chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives on buttocks; outbreak on scalp; little bit itchy; worm and hot; swollen arm; incomplete course of vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives on buttocks) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (little bit itchy), VACCINATION SITE WARMTH (worm and hot) and VACCINATION SITE SWELLING (swollen arm). On 08-Feb-2021, the patient experienced URTICARIA (hives on buttocks) (seriousness criterion hospitalization). On 18-Feb-2021, the patient experienced RASH (outbreak on scalp). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination). On 08-Feb-2021, PRURITUS (little bit itchy), VACCINATION SITE WARMTH (worm and hot) and VACCINATION SITE SWELLING (swollen arm) had resolved. On 23-Feb-2021, URTICARIA (hives on buttocks) and RASH (outbreak on scalp) had resolved. At the time of the report, INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Hives on buttock cheeks that was severe and was hospitalized and given treatment for the hives included Doxycycline, Prednisone, and Benadryl  Patient then kept postponing the second shot of the vaccine due to the symptoms experienced. Now patient is scheduled to take the second shot on 27Feb2021.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of incomplete course of vaccination (second dose) for mRNA-1273, lot # unknown  with associated AEs vaccination site swelling, vaccination site warmth, rash,prurits, and urticaria.     Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Patient received FLUVIRIN around 7:40 PM 9/27/10. Within 5 minutes developed rash at injection site and on chest and neck. Patient was given 100 mg of BENADRYL, at around 7:45 PM, rashes subsided by 8:00 pm. EMT's arrived at about 8:05 to double check patient's condition.
Moderna COVID-19 Vaccine. Overnight I had very restless sleep including intense dreams.  The following day, I experienced headache, lethargy, nausea, and mild body aches.  I took acetaminophen, (2 500mg Tylenol Extra Strength tablets every 6 hours, 3 doses total).
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 13-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Patient felt symptoms like anxiety and shortness of breath 10 minutes after vaccine was administered. 911 was called and patient was transported to the emergency room.
OBSERVATION DISCHARGE NOTE   Assessment and Plan Patient is a 70 y.o. female patient of DO with history of COVID 19, HTN, depression MS, HLD presented with tachycardia and sob.    Bilateral PE  COVID 19  Did not feel well the week of July 18th. Positive home COVID test July 25th.  Symptoms of fatigue and sob. Husband also tested positive  Vaccinated status: vaccinated and boostered  O2 sats >90% on RA  EKG - SR LA enlargement  Telemetry - SR VR 70s  Echocardiogram - no right heart strain. EF 60-65%  Venous doppler LE: No evidence of deep or superficial vein thrombosis in the right or left lower extremities Lovenox on admission  Consult pharmacy regarding NOAC - cost and education please  She is requesting discharge home this morning. Pending results of echocardiogram, venous doppler and cost of NOAC will plan on discharge hoe later today.    Hypokalemia  Replace and recheck    HTN  SBP 130s   MS  Very well controlled per patient
Over the course of the day I felt numbness in my arm and by the evening I felt excruciating heart pain
no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 13:52 hours, the patinet was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) with a valid lot # S023219 and expiration date on 03-MAR-2022 at a dose of 0.5 mL intramuscularly (IM) on the left tight (LT) and with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) at a dose of 0.5 mL intramuscularly (IM) on the right tight (RT) lot # reported as 747P5; an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # AT8585; and a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoidr prophylaxis, however no adverse effects reported.   Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) and Hepatitis A Vaccine, Inactivated (VAQTA) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008889: US-009507513-2008USA008883: US-009507513-2008USA008885: US-009507513-2008USA008884: US-009507513-2008USA008882: US-009507513-2003USA002275: US-009507513-2008USA008879: US-009507513-2008USA008886: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008875: US-009507513-2008USA008890: US-009507513-2008USA008877: US-009507513-2008USA008903: US-009507513-2008USA008901: US-009507513-2008USA008913: US-009507513-2008USA008912: US-009507513-2008USA008931: US-009507513-2008USA008930: US-009507513-2008USA008900: US-009507513-2008USA008899: US-009507513-2008USA008929: US-009507513-2008USA008898: US-009507513-2008USA008927: US-009507513-2008USA008926: US-009507513-2008USA008925: US-009507513-2008USA008896: US-009507513-2008USA008923: US-009507513-2008USA008922: US-009507513-2008USA008921: US-009507513-2008USA008920: US-009507513-2008USA008890: US-009507513-2008USA008911: US-009507513-2008USA008910: US-009507513-2008USA008914: US-009507513-2008USA008887: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008909:
On 8/9/21: Began to exerience headache, fatigue, and light headedness. Injection site (right arm) became swollen and painful on 8/11/21.
No adverse event; received the bivalent booster dose before 2 months of her last dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the bivalent booster dose before 2 months of her last dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140c) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the bivalent booster dose before 2 months of her last dose of the Moderna COVID19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the bivalent booster dose before 2 months of her last dose of the Moderna COVID19 vaccine) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the bivalent booster dose before 2 months of her last dose of the Moderna COVID19 vaccine).    It was reported that the patients last dose was given on 07-Aug-2022. Concomitant medication list was not provided. It was reported that the patient received bivalent booster less than 2 months after their last booster. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received: updated narrative.
Approximately 20 minutes after delivery, I experienced transient increased heart rate and numbness/tingling in the left side of my face. Within 24 hours I began experiencing very strong tinnitus in both ears. The sensations included tones as well as hissing. The intensity of tones eventually became less pronounced after about a month. The hissing remains still after almost 1 year. I sought medical attention for these symptoms but there has been no effective treatment.
Generalized hives developed starting at site of vaccine administration. BENADRYL given and within 24 hours, hives resolved. Hives initially developed approximately 18-24 hours after the vaccination.
SkinRash SKIN RASH TO FACE WHEN SHE GETS HOT Narrative:  SHE REPORTS MAKING APPOINTMENT TO SEE AN ALLERGY DOCTOR. SHE STATES THE RASH BEGAN AFTER THE FIRST DOSE OF MODERNA AND HAS GOTTEN WORSE SINCE RECEIVING THE 2 DOSE. RED, RAISED, ITCHING RASH TO FACE WHEN SHE GETS HOT.
C/O being very tired, loss of appetite, nausea, stomach ache, muscle arch, fever (no thermometer to take temp), starting at about 4pm lasting a few hours slept well rest of night and woke in AM without further SX.
Extreme numbness, tingling and pain in arms, hands and feet.  Body tremors(whole body jerks) 100 +per day, feels like a electric signal is pulsing thru my hands, fingers and specific areas on both feet.  Brain fog and short term memory loss have increased.
Patient began to have sore joints and to have rash consistent with measles.  No fever.
This case involves (Adult and unknown gender patient) who experienced 2 times got it in the past ended up sick (illness) while receiving vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatments, vaccinations, concomitant medications, and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number, expiry date not reported) via unknown route in unknown administration site for Prophylactic Vaccination. On an unknown date the patient experienced a non-serious 2 times got it in the past ended up sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported" Can't pay me to get that one either now. The 2 times I got it in the past I ended up sick. So. No thanks. I'm not going to take something that WILL MAKE ME SICK". It is unknown if the patient experienced any additional symptoms/ events. It is unknown if there were lab data/ results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of the reported event was unknown. There will be no information on the batch number for this case.
We first noticed her lymph node swelling on the right side of her neck approximentally 02/17/2017 where it had swelled roughly the size of a dime with no dis-coloration. It could have been swollen sooner, but gone unoticed. I waited around 7 weeks before taking her in since it didn't grow very much in size at first, she had no symptoms like fever, or pain in the area when it was touched or rubbed, and we honestly contributed it to allergy season. However, it started to swell more, so I took her in first 04/07/2017, where they assumed allergies as well at the time being, and prescribed Cetirizine HCI 1MG/ML which we gave her as directed. It's important to note that on this visit, they also went ahead and gave her the HEP A VAC PED/ADOL, 2DOSE INTRAMU (90633). After this visit, her node began to more rapidly swell, started showing red discoloration and she started showing some discomfort. We took her in again, a week or so later, (I can't find the paperwork when exactly) and they prescribed Clindamycin Palmitate HCI 75MG/5ML which we took as directed for the course of time directed. We brought her back in 04/27/2017 where they started her on Amoxicillin-Pot Clavulanate 600-42.9MG/5ML, which we started giving as directed, but after 5 days I stopped it after it gave her thrush, made her more irritable, and I simply wasn't convinced it, or the previous medication was working, and wanted better answers as to why this may be happening. We were then sent to Medical Center at their ENT department to see NP where they prescribed taking Clarithromycin (BIAXIN) 50 MG/ML until her appointment with Dr. on 05/17/2017. I was still insistant that medication wasn't working, as it kept giving her diarrhea, thrush, and horrible rashes, and wanted a hospital visit to find out what was wrong since everyone seemed stumped. I asked of course, if it had anything to do with vaccines, but the notion was shut down by every doctor I asked. We were admitted to the Medical Center. After several tests, to include a sonogram, they still couldn't determine what caused the reaction, but concluded it wasn't systemic, which is why medications weren't working, and essentially the lymph node had become like a cyst. We were told to give her Azithromycin 40 MG/ML for 4 days, which I did as directed, and to allow the node (which at this point was about the size of a silver dollar and completely red with some purple, and seemed to cause discomfort when we touched it.) to simpy pop and drain on its own. Which it did a few days later in the middle of the night. Dr. recommended a type of cosmetic surgery upon our visit to him on 05/17/2017, which I turned down. Since then, we've been instructed to let it heal on its own, and "see what it does". No one still seems to know or accept what truly caused it in the first place, or what any long term damage might be yet, and it hasn't been further addressed since the follow-up appointment after the hospital visit. No more vaccines, or medications have been administered to pt since.
I went to bed with a stomach ache around 10:00pm.  At 3:00am I was awoken by severe abdominal pains/cramps and in a cold sweat.  When I got out of bed I was lightheaded and passed out in the bathroom as I was getting Tylenol.  I took 2 Tylenol and had diarrhea about 10 mins later.  I went to get some gatorade and passed out again in the hallway on the way to the kitchen.  About an hour after taking Tylenol symptoms began to improve but became nauseous and couldn't get back to sleep.  As of 2pm Sunday current symptoms are extreme nausea and extreme exhaustion.
Post-herpetic neuralgia; Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 27-SEP-2012, at age 73 years, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (dosage, site and route of administration and lot number not provided). On an unknown date, the patient was treated by a family nurse practitioner (FNP) at a hospital for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster and  post-herpetic neuralgia respectively. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster and  post-herpetic neuralgia is unknown.  Additional information was received on 11-APR-2019 from a lawyer regarding a female patient.  The patient's address was updated as she had moved from one state to another state.  No other new information.  Additional information has been requested.
Day 1 after vaccination Approx 14 hrs after injection:  initially:Malaise,  muscle and joint aches, headache as day progressed: Fever of 100.8 F by 6pm (24 hrs after injection):  fever a little lower, and then felt freezing cold/chills.  Had to take hot shower and wear many layers of clothing. Felt fatigued, unable to concentrate.    Too unstable to take a walk. Day 2 after vaccination:  No fever, but felt  too weak for a walk until around 8pm. then able to take a short walk. Day 3: still tired, brain fogged.   Brain fog lessened but persisted until day 8 (1 week later).
Erythema around site and down media aspect of leg; no edema or induration or other rash. Developed day of immunization to next day. Reevaluated in clinic 3 days later.
Redness to left outer upper arm at vaccine site given on 8/13/07. Seen by same provider 8/15/07. Ice packs ordered. Benadryl 12.5mg/5ml 2 tsp stat then q6-8h prn for itching. informed to go to ER if symptoms worsen or fever. Recheck appt given 8/22/07
11:50 AM ABOUT 30 MINS AFTER THE VACCINE ADMIN. SHE FELT DIZZY, SOB, AND PALPITATIONS, IMMEDIATELY WENT TO THE ER TO BE SEEN. EMPLOYEE IS A DIETARY EMPLOYEE DELIVERING TRAYS AND FELT THESES SYMPTOMS.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 12:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 12:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 52.76.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 3-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM:38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM:41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient presents redness in chest area after 20 minutes of administration of TDAP BOOSTRIX Vaccine.
Presented to the ED complaining of dehydration on 10/6/2021, c/o worsening cough and SOB, treated w/ supplemental O2 in ED & admitted for dehydration, COVID-19 & suspected PNA; 10/6 - tx w/Remdesivir, Ceftriaxone, dexamethasone & zinc. Patient was weaned off oxygen and she was discharged home on room air.
inappropriate schedule of; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2018 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient not yet receive the second dose, which led to incomplete course of vaccination. The VAERS details were reported for the 1st dose.
Papular, confluent non discolored pruritis rash developed ~ 4 days after MMR vaccination on L arm.  Rash spread down L axilla - trunk - leg.  No systemic reaction, fever, neurologic Sx.