chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am currently having extreme itching ,swelling,redness and heat to touch where the injection wa given. Slight headache and tiredness on the day after injection. Currently headache
chills; headache; feel like fever but its normal 98.6F; arm hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-015117 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ET7534), on 12Apr2021 as dose 2, single (Lot number: EW0151) and on 01Dec2021 as dose 3 (booster), single (Lot number: 300308D), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Jul2020 (unspecified if ongoing), notes: Has patient ever had COVID + test or diagnosis? If yes, provide date.: Yes, July2020. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered"; HEADACHE (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "feel like fever but its normal 98.6F"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm hurts". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient wants to know if its okay if she got another first booster (twice). Response: Spoke from FAQS-Reactive Talking Points for Questions on the Emergency Use Authorization of 2.5mL vial for booster and 2nd booster authorization and refer to HCP. 06Jun2022. Title: FAQS-Reactive Talking Points for Questions on the Emergency use Authorization of 2.5mL vial for booster and 2nd booster authorization. General Adverse Event script - please use for any AE/Safety events experienced with EUA/Marketed products. Patient information: Height. Past Medical History Allergies (medications, food and other products): No Has patient ever had COVID + test or diagnosis, If yes, provide date: Yes, Jul2020. Medical Hx: Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination: no. Recent change in status such as improvement or worsening: N/A. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #): N/A. Manufacturer and dose of all COVID-19 vaccinations received. First dose on ET7534 22Mar2021 (Pfizer), Second dose on EW0151 on 12Apr2021 (Pfizer), Booster (Pfizer) 300308D on 1Dec2021, Second booster (Moderna) 054A22A 5Jun2022. Adverse Event Verbatim term: Second booster (Moderna) gave chills, headache, feel like fever but its normal 98.6F, arm hurts where got the vaccine left arm. No AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). Has the patient experienced a similar event in the past, Yes for one day after the Pfizer vaccine. No AE Outcome (recovered, residual effects, ongoing, unknown). No cause of death and was autopsy done. symptoms Not worsening, shoulder hurts. Transfer to safety 06Jun2022. Batch Number: ET7534, Dose Form Injection, Route Intramuscular, Frequency Drug Start Date 22Mar2021, Drug Stop Date Indication COVID-19 vaccine. There is no concomitant list.  No follow-up attempts are possible, No further information is expected.
Pregnant; Didnt make it to your second appointment (fir second shot); This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and PRODUCT DOSE OMISSION ISSUE (Didnt make it to your second appointment (fir second shot)) in an elderly female patient (gravida 1) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant) and PRODUCT DOSE OMISSION ISSUE (Didnt make it to your second appointment (fir second shot)). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) and PRODUCT DOSE OMISSION ISSUE (Didnt make it to your second appointment (fir second shot)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
His arm is been soar and in pain; I'm in bed, I feel weak, I feel pain, swollen and I am feeling weak; I'm in bed, I feel weak, I feel pain, swollen and I am feeling weak; This is a spontaneous report from a contactable consumer. A 58-year-old male patient (reporter's dad) received bnt162b2 (formulation: solution for injection; manufacturer: Unspecified; NDC number, UPC number and Expiry Date: Unknown; lot number: unknown), via an unspecified route of administration on an unspecified date as unknown dose number, single for covid-19 immunisation. Medical history included ongoing diabetes from an unknown date. Concomitant medication included insulin aspart (NOVOLOG; injection) taken for diabetes, the patient had been taking it morning and afternoon. He takes the dose 28 to 26 unit in morning, afternoon he gets 66 unit start and stop date were not reported. Reporter reported that, on 19May2021, has been having side effects, he is weak right now. His arm is been soar and in pain from the covid vaccine. Patient reported ''I am in bed, I feel weak, I feel pain, swollen and I am feeling weak''. The patient did not take any therapeutic measure for the events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Headache; This is a spontaneous report from a contactable Consumer or other non-HCP (patient) communicated to Pfizer sponsored Program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), dose 1, via an unspecified route of administration on unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant were not reported. The patient stated, she got her second COVID Shot evening about 5:30 on 04Mar2021 (as reported on Thursday) and before she went to get it, she had a terrible headache (after the first dose) on an unspecified date, and she took two Tylenol on unspecified date. So, consumer went ahead and got the second shot, everything went fine and when she came home, she looked online something but somewhere she cannot find it now, but she read that you should not take Tylenol before you have your COVID Shot. But she did take Tylenol before getting the vaccine. Her arm was not very sore and did not have any symptoms. She was just more tired than usual. She wanted to know if that all effect the vaccine. Was that Tylenol going to tick over from the COVID, she means would the COVID Shot still going to be good. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient received Pfizer COVID-19 vaccine on 4/6/2021.  Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives.    Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient.   Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving.   In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.
Leakage of the vaccine from between the needle and the syringe tip due to the needle not being secure on the syringe with no AE; The needle was not on tight and the vaccine rolled down the arm of the consumer with no AE; Patient getting a dose less than the 0.5 ml due to leakage of the vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from Pharmacist via Medical Information (MI) (Reference number- 00360254) and transmitted to Sanofi on 16-Nov-2020.  This case involves a 47 years old female patient who got a dose less than the 0.5 mL of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled syringe, lot UT7115LA and expiration date: 30-Jun-2021) via intramuscular route in the right arm for prophylactic vaccination (underdose). This occurred due to leakage of the vaccine from between the needle and the syringe tip due to the needle not being secure on the syringe (device connection issue) as the needle was not on tight and the vaccine rolled down the arm of the patient (exposure via skin contact) on unknown date.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to exposure via skin contact and vaccine underdose (latency on the same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A 5 year old child with URI symptoms 3-5 days later developed vesicular rash comparative with chicken pox.
mom reports pt stopped breathing eyes rolled back in head & slumped over; entire episode lasted a few seconds;
45 minute seizure activity on 2/25/12 - required ATIVAN and KEPPRA load to stop seizure. Fever and no other symptoms at the time. Hospitalized for spinal tap, labs, observation. Blood cx, CSF cx's were negative. Discharged after 24 hours. MRI/EEG done.
It got worse/ his hips have gotten worse; developed pain and stiffness in both hips and shoulders simultaneously; developed pain and stiffness in both hips and shoulders simultaneously; developed pain and stiffness in both hips and shoulders simultaneously; developed pain and stiffness in both hips and shoulders simultaneously; This is a spontaneous report from a contactable consumer(patient).A 73-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. In Mar2021, week after vaccination the patient developed pain and stiffness in both hips and shoulders simultaneously. The patient stated he never had pain before other than pain usually associated with yard work. On 22Mar2021, he went for his semiannual physical with his doctor, he was told it might be some kind of reaction to the vaccine. It got worse, so on his following visit on 05May2021, he got a lot of bloodwork done (checked for lupus, inflammation, rheumatoid arthritis, etc), 4 days later, his results were normal. The patient was referred to a rheumatologist, whom he will see on 09Jun2021. However, his hips have gotten worse, his right shoulder is extremely sore, and on some days, he can't lift the right arm above the right shoulder. The outcome events were unknown.  Information on the lot/batch number has been requested.
Left arm inflammatory response leading to frozen shoulder Left. Left Should Capsulitis Steroid injection and PT exercises required to help resolve by Orthopedics. Still not totally resolved
Headache, chills, fever, body aches, nausea, and a general malaise were experienced beginning approximately 8 hours after receiving the shot and lasted approximately  36 hours.  Approximately 4 days after the shot, i experienced a severe bout of vertigo, which I've never experienced in my life.  This included severe dizziness and vomiting for about 12 hours and a headache and light dizziness for an additional 24 hours.
Case number PHEH2014US003593 is an initial spontaneous report received from a pharmacist on 21 Feb 2014. This report refers to a 16 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly on 11 Jan 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 21 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug use in unapproved population".
Pain and soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain and soreness at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).    On 05-Mar-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 11:00 PM, the patient experienced VACCINATION SITE PAIN (Pain and soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain and soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment details was not provided.
The patient began to experience dyspnea, then shortly thereafter began to develop flushing of the face.
Information has been received from an RN concerning a 4 month old male who was vaccinated at an unspecified date. Immediately, post vax, the pt developed pinpoint hives which came and went for about 30 minutes. The pt was treated with Benadryl. The pt was held in the office for 90 minutes, post vax. Additional information has been requested.
At around 3 am started intense shivers, temp was over 100, spent night with chills and shivers, and couldnt move my injection site arm due to pain.   Next morning, had intense headache, joint pain, and my eyes burned. Couldn't get up without assistance because of how weak I was. Fever 102.6 around noon took tylenol. Don't think i have ever felt this sick in my life. Fever all day over 100. Sweating, muscle and joint pain (worse at joint between neck and head, hips and wrists). Nausea throughout, had soup to hydrate at around 5pm. Started to feel better but fatigued still with fever of 100 by midnight. Spent night sweating with headache, woke up 2/7 still with 99.8 temp, much lower temp without tylenol. Throughout the day i have had joint and muscle aches, and fatigue, a mild headache. Finally around 4pm stated to improve, haven't had a fever since noon, still achy but have a little more energy.
Patient came back to my pharmacy 5/28 and said his shot on 5/25 gave him suicidal ideations.  He previous had these when taking Cipro.  He wants to make sure its being studied as he wants to help others.  He has a history of depression, currently on Trintellix but this medication caused him some great deal of suicidal ideation.  He had a headache start 4 hours after the shot.  The ideation happened the next 2 days on the 26th and 27th.  On the 28th he came in said he's feeling much better but he is reaching out to his psychiatrist.  He had pfizer on his other 3 doses and said he will probably not get moderna again unless he has a "babysitter".
Seizure lasting more than 5 min. with incontinence & loss of consciousness.  Stupor with return of consciousness.  Transported by ambulance to hospital, then to other hospital. 1/15/09-records received for DOS 11/1-11/3/08- DC DX: Seizure-like activity; viral infection with fever. Presented with seizure-like activities. Jerking movements, shaking all over, head jerking backwards, eyes rolled toward back of head. Urinated on self. Unresponsive throughout the 5 minute activity. Lethargic. Blood pressure increased, heart rate increased, temperature elevated.  Vomited, drowsy and tired. PE: eczema.
Persistant, inconsolable crying lasting more than 3 hrs w/unusual high pitched cry occurred w/in 2 hrs;
Immediately following I started to notice abdominal discomfort. A month out I had gained 30 lbs. I have been the same weight since I was 15, approximately 125 give or take 10 lbs. I began experiencing diarrhea and then extreme constipation. The constipation was so severe I had to start seeing a GI due to the extreme pain, nausea, lightheadedness, etc. Simulataneously I developed nummular eczema, and eczema around my hairline, which I had never had prior. The nummular eczema cleared up once I was prescribed a steroid cream. The eczema around my hairline is still present but isn?t as troubling as the IBS. The IBS has caused me to miss work due to inability to be away from the toilet, nausea, vomiting, and extreme abdominal pain. This all began after the Pfizer vaccine was ACCIDENTALLY administered. I had 2 Moderna vaccines prior and was under the impression I was getting a third one. The technician informed me that it was Pfizer after the fact and apologized.
Patient returned to clinic almost an hour after receiving the vaccine complaining of dizziness (7/10). HR=57b/min, RR=16br/min, SpO2=99% on room air. Patient received liquid diphenhydramine 40mL/100mg PO immediately. Fifteen minutes later, patient notes dizziness significantly improved (3/10) and was discharged to go home and not to return to work. Patient was educated on s/s and need to visit ER if symptoms recur.
Vertigo; Very very sick; This case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vertigo and sickness. On an unknown date, the outcome of the vertigo and sickness were recovered/resolved.   It was unknown if the reporter considered the vertigo and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had vertigo for six weeks after flu shot and was very very sick.
Full body rash that started within 12 hours of injection and lasted another 36 hours General aches and chills and swelling at site of injection that lasted about 48 hours Painful Lymph node swelling under both arms, but the worst was under the right arm that started about 36 hours after injection and is still very sensitive, but the swelling is decreasing. 3 consecutive nights of night sweats, worst night was soaking bed clothes and sheets
Pt receiving injection, started dreaming & got really disoriented.  Pt started a jerking motion & became cross eyed & teary eyed.  Passed out for about 3-5 seconds & became conscious again.
Arthritis flare up / Arthritis had been Acting up; Gastric disorder / Issues with Stomach; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis flare up / Arthritis had been Acting up) and GASTRIC DISORDER (Gastric disorder / Issues with Stomach) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis flare up / Arthritis had been Acting up) and GASTRIC DISORDER (Gastric disorder / Issues with Stomach). At the time of the report, ARTHRITIS (Arthritis flare up / Arthritis had been Acting up) and GASTRIC DISORDER (Gastric disorder / Issues with Stomach) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company comment  This is a spontaneous case reported by a consumer, concerning a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected, non- serious AESI of arthritis (arthritis flare up / arthritis had been acting up) on an unknown date after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was also receiving Adalimumab (HUMIRA) for Rheumatoid arthritis, which could be considered as a confounding factor. No details on risk factors, comorbidities, triggers, labs, diagnostic tests, and treatment details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgement; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected, non- serious AESI of arthritis (arthritis flare up / arthritis had been acting up) on an unknown date after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was also receiving Adalimumab (HUMIRA) for Rheumatoid arthritis, which could be considered as a confounding factor. No details on risk factors, comorbidities, triggers, labs, diagnostic tests, and treatment details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgement
Patient under 18 years of age old had vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old had vaccine administered) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old had vaccine administered). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old had vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
REDNESS, ITCHINESS, RASH AT SITE OF INJECTION ONE WEEK AFTER SHOT. USED CORTIZONE TO NO AVAIL. I ADVISED HER TO USE BENADRYLL NOW AND EVENING AFTER 2ND DOSE.
Petechiae, thrombocytopenia; required immunoglobulin infusions (2).