chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three days after second Moderna vaccine my right leg from the knee to the foot began to swell and got hard to the touch as tissue filling with water. I went to my pcp with no outcome prescribed a water pill it didn?t reduce swelling I went to my rheumatologist, dermatologist, heart doctor, podiatrist  and orthopedic with no results.  They all said that my system was compromised by the Moderna vaccine. Cardio doctor sent me for  DVT and EKG results was there was no blockage and the valves in the leg were functioning properly . Swelling subsided Dec 2021
pt recvd vax; t 106; tremors & weakness of legs; v; irritability; 17nov94 groggy;
On Thursday, September 16th, 2022, at a HCF, we administered the new bivalent Modena Booster Vaccines to the following patients (listed below). Our Nurse Practitioner on duty was used to the ?0.25mg per dose' booster vaccines which yields 20 doses per vial. She was aware of a difference between the previous monovalent and the new bivalent but wasn?t aware of a vast difference. The bivalent vaccines appear to give 5 doses per vial (0.5mg per dose) versus the monovalent which yielded 20 doses per vial. Our provider was under the impression that it yielded 10 doses per vial. Since 10 doses per vial were administered each patient received 0.25mg instead of 0.5mg.   Each patient did not receive the recommended amount. The POC at the facility is aware of this. There were no adverse reactions noted and everyone seemed to be in good health status prior to our departure. ??
immed p/vax pt exp severe arm pain from shoulder to hand;pain resolved p/20-30min;this is 1 of 2 pt of this facility to exp arm pain p/vax lot# 4978143;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 11:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 11:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 73.56  Concomitant products were not provided.  On 07-Jan-2021 Excursion time was reported at 09 am and 10 am with temperature as 34 and 34 degrees Fahrenheit respectively , total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 06 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient stated several hours after receiving vaccine she felt ill and had symptoms of chills, vomiting, tachycardia and achiness.
Pain in my knees, back, both arms, joints and shoulders. The next 24 hours, the pain peaked but I rested. By the next day I had no pain. No pain relievers were taken. Only rest.
red spot on his arm, "7 day itch"; red spot on his arm, "7 day itch"; red spot on his arm after first shot and a little bit of swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (red spot on his arm after first shot and a little bit of swelling) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE SWELLING (red spot on his arm after first shot and a little bit of swelling). At the time of the report, VACCINATION SITE SWELLING (red spot on his arm after first shot and a little bit of swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported No treatment medications were reported
The pt complained of aching in the left shoulder, left scapular area, tingling in the the left little ring finger.
Patient required hospitalization due to breakthrough infection, Patient received J&J vaccine on 03/08/2021. Patient required hospitalization from 10/27/2021 - 10/28/2021. Below is copied from discharge summary:   Patient is a 73 y.o. female patient who is being discharged today.   Hospital Course: Patient is a 73 y.o. female with a history of hypertension, hyperlipidemia, peripheral artery disease, carotid stenosis and COPD not on home oxygen who presented to the emergency department with complaints worsening dyspnea on exertion x2 weeks. Chest x-ray neg. Afebrile. Patient given steroids, Duoneb treatments and doxycycline in ER    Acute COPD exacerbation do to COVID 19 . - FEV1 42% pred, GOLD 3, PFT 8/19/21  - Curretly on Oxygen 2lts - Home Oxxygenqualification test done and qualified - Dexamethsone 6mg Po day x 10days - Albuterol inhaler prn - Procal 0.18, no need ffor AB - Negative respiratory panel, urine antigens  - Contineu primary care prescribed meds   Hypomagnesemia  - repleted   Normocytic anemia  - stable, monitor, outpatient PCP follow up    Hypertension  - cont amlodipine, carvedilol, losartan and HCTZ   Hyperlipidemia  - cont statin    Peripheral artery disease  - cont aspirin    Gastroesophageal reflux disease - home medication non formulary, cont with Protonix    Dispo: Dc home today with above recs.  Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
I was in pain in my arm; my hand closed up; it was my right hand they closed up I was in pain in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0175, Expiration Date: 31Aug2021), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "I was in pain in my arm"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "my hand closed up; it was my right hand they closed up I was in pain in my arm". Therapeutic measures were not taken as a result of pain in extremity, limb discomfort.  Additional information: Anatomical site of administration: Consumer stated, it was her right hand they closed up I was in pain in my arm. Consumer was informed about the role of Pfizer Drug Safety. Consumer stated, she just want to because she got the first Pfizer shot back in May (not clarified) and she had a reaction on that while she got the shot before and she was trying to get jab and her doctor told her to not take second one because her hand closed up and it was 3 days after it was back to normal and she want to know how she could go and get the no saying that she could not take the second shot. No other investigations and no other conditions reported.  No follow-up attempts are possible. No further information is expected.
Within a week I had vertigo on the right side.  Then both sides, then looking up and down. Going to Clinic for PT.   I had the exact same experience in 2022 after the booster. The vertigo lasted 4 months and was much worse than this years.
Fever, left deltoid redness, swelling and tenderness, left axillae swelling.
travel then husband had covid 11May then she got it sx 16May and then PCR positive 17May.; travel then husband had covid 11May then she got it sx 16May and then PCR positive 17May.; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 65-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2, Solution for injection), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 24Feb2021 as dose 2, single (Lot number: EL3247), on 16Nov2021 as dose 3 (booster), single (Lot number: FF2589) and on 22Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "unknown" and all described as "travel then husband had covid 11May then she got it sx 16May and then PCR positive 17May.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: It was unknown If other vaccine were received in four weeks. Covid prior vaccination was unknown. Covid was tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (I have a cold) 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 NASOPHARYNGITIS (I have a cold). At the time of the report, NASOPHARYNGITIS (I have a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient had cold on the scheduled day of second shot and he was asking if he should take second shot or not.
weakness; Light-headed/Dizziness; blood pressure 73/56; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 27Mar2021, outcome "unknown", described as "weakness"; DIZZINESS (non-serious) with onset 27Mar2021, outcome "unknown", described as "Light-headed/Dizziness"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 27Mar2021, outcome "unknown", described as "blood pressure 73/56". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller reports that she got home and thought it would go away but reported I noticed it was not going away and that she was feeling both dizziness and weakness. Caller reported that she read on the fact sheet that dizziness can be experienced but she also noticed that her blood pressure was really low (73/56) and she asks, is low blood pressure a side effect and if not what was the cause of the dizziness that people experienced as the side effect. Last Tuesday Patient had got her first dose and everything was okay, her arm was fine, Patient was sitting and playing with her device and had 4 minutes left till it was time to go from the vaccination facility and patient felt lightheaded, they put her down and recovered. She has blood pressure monitor, she was checking her Blood pressure it was 73/56. She usually has a low pulse because she is a runner and even her Hear rate is usually like 56 or 54 so she was not concerned by that but she was wit her pressure 73/56, that was next day on Wednesday. Yesterday Sunday her pressure was 85 or something over 65. This morning 88 over something. She had her morning coffee and that always helps to boost her pressure, it went over 90 over something. Her pressure is climbing up slowly, but she cannot do her work outs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Strong metallic taste in my mouth that lasted for about 28 hours. It did stop after 28 hours. No adverse impact from having this side effect.
Janssen Covid-19 Vaccine EAU I experienced chills, high fever, nausea, and vomiting Starting about 10 hours after the vaccination and lasting about  4 hours.  After vomiting twice around 13 hours post vaccination my symptoms began to significantly improve. I experienced fatigue and minor stomach irritation the following day. My symptoms were completely gone within 48 hours.
Patient reported anaphylactic reaction to a dose of Influenza vaccine 16 years ago.  Per Pfizer EUA guidelines, patient was observed for over 30 minutes following the administration of  Covid-19 vaccine dose, given at 13:35.  At 16:40 patient noticed voice changes while talking on the phone and increased throat irritation.  Patients vital were as follows: Pulse 120  / BP 124/64 at 16:42.  EpiPen 0.3mg was administered at 16:43. IV placed in A/C by onsite EMS and a dose of Diphenhydramine 50mg was also administered intravenously.  Patient was take to ER.
Itchy rashes on both forearms; Inappropriate dose of drug administered; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rashes on both forearms) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002821A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Oxycodone cause itching).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter once. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter once. On 13-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered). On 15-Mar-2021, the patient experienced RASH PRURITIC (Itchy rashes on both forearms). On 13-Mar-2021, INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered) had resolved. At the time of the report, RASH PRURITIC (Itchy rashes on both forearms) had not resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Bright red spot on big left toe / continues to be bright red; It itched a lot / itching; Big toe got crusty; Big toe / had blisters; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (mild case of shingles years ago after hysterectomy) and hysterectomy (years ago). Concurrent medical conditions included drug allergy (allergic to tetracycline, levaquin, macrobid, lasix).   On 26th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th January 2021, 15 days after receiving Shingrix and an unknown time after starting mupirocin and Valacyclovir, the patient experienced erythema of extremities, pruritus, crust and blister. The patient was treated with mupirocin, valaciclovir hydrochloride (Valacyclovir) and azithromycin (Z Pak). On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved and the outcome of the pruritus, crust and blister were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, pruritus, crust and blister to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received the Shingrix vaccine into the left arm.  The lot number and expiry date were not provided by the reporter. 2 weeks later, the patient developed a bright red spot on big left toe, it itched a lot but was not painful. Her podiatrist gave ointment TAC mupirocin 2% which was helping. Her dermatologist gave zpak and valacyclovir which helped for itching.  The patient's big toe got crusty and had blisters and she also used vinegar and water and crusty blisters resolved. Her left big toe continued o be bright red.  The patient had her first COVID (Corona Virus Disease) vaccine on 3rd March 2021. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021057758:Same reporter.
face rash, itchy skin, inflamed skin, itchy eyes, itchy eye lids Spreading down my neck onto my chest some shortness of breath I have an allergy to colophony.  At the time of the injection my diagnosis is contact allergy, so the nurses continued with the injection.  It wasn't until 12-14 days later that this reaction started.  It is intensifying.  I have reviewed everything I eat and products I use, and nothing has changed other than having the first shot. I have some skin irritation and itchy if I do come in contact with an allergen or eat something, but it subsides after a day or two.   This continues to get worse and it is going on 5 days.
Approximately 20 hours after the vaccine I woke up very confused.  I was dizzy.  I had a very poor sense of balance and could only  walk by holding onto walls.  This resolved after  approximately 10 hours
Patient says her left shoulder hurts badly ever since vaccine administration and she has been unable to move her left arm across her body since morning after vaccine administration (2 weeks).
Pinpoint, diffuse rash bilat thighs. Denies itching, problems breathing , diarrhea , temp., etc. Mom states she has had this rash 2-3x before and she thinks that it has been a day or so after shots. Can't remember which shots. Mom states unchanged and mild.
allergic rx, area of infection red warm and swollen w/poss. early cellulitis.
Fully vaccinated patient tested positive for COVID-19 on 12/28/2021 at ED visit. Patient is a 66-year-old male, history of diabetes hypertension presenting with 2 days of generalized fatigue, body aches and nonproductive cough. He complained of a low-grade fever and exertional dyspnea. No chest pain. Patient left.
Pt returned to pharmacy with "excessive" soreness. RPh examined area of injection (no redness, no swelling). Pt did have 4 small blisters on hand (of same injection arm). Gave pt BENADRYL 25mg.
Patient said the day of the vaccination she developed a red patch about 1/2 inch in diameter that was red and swollen and a little tender. Patient reported that it was periodically itchy and she has been scratching it. She stated that yesterday (day 9 after vaccination) that she noticed the size of the redness had increased. She said it was still periodically itchy and only slightly tender to the touch. She said she felt otherwise fine no systemic effects reported. Patient had not taken anything. Recommended benadryl and icing the area. Treatment outcome unknown at this time.
large dark pink welt on left arm. Itchy and painful. Extends past direct injection site. Onset about 9 hours after time of injection.
Patient was in allergy  lane due to itchy throat form 1st dose on 3-16-21. After 2nd dose felt S.O.B vaccinator recommended using a puff from Albuterol Inhaler Onsite EMS was called vitals BP 134/82   HR 93. She felt better and was released home.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient called 12/5/2021 to report generalized rash and itching the day after Moderna booster. Patient reported history of anaphylaxis to tree nuts. He has an EpiPen on hand. He reported no other symptoms. Advised patient to take antihistamine & monitor. Patient received Pfizer as first 2 doses without issue. Patient will follow-up with primary care physician.
Initial unsolicited case received from a nurse on 05 Oct 2017. This case is linked with the cases 2017SA199664 and 2017SA199663 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE MULTI DOSE VIALS (Batch number (reported as product 627-15), expiry date, dose, dose in series, route and site of administration were not reported) on 03 Oct 2017. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient developed metallic taste in mouth, followed by redness at injection site, progressing up arm to neck with hoarseness. It was reported as the patient required treatment in Emergency department. Relevant lab tests and corrective treatment was not reported. Outcome of all the events were not reported. List of documents held by sender: none.
Pregnant and had emergency C-section, My blood pleasure dropped and when I woke up I was throwing up. I've had surgeries before and I had never had any reaction like this.
Stroke.  ER treatment.  Hospitalization.  Skilled Nursing Facility.  Symptoms:  Weakness/fell to the floor/terrible bruises entire left side of body/slurred speech/confusion.   Treatment:  TPA administered.  Hospitalized for 10 days, followed by continuing stay in skilled nursing facility.