chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very hot to the touch; Very red around injection site; Swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Very hot to the touch), VACCINATION SITE ERYTHEMA (Very red around injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 027D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Very hot to the touch), VACCINATION SITE ERYTHEMA (Very red around injection site) and VACCINATION SITE SWELLING (Swollen at the injection site). At the time of the report, VACCINATION SITE WARMTH (Very hot to the touch), VACCINATION SITE ERYTHEMA (Very red around injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature: high (High) Running high temperature, two lines over 102.         No concomitant medications were reported.  The patient kept ice on vaccination site as her Pharmacist recommended to do.
Pt's Vaccine Card was misleading. Pt was administered 0.5mL of Moderna  as a second vaccine. Pt was actually due for her BOOSTER vaccine of 0.25mL, Moderna.
This case was reported by a healthcare professional and described the occurrence of jaw numbness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 27 October 2010 at 10:30 the subject received unspecified dose of FLULAVAL (unknown, left arm); lot number reported as" ASLLA602AB". At an unspecified time after vaccination with FLULAVAL, the subject experienced jaw numbness, arm pain and arm tingling. The healthcare professional reported that the subject was administered FLULAVAL vaccine and experienced left jaw numbness and pain and tingling in the left arm. No additional details were provided because the vaccine was administered at a separate location. At the time of reporting the jaw numbness, arm pain and arm tingling were improved. The healthcare professional reported another case regarding FLULAVAL, see case A0890086A.
Sudden onset of itching in area of vaccination began 2 weeks after inoculation, increased over several days with intense itching, redness, swelling 9x6 cm, and some warmth.  No blistering.  No firmness.  Discomfort with deep palpation for several days. Controlled symptoms with oral antihistamines. Still present but symptoms are waning as of this date.
Approx 7-8 weeks after second shot of Moderna covid-19 vaccine developed chronic spontaneous urticaria (csu).  Still having chronic spontaneous urticaria (csu) 7 months later.  Treatment is Zyrtec in a.m. and Benadryl in p.m.
afraid of needles; felt like I had the mini flu / felt flu like; crying; call out from work place; felt tired; little rashes / arm was breaking out / me back the next afternoon to the same place on the right arm, right shoulder, then a rash on my left calf, and left arm, closer to the injection site; headache in back of my head; lips kinda swelled up; left eye swelling; fair skinned; lethargic; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).   A female patient of an (age:59, Unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included allergy to animal from an unknown date and unknown if ongoing, allergies to a lot of things, like cats and concomitant medications were not reported. On 08Mar2021 it was reported that, the patient experienced call out from work place, felt tired, little rashes / arm was breaking out / she back the next afternoon to the same place on the right arm, right shoulder, then a rash on her left calf, and left arm, closer to the injection site, headache in back of her head, lips kinda swelled up, left eye swelling, fair skinned, lethargic, afraid of needles on an unspecified date, felt like she had the mini flu / felt flu like and crying. She was afraid of needles, The outcome of the events was recovering and other event afraid of needles was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called on 07/24 and said she was having a reaction.  She said it started the morning of 07/24 and started out as small bumps under her eye.  She called at 2:20pm and stated that the bumps had gotten larger in size.  Patient was advised to seek medical care at an urgent care or emergency room.
3 hours post vaccine Pt experiences left arm soreness, a slight rash,  a flush feeling, and hives to injection site.  She experienced an increase in hives and a rash localized above injection site one day after vaccine. She continues to have left arm muscle soreness at injection site and fatigue today (4 days post vaccine). Rash has improved 4 days post vaccine. Hives have resolved 2-3 days post vaccine.
Patient, called on 04/22/2021 stating that she was going to have a colonoscopy today, but got cancelled due to her high glucose level of 400+ .  Her colonoscopy is being performed for requirement of an upcoming weight loss surgery.  Patient wanted to know if the blood sugar is high due to the recent covid vaccine she received, Johnson & Johnson by our office on 04/10/2021. Upon questioning patient stated she has had recent increased blood sugars since she has had the vaccine from her normal 160 after meals to 270 after meals.  Patient c/o headache, run down, diarrhea, nausea and lower abdominal pain (Lower Middle Quadrant), which started the day after her vaccine and has not gone away.  She takes Tylenol ES 500 mg twice daily in AM and PM, but only takes the edge off for her headache.  Her arm was sore without redness or swelling at vaccination site, right deltoid. Patient did confirm with me that she does have an appointment with her family physician, today at 1:15 pm about an hour from now.  I notified patient that she should inform her doctor of her recent J& J vaccine, we are reporting to Vaers, and to follow up with our office if she could.  Patient verbalized understanding that this may or may not be attributed to her recent vaccine, needs to immediately contact and follow up with her physician, Dr.
During the 15 minute observation period after injection, patient returned to the check-in desk complaining of dizziness. He was brought immediately to exam room where he became pale, diaphoretic, and stated he "felt like he was in a dream." Seated BP was 74/palp. He was placed in supine position on exam table, cool compresses placed on forehead and back of neck. He complained of some nausea, which quickly improved. He never lost consciousness. His color and alertness improved steadily over the next 10 minutes. Repeat BP (lying) was 100/50. After a few minutes he sat up on exam table, dangling legs. BP remained stable at 110/60, HR 84. He continued to improve and stated that he felt better, drank some water and ate some goldfish crackers. Reported that he just remembered he had not eaten since lunch. After another 5-10 minutes he was alert, oriented, able to walk unassisted. Final BP 114/70, HR 80. His wife remained with him and confirmed she could drive him home. Discussed that although I feel confident this was a vasovagal near-syncope, if symptoms recur or worsen, he should go to ER for evaluation. Understanding verbalized.
eyeballs, eyelids swollen, then face swollen and blotched, then second layer of skin became scalding on fire hot but no temp. then whole face and ears swollen.  then swelling and blotch moved down into neck and upper chest. had been having trouble breathing from beginning of symptoms was getting worse.
Redness and swelling that started at site and spread down and to the inside of the arm.
pt recv vax 4MAY94 & the same day devel a cough w/hemoptysis, coughing up clear mucus & no nasal sx & c/o of flu-like sx; No further details were provided;
Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # not available). Subsequently, the patient experienced Guillain-Barre syndrome. It was unknown if medical attention was sought. On 8/26/04 it was reported that the event did not improve and the patient's present status was reported as unknown. Upon internal review, Guillain-Barre syndrome was determined to be an other important medical event (OMIC). No further information is available. Follow up 03/03/05: Patient has not recovered from the event(s).
sudden chills and fever lasting 36 hours, (flu-like symptoms) bed rest and Tylenol, lingering muscle weakness, fatigue
Severe Diarrhea. Also had this happen after a Covid vaccine on August 24, 2021 but I didn't relate the two until it happened again.
shingles, including any and all of its sequelae.; as well as other severe and personal injuries/Shingles and other related health complications; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 77-year-old male patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 27-SEP-2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) at a pharmacy for prophylaxis. As a result of his receipt of zoster vaccine live(ZOSTAVAX), on 02-MAY-2017, he was caused to suffer shingles, including any and all of its sequelae. The patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient claimed that he suffered shingles and other related health complications. In addition, he required and will continue to require healthcare and services. Plaintiff has incurred and will continue to incur medical and related expenses. He also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. His direct medical losses and costs included physician care, monitoring, and treatment. Plaintiff has incurred and will continue to incur mental and physical pain and suffering. The outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).  The events shingles and other severe and personal injuries/ other related health complications were assessed as serious due to disability.
Black spots on tongue, jaw, inside of lip, red pin-dot rash on knees and elbows, platelet count of 2 (yes TWO), and bruising.
(Johnson and Johnson vax not on dropdown.)  Chills, fever (100.2), diffuse myalgias, headdache; started 7hours after vaccine; chills, fever, myalgias lasted about 6 hours; the headache persisted about 16 hours
About two weeks after receiving the first Covid-19 vaccine dose, patient had yellow-red urine for a day. No dysuria, or any other symptoms.
Sore arm; Body aches; Chills; Feverish; Muscle pain; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Feverish) and MYALGIA (Muscle pain) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Feverish) and MYALGIA (Muscle pain). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Feverish) and MYALGIA (Muscle pain) 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 medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable
This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), PERIPHERAL SWELLING (Arm is swollen) and FEELING HOT (Head feels hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036_21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Vertigo. Concomitant products included MECLIZINE [MECLOZINE] for Dizziness. On 14-Apr-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach) and NAUSEA (Nausea). On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Head feels hot) and MYALGIA (Body Aches). On 16-Apr-2021, the patient experienced HEADACHE (headache) and FATIGUE (tiredness). On 22-Apr-2021, the patient experienced DIZZINESS (dizziness). On 13-May-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced VERTIGO (Vertigo, off balanced), INFLUENZA (flu) and SOMNOLENCE (Sleepy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at a dose of UNK, bid and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of UNK, bid. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Head feels hot), INFLUENZA (flu), SOMNOLENCE (Sleepy), HEADACHE (headache), NAUSEA (Nausea), MYALGIA (Body Aches) and FATIGUE (tiredness) outcome was unknown and VERTIGO (Vertigo, off balanced) and CHILLS (Chills) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-054733 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 22 Apr 2021 included information of additional events after second dose. The events experienced were headache, dizziness, vertigo, fatigue, influenza and somnolence. On 22-May-2021: Additional information included event outcome and concomitant medication was updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-054733:For First dose
Pt received MMR, HPV, & MCV 4 at 1545. At approx 1830, pt developed a lump in her throat & SOB. Also, tingling in her upper extremities. EPI given by EMS - symptoms resolved.
The patient was inadvertently administered an expired dose of M-M-R II; This spontaneous report was received from an office manager, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (DILUENT MRK). The patient's medical history, historical drugs, concurrent conditions or drug reactions or allergies were not provided.   On 28-DEC-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(recombinant human albumin)(M-M-R II) lot # N032749, with expiration date 20-NOV-2019 for prophylaxis (strength, frequency, route, vaccination scheme and anatomical location were not provided. No temperature excursion were reported).
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 12-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Bells Palsy burning back pain that radiates to arms, legs, head occurs at night when resting
Itching at the injection site; headaches; Redness at the injection site; Swelling at the injection site; Fatigue; muscle pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), HEADACHE (headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and FATIGUE (Fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), HEADACHE (headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), HEADACHE (headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
High fever of 101.7, extreme chills and body aches, leg muscles twitching
A non-serious spontaneous report of she got a flu shot and then FLUMIST was received from a medical assistant concerning a 19-year-old female. No relevant medical history information has been reported for this patient. On 01-Oct-2009, the patient received a flu shot. On 23-Oct-2009, the patient went to get an H1N1 but was inadvertently given a FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reported causality assessments are not applicable, and the event is considered resolved.
10 mins p/vax pt arm became numb from shoulder to fingers; 7 1/2 cm area around inject site became red & indurated; pt also became lightheaded;
A week after the injection hardly able to move arm. large red spot and appeared swollen.  Dr. advised to give it time, then after several weeks of no improvement Dr. referred her to   physical therapy. On 5-20-2021 before she could respond she suffered a stroke that has paralyzed her left side, can't walk, can't talk or eat on her own. Has a feeding tube and is currently in Rehab facility.
Presented to ED for shortness of breath. Patient had IV placed, labs and CXR imaging performed. On attempt to ambulate the patient, after only a couple of steps she becomes quite hypoxic dropping her sats into the 80s and tachycardic.  It is unclear to me the cause of her symptoms, however due to her persisted hypoxia upon exertion and oxygen requirement she will be admitted to the hospital for ongoing management.
Best Use Date was 4/21/2022 and actual expiration date was May  31 2022
Within 10-15 minutes after the vaccination and no complaints of illness, my son suddenly fainted and started to shake. He lost consciousnes for about 1 minute.  He looked pale white, ashey and lips were blue/gray.
Pt. returned to store on 10/19 with welt that was warm & tender/painful. Advised to take Diphenhydramine. Followed up w/pt on 10/22. She said it was less swollen but had gotten bigger. Advised to continue Diphenhydramine and contact PCP.
RECEIVED MONOVALENT INSTEAD OF BIVALENT AS THE 4TH SHOT
The patient developed weakness in the left arm 5 minutes after vaccine administration.  The issue resolved after observation.
Patient developed DVT of left LE following 1st dose of vaccine series then subsequently developed DVT following the booster vaccine dose.  Dose one on 1/5/21 and dose 2 on 1/28/21 with start of pain in left LE on 2/21/22 and with  ER visit on 2/28/21 ultrasound confirming DVT, patient completed treatment for DVT with Xarelto, ultrasound has been performed confirmed clot clearance. Then booster dose on 1/28/22 with symptoms of pain in left LE starting on 1/31/22, telehealth phone call with provider on 2/3/22 at which time ultrasound was ordered, then scheduled ultrasound confirming left LE DVT formation on 2/8/22. Patient restarted on Xeralto. Discussed possible referral to Hematology on 3/15/22 for which patient defers at this time due to other medical workup.
Patient said she felt like she was going to pass out. Was advised to sit down immediately. Patients breathing was fine, but she was extremely lethargic/limp. Was coherent but slow to answer questions, excessively sweating and pale, small amount of vomit. At one point, patient said that she did not know where she was. Said that her fingers felt numb and tingly (could not pick up water or orange juice...we had to put water and juice to her lips to drink). She said that she needed to lay down. Per patient she had oatmeal with very little sugar for breakfast and coffee. Believe the reaction was a vasovagal response.
swelling and redness . went to urgent care and was told she had cellulitis. got cephalexin 500mg qid for 10 days,  and Bactrim ds   BID for 10 days.   she is doing better today Tuesday the 18th of July 2023.
PATIENT REFERS DIZZINESS, EXCESSIVE SWEATING, BURNING SENSATION IN CHEST, PRESSURE IN HEAD AND CHEST. DIABETIC PATIENT.