Link).
Information has been received from an RN concerning a 22 year old female pt who on 8/29/00 was vaccinated with a 1st dose of Hep-B and subsequently, 12 hours, post vax, the pt developed "hives at the injection site which spread to her whole body." The pt sought medical attention and was given Benadryl which helped to relieve the hives. Additional information has been requested.
Patient said day after receiving Pfizer covid vaccine she developed a rash on one breast, the same side her shot was administered (left side). Denies any other symptoms.
herpes zoster; This initial spontaneous report has been received from a lawyer regarding a case in litigation and refers to a currently 65 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 20-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for occipital neuralgia and varicella meningitis. The outcome of the events occipital neuralgia and varicella meningitis was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000862: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-0095075131-907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000925: US-009507513-1907USA000882: US-009507513-1907USA000924: US-009507513-1907USA000937:
Sore arm. Sore arm has gotten increasingly worse since the injection over two weeks ago. Less mobile and occasional sharp pain. No treatment (home care: ice/heat/stretching/movement). No improvement.
Pt came in office 10/25/06 with moderate case of chickenpox, Varicella vaccine 4/15/04, verified by viral culture 11/01/06, Varicella Zoster IgG AB Neg 10/26/06.
This case was reported by a physician and described the occurrence of fussy in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 8 September 2011 the subject received unspecified dose of Rotavirus vaccine (oral). Less than one month after vaccination with Rotavirus vaccine, the subject experienced fussiness, refusal to eat and discolored area under tongue. At the time of reporting the outcome of fussiness and refused to eat was unspecified. Attribution of these events to vaccination with Rotavirus vaccine was not known. Discoloration under tongue resolved on an unspecified date. This event was considered unrelated to vaccination with Rotavirus. Follow-up received from the physician on 12 October 2011: The physician reported that the original reporter of the adverse event was a child abuse specialist and the physician did not agree with what was reported. The physician believed that the subject had a bruise and that the vaccine did not cause an adverse event. The physician confirmed that she did not believe that the subject experienced an adverse event.
I received the boost of Pfizer at 1600 on 09/29/21. I woke up at 0000 on 09/30/21 with vulvar burning. I noticed the time and thought it was odd that it was eight hours after my vaccine but didn't think about it much more. I think I was developing a yeast infection and thought that was strange because I had no recent antibiotic use or changes from normal hygiene habits. Being an RN myself I simply sought OTC Miconazole cream. Over the course of a week my symptoms began to worsen and eventually developed into pain with urination. On 10/04/21 I was seen by my PCP who noted deep, bilateral "kissing" lesions on my labia minora. She immediately referred me to Dr. MD-OBGYN on the same day. Dr. noted my lesions and consulted multiple specialty groups. Due to my history, health, and monogamous relationship with my spouse, it was determined that I had a incredibly rare Lipschutz ulcer. Dr. determined that the Lipschutz ulcer most likely developed due to an antibody response triggered by the booster shot.  The treatment for the ulcers were simply to use silvadene cream to act as a barrier to ease pain and prevent adhesion. We attempted to use lidocaine cream but the cream caused burning that lasted for hours with no relief. At it's worse, the ulcers covered more than 80% of the labia minora surface bilaterally and even caused complete tearing in one spot. Due to the incredible pain caused by voiding I limited my intake of water and subsequently lost 8 lbs over the course of 39 days. While the ulcers completely closed after 39 days, I still have extreme dryness, tenderness, and scarring today. My labia are no longer symmetrical and intercourse is often uncomfortable and even painful with the use of lubrication. I have no previous history of reactions to vaccines.
Injection site swelling; Injection site pain; more tired than usual; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (more tired than usual) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (more tired than usual). At the time of the report, INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (more tired than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Skin Rash, hives, Seborrhic Dermatitis Face Chapped Lips Hair Loss tooth loss Dandruff Constant Eyeglass Prescriptive Wearing.