chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse event; HCP Calling to report AE for TE (case #02408076); This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 23-APR-2023, the patient was vaccinated with improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) a single dose, lot # X004813 and expiration date 28-JUL-2024, and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) a single dose, lot # U039910 rHA expiration date 16-DEC-2023 and administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 50.14 degree fahrenheit for 3 hours on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported.
Redness; Pain; Swelling; Fatigue; Nausea; Vomiting; Chest Pain; Neck Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fatigue, nausea, vomiting, chest pain and neck pain. On 18th August 2019, the patient experienced injection site erythema, injection site pain and injection site swelling. On 22nd August 2019, the outcome of the injection site erythema, injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the fatigue, nausea, vomiting, chest pain and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, fatigue, nausea, vomiting, chest pain and neck pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The case was reported by patient's husband. The patient received 1st dose Shingrix vaccine and had immediate pain, redness and swelling at the injection site that lasted approximately 3 to 4 days.  Since then the patient had significant fatigue, nausea and vomiting, anterior chest pain around her collar bones, and generalized neck pain that had not resolved. The reporter consented to follow up. The reporter to provide further information (initials and DOB).
no additional AE; PROQUAD administered post temperature excursion; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not reported.  On 27-AUG-2020,  the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) 0.5 ml, lot # S031706, expiration date 06-APR-2021 (route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion from -9 Celsius degrees to 8 Celsius degrees (-2.8 Celsius degrees) for 5 hours and 2 minutes. No previous temperature excursion was reported. Digital data logger was used. No adverse event was reported.
Moderna covid vaccine found to be out of date after administration on 8/APR/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/21) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/21). On 08-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Drop in blood pressure,  Respiratory Reaction, Dizziness, Nauseous, Nose Bleeding, tremors, headaches, fever, cognitive cloudiness, mobility issues, chills
I tested positive for COVID-19 the day after the November holiday. I tested because my son was showing symptoms and tested positive three days prior. I started to develop symptoms of a high fever, bad cough and chest tightness. I went to the ER since I was feeling this way and I was given a prescription for PAXLOVID. I started taking it on 11/26/2022. Within 24 hours of taking PAXLOVID I noticed that my symptoms were going away.
SWELLING, REDNESS, WARMTH AT INJECTION SITE AND A HEADACHE LASTING FOR 4 DAYS.  NO LONG TERM PROBLEM. Reaction occured on left arm, site of Flu and Pneumonia.
Presented to ER on 11/6/21 and was admitted. brought in by EMS for an " unresponsive episode".  Apparently EMS found patient seated in chair and was slow to respond.  Patient lives with multiple family members who had tested positive for COVID.  He states that he has received both COVID vaccinations.  Denies any difficulty breathing or chest pain.  No fevers.  No other significant complaints.  After obtaining further history from daughter it appears that patient has been weak over the past 2-3 days and more lethargic   With decreased appetite.     Workup in the ED did reveal temperature of 97.3 otherwise rest of the vitals was stable he is saturating 100% on room air influenza was negative COVID was positive he has 3+ esterase nitrites positive packed WBCs large amount of squamous epithelial cells procalcitonin 0.08 electrolytes within normal limits BNP 12 troponin negative blood counts within normal limits lactic acid did mildly elevated at 2.83 chest x-ray did reveal blunting of the right lateral costophrenic sulcus. Patient was treated with ceftriaxone and vancomycin.  Initial blood culture did reveal growth of Enterococcus faecalis that was sensitive to vancomycin, repeat cultures on 11/09/2021 to reveal growth of Staphylococcus hominis which is present in 1/3 cultures.  His urine culture did reveal growth of E coli which is resistant to Unasyn.
Some periods of chills; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 10Feb2021 (Lot Number: EM9810, expiry date: unknown) as dose 1, single for covid-19 immunisation (age at vaccination: 69-years-old) from hospital. Medical history included glaucoma (atleast 15 - 20 years ago), raynaud's phenomenon. Concomitant medication(s) included latanoprost, netarsudil mesilate (ROCKLATAN) 1 drop, 1x/day (One drop right eye only once a day); dorzolamide hydrochloride, timolol maleate (COSOPT) 1 drop, 3x/day taken for glaucoma. On 17Feb2021 the patient experienced some periods of chills. States had a history of Raynaud's syndrome; it is a condition where, as temperature starts to get colder, the small blood vessels and extremities tends to close down which causes extremities like finger tips to turn red and then to white and this happens with everybody and it happens with Raynaud's people before it's almost like; it's over reaction to cold, it's not very serious its annoying more than it is serious but experienced may be not even full day but some periods of chills, and don't know if it had anything to do with Raynaud's or not this was about may be a week after the shot, know the chills can be among be the symptoms or side effects of the vaccine. Stated, "in this case anyone else might have similar reactions who has Raynaud's.". States " experienced it for 3 period of time; it is improved; not having the symptoms." The patient had not received treatment for the event. The outcome of the event is recovering.  Follow-up attempts completed. No further information expected.
myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Information has been received from a physician concerning an 18 year old female patient who on 29-JUL-2010 was vaccinated with a dose of GARDASIL (Lot #, expire date and route not reported). The physician stated that on 29-JUL-2010 after receiving the dose of GARDASIL the patient experienced fainting, banging her head on a counter, having a seizure and blacking out for about a minute. Physician also said that patient was taken via ambulance to a nearby unspecified hospital where she received unspecified treatment and was released later the same day. Fainting, banging her head on a counter, having a seizure and blacking out were considered to be an other important medical event by the physician. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a 37-year-old female patient. Her concurrent condition, pertinent medical history, concomitant medication and drug reactions/allergies were not provided. On 06-MAR-2019, the patient was vaccinated with an expired dose of (rHA) M-M-R II injection, lot # N004433, expiry date 07-FEB-2019 (strength, dose and route of administration were not reported) for prophylaxis. The pharmacist was inquiring about revaccination of the patient. The outcome of the patient receiving an expired vaccine was unknown.
Information has been received from a nurse, referring to four unspecified patient of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On 30-AUG-2017, the patient vaccinated with the improperly stored M-M-R II recombinant human albumin (RHA) (lot # M002418, expiration date of 12-JAN-2018, route, dose and dose# unknown)  reconstituted with properly stored sterile diluent (manufacturer unknown), for prophylaxis. All the M-M-R II recombinant human albumin (RHA) were administrated after the previous excursion. No adverse effects were reported. The administered doses of vaccine was underwent the temperature excursion from 47 to 77 degrees Fahrenheit for 10 hours 30 minutes. The previous temperature excursions was reported as from 47 to 77 degrees Fahrenheit for 2 hours. Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1709USA009699: US-009507513-1709USA009700: US-009507513-1709USA000552.
symptoms started the next morning after shot was administered - muscle pain, headache, loss of energy, low grade fever of 100.6F.  Side effects lasted approx. two days, easing on the 2nd day.
irregular menstruation; significant cramping 4 days after 2nd dose after bedtime, strong cramps, nausea and headaches continue for 5 days, bleeding continues as of day 6, significant mood swings, normal period typically lasts 3-4 days with only a few hours of cramps.  Last previous period ended 14 days earlier.
Patient died 04/06/2021 Covid vaccine #1 Pfizer 03/16/2021 Lot #EN6207 Covid Vaccine #2 Pfizer 03/19/2021 Lot # N/A
This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste). At the time of the report, DYSGEUSIA (Metallic taste) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.  Patient gave consent to be followed up by safety.
Father called to report daughter developed fever 101.5 body aches and sore arms 12 hours after the shots. "it was so bad, I almost took her to hospital."
I have felt more tired and lethargic than usual.  The muscles in my extremities have felt weak and have caused involuntary movements.  I have only rested more and waited to see if it would resolve.
Pt had second dose on 4/1/2021 and tested positive for COVID on 5/18/2021. Received antibody infusion on 5/20. Was admitted to the hospital on 5/21/2021 for pneumonia secondary to COVID-19 infection.
Patient developed hundreds of vesicular and papular lesions, described as "itchy", on trunk and LE.
High fever for 18 hours 103 degrees, severe headache, earache, backache, legs felt strange, had hallucinations, nausea, still have pain in injection site and surrounding area after 48 hours.
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400077, PJP200400078, PJP200400079.
"Patient c/o chest pain, states happened after first dose and resolved.  Vital signs taken at 1004: pain 3/10, BP 100/p, pulse 66, Spo2 98%.  Denied need for medical attention, felt comfortable leaving - instructed to notify physician and call EMS if condition worsens.  Verbalized understanding."
Patient was found to have a SBO with signs of bowel ischemia on CT; underwent exploratory laparotomy with placement of  wound vac. Treated and discharged. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
June 28- tired, dizzy June 29-30 flu symptoms July 1st swollen lymph node left collar bone July 2-9 fever (99.5-100.3) July 3rd swollen node under neck July 10- fever/lymph node reduced bit upped lip. swelled and large dark bruise under lip
Patient with history of diabetes, wheelchair dependent.   The morning of 11/10, group home staff noticed that the patient was warm and "not acting right". EMS was called and on arrival, patient was mildly hypoxic. In the ED, he was noted to be COVID-19 positive by PCR.   Ultimately patient was admitted on 11/10 with "severe sepsis and acute hypoxemic respiratory failure due to healthcare associated pneumonia, further complicated by moderate to severe COVID-19."  He was weaned off supplemental O2 11/15/22. Patient clinically worsening, and ultimately transitioned to inpatient comfort cares and passed away 11/17/22. He has received the COVID primary vaccine series.
Presented with AMS; dx UTI and Covid +; Tx:  Rocephin, Maxipime, decadron, Vit C, doxycycline, lovenox, zinc; on supplemental O2 up to 6 LPM per NC initially, down to room air at D/C; Rec'd 4 doses of ivermectin per family request; d'ced due to elevated liver enzymes; MD spoke with family as they requested again but MD refused since it is not standard of care
p/vax pt devel herpes zoster; attending pediatrician reported that pt spiked a temp of 103.5;4 days later devel herpes zoster w/grouped vesicles under the lt eye & lt cheek;
A patient received the first dose of the Moderna Covid vaccine. After about 10 min, he suddenly got really hot and started sweating profusely. He also reported numbness in his right arm and mild difficulty breathing. He then began to vomit. One 0.3mg EpiPen was administered and 911 was called. He began feeling better immediately and left the pharmacy with paramedics.
Within 10 minutes after my vaccine, the roof of my mouth began to itch, and 3 days after my vaccine, I developed hives across my abdomen that started at 5am and did not subside until I was able to take a Benedryl before bedtime. Three weeks after my vaccination, my shot site began to hurt and then I started to exhibit an allergic reaction to foods I had never been allergic to previously. First it was ground turkey, and then two days later, I had an allergic reaction (hives, itchy mouth, and anaphylaxis) to chicken. A few days later I developed the same reaction to beef, and now I have the same reaction to berries and vegetables. My body seems to be attacking everything I eat.
Right after the immunizations were administered, patient complained of whole body stiffness and discomfort with chest pain. She said she was not able to move. Patient was sweating, skin felt warm and appeared red. She mentioned she had difficulty breathing. 911 was called immediately and patient appeared better after the parameters came.
day p/vax pt was breaking out in welps on forehead & abd;mom was instructed to take pt to PMD; mom stated MD sai it was a rxn to the MMR vax;MD prescribed med for rash & itching;pt recovered;
Pfizer-Bio-Tech COVID-19 Vaccine: Individual was given vaccine at 10:50 am. 10 minutes after receiving the vaccine individual developed itchy flushed skin with a rash. She was given Benadryl 50 mg IM in Right arm at 11:00 am. 11:37 am the itchy skin was less intensified and vitals were stable. Individual went home with husband.
Upon waking up on 9/22, I nearly passed out and have had constant dizziness ever since. I was diagnosed on 9/24 with Vertigo. I have never had this before.
I had a flare up of my lichen planus starting about a week after the vaccine. It lasted about a week and a half and included rash and my skin peeling.
This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an unspecified number of patients (age and gender unknown). The healthcare worker stated that improperly stored PROQUAD (Merck) (administration/dosage details unspecified)had been possibly administered to these patients between 17-DEC-2014 and 06-JAN-2015. Concomitant medications were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
It started with a general malaise and then my arm started to hurt and I could not move it, I was one night and all the next time with temperature ranging between 100.4 and 99.7, pain throughout the body, headache and in the arm I found a red spot and very hot and inflamed, a feeling of extreme tiredness.
I had a fever of 101.5, sore throat, cough, I was exhausted, my lymph nodes were very tender. The symptoms weren't to the point where I needed to go to urgent care or the hospital.
This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L045678 expiration date 09-MAY-2017. The patient's concomitant medications were not reported. The pharmacist stated, that PROQUAD (Merck) was exposed to a temperature excursion of -4 degrees C for 1 hour time frame. There was not previous temperature excursion reported. At the time of the report, no adverse effects were reported and no product quality issues was involved. Additional information has been requested. This is one of several reports received from the same reporter. (1603USA010621).
10 minutes after receiving her vaccination, pts face became red and reported extreme itching on her face and head. Pt sent to ED.
w/in 15min extremely dizzy, stomach pains cont dizziness & nausea 3 hrs p/ Itching started about 2PM; red macular rash extremities including feet;
VAERS form completed due to pt completing Pfizer COVID-19 vaccine series prior to  positive COVID-19 Antigen test.
Diagnosed with seizures, ear infection and lung infection on the evening of 9/15/03. This was reported by the ICU physician. Followed up with the ICU physician few days later and he stated the child was recovering. Have been unable to contact the mother for further details.
Patient came in for what I believed to be his first covid vaccine. He filled out questionnaire and checked "No" that he had not received any vaccines in the last 4 weeks.  I counseled the patient on the vaccine, that it would be two doses separated by 28 days, what he could expect as far as side effects and asked him which arm he would prefer.  I gave vaccine, asked him to wait 15 minutes in store for observation.  Went to enter the vaccine information into the patients Immunet profile where I discovered he had already gotten his first dose of Moderna on 7/26/21 at a different facility.  Since the patient was still in store I questioned him and he said yes I got one dose and the doctor said I needed to get a second.  I told him the standard amount of time to wait in between doses is 28 days and asked him why he did not check the box that he had gotten a vaccine in the last 4 weeks and I got a blank stare.
HOSPITAL COURSE: This is 67 years old female with history of paroxsymal atrial fibrillation diagnosed on March 2021.  She was placed on Xarelto with instruction to follow-up with cardiology in 6 weeks to review Zio result.  PTA Pt decided Not taking anticoagulation. She also has hx of breast cancer, status post lumpectomy and radiation, lymphoma status post chemo treatment and depression. She has not kept her outpt follow up appt with oncology.  patient test positive for COVID-19 on 12/28.  Pt presented to the ED with a complaint of shortness of breath.  She found to have bilateral PE.  Echo with nl EF, no pulm HTN.  Initially patient was started on heparin infusion.  Then we transition her to oral anticoagulation Xarelto, we also started patient on dexamethasone for her recent COVID-19 infection.  Gradually her respiratory failure hypoxia resolved. Pulmonary embolism and infarction (HCC) Today patient will be discharged home.  At the time of discharge patient no longer has hypoxia
itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat