chrisvoncsefalvay/vaers-outcomes huggingface dataset:
myopericarditis; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 28Apr2021 at 13:00 (at 21 years old, no pregnant, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. No other medical history and no known allergies. The patient not had Covid prior vaccination. The patient previous took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 07Apr2021 at 13:00 (at 21 years old, no pregnant, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's concomitant medications were not reported. The patient was ended up in the hospital with myopericarditis on 02May2021 at 06:45AM. Patient was a health 21 years old who had no heart problems before. Also had no heart problems in the family. The event was resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalized 1 day. Prescribed colchicine and metoprolol for event. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on 02May2021. The outcome of the event was recovering.  Information about the Lot/batch number has been requested.
Exactly 7 days After first shot, a huge, hard, hot to the touch welt appeared around the injection site. It was ridged and resembled cellulitis. Dr. prescribed antibiotics. Had second shot and same reaction, only it happened 2 days after the shot.
Started with a rash on his right upper arm, spread on Friday, went to pediatrician on Saturday who sent us to ED.  Shingles in the C6 dermatome.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was unspecified. On an unknown date, the unspecified number of patients were vaccinated with MMR II (dose, frequency and route were unspecified). On an unknown date, the patients experienced arthritis pain. The pharmacist reported that she does not know if this was an exacerbation of pre-existing arthritis or a new diagnosis of arthritis. It was also reported that these cases were so many years ago. The outcome of arthritis pain was unknown. The relatedness of arthritis pain with MMR II, live was not reported. No product quality complaint (PQC) was reported for MMR II. Additional information has been requested.
Soreness at injection site Supraclavicular lymphadenopathy on side of injection; Soreness at injection site Supraclavicular lymphadenopathy on side of injection; This is a spontaneous report from a non-contactable other health care professional (patient). A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration (arm left) second dose on 08Jan2021 17:15 at single dose for COVID-19 immunisation. The patient's medical history was not reported.  The patient's concomitant medications included venlafaxine and levothyroxine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 for covid-19 immunisation (first dose, left arm, lot number EH9899). On 10Jan2021, the patient experienced Soreness at injection site, Supraclavicular lymphadenopathy on side of injection. No treatment was given. The outcome of the events was unknown. Facility where the most recent COVID-19 vaccine was administered was in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 04-SEP-2012.. Lot # was reported as 0709AE, expiration date: 04-JAN-2012. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), 04.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour 10 minutes." This is one of several reports received from the same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008612, 1209USA008613, 1209USA008614 Additional information has been requested.
Woke all in sweat with two fingers numb on the right hand, all back in burning sensation, stood up from bed and went to the toilet, almost faded, was about to pass out for 40 min, had very strong nausea, started to feel burning sensation all over the body and tingling, especially on the face, head and back. Went to the emergency room, left leg felt numb, was having on and off nausea and burning sensation, felt dizzy and confused, around 4 pm in the ER started to feel burning tingling sensation very strong on chest and neck. My blood pressure was high for me. Doctors performed blood and urine tests, told me it looks like I have a virus, but overall said analysis are fine, sent me home at 12.00 AM next day. When I came home I started to have nausea and burning sensation again all over my body, couldn't sleep till 6 a.m, still have the same symptoms.
High fever-102 Nausea, throwing up Severe headache Muscle, joint ache No appetite, lethargic Swollen arm with red circle around Site Swollen glands Light sensitive
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted while waiting 15 mintues after vaccination.  Responded immediately upon shoulder touch and vocal prompting.  Indicated history of fainting post vaccination.  911 was called, paramedics deemed no further follow-up was needed.  patient left 15 minutes later showing no symptoms
hoarseness, weakness, fever, muscle aches  10/30/09 ICD9 codes and  Medical records received for DOS 9/23.  ED visit DX: acute hypoxia, sever dyspnea, sinus tachycardia, hypokalemia, renal insufficiency, elevated D-dimer, r/o PE.  Patient developed weakness, nausea, vomiting x1, chills and joint pain s/p flu vaccine. Ibuprofen resolved. Later developed SOB and took nitro tab. BP dropped. 911 activated.  Presented w/pulse 119, BP 114/55. O2 sat 94% on room air and dropped to high 80's. Increased to 90 and 96 on O2. Accucheck 163.  Hypokalemia, renal insufficiency. Doppler results- thrombus L greater saphenous vein.   ICD9 Codes: 276.51, 458.9, 278.8, 401.9, 272.4, 530.81, 250.0, 799.02, 427.89, 593.9.  Medical records and ICD9 codes  received for DOS 10/24/09. Final DX: Acute sinusitis, Acute upper respiratory infection. Nasal discharge, yellow and blood tinged, cough x2 days. Teeth pain. Pain over cheek and forehead. Sinusitis.  D/C to home. Supportive care. ICD9 Codes: 461.9, 465.9.
Moderate soreness in left arm; Mild body aches; Slight head congestion; Overall feeling of fatigue; This is a spontaneous report from a contactable consumer. A 22-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EL3247) on 10Feb2021 11:15 unspecified route of administration in the right arm, both as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EL3247) on 20Jan2021 11:15 (at the age of 22-years-old) unspecified route of administration in the right arm for COVID-19 immunization.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced moderate soreness in left arm, mild body aches, slight head congestion, overall feeling of fatigue all on 11Feb2021 09:30. The patient was not tested COVID-19 post vaccination It was reported that the patient did not receive treatment for the adverse event. The outcome of the events recovering.
MMR #1 and Varivax #1 received on 05/06/2003. Fever and rash developed 05/14-05/15/03. Eval. in office 05/15/2003. Rash is papular discrete, non confluent, , blanchable. Rash on trunk, face, groin, not on hands/feet.
red hot patch; big red square right underneath injection site; tired; nauseous; feel pain in my left side of chest / pain in chest sharp short pain; dizzy; Burning; Aching; throbbing; pain shoulder to fingers; under arm lymph note was swollen; arm was severally sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain), DIZZINESS (dizzy), BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching) and MYALGIA (throbbing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced MYALGIA (arm was severally sore). On 20-Aug-2021, the patient experienced BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching), MYALGIA (throbbing), LYMPHADENOPATHY (under arm lymph note was swollen) and ARTHRALGIA (pain shoulder to fingers). On 23-Aug-2021, the patient experienced CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain). 23-Aug-2021, the patient experienced DIZZINESS (dizzy), NAUSEA (nauseous) and FATIGUE (tired). On 24-Aug-2021, the patient experienced INJECTION SITE ERYTHEMA (big red square right underneath injection site). On 25-Aug-2021, the patient experienced RASH (red hot patch). At the time of the report, CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain), RASH (red hot patch) and MYALGIA (arm was severally sore) outcome was unknown and DIZZINESS (dizzy), BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching), MYALGIA (throbbing), NAUSEA (nauseous), LYMPHADENOPATHY (under arm lymph note was swollen), INJECTION SITE ERYTHEMA (big red square right underneath injection site), FATIGUE (tired) and ARTHRALGIA (pain shoulder to fingers) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient was extremely healthy and great cardio shape.  Patient states that she took birth control pills.  No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up received and updated concomitant medication.
This spontaneous prospective pregnancy report was received from a registered nurse refers to currently a 23 years old female patient of unknown age. She did not have past medical history and pregnancies. On 27-MAR-2017, the patient was vaccinated with third dose of GARDASIL 9 from lot # M041990 (dose, route and anatomical location not reported), for prophylaxis (also indicated GARDASIL). Concomitant medication included PRENATAL. On 29-MAR-2017, the patient had an ultrasound showed the patient was pregnant, singleton. The last menstrual period (LMP) and estimated date of delivery (EDD) were reported to be 16-JAN-2017 and 23-OCT-2017, respectively. Outcome of pregnancy was pending. Additional information has been requested.
Product Complaint; cellulitis at the site; last evening had pain and cellulitis at the site; This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA64AZ, expiry date 31st October 2021) for prophylaxis. This case was associated with a product complaint.   On 4th March 2020, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On 4th March 2020, less than a day after receiving Bexsero, the patient experienced injection site cellulitis and injection site pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site cellulitis and injection site pain were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the injection site cellulitis and injection site pain to be related to Bexsero.  Additional details were provided as follows: A day before reporting, the patient received a dose of Bexsero on left deltoid. At the evening, the patent experienced pain and cellulitis at the site. The patient returned to office this morning, with worsening of the events. The health care professional reviewed prescribing information of the events reported and the post marketing information. No product to return and no replacement at the time of reporting. The patient required to visit emergency room. The reporter consented to follow up. This case has been linked with case US2020040989, reported by the same reporter.
C/o chest pain 9d following vaccination. Discovered at that time to be pregnant. Currently d/w pericarditis.
This spontaneous report was received from a nurse practitioner via company representative refers to unspecified number patients of unknown age and gender. The nurse reported that the physician's office had unspecified number of patients who were administered GARDASIL (lot # H021861, expiration date: 09-OCT-2015) route, dose and location unspecified on an unspecified date and experienced syncope. The physician inquired "is there increased risk of syncope associated with GARDASIL lot # H021861". At the time of report, the outcome of syncope was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
After about 14 hours pain in left arm felt like a vice squeezing my arm.  Back pain, arm, neck and shoulder pain,  muscle pain and muscle cramps in legs, lethargy, mild fever under 100, headache.  About 24 hrs after the shot moving was painful, my muscles felt like I was ran over.  This got better on 4/21 /21 when the muscle pain reduced to muscle aching, especially arms, neck and shoulders were very achy.  Still very lethargic and wanted to sleep. Woke up on 4/22/21 and muscle aches were much better,  I just feel tired and worn out but going to try to go to work tonight since most symptoms have gone away.
Patient in usual state of great health on leave from work for 2 wks decided to have her small pox vaccination and GARDASIL vaccine May 12, 2008 with a good take of small pox after 15 jabs and had no fever no chills no sweats no red or swelling around the site no sore lymphnodes but felt perhaps tight. She did not chest pain on May 16 (4 days post) sharp pain upper mid sternum lasting all night after beginning 2000 and going to the next day approx 12 hours nonradiating approx 9/10 causing some shortness of breath and difficulty sleeping worse with rolling over and deep breath but not worse with palpation or meals and made better by nothing except time neither sitting up nor eating anything made it better. She did not take anything for it no ASA no TYLENOL she did note some associated symptoms of breath with this hurting and is able to distinguish that this shortness of breath was more due to not wanting to cause pain rather than a suffocating sensation. She had no palpitations no dizziness no syncope no tachy or brady sensations. She has had CHF symptoms no PND no orthopnea no edema no nocuturia change from usual nightly no cough on wgt gain. Symptoms: Chest pain, sub-sternal.
Severe pain and swelling in arm, followed by pain and tingling on left side of breast, followed by swollen left lymph node, tingling on left side of face, and some type of allergic reaction/sore on left side of forehead near left eye.
Tetanus Toxoid Reduced Diphtheria toxoid and Acellular pertussis vaccine TDAP Boostrix given to a 22 month old.
Weakness; Nausea; Muscle pain; Fever (she is pretty hot); This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), NAUSEA (Nausea), MYALGIA (Muscle pain) and PYREXIA (Fever (she is pretty hot)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included OMEPRAZOLE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced ASTHENIA (Weakness), NAUSEA (Nausea), MYALGIA (Muscle pain) and PYREXIA (Fever (she is pretty hot)). On 15-Apr-2021, ASTHENIA (Weakness), NAUSEA (Nausea), MYALGIA (Muscle pain) and PYREXIA (Fever (she is pretty hot)) had resolved.            Concomitant medications included High blood pressure medications and Heart medication. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-076479, MODERNATX, INC.-MOD-2021-076514, MODERNATX, INC.-MOD-2021-076603 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-076479:1st dose vaccine - husband MODERNATX, INC.-MOD-2021-076514:2nd dose vaccine - husband MODERNATX, INC.-MOD-2021-076603:1st dose vaccine - Wife
After administration of vaccine, Patient was alert and talking, color was WNL. When Pt got to car mom stated pt. slumped over and then continued to vomit. Mother came back into clinic, pt. was pale with no signs of distress. Pt was placed in clinic room to monitor breathing and Respirations. all were WNL. Pt. was able to sip on Juice box with no other episodes of emesis. Pt monitored for 20 Mins. Patient left clinic stating she was feeling back to normal.
I was really tired and I could not leave the bed; shiver and chill and may be low fever; I had very bad collar bone and lymph node in my neck swollen; I have a joint pain like my knee hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EW0150) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1, Pfizer covid-19 vaccine: Yes, Batch/Lot Number:EN6208), administration date: 17Mar2021, when the patient was 33 years old, for Covid 19 immunization, reaction(s): "Sick". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I was really tired and I could not leave the bed"; PYREXIA (non-serious), outcome "unknown", described as "shiver and chill and may be low fever"; LYMPHADENITIS (non-serious), outcome "unknown", described as "I had very bad collar bone and lymph node in my neck swollen"; ARTHRALGIA (non-serious), outcome "unknown", described as "I have a joint pain like my knee hurts". Therapeutic measures were not taken as a result of fatigue, pyrexia, lymphadenitis, arthralgia.  Additional information: After the second shot, the second day of second shot, I was really tired and I could not leave the bed but then all the symptoms were gone on the third day afternoon.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101727151 Same patient and drug, different dose;US-PFIZER INC-202101727462 Same patient and drug, different dose
Injection site warm to touch; Injection site welted up; Injection site sore; Rash/rash got worse; Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), VACCINATION SITE WARMTH (Injection site warm to touch), RASH (Rash/rash got worse), VACCINATION SITE URTICARIA (Injection site welted up) and VACCINATION SITE PAIN (Injection site sore) 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 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2021, the patient experienced URTICARIA (Hives) and RASH (Rash/rash got worse). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE URTICARIA (Injection site welted up) and VACCINATION SITE PAIN (Injection site sore). At the time of the report, URTICARIA (Hives), VACCINATION SITE WARMTH (Injection site warm to touch), RASH (Rash/rash got worse), VACCINATION SITE URTICARIA (Injection site welted up) and VACCINATION SITE PAIN (Injection site sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment medications were reported.
Onset 1 hour after injection noted pain upper right arm - shoulder - couldn't lift shoulder, arm - very painful. Redness evening of injection upper right arm. Pain better now. Redness inner aspect upper arm/anticubetal area now.
Otitis Media diagnosed 1 day after administration of MMR. Had atypical seizure manifesting as GTC movement of upper extremities, cyanosis lasting 60 minutes. Required ativan, intubation and medical transport.
Pt received dose 10/07/2022 lot expired 09/30/2022 then updated expiration 10/19/2022
This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (like I've got the flu), ABDOMINAL DISCOMFORT (sick to my stomach), MYALGIA (muscle aches/Muscle pains), ARTHRALGIA (joint aches/joint pains) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It is unknown that patient had an allergies, medical history and other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (like I've got the flu), ABDOMINAL DISCOMFORT (sick to my stomach), MYALGIA (muscle aches/Muscle pains), ARTHRALGIA (joint aches/joint pains), CHILLS (chills) and NAUSEA (nausea). At the time of the report, INFLUENZA (like I've got the flu), ABDOMINAL DISCOMFORT (sick to my stomach), MYALGIA (muscle aches/Muscle pains), ARTHRALGIA (joint aches/joint pains), CHILLS (chills) and NAUSEA (nausea) had resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Unknown that the patient experienced a similar event in the past. No treatment information was provided.   This case was linked to MOD-2022-573336, MOD-2022-573338, MOD-2022-573339 (Patient Link).
Not sure if related. TIA 1pm 11/12/21  transported from fire station to hospital unresponsive by ambulance. Hospital physician ruled it Metobolic Enceplethopy. Metabolic acadosis. TIA Global event. No speech/slurred/stuttering speech to total unresponsiveness. In this condition about 2-3 hours. Spent 6 days in hospital. Released. 11/17/21.
About 2 weeks after my first dose, i began experiencing tinnitus in my left ear.  It is so annoying and is still there a week now already!