chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 little balls or nodules very close together on her left clavicle that were painful to touch; Left arm pit was swollen; Next to her chest beside her breast was painful; Under her arm was painful; Left Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (2 little balls or nodules very close together on her left clavicle that were painful to touch), PERIPHERAL SWELLING (Left arm pit was swollen), LYMPH NODE PAIN (Next to her chest beside her breast was painful), INJECTION SITE PAIN (Left Arm hurt) and AXILLARY PAIN (Under her arm was painful) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 045C21A) for COVID-19 vaccination.     Concurrent medical conditions included Menopause.   On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Aug-2021, the patient experienced INJECTION SITE PAIN (Left Arm hurt). On 09-Aug-2021 at 6:00 PM, the patient experienced NODULE (2 little balls or nodules very close together on her left clavicle that were painful to touch), PERIPHERAL SWELLING (Left arm pit was swollen), LYMPH NODE PAIN (Next to her chest beside her breast was painful) and AXILLARY PAIN (Under her arm was painful). At the time of the report, NODULE (2 little balls or nodules very close together on her left clavicle that were painful to touch) was resolving and PERIPHERAL SWELLING (Left arm pit was swollen), LYMPH NODE PAIN (Next to her chest beside her breast was painful), INJECTION SITE PAIN (Left Arm hurt) and AXILLARY PAIN (Under her arm was painful) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Within two weeks of the vaccine (specifically 7-22-19), I woke up with horrible joint pain all over my body. I could not bend any joint, it hurt to walk or straighten out my arms/legs. My joints were all swollen and without being cold, my upper and lower extremities would turn white. Little did I know, this was Raynaud?s.  I was carried to the car and taken to a  Urgent Care Facility where I was blood tested for a tick disease. Those came back negative. The pain continued and I went to a walk in facility the next day where I was given Augmentin. I threw the medicine up all night and went back the next day to request a lower dose antibiotic, but at this point was still in pain. The next day at the urgent care, I was given a steroid shot. Within hours the pain and swelling had subsided. I was able to get in pretty quickly to a PCP office where I was given a full CBC and Diff, CRP and Comp Metabolic Panel. Because of the elevated inflammatory markers and elevated Rheumatic Factor, she referred me to a Rheumatologist. He reviewed the blood panel and ordered additional blood work which showed that I had Lupus and Sjrogen's with a still elevated CRP level at that time. I am still dealing with the ramifications to this day.
Directly after receiving the flu shot patient instantly felt sick. Headaches, body aches, cramps, fever. This has been a week with the Sx. Pt received her EMBREL shot the day before getting her flu vx. Tx: Chest x-ray, TYLENOL.
Ulcerative colitis flare-ups following mRNA COVID-19 vaccination; This is a literature report for the following literature source(s): (removed). Case description/methods: A 36-year-old female with past medical history of ulcerative colitis, autoimmune pancreatitis presented with intermittent lower abdominal pain and diarrhea for 2 weeks with fever for 1 day. Her last flare-up was 3 years ago before she was put on Tofacitinib. She never required hospitalization. Her symptoms started the second day after she received the second dose of Pfizer COVID-19 vaccine. She had daily 5-10 times of non-bloody diarrhea and abdominal cramps. Her symptoms subsided after 7 days of initial onset. On day 11, she started to have daily up to 15 times bloody bowel movements, along with nausea, vomiting, unable to maintain oral intake. Day 17 after vaccination, patient went to ED after fever of 100.5F. On presentation, she is afebrile, WBC 11.9, CRP 61.8, calprotectin 1840, Clostridioides difficile negative, GI Panel negative. CT showed severe colitis involving the left colon from splenic flexure to rectum. Colonoscopy showed erythematous, granular, hemorrhagic, and ulcerated mucosa in the entire examined colon. Terminal ileum, cecum, ascending, transverse, descending, sigmoid and rectum biopsies were negative for CMV, showed chronic active colitis. Patient received intravenous Methylprednisolone, then transited to oral Prednisone taper and resumed her Tofacitinib. Her symptoms gradually improved.  Discussion(s): To our best knowledge, no report has shown the association of mRNA vaccine and UC flare-up. In general, non-live vaccines are safe for UC patients regardless of immunosuppressants usage. Live vaccines are also contraindicated Tofacitinib users like our patient. In the Pfizer COVID- 19 vaccine trial, patients on immunosuppressive therapy were excluded. Given the temporal relationship between the vaccine and her flare-up in the setting of long-term remission history, we are concerned that the stress induced by the mRNA vaccine may increase the risk of flare-up. More studies need to be done to evaluate the safety profile of mRNA vaccine for UC patients on immunosuppressants.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
Debilitating migraine attack after receiving COVID vaccine.  Roughly 12 hours after receiving vaccine.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient developed a flat, red rash on her arm in the area of the injection site 8 days after the shot. It doubled in size from 1 quarter to approximately 2 quarters in size overnight. Patient advised to contact us with any further reaction.
Arm blue and purple at site of injection. Looks slightly high for area of injection.  Patient states painful and feels swollen
patient received vaccine, was fine sitting in chair, stated she moved her arm and felt pain and passed out
Bump, pain, warmth at injection site. Seen by MD on 8/6/07 x2, areas of induration about 1cm, non-tender, sl swelling, warmth; no cellulitis noted at placement.
This spontaneous report was received from a medical assistant refers to a 28 year old patient of unknown gender. On 17-NOV-2015, the patient was vaccinated with first dose of RECOMBIVAX HB 0.5 ml. The reporter stated that the patient received the pediatric dose of RECOMBIVAX HB on 17-NOV-2015. No symptoms were reported. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. This case is linked to case 1511USA014540 and 1511USA011479 (same reporter link). Additional information has been requested.
Chills; Fever; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue). In February 2021, CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment medications was not reported.
On 5/6/21, patient developed BLE progressive weakness, numbness/tingling, then progressed to BUE numbness/tingling weakness, presented to Hospital 5/8 ED, discharged, then presented to 5/9 Hospital, eventually diagnosed with AIDP / GBS. Given IVIG 5d course through 5/14. Required mechanical ventilation 5/14. Pending ongoing management at Hospital Neurologic Intensive Care Unit
At 3:09 PM Hives noted to legs and Abdomen. At 3:10 PM 25 mg PO Benadryl given and EMS called. At 3:12 PM vitals were BP 195/108, SPO2 98%, Pulse 127. At 3:15 PM EMS arrived. At 3:17 PM Patient Left office with EMS.
Only recieved one dose; Arm started getting itchy in left arm which was injection arm; Had a red circle; Swelled up bigger than golf ball, took up her whole arm / three days later it started to puff up again; Other parts of her body were getting itchy, like her head and arms and legs / bruise was itchy; She had a bruise it's not just a bruise, it's itchy; It was warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Other parts of her body were getting itchy, like her head and arms and legs / bruise was itchy), CONTUSION (She had a bruise it's not just a bruise, it's itchy), VACCINATION SITE WARMTH (It was warm to touch), PRODUCT DOSE OMISSION ISSUE (Only recieved one dose) and VACCINATION SITE PRURITUS (Arm started getting itchy in left arm which was injection arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRURITUS (Other parts of her body were getting itchy, like her head and arms and legs / bruise was itchy), CONTUSION (She had a bruise it's not just a bruise, it's itchy), VACCINATION SITE WARMTH (It was warm to touch), VACCINATION SITE PRURITUS (Arm started getting itchy in left arm which was injection arm), VACCINATION SITE ERYTHEMA (Had a red circle) and VACCINATION SITE SWELLING (Swelled up bigger than golf ball, took up her whole arm / three days later it started to puff up again). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only recieved one dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. In April 2021, VACCINATION SITE WARMTH (It was warm to touch) had resolved. At the time of the report, PRURITUS (Other parts of her body were getting itchy, like her head and arms and legs / bruise was itchy) and VACCINATION SITE ERYTHEMA (Had a red circle) had not resolved and CONTUSION (She had a bruise it's not just a bruise, it's itchy), PRODUCT DOSE OMISSION ISSUE (Only recieved one dose), VACCINATION SITE PRURITUS (Arm started getting itchy in left arm which was injection arm) and VACCINATION SITE SWELLING (Swelled up bigger than golf ball, took up her whole arm / three days later it started to puff up again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient reported that three days post the events the region again started to puff up and itchiness keeps her awake at night. This was seen once a week since the first time she had swelling in arm.
We came to the facility to give 1st doses of Moderna. Patient was non-verbal. Facility staff stated she had not received a vaccine. When system was checked after vaccination, it was discovered that patient had already received 2 doses of Pfizer.
POTS-like symptoms  with new  onset of resting tachycardia to 140s with new dyspnea at rest that would get significantly worse with minimal exertion. Some associated lightheadedness initially. Resting HR declined by about 10 bpm each week, but as of today  still with resting tachycardia most of the time between 100-105. April 2021 still with HR spike to 140s during a warm bath.
Intermittent dizziness 4-5 times per day. Unable to link it to any activity and lasts for less then 1 minute each time it happens.
Pt received FLUMIST within hour, face started to itch. 4p - face red. 5p (6) red spots on face - next hour red spots began to expand and multiply to 20 - 30 spots - as large as hand. Dr's office called - liq BENADRYL given. Most spots gone by 9 pm. Pt has receive FLUMIST in past - no problems.
Mom reports p/3rd DTP about 20min later became limp, pale, eyes rolled back in head, no strength; pt was seen locally by MD & transferred to another MD & hospitalized for severe rxn to DTP;
missed dose of Gardasil 9/they received their second dose of GARDASIL 9 roughly 5 years and 8 months ago; missed dose of Gardasil 9/they received their second dose of GARDASIL 9 roughly 5 years and 8 months ago; No additional AE information; This spontaneous report was received from an unspecified consumer of unknown age reporting on them self. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and the expiration date were not reported) for prophylaxis.    On 30-APR-2016 (reported as roughly 5 years and 8 months ago), the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and the expiration date were not reported) for prophylaxis.   Caller was requiring what the next steps regarding the missed dose (inappropriate schedule of product administration and product dose omission issue). No additional adverse events.
a nine year old patient received a dose of Flublok vaccine/No AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a nine years old patient (gender unknown) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Patient developed a feeling of heaviness of her left leg and left arm after approximately 30 minutes after vaccine administration. Her tongue became numb. Temperature was normal @ 98.2 F.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 24-SEP-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a 65 year old Caucasian female family member with no known drug allergies and a past medical history of thyroid cancer (2000) who on 07/11/01 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent, in the left upper arm. Concomitant medications included levothyroxine sodium (Synthroid) and hormone replacement therapy. On 07/12/01, within 72 hours of vaccination, the patient developed redness, swelling (induration) and warmth from the injection site to the elbow. It was also reported that the patient developed a fever which lasted for one day. The attending physician advised elevation and cool compresses to the affected area. It was reported that the patient recovered. No further information is expected.
Myalgia, Arthralgia, Fever, chills, fatigue Narrative: Myalgia, arthralgia, fever, chills, fatigue, "woozy"; took Tylenol, ibuprofen; resolving.
Pt was called by clinic to follow based on prior pt's having some symptoms related to same vaccine. Pt received pneumococcal vaccine 12/8/04 pt noted sore arm, difficulty sleeping, next day felt like stomach flu, achy sore arm, 12/10/04 arm better, slept better.
I have not had a menstrual period since I received the 1st dose of the vaccine. I had intense hot flashes for several weeks after receiving the vaccine, that have now subsided. My doctor's office ran blood tests to check my hormone levels and they are now at peri and post menopausal levels (depending on the hormone).
Customer reported that improperly stored vaccine was administered to 10 separate patients. No additional AE reported; Customer reported that improperly stored vaccine was administered to 10 separate patients. No additional AE reported; This spontaneous report was received from an office manager referring to a 18 months patient, gender unknown. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-APR-2022, the patient was vaccinated with an improperly stored of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # T042013 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 22-JUL-2023) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 11.43° Celsius (C) for 1 hour and 45 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.; Sender's Comments:  US-009507513-2205USA003131:
Redness, welt, hot to touch, started day  vaccine was administered, next day a little worse per mother. Pt was eval and treated on 08/05/22, given Benadryl, PO, iced in office. Pt reaction reduced, discharged home.
Fever up to 101.6 lasting less than 12 hours Body aches Fatigue
Coughing, beginning next day. Partial throat swelling - only able to eat soup. Weight loss to date - 19 lbs.
That night, I jumped into the shower and I was a freezing cold. I had really bad chills. I went to bed and I was shivering all night long and the next morning, my head was pounding, I  had a migraine. I had a high fever and abdomen cramps that lasted for a few weeks. I started having migraines constantly. They would last all afternoon. My vision had changed, it had become blurry all of sudden. Things looked hazy. I had a foggy brain, had trouble remembering things. My migraines and vision problems lasted for weeks. There was terrible pressure on the back of my eyes.  My vision is still messed up.  I went to the eye doctor and she told me to keep an eye on it. I had not changed enough for a prescription, but it is blurrier than normal. My migraines have gone away.
Developed a hive looking rash on opposite arm as the vaccine on forearm (inside and outside) and elbow area. It itches and parts look like red sores
Several hours after getting the vaccine, I developed a fever, terrible fatigue, and dizziness. the fatigue was the worse, as I could hardly get out of bed.
This spontaneous report as received from a nurse refers to a 12 years old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Parasthesia in both hands and fingers; muscle tightness and heaviness in both legs and knees, graduating to arm muscles next day.  Feelings of shakiness.  No pain at all. Developed pins and needles in hands and feet as the week progressed. 4 weeks later, still having same symptoms.  No paralysis, reflexes good.  Stiffness in muscles and joints and parasthesia continue.
been up since 5a and it's now 6a; woke up and feeling like was in a fog; Feeling uneasy on feet; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 10:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 20Mar2021 at 13:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 11Apr2021 at 05:00, the patient woke up and feeling like was in a fog and was feeling uneasy on feet, went away within 4-5 hours. It was reported that on 12Apr2021 (Monday), the patient woke up and again feeling like she was in a fog, feeling uneasy on feet. The patient had been up since 05:00 and it was 06:00 at the time of report. Therapeutic measures were not taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events woke up and feeling like was in a fog, feeling uneasy on feet and had been up since 05:00 and it was 06:00 at that time was not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A physician provided information concerning an otherwise healthy 12 year old white male who developed "ill-defined" symptoms following vaccination in December 1998, with 2nd dose of Hep-B vaccine recombinant. Subsequently, post vax, "the pt has been experiencing chronic tiredness, nausea and vomiting, increased stuttering and generalized weakness". The pt received the 1st dose of the vaccine in November 1998. It was indicated that "the 3rd dose was refused". At the time of the report, the pt's symptoms persisted. The reporting physician believed there was no association between the pt's symptoms and the vaccine. No further details were provided.