chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inject site react: Post vax, same day, pt devel inject site react characterized by redness, inflamation, big muscle knot & swelling extending to elbow. Soreness on shoulder blade, back of neck. Next day felt like on "a big drunk."
Most of Upper arm very red even on day 3, feels hot to touch Headache Shivering fever nausea feeling of being really tired
On Dec 25th, I felt  strange and decided to take my blood pressure at home. The top number was 190. I made an appointment with a cardiologist, and saw him on Jan 3. Leading up to the visit, my blood pressure was a little better than the 190 reading, but at the doctors office, it reached 199/100. My pulse is normal.  I recieved the 1st and second vaccine dose in March and April 2021. In may, my doctor had me monitoring my blood pressure suspecting high blood pressure. There were some high readings,  but it improved on its own, and I stopped monitoring until I felt funny on Dec 25th 2 days after receiving the booster.  I have started Nebivolol, which is helping. But I am experiencing Tremors, and this is a problem that seems to have started after being vaccinated
Information has been received from a registered nurse concerning a 11 year old caucasian male with a hypersensitivity to seltzer and no known medical history was vaccinated SC in the left arm on 06-MAY-1998 with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot number, 625051/1578E). There was no illness at the time of vaccination. There were no concomitant medications. It was reported that the patient was seen in the physician's office 23-APR-2007 with a two day history of rash on his abdomen. The symptoms were described as 40 red papules (central papules on red base) which were scattered over his trunk, extremities and face. No laboratory tests were reported. No product quality complaint was involved. Information was received from the registered nurse reporting that the patient was seen in the office on 23-APR-2007 with a two day history of rash noted as 40 red papules. The patient was rechecked on 25-APR-2007 and it was felt that this was not chicken pox. The diagnosis was impetigo. On 28-APR-2007, the patient recovered. Additional information is not expected.
Information has been received from a physician concerning a 42 year old white female with no past medical history and an allergy to penicillin, who on 04/15/2002 at 9:30 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(lot # 367431/0026L) in the left deltoid.  There was no concomitant medication or illness at the time of vaccination.  On 04/26/2002 the pa/tient developed flu-like symptoms described as fatigue, body aches and general malaise.  On 04/28/2002 a rash started appearing on her neck and face and was reported to be "spreading downward."  The physician described the rash as morbilliform and maculopapular.  The patient sought unspecified medical attention and subsequently recovered.  When the physician's office contacted her on 07/22/2002 she was reportedly "fine".  No further information is expected.
Moderna COVID-19 Vaccine EUA: Patient hospitalized with hypertensive urgency and possible systemic inflammatory response syndrome. Received lorazepam, antihypertensive medications, and intravenous fluids and event resolved. Discharged to home medically stable.
Patient developed severe bruising on left inner side of the arm. This developed around one week after the second dose of the Moderna vaccine. He also informed us that the night before he had wrapped a CPAP cord around the arm. The arm had a ball that was painful at touch. Patient came in today (05/04/21). The bruise was still there but formed a yellow color indicating the bruise is dissolving. There was no heat or nodule in the middle. Informed patient to call his PCP as soon as he can. He is due to have surgery next week for his DVT issue on the left leg.
we both don't feel well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (we both don't feel well) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced MALAISE (we both don't feel well).        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.   This case was linked to MOD-2021-009867, MOD-2021-009867 (Patient Link).
Information has been received from a physician concerning an 18 year old female with a history of syncope and no drug reactions or allergies who on 05-AUG-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast). Concomitant therapy included MENACTRA vaccine (dip toxoid). On 05-AUG-2008 the patient fainted. When the patient fell off the table, she cut her head open. It was reported that after the first dose of GARDASIL vaccine (yeast), the adverse events improved. The outcome of the patient was not reported. Additional information has been requested.
A report has been received from a Health Professional concerning a male patient. No information was provided regarding the concomitant medications, concurrent diseases and medical history of the patient. The patient number eight received the FLUMIST vaccine (intranasal), 0.2 ml dose, one time intranasally, date of vaccination not provided. It was unknown if the dose of 0.1 ml was given in each nostril. The office refrigerator had a temperature excursion of 1.5 degrees C for a total of 17.5 hours. The temperature would be at recommended temperature range and then dip to 1.5 degrees C, then go back to original range. FLUMIST Quadrivalent was continued. The outcome of the events of patient number eight given FLUMIST vaccine that underwent a temperature excursion, and it is unknown if the dose of 0.1ml was given in each nostril was unknown. The report was considered to be non-serious by company physician.
After 15 minutes of the vaccination patient became dizzy and nausea. Gave patient water and candy bar. Patient feels better after water and candy bar.
Pt given vaccine Adacel 7/23/07 (L) deltoid, now at area approx 4" diameter red, warm and tender at injection site. Pt to take Keflex 500mg one tab po every hr x 7d. Also prn HCT po Benadryl po top. daily
tested positive for COVID-19; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 10 year-old male patient received bnt162b2 (COMIRNATY), administration date 10Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 07Jan2022, outcome "unknown", described as "tested positive for COVID-19"; COVID-19 (medically significant) with onset 07Jan2022, outcome "unknown", described as "tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive. He was currently quarantining and he could not get his second dose until 26Feb2022 or on 02Mar2022 with his pediatrician, 11 weeks after first dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
3+ weeks post vaccine "felt like food poisoning" then pt concerned may have been yellow fever vaccine.  Fever, malaise, vomiting. Self limiting in approx. 3 days.
Patient states that when needle was inserted she felt pain. Almost immediately she had trouble moving her arm, and is still having the symptoms.  MD has treated with steroids and muscle relaxants.  MD diagnosed as a hematoma.
I was 12 weeks pregnant, and I had a miscarriage. The symptoms of the miscarriage started on Sept. 28th, and I did not know that I was having a miscarriage. On October 01, it was confirmed that I did have a miscarriage. I was in ER. They ran and HCG level and did an abdominal ultrasound.
Approximately 1 day after vaccination, patient had fever, general malaise inflammation at injection site going down towards elbow. Physician believes cellulitis infection inflammation on right arm only (Prevnar site)
Severe headache  Extreme ongoing fatigue starting the day after vaccination and ongoing Chest discomfort, ongoing
On 2/5/01 Pt's mother reported complaints of left leg swelling at injection site, on Sat 2/3/01 swelling with redness since Sat 2/3/01. Dr performed pt evaluation. Pt' mother informed to RTC if induration/erythma increased. Pt seen 2/6/01 no treatment.
localized erythema r deltoid erythema measures 2.5 inches by 2 inches and  left deltoid erythema measures 1.5 inches by 1 inch . site red and slightly warm to touch, arm hurts
Bumps on torso as well- ro belly button, up shoulder, and on back. (High density around the injection site, far less as moving away); Bumps on torso as well- ro belly button, up shoulder, and on back. (High density around the injection site, far less as moving away); Rash; Itchy; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 14:00 (Lot number: Fk5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII. The following information was reported: VACCINATION SITE RASH (non-serious), RASH (non-serious), outcome "recovered" and all described as "Bumps on torso as well- ro belly button, up shoulder, and on back. (High density around the injection site, far less as moving away)"; RASH (non-serious) with onset 08Nov2021, outcome "recovered" (12Nov2021), described as "Rash"; PRURITUS (non-serious) with onset 08Nov2021, outcome "recovered" (12Nov2021), described as "Itchy". Therapeutic measures were taken as a result of vaccination site rash, rash, pruritus, rash.  Additional information: Patient received Flu vaccine with in four weeks.  No follow-up attempts are possible. No further information is expected.
around the injection site is itchy red and pink; around the injection site is itchy red and pink; at the site not sore but if you touch it might be a little warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 2023, outcome "unknown" and all described as "around the injection site is itchy red and pink"; VACCINATION SITE WARMTH (non-serious) with onset 2023, outcome "unknown", described as "at the site not sore but if you touch it might be a little warm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that she got the COVID vaccine and around the injection site is itchy red and pink wants to know if this is normal or something to be concerned about. It's about 1/3 quarters to 2 inches in diameter the redness it's kind of pink and itchy at the site not sore but if you touch it might be a little warm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
"It felt like I was having a heart attack"; severe stomach/diaphragm pain; evere stomach/diaphragm pain; spasms; Felt like gas and came on right after she ate bread and butter.  She felt like it was in her back and chest "100 times worse than what I'm used to."; she is "unwell in general" and it is around her chest/upper stomach; She thought it was chest pain or gas; fever; Chills; Headache; body ache; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10May2021 at the age of 30-years-old (Lot Number: EW0173) as single dose for COVID-19 immunisation. Patient received the first dose on 19Apr2021 at the age of 30-years-old, Lot: EW0161, administered in left arm. Concomitant medications included ongoing vitamins NOS (DAILY MULTIVITAMIN); ongoing drospirenone, ethinylestradiol (LORYNA). The patient received the second dose of the Pfizer Covid 19 vaccine 10May2021. She had a fever 102.6 or 102.8 degrees Fahrenheit. It went up to 103 degrees and was now down to 101 degrees. She had chills, headache, body ache and soreness at the injection site. These symptoms started around 9:00 or 9:30pm last night. Fever, chills, headache, body ache and soreness at the injection site were with onset date 10May2021. She was hit with the whole nine yards of symptoms. She ate bread and toast earlier 11May2021 and has been having severe stomach/diaphragm pain, spasms and contractions. She thought it was chest pain or gas. She was unsure if she should be worried or if this is a side effect. This pain started around noon 11May2021. An AE was being filed however she ate bread/toast early this morning and she began having stomach/diaphragm area pain, like spasms and contractions. Patient stated symptoms have resolved for the moment and the last "attack" she had was while she was calling Pfizer. She said it came and went. Felt like gas and came on right after she ate bread and butter. She felt like it was in her back and chest "100 times worse than what I'm used to." She said she was "unwell in general" and it was around her chest/upper stomach. "It felt like I was having a heart attack". "Is this a side effect of the vaccine? Should I seek medical attention if it gets worse?" The outcome of events (severe stomach/diaphragm pain, spasms, contractions, fever, chills, headache, body ache and soreness at the injection site) was not recovered, outcome of other events was unknown.
03/08 SWELLING THE SIZE OF LEMONS UNDER LEFT ARMPIT AND SIDE IN GLANDS AND PAIN. 03/09 SPOT ON RIGHT TEMPLE LARGER THAN A QUARTER, BLISTERED RED & PAINFUL, SWELLING ALONG RIGHT SIDE OF FACE, IN JAW AND BEHIND EAR. 03/10 ITCHING AND PAIN IN SCALP, FOREHEAD, FACE, AND SAME SYMPTOMS AS DAY BEFORE. 03/11 UPON WAKING IN MORNING RIGHT EYE SWELLED UP AND BRUISED AND EYEBALL BRIGHT RED. PLUS SAME SYMPTOMS AS DAYS BEFORE. TOOK 4 WEEKS TO RECOVER FROM SORE AS IT HAD PUSS UNDER THE SCAB DAILY THAT HAD TO BE CLEANED. LEFT DEEP SCAR.
This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a 85-year-old male patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unchanged. The reporter considered the diarrhea to be possibly related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medications included Vitamins. The patient received SHINGRIX in the left deltoid. The patient experienced diarrhea since receiving the SHINGRIX vaccination. The reporter was unable to provide additional information. The call was transferred to medical information.
After 25-30 mins Patient stated tongue felt numb, patient was pale and anxious and hadn't eaten, Patient took an Allegra 24 hr 180mg tab, pt was then assessed by the facility who felt pt was having an anxiety reaction. Pulse  was 80 and O2 Sat 100%. Patient was escorted to ER for evaluation.
The flu vaccine was administered at 14:45 on 10/15/03. At 16:00, the pt's arm was noted to be painful and swollen at the injection site. A warm pack was applied and the pt was observed for an hour prior to discharge.
Received flu shot 11/15/12. Began with (L) arm swelling, erythema & warmth 11/16/12 --> put on KEFLEX. Redness continued to spread 11/17/12 & changed to BACTRIM. Admitted to hospital 11/17/12 for IV antibiotics & SOLUMEDROL. Unclear if infectious or allergic reaction. Allergy felt it was non infectious & just upper extremity swelling secondary to immunization.
My first shot was March 26; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (My first shot was March 26) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (My first shot was March 26). At the time of the report, PRODUCT DOSE OMISSION ISSUE (My first shot was March 26) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient had developed hives, general body swelling, itching and swelling of lips and face less than 24 hours after receiving flu vaccine intramuscularly.  Instructed to use cool soda baths for itching and also was given a shot of 40gm Depo Medrol and was given Medrol Dosepak.  Patient is to return as needed.
sore arm; she got a little sick; a little nauseous; nausea lasted for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ILLNESS (she got a little sick) and NAUSEA (a little nauseous; nausea lasted for a day) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Blood pressure high, Diabetes and Obesity.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-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 experienced PAIN IN EXTREMITY (sore arm), ILLNESS (she got a little sick) and NAUSEA (a little nauseous; nausea lasted for a day). At the time of the report, PAIN IN EXTREMITY (sore arm) and ILLNESS (she got a little sick) outcome was unknown and NAUSEA (a little nauseous; nausea lasted for a day) had resolved.            Concomitant product use was not provided by the reporter. After the 2nd dose she got a little sick, a little nauseous, and sore arm. The nausea lasted for 2 days. No treatment information was provided.   This case was linked to MOD-2022-494417, MOD-2022-494503 (Patient Link).
Information has been received from the author of a literature. This retrospective, descriptive study was to investigate the hepatitis B virus (HBV) seroconversion rate among health sciences students. The study included pharmacy, doctor of nursing, and medical students over 18 years of age enrolled at a university between 2007 and 2011. The primary end point was HBV seroconversion rates among students at the initial reporting period. Seroconversion was defined as hepatitis B surface antibody (anti-HBs) level greater than or equal to 10 mIU/mL. Multivariate regression analysis was used to determine predictive factors of seroconversion. Of 777 records, data were available for 709 students. An 83.9% seroconversion rate was observed after a mean of 10 years between vaccine receipt and anti-HBs evaluation. Students with incomplete HBV vaccine series and longer time between initial series and evaluation were less likely to exhibit antibody response. This case refers to two patients of unknown age and gender. On unknown dates, the patients were vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route, lot #, expiration date not reported) for prophylaxis. On an unknown date, after receiving 3 booster vaccinations, the patients' anti-HBs value remained seronegative (nonresponders). The outcome of the event was unknown. The causality between hepatitis b vaccine (recombinant) (manufacturer unknown) and the event was related. This is one of two reports received from the same literature (Linked report MARRS # 1702USA008162). Additional information has been requested. Sender's Comments: US-009507513-1702USA008162.
pt screamed cont for 5-6 hrs could not move leg for days temp 101.8;
2 days after injection of Varivax into left arm, developed local reaction: swelling, redness, and itching about size of orange - did not measure.  When seen in office symptoms had decreased.
About 24 hours after I received the 2nd dose of Pfizer a lump (tennis ball size) appeared on my left breast of opposite arm of injection. The lump was not going away after 7 days so I reached out for; nothing could be explained for the lump that still had the same size, shape, and constant pain.; This is a spontaneous report from a contactable other HCP. A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration in the left arm on 25Jan2021 16:15 as SINGLE DOSE for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. She had not any known allergies and other history. She had not COVID prior vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration, in left arm on 04Jan2021 17: 30 as single dose for covid-19 immunisation. On 25Jan2021 03:00 about 24 hours after she received the 2nd dose of Pfizer a lump (tennis ball size) appeared on her left breast of opposite arm of injection. The lump was not going away after 7 days so she reached out for medical help and after multiple antibiotics, ultrasounds, and mammograms, nothing could be explained for the lump that still had the same size, shape, and constant pain. It was now day 25 of this painful lump and she wanted to reach out to see if there were any cases related. She had not any injury, diet change, allergic reaction that could had caused this other than getting the 2nd dose of the Pfizer vaccine. She needed help and doctors here refused to believe it was related. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021. She received antibiotics treatment. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
weakness, paresthesia in lt arm, h/a, body aches, fever, SOB & soreness in lt chest for 3 days, body chills;