chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I'm dizzy at times; a mild headache/head a little swirly, & a mild headache; My right ankle is painful; My right ankle is incredibly stiff, I have to loosen it up to get it going; achiness; kind of run down/Super fatigued; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (My right ankle is incredibly stiff, I have to loosen it up to get it going), DIZZINESS (I'm dizzy at times), MYALGIA (achiness), FATIGUE (kind of run down/Super fatigued) and HEADACHE (a mild headache/head a little swirly, & a mild headache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001JN2A, 027C21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced MYALGIA (achiness) and FATIGUE (kind of run down/Super fatigued). On 16-Jan-2022, the patient experienced JOINT STIFFNESS (My right ankle is incredibly stiff, I have to loosen it up to get it going) and ARTHRALGIA (My right ankle is painful). On 19-Jan-2022, the patient experienced DIZZINESS (I'm dizzy at times) and HEADACHE (a mild headache/head a little swirly, & a mild headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 400mg.. At the time of the report, JOINT STIFFNESS (My right ankle is incredibly stiff, I have to loosen it up to get it going), DIZZINESS (I'm dizzy at times), MYALGIA (achiness), FATIGUE (kind of run down/Super fatigued), HEADACHE (a mild headache/head a little swirly, & a mild headache) and ARTHRALGIA (My right ankle is painful) outcome was unknown.            Concomitant medication was not provided.
Slight numbness on my upper part of my mouth; Felt aching joints; Wheezing; Headache; Cough; This is a spontaneous report from a contactable consumer (patient). A 59-years-old patient of an unspecified gender received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0167, Expiration Date: Aug2021), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Medical history included Hypertension (Blood pressure high), Antiphospholipid syndrome, Seizures. Concomitant medication(s) included oxcarbazepine (TRILEPTAL) taken for seizure; metoprolol taken for an unspecified indication; simvastatin taken for an unspecified indication; warfarin taken for an unspecified indication. On an unspecified date patient experienced slight numbness on my upper part of my mouth, felt aching joints, wheezing, headache, cough. Consumer stated, "I think it was, it was Friday the 28th of April (year not clarified), believe that was the day I got my Pfizer Vaccine and it like within a few minutes I felt like a slight numbness on my upper part of my mouth and then it went on from there and later that day I just felt aching joints like all of my joints. I had a wheezing, cough, it just kept progressively getting worse and worse, until it's still that way right now. I take Tylenol. My doctor said that it's alright because I already have like a blood sickness problem. I have to take Coumadin to keep my blood thin enough so I will not have a seizure or stroke. Those are the two things. So, I was supposed to call and tell you according to my doctor's office that I should tell the company what my reaction was and it just, it is not what I expected. I never thought it would bother me at all and it also covered my daughter too (Further clarification unknown). She felts better now, I don't. When I have a headache every time the Tylenol wears off and that's what like, you know the whiplashes like if you get ruined in the car and your head snaps back and you get your head hurt usually after you get in an accident, at the back of my neck it's like that, that's what I had everyday I wake up, without Tylenol. I just feel so terrible so I don't know what you wanna do with reaction I just was recommended to tell that to you so the company (incomplete sentence.)" When probed for the treatment, consumer stated, "Just Tylenol. Consumer stated, "I don't think I can take the last shot if that one hit me this hard. I don't think I'm going to take it. I will not be taking the second shot of the vaccination. I just can't risk that. I can't have it, not worth the reaction. I'm not going to do it." The outcome of all events was unknown.  QR comment: This case might be a split. However, split case not made by the call handler.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The pt experienced serum sickness, the same evening of the vax. The pt also experienced a red raised rash on the legs and swollen purple feet. Was seen in the office and confirmed to have serum sickness.
L Jaw paresthesia; L UE paresthesia; L LE paresthesia >woke during night with these symptoms.
Airways closed. Took Benadryl and albuterol inhaler.  Continued treatment for another 24 hours
Pfizer COVID vaccines received on 04/01/2021 and 04/23/2021. Hospitalized on 11/17/2021. Diagnosis: Symptomatic bradycardia and COVID pneumonia Treatment: Patient took azithromycin, medrol dose pack, Advair Diskus, and Flovent before ER then while hospitalized Decadron, anti-infectives, supplemental oxygen
She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away; Covid-19 after the 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19 after the 1st dose) and INTENTIONAL PRODUCT USE ISSUE (She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced COVID-19 (Covid-19 after the 1st dose). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away). The patient was treated with Manual therapy (monoclonal antibodies on 29-Mar-2021) for COVID-19. At the time of the report, COVID-19 (Covid-19 after the 1st dose) and INTENTIONAL PRODUCT USE ISSUE (She was given the another dose of the vaccine on 11Jul2021 but when she went back for for the next dose she was turned away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.
Inconsolable crying and jaw clenching with myoclonic jerks beginning 5 hrs post vaccination, lasting for 6 hrs. Temp 100.2 in ER.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-MAY-2015 the patient was received improperly stored VARIVAX (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Pt awoke at 0200 on 8/13/20 with fever of 102.8F, redness on L arm at site of injection. Pt was given Ibuprofen and fever improved to 101F. Pt had redness and tenderness extending from injection site toward elbow.
7 days after my second shot I got a itchy rash on my left breast that last for 48 hours.
We waited the 15 minutes after the shot before leaving.  On the drive home, throat became "scratchy" - her description. And her nose started to bother her.  She took a Benadryl, a two hour nap, and then she was fine. She's never had an allergic reaction to anything, but it seems like she may have just had her first.  I received the same vaccination at the same time, and no reaction at all for me.
no adverse event; expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    Patient's age was reported 68 years 0 months.  No concomitant medications were reported.  The reporter informed that, the expired Moderna vaccine was administered to the patient between 08-Apr-2022 to 15-Dec-2022.  No treatment medications were reported.
Shoulder Pain to the level 10 at onset.  Burning at injection site.  Then pain extending up the neck and affecting the trigeminal nerve giving pain over the entire scalp.   For three months surface headache varying between pain levels 5 to 8.  Now at six months, headache pain varying between 3 to 5 with an occasional pain to 8. Consulted an orthopaedic doctor for a shoulder xray, which showed nothing visable.  Consulted a neurologist who explained the trigeminal nerve involvement.  Tried prednisone.  No affect.  Tried 4 accupuncture treatments with an MD.  No effect.  Can still feel the shoulder pain and a cuff of burning at the injection site.  Use Aleve occassionally when going somewhere important.
48 hrs after vaccine given, deltoid muscle became markedly swollen, red, firmness at site of vaccine, markedly tender.  Pt has returned to be seen twice for this concern at our office.  Site is improving as of 4/29/10.
Chills and very cold for over 12 hours. loss of appetite 48 hrs.  Stiffness in muscles over entire body till Saturday afternoon.
Woke up w/fever 18SEP-not measured until eve; when t105 R; APAP given & sponge bath; Pt taken to MD- app no prob w/throat, ears, chest, etc; MD felt fever related to pertussis immun; 14-15SEP pt "up all noc", fussy, but no fever;
Received FLUVIRIN 2013-2014 -0.5 ml dose on 10/3/2013. Came down with flu 4 days after receiving flu shot. Have been taking medication for cough and TYLENOL since 10/07/2013 to date 10/19/2013.
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional via other company (Pfizer) (2018071202). This case involves a 12 months old patient who received QUADRACEL instead of PREVNAR 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR Vaccine; and VARIVAX  (OKA/MERCK). On 14-Dec-2017, the patient received a 0.5 ml single dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine lot C5325BA via intramuscular route in the left arm. It was a case of actual medication error due to wrong vaccine administered. It was reported that no adverse event was observed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Approx 24 hr after time of vaccination patient reports breaking out in itchy blister-like rash on bilateral arms, trunk, and bilateral legs. Patient reports taking benadryl x1 with no relief.
After receiving a flu shot and Tdap the pt fainted while signing out for the vaccines. After checking on the pt he stated he hadn't eaten, was given juice and monitored for 15 mins pallor diminished and was alert/oriented, declined offer to call 911 and wanted to leave.
Developed a slight temperature and fever with some chills the night after getting the shot which is 9/11/2021.  On 9/12/2021, the fever broke in the morning and returned to normalcy the next morning till mid afternoon. I proceeded to feel intense stomach pain in  my abdomen around 3pm, this continued despite efforts to treat with basic over the counter medications (Tylenol) and some laxatives (mirilax) to relieve what I thought was constipation issue at the time based on what I ate for lunch. Finally went to the ER around 9:45pm with an intensely high heart rate of 140 (bpm). Got some Cat scans done and they determined that the issue was that I had appendicitis around 11:30pm-11:45pm from what I recall.  Stayed at the ER until 2:45am on 9/13/2021 where I was transferred after receiving and lot of fluids, antibiotic, and magnesium. Was transferred to the hospital after that were around 3-5pm I had an appendectomy to resolve my appendicitis. Currently on the course for recovery and discharged the next day in the morning.
This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was vaccinated with improperly stored dose of oral, ROTATEQ (dose, frequency and indication were not reported; lot # L037924 with expiration date: 22-JUN-2017). Concomitant therapies was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice; brain fog/brain fog never went away; hands & feet started to hurt; fingers started to swell especially the middle joints and fingers/Swell; extreme fatigue; joints started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice), FEELING ABNORMAL (brain fog/brain fog never went away), PAIN IN EXTREMITY (hands & feet started to hurt), PERIPHERAL SWELLING (fingers started to swell especially the middle joints and fingers/Swell) and FATIGUE (extreme fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING COLD (get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice), FEELING ABNORMAL (brain fog/brain fog never went away), PAIN IN EXTREMITY (hands & feet started to hurt), PERIPHERAL SWELLING (fingers started to swell especially the middle joints and fingers/Swell), FATIGUE (extreme fatigue) and ARTHRALGIA (joints started to hurt). At the time of the report, FEELING COLD (get cold, bone cold on the inside and soon rest of body started to get cold/oldness was horrible/she was turning into a block of ice) and FEELING ABNORMAL (brain fog/brain fog never went away) had not resolved and PAIN IN EXTREMITY (hands & feet started to hurt), PERIPHERAL SWELLING (fingers started to swell especially the middle joints and fingers/Swell), FATIGUE (extreme fatigue) and ARTHRALGIA (joints started to hurt) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The patient stated that no shivers yet but stated that it was an immune response. The coldness was horrible and was turning into a block of ice. Coldness sensitivity never went away completely.  Patient had no side effects until 9 hours later after 2nd dose. Patient kept on covering himself and was drinking warm fluids, but it had no effect, and this lasted for 4 days.   This case was linked to MOD-2021-404879 (Patient Link).
Administration error.  Patient received 0.3 ml instead of 0.5 ml dose.  Per CDC guidelines, dose was not repeated.
RINGING IN THE EARS BILATERALLY; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced ringing in the ears bilaterally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in the ears bilaterally. This report was non-serious.
50 minutes after administration of the vaccine, the patient started to feel  like her throat was somewhat itchy and tight.  There was no wheezing or difficulty breathing.  IM benadryl was administered immediately, and blood pressure taken--which was found to be elevated.  Blood pressure continued to elevate further to the 180s/110s, and patient developed a "pounding headache"  She also complained of pressure behind her eyes and "a funny feeling in my face" (bilateral).  She was given 0.1mg of clonidine and was taken to the hospital by EMS
COVID-19 infection confirmed 4/19/2020 with hospital admission for acute hypoxic respiratory failure
Covid arm. 2 days after 2nd dose. Redness swelling itchy around vaccine site
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 5 (booster), single (Lot number: Gh9703) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3249), in left arm, as dose 2, single (Lot number: EW5318), in left arm, on 01Sep2021 as dose 3 (booster), single (Lot number: EW0179), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa: Allergy" (unspecified if ongoing), notes: Sulfa: Allergy. The patient's concomitant medications were not reported. Past drug history included: Sudafed, start date: 03Feb2021, stop date: 03Feb2021, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment for the event.
Pt vaccinated with Pedvac/DTP/OPV developed unusual high pitched cry, pain to touch on the HIB leg, irritable, & tired.
got the two covid shots and  the other one, the booster.  ended up, just now, found out he probably got covid; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (got the two covid shots and  the other one, the booster.  ended up, just now, found out he probably got covid) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (got the two covid shots and  the other one, the booster.  ended up, just now, found out he probably got covid). At the time of the report, SUSPECTED COVID-19 (got the two covid shots and  the other one, the booster.  ended up, just now, found out he probably got covid) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company comment- This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Suspected covid. The caller stated that he got the two Covid vaccinations and  a booster but still probably got Covid. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Suspected covid. The caller stated that he got the two Covid vaccinations and  a booster but still probably got Covid. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
About 24 hours after 1st shot: arm felt like punched it - however - also felt like hands and feet were tingling like they were asleep and  left front thigh was sore , back of left calf was sore then hands and feet were not only asleep but on fire and body sore all over like the flu and then felt like I was being pulled and stretched by my hands and feet that were on fire.  Next day hands still tingle just slightly up arms and down my knees to outside my legs to my feet still tingle along with arm still feels like hit it.