chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The spot where the vaccine is given is red; Case reference number US-BN-2022-002008 is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV22-1106) on 22-Aug-2022 and concerns a male patient of unknown age.    The patient's medical history and concomitant medication details were not provided.   On 18-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided) at an unknown dose, route or site of administration for unknown indication.    On an unspecified date, unknown amount of time after the first dose, the patient's spot where the vaccine was given became red.  At the time of this report, the outcome of the event 'injection site redness' was unknown.  The reporter assessed the event as non-serious and possibly related to Jynneos vaccine.  Additional information received from Bavarian Nordic on 23-Aug-2022 included local BN case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with first dose of Jynneos, at an unknown dose, route or site of administration for unknown indication. Unknown time after the first dose, the patient's spot where the vaccine was given became red. Injection site erythema is listed and expected according to RA and RA for Jynneos. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Injection site erythema is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with first dose of Jynneos, at an unknown dose, route or site of administration for unknown indication. Unknown time after the first dose, the patient's spot where the vaccine was given became red. Injection site erythema is listed and expected according to RA and RA for Jynneos. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Injection site erythema is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is non-serious.
On Wednesday the 9th he woke up a slightly elevated temperature of 103F and a headache. Later that day he woke up with a higher temperature. My son was on a playdate that we later found out that the child tested positive for flu. I had given him a home COVID-19 test that came back negative. He had a cough, said his throat felt like it was closing up. Took him to the doctor they tested him for both COVID-19 and influenza. The test for COVID-19 came back negative, the test for flu came back positive. They gave us medication and sent us He is getting better.
shakes and tremors that are getting worse by the day; fever; felt okay not great; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt okay not great), TREMOR (shakes and tremors that are getting worse by the day) and PYREXIA (fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included MS (Had inflammation but it got better after a few months) in 2004. Concurrent medical conditions included Gluten sensitivity, Sulfonamide allergy, Protein allergy and Depression. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (felt okay not great). On 24-Apr-2021, the patient experienced TREMOR (shakes and tremors that are getting worse by the day). 24-Apr-2021, the patient experienced PYREXIA (fever). The patient was treated with CLONAZEPAM at a dose of 0.25 mg. At the time of the report, FEELING ABNORMAL (felt okay not great), TREMOR (shakes and tremors that are getting worse by the day) and PYREXIA (fever) had resolved.            Treatment medication included CBD with THC3% and trying to eat but nothing is helping.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Additional document received and contains no new information On 20-Jul-2021: Patient demographics were added.Allergies includes Sulpha,Gluten,Caesin were added.Medical condition includes MS was added.Dose 1 information was provided.Concomitant products include Welbutrin was added.Events outcome was updated from unknown to recovered.
1-30-08 developed malaise and chills.  Subsequently developed fever and rash on trunk few hours later.  Evaluated 1-31-08.  Will treat symptomatically.
Patient came back to pharmacy with a red patch on her upper inner arm on Friday 10/11/13 and inquired as to if it was a vaccine reaction; patch was not at site of injection.  Patient denied itching or pain, but area was warm to the touch.  Patient was advised to call MD to determine if further assessment was needed.
Catatonic Reaction to DPT later was diagnosed with Kawasaki Disease 4 1/2 years later at age 5. No other DPTs given
Father of patient informed of inadvertent administration of wrong dose of vaccine. Father grateful for the call and reassured that steps are being taken to prevent this from happening again. Discussed sx's to watch for and dosing of 2nd shot.
f/u redness and swelling to left upper arm x 4 days s/p pneumococcal vaccination 28NOV08. Reports onset of symptoms one day following vaccination with fevers and chills at onset. Reports mild stiff neck and general myalgias currently. Currently treating symptoms with motrin. Diagnosis-CELLULITIS: Area of erythema and level of discomfort increased from yesterday will initiate treatment with septra DS borders marked. Pt advised to limit activity with left arm f/u 24 hrs. Dec 19 08, f/u of cellulitis to left shoulder. Reports redness and swelling resolved after completing course of septra last week. Reports pain improved but never completely resolved now having increased pain and mild redness for past few days. Reports subjective fevers. ELLULITIS: Pt with cellulitis to left deltoid s/p pneumococcal vaccination originally improved with septra now having increased symptoms will tx with double strength septra and rifampin.
Information was received from a physician regarding an unspecified patient (unknown age and gender). No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The physician reported that an expired dose of PNEUMOVAX 23 (lot # L018503, expiration date 16-MAR-2017) was administered to the unspecified patient on 07-APR-2017 (dosage and route of administration not provided). No temperature excursion was reported. No adverse effects reported. No further information to report. Additional information has been requested.
Developed tightness base of head/neck then lost vision (L) eye with kaleidoscope appearance of vision lasting 1 hr. Spoke with ophthalmologist on phone. States most likely cause was vaccination.
PAIN AT THE INJECTION; SWELLING AT THE INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included glaucoma, and concurrent conditions included osteoporosis, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, once total, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced pain at the injection. On 12-MAR-2021, the subject experienced swelling at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling at the injection site, and had not recovered from pain at the injection. This report was non-serious.
Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA. The manufacture provided 0.5mL per vial instead of 0.25mL/ vial.
myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.            No concomitant medications reported. No treatment reported.  Company Comment: This is a Spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced the expected, serious (medically significant), and AESI of Myocarditis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-546789 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced the expected, serious (medically significant), and AESI of Myocarditis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Can't taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Can't taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Can't taste). At the time of the report, AGEUSIA (Can't taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. The treatment information was not provided.   Reporter did not allow further contact
11x10cm area of induration and erythema at left upper arm at site of DTap and IPV Benadryl PRN.
Pt states she woke up with painful blisters on her buttocks on 7-13-07. Saw PCP. Culture taken.
This spontaneous report received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age. On an unknown dates the patients were vaccinated with a improperly stored dose of VAQTA (route, dose, strength, lot # and expiration date was not provided). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Severe chills and body aches with moderate fever (100 +/-). Symptoms lasted for 48 hrs.
1) Fever & seizure-8PM-07/21/04 at home. 10 minutes. Brought to ER. Febrile seizure-Rocephin IM. 2) Office follow up-07/22/04-no fever. Zithromax, Valium. 3) 07/22/04: Flu, fever, seen at hospital, no medication. 4) 07/23/04-no fever. Acute OM. 5) 07/25/04-5:00AM-fever, seen at hospital; 7:20PM-seizure, seen at hospital
Sluggish/Does not felt like doing anything except lay on couch; Real tired; Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering; Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering; Had jitters; Could not sleep; This spontaneous case was reported by a patient and describes the occurrence of FEELING JITTERY (Had jitters), INSOMNIA (Could not sleep), SLUGGISHNESS (Sluggish/Does not felt like doing anything except lay on couch), PYREXIA (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) and FATIGUE (Real tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A, 939905, 014M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Demerol), Sulfonamide allergy (Sulfa), Hay fever and Blood pressure high. Concomitant products included FISH OIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2022, the patient experienced FEELING JITTERY (Had jitters), INSOMNIA (Could not sleep), PYREXIA (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) and CHILLS (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering). On 21-Jul-2022, the patient experienced SLUGGISHNESS (Sluggish/Does not felt like doing anything except lay on couch) and FATIGUE (Real tired). The patient was treated with TICAGRELOR (BRILINTA) at an unspecified dose and frequency. At the time of the report, FEELING JITTERY (Had jitters), INSOMNIA (Could not sleep), SLUGGISHNESS (Sluggish/Does not felt like doing anything except lay on couch), FATIGUE (Real tired) and CHILLS (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) outcome was unknown and PYREXIA (Had a temperature of 99.7 degrees Fahrenheit/Was freezing, could not get warm/got hot versus shivering) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, Body temperature: 99.7 99.7 degrees Fahrenheit and 98.7 98.7 degrees Fahrenheit.         Concomitant medications information included: Blood pressure medicines (unspecified) and over the counter fish oil. The patient not had COVID test or diagnosis.   This case was linked to MOD-2022-611794 (Patient Link).
Patient reported that the site where the shingles vaccination was given appeared red, erythematous, hard to the touch. The site was swollen.
Strong shivers along with high fever and pain in legs until current day (04/14). Also shortness of breath
22may90 pt vax hepta B. 23may90 pt ex soreness and pain in neck, chest, and under her breasts for 20 min.; achiness in wrists, ankles, elbow, and leg joints and freq. soft stools. pt to er w/ joint/muscle achiness, slight n/ and tender thrt
nausea; decreased appetite; receiving the booster shot; tiredness; headache; muscle pain; chills; fever; This is a spontaneous report from a non-contactable consumer or other non health care professional. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. On an unspecified date approximately twelve hours after receiving the booster shot for pfizer the patient experience tiredness headache muscle pain chills fever nausea and decreased appetite. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bilateral Eyelid edema, self-improvement within 4 hours of onset, continue monitoring, avoidance of ibuprofen.
After second shot I had substantial muscle tightness extending up my left arm and into my neck; It actually affected my swallowing a bit. (This was not a sore throat.); This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 05Mar2021 at 09:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (afib), aortic valve replacement (AVR), high cholesterol. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO), rosuvastatin calcium (CRESTOR), vitamin d nos (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN) for unknown indication. The patient had allergy to IV dye (contrast dye). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the arm left on 12Feb2021 at 08:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation.  On 05Mar2021 at 05:00, after second shot, the patient had substantial muscle tightness extending up his left arm and into neck. It actually affected his swallowing a bit. (This was not a sore throat.) It has subsided quite a bit but the tightness lingers on the left side of his neck. He had no fever or other effects. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event It actually affected swallowing a bit. (This was not a sore throat.) and substantial muscle tightness were recovered with sequelae on an unknown date in 2021.
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) for prophylaxis. Concomitant products included doxazosin and antihypertensives nos (High Blood Pressure Medication (Nos)). On 4th June 2018, the patient received SHINGRIX .5 ml. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, nausea, chills and loss of energy. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the general body pain was unknown and the outcome of the nausea, chills and loss of energy were not recovered/not resolved. The reporter considered the general body pain, nausea, chills and loss of energy to be related to SHINGRIX. Additional details were provided as follows: The patient took HIGH BLOOD PRESSURE MEDICATION as concomitant drug. The patient received Shingrix vaccine on left arm on 4th June 2018 at 14: 58. The pharmacist reported that the patient experienced side effects after receiving the SHINGRIX vaccine. The patient had body aches, loss of energy, nausea with chills. The pharmacist advised the patient to take regular Tylenol and she would follow-up with the patient on the day of reporting. The pharmacist spoke with the patient on the day of reporting and the patient was feeling better.  The patient took Motrin on the last night instead of Tylenol.
For Days. 1-3 post injection, I had headaches, chills (no fever) fatigue, aching joints).  Subsequent to that I began to develop muscle weakness in my legs and very fatigued and had a loss of cognitive functioning.   This lasted for approximately 14 days.  .
heavy bleeding clot like; heavy bleeding clot like; extreme low back pain; nausea; sweating; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at 33 years old, not pregnant) as unknown, single for covid-19 immunisation. Medical history included allergies: Penicillin, Have not had menstrual cycle in years (Have not had menstrual cycle in years as taking continuous birth control.) all from an unknown date. Concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIN-D); ethinylestradiol, levonorgestrel (LESSINA); sertraline hydrochloride (ZOLOFT). No other vaccine in four weeks. On 15Apr2021, patient experienced heavy bleeding clot like, extreme low back pain, nausea, and sweating. Has been occuring for 3 weeks. Went to doc to rule out serious issues. Everything came back negative.The outcome of the events was not recovered. No treatment for the adverse events. No covid prior vaccination.Not covid tested post vaccination.  Information about lot/batch number has been requested.
Patient received moderna covid shot on 1/6/22.  He had previously had covid in September of 2021 and had recovered well.  He also received J&J covid shot on 10/12/21 with no known adverse reaction.  Pt presented to emergency room on the AM of 1/14/22 with complaints of chest pain and SOB of onset earlier that day.  CTA chest was done on 1/14/22 which revealed extensive bilateral pulmonary embolisms.  He had interventional radiology thrombectomy procedure on 1/15/22 with good effect on clot removal.  Also had venous duplex ultrasound which showed acute occlusive deep vein thrombosis present in the left popliteal, posterior tibial, and peroneal veins on 1/15/22.  Pt reported improvement in breathing, was started on eliquis and transitioned off heparin drip and was discharged on 1/17/22.  Per chart review and discussion with patient he had not had recent immobility, previous thromboembolisms, or any clinical evidence of malignancy.  This was an unprovoked DVT/PE.
Information regarding PREVNAR 13 vaccine was received from a nurse regarding several patients who experienced redness and swelling subsequent to receiving PREVNAR 13. The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced redness and swelling subsequent to receiving PREVNAR 13 (swelling) (erythema). Outcome was unknown. No additional information was available at the time of this report.