chrisvoncsefalvay/vaers-outcomes huggingface dataset:
During observation of patient after receiving vaccination, she became quiet, stopped talking, her eyes were open, crossed, then closed.  I assisted patient who was seated in a chair, I continued to speak to her, calling her name.  Her Mom was present, and came into room to assist.  We were able to help patient to lie down on the floor.  Ice packs were used, and when patient was alert and conscious, she was given a popsicle at her Mom's request.  Patient did experience, she had her own zofran odt tablet, which she did take.  Episode did last about 20 minutes.  Pt. did recover, was able to walk to her car, her Mom drove them home.  Patient did express she has experienced this before while receiving shots or giving blood.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 12:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 12:53 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, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 provided as 67.52 years  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, temperature was 32, At Excursion time 10 AM, temperature was 32, At Excursion time 11 AM, temperature was 32, At Excursion time 2 PM, temperature was 35 and At Excursion time 3PM, temperature was 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 14-Feb-2022, vials were stored in cooler 2, at following time and temperature respectively, 9 AM: 32, 10 AM: 32, 11 AM: 32, 12 AM: 39, 1PM: 37, 2 PM: 35, 3 PM: 35, 4 PM: 36.  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.
Information has been received from a physician and a licensed practical nurse concerning an 86 year old female patient with hypertension, coronary artery disease, hyperlipidemia and is allergic to DAPSONE, PLAQUENIL, MONCYCLINE and ROFECOXIB (MSD) and three other undecipherable medications, who on 16-NOV-2006 was vaccinated with a dose of ZOSTAVAX (lot # 652965/0622F) 0.65 ml on the left deltoid.  Concomitant therapy included NORVASC, METOPROLOL, LIPITOR and amitriptyline hydrochloride.  Patient has not had any recent exposure to chickenpox or herpes zoster.  On 03-FEB-2009 the patient developed shingles and experienced pain.  Patient had 7 vesicular lesions, "quarter size vesicular rash", on the right buttock zone.  Patient sought unspecified medical attention.  Patient's maximum temperature was 96.9  Subsequently, the patient recovered from shingles but her pain persisted.  Additional information has been requested.
After receiving hep A shot, within 10 sec pt passed out, slumped over and began to contract all extremities. When I called and shook him, he became alert immediately. BP 80/x, pulse 54, layed down w/ feet up, until stable.
First passed out on June 26, 2021, then passed out July 6, 2021.  Determined needed to get pacemaker.  Pacemaker put in July 16, 2021.
I received the flu shot as part of annual physical on November 8, 2018 at the office of Dr., my primary care physician. I do have a reaction to flu vaccines. The reaction is swelling, pain and redness around the shot area about the size of a quarter. This time I also had pain. As the day continued by the next morning I had hives on my face and the area around the shot was swollen, bruised and larger than my hand, about 8- 10 inches. I called and left a message for my doctor. I then called my allergist . Over the phone we went through my allergy checklist, possible exposures and concluded the reaction was not related to any of my allergies but was a reaction to the flu vaccine. I called my doctor again and left a message. I was able to get an appointment at 2:20pm Nov. 9. Dr. concluded that I had an allergic reaction to a preervative in the flu vaccine. Since my reaction included hives, I will no longer receive a flu vaccine.
07/26/2017 9:00 pm client reports, felt ears begin to stop up and throat began to feel tight. Noted lymph nodes to throat area were swollen. She noted few raised red whlelps at the vaccine site to the left arm. Reports, had chicken pox as a child at age 7. 07/27/2017 09:15 am client phone clinic and instructed to come to clinic and VAERS would be completed.
some shoulder discomfort; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (some shoulder discomfort) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history not  included . Concomitant products included OMEPRAZOLE, HYDROCHLOROTHIAZIDE and DILTIAZEM HYDROCHLORIDE (CARTIA XT) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (some shoulder discomfort). At the time of the report, MUSCULOSKELETAL DISCOMFORT (some shoulder discomfort) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
itching, inflamation, swelling lt arm @ inject site; also on areas of lt lower arm warmth @ site of swelling on arm; t98.2; low grade temp;
Family member indicates that after the administration of the second dose of Moderna, in the following days started to have difficulty breathing.
Per the patient's father, on 6/2/20 she woke up with swelling and redness at the site on her right upper arm. He has been treating it with ice packs and Tylenol. He states her arm is much better today. She presents with some mild redness and mild swelling at the injection site that is slightly warm to the touch. Temp: 97.5. She does not complain of pain.
This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) lot number Vaccines for Children (VFC) Vaccines and for private vaccine stock J012645, expiration date 14-OCT-2015 (dose and route were not reported) that had a temperature excursion. Patients were also vaccinated with improperly stored Tetanus-Diphtheria (TD). No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested.
Client reports worst headache ever about 7:30 pm on 9/27/04, followed by nausea and vomiting around 2-3am on 9/28/04. States headache continues a.m. 9/28/04 during phone calls to health department. Advised to seek medical evaluation. Client calls 9/29/04. Was seen by physician who is unable to find reason for sxs. Client to follow up on 9/30/04. Contacted : attempted by phone and email . Client did not return call.
Feels like hit in the chest with a softball,pain in the chest; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Feels like hit in the chest with a softball,pain in the chest) and DIZZINESS (Dizziness) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04C21A, 018821A and 046821A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced CHEST PAIN (Feels like hit in the chest with a softball,pain in the chest) and DIZZINESS (Dizziness). At the time of the report, CHEST PAIN (Feels like hit in the chest with a softball,pain in the chest) and DIZZINESS (Dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided. patient stated that he had Cardiac related signs and symptoms: Chest pressure rapid heart rate.
- 57 year old M experiencing dizziness following receipt of PFIZER COVID19 vaccine #1. Likely vasovagal symptoms. Symptoms resolved with Trendelenburg positioning and juice. Noted to be quite hypertensive though denies experiencing symptoms of hypertensive urgency or emergency therefore discharged to follow up with his PCM as already scheduled.
This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported a 51-year-old female patient of an unspecified ethnicity received PREVNAR 13, (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization; methotrexate sodium, ESTROVEN, NORCO, prednisone, albuterol via respiratory inhalation and AMBIEN all via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergies with methotrexate, prednisone, zolpidem tartrate, hydrocodone bitartrate, paracetamol, albuterol, boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos and pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The action taken in response to the event for methotrexate sodium, boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos, hydrocodone bitartrate, paracetamol, prednisone, salbutamol and zolpidem tartrate was unknown. The outcome of the event was unknown. Pfizer is a marketing authorization holder of methotrexate sodium in the reporter's country. This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities. The following information on the batch number has been requested.
Patient fainted within 50 sec. after given the GARDASIL 9 dose. Recovered and fainted a second time followed by vomiting. I requested pt stay seated for 15 minute under supervision of Parent and pharmacist and pt managed to eat a small amount of a candy bar and recover sufficiently to walk to the vehicle waiting for her.
Patient received dose #1 of Pfizer vaccine on 8/13/2021 from a different vendor and received dose #2 11 days later on 8/24/2021 as documented on this report.
Redness surrounding injection site started day after injection given and increased to approximately 4-6 cm. Site hard to palpation and itchy. Pt seen in clinic on 03-17-14. At that time area of redness was approximately 2-3 cm, shallowly indurated surrounding injection site. Treatment with CLARITIN 5 mg daily and Ibuprofen prn.
fever; chills; body ache; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever), CHILLS (chills) and PAIN (body ache) in a 70-year-old female patient who received mRNA-1273 (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and PAIN (body ache). At the time of the report, PYREXIA (fever), CHILLS (chills) and PAIN (body ache) had resolved. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   At some point her husband tested positive for COVID-19. She didn't take the test and directly decided to stay home.  Now she feels alright and recently tested negative for COVID-19. Treatment included ibuprofen, Nyquil and Dayquil.   This case was linked to MOD21-079084 (E2B Linked Report).; Sender's Comments:  MOD21-079084:cross linked
diagnosed with Bell's palsy; severe watering of left eye; tingling around mouth area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (diagnosed with Bell's palsy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 362A1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent insertion NOS in 2008. Concurrent medical conditions included Lyme disease since 09-Mar-2021 and Bell's palsy since 09-Mar-2021.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced FACIAL PARALYSIS (diagnosed with Bell's palsy) (seriousness criterion medically significant), LACRIMATION INCREASED (severe watering of left eye) and PARAESTHESIA (tingling around mouth area). At the time of the report, FACIAL PARALYSIS (diagnosed with Bell's palsy), LACRIMATION INCREASED (severe watering of left eye) and PARAESTHESIA (tingling around mouth area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Of note, patient has a  history of Lyme disease, Bell's palsy.
Abnormal uterine bleeding after vaccines is on nexplanon implant. Started having menses two months ago brown and clumpy and spotting in between started after vaccinations.
Vomited, febrile 103.7 axillary in ER (1525), mottle skin immunication 1100 in am 07/25/02. Tyl at 1300-vomited. ER Motrin 1535 (spit up) 1645 Motrin 2cc 1550-temp 100.8, 1605-temp 102 degrees. ER dc'd -smiling, interactive, taking bottle well. Pt in for WCC slight fever 99.2 reaction? or existing illness.
Soreness; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and PYREXIA (Slight fever) in a male 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 reported).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (Soreness) and PYREXIA (Slight fever). At the time of the report, PAIN (Soreness) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
12/21/11 son reports patient with temp 101 degrees F, chills, no hives or breathing difficulty. 12/22/11 no increase temp. feeling better. 12/23/11 patient reports pain & swelling on (L) upper arm on site of injection pain also had stiffness on her neck left side. MD consulted and ER visit done rec heat/cold pack and pain reliever and released to home. 1/3/12 patient has swelling on (L) upper arm extending to her elbow and pain, continues heating pad and pain reliever.
Tactile fever begininng around 11pm on 3/22/18 and copious loose stools at 2 AM on 3/23/18. Decreased appetite. Resolved fully in 72 hours.
Chronic urticaria and angioedema starting one month after 4th anthrax immunization and 1st smallpox.
At vaccination site 30 minutes after 2nd dose vaccination I started having numbness in my front teeth then quickly went to nose, lips, roof of mouth and throat.  Honked  horn physician came over, performed simple neurologic test and advised allergic reaction.  Had me roll down windows and sip water and to wait another 10-15 minutes. After 5 minutes throat and nose felt like they were closing. Paramedics came over and checked BP, which was elevated, and blood sugar which was very low. They continued to monitor me until symptoms started subsiding.  Asked if I wanted to go to ER, declined.  They recommended me to take 50 mg of Benadryl and to go to ER or call 911 if symptoms persisted or worsened.  Took Benadryl within 15 minutes of leaving and about 10 minutes afterwards all symptoms were gone.
sudden onset h/a then in 4 hrs myalgia/arthralgia & diplopia w/in an hr; shortly p/fever 103-104 & shaking chills; same clavicular & costal margin pain w/deep inspiration; shaking chills, h/a, diplopia suddenly stopped p/16 hrs;
patient developed a red hot rash that took up the majority of her left upper arm. once that resolved, she developed white pustules in several areas over her body that intensely itched for several weeks. she went to see her doctor who prescribed her a topical to relieve the itching and told her not to receive the 2nd dose of series. symptoms resolved by time of discussion with pharmacist, though her skin is scarred where the pustules were.
Right arm hurt where the injection was (10 hours after vaccination); light headed for 5 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient (reported as patient's age: 59; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "light headed for 5 minutes"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Right arm hurt where the injection was (10 hours after vaccination)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had her vaccination on Wednesday 7/18/18 at 1:30 in the afternoon, she called in today 7/20/18 at 1:30pm saying that this morning she started with redness, swelling, hardness and heat at the site of the injection. I told her to put a cool compress on the site and take some ibuprofen to help with the inflammation. I also told her to keep a watch on it and if any changes to call me back otherwise I will call and check in with her later today.
One week after Bivalent vaccine, tested positive for COVID-19 with a home test; Husband tested positive a few days before her; Doctor prescribed molnupiravir and BROMPHEN cough syrup. Still currently has it.
Woke up the morning after vaccination with chills and joint pain. Developed a severe headache, fatigue, muscle aches and low grade fever throughout the day.  Symptoms subsided somewhat with Tylenol (except headache) and continued through the next day with some improvement.
No additional AE information; temperature excursions since 1NOV2020 through the end of Feb 2021 and it was administered to patients during that time; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-NOV-2020, the patient was vaccinated with an improperly stored dose of Measles (+) Mumps (+) Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) 0.5 milliliter, lot # S027465, expiration date 02-MAR-2021 (route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced multiple temperature excursions from 01-NOV-2020 through the end of February 2021. Total accumulative excursion time for this vaccine was 615 minutes (10.25 hours) in temperature from -14 degrees Celsius to -10 degrees Celsius. Digital data logger was involved. There was no adverse event reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2103USA002929: US-009507513-2103USA001166: US-009507513-2103USA001209: US-009507513-2103USA000942: US-009507513-2103USA000947: US-009507513-2103USA000993: US-009507513-2103USA001002: US-009507513-2103USA001024: US-009507513-2103USA001088: US-009507513-2103USA001184: US-009507513-2103USA001252: US-009507513-2103USA001343: