chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itch at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up received and contains no new information.
Erythema nodosum, assymetric joint swelling and shortness of breath noted. Medical care sought March 29th. CT and CXR demonstrated bilateral mediastinal lymphadenopathy. Abdominal lymphadenopathy also demonstrated on CT. Biopsy  demonstrated sarcoidosis (lymph node biopsy)  Responded well to 6 months of tapered prednisone  Felt to be a Lofgrens syndrome triggered by vaccination administration  (Would love guidance on how to proceed with vaccination moving forward)
12/4 Elevated temp 101 F., cold, shaking 12/5 no temp and feeling better
Blotchy redness, slight swelling, and firmness and sensitivity to touch at injection site. Started about a week after the injection.
"Severe body aches, entire body, migraine level headache, foot cramps, toes locked-up, chills, and fatigue.
pt recvd vax 1PM leg red & sore started about 6PM to cry high pitched, cried til 930PM; wouldn't eat OK next day; MD ordered ped DT:
This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown ages and gender. On an unspecified date the multiple unspecified patients were administered VAQTA (Lot# unspecified) (dose, frequency, route and location unspecified) that was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects were reported. Follow up information has been received from the registered nurse via telephone call indicating that she did nothave the information available at that time and she might be able to fax it early the following week. This is one of several received from the registered nurse. The nurse provided lot numbers, expiration dates and a list of patient identifiers representing patients given affected vaccine from 16-APR-2014 through 23-APR-2014, 11 (eleven) patients were given affected VAQTA (lot # J011629, expiration date: 20-SEP-2015). The 11 patients included: MARRS# 1404USA014966, MARRS# 1405USA013228, MARRS# 1405USA013233, MARRS# 1405USA013234, MARRS# 1405USA013235, MARRS# 1405USA013236, MARRS# 1405USA013232, MARRS# 1405USA013231, MARRS# 1405USA013237, MARRS# USA013229, MARRS# 1405USA013230. Additional information is not expected.
Body and muscle pain Headache  Chills  Nausea Elevated heart rate  Upset stomach
3/11 woke up with severe chills, joint pain and headache 3/25 experienced numbness down my entire left side, had a severe headache and difficulty walking
pt recv vax;exp hurting & burning sensation; 2jul red & warm, firm; MD advised cold compresses & apap; pt ok now;
symptoms are " like its something inside his legs and its eating away at it" , no fever no overall body aches. Symptoms started 2 days after vaccine. Has appt. on 3/8 with PCP. He has not taken any medication, states it upsets his stomach.
HCP called to report Administered supported TE for PEDVAX HIB and VAXNEUVANCE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 31-OCT-2023, the patient was vaccinated with a improperly stored dose (of product storage error) of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot  number X002099 with expiration date 14-JUN-2025; with a dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) lot number X005583 with expiration date 10-DEC-2024 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature of 33.9 degrees Fahrenheit for 42 hours and 5 minutes. There was no previous temperature excursion.
Patient developed large red circle around the area of the Flublock injection on right deltoid/arm - approximately 4 inches across .  patient developed blotches on skin of  neck/chest - mostly on right side of body and some redness of whole face.  Patientwas given benadryl 25mg oral tablet x 1 dose immediately and about 20 - 30 minutes later- she complained  of upset stomach, vomited and then felt better shortly afterward.  Patient was observed until 4:15pm when she stated she had to go home- patient was advised by physician to take another dose of 25 mg of benadryl when arrived home along with 40 mg of pepcid .  A medrol dose pack was sent to the pharmacy for patient to get Just in case she needs it/ if symptoms do not subside with first recommendations.   9-29-21 followed up with patient, no further Gi symptoms , rash or flushing. patient does still have some soreness in right arm  today 9-29-21
I actually started to notice an adverse event with the 1st dose (Lot EL0140 IMLA). On 1/6/2021 I notice a knot swelling in my right  arm pit. The inflammation traveled like a rope like formation to my elbow. It was red, inflamed and painful to the touch. I contacted my PCP and thought I had a blood clot. I was sent for an ultrasound to check for a DVT on 1/6/2021 and it was negative for a blood clot. I started taking aspirin and a week later, started on an antibiotic Doxycycline. It has improved but not completed resolved. I went ahead and proceeded to get my 2nd dose (EL3246 IM RA). I had no symptoms or adverse event with my 2nd dose.
pyrexia; Shortness of Breath; oxygen saturation went down of 86%; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), OXYGEN SATURATION DECREASED (oxygen saturation went down of 86%) and PYREXIA (pyrexia) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Hypertension. Concomitant products included OXYGEN for COPD, AMLODIPINE and LISINOPRIL for Hypertension arterial.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Shortness of Breath) and OXYGEN SATURATION DECREASED (oxygen saturation went down of 86%). On an unknown date, the patient experienced PYREXIA (pyrexia). The patient was treated with OXYGEN on 17-Apr-2021 for Oxygen saturation decreased, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of Breath), OXYGEN SATURATION DECREASED (oxygen saturation went down of 86%) and PYREXIA (pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Oxygen saturation: 86% (Low) 86%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.   This case was linked to-MOD-2021-122565 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Followup received included date of birth and pyrexia as event.; 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. MOD-2021-122565:Wife case
Redness, shining skin due to swelling. The swelling started out normal than continued till about the size of a grapefruit. It covered a large area of my arm, almost to my shoulder. I used ibuprofen and ice bags all night. Was a localized event.
Pain in right deltoid, swelling, inflammation, rash, warmth down to elbow.
11/18/2021:  Severe chills to the core, causing shivering for about 20 minutes in afternoon; 11/19-21:  Dull headache, and body aches (muscular) for next few days;  11/19-24:  Upper respiratory drainage with slight sore throat and cough;   11/20:  Received Covid-19 test at pharmacy; 11/23:  Test results received:  NEGATIVE;  11/22 - present (11/28/2021):   Very thick, sticky clear mucus in lungs with productive coughs with frequency of coughing and mucus improving.  Recovery anticipated. Treatment was taking 2 aspirins per day for 2-days on 11/19-20.
L arm pain and bruise lasting 3 weeks. No swelling. Still has pain in arm at injection site whenever she moves it.
Fever; A spontaneous report was received from a healthcare professional concerning a 86-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 010M20A and expiration date 12/31/2021) unknown route in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, fever.She provided consent to follow up with her.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, fever was unknown.
The WORST Tension headaches. None stop. 60% Strong,  40% Dull but 100% constant.    It's been a month+.  I don't have any other major symptoms other than slightly worn out from bit doing regular activity in the fear of making the headache worse.  The second shot also triggered shingles.  Had them before and received a vaccine for it 7-8 years ago but that wasn't fun.    This is it. Tension headaches are not acknowledged anywhere in writeups; but when I started digging, there are communities with this as a serious side affect. Please address this.  I can't keep pumping myself with 4 advils every 6 hours.
3 WEEKS AFTER 1ST MODERNA VACCINATION: SORE THROAT, HEADACHE, NASAL DRAINAGE/CONGESTION, FATIGUE, ALTERED TASTE AND SMELL, LOW GRADE FEVER FOR 36 HOURS AFTER THE 2ND MODERNA VACCINATION:  CHILLS, SWEATS, ACHES, LOW GRADE FEVER 9 DAYS AFTER 2ND MODERNA VACCINATION: ONSET HIVES, "PRICKLING AND BURNING" RASH, STARTED PERIPHERALLY AT HANDS AND FEET AND MOVED TO TORSO.  INTRA ORAL LESIONS WITH SLOUGHING MUCOSA.  FEVER UP TO 102F, CHILLS, FATIGUE AND MUSCLE ACHES ABOVE SYMPTOMS LASTED 5 DAYS.  WENT TO ER ON DAY 15 AFTER 2ND VACCINE AND WAS GIVE PREDNISONE 2 WEEKS AFTER 2ND VACCINE CONTINUES TO HAVE NIGHT SWEATS.  RASH APPEARS MORE PETECHIAL AND IS RESOLVING, STILL ON PREDNISONE.
Severe back neck pain (whole spine) in the weeks following pain started spreading through out the whole back and into shoulders. Then a couple weeks later arm and leg soreness. A few more weeks go by and severe headaches are occurring.  She started physical therapy on 11/12/13 1x per week she is taking 2 200 mg ibuprofen 2 to 3 times per day and 1 1000 iu of vitamin D.  Pain is not getting any better only worse.
After the vaccine I felt very hot and immediately sweated a lot, I told the paramedics and they told me it was my nerves; I drove and after 5 minutes half of my body fell asleep and my neck was stiff, I was very scared; upon arrival home report my condition to the CDC; and they called at 4:00PM, but I had no energy, I had no energy and since it was Saturday I called my doctor and he told me to wait until Monday or to go to the emergency room. I fell asleep at 6:30 PM, I didn't move, I didn't react, and I woke up around 10:00PM and my body felt asleep and very cold and I vomited and had a fever, bone pain, my body trembled and a lot of pain. I went to bed again and for 5 days I couldn't get up, I had diarrhea and abdominal pain. I had back pain. The doctor told me it was the vaccine, symptoms similar to COVID-19. He gave me TYLENOL and told me to try to relax. I couldn't get tested for COVID-19 because I had just had the vaccine.
Janssen COVID-19 Vaccine EUA Left arm soreness (including extreme finger and elbow joint pain) all first 36+ hours Low grade fever after 24 hours (lasting about 3 hours) Full body aches on and off for first 36 hours, worst at 24 hour mark Nausea at 36 hour mark  Treatment: rest, hydration, some Tylenol at 24 hour mark, pepto for nausea at 36 hour mark
This spontaneous report was received from a nurse prescriber and refers to a pediatric patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 13-AUG-2018, the patient was vaccinated with a first dose of VAQTA (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On 14-NOV-2018, the patient received a second dose of VAQTA lot # R013857, expiration date 22-APR-2019 (dose and route of administration were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No adverse effects were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1811USA010882.
100.00 fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2020AMR210049).   On 16th October 2020, the patient received the 2nd dose of Shingrix. On 19th October 2020, 3 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received 2nd Shingrix vaccination on Thursday and developed 100.00 fever on Monday. No side effects other than local soreness with first vaccination and until time of reporting with second.  The reporter asked if developing a fever three days post vaccination was an expected side effect.?; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR210049:Same patient, 2nd dose
Pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep disorder. Concomitant products included PRENATAL MULTIVITAMIN + DHA from November 2021 to an unknown date for Pregnancy, MELATONIN from January 2020 to an unknown date for Sleep disorder.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 30-Oct-2021. On 22-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2021: Follow-up information received on 16-Jun-2021 contains updated information of patient demographics, contact information, current condition, pregnancy details, first dose details and concomitant medications.
sharp shooting pain in bicep that goes down her arm into her hand on the arm. Pain comes and goes; sharp shooting pain in bicep that goes down her arm into her hand on the arm. Pain comes and goes; mild chills; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982) second dose in left arm via an unspecified route of administration on 29Jan2021 at 04:15 PM at single dose for COVID-19 immunization. Medical history included hypertension, diabetes type 2, migraine, ADHD/Attention deficit hyperactivity disorder. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metformin, losartan, amlodipine, nabumetone. The patient previously took lamotrigine (LAMICTAL) and had allergies; also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) first dose at the age of 33 years in left arm on 08Jan2021 at 04:15 PM for COVID-19 immunization. On 30Jan2021 10:30 am, the patient experienced sharp shooting pain in bicep that goes down her arm into her hand on the arm. Pain comes and goes. No pain at injection site. Experiencing mild chills. No treatment was received for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not recovered.
COVID-19; 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 73-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high BP" (unspecified if ongoing); "stents" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; CLOPIDOGREL; BABY ASPIRIN; METOPROLOL; TADALAFIL, stop date: 13Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with anti viral Paxlovid from 13Jul2022 to 18Jul2022 for the treatment of COVID 19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
EXPIRED VACCINE USED; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03BB2UA, 04212OA and O22M2OA) for COVID-19 vaccination.     The patient's past medical history included Hematuria (Hematuria, unspecified), Carotid artery stenosis (Carotid artery stenasis, right mid), Hyperlipidemia, Dizziness, Visual disturbance, Dyspepsia (Dyspepsia), Osteoarthritis, Carpal tunnel syndrome (Carpal tunnel! syndrome; left), Shoulder pain (Shoulder pain, right), Sciatica, Urinary incontinence (Urinary incontinence, urgency), Knee pain (Knee pain, right medial), UTI, Diverticulitis, Mitral regurgitation, Carotid bruit, Cervical radiculopathy, Constipation, Keratosis (Keratosis, actinic), Osteopenia, Hip discomfort (HIP PAIN, RIGHT, CHRONIC), Osteoporosis (SCREEN, OSTEOPOROSIS), Skin cancer (SCREEN SKIN CANCER), Shingles, Dyspnea, Vitamin D (VITAMIN D, DEFICINECY), Colon cancer, Breast cancer, Heart disease, unspecified, Diabetes, High cholesterol, Ovarian cancer and Lung cancer. Previously administered products included for Product used for unknown indication: Influenza Vaccine on 02-Oct-2018, Influenza vaccine on 14-Sep-2021, Influenza vaccine on 18-Sep-2021 and Influenza vaccine on 21-Oct-2021. Past adverse reactions to the above products included No adverse event with Influenza Vaccine, Influenza vaccine, Influenza vaccine and Influenza vaccine. Concomitant products included CALCIUM CARBONATE, CHOLECALCIFEROL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and AMLODIPINE BESYLATE for an unknown indication, CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM), CYANOCOBALAMIN, LOSARTAN POTASSIUM, SIMVASTATIN, CELECOXIB and SOLIFENACIN SUCCINATE.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: impaired (abnormal) Glucose - Impaired. On an unknown date, C-reactive protein: high (High) C-reactive protein - elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient past medical history includes - Lab exam, Observation and evaluation for suspected exposure to other biological  product, physical exam routine and cervical strain   Pre operative examination   Treatment information not provided.
Her face,eyes and lips were swollen; Her face,eyes and lips were swollen; Her face,eyes and lips were swollen; Fever; Chills; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 19-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (at the age of 19-year-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Patient was taking medications for birth control. On 15Apr2021, the patient experienced her face, eyes and lips were swollen, fever, chills. Clinical course: the next morning she had a severe allergic reactions and her face was swollen, her eyes was swollen, and her lips were swollen. She did not have any trouble breathing. The paediatrician recommended to get guidance in regards to getting the second dose. Therapeutic measures were taken as a result of fever, chills included advil. The outcome of the events was her face was swollen, her eyes was swollen, and her lips were swollen was recovered on 15Apr2021, fever and chills was recovered on an unspecified date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt had immediate body aches, fatigue, but 3 days after started getting rash on right arm which was worsening. She called a helpline at local hospital who advised her to be seen in ER. She was then diagnosed with "Covid arm". She was not treated with any medications and was told to monitor. She came to me, her PCP for followup later that day with a large wheal covering her entire right upper arm and joint pains.