chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; tired; sore right arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EL9264) via an unspecified route of administration right arm on 01Feb2021 at 08:15 AM (at the age of 71-years-old) at single dose for COVID -19 immunisation. Medical history included high cholesterol and allergy to Beta iodine. No other vaccine in four weeks was received. No other medications taken in two weeks. On 01feb2021, she experienced sore right arm 18 hours after shot, also experienced headache and very tired on the same day at 10:00 AM. Events lasted for 24 hours. She did not COVID prior vaccination and there was no COVID tested post vaccination. She did not have fever. She did not receive treatment for the events. Outcome of events pain in extremity and fatigue was recovered on 02Feb2021 and headache recovered on an unknown date in Feb2021.  No follow-up attempts are possible. No further information was expected.
A fever at approximately 1:00am, chills, body aches, jaw hurt, headache, high heart rate
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional. This case involves a 65 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE via intramuscular route in the left deltoid on 04-Sep-2018 (lot no UJ004AB, expiry date: 30-APR-2019) and 19-Sep-2018 (lot no UJ010AC expiry date: 22-APR-2019) respectively. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to extra dose administered. It was reported that a 65 year old female received the Fluzone High Dose vaccine twice in error. It was reported that patient had no adverse reaction and has not gone to the emergency room. 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. Documents held by sender- none.
Developed severe pain in R shoulder radiating down to R wrist.  No weakness, numbness or tingling.  Seen by neurologist who dx brachial plexus neuritis.  Treated with course of po prednisone without improvement.  Now pending MRI.
The vaccine administered was found to be expired on 10/13/21 and the vaccine was administered on 10/20/21.
Following the vaccine I had a fever of 104.3. My temp stayed the same for a while and over the next month I had random fevers. I started getting what felt like brain zaps on the left side of my head. The skin on the left side of the roof of my mouth was peeling off so I went to urgent care. They prescribed me with liquid lidocaine and a paste to go on the area to allow it to heal. That took about a week and a half to heal.  My heart rate was also elevated at random times and this is still continuing. I am currently wearing a heart monitor. I was diagnosed with POTS (Postural orthopedic tachycardia syndrome). Also, I now sweat so much in my sleep that the medical grade tape for my heart monitor comes off every night and my bed is soaked. Upon further testing my doctor believes I have hyper adrenal POTS. I am currently taking salt tablet and heart medication (metoprolol).
Patient presented for first dose of COVID -19 vaccine. Patient was screened and counseled about risks, and side effects of vaccine. Patient given appropriate dose of Moderna (Spikevax) for fist dose, .5ml. Nursing staff was informed upon data entry that the patient had already received J&J on August 9, 2021. Nursing staff had overlooked this entry in patient's electronic record. However, Patient did present asking for his first dose and did not disclose any other COVID vaccination.
Information has been received from a RN concerning an 11 yr old white male who has no pre-existing allergies or medical conditions, who on 01Jan96 was vaccinated with a first dose of varicella virus vaccine live. The pt was not ill at the time of vaccination. On 04Dec05 the pt's mother called to report that the pt has approx 100 lesions on his body with itching. It was reported that a girl in the pt's class had chickenpox and exposed the whole class. It was also reported that 8 or 9 children in the class have come down with varicella. There were no laboratory tests performed. The pt recovered on 12Dec05. Additional information has been requested.
Dizziness & shakiness after the vaccination. No diaphoresis, nausea, tunnel vision, SOB, CP. Initial BP was 162/76, Pulse 66, )2 sat 98%.   BP progressively improved to 149/81.    Pulse & O2 sat remained normal. No orthostasis. Symptoms resolved complelely on their own with 20 minute observation.
aches all over body - she hurt all over; chills; fever; aches in muscles/pains in muscles; aches in joints/pains in joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches all over body - she hurt all over), CHILLS (chills), PYREXIA (fever), MYALGIA (aches in muscles/pains in muscles) and ARTHRALGIA (aches in joints/pains in joints) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN (aches all over body - she hurt all over), CHILLS (chills), PYREXIA (fever), MYALGIA (aches in muscles/pains in muscles) and ARTHRALGIA (aches in joints/pains in joints). At the time of the report, PAIN (aches all over body - she hurt all over), CHILLS (chills), PYREXIA (fever), MYALGIA (aches in muscles/pains in muscles) and ARTHRALGIA (aches in joints/pains in joints) outcome was unknown.            No concomitant information was reported. No treatment information was reported.
pt cried on & off for 3 days; felt hot x 3 days & was treated w/APAP; pt slept less & would get up during the noc frequently;
This spontaneous report as received from a pharmacist refers to a 32 year old female patient. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, in 2017, the patient was vaccinated with the first dose of VARIVAX on an unspecified physician's office and on 28-JUN-2018, the second dose at an unspecified facility subcutaneous for varicella vaccination (lot number and expiration date were not reported). On 27-SEP-2018, the patient informed the pharmacist that an unspecified lab test resulted in negative titers for varicella antibody (antibody test negative). The outcome of antibody test negative and the causal relationship between VARIVAX and the event antibody test negative were not reported.
Moderna vaccine caused achiness; Moderna vaccine caused fever; Moderna vaccine caused fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Moderna vaccine caused achiness), PYREXIA (Moderna vaccine caused fever) and FATIGUE (Moderna vaccine caused fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PAIN (Moderna vaccine caused achiness), PYREXIA (Moderna vaccine caused fever) and FATIGUE (Moderna vaccine caused fatigue). At the time of the report, PAIN (Moderna vaccine caused achiness), PYREXIA (Moderna vaccine caused fever) and FATIGUE (Moderna vaccine caused fatigue) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  Patient had Moderna vaccine and second dose caused fever, fatigue, and achiness.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of Moderna vaccine caused fever, Moderna vaccine caused fatigue, Moderna vaccine caused achiness with Skyrizi (risankizumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-630370 (Patient Link).
This spontaneous report as received from a healthcare worker, office manager, refers to an unknown number of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unspecified dates the unknown number of patients were vaccinated with doses of ROTATEQ (lot#, dose and frequency were not provided), which were exposed to supported temperatures out of range, orally. No adverse effect had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
pt devel red rash all over body on 11AUG92 & disappeared in 2 days & then returned; mom states it continued to occur approx every 2 days; pt was seen by MD 19AUG92 & given DPH;
Shortly after first dose on  5/17  (don?t have exact time or date when I felt pain  as I didn?t at the time relate this to the vaccine)  I started noticing pain in both thumb muscles. I adjusted my work to handle the pain due to this. Had to use two hands to squeeze sauce bottles, writing was painful, taking heavy pans out of the oven hurt me as well. Didn?t think much of it at the time. I work 50 plus hours a week and just thought it would go away.   5 days after my  second dose (a different location), while I was going to bed, both my arms went completely numb. Not a painful feeling at the time, but extremely scary and uncomfortable feeling. Like they weren?t part of my body.  Went to work the next day and the numbness got way worse and started the tingling pin and needle feeling. Started getting muscle burning, running out of space, but now have numbness in scalp,feet
pt recvd vax & exp painful hips & lower back, problems walking, & malaise; treated w/Naprosyn, APAP w/codeine & Flexeril; pt also exp uncontrollable diarrhea & a weak bladder;
Patient had Pfizer vaccine.  Approximately 20 minutes after vaccine, patient unable to stand upright.  Patient said she felt dizzy.  After sitting and having 8oz of water, patient complained of dizziness.  Dr. called and came to assess patient.  Dr. assessed patient and referred patient to ED for further evaluation unrelated to vaccine.  Patient transported to ED via wheelchair and assessed by triage.  Patient will remain in ED for further evaluation.
patient experienced onset of fevers, headache, neck pain, generalized malaise/fatigue/weakness, diarrhea/abd pain, with 2 ED visits ultimately admitted to hospital and diagnosed with MIS-A with elevated bnp, troponin, and inflammatory markers, and treated with dex 6mg x 10 days with complete resolution on follow-up.
34 weeks pregnant when received. 2-3 days after receiving vaccine swelling in feet started. A few days later swelling in hands started. Blood pressure noted to be elevated roughly one week post vaccination. This is second pregnancy and did not have gestational hypertension or preeclampsia with previous pregnancy. Currently diagnosed with gestational hypertension and wondering if this could be caused by this vaccination due to no other risk factors.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 17Jul2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: vaccine received and Other medication in 2weeks product: Melatonin, Benzonatate and Acetaminophen start date 05Jul2022, stop date 09Jul2022.Treatment: Paxlovid start date 05Jul2022 and stop date 09Jul2022 for Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pain; I couldn't work; pain and soreness at the injection site/arm is still sore and painful; Body ache and pain/I can still feel it with slight movements; chills; slight pain in my joints to the point were I couldn't work; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), IMPAIRED WORK ABILITY (I couldn't work), VACCINATION SITE PAIN (pain and soreness at the injection site/arm is still sore and painful), MYALGIA (Body ache and pain/I can still feel it with slight movements) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 007C21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Allergy NOS.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced PAIN (pain), VACCINATION SITE PAIN (pain and soreness at the injection site/arm is still sore and painful), MYALGIA (Body ache and pain/I can still feel it with slight movements), CHILLS (chills) and ARTHRALGIA (slight pain in my joints to the point were I couldn't work). 14-Dec-2021, the patient experienced IMPAIRED WORK ABILITY (I couldn't work). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Adverse event, at an unspecified dose and frequency. On 14-Dec-2021, CHILLS (chills) had resolved. At the time of the report, PAIN (pain), VACCINATION SITE PAIN (pain and soreness at the injection site/arm is still sore and painful), MYALGIA (Body ache and pain/I can still feel it with slight movements) and ARTHRALGIA (slight pain in my joints to the point were I couldn't work) had not resolved and IMPAIRED WORK ABILITY (I couldn't work) outcome was unknown.            The patient was on blood pressure medication and allergy medications concomitantly.   This case was linked to MOD-2021-415972 (Patient Link).   Reporter did not allow further contact
I had right side pain fever of 101 shortness of breath and nausea with dizziness including  pain
TIGHTNESS AND CRAMPING IN LEFT LEG AND RIGHT ARM; CONFUSED; GROGGY; TIGHTNESS AND CRAMPING IN LEFT LEG AND RIGHT ARM; TIRED; UPSET STOMACH; HEADACHE; MUSCLE ACHES; SHARP PAIN IN LEFT ARM; SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 205 pounds, and height was 73 inches. The patient's concurrent conditions included irritable bowel syndrome, alcohol user, cigarette smoker, and depression, and other pre-existing medical conditions included patient had no know allergy and no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced nausea. On 27-MAY-2021, the subject experienced sharp pain in left arm. On 27-MAY-2021, the subject experienced sore arm. On 30-MAY-2021, the subject experienced upset stomach. On 30-MAY-2021, the subject experienced headache. On 30-MAY-2021, the subject experienced muscle aches. On 31-MAY-2021, the subject experienced tightness and cramping in left leg and right arm. On 31-MAY-2021, the subject experienced confused. On 31-MAY-2021, the subject experienced groggy. On 31-MAY-2021, the subject experienced tightness and cramping in left leg and right arm. On 31-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate, and ondansetron. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain in left arm on 27-MAY-2021, had not recovered from sore arm, upset stomach, headache, muscle aches, tightness and cramping in left leg and right arm, tired, confused, groggy, and tightness and cramping in left leg and right arm, and the outcome of nausea was not reported. This report was non-serious.
feel her heart beating like crazy; temperature of 100; arm swelled up at the injection site; it turned bright red; arm has a lump in it; uncomfortable; very itchy; sore arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (uncomfortable), PRURITUS (very itchy), PALPITATIONS (feel her heart beating like crazy), INJECTION SITE MASS (arm has a lump in it) and VACCINATION SITE PAIN (sore arm) in a 67-year-old female patient 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 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and FATIGUE (tired). On 26-Feb-2021, the patient experienced FEELING ABNORMAL (uncomfortable), PRURITUS (very itchy), INJECTION SITE MASS (arm has a lump in it), VACCINATION SITE SWELLING (arm swelled up at the injection site) and VACCINATION SITE ERYTHEMA (it turned bright red). On 28-Feb-2021, the patient experienced PYREXIA (temperature of 100). On an unknown date, the patient experienced PALPITATIONS (feel her heart beating like crazy). On 22-Feb-2021, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, FEELING ABNORMAL (uncomfortable), PRURITUS (very itchy), PALPITATIONS (feel her heart beating like crazy), INJECTION SITE MASS (arm has a lump in it), VACCINATION SITE SWELLING (arm swelled up at the injection site), VACCINATION SITE ERYTHEMA (it turned bright red), PYREXIA (temperature of 100) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
got the horrible joint pain that I got with the first two shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "got the horrible joint pain that I got with the first two shots".  Additional information: Consumer stated, "I just have a question. I don't need to be reporting, I just have a question about booster that I got. I received the Pfizer Booster (Name not clarified, hence captured as Unspecified booster) yesterday around 11 and I was fine and then I got the horrible joint pain that I got with the first two shots (Further clarification unknown, hence suspect captured conservatively as unspecified shots; Manufacture not clarified, hence tab left unchecked) now I have like joint pain and chills and may be a fever but I don't know but you know tiredness and having horrible nightmare when I fall asleep. So, my question is how long is this last because its not severe enough to go hospital but I really feel awful." Consumer was informed about Pfizer drug safety role. Consumer was informed medical information department.Consumer stated, "By then hopefully the side effect will go away by Monday, wouldn't you think. They don't last forever when you get the shot. They should have somebody there all weekend because they want you to call and you are felling terrible you cant go the the hospital. So, they want people to get the vaccine, they should tell us if you getting this shot on weekend we are close. I am not blaming you but its ridiculous they want these people to get these vaccine, oh I am am sorry we cant talk to you now because we are not working that's just awful. You also give me the number I will wait till Monday." Consumer stated, "No, I am not doing that because its the same side effect that's they have on the list. It's not anything different, my question is how long do I have that its not anything new so no point documenting anything, if am feeling something unusual but its not its stuff they do know."  QR Comment: Reporter type could not be probed, hence captured as consumer or other non-health professional.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835533 Same patient, same product, different dose.