chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dt booster 5/17/05, chest pain 5/18/05, red raised rash, sore throat 5/19/05, fever 5/20/05, vomiting 5/22-5/24, Increased WBC 191200. There are an additional 4 pages of report of consultation. 15 year old was in good health until 5/17/05 when he received a tetanus vaccine. Within one hour he developed some mild chest pain. While he went to school the following day, the original chest pain was worrisome and he went to his PCP office on 5/18 for evaluation. I do not believe that any clear diagnosis was made. By the following day 5/19, the pt developed some palmar tenderness and within several hours he recalls having bumps under the skin of his hands and some associated hand pain. During the course of the day, the exanthem spread to involve his forearms and then his chest and abdomen. He was seen in the emergency dept on 5/19 where he was found to have a temperature of 98.9, blood pressure of 117/70 and O2 sat 99% on room air. His palms are noted to be slightly erythematous and mildly tender to palpation and he had an erythematous papular rash involving the forearms and abdomen, this was felt to involve primarily the hair follicles and a ? of folliculitis was raised. A rapid strep test was negative. Benadryl and Pepcid were prescribed as the pt was complaining of some mild dyspepsia at the time. By 5/20, the pt began having fevers and loose stools three or more each day and described as watery. The exanthem became more confluent. On that day, he saw his PCP office again and was thought to have a possible viral process. Over the ensuing two days, the pt developed some nausea and vomiting and had continued watery diarrhea. He noted that he had no significant headache at that point, he did have some burning of his tongue and he developed dry cough. He did not recall any skin tenderness nor any arthralgias or arthropathy, no difficulty with urination and no abdominal pain. With his complaints of rash and fevers, he presented to the emergency dept on 5/24. Initial evaluation was notable for temp of 101.3, blood pressure of 116/65, respirations 16 and O2 Stat 95% on room air. He was noted to have a diffuse exanthem, mild injection of the conjunctiva bilaterally and a dry cough. Further eval included a WBC of 19.2 with an ANC of 17.2.  A comprehensive metabolic profile was notable for normal renal function, an AST of 45 and an ALT elevated at 75 and an alkaline phosphatase of 179. Two blood cultures were drawn, a throat culture was obtained and the pt was admitted The pt was seen by a dermatologist. No vasculitis was felt to be present. The pustules were found to be present on the trunk and again described as a folliculitis. Over the night, the pt had a temp as high as 103.9 and a mild dry cough. He was felt to have mild overall thrush and has been started on Mycelex. Today, the exanthem has taken on a sandpaper quality and appears to be increased along body creases. There is a marked desquamative quality to the rash especially in the axilla and groin. I was asked to see the pt regarding further thoughts on a differential diagnosis and antimicrobial management.
severe chills for 4-5 hours, grapefruit size of red around injection site,  unable to get up for 24 hours, arm very sore and still red at the site
minor skin eruption; This spontaneous case was reported by a consumer and describes the occurrence of RASH (minor skin eruption) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (minor skin eruption). At the time of the report, RASH (minor skin eruption) outcome was unknown.            No Treatment medications were provided No  Concomitant medications were provided  Patient reported he broke out with minor skin eruption. He visited a medical doctor and a dermatologist, and was prescribed an antihistamine and a steroid pack The symptoms were starting to resolve after taking an antihistamine (either Zyrtec or Claritin)   This case was linked to MOD-2022-454183, MOD-2022-455291 (Patient Link).
Breakthrough case of COVID; Breakthrough case of COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Breakthrough case of COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient's symptoms began on Tuesday evening, 31May and he began taking Paxlovid in a.m., Wednesday, 01Jun. He was on day 4 of 5 (Sat, 04Jun).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt experienced dizziness after vaccination. Offered juice & crackers, pt felt better. Stable and left 25 minutes post vaccination. BP 138/94; HR 84; RR 18; T 97.6
Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M027347 with expiration date 01-JUN-2018, lot # M024677 with expiration date 18-MAY-2018, lot # M027885 with expiration date 03-JUN-2018; dose and route unknown). No adverse effects were reported. Temperature Excursion Details were as below: -9.5 centigrade for 48 minutes, 4.6 centigrade for 31 hours and 8 minutes and -9.7 centigrade for 46 minutes. Data logger was involved. Additional information has been requested.
Severe and chronic arm pain at and around injection site lasting more than 2 and a half weeks
Arm started getting a little sore/painful and about 1/2 inch below the injection site there is a 2 inch by 1.5 inch area of swelling (hardness) with mild redness
Pt recvd vax & 2 wks later pt presented w/an erythematous rash over the elbows & knees;
Redness, swelling, and pain in the area of her right upper arm around the lateral deltoid where she was given a Tdap on 9/5/19. Meloxicam and doxycycline given for oral treatment. Tdap vaccine added to patients allergies.
Developed pruritic rash approximately 12 hours after administ. Band-like around (R) upper arm, scattered hives 1-3" diameter on scalp, face, neck, and upper.
On March 11, 2023, I tested positive for COVID-19.  I called my doctor.  On the next day I had a mild fever and was coughing.  I had tightness in my breathing, so I had to get another prescription for inhaled steroids.  I also began taking Paxlovid on March 12th.  For three weeks I was fatigued and had to take naps every afternoon.  After 3 weeks I did have diarrhea for about a week.  I took probiotics and it was resolved.
Immediate pain not normal with flu shot.  Couldn't lift my arm up.  Have limited use of my arm and constant pain, sometimes numbness in fingers.  Both doctors I have seen agreed shot was given too high and has caused possible nerve damage or SIRVA.  Have spent money on a doctors visit, specialist (neurologist), blood work, ultrasound, and a course of steroids.  Will begin physical therapy and need future testing with the nerologist in January.
occasional cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (occasional cough) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (occasional cough). At the time of the report, COUGH (occasional cough) outcome was unknown.            NO CONCOMITANT AND TREATMENT MEDICATION WERE USED
Felt Oozy after the 3rd dose; Could not concentrate after the 3rd dose/Could not concentrate to drive safely after the 3rd dose; Could not drive after the 3rd dose/Could not concentrate to drive safely after the 3rd dose; Body pain after the 3rd dose; Fever on & off after the 3rd dose; Fever 100F for 2 days after the 3rd dose; Extra dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt Oozy after the 3rd dose), DISTURBANCE IN ATTENTION (Could not concentrate after the 3rd dose/Could not concentrate to drive safely after the 3rd dose), IMPAIRED DRIVING ABILITY (Could not drive after the 3rd dose/Could not concentrate to drive safely after the 3rd dose), MYALGIA (Body pain after the 3rd dose) and PYREXIA (Fever on & off after the 3rd dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9339901, 027620A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced PYREXIA (Fever 100F for 2 days after the 3rd dose) and EXTRA DOSE ADMINISTERED (Extra dose). On 07-Oct-2021, the patient experienced PYREXIA (Fever on & off after the 3rd dose). On 12-Oct-2021, the patient experienced DIZZINESS (Felt Oozy after the 3rd dose), DISTURBANCE IN ATTENTION (Could not concentrate after the 3rd dose/Could not concentrate to drive safely after the 3rd dose), IMPAIRED DRIVING ABILITY (Could not drive after the 3rd dose/Could not concentrate to drive safely after the 3rd dose) and MYALGIA (Body pain after the 3rd dose). The patient was treated with IBUPROFEN on 04-Oct-2021 for Fever, at an unspecified dose and frequency. On 04-Oct-2021, EXTRA DOSE ADMINISTERED (Extra dose) had resolved. On 06-Oct-2021, PYREXIA (Fever 100F for 2 days after the 3rd dose) had resolved. At the time of the report, DIZZINESS (Felt Oozy after the 3rd dose), DISTURBANCE IN ATTENTION (Could not concentrate after the 3rd dose/Could not concentrate to drive safely after the 3rd dose), IMPAIRED DRIVING ABILITY (Could not drive after the 3rd dose/Could not concentrate to drive safely after the 3rd dose) and MYALGIA (Body pain after the 3rd dose) outcome was unknown and PYREXIA (Fever on & off after the 3rd dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, Body temperature: 100f (High) Fever-100F.   No concomitant medications were provided.  Patient has reported that she has concern regarding administration of booster/third dose by the nurse though she was not a immunocompromised patient.
Experienced urticaria and symptoms similar to dermatographism.  Plan: order COVID test due to fever. Benadryl at night, Zyrtec during the day. Cortisone cream on rash. Providing Prednisone 10mg for severe urticaria. Advised to seek further medical care if feeling any swelling/tingling around mouth.
p/vax pt c/o pain on inj site; lt arm tender but not red over it; lt axillary lymphadenitis;
Became hyper in evening, could not fall to sleep, fever in middle of night, chills, and  every muscle, bone and gland hurt , severe headache, temp was 102.5. I , shortness of breath and gasping for air, cough. I tried to get out of bed to get Tylenol and staggered , going into walls and almost going down several times., later I became nauseated.. I was absolutely unable to function at all. Had the shot on wed. And I missed Thursday completely.  By Friday, I was lying in drench soaked bed and fever down to 100.5. I have never been more sick.  Day 5, I was able to begin to eat and move around a bit. I still don?t feel well but I am way better. I could not eat at all for 2 days and soup on 3
the adverse event its a error on administration. Patient comes to the clinic for his 3th dose (1rst booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine (0.25 ml administered), the administered vaccine doesn't present any previous temperature excursion or any related problems. We are waiting responses of the immunization system to see how proceed with the patient, if we need to revaccinate the patient(s) or what else we can do.
Patient reported feeling dizzy and lightheaded 10 minutes after receiving vaccine. Patients vital signs were taken BP 110/80, HR 97 and O2 sat 98%. Patient was asked to sit down and after a few minutes she reported feeling better. Patient stayed an additional 30 minutes to be monitored. Patient denied feeling dizzy or lightheaded and walked herself out of clinic.
Itching all over his body which feels like mosquito bites/This sensation has coming and going and occurs on both his arms and legs, and his back; An allergy test positive for dust, cats, and shrimp; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching all over his body which feels like mosquito bites/This sensation has coming and going and occurs on both his arms and legs, and his back) and HYPERSENSITIVITY (An allergy test positive for dust, cats, and shrimp) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 017C21A and 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced PRURITUS (Itching all over his body which feels like mosquito bites/This sensation has coming and going and occurs on both his arms and legs, and his back) and HYPERSENSITIVITY (An allergy test positive for dust, cats, and shrimp). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PRAMOCAINE HYDROCHLORIDE (CERAVE ITCH RELIEF) at an unspecified dose and frequency and CLOBETASOL PROPIONATE (CLOBETASOL E) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over his body which feels like mosquito bites/This sensation has coming and going and occurs on both his arms and legs, and his back) had not resolved and HYPERSENSITIVITY (An allergy test positive for dust, cats, and shrimp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  After booster vaccination 1 month later started itching all over the body which felt like mosquito bites. If scratches on one side of body, it starts itching on the other side in the same spot. This sensation was coming and going and occured on both arms and legs, and back. Patient went to see HCP who administered an allergy test positive for dust, cats, and shrimp. Patient had seen his HCP and a dermatologist 7 times for this issue.  He had been taking Allergy meds Hives (started taking 2 weeks ago), Allergy meds, steroid cream, itch cream mixed with oatmeal baths and a 7-day course of steroids. The steroids had provided some improvement. Symptoms were continuing up until now.
inject site was red immed p/inject; redness & swelling became inc worse & by 7AUG93 was red & swollen, fever not measured but mom guesses it was quite high during the noc; exp h/a, nausea, vomited x 1; dx cellulitis; also anorexia;
Janssen COVID-19 Woke up day after vaccine severely fatigued and exhausted. Ibuprofen helped minimally. Progression of the day symptoms got worse. By 2pm I had to leave work and go home. By this point my whole body was sore and felt like I had severe sunburn. By 7pm I had a low grade fever. Ibuprofen taken again allowed me to get to sleep. I sleep for nearly 15 hours.
[mRNA COVID-19 vaccines] use for COVID-19 under Emergency Use Authorization (EAU):[Product name] use mRNA vaccine COVID-19 under Emergency Use Authorization (EAU): RBC rouleaux formation in several patients Several patients with RBC rouleaux formation in peripheral blood smears after receiving mRNA COVID-19 vaccines. Because I have not been able to speak with a live person at FDA to ask if this occurrence is already known to the FDA, I am writing the information in this FDA website form. Please contact me as soon as possible. Thanks.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient felt lighthead and almost passed out. Sweating was profuse but no fever.
Every day since getting the 2nd shot (4 months now) I have had a headache on the back left side of my head and pain shooting down my neck into my left shoulder. It feels like a nerve.
Consumer reported that she had this first shot 2 weeks ago and she is due for second dose next week. Consumer reported that the arm pain at injection site has not stopped.; 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 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Consumer reported that she had this first shot 2 weeks ago and she is due for second dose next week. Consumer reported that the arm pain at injection site has not stopped".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Patient received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster from booster dose only presentation vial). No concomitant product use was reported.  Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. Patient received booster dose (0.25 ml). It was unknown if patient experienced any symptoms after getting the vaccine. Treatment information was not provided.
On 7/20/10 this 9 1/2 yr pt was given the BOOSTRIX vaccine which is for age 10 to 64.  No reaction/ no treatment needed.  VAERS form completed to report off label dosing.
cellulitis of rt arm;septic shock went to ER on 2OCT96;
Patient noted redness of injection site, pain, swelling. since the shot (2nd day onwards). Didn't feel good. Slowly getting better but still with pain, redness and swelling. It is 7x10 cm area erythema, inch induration.
It's called foot drop. What happened is that from the tips of my toes to the top of the arch of my foot and around to the left of my ankle went numb and I had no control of the muscles. This started two days after. So when I was walking when I moved my foot forward my toes would curl under because I had no ability to keep my foot up and ended up tripping. So that was the situation. On the the wen 29th I saw a GP. On the 30/31st I saw a Neurologist. They ran a battery of tests and established the fact that the nerve was a bit like a water hose that was folded and not allow water to flow. It wasn't a stroke or blood clot but there was some crimping of the nerve slowing the communication from my knee to the lower part of my foot. They told me I may have been the 1st case only happening in one leg.
Patient claim that when the shot was given she felt pain in the area of the shot. She received the shot on 10/19/2016 but later called today 03/14/18 to say that the shooting pain went down to her elbow and it's bothering her and wants to find out if the injection is causing this pain.
On 1/10/22 patient did not receive COVID-19 Moderna booster as requested and was injected with empty syringe in error.  Patient was contacted and booster vaccination TBD.
Presented to clinic a few hours post vaccination with induration at vaccination site/redness. Patient concerned of a more serious reaction may develop so wanted to have event documented. No history of prior reactions to vaccines.
Flatly soreness at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Flatly soreness at injection site) and FATIGUE (fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, METOPROLOL and BENAZEPRIL for an unknown indication.   On 25-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 25-Feb-2021, the patient experienced INJECTION SITE PAIN (Flatly soreness at injection site) and FATIGUE (fatigue). At the time of the report, INJECTION SITE PAIN (Flatly soreness at injection site) and FATIGUE (fatigue) outcome was unknown.            Action taken with mRNA-1273 in responsible to the events were not applicable.  No treatment information was provided