chrisvoncsefalvay/vaers-outcomes huggingface dataset:
njection site is red; injection site is itchy; injection site is the size of a golf ball; injection site soreness/injection site tenderness; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site soreness/injection site tenderness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (njection site is red), INJECTION SITE PRURITUS (injection site is itchy) and INJECTION SITE HYPERTROPHY (injection site is the size of a golf ball) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness/injection site tenderness) and INJECTION SITE SWELLING (injection site swelling). On 07-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (njection site is red), INJECTION SITE PRURITUS (injection site is itchy) and INJECTION SITE HYPERTROPHY (injection site is the size of a golf ball). At the time of the report, VACCINATION SITE PAIN (injection site soreness/injection site tenderness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (njection site is red), INJECTION SITE PRURITUS (injection site is itchy) and INJECTION SITE HYPERTROPHY (injection site is the size of a golf ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were  provided by Reporter No Treatment Medications were  provided by Reporter   Reporter did not allow further contact
This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored M-M-R II (dose, route and lot were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, because it not possible contact the physician.
Information has been received from a physician concerning a 7 year old male who in 1998 was vaccinated SC with a dose of varicella virus vaccine live (lot # 627332/1243H). On 1/17/04 the patient developed breakthrough chicken pox. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the patient's sister developed chicken pox after vaccination. Additional information has been requested.
Patient was seen for routine well child visit on 12/6/12. Hepatitis A#1 and Influenza vaccines were given. Patient presented to emergency room on 12/9/12 with urticaria on trunk, arms and legs. He also had swelling of hands & legs. Treated with prednisolone, BENADRYL & cetirizine. Symptoms resolved by 12/13/12. No respiratory symptoms.
Patient called pharmacy on 5/8 reporting that he thought he might be having a reaction to his vaccine he received on 5/6. He reported a large triangular area of his arm that was red, tender, and warm to the touch. He said it began the day after he got the vaccine. He came into the pharmacy on 5/9 to have the pharmacist inspect the site. Site of injection (left deltoid) is showing no signs of anything, but he does have a large red area, warm to touch, and tender, farther distal on the arm closer to the elbow. He had been to his dr office that day to have it looked at and they suggested he show pharmacist so we could report at AE of vaccine. Redness and tenderness seem to be getting better every day he reports. Confirmed with immunizing pharmacist that injection was definitely given IM in the deltoid.
I am on continuous birth control, so I do not have a period and haven't had one in many years. About four days after I received my second Covid vaccine shot I started having breakthrough bleeding, which I've never had before. I did visit my provider and they did an exam but did not find anything wrong. The period I had was the heaviest I've ever had in my life. Large volume of blood and large blood clots. Some days with painful cramps and bloating. My provider suggested that I continue with my active birth control pill and take the placebo week. My system should reset after the placebo week. It took about five days after the end of my placebo week for my period to completely stop. In total, my period lasted about 33 days.
Fever, Headache, tightness in chest, fatigue, muscle and joint pain....
Cough; Feel horrible; no appetite; Sneezing; Just sleeping in Bed; Fever; Chills; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), FEELING ABNORMAL (Feel horrible), DECREASED APPETITE (no appetite), SNEEZING (Sneezing) and SOMNOLENCE (Just sleeping in Bed) in a male 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.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), FEELING ABNORMAL (Feel horrible), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), SOMNOLENCE (Just sleeping in Bed), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea). At the time of the report, COUGH (Cough), FEELING ABNORMAL (Feel horrible), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), SOMNOLENCE (Just sleeping in Bed), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
erythematous papule rash on face, uper back and shoulders.  Began on post vaccination day 28, resolved day 35.  No fever, pain purizis.
On 10/27/00 the pt was rushed to the doctor with colic like symptoms, jaundice, not eating, running a fever of 101.1. A lumbar puncture was performed and meningitis was found. The pt was admitted to the hospital and stayed for 14 days. The pt is still recovering from minor side effects.
Headache started one day after vaccination. Followed by heart palpitations, nausea, weakness, dizzines, disoriented lasting for 3-4 days.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (She was hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (She was hurting). At the time of the report, MYALGIA (She was hurting) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Patient want to know whether Tylenol can be taken.
Adverse event was administration error. Patient received their first dose of Moderna at the  Clinic and then came to our clinic a week later where she received a dose of Pfizer. She filled out a questionnaire indicating she had not received a COVID vaccine previously and her vaccine record was not viewable in our EMR.  We are still trying to reach the patient to understand her reasoning for seeking two vaccines so close together. We are recommending that she not receive any further COVID vaccines at this time.  Please let me know if there is different recommendations.
SHINGLES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included shingles, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 10-MAR-2021, and had not recovered from shingles. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
4 y/o M BIB mother for routine 4 year WCC. Normal exam prior to receiving DTaP, Flu, and IPV vaccines. Pt developed flat reddish-pink rash on face, arms, trunk, reddish papules on upper back. Received Children's BENADRYL 12.5mg/5ml, 2.5ml PO x1 and itch and rash faded.
Fever; Cough; Runny nose; Headache; Body ache; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Nov2021 at 20:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 18Nov2021, the patient experienced fever, cough, runny nose, headache, body ache and upset stomach. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, cough, runny nose, headache, body ache and upset stomach was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
headaches; feels very nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 25Mar2021, outcome "unknown", described as "headaches"; NAUSEA (non-serious) with onset 25Mar2021, outcome "unknown", described as "feels very nauseated".  Additional information: The patient got the vaccine on 25Mar2021 and since then she been having headaches and felt very nauseated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt complained of non ROM, can not grip with right hand, cannot bend at the elbow.
The morning after the vaccine, I woke up with a horrific migraine, aches, muscle weakness, and dizziness. The following day, Wednesday, at 5:00 pm I began experiencing Vertigo symptoms that ultimately put me in the ER. after rotating between vomiting and diarrhea every 10 minutes. I was given Zofran 4 MG orally and Meclizine 25 MG to control vertigo. The vertigo was severe and I could not lay down at all and even closing my eyes or changing directions made me nearly fall. It was another 24 hours when vertigo ended and just occasional dizziness remains. Diarrhea lasted until Friday, March 26. I had a CT brain and head scan at 3/25/2021 at 8:42 AM to rule out stroke.
Positive antigen test 9Aug2022. Went to Urgent Care 10Aug2022 positive PCR; Positive antigen test 9Aug2022. Went to Urgent Care 10Aug2022 positive PCR; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 12:00 as dose 2, single (Lot number: EN6206) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Smoker" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "not recovered" and all described as "Positive antigen test 9Aug2022. Went to Urgent Care 10Aug2022 positive PCR". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2022) Positive, notes: Positive antigen test 09Aug2022; (15Aug2022) Negative, notes: Took antigen test 15Aug2022 at 07:15hrs result negative; (20Aug2022) Positive, notes: Tested at home antigen kit 20Aug2022 at 09:30hrs with positive result; (10Aug2022) Positive, notes: Went to Urgent Care 10Aug2022 positive PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 10Aug2022 to 15Aug2022. The patient had no other medication in 2 weeks.
Patient given injection without flu vaccine in syringe.  Needed to have 2nd injection - resulted in two needed sticks - 2nd injection given vaccine.
Headache, Sedation, Myalgia, Fever, CoughWheeze & Syncope  Narrative:  referred to PCP or UC practice for fever of 103.0 Employee verbally agreed and reported taking ibuprofen as soon as she saw high temp.
Patient received 2nd Moderna vaccine 06/04/2021 through his college. Around 06/30/2021, patient started having upper respiratory symptoms and sought care on 07/10/2021. At this time he had EKG changes and was scheduled for an ECHO on 07/13/2021. Patient received ECHO on 07/13/2021 and STEMI alerted from ED. Taken to cath lab after ECHO showed acute systolic HF. LHC to work up anterior STEMI, acute systolic heart failure and cardiogenic shock. RRA access. Acute thrombotic occlusion of the distal LAD and the D2. Temporary mechanical circulatory support was placed using an Impella. Patient was transferred to another Medical Center, cannulated and is now status post LVAD and temporary RVAD. Hypercoagulable work up is in process.
Provider summary: " 68 YO year old female with a history of lupus, rheumatoid arthritis, EDS, hypertension, hyperlipidemia, chronic pain, and anxiety/depression who presented to the ED on 11/25/2021 with worsening shortness of breath. She first noted some "cold" symptoms about 3 weeks ago following surgery on her right knee - chest tightness, cough, congestion, etc. Since that time, she noticed progressively worsening shortness of breath, wheezing, and extreme fatigue. In the ED, vitals were as follows: T - 100.2, HR - 89, BP - 132/89, RR - 20, SpO2 - 91% on RA. Initial labs were significant for WBC 5.7, Hgb 12.9, Plt 142, Na 138, K 3.3, Cr 0.6, and Glu 102. Liver enzymes were mildly elevated. ESR and CRP were both elevated. COVID and RVP were largely unremarkable. D-dimer was elevated, but subsequent CTA chest did not reveal any pulmonary emboli. With that said, the CT scan did demonstrate multiple focal, ground-glass opacities throughout both lungs suggestive of an infiltrate/pneumonia. Upon getting up to walk the patient desaturated into the 80s. She was administered a dose prednisone and Doxycycline before being admitted to the general medicine team for further evaluation and management. Her hospital course was significant for a CT chest which was done to evaluate for interstitial lung disease, this was negative. Patient also had another send out COVID test which ended up coming back positive. Antibiotics were stopped. Patient was not hypoxic on 11/28 and was stable for discharge. Will restart her arava on discharge"
?Paged by husband at 11:50 pm that patient had gotten her flu shot today and then they went out to dinner with friends and she had "several" drinks and c/o feeling achy and feverish and tired and that her "chest felt crackly." When they got home he describes that she became "delirious" and was frantically saying things like "I have to hold our babies, let me hold my baby." and "I have to go for a walk." He then called the answering service to have me paged and in the intervening time she has now fallen asleep and is feeling comfortably. He says that she seems to be breathing peacefully and does not feel hot to the touch and has no rashes. Has never had this happen before after flu shots. Urged him to keep an eye on her during the night - if she awakens disoriented or has any further symptoms call me back, otherwise assess her mental status in the morning and if not normal call ASAP. Suspect alcohol + anxiety over symptoms related to flu shot, but difficult to tell for sure. He agrees.
Hive like rash with purpulish areas underarms and groin, no fever.
This spontaneous report was received from a mother of patient refers to her daughter who is now 14 months old received her first dose of (Merck) VARIVAX (dose, route, lot # were not reported) 1 single shot when she was 12 months old. The reporter received a letter from physicians office informing the first dose of (Merck) VARIVAX the patient received was improperly stored and she will need to be revaccinated. No adverse effects were reported. Additional information has been requested.
Covid arm/ I had Covid arm 3 times  last time was on May 10th, 8 weeks after the last vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm/ I had Covid arm 3 times  last time was on May 10th, 8 weeks after the last vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm/ I had Covid arm 3 times  last time was on May 10th, 8 weeks after the last vaccine). At the time of the report, VACCINATION SITE REACTION (Covid arm/ I had Covid arm 3 times  last time was on May 10th, 8 weeks after the last vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported , No treatment medication was reported .
The patient was given an expired vaccination. The vaccine expired on 1/23/2022 and was given on 1/26/2022. The patient had no adverse reactions.
shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath"; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath") in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038c21a and 038c21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient added that he can't do things without running out of breath). Concomitant products included PARACETAMOL (TYLENOL) and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced DYSPNOEA (shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath"). At the time of the report, DYSPNOEA (shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.  Patient reported being on Sedatives medication and Stomach medication.
This study case was received from the investigator on 27 September 2012. A 20 year-old male subject with no significant medical history was found to have non-specific myocarditis 11 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 22 May 2012. Relevant laboratory data included: not available Troponin I, not available ECG, not available Echocardiogram, not performed MRI (brain, spinal cord, heart) and a not performed Lumbar puncture. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Shoulder Injury Related to Vaccine Administration. Pt given seasonal flu shot, called 13 days later with persistent shoulder soreness.  Came in and advised to take ibuprofen, pain persisted, Pt returned with worsening pain, mainly at from rolling onto shoulder while sleeping at night. Added Tylenol, cold compress, and Tramadol for sleep. Pain persists and pt was referred to ortho.
9/26/11 pt presented with lesions; pt broke out on the Acyclovir; pt was then given an experiemental drug named CMX 001 because of breaking out a month after vaccination; pt has kidney transplant in 2000; pt had liver transplant in 2008.
Fever; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 2nd dose of bnt162b2 (Pfizer Covid 19 vaccine,Batch/Lot number was not reported), via an unspecified route of administration on 01Aug2021 as Dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced fever on 02Aug2021.Therapeutic measures were taken as a result of fever.The caller stated that after giving her daughter Tylenol,after two hours the fever goes back up.Caller was asking what should be given to her daughter now.The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
patient experienced a wave of nausea, light-headedness, and briefly lost consciousness during vaccination. When she lost consciousness, I supported her weight and she remained in the chair for approx 15 seconds until she regained consciousness. I  had two technicians to assist in calling a code white and documenting the event. At 10:43 am, patient lost consciousness and regained 15 seconds later. Once I knew the patient was stable enough to support her own weight, i held her hands to make sure she was not going to lose consciuosness again. I administered an ice pack and a cool towel at 10:45 am. Code white was responded to by associates from AP and manager. I observed the patient for 15 minutes, and AP associate observed for another 15 minutes for a total of 30 minutes. The patient recovered fully and had a friend drive her home.