chrisvoncsefalvay/vaers-outcomes huggingface dataset:
irritation on arm; very itchy at site of injection; really red at site of injection; swollen at site of injection; a little sore at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (irritation on arm), VACCINATION SITE PRURITUS (very itchy at site of injection), VACCINATION SITE ERYTHEMA (really red at site of injection), VACCINATION SITE SWELLING (swollen at site of injection) and VACCINATION SITE PAIN (a little sore at site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history information was provided).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (irritation on arm), VACCINATION SITE PRURITUS (very itchy at site of injection), VACCINATION SITE ERYTHEMA (really red at site of injection), VACCINATION SITE SWELLING (swollen at site of injection) and VACCINATION SITE PAIN (a little sore at site of injection). At the time of the report, SKIN IRRITATION (irritation on arm), VACCINATION SITE PRURITUS (very itchy at site of injection), VACCINATION SITE ERYTHEMA (really red at site of injection), VACCINATION SITE SWELLING (swollen at site of injection) and VACCINATION SITE PAIN (a little sore at site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
My whole arm hurts it doesn't feel like it's getting better; My fingers are like I got to be say numb and hard to move, like I move it and it just feels so unnatural; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, expiration date: unknown), dose 2 via an unspecified route of administration on an unspecified date in Jul2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine, the patient received first dose BNT162B2, dose 1 on an unspecified date as single for COVID-19 immunisation. On an unspecified date in Jul2021 the patient's whole arm hurted, it didn't feel like it's getting better and fingers were like patient got to be say numb and hard to move, like if patient move it and it just felt so unnatural. Outcome of the event patient's whole arm hurted, it didn't felt like it's getting better was not resolved and patient's fingers were like, patient got to be say numb and hard to move, like if patient move it and it just felt so unnatural was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came in 4/25/22, stating she developed an itchy rash inside the arm of her elbows and the back of her knees within 2 days of receiving her second booster dose (4th dose) of Moderna vaccine on 4/18/22.
1. local reaction 5 inches erythema and induration/pain lasted 2 weeks despite clindamycin and Benadryl 2. severe headache with school absence since immunization > 2 months, hospitalized 2/5-2/9 and 3/27/12. increased intracranial pressure
Patient is a healthy 15 year old male presenting with chest pain in the setting of recent SARS-CoV2 vaccination. He was in his usual state of health until he received the second dose of the Pfizer/BNT SARS-CoV2 vaccination on Thursday 6/10. Shortly after and into the following day, he developed fatigue, chills, and a headache, which resolved within 24 hours. However, early this morning at around 2am, he awoke with sharp central chest pain associated with some shortness of breath, radiating to his left, prompting him to present to the ED.  Initially presented to Hospital ED. Vitals stable. Labs notable for troponin 0.07 and d-dimer 1.48. EKG with sinus rhythm, ST elevation in inferior leads. Given ibuprofen 600mg and contacted Cardiology, who recommended transfer to another ED for echocardiogram and further evaluation.  Here in the ED, vital stable, exam non-focal. Labs notable for troponin 0.13 and CRP 3.0; CBC, chem 10, LFTs, BNP, all within normal limits. CXR normal. Echo done which showed normal function (prelim read). Seen by ID who recommended standard workup for vaccine-induced myocarditis. He was admitted to the floor in stable condition.  Hospital Course: Due to rising troponin during hospital day 1 (peak 0.23), patient was treated with IVIG 2 g/kg (6/14) and methylprednisone 30 mg BID (6/14 - 6/15). On 6/15 a cardiac MRI was obtained that showed a small area of late gadolinium enhancement of the LV with normal function.  Troponin was trended every 12 hours and had decreased to 0.11 on 6/15 AM. He was transitioned to oral prednisone 30 mg BID to complete a total steroid course of 5 days (6/14 - 6/18). During admission he was found to be EBV PCR positive with all other viral testing including EBV serologies pending. It is still thought this is likely due to post-vaccine inflammation and not viral myocarditis but serologies should be followed up as outpatient.   By time of discharge, patient was well-appearing, vitals stable, demonstrating good PO intake. Prescriptions sent to preferred pharmacy. Follow up with cardiology. Discharge instructions and return precautions reviewed with patient and parent, who expressed good understanding and agreement with plan.   Reasons for new, changed, and discontinued medications:  Prednisone for myocarditis  Famotidine for stomach protection while on prednisone  Discharged home with follow up tests scheduled for 6/17/21.
Within hours of vaccination, patient with headache, muscle tenderness in thigh, soreness in legs, temperature 99.5. Chills, overall feeling poor.
Patient developed a warm, erythematous patch 9 10 cm x 10 1/2cm) on right upper extremity (deltoid), where he received IPV and DTAP.  No fevers/pain/itchiness.  Prescribed Tylenol and Benadryl and Motrin.
Sore arm for more than 24 hours, developed low grade fever (99.4) about 8 hours after injection, fever still going after 16 hours. Using ibuprofen for fever and arm pain.
On 2/1/04 noticed red rash with intense itching that began on left arm/ shoulder at site of injection and progressed to chest, both breasts, and nipples. Since vaccination, only other s/s was a "normal headache" for a couple of days.
Large red area from inj site down inside of arm, red warm to touch. Treated for cellulitis vs med reaction.
patient lying on exam table. While lying on exam table she fainted and arms flailed up. Nurse called patients name and she immediatley opened her eyes and was aware of surroundings. Nurse took pulse, B/P, and resp. All her vitals were within normal limits. Patient had fainted with the first HPV vaccination.
pt recvd vax & 18 hrs later exp a rash, chills, fever (trunk), & sweats;
BUD date excursion, vaccine given after the BUD. BUD date was 4-7-23, and was administered 4-22-23.
PER PATIENT: SHE HAD FEVER, HEADACHE, VERY  TIRED  ON 12/26/2021 AT 4:30PM  SHE WAS HOME NOT FEELING GOOD. ON 01/04/2022 SHE WENT TO THE HOSPITAL AND AT THE DR. SAID SHE HAS FLUID IN HEART.  SHE WAS IN THE HOSPITAL UNTIL 01/09/2022 MORNING.  SHE SAID SHE DID CALL HER DR. TO LET DR. KNOW WHAT TOOK PLACE ON 01/04/2022,
Hospitalized 01/10/2022-still currently admitted; COVID-19 positive 01/09/2022; fully vaccinated plus booster  CHIEF COMPLAINT: COVID  Assessment/Plan    ASSESSMENT / PLAN:  Acute hypoxemic resp failure secondary to COVID-19 pneumonia -positive PCR 1/9/2022 -decadron 6mg qdaily -dvt px: SQ lovenox as below -current o2 req: wean as able  Atrial flutter with RVR Reported history of paroxysmal atrial fibrillation, (remote, post-op) -CHADS-vasc score: at least 6 -Echo ordered  -rate control: received IV and PO diltiazem at OHS. Start toprol XL, titrate prn -TSH ordered ordered -anticoagulation: high risk of falls, will defer systemic therapeutic anticoagulation after discussion with wife, discussed risks/benefits of oac and stroke risk. Continue lovenox at prophylactic doses  Generalized weakness -primary reason for presentation to hospital per wife -monitor oral intake -PT/OT to see 01/13/2022 notes: ASSESSMENT / PLAN: Acute hypoxemic resp failure secondary to COVID-19 pneumonia/ CHF -CXR 1/12: Slightly worsened chest. Follow-up recommended. -positive PCR 1/9/2022 -decadron 1/10-12, Solumedrol 40 mg bid 1/12- -Lovenox 40 mg sq daily  -currently HFNC FiO2 95-- >85% -- > 50-- >40 l/min -CRP 72-- >150.9 -D-dimer 440-- > 560  01/19/2022 notes: ASSESSMENT / PLAN: Acute hypoxemic resp failure secondary to COVID-19 pneumonia/ CHF -CXR 1/17: No significant interval change in diffuse bilateral interstitial opacities and patchy left basilar airspace consolidation. -positive PCR 1/9/2022 -decadron 1/10-12, Solumedrol 40 mg bid 1/12- -Lovenox 40 mg sq daily  -still on HFNC FiO2 95-- >90%, 55 l/min  -CRP 72-- >150.9-- >73.9 -D-dimer 440-- > 560-- >490 -Cefepim/Dox day # 3/5
SkinRash Rash was on knees, thighs & pelvis Narrative: Pt experienced as rash on thighs, knees and pelvis on same day vaccine received. Treated with topical Benadryl cream and topical hydrocortisone cream.
for roughly 40 hours I experienced a fever as high as 102.9, shaking, chills, body aches, headache, right kidney pain
Narrative:  Patient admitted to the hospital 2/7/21 following episode of nausea/vomiting, elevated blood pressure, bradycardia, elevated lactate, fever, and leukocytosis. Patient treated with intravenous fluids and started on intravenous antibiotics. CT of the abdomen on 2/8/21 identifies mild acute diverticulitis.
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were provided. Patient didn't reported any adverse events. The vials didn't undergo any temperature excursion. The vaccine was kept in the refrigerator on 21/09/2021.
cold sweats; sore arm; Soaking Wet; cold chills; felt real tired for 2 days and a half; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (Soaking Wet), CHILLS (cold chills) and FATIGUE (felt real tired for 2 days and a half) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLD SWEAT (cold sweats), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (Soaking Wet), CHILLS (cold chills), FATIGUE (felt real tired for 2 days and a half) and MYALGIA (myalgia). At the time of the report, COLD SWEAT (cold sweats), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (Soaking Wet), CHILLS (cold chills) and MYALGIA (myalgia) outcome was unknown and FATIGUE (felt real tired for 2 days and a half) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received on 04-NOV-2021 and contains no new information. Updated event soaking wet and outcome of an event fatigue from unknown to recovered/resolved from initial document.
Redness around administration site, tenderness and pain in arm, armpit and radiating into breast.
Pt with migraine history who had HA for past few days prior to vaccine had onset of severe HA behind eyes beginning 4.5 hours after vaccination. Then work up with high fever and myalgias about 16 hours after vaccination. Went to ER. Treated with IF fluid and Motrin. Fever now 37.3. CDC and SMA-12 basically WNL. Will be discharged to home today. Temp now 37.3 after Motrin.
Patient describes after receiving Adacel and day later became very sick, projectile vomiting, temperature. Went to ER 2 days after and was admitted to ICU. Discharged 3 days later. Diagnosis is also Pneumonia. Information from 60 day follow-up report states: Vaccinee back to work no residual problems.
Some soreness in the arm at the injection site; A spontaneous report was received from a physician concerning a, 49-year-old, female consumer who received Moderna's COVID-19 vaccine and developed soreness in the arm at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, after she received the vaccine, the patient experienced soreness in the arm at the injection site. The soreness on the pain scale of 6 out of 10 severity. No treatment information was reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events, soreness in the arm at the injection site, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
03/01/2023  I woke up with an erratic heart beat and a pulse of 150. I called an ambulance and was taken to the Hospital. I was on cardiac monitoring and did a chest Xray. I was given Flecainide.
Blue spots on chest and legs skin; This is a spontaneous report from a contactable consumer reporting for the father. A 91-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Mar2021, as single dose, for COVID-19 immunisation and apixaban (ELIQUIS), via an unspecified route of administration, from an unspecified date and ongoing, at unspecified posology, as anticoagulant therapy. The patient's medical history and concomitant medications were not reported. The patient experienced blue spots on chest and legs skin (non-serious) on 18Mar2021 with outcome of recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
During the night chills, arm extremely sore at injection sight  On 3/6 nausea chills fever headache body aches, could not even get out of bed, could barely sip water to take Tylenol for fever, could not eat, just out of it, I feel like I wasn?t aware the whole day  3/7 a little better but still headache body aches fever moved to couch but that?s it  3/8 a little better still low grade fever and 101 in evening still no energy, left underarm very swollen  Could not go back to work until 3/10 and it was hard, Moving slowly no energy 3/12 left arm pain going up into neck  3/13 still do not feel like myself, everything feels weighed down even in my voice
Headache; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): UNT-2022-000931.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; treprostinil sodium (TREPROSTINIL SODIUM), first regimen since 09Jul2021 (Lot number: 2102084, Expiration Date: 31Mar2023) at 4x/day (unk, 4x/day [18-72 µg (3-12 breaths), qid, inhalation]) and second regimen (Lot number: 2102100, Expiration Date: 31Mar2023) for pulmonary arterial hypertension. Relevant medical history included: "Pulmonary arterial hypertension" (ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single; MANUFACTURER UNKNOWN), for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "Headache"; PAIN (non-serious), outcome "not recovered", described as "body aches". The action taken for treprostinil sodium was unknown.  Additional information: patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 09Jul2021 for primary pulmonary arterial hypertension. The current dose was reported as 18-72 µg (3-12 breaths), four times a day. On an unreported date, the patient experienced the events of headaches (headache) and body aches (pain). On 12Jan2022, it was reported that the patient had unspecified side effects from the COVID-19 booster. On 18Jan2022, it was reported that she had continued headaches and body aches. Action taken with IH Tyvaso was not reported for the events of headache and pain. At the time of reporting, the outcome of headache and pain was not resolved. The reporter did not provide causality for the events of headache and pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
relapse pericarditis unresponsive to customary treatment of Indocen 50mg 4x daily
Slight fever and shakiness about 12 hours later. Then pt. took an ALEVE and the symptoms subsided.
I received my second dose on Tuesday, 2/2 @ 3;30 PM, with L arm tingling starting 30 minutes after my dose. Tingling, numbness, and coldness later expanded to the entire left side of my body, which persisted for more than 8 hours. It felt like the left side of my body was somewhat disassociated from the other side.
Muscle aches and bone aches worse first thing in AM/when sitting for awhile or at night when in bed.
This patient received Varicella immunization on 03/14/01. One other sibling received vaccination on 03/14/01, 2 other siblings received immunization on 03/15/01. The mother broke out on 03/24/01. 2 other adults in the home broke out. The patient had 50 + lesions, 1 - 2 tactile temp.
Patient was 12yrs and 2 days old. Received pediatric dose for 1st dose in series.
Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good); She has been experiencing a lot of anxiety; She was not feeling well; Her husband states that she looked pale; She was sweaty; She was hot and cold; very sore arm, like she was punched in the arm; 7 hours later, she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included ETONOGESTREL (NEXPLANON) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good)) (seriousness criterion medically significant), ANXIETY (She has been experiencing a lot of anxiety), MALAISE (She was not feeling well), PALLOR (Her husband states that she looked pale), HYPERHIDROSIS (She was sweaty), FEELING OF BODY TEMPERATURE CHANGE (She was hot and cold), PAIN IN EXTREMITY (very sore arm, like she was punched in the arm) and PYREXIA (7 hours later, she had a fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 17-Jun-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Within 2.5 minutes of receiving her shot at the pharmacy, she literally passed out (She could not speak, Hearing was not good)), ANXIETY (She has been experiencing a lot of anxiety), MALAISE (She was not feeling well), PALLOR (Her husband states that she looked pale), HYPERHIDROSIS (She was sweaty), FEELING OF BODY TEMPERATURE CHANGE (She was hot and cold), PAIN IN EXTREMITY (very sore arm, like she was punched in the arm) and PYREXIA (7 hours later, she had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company Comment:  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.; Sender'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.
My left arm was so painful I took 2 oxycodone. The first did nothing, the second relieved the pain. The next day, 4/24/18 I had chills so badly I wore four layers of clothing: turtle neck, silk/cotton sweater, yak sweater, vest.
Patient received vaccine. Approximately 10 minutes later, fainted. She fell out of her chair in the waiting area and hit her head on the ground. Ambulance was called and she was transported to hospital.
It was a little red and sore the first. It was more red and swollen the next day  so I went to the doctor. The doctor said it was cellulitis and I was treated with antibiotics.