chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine administered; a  little sore in his left arm, where he got the booster, but thinks maybe was him in the shower because he use the soap that dries his skin or  maybe it could be the flu shot that he got two week ago; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a  little sore in his left arm, where he got the booster, but thinks maybe was him in the shower because he use the soap that dries his skin or  maybe it could be the flu shot that he got two week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049c21a and 939676) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV infection, MULTIVITAMIN [VITAMINS NOS], KERATIN and NALTREXONE for an unknown indication.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE PAIN (a  little sore in his left arm, where he got the booster, but thinks maybe was him in the shower because he use the soap that dries his skin or  maybe it could be the flu shot that he got two week ago). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 11-Nov-2021, VACCINATION SITE PAIN (a  little sore in his left arm, where he got the booster, but thinks maybe was him in the shower because he use the soap that dries his skin or  maybe it could be the flu shot that he got two week ago) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Patient is also taking concomitant medications Ciamin vitamin A  and Liver Medications. No treatment information was provided
Subsequent to receiving first and second doses of varicella virus vaccine live the pt tested negative for VZV IgG antibodies.
I gave an expired vaccination on 04/12/2021. The vaccination expired on 04/11/2021. The patient was notified and there was no adverse reactions to this vaccination.
around 2:20 AM he got up to go the bathroom when his wife heard him yelling "please help me" then heard a thud which was him falling to the ground.  He could not stand up and she could barely understand what he was saying therefore EMS was called.
Fever 104 x 48 hrs; at 48 hrs arm red, hot with wheal from shoulder to elbow; SOB;
TINGLING IN TONGUE & GUMS ADVANCED TO BURNING & NUMBNESS- TONGUE FEELING OF THICKNESS WITH RAPID HEART RATE. TREATED WITH BENADRYL & PREDNISONE 20MG 1 DAILY FOR 5 DAYS STILL FEEL AFFECTS 02/05/2021
8/21/08 - at night - itching/swelling/firmness and redness noted at site where Varicella vaccine given on 8/20/08 (5 1/2 cm x 7 cm post left deltoid).  Recommend Benadryl as needed.
patient received an expired dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 36-year-old male patient who received HAV (Havrix) (batch number K2L279, expiry date 12th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 21st October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-OCT-2022 Reporter's comment: A pharmacist had reported that a patient had received an expired dose of Havrix. The dose was expired since 12th August 2022. The reporter did not consented to follow up. Additional supportive information: The patient had received an expired dose of Havrix, which led to expired vaccine used.
Patient received first dose of Pfizer COVID vaccine today. Shortly after, while in observation area, he told a nurse he did not feel well and ended up collapsing in her arms. The nurse assisted him to the ground. Patient reports feeling anxious, hot, sweaty and has numbness in hands. Medical emergency response team called. Vitals taken. BP: 80/39 HR 50, SpO2 100%. Patient given water. Vitals repeated: BP 111/61 HR 72. Patient continuously monitored until MERT arrived. MERT took vitals. BP 115/73 HR 84, SpO2 100%. Patient reports felling like his "heart is working hard". Patient assisted to chair and reports feeling better. He calls his mother. Mother is going to pick him up from vaccine clinic. Patient asked by MERT if he wanted to be evaluated in ED but patient and mom decide to go home and if he does not feel well again they will go to ED.
Patient had the initial Pfizer COVID vaccine on December 18th.  She started to having arthralgias, myalgias, fever, fatigue and weakness starting on  December 20th.  The patient continuously had arthralgias, myalgias and weakness for the next few weeks.  Patient follow up with physical therapist once a week to work on muscle weakness.  The patient continuously had arthralgias and myalgias until January 10th.  Primary care provider on January 7th orders CBC, autoimmune and thyroid panel since patient was having ongoing myalgias and arthralgias.  Patient postpone 2nd dose because side effects from previous vaccine were ongoing.  Patient got 2nd dose vaccine on January 12th at 4:30pm.  On January 13th at 11am the patient initially had nausea and arthralgias.  Patient took Zofran 4mg ODT about 11:15am.  30mins later the patient tongue swelled.  No lips swelling and no SOB.  Patient immediately took liquid Benadryl 50mg to 75mg PO.  Patient immediately drove to ED.  Patient was observed until 2pm for signs and symptoms of allergic reaction.  Patient was discharge and advised to take Benadryl 25mg to 50mg  every 4 to 6 hrs prn allergic reaction,  Patient took famotidine 20mg at 4pm along with 25mg of Benadryl PO.  Tongue swelling began to decrease.  Patient also had fever, myalgia and arthralgias at 4:30pm.  Took Tylenol 1,000mg and symptoms subsided  (fever, myalgia and arthralgias).
no adverse event; was administered MMR-II that expired; This spontaneous report was received from an office manager and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-DEC-2021, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human Albumin (rHA) (M-M-R II) dose of 0.5 milliliter, lot #S039310, expiration date: 04-DEC-2021, administered as prophylaxis (strength, anatomical location and route of administration were not provided). The patient has not experienced any other adverse events. The office manager stated that there was no temperature excursion and that the only issue was that the vaccine expired.
I feel as if I am tipsy, as if I am in a dream and a little dizzy.  When I look at an object, it's a little out of focus and it takes 2-3 seconds to focus.
Pneumovax vaccine given on 11/19/2011@17:35 by RN on 4W. At morning assessment, area of injection was warm and reddened and somewhat tender to touch. By 15:00, pt had temp 100.2F, loss of appetite and arm area was very warm, very tender to touch and seemed to be more inflamed. Red spots also appeared on patient's face. Improved with APAP and diphenhydramine. Pt ok'd for d/c 11/21/2011 affected area on arm has not increased in size, continue supportive care.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-FEB-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Miscarriage; Electing not to receive second Moderna dose after learning she was pregnant; Pregnant when she received her first Moderna dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Polycystic ovarian syndrome and Hypothyroidism. Concomitant products included LEVOTHYROXINE and METFORMIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose). On 05-Feb-2021, the patient experienced INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant). On 27-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose) had resolved. On 05-Feb-2021, INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant) had resolved. On 27-Apr-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information regarding treatment was provided.  Nurse reported she was unaware she was pregnant when she received her first Moderna dose on 08-Jan-2021. Nurse reported that she discovered she was pregnant a week 29-Jan-2021 prior to her scheduled second Moderna dose on 05-Feb-2021. Testing was performed on the fetus and physicians determined the baby was a normal healthy girl with no genetic abnormalities or findings. Reportedly, she stopped metformin during her pregnancy so glucose testing could be performed.
swelling of (L) upper arm starting 1-2" below site of injection,  6/3 Dr. took measurements. Red, warm, itchy, pain. Also, a smaller red patch (much redder) in the same area on KEFLEX and Lotrimin since 6/3/19
Left sided pain in chest area. Feels like sore muscles. Pain still present 24 hours later. Will see my doctor next week if it does not clear up.
Sudden onset fever, severe aches and chills starting the morning after immunization resolving within 24 hours with no reasonable other cause.
Varicella - information has been received from a registered nurse concerning a 6 year old male patient who on 01-Nov 1995 was vaccinated with varicella virus vaccine live . on 30 mar 2000, the patient developed chickenpox consisting of approximately 50 lesions.  The patient sought unspecified medial attention.  Additional information has been requested.
Mom complained of child breaking out with pinkish rash sparsely distributed entire body on 9/21/02. Child received DTaP, TB skin test on 9/19/02. Mom stated rash disappeared on 9/21/02 evening; reappeared 9/22/02 AM and child had loose stool 5 times. Patient drank juice, ate chicken. Child not in distress; drinking milk via bottle. Clinic supervisor checked rash with this nurse. Stated mom to observe if condition get worse to go to ER.
bleeding; itchy skin; bruises; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 15Apr2021 at 12:00 (at the age of 30-years-old) as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 15Apr2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included prior to the vaccination, the patient was diagnosed with COVID-19. Patient have family history of heart problems. The patient did not have any allergies to medications, food, or other products. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 18:00 the patient experienced itchy skin ever since she got the first shot and it had been a month since second vaccine and she had itchy skin like crazy and the patient itched until there were bruises and patient were bleeding. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of itchy skin and included treatment with Benadryl and allergy medication since an unknown start date to an unknown stop date. The clinical outcome of the event itchy skin, bruises,bleeding was not recovered at the time of this report.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Stomach is squeezy.; I developed a "covid arm; I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch; It's like 3-and-a-half-inch medium pink spot that was itching; This was a nightmare getting my shot.; It's like 3-and-a-half-inch medium pink spot that was itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I developed a "covid arm), VACCINATION SITE MASS (I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch), VACCINATION SITE DISCOLOURATION (It's like 3-and-a-half-inch medium pink spot that was itching), ABDOMINAL PAIN UPPER (Stomach is squeezy.) and NIGHTMARE (This was a nightmare getting my shot.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included HRT.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch), VACCINATION SITE DISCOLOURATION (It's like 3-and-a-half-inch medium pink spot that was itching), NIGHTMARE (This was a nightmare getting my shot.) and VACCINATION SITE PRURITUS (It's like 3-and-a-half-inch medium pink spot that was itching). On 03-Apr-2021, the patient experienced VACCINATION SITE REACTION (I developed a "covid arm). On 04-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach is squeezy.). At the time of the report, VACCINATION SITE REACTION (I developed a "covid arm), VACCINATION SITE MASS (I felt a small kind of hard area, like a size of a quarter hard under the skin that started to itch), VACCINATION SITE DISCOLOURATION (It's like 3-and-a-half-inch medium pink spot that was itching), ABDOMINAL PAIN UPPER (Stomach is squeezy.), NIGHTMARE (This was a nightmare getting my shot.) and VACCINATION SITE PRURITUS (It's like 3-and-a-half-inch medium pink spot that was itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.Concomitant medication was on a low dose of Hormone replacement therapy (HRT) for 20 years.
Fine red rash at base of back of neck-itchy-occurred 2 days post JE#2 Caladryl lotion applied.
Hot to Touch Sensation - Near Injection Site; Swelling (hardness) - Near Injection Site; Fever; Chills; Arm Pain - Near Injection Site; Body Aches; Arm Pain - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), the first episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Herpes NOS. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Herpes NOS, HYDROCHLOROTHIAZIDE and LOSARTAN for Hypertension, VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]) for Vitamin B complex supplementation, VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (Body Aches), the first episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), PYREXIA (Fever), CHILLS (Chills) and the second episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site). The patient was treated with NAPROXEN at an unspecified dose and frequency. On 30-Jan-2021, PAIN (Body Aches), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE INDURATION (Swelling (hardness) - Near Injection Site), PYREXIA (Fever), CHILLS (Chills) and the last episode of VACCINATION SITE PAIN (Arm Pain - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No treatment information was reported.
This spontaneous report as received from a healthcare professional refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On an unknown dates, the patients were vaccinated with the dose of improperly stored M-M- R II injection, lot # K024825, expiration date 02-DEC-2016 (dose and route of administration were not reported). No adverse effects were reported. Data logger was involved. The vaccine was exposed to a temperature of 22 Celsius (C), time frame of excursion was reported as 1104 hours total cumulative time. There was no previous excursions. This is one of several reports from the same reporter. Additional information has been requested.
swelling and pain in the arm where the shot was given. Extreme fatique next morning and feeling of fogginess and lack of concentration. The top of my right hand (shot side) hurts when I make a fist or type.
Patient reported a positive TB serum test with no known exposure 6 weeks after receiving the vaccine.  Her primary care provider recommended a chest x-ray to rule out active TB infection with the results pending
Fever, chills, nausea, headache, sore throat, runny/stuffy nose. Symptoms lasted about five days. Did not see Dr. but treated with ibuprofen.
Pt recvd DTP/OPV/HIB/MMR 16APR92 & 25APR92 had sudden spike of 104 fever, had sz & quit breathing; taken to hosp; blood work drawn observed x 5 hrs; broke out w/a rash afterwards x2 days;
Within 24 hrs of vaccine patient developed rash on buttocks, symmetrical, papular. Rash then spread to upper legs, anterior and behind knees within the next 24 hours. Rash consistent with Gianotti Crosti.
Approx 5 min. after getting GARDASIL pt passed out for 1-3 min. Pt was moved to a laying pos and monitored for 30 min.
3 hours after immunization, 2 episodes of nystagmus last 2-3 minutes each. Resolved.
postherpetic neuralgia; shingles; Information has been received regarding a case in litigation from a lawyer and consumers, referring to a female patient of unknown age. Information about concurrent condition, historical condition and concomitant medication was unknown.   On 02-DEC-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (dose, frequency and route unknown) in a pharmacy for the routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   In approximately December 2016 (reported as within approximately 1 month), the patient experienced a severe outbreak of shingles. Since this initial outbreak, the patient had additional outbreaks of painful and debilitating shingles, all caused by the zoster vaccine live (ZOSTAVAX). As a result of the zoster vaccine live (ZOSTAVAX), the patient was formally diagnosed with postherpetic neuralgia (PHN). These injuries resulted in extensive medical care and treatment.   As a result of zoster vaccine live (ZOSTAVAX), the patient's husband suffered loss of services and society and asserts a loss of consortium claim. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered severe injuries and disfigurement not present prior to using the product, which were directly caused by the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries, including emotional injuries and loss of consortium. The patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of post herpetic neuralgia and herpes zoster was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).     Both events herpes zoster and post herpetic neuralgia were considered to be disabling.