chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, cold/chills and sweats.  Had to take 1 day off of work for the 1st shot and 3 days off the 2nd round.  Felt 10x worse than when I had Covid back in November.; Cold; Chills; Sweats; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 16:00 (at the age of 44-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Apr2021 (at the age of 44-year-old); both as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On an unknown date in Apr2021 at 16:00, the patient experienced fever, cold, chills and sweats, had to take 1 day off of work for the 1st shot and 3 days off the 2nd round, felt 10 times worse than when, had COVID back in November. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, fever, cold, chills and sweats was resolved with sequelae on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Major chills and body aches. Started almost 12 hours after vaccine, lasted for about 12 hours.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (dosing details were not reported (lot # M018810, expiry date: 28-MAY-2018 (incorrect product storage). No adverse effect were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.
shortness of breath, tightness in chest, vertigo, naseau, diziness, disorientation, soreness at site
c/o lt arm sore & achy where needle went in bumped up sl red about 1" in diameter-did not take temp-warm to touch;took APAP & ice packs;
After I received the first dose, I left observation after 15 minutes. At about 9:00am (30min after I received my shot) my face felt numb and itchy for about 2 hours. I did not report this reaction to any health professional because I did not believe it was severe enough for treatment.
initial severe headache , myalgia, fatigue.   most onset within 12 hrs.  resolved approx 2 days.    back pain and left thigh pain persist one week after injection.
Headache, Rash on L bicep, itchy skin all over body w/out visible rash, fatigue, joint pain, especially in L hip and knee. Oatmeal bath, BENADRYL, Calamine lotion, 800mg Ibuprofen
Loss of vision in left eye; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Loss of vision in left eye) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced BLINDNESS UNILATERAL (Loss of vision in left eye) (seriousness criterion medically significant). At the time of the report, BLINDNESS UNILATERAL (Loss of vision in left eye) had not resolved. Not Provided          On 23-Apr-2021 (2 weeks after receiving the second dose), patient had loss of vision in the left eye.   Concomitant product use was not provided by the reporter. No treatment was received by the patient.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Pt developed vomiting x 6 during night of 31JAN91; had bad smelling diarrhea the morning of 1FEB91; poss low grade temp morning of 1FEB91;
Hives appeared on cheeks, triceps, elbows, buttocks, hamstrings, knees lasting more than 10 hours. Treatment: Benadryl + topical hydrocortisone gel
I feel nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (I feel nauseous) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (I feel nauseous). At the time of the report, NAUSEA (I feel nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants medication were provided.  No treatment medication were provided.
tinnitus/noticed a ringing in my ear; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 60-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7533, Expiration date: unknown), via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 60-years-old) as dose 2, single for covid-19 immunisation.The patient medical history included patient had known allergies. The patient concomitant medications were not reported.The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route on 21Mar2021 at 13:00 (at the age of 60-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.The patient did not receive any other medications within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 15Apr2021, the patient experienced tinnitus noticed a ringing in his ear. Patient stated that prior to the vaccine he did not had any issues with my hearing. Subsequent to the vaccine he noticed a ringing in his ear.The patient underwent lab tests and procedures which included COVID Nasal Swab test was negative on 06Jul2021.The patient did not receive treatment for event. The event was assessed as serious disability. The outcome of the event was not recovered.
A couple of days after the  first vaccine shot my ears began to itch uncontrollably. After 2 weeks, it progressed to my neck, but was manageable with over the counter lotion. After the second shot a month later, the itching progressed to my chest and arms. It?s become painfully itchy and I believe it to be eczema. However, I have never had this skin condition in the past. I have kept the skin clean and tried many treatments short of going to a doctor. Rubbing alcohol, witch hazel, eucerin cream, hydrocortisone cream, Benadryl anti itch cream, Benadryl, washing my bedding, and cutting my hair away from the affected areas provided no relief.  It?s been 2 months since the first symptoms and nothing has changed. In fact, it?s progressively gotten worse.
hypoxic, ecephalopathic, influenza A, COPD - reqiring BIPAP, IV diuretics,  steroids, 5 days of tamiflu. 3/3 + COVID test. AFIB with RVR on amioderone; AKI; O2 at 2L - will continue at dc. recommnent SN at dc, family prefer to take pt home.
Within 1 week I had aching and pain going down the same arm and in my left hand that continued for a month.
Large red circle, approximately 3 inches wide, appeared on my left arm 8 days after getting the first vaccine shot. No pain associated but it itches and is red
After the second Covid vaccine, my 13 year old daughter began having a heavy period that has not stopped at all.  She has been bleeding for 4 months straight. She also has had nausea, dizziness, abdominal pain and decrease PO intake. The doctor put her on birth control and had to increase the dose but she is still bleeding!!! If I would have known this could have happened, I never would have allowed her to get the vaccine.  She missed several days of school because of her symptoms. I have to call her gynecologist back again and increase her birth control dose again to try and stop the bleeding!
16 year old boy got vaccinated by mistake with first dose; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old boy got vaccinated by mistake with first dose) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old boy got vaccinated by mistake with first dose). On 11-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old boy got vaccinated by mistake with first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number 030A21A) with no associated AEs reported.
Information was received on 18NOV2014 via a telephone call from a pharmacist regarding a male patient. The pharmacist reported that on 17NOV2014 the patient received a dose of ZOSTAVAX (0.65ml subcutaneous) that underwent a temperature excursion. No adverse event was reported. No further information was provided. Additional information is not expected.
Report cough, congestion and fatigue.  Treatment: none  Outcome: Does not interfere with ADLs, will PCP for cough an congestion for possible COVID test.
Several hrs. after receiving both flu vaccines, pt began having H/A, swollen feeling and generalized papular rash.
Mother declined the HPV vaccine on 10/12/2022, therefore Dr. did not place an order. MA proceeded to administer the vaccine even though there was no written order. MA failed to document the given vaccine although it was administered incorrectly. Patient came for a second visit 10/26/22 now accompanied by father. Father was unaware of the situation and was offered the HPV vaccine, to which he consented. Patient received an invalid second dose not within the vaccine schedule. Mother has been informed. As advised my Dr., there is no harm to patient, patient received an additional dose.
On an unspecified date caller received 2nd Pfizer Covid vaccine the end of March and started chemo in April, did not share when she was diagnosed with cancer; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date (as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On an unspecified date caller received 2nd Pfizer Covid vaccine the end of March and started chemo in April, did not share when she was diagnosed with cancer. She would like to know if she has immunity to the Coronavirus if she started chemo so soon after receiving the vaccine. The patient received treatment with chemo. The outcome of the event was unknown.  Information about lot/batch number has been requested.
nasal congestion; Feeling abnormal; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion) and FEELING ABNORMAL (Feeling abnormal) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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 04-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling abnormal). On 05-Jan-2021, the patient experienced NASAL CONGESTION (nasal congestion). On 04-Jan-2021, FEELING ABNORMAL (Feeling abnormal) had resolved. On 19-Jan-2021, NASAL CONGESTION (nasal congestion) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-062598 (E2B Linked Report). This case was linked to MOD-2021-062598 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062598:
Redness, swelling, warm to touch on 8/26/06. DTaP given on 8/24/06. Instructed to use Benadryl.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: After the vacccine was administered, patient started feeling dizzy and faint. Patient never fainted, just felt faint and a bit nauseous. Recevied permission from patient to call 911 to have her closely monitored. Paramedics came and took vitals and spoke with her. They offered to take her in but patient refused and said she felt fine after vaccine was given and can go home on her own. Her husband came in afterwards and they left together.
Full Body Rash - I've had this for the last couple days.  This is not an abnormal response for me as I often get a rash if I have a fever or before menopause when I would be on my period.  And a rash is the allergic reaction I get when I take penicillin or amoxycillin. But I don't have a fever accompanying this (or any other symptoms) and it is more extensive and longer lasting than I've experienced before
Extreme shortness of breath. Initially 1 day a week for 15 min. Then every other day, then every day, then twice a day. Length of attacks now ranges 15min-all day.
Symptoms appeared approximately 12 hours after injection.  Extremely tired; severe headache which lasted almost 24 hours;  left arm extremely sore and swollen at injection site; joints sore, could not sleep through the night because of discomfort
Information has been received from a nurse, concerning a currently 14 years old female patient. The patient's current condition included postural orthostatic tachycardia syndrome (POTS). Concomitant medications included propranolol 10 mg, 1 tablet bid, hydroxyzine for sleep issues and birth control pill. The patient had not known drug allergies. On 18-FEB-2019, the patient was vaccinated with the second dose of GARDASIL 9 intramuscular injection, lot number R024264 with expiration date 29-OCT-2019 for prevention human papilloma virus (HPV) (dose and anatomical location not reported). On 20-FEB-2019, the patient experienced swollen lymph nodes in the axilla of the injection arm, localized injection site pain and pain with movement of arm. On 21-FEB-2019, the patient went to the office and had an x-ray that was negative. A complete blood count was performed on the same date, and no results were provided. The patient still had injection site soreness on 21-FEB-2019. On an unspecified date, the patient received and unspecified treatment for the adverse events. The patient was not recovered from the adverse events at the time of this report.
Acute bursitis - pain when lifting arm due to vaccine being injected right below the acromion rather than into the deltoid muscle. This is the first time I've ever experienced such pain during and after vaccination.
Patient returned to pharmacy reporting arm is still painful to the point that she cannot use for extended period of time.
12 hours after vaccination -->generalized muscle aches and arthralgia (of major joints symmetrically painful (both knees, lateral movement of neck stiff) no joint swelling; felt chills no fever. No URI symptoms; and both thigh pain aggravated by change of position (standing from sitting to rising from chair)and even going down flight of stairs. Generalized malaise, felt sick and tired.  NO diarrhea no loss of taste. The following day (Sunday) all complaints resolved. No meds taken throughout post vaccination
Child developed erythema and swelling at injection site. Area measured 8cmx10.5cm right anterior thigh where vaccine appeared to be given.
mom stated went to PMD p/leaving clinic had 7-8 whelps on lt leg; t102; stated MD gave DPH; stated also that pt became lethargic;
Headache, neck and shoulder pain. 1 week following vaccine had red itchiness at site of injection.
swollen arm; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, But it was considered as invalid and restarted vaccination.), for COVID-19 Immunization, reaction(s): "feeling week", "swollen arm where injected". The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen arm"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: Patient got first dose at withheld clinic and did get few side effects like feeling week and swollen arm where injected. Reported as, now it was invalid so patient started revaccination and got first dose this Monday April 19th (considered as dose 2) with side effects like swollen arm and headaches. Patient's next dose (reported as second dose) scheduled on May 10th. Based on the above observations patient had a feeling if dose with withheld is valid, May 10th dose will be 3rd dose. But it was mentioned that clinical trials are going on to see what happens with 3rd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VACCINE SPRAYED OUT THE SIDE OF THE SYRINGE AND PT ONLY GOT HALF OF DOSE
Patient was given the incorrect medication. Patient received monovalent Pfizer COVID vaccine instead of the bivalent vaccine. No known adverse reactions from the vaccine. Patient was contacted today and states that she isn't feeling any adverse effects from vaccination. Patient wasn't able to be reached yesterday.
Fatty deposits developing on lower back, water blisters on feet, A.D.H.D like symptoms, aggression, panic attacks, depression, rapid tooth decay. Hospitalized for severe depression. Currently undergoing counseling.
Pulsatory tinnitus. Headache that worsens when bending over. Both symptoms worsen as the day progresses. As of this report 09/23/2021 the symptoms persist.
Hospitalization: Admit date 8/5/2022; Discharged 8/23/2022  Presentation to the ED: by ambulance, chief complaint of R Knee pain. Patient was diagnosed with sepsis on this admission. Treatment: Vancomycin for sepsis monitoring. No documentation of COVID prophalyxis treatment.  COVID + result: 8/5/2022  Discharge: Facility
expired Fluzone vaccine was administered with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA418873(CLUSTER).  This case involves a 2 years old female patient to whom expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-OCT-2022, the patient received 0.5 ml of expired INFLUENZA QUADRIVAL A-B VACCINE with no reported adverse event (expired product administered) (lot UT7378MA and expiry date- 30-Jun-2022) via intramuscular route in unknown administration site for immunization or TB test.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
Information has been received from a registered nurse (R.N.) concerning a patient who on 03-JUN-2008 was inadvertently vaccinated subcutaneosly with a 0.5 ml dose of VARIVAX (Merck) (Lot #658053/1009U) instead of ZOSTAVAX (Merck). This was a human error. The VARIVAX (Merck) and ZOSTAVAX (Merck) were in the same location and the R.N. said that she just picked the wrong vaccine. No adverse events reported. Later that day (on 03-JUN-2008) the patient also received a dose of ZOSTAVAX (Merck) with no ill effects. The patient was seen at office. Additional information has been requested.
Fever, Chills and Body Aches onset 9 hours after injection.  Tachycardia and Insomnia continued until approximately 4am on 10/26. Symptoms persisted, including fever and night sweats, until the morning of 10/28/21.  Injection site soreness persists.
He was doing fine when I escorted him to the waiting area. Upon a few minutes later, he started to fell down. I was called and came to check on him. He told me he closed his eyes for a bit and started to fall down. I was not sure if the fall was because he lost balance or the shot made him fainted. There was no respiratory distress or any anaphylactic reaction so no Epipen was use. I applied cold pack to him and he recovered a few minutes later.
fever >101, chills, body aches, nausea, Headache, fatigue
Patient reports the following: -swollen arm (shoulder to elbow) -4x6 patch of redness and swollen on injection site -1 hour after injection, pain started traveling from left side to thigh -lump on thigh (no redness) -painful to touch (shower water is painful) -unable to take meds to help  Upon reporting these symptoms to pharmacy, we advised her to contact her primary care provider.  She stated she did not have one and no insurance. We advised her to seek out care to an Urgent Care center.  We also advised loratadine or diphenhydramine (but warned of drowsiness).