chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt some soreness after 15 minutes/pain is really unbearable, that her arm is very sore; bump at injection site; A spontaneous report was received from a 50-year old, female patient, who received Moderna's COVID-19 vaccine and experienced bump at injection site and felt some soreness after 15 minutes/pain is really unbearable, that her arm is very sore.   The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 27 DEC 2020 at 11:30, the patient received her first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 27 DEC 2020, the patient received a COVID-19 injection in her right shoulder. She felt some soreness after 15 minutes, but was not uncomfortable. On 28 DEC 2020, the patient reported that the pain was really unbearable and that her arm was really sore. There was no redness or swelling at the time, but she said there was a bump at the injection site. Treatment for the events included paracetamol wiping the injection site with alcohol, and rinsing it with hot water.   Action taken with mRNA-1273 in response to the events was not reported.   The events bump at injection site and felt some soreness after 15 minutes/pain is really unbearable, that her harm is very sore were considered not resolved.   The reporter did not provide an assessment for the events bump at injection site and felt some soreness after 15 minutes/pain is really unbearable, that her arm is very sore.; Reporter's Comments: This case concerns 50-year old, female patient, who experienced non-serious , expected event of pain and arm and non-serious unexpected event of injection site mass 15 minutes after the first dose of mRNA-1273 vaccine.. The event was assessed as possibly related due to temporal association.
ADMINISTRATION ERROR: Patient was given incorrect vaccine for 2nd dose. Patient was given Pfizer instead of Moderna.
Severe heartburn; Migraine; Vomiting; Elevated heart rate; Feeling clammy; This is a spontaneous report from a contactable consumer or other non- healthcare professional (Reporter's daughter). A female patient of an unspecified age (Age: 30; units: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that, daughter, speech therapist, aged 30, received Pfizer vaccine this past Friday (05Feb2021). She had severe heartburn, migraine, vomiting starting around 6 am, elevated heart rate, and feeling clammy on unknown date in Feb2021. The reporter enquired should the patient need to visit emergency department. The patient underwent lab tests and procedures which included heart rate: elevated on an unknown date in Feb2021. The outcome of the events was unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Her left arm was stiff & sore; her left arm was stiff & sore; Felt really bad chills; Headachy; Tired; sleepy headed/Fell asleep for a couple of hours; vomiting/vomited once; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Her left arm was stiff & sore), SOMNOLENCE (sleepy headed/Fell asleep for a couple of hours), PAIN IN EXTREMITY (her left arm was stiff & sore), VOMITING (vomiting/vomited once) and CHILLS (Felt really bad chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced VOMITING (vomiting/vomited once). On 09-Aug-2021, the patient experienced SOMNOLENCE (sleepy headed/Fell asleep for a couple of hours), HEADACHE (Headachy) and FATIGUE (Tired). On 16-Aug-2021, the patient experienced CHILLS (Felt really bad chills). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Her left arm was stiff & sore) and PAIN IN EXTREMITY (her left arm was stiff & sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (Her left arm was stiff & sore), SOMNOLENCE (sleepy headed/Fell asleep for a couple of hours), PAIN IN EXTREMITY (her left arm was stiff & sore), VOMITING (vomiting/vomited once), HEADACHE (Headachy) and FATIGUE (Tired) outcome was unknown and CHILLS (Felt really bad chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Patient presented at pharmacy 12/8/12 at 7 pm. She had visible redness that radiated up and down her left arm above and below her injection site. She stated the area was painful and she had had a headache since the inj. was given.
This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 03Mar2021 (at the age of 62-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date of Mar2021, patient experienced headache, fever, chills, itching all over and face was swelling. Patient took couple of Tylenol as treatment for headache. No lab work was done. The outcome of all the events was unknown.mNo follow-up attempts are possible. No further information is expected.
Dizziness, hypertension, hyperglycemia, difficulty walking, dysphasia, fever, shortness of breath, dyspnea, fatigue, confusion, headache (not relieved by Naproxen, Acetaminophen, or Percocet). Lasted from 0630 to 2200 on Monday, November 1st, 2021.
, Additional Details: Patient jerked arm a little when shot was administered about 2:15pm 5/31/2022. Patient called back at 6:30pm 5/31/2022 to say her arm was really sore. She took tylenol and said she was using ice packs on her arm.
Diagnosed with bursitis; My arm was super swollen; My arm / couldn't move it to get dress or comb my hair; Pain is back on shoulder; Have stiff neck; Feel glands are swollen; I haven't gone for second doses; This case was reported by a consumer via  interactive digital media and described the occurrence of bursitis in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced bursitis, swelling arm, mobility decreased, shoulder pain, stiff neck, swollen glands and incomplete course of vaccination. On an unknown date, the outcome of the bursitis, swelling arm, mobility decreased, shoulder pain, stiff neck and swollen glands were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the bursitis, swelling arm, mobility decreased, shoulder pain, stiff neck and swollen glands to be related to Shingles vaccine.  Additional details were reported as follows: The age group was not reported but was captured as adult as per vaccine indication. The age at the vaccination was not reported. The age at the vaccination was not applicable for the 2nd dose of Shingles vaccine. The patient received dose of shingles and arm was super swollen and couldn't move it to get dress or comb his/her hair, went to ER was diagnosed with bursitis. Doctor referred the patient to orthopedics, got a shot it lasted about one month. Pain was back on shoulder, had stiff neck and felt glands were swollen. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Rash back on the  neck; L arm pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash back on the  neck) and PAIN IN EXTREMITY (L arm pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included DIHYDRALAZINE SULFATE, HYDROCHLOROTHIAZIDE, RESERPINE, TRIAMTERENE (NO 0) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced RASH (Rash back on the  neck) and PAIN IN EXTREMITY (L arm pain). At the time of the report, RASH (Rash back on the  neck) and PAIN IN EXTREMITY (L arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Event occurred after 2nd vaccine. First vaccine was on 2/22/21 and the second one on 3/15/21. Pt tested positive for COVID-19 on  11/29/21.
PATIENT EXPERIENCED VOMITING SHORTLY (WITHIN 30 MINUTES)AFTER RECEIVING TWO IMMUNIZATIONS (AFLURIA PF 16-17, PNEUMOVAX 23) AND IT LASTED FOR 6 HOURS. PATIENT ALSO DEVELOPED A FEVER AND A RASH ( ON ARMS, TRUNK, HIPS ANFD THIGHS) OVER THE NEXT 2 DAYS. PATIENT REPORTED HAVING RECEIVED THE FLU VACCINE BEFORE WITHOUT ANY PROBLEMS.
Per father:  Child woke up in the AM before school and noticed bleeding from mouth.  Had a loose tooth for several days but bleeding appeared more than usual. Over course of day in school bruising and petechiae were noticed.  Took child to Urgent Care where platelet count was 2000.  Transferred to Hospital for admission and treatment.
Patient experience sharp jabbing pain in left lower chest below the nipple line after vaccination. Patient reported that pain was coming and going
patient stated his leg started hurting the night/evening after getting vaccine. does not normally have pain in that knee. patient took some tylenol to get thru the night and some more this morning so that he could come to work. patient was advised if it continued or got worse to contact his MD or go to the ER. was advised to stay off of it as much as possible and do heating pad to see if it would help
Elevated BP, tachycardia, nausea, vomiting, diarrhea, headache, fatigue
After receiving both shots, patient complained of chest, arm, and leg pain, and felt shaky.  We called 911.  Pharmacist stayed with patient and gave patient water to drink.  Patient stated she started to feel better as time passed.  Patient left with EMT to be taken to hospital.
swelling & redness on lt arm about a little larger than dollar size, hot to touch;f/u red rash @ site & red-getting better;
28nov89 pt vax hepta B. pt ex pain at inject site,  28dec89 pt vax 2nd hepta B. pt ex prolonged pain and tenderness at inject site which lasted 2 days to 1 week. pt recovered.
edges seem to be irregular, a little lighter; warm; redness appeared around the site, getting larger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (edges seem to be irregular, a little lighter), VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (redness appeared around the site, getting larger) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MULTIVITAMIN & MINERAL for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (redness appeared around the site, getting larger). On 26-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (edges seem to be irregular, a little lighter). On 25-Feb-2021, VACCINATION SITE ERYTHEMA (redness appeared around the site, getting larger) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (edges seem to be irregular, a little lighter) and VACCINATION SITE WARMTH (warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking 2x high blood pressure medication and cholesterol medication. Patient Treatment information was not provided.
Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 26-Apr-2022; patients were administered the expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered the expired vaccine) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 26-Apr-2022) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered the expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 26-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered the expired vaccine) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 26-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was not receiving any concomitant medication. It was unknown whether patient ever had COVID positive  test or diagnosis. It was reported that no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The pharmacist reported that 4 of their Moderna vials expired on 01 Apr 2022 and on 21 Apr 2022 through 26 Apr 2022, 5 patients were administered the expired vaccine. The vial was initially stored in the refrigerator on 20 Apr 2022 at 6:44PM. The vial did not undergo any temperature excursions. The patient received first and second dose of vaccination from unknown manufacturer. On 26 Apr 2022 patient received booster dose. The event did not cause patient to seek medical care. The patient had no allergies. No acute and chronic medical illnesses at the time of vaccination. No treatment drug was reported.   This case was linked to MOD-2022-555058, MOD-2022-555063, MOD-2022-555064, MOD-2022-555065 (Patient Link).
Fever 101.8-102.3 with MOTRIN. Measle rash over torso and back chicken pox rash to extremities and face, diarrhea.
Bicep area is a little pink, pinkish red; little big, quite the size of, like a 1 dollar coin; Fever/100.3 degree fever/99.2; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 23Mar2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer second shot on Tuesday. On 24Mar2021, the patient had fever last 2 days. Two days ago on 24Mar2021, the patient had a 100.3 degree fever, the patient took Tylenol and that went away and yesterday morning on 25Mar2021 at 7:00 am, the patient had 99.2 and took Tylenol that went away. The patient had not had a fever since. But last night on an unspecified date, the patient noticed it wasn't where the shot was but like just below the shot, like in the muscle, the bicep area was a little pink, pinkish red and it was little big, quite the size of, like a 1 dollar coin. Last night, on an unspecified date, all with a red pinkish spot on arm, not where the shot was but that morning the patient looked to see if it was better, but it was a little bigger. So it was still there a little pink. The patient didn't know if the patient should be concerned about that. The outcome of the event erythema was not resolved. The outcome of the event pyrexia was resolved on an unspecified date in 2021.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Back pain; Radiating leg pain; This case was reported by a nurse via call center representative and described the occurrence of back pain in a 58-year-old male patient who received Flu Seasonal QIV (FluLaval Tetra 2019-2020 season) (batch number 97S5T, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 9th October 2019, 1 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced back pain and leg pain. On an unknown date, the outcome of the back pain and leg pain were recovering/resolving.   It was unknown if the reporter considered the back pain and leg pain to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The reporter stated that the patient after vaccination woke up with low back pain with radiating leg pain. The reporter consented to follow up. This case has been linked with cases US2019186959, US2019186960, US2019187944, reported by the same reporter.
Moderna Booster Vaccine expired 11/9/21, prior to administration. No adverse effects noted with pt.
Received vaccine 1/26/22.  no adverse symptoms developed  suffered cardiac arrest with Ventricular fibrillation as presenting arrhythmia.  pulseless non breather  unable to be defibrillated or revived.  no history of cardiac disease or know prodromal symptoms
After receiving vaccine, injection area turned black with swelling/Throbbing headache after 4/5 days
This spontaneous report was received from a nurse regarding to unspecified number of patients of unknown age and gender. Patient demographics were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # L018351, expiry date 11-AUG-2017 9 (dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccine was stored at cumulative minimum temperature of -40.3 degree Fahrenheit for 193 hours. There was no previous temperature excursion performed. This is one of several reports received from same reporter. Additional information has been requested.
Lump in arm 2/3 size of golf ball at injection site 3 weeks after injection. Pt. states it is non-tender.
Patient had symptoms start on Monday 12/12/22. She had a fever & started ibuprofen. She has soreness in her arm at injection site. There is a small red mark/bruise at site. She is reporting sores on her mouth as well.
Child went back to classroom and teacher reported child fell asleep at desk. EMS notified. Child appeared drowsy and could answer simple questions. BP 90/60. P-63. O2 Sat 98%. Blood Sugar 101. R-22. Pt transported to hospital via ambulance.
Stated that she felt like she had flu; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9810), dose 1 via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunisation. Medical history included blocked subclavian artery and arteriosclerosis, both were diagnosed seven years ago and are ongoing. The concomitants medication was not provided. About 36 hours after vaccination, the patient experienced all side effects except fever and nausea, felt like she had flu and severe allergic reaction. The patient ended up going to bed and taking fluids for two days. The patient had flu for a few days and slept for a few days. She was back to normal. She is scheduled for a second shot in couple of weeks. She wanted to know the likelihood is great for this to happen again so that she can mentally prepare. The patient stated that the majority of the side effects in her age group did increase after the second dose. She stated one should not get the Pfizer-BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of this vaccine. The reporter assessed the event as non-serious. The outcome of the events was unknown.
1) Headaches - > 3 yrs. These have become daily occurrences that are of insidious onset, any time/location and can last several hrs. These headaches are occipital, 4/10, radiating slightly to neck, no provocative measures, palliated w/OTC Excedrin. No aura, no N/V, no photo/+phonophobia, no N/T/W. No previous H/A hx. 2) Dizziness - @ 4 yrs. These Sx are intermittent from once a month to twice per week. They can last seconds to 1.5 days. PT feels room spinning, disoriented, can't focus, +N/-V, no syncopal episodes. Sx Tx'd with Meclizine. 3) "Heart Murmur" - PT was told he had palpitations. A holter monitor was performed, which was apparently benign and PT was given reassurance. These Sx occur at once/month, last secs to mins. No CP, SOB, lightheaded, diaphoretic. 4) Fatigue x @ 3 yrs. This Sx has been increasing. They are intermittent, least weekly occurring any time throughout the day. PT sleeps well. He does admit to snoring, but not bad enough to wake himself. +cold intolerance which occurs when not wearing ear protection. 10 lbs wt gain last 1.5 yrs no constipation. Diet average, +exercise. 5) SOB - X ___. PT feels when going to sleep, either upright or lying feels winded and has to take 7-8 breaths to get back to normal breathing. No Sx w/exercise. No LE edema. No tobacco, no asthma, hx. Rash R>L eyelids X 1.5 yrs. Rash occurs just below eyelid. +pruritic. Uncertain of past Tx. PT has been a German OTC cream with so-so relief. No hx eczema/atopic dermatitis. 7) Short-term memory loss. PT states he has to write everything down - i.e. apts, conversations. No problems w/long-term memory. No previous prob's. 8) Chronic sinusitis since 98. PT states he is chronically stuffy, no ocular Sx, +post-nasal drainage, no sneezing, slight cough, no F/C. No hx AR. Tx'd w/Benadryl w/out significant relief. Complete. PE to include HEENT, neck, heart, lungs, abdomen, and neurologic exam notable only for slight nasal mucosa bogginess w/scant clear rhinorrhea. Current Tx: we are monitoring headaches as they seem to be tension-type headaches and at last visit improving. Monitoring vertigo as we work on his sinuses to see if related. Monitoring palpitations given already had w/u - consider beta blocker if persists and negative SOB w/u. For fatigue check labs, CBC, Met Panel, TSH, EBV, CMV, ANA improving diet and increasing regular cardiovascular exercise. SOB likely d/t sinuses and post-nasal drainage - further w/u pending results of Tx. Dermatitis consistent w/seb derm or eczematous - we are doing a trial of hydrocortisone 1% to AA BID/PRN. Subjective short-term memory loss - monitoring w/nl PE - may need neuro eval if persist/worsen. Chronic sinusitis - currently starting Allegra, Deconsal II, and Biaxin.