chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chilly; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chilly) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chilly). At the time of the report, CHILLS (chilly) had resolved.            No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-067699 (Patient Link).; Sender'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.
His legs are especially painful; Got real sore that night and hasn't gone away; Achy joints from the hips down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His legs are especially painful), MYALGIA (Got real sore that night and hasn't gone away) and ARTHRALGIA (Achy joints from the hips down) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (Got real sore that night and hasn't gone away) and ARTHRALGIA (Achy joints from the hips down). On an unknown date, the patient experienced PAIN IN EXTREMITY (His legs are especially painful). At the time of the report, PAIN IN EXTREMITY (His legs are especially painful), MYALGIA (Got real sore that night and hasn't gone away) and ARTHRALGIA (Achy joints from the hips down) outcome was unknown.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 11:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 11:28 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had received booster dose. It was reported that patient had received lot 066H21A past its 30 days expiry date. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Right thigh swelling within 2-4 hours after vaccines.  Swelling peaked at 2 days.  As swelling decreased, mom noted hard, dime sized lumps in thigh.  Lump has lasted for more than 6 weeks.  Swelling gone.  No treatment.  Using legs normally.
Heat; Elbow swelling; She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck; A lot of inflammation; Redness; Arm swelling/shoulder swelling; Armpit swelling; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Heat), JOINT SWELLING (Elbow swelling), HYPOKINESIA (She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck), INFLAMMATION (A lot of inflammation) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was unknown whether patient has diagnosed/tested positive for COVID-19.  It was reported acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Heat), JOINT SWELLING (Elbow swelling), HYPOKINESIA (She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck), INFLAMMATION (A lot of inflammation), ERYTHEMA (Redness), PERIPHERAL SWELLING (Arm swelling/shoulder swelling) and LYMPHADENOPATHY (Armpit swelling). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING HOT (Heat), JOINT SWELLING (Elbow swelling), HYPOKINESIA (She had to rest in bed because she couldn't move her arm/she felt like her arm was stuck), INFLAMMATION (A lot of inflammation), ERYTHEMA (Redness), PERIPHERAL SWELLING (Arm swelling/shoulder swelling) and LYMPHADENOPATHY (Armpit swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: Nothing wrong.         No concomitant medication were provided.  Patient received booster dose.  It was reported that patient had to rest in bed because patient couldn't move arm during 4 days, Patient felt like arm was stuck. Patient went to urgent care but there was nothing wrong when doctors checked x-ray studies, and was sent patient to an orthopedic doctor, who recommended physical therapy. It did not improve with Ibuprofen, and even ice did not resolved swelling. Patient visited a HCP and was told it might be due to an administration error, that vaccine was not administered intramuscularly, or maybe due to an autoimmune disease. It was unknown if patient was under any regular medications.
I started getting burning, itchy, rashes and hives throughout my body 18 days after I got my 3rd Moderna shot. It?s been a week now and I still get these every hour of everyday. They last around 10-20 minutes, then pop up on another part of my body. This did not happened when taking the first two vaccine doses (except for a small rash in the arm where the shot was administered for a few days). I?ve taken Allegra but I still get them while taking it the medication.
This is a spontaneous report from a contactable nurse practitioner through a Pfizer Hospital representative. A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced cellulitis at the injection site on an unspecified date. The event was reported as serious due to hospitalization. At hospital, the patient received unspecified IV antibiotic. The outcome of the event was unknown.
Woke up next morning with severe chills, all over muscle/joint pain and fatigue. The following day she had a huge red welt where injection was given.
Pt called in on 3/27/07 to inform of muscle pain and intermittent "Charlie horse" in left deltoid where he received her tetanus shot on 3/26/2007.
STARTED FEELING WOOZY AND BECAME UNAWARE PT PLACED ON COT AND AMMONIA INHALANT USED.  BECAME MORE ALERT AND FEELING BATTER
Tightness in chest coughing, tightness in throat, difficulty swallowing. Occurred 3hrs after vaccination. Went to ER - told to take Benadryl.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to urgent care reporting shortness of breath, cough, and chest pain. Transferred to emergency department then admitted to current facility for a management of new onset heart failure with possible etiologies of myocarditis or sarcoid. Also found to have LV thrombus, anemia, and lymphadenopathy. Patient initiated on medications to manage heart failure and anemia and anticoagulated. Patient improved and discharged to home medically stable.
Employee at facility was given MMRV instead of MMR and Varicella seperately. MMRV Proquad dose given to 20 year old employee this was her  second dose of MMR and Varicella. No vaccine reaction reported by Employee. Employee contacted CDC for further direction  on if a booster dose is needed or if MMRV doses are valid. Employee notified of the error and supervisors have been made aware of medication error.
AFTER PT WAS INJECTED WITH THE IMMUNIZATION, HE BLACKED OUT FOR A FEW SECONDS.
Hugely swollen arm at injection site that started one week after vaccine. No real symptoms appeared until one week after injection. Hot, swollen, distended, hard, painful from about the top of my shoulder down to my elbow.
vasovagal episode following vaccination. Spostaneous resolution when put in supine position. Paramedics on site. No treatment required.
This spontaneous case was reported by an other health care professional and describes the occurrence of BODY TEMPERATURE DECREASED (The patient in this report had reported a low grade temperature), DECREASED APPETITE (The patient in this report had reported a low grade temperature and poor appetite on 1MAR2023) and EXPIRED PRODUCT ADMINISTERED (HCP states that 4 patients were administered an expired dose of the Moderna COVID-19 vaccine on 27FEB2023.) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    O  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2023: Non significant live follow up received.
Patient passed away 18 days after vaccine receipt.  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient had end-stage Parkinson's dementia which was the cause of death. Not attributed to vaccination.
Information has been received from a physician concerning a 12 month old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown). The patient experienced sterile abscess. The outcome was unknown at the time of reporting. The patient's sibling developed an AE after vaccination with VARIVAX (Merck) (WAES# 0804USA03479). Additional information has been requested.
I got diagnosis with Vertigo. The doctor prescribe medication. After the completion my ear and head started to hurt. I was told I had an sinus infection.
"20mins post vaccination, Pt reported left sided 2/10 chest pain- felt like pulsing/ pressure while sitting post vaccine. Upon walking to observation area symptoms decreased and stopped by the time he was sitting in observation area.  Initial vitals BP 99/602-119/74, HR 72-75, RR 18, SpO2 97%  - vital signs stable- 128/85, HR 75, SpO2 96, RR 18. Pt given apple juice, water, graham crackers, reported complete resolution of symptoms. He was observed for 30 minutes, ambulated  without recurrence of symptoms.  Pt stable and released from the vaccination site."
Pt had a vasovagal response.  He became pale and felt as though he could vomit.  Pt was placed in supine position and given cold wash rag.  He did eat a popsicle.  Symptoms lasted about 4 minutes.  VSS throughout this time.
heart started in CHF from the first two shots; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6198), in left arm and on 30Mar2021 as dose 2, single (Lot number: ER8732) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; METHOTREXATE; VENLAFAXINE; RESTASIS.  The following information was reported: CARDIAC FAILURE CONGESTIVE (hospitalization, medically significant, life threatening) with onset Mar2021, outcome "recovering", described as "heart started in CHF from the first two shots". The event "heart started in chf from the first two shots" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: (unspecified date) normal; Computerised tomogram: (unspecified date) my lungs were filled with fluid; Magnetic resonance imaging: (unspecified date) scarring of the heart; SARS-CoV-2 test: (08Oct2021) Negative, notes: Nasal Swab; Ultrasound scan: (unspecified date) Severe congestive heart, notes: next day; (2019) my heart was normal, notes: I have no risk factors for the CHF. Therapeutic measures were taken as a result of cardiac failure congestive. Clinical course: Patient was a avid cyclist and noticed all last summer her cardio endurance was not very good- think her heart started in CHF from the first two shots.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
COVID breakthrough report. I received my 2nd booster shot on 04/06/2022 and my adverse event started on 05/14/2022  in the morning around 8:00 sore throat and a little bit of headache. I did a couple of rapid tests Wed, Thurs, Friday, Sat,  on Sat it was still positive. It feels like allergies. I have runny nose as well. On Sat I did a tele health to medical they gave me no medications but suggested me to take ibuprofen every 8 hours, Benadryl, vitamin C, salt water gargles, plenty of liquid soup's etc. I have no complains about the vaccine. It worked for me.
I had the flu like symptoms twelve hours after the shot. Four days after the shot I was extremely depressed. Four days after the shot I got vomiting and Diarrhea that lasted two days.  Four days after the shot I was extremely depressed. I do have problems with depression due to grief. This was extreme depression that started on the morning of the fifth day after the shot. I was extremely emotional and weepy and sobbing uncontrollable. It was scary and it lasted for three or four days. I was very lethargic and unmotivated. I consulted my therapist and she advised that it may be related to the vaccine. It was more extreme than I normally experience. but my mood has returned to normal.
This initial spontaneous case was received on 03-Oct-2017, from other health professional, concerning a 67-year-old, elderly, female patient. The patient's medical history and medication history were not reported. On 03-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid muscle of upper arm, batch number: 160301, expiry date: May-2017, trade name, manufacturer: not reported). It was reported that previous year's FLUVIRIN was administered to the patient (explicitly coded as expired vaccine used) and patient had not experienced any adverse effects. The reporter assessed the events as non-serious. Follow-up received on 12-Oct-2017: The reporter stated that, the vaccine was administered intramuscularly in the deltoid muscle of upper arm and reported that, the patient had not experienced any adverse effects. Non-significant case correction received with IRD 03-OCT-2017: The narrative was corrected.
Medical record prompt indicated patient WAS due for bivalent when she had already received it. Nurse gave it. When nurse looked at immunization record, it showed she had received bivalent in October. So she got an extra bivalent today.
Hot Red Swollen Hard Large 2 to 3 inches in diameter around the injection site.
Her heart beat faster, it 'went up and down' all day; This is a spontaneous report from a sponsored program. A contactable female patient of an unspecified age received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, on the day of her scheduled second dose, her heartbeat faster, it went up and down all day. The outcome was reported as unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
pt went limp 8 days p/2nd time 3 months later-unk if occurred in between during sleeping hrs; 2nd episode occurred 4 wks p/HIB vax & OPV vax;
Acute Respiratory Failure/CHF Exacerbation Inability to Walk Dis-coordination of Gait
On the same evening of my first Zoster shot, it made a small sore in the center of my chest, above the breast area. The next day the sore dried up and became a scab, which went away. From the first injection/shot on 06/27/2018, until this day, my left upper arm is still sore and hurts a lot.  Sometimes I feel like I'm about to have a heart attack, and experienced short of breath.
pt recv vax 6JAN98 & 15JAN98 pt exp a rash on neck & torso area & temp of 103;16JAN98 pt temp 101.5;
5minutes after I was giving the first shot I had a Histamine reaction. And the Histamine reaction continued every day into February when I had to get the second dose of the moderna. I continued to itch every day. In March on the 12th I gave a massage and my right are hurt severely after wards. the next day I noticed swelling in my whole right arm and could not work the next day and  Have not given a massage since. I had Lymphedema in my right arm  and both Axillary regions. My upper lymph system down the center line of my body and across my back were extremely tender to the touch and cause sever discomfort. Before I took my EMG  the Histamine stopped and It turned to nerve pain. There were days that all I could do was lay in bed and not move so that it wouldn't hurt. I still have burning nerve pain and  pins and needles in my arms legs and sometimes my face.
On 5/7/00, the pt received his 1st dose of Lymerix. One week later, on 5/14/00, he experienced shoulder joint soreness which resolved in 2-3 days. Three days later, on 5/17/00, he experienced knee joint pain. No treatment was given. The most recent information received on 6/7/00, reports the condition of the vaccinee is "almost resolved".
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28 F (-2.2 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Patient is impaired and while institutionalized earlier in the year was administered the J&J vaccine.  He later came to our facility and we administer both pfizer doses to this patient.  He requested the covid vaccine at initial injections and did not acknowledge that he had received another vaccine.  1st administered 8/13/2021 2nd dose administered 9/8/2021
This is a 98 year old male with past medical history significant for PAF on Xarelto, HTN, HLP, SSS s/p PPM, CKD, TIA, OSA, CAD, Aortic stenosis, Mital regurgitation s/p AVR/MVR, Pulmonary HTN, who presented to the ED for increased SOB over the past week, leg swelling, and s/p mechanical fall. The patient reports several fall recently. Today he fell and hit his head sustaining a laceration. He is on Xarelto. He also tested positive for Covid. He is is vaccinated with Johnson and Johnson. The patient is AAO x 3, HOH. He lives at home with his wife. Apparently he has had increased SOB, leg swelling, and his Lasix was reecntly increased by his Cardiologist. On arrival a CXR showed interstitial abnormalities, trace effusions, pulmonary edema vs pna. A BNP was elevated at 239. His CRP was 4.14. He was given 40 mg IV Lasix. A Ddimer was elevated at 375. His sats are stable on room air. A CT of the head showed no acute abnormalities
July 26th I had my normal physical exam and it looked like I had AFib. I made an appointment with my doctor the next day who said I have AFib as well. He got me scheduled for a procedure on August 10th. I received an electroshock to get my heart beat corrected and it worked. August 16th I started experiencing very short 10 second weaknesses that came and went. I checked my  blood pressure and it read 86/55 which is low so I informed my doctor about it. August 26th they gave me a prescription midodrine which is for low blood pressure. I am going to see that doctor again to get fitted for a meter that I'll wear for 10 days to check the status of my heart.