chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for COVID-19; tested positive for COVID-19; Headache; feeling unwell; muscle pain; This is a spontaneous report from a contactable nurse reporting on himself. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 28Dec2020 at 08:15 AM (at the age of 61 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided.  The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jan2021, the patient experienced mild side effects consisting of headache with feeling unwell and muscle pain. The patient reported this happened on 01Jan2021, and 02Jan2021 and on 03Jan2021 and later, the patient did not experience any side effect. Since the vaccination, the patient was tested for COVID-19 on 02Jan2021 with a Nasal Swab Rapid Test and tested positive for COVID-19. The adverse events resulted in Emergency room/department or urgent care visit. The patient did not receive any treatment for these events. The outcome of the events headache with feeling unwell and muscle pain and tested positive for COVID-19 was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Upset stomach; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and FATIGUE (Tired) had not resolved.            Concomitant product use and treatment information was not provided.  There was no information regarding consent for followup.
Patient's menstrual period has been extremely painful and has had a heavy flow since she has had the vaccine.
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (moving it is very difficult/ When she changes her clothes her left arm doesn't work well), LIMB DISCOMFORT (Her arm also felt heavy upon returning home/It feels heavy), STRESS (very stressed), VACCINATION SITE PRURITUS (after receiving the vaccine she started to experience itching on her left arm) and VACCINATION SITE PAIN (she has pain in her left arm) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Food allergy.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Contact has received 2 primary vaccine doses on 27SEP2021 (lot number 062E21A) and 25OCT2021 (lot number 040021A). She received a booster dose on 9NOV2022 (lot number 016H22A). While she was waiting for 15 minutes after receiving the vaccine, she started to experience itching on her left arm. She went home and continued to feel itching. She took 10 mg of Hydroxyzine, which she sometimes takes for food allergies and her itching went away 1 hour after that. Her arm also felt heavy upon returning home. She had been using a heat pad and ice pack on her arm.
Headache, joint and body pain, weakness in limbs  unable to work for 2 weeks  this occur two years in a row So I have never taken flu vaccine again.  I contracted COVID19 in March 2020 and I still have antibody---- I think taking the vaccine I will have adverse reaction. I have a cousin who died recently after taking the vaccine.
3/23/2000 experienced headache, eyes sore and slight fever. 3/25/2000, rash from head to knees. Fever 102, went to emergency room on 3/26/2000. Received steroid injection. Instructed to take Benadryl as needed. 3/28/2000 no better, gotten worse and went to family physician script for steroids and Zyrtec. No problems noted after 4/1.
I was given a 0.25ml dose instead of a 0.5ml dose.  I am NOT immunocompromised, I am a health care professional.  I cannot get the facility to speak with me in regards to what I need to do now.
Initial unsolicited report received from a pharmacist on 15-Jan-2016. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of Adacel (batch number- U5279AA, expiry date- 18-Mar-2018, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient experienced cellulitis at injection site. Laboratory investigations and corrective treatments were not reported. Outcome of the event was reported as unknown. Documents held by sender: none.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
CHILD COMPLAINED TO PARENTS THAT ARM ACHED AND WAS PAINFUL TO THE TOUCH. AFTER 1-2 DAYS, PARENTS LOOKED AT ARM BECAUSE CHILD WAS STILL COMPLAINING, AND ARM WAS RED AND HOT TO THE TOUCH. AREA WAS RED ABOUT 6" IN DIAMETER AROUND INJECTION SITE. PAINFUL TO TOUCH. RED AREA HAS GONE DOWN SLIGHTLY SINCE YESTERDAY, AND CHILD DOES NOT COMPLAIN AS MUCH.
Rash, itching started 2/11/11 & continued to get worse no relief with BENADRYL OTC called & presented to clinic 2/15/11 Methylpred sodium su 125 mg IM & Prednisone taper 2/16/11 I left a message for pt to call if symptoms no improved.
bad taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bad taste in her mouth) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atopic dermatitis. Concomitant products included DUPILUMAB (DUPIXENT) for Atopic dermatitis.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In March 2021, the patient experienced DYSGEUSIA (bad taste in her mouth). At the time of the report, DYSGEUSIA (bad taste in her mouth) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In February 2019, Patient started taking dupilumab 300 mg every other week subcutaneous, strength: 300mg/2ml (with an unknown formulation, expiry date- 30-Sep-2023). Pharmacist advised there were no Interactions with dupilumab and the covid Vaccine. This was not a listed side effect of dupilumab. Patient was going to see her md office that day.  No treatment information was provided the reporter
Bee-Sting like big spot on the Injection Site ( > 3") /Red (more than 3 inches oval shape); Swollen Injection Site; Warm to the touch Injection Site; Itching Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Bee-Sting like big spot on the Injection Site ( > 3") /Red (more than 3 inches oval shape)), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE WARMTH (Warm to the touch Injection Site) and INJECTION SITE PRURITUS (Itching Injection Site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Bee-Sting like big spot on the Injection Site ( > 3") /Red (more than 3 inches oval shape)), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE WARMTH (Warm to the touch Injection Site) and INJECTION SITE PRURITUS (Itching Injection Site). At the time of the report, VACCINATION SITE ERYTHEMA (Bee-Sting like big spot on the Injection Site ( > 3") /Red (more than 3 inches oval shape)), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE WARMTH (Warm to the touch Injection Site) and INJECTION SITE PRURITUS (Itching Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Erythema, swelling from biceps to elbow, urticaria on dorsal aspect of arm, area very warm to touch, tender at tricep of right arm
Pt recvd vax @9AM, mom called @ 1 & stated that pt was screaming 2 hrs, site of inject little red & swollen; Mom was told to call MD-MD said put pt in hosp for observation; Later mom reported pt did not stop crying until 6AM;
4/3/03 4 PM: Dr's office called to report pt visited their office today. Pt presented with left arm swelling/redness, (blisters where bandaid was). 7 PM after several attempts, able to reach pt's mom, child is fine. Antiobiotic was prescribed, mom needs to fill Rx. 4/7/03: Pt recovering, swelling and redness down.
I woke Sunday morning (03/07/2020) feeling itchy around the injection site on my upper left arm. I showered and applied coconut oil to the area and the itchiness subsided. The itchy feeling returned at the end of the day, but was tolerable. I awoke the next morning and the site was itchy, hard, slightly swollen and  hot to the touch. It was visibly red and bumpy. That morning I felt very cold, tired and had a bad case of diarrhea. I took a nap, and when I woke I felt much better.  That afternoon and evening I applied cold compresses to the site which helped to soothe the discomfort. It took several days for the swelling and rash to go away. By Friday morning (03/12/2021) the itchy feeling was gone and my arm was back to normal.
Interaction with blood thinners and cholesterol medicine (Plavix and Lipitor); Dry mouth; Joint pain; Muscle pain; I haven't slept in three days; Headache; Fever; Nausea; I cant taste Water; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization; atorvastatin calcium (LIPITOR), with route of administration, therapy dates, dose and frequency unspecified, for abnormal cholesterol; and clopidogrel bisulfate (PLAVIX), with route of administration, therapy dates, dose and frequency unspecified, as blood thinner. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had dry mouth; BNT162B2 had interaction with the patient's blood thinners and cholesterol medicine (clopidogrel bisulfate and atorvastatin calcium); joint pain; muscle pain; had not slept for three days; headache; fever; nausea; and could not taste water. The action taken in response to the events was not applicable for BNT162B2; and was unknown for clopidogrel bisulfate and atorvastatin calcium. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
headaches, chills, sweat, dizzy, no energy, nausea, unable to get up and function
Patient states that his arm has been and still is sore.  He has lost mobility and it's painful (7 on pain scale) when trying to raise his arm above his head.  He can perform pull movements, but cannot perform any push movements.
Within one hour of vaccine administration, the left side of my face from throat up to me eye began to tingle, then became numb.  The left side of my face became swollen.  The left side of  my mouth began to droop.  My tongue began to swell, my throat felt like there was something in it and it became increasingly difficult to breathe.  I called the Hotline provided by Hospital.  I was directed to Urgent Care.  At the urgent care, an IV was placed.  Solumedrol, Benadryl, and epi pen were administered.  I was transferred by EMS to Hospital.  In EMS, an additional IV was placed.  I was given IVFluids.  I was also given additional Benadryl and Pepcid.
a week later broke out with shingles on her forehead; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-Oct-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter saw a lady (patient) yesterday (day before reporting) who got the Shingles vaccine and a week later broke out with shingles on her forehead.  The reporter stated so much for vaccines. Additional Supportive Information: Follow-up would not possible as no contact details were available.
urinary infection; pain when urinating and very low volume and very frequent; pain when urinating and very low volume and very frequent; pain when urinating and very low volume and very frequent; not feeling well; chills; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary infection), DYSURIA (pain when urinating and very low volume and very frequent), POLLAKIURIA (pain when urinating and very low volume and very frequent), URINE OUTPUT DECREASED (pain when urinating and very low volume and very frequent) and MALAISE (not feeling well) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary infection), DYSURIA (pain when urinating and very low volume and very frequent), POLLAKIURIA (pain when urinating and very low volume and very frequent), URINE OUTPUT DECREASED (pain when urinating and very low volume and very frequent), MALAISE (not feeling well) and CHILLS (chills). The patient was treated with AMOXICILLIN for Urinary infection, at a dose of 500 mg and AZITHROMYCIN (AZO) for Urinary infection, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (urinary infection), DYSURIA (pain when urinating and very low volume and very frequent), POLLAKIURIA (pain when urinating and very low volume and very frequent), URINE OUTPUT DECREASED (pain when urinating and very low volume and very frequent), MALAISE (not feeling well) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Patient took Amoxicillin 500mg and Azo as treatment for the events.
Narrative: Patient received vaccines 11/16/2021. On 11/17/2021 patient was found unresponsive in his yard by his son in law, EMS was called and patient taken to outside emergency facility. Noted to be in cardio/respiratory arrest by EMS while in route to hospital. Patient was placed on a ventilator at the outside facility and expired later that day. ER documents not available at this time.
FEVER 101 , BODY ACHES, FATIGUE AND CHILLS FOR 3 DAYS. I HAD COVID 6 MONTHS AGO IN AUGUST 2020 - FELT LIKE I HAD COVID AGAIN.
Patient presented with nausea, vomiting, and chest pain and admitted with work-up concerning for non-ST elevation MI. She required a diltiazem drip for rate control and heparin was concerned for acute coronary syndrome.  Cardiology was consulted and proceeded with left heart catheterization that showed high-grade mid LAD stenosis status post PCI with a drug-eluting stent. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
onset nephrotic syndrome within 10 days of the covid vaccine, kidney biopsy 6/3/2021 with minimal change disease (also underlying thin basement membrane disease)   No prior hx of proteinuria, one episode of gross hematuria as college student with negative urologic workup, no history of proteinuria, no hx edema  Being tx'd now with prednisone
Given expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) outcome was unknown.            Treatment information not provided. concomitant medications were not provided.
Headache, chills, fever, body aches, soreness at site of injection (until following afternoon). Took motrin to fend off fever
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's mother. The age at vaccination was not reported. The patient received Shingles vaccine, several years ago from the date of reporting. Recently the patient received Covid vaccine and a week later, the patient got shingles. It was unknown if the reporter considered the shingles to be related to COVID-19 VACCINE. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Shingles after 2nd dose of Pfizer Covid vaccine; This is a spontaneous report from a contactable male consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: unknown), via an unspecified route of administration on 09Mar2021 at 13:45 (at the age of 54-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of bnt162b2, dose 1 on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks. The patient did not receive any other medications in 2 weeks. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested COVID-19 post vaccination. The patient experienced shingles after 2nd dose of Pfizer COVID vaccine on 12Mar2021 at 06:00. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received anti-viral as a treatment medication for the event. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recv vax on 1/25/99; on 1/29/99 pt exp rash on arms & legs, joint pain w/ itching; tx=Benadryl
CHILD'S DATE OF BIRTH WRITTEN AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN SYSTEM WITH DATE OF BIRTH. CHILD TOO YOUNG FOR VACCINE IN SEPTEMBER 2021.  SEE Agency FOR FIRST DOSE ON 8/12/21.
Moderna COVID-19 vaccine EUA.  Adverse events: headache, muscle pain, chills, nausea and vomiting
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299814, 2018SA299809, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 77 years old female patient (height: 68 weight: 196 lbs) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. 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. List of documents held by sender: none.
Parosmia. Initially lost taste and smell after COVID infection In December 2020. 3 days after COVID vaccine, she developed abnormal smell/taste. Food smelled and tasted like garbage or sewage. Patient lost a significant amount of weight. Symptoms are only somewhat better 6 months later.
Narrative: Patient presented to lab for bloodwork following vaccination and was observed to have a rash that turned into welts and extreme itching.