chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Pain at Injection Site-Medium, Additional Details: Patient is complaining of arm bicep pain that can extend into his shoulder and down to his forearm.  It has been happening since he got his second dose. Patient did not receive his second dose at our facility and did not have his CDC card with him.  But he said that it switched from pain in his left arm after the second dose to pain in his right arm after his booster dose.
patient fainted while standing about 4-5 minutes after receiving Flucelvax vaccine. Patient sat up immediately after fainting. Paramedics were called onto the scene, where they took the patient's vitals. Patient and family declined being taken to hospital, and went home.
Dose of Shingrix more than a year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received more than a years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient received 1st dose more than a years ago, and now wanted to receiv 2nd dose. Till the time of reporting, the patient did not receive 2nd dose, which led to  incomplete course of vaccination. No further information provided. The reporter consented to follow up.
Patient states she experienced jaw pain with the inability to open her mouth, chest pain radiating to central area of chest, and soreness in left arm.
2 days after vaccine, woke up not feeling well and had severe headache, and aching and pressure in (L) elbow that radiated down ulnar side to 4th and 5th fingers - also had weakness in triceps; progressed to radial side up to shoulder, clavicle, and back. One week into it 2nd finger became numb, lost feeling. Went to phys. ther. with a little improvement.
Onset of tinnitus in both ears as well as increased hyperacusis.   I have an appointment scheduled with an ear specialist so have not treated yet.
Slight numbness of her arms, legs, face and hands; Injection site itchy; Injection site rash; Injection site red; Injection site swollen; Injection site painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Slight numbness of her arms, legs, face and hands), INJECTION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), INJECTION SITE ERYTHEMA (Injection site red) and VACCINATION SITE SWELLING (Injection site swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Historical condition not reported.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPOAESTHESIA (Slight numbness of her arms, legs, face and hands), INJECTION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), INJECTION SITE ERYTHEMA (Injection site red), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site painful). At the time of the report, HYPOAESTHESIA (Slight numbness of her arms, legs, face and hands), INJECTION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), INJECTION SITE ERYTHEMA (Injection site red), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported Treatment drugs were not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-080174 (E2B Linked Report).
Elevated liver function tests.  Patient only very rarely uses alcohol or tylenol.  Last alcohol use was one year ago.  She does not take any unlisted supplements.  No other potential hepatotoxins identified.
1 fever,chills, muscle ache, headache  2. Enlarged lymph nodes-persistent  Treatment-acetaminophen, sumatriptan
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated subcutaneously with the first dose of live ZOSTAVAX (dose and lot# not reported) in January, 2011 and the second dose of live ZOSTAVAX in August, 2011. It was reported that while on live ZOSTAVAX, the patient experienced bumps in her right ear that developed into a painful scalding rash on the right side of her face. The outcome of events was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Hyper sensitive to mosquito bites resulting in large red welt last upwards of 2 weeks
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 at 08:30 as dose 3 (booster), single (Lot number: EP6955) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant),all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Covid-19 therapeutic measure included paxlovid with start date on 13Jul2022 and stop date on 17Jul2022. No other medications were taken within 2 weeks.  No follow-up attempts are possible. No further information is expected.
18JAN96 screaming & crying for more than 45mins;cont off & on throughout noc into next day;fever 100;tx APAP 19JAN96 infant OK @ time of  report
expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268355, 2019SA268356, 2019SA268346, 2019SA268358, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 86 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the left deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  List of documents held by sender: none.
Patient had just received Zostavax vaccine and walked away from pharmacy when she started to feel queasy and light headed and tingly all over. EMS was called to evaluate patient.
sick over a vaccine; neck and shoulder meet is sore to touch; area where neck and shoulder meet is sore to touch and swollen; Very tired; Injection site of arm is sore; Sweats; Aching if she had flu; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Aching if she had flu), MALAISE (sick over a vaccine), NECK PAIN (neck and shoulder meet is sore to touch) and SWELLING (area where neck and shoulder meet is sore to touch and swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-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) (Intramuscular) 1. On 28-Apr-2021, the patient experienced HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Aching if she had flu), NECK PAIN (neck and shoulder meet is sore to touch), SWELLING (area where neck and shoulder meet is sore to touch and swollen), FATIGUE (Very tired) and VACCINATION SITE PAIN (Injection site of arm is sore). On 29-Apr-2021, the patient experienced MALAISE (sick over a vaccine). At the time of the report, HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (Aching if she had flu), MALAISE (sick over a vaccine), NECK PAIN (neck and shoulder meet is sore to touch), SWELLING (area where neck and shoulder meet is sore to touch and swollen), FATIGUE (Very tired) and VACCINATION SITE PAIN (Injection site of arm is sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. The patient did not have any pre-existing medical condition apart from taking blood pressure medication.   Reporter did not allow further contact
Several blisters on outside of mouth, some bleeding blisters; Several blisters on outside of mouth, some bleeding blisters; throat almost closing; Layers of blister in throat, throat almost closing; A spontaneous report was received from a consumer concerning a 68 year old, female patient who received Moderna's COVID-19 vaccine and experienced events Layers of blister in throat, throat almost closing, Several blisters in throat, some bleeding blisters, Several blisters on outside of mouth.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04Mar2021, prior to the onset of event, the patient received her first of two planned doses of mRNA-1273 (Batch/Lot number: 027A21A) via Intramuscular route on Left Arm for COVID-19 infection prophylaxis  On 05 March 2021, patient had blisters in their throat, in/around mouth, and  nose. Patient stated the clusters in the throat were extremely bad for 48 hours, during the 48 hours patient states there were layers of blisters in throat so bad that the patient felt as if their throat was closing. Patient states the blister on them mouth was also excessive and bleeding, patient reports using a whole tube Abreva and almost a whole tube of generic Lysine. On 14 March 2021 the patient went to Urgent Care, patient could not open mouth due to blisters  inside of mouth. The HCP at Urgent Care was able to open the mouth  leaving the corners of the mouth bleeding on the outside. Once HCP looked in, they immediately referred patient to Throat Specialist due to concern of the patient possibly having throat cancer. Patient went to Throat Specialist; HCP confirmed the patient did not have throat cancer and was having a severe reaction to the vaccination. Since the patient could not afford treatment HCP recommended taking Allegra D 2 tablets every 12 hours  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events Layers of blister in throat, throat almost closing, Several blisters on outside of mouth, some bleeding blisters/Blister rupture, Oral mucosal blistering was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Employee states she received influenza immunization at 530am on 11-3-15 at work. She reports, on 11-6-15 430 AM, feeling more severe pain at right lower back, buttock. Treatment = massage therapist appointment at medical center.
Immunized afternoon of 12/10/05. Afternoon 12/17/05 developed arm pain, body aches worsened 12/18/05 - developed redness/warmth. Circumferential diagonal  around 2/3 of upper arm - pm of 12/19 started to have some improvement. Recommended Aleve 2 BID and heat.
Fever, chills, vomiting, diarrhea, joint pain & muscle aches
1.5-2hrs after pt received a flu shot pt developed a rash on her face, trunk and arms face began to swell. No lip or tongue swelling or breathing issues. Mom gave BENADRYL 1ml and since then swelling is down rash gone. 4hrs late no swelling or rash. - Per mom pt eats eggs daily.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: Ej1685), in left arm, on 12Jan2021 as dose 2, single (Lot number: El3249), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: Ew0217) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 04Aug2015; METOPROLOL, start date: 04Aug2014; HYDROCHLOROTHIAZIDE, start date: 04Nov2014. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (27Jul2022) negative, notes: Two days after finish treatment tested negative; (30Jul2022) positive, notes: tested positive on day 5 after treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took Paxlovid(LOT NO: Gd7762) (Pfizer ) from 20Jul2022 to 25Jul2022 For the Treatment of COVID-19, Two days after finish treatment tested negative . Day 3 Covid symptom worsened diarrhea congestion. Low grade fever and tested positive on day 5 after treatment last day. Patient had no Known allergies.; Sender's Comments: Based on the information in the case, an association between the reported non events covid 19 and Vaccination failure and the suspect product bnt162b2 cannot be ruled out
The patient received his second dose of the Pfizer COVID vaccine on 12/8/21. Around 3 weeks later he developed progressive weakness, sensory loss and bowel/bladder dysfunction. Clinically he had flaccid weakness (distal worse than proximal), sensory loss and areflexia all very suspicious for Guillain-Barre syndrome.
(R) arm swollen from chicken pox vaccine injection site down to elbow. Knot (quarter size) noted to chicken pox injection site. Fever of 102 started this am.
COVID Vaccine received on 12/30/2020 at 2:00pm on her left deltoid.  On 12/31/2020 she reports severe fatigue8/10) with LUE burning and numbness from injection site to her 4th and 5th digit on her Left hand. She took Tylenol at 0500 am with minimal relief noted. She also reports around 9:00 pm her right eye began to swell and she took 25 mg of Benadryl with some improvement noted.
patient received Covid vaccine at pharmacy L deltoid pain at time of injection, sore for two days. Started to become warm, red, hard with "knots" Arm now feeling weak, Cannot lift arm above head. pain is radiating to left shoulder and left forearm. Feeling nausea earlier today. Exam shows hard swollen demarcated area in deltoid. very tender and warm. pt with reduced left arm abduction. Patient was treated today with Augmentin to cover for potential infection and asked to use warm compresses patient had pneumococcal and influenza vaccine end of Dec without adverse side effects
1/18/2010- Patient returned to report "allergic rxn to vaccine" administered 1/13/2010. Mom reports her son developed hives over his abdomen, back and right leg on Friday night, 1/15/2010. Mom notified her PCP who instructed her to administer children's Benadryl to her son as needed. This has helped reduce the rash and relieved the itching. Mom denies any wheezing or SOB and states that her son's rash has almost completely resolved. Today the patient presents with a mild hive-like rash visible only over his right abdomen and side. Resp exam- no s/s of wheezing, Bilat lungs CTA. Plan- Advised patient to continue diphenhydramine as needed and informed mom of possible drowsiness from medication. Also advised to take loratadine 10 mg p.o. daily until hives resolve. Advised to f/u with PCP and to call 911 if s/s of anaphylaxis, including SOB, wheezing occur. Patient and mom agreed with plan and will schedule to see PCP tomorrow.
Reaction began to develop 8 days after getting vaccinated. The injection site turned red, was swollen and warm and has spread in size for a couple of days. I had a headache for a few days prior to my reaction on Wednesdays and my left underarm hurt. Additionally, swallowing after eating or drinking hurt for a couple of days. My body was weak and I felt feverish despite not having any fever. I am currently being treated by my physician as if I have Cellulitis and was prescribed antibiotics as well as instructed to take an antihistamine with the antibiotic. Today is my first day on the medication so I do not know the outcome yet.
Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 09-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
General unwell feeling; fever of 102 F; Body chills; Headache; Tired; 1 mL for dose 1; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On 23-Apr-2021, the patient experienced FEELING ABNORMAL (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache), FATIGUE (Tired) and ACCIDENTAL OVERDOSE (1 mL for dose 1). On 23-Apr-2021, ACCIDENTAL OVERDOSE (1 mL for dose 1) had resolved. On 24-Apr-2021, FEELING ABNORMAL (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-403397 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow Up received and contains no new information.
The day I got the shot, I felt lightheaded and dizzy and my equilibrium, was off. Extreme Fatigue that day and several days after. Body aches, breaking out in rashes all over, and not GI issues and pain in my stomach. I am still dealing with all of this now. I went home and rested and texted my doctor, but I didn't see her in person until the 23rd. I am still dealing with all of this, I am a COVID long hauler. I am scheduled a barium swallow on the 14th and Abdominal CT on the 15th.
The pt returned to the clinic the same day of vax with wheals on her face. No other complaints. Was referred to another facility. Requested the Mom to call the clinic to report.
Approx. 2 mins. after receiving immunizations, pt. had syncope episode, vital signs and pt.  monitored for15 mins.
Should have received the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Should have received the full dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 046B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Should have received the full dose). On 10-Nov-2021, ACCIDENTAL UNDERDOSE (Should have received the full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
feeling side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling side effects) in a patient of an unknown age and gender 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 VACCINATION COMPLICATION (feeling side effects). At the time of the report, VACCINATION COMPLICATION (feeling side effects) outcome was unknown.         Reportedly, Consent for follow up was accepted.  Concomitant product use was not provided.  Treatment product information was not provided.