chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headaches; Body aches; Teeth chattering/Chills; Arm sore; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Aug2021 at 15:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, pre-diabetic, sleep apnea, polycystic ovarian syndrome (PCOS), allergies to milk and shrimp. Prior to the vaccination, the patient was diagnosed with COVID-19. On 24Aug2021, the patient underwent nasal swab test and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 31Aug2021, the patient experienced headaches, body aches, chills, arm sore and teeth chattering. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, body aches, chills, teeth chattering and arm sore was recovered on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a 60 year old female patient regarding herself. The patient's medical history was not reported. The patient's concurrent conditions included allergy to ampicillin, neosporin oils and baby oil. On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX (Lot number, dose and route were not reported). Concomitant medications included unspecified hormone medicines. On an unknown date in 2011, after receiving the shot she did not feel well, a few hours later she noticed white bumps with pus-like liquid on her face that were burning and itching. The patient recovered from the events after few days. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
head feels heavy; eyelids feel heavy/eyelids feel watery; was in bed all day with profound weakness; fatigue; chills/shivering; headache; fever of 101; This spontaneous case was reported by a nurse and describes the occurrence of HEAD DISCOMFORT (head feels heavy), EYELID IRRITATION (eyelids feel heavy/eyelids feel watery), ASTHENIA (was in bed all day with profound weakness), FATIGUE (fatigue) and CHILLS (chills/shivering) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 025L20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced ASTHENIA (was in bed all day with profound weakness), FATIGUE (fatigue), CHILLS (chills/shivering), HEADACHE (headache) and PYREXIA (fever of 101). On 09-Nov-2021, the patient experienced HEAD DISCOMFORT (head feels heavy) and EYELID IRRITATION (eyelids feel heavy/eyelids feel watery). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date for Adverse event, at a dose of 2 dosage form and IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 600 mg. At the time of the report, HEAD DISCOMFORT (head feels heavy) and EYELID IRRITATION (eyelids feel heavy/eyelids feel watery) outcome was unknown, ASTHENIA (was in bed all day with profound weakness), CHILLS (chills/shivering), HEADACHE (headache) and PYREXIA (fever of 101) was resolving and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 101 (High) fever of 101 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient reported that, after getting the booster shot, on 06-Nov-2021, she had chills, shivering, headache and fever of 101 that started day after booster dose. She stated she was in bed all day with profound weakness. On 07-Nov-2021, she still had the symptoms but to a mild degree, she had burst of energy for 2 hours but felt fatigued after that. She reports having fatigue on and off on 07-Nov-2021. And on 08-Nov-2021, the fatigue was not on and off, only had one incident where she had energy. She stated on 09-Nov-2021, she still has fatigue. She stated headache was not as bad, head feels heavy, eyelids feel heavy and watery. She mentioned her reaction to the booster was not as severe as the second dose.   This case was linked to MOD-2021-380979, MOD-2021-380951 (Patient Link).
High fever and body aches 12 hours after injection. Headache 6 hours after injection continuing up to 48 hours. Extreme pain in arm 48 hours after with pain increasing.
Z79.01 - Chronic anticoagulation J18.9 - Left lower lobe pneumonia R29.6 - Multiple falls A41.9 - Sepsis (CMS/HCC) R09.02 - Hypoxemia J44.1 - COPD exacerbation (CMS/HCC) I50.9 - CHF exacerbation (CMS/HCC) R79.89 - Elevated brain natriuretic peptide (BNP) level
Pt states that she experienced sharp throbbing pain that radiated up her shoulder increasing burns. Onset approx. 10-15 post vaccination which progressively worse within the hour.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 09-MAR-2018 (reported as "2 months ago"), the patient was vaccinated with the first dose of GARDASIL 9 intramuscular route, in her left upper arm region (dose, frequency, anatomical location, lot # and expiration date were unknown) for human papillomavirus (HPV) prevention. On an unspecified date in May 2018, (reported as "a few days") after receiving injection, the patient reported what felt like "a small pebble under her skin at the injection site". Pharmacist reported that on 08-MAY-2018 patient returned to the Pharmacy and she palpated the small pebble under the skin at injection site. At the time of the report, the outcome of injection site mass was unknown. The pharmacist did not mention the causality assessment between the events of injection site mass and GARDASIL 9. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA004067.
Covid test date: 02Feb2022 Covid test result: Positive; Covid test date: 02Feb2022 Covid test result: Positive; high fever; Congestion; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 27 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 23Mar2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 02Mar2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Feb2022, outcome "unknown" and all described as "Covid test date: 02Feb2022 Covid test result: Positive"; PYREXIA (non-serious) with onset 29Jan2022, outcome "unknown", described as "high fever"; NASAL CONGESTION (non-serious) with onset 29Jan2022, outcome "unknown", described as "Congestion"; FATIGUE (non-serious) with onset 29Jan2022, outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) unknown results; sars-cov-2 test: (02Feb2022) positive. It was unknown if therapeutic measures were taken as a result of pyrexia, nasal congestion, fatigue.  Clinical course was reported as: Adverse event: sx 29Jan high fever congestion and fatigue no known exposure remote worker. The patient had received covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Later night of vax, pt exp left arm throbbing, large area of erythema, swelling & pain left lateral deltoid region, tender to palpation
She has had an MMR in the past here in our hospital without reaction. This was her second MMR- she read the VIS after getting her shot. She said that about 5 hours later she started with the following symptoms: fever, joint pain, itching, BP up and down, glucose up and down, ringing in her ears, sore throat. States she passed out at home in the shower, she thinks 5/31-- but thinks due to low BP. She said she was not injured in the shower, no bruises and was alert when she came to. She started drinking more fluids and that didn't happen again. She said that her symptoms aren't getting better, but worse. BP today (6/3) 152/100, HR 80, temp 97.8 F. Will send to clinic for care or ER if she prefers. No noticeable redness on arms, neck. Cheeks are somewhat red. Talking without difficulty. Hears well with conversation. Last bowel movement was 6/2/16-- only once and was just slightly loose stool. No vomiting since 5/28.
On the evening of vaccination child developed a hoarse voice progressing to cough and general malaise "feeling bad". On 2-16-08 reported increased hoarseness of voice, "wheezing", cough and fever 101deg - No respiratory distress or change in level of consciousness. On 2-17-08 am feeling better - less wheezing and voice coming back. 2-18-08 fever again 101deg. Seen at clinic on 2-19-08 exam Afebrile, O2 Sat 100% room air, breath sounds clear and productive cough - but improved per "patient". Continued to have cough through week and on 2-22-08 pm developed hives over body which responded to Benadryl. Denied respiratory distress or decreased LOC. Seen 2-26-08 at clinic diagnosed with cough, lower respiratory tract infection. To begin Azithromycin- No respiratory distress, Afebrile, O2 Sat 99%; she continues to have intermittent hives
Diagnosed with sudden onset SNHL 5 days after Moderna Booster shot. Drastic hearing loss in Rt. EAR. Treatment was high-dose steroid taper starting at 60 mg down to 10mg over the course of 14 days. After treatment hearing improved.
Patient came to the pharmacy on 12/1/2020 at 12PM expressing concerns about the area of injection on his left arm. After the shot on 10/12/2020, patient experienced soreness, difficulty in lifting items and decreased range of motion. He said he has not seek medical attention for this . He has tried compress but did not work. Suggest patient to try OTC NSAID to help with the pain and compress. Informed him to seek medical care if there are no improvement of symptoms after couple days.
On 05/03/2022, the Tuesday following my fourth dose of Pfizer, I had the worst headache I had ever experienced. Three days later, I began to have double vision. A friend took me to the local emergency room. I was ultimately diagnosed with having a slight stroke. They took me to a larger hospital and did an MRI of my brain. The MRI that was done showed a bleed in the left temporal. I have never had high blood pressure or high cholesterol and have had a good health history, so this was all sort of out of blue.
Sore arm after first vaccine for 1 day. Resolved. Sore arm after 2nd vaccine about 2 hours after. 21 hours after, chills, lathargic, slight headache. Not feeling feverish but had a fever of 101.2 Took tylenol, waiting to see if it resolves.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 29-AUG-2016, the patient was vaccinated with an improperly stored dose of RECOMIBVAX HB injection, lot # L048849, expiration date: 04-FEB-2018, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 1.8 degree Celsius for 7 minutes, 1.9 degree Celsius for 7 minutes and 1.0 degree Celsius for 35 minutes, respectively. The temperature excursion was captured using digital data logger. No prior excursions were reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Breakthrough COVID infection in fully vaccinated patient. Positive date 07/15/2021.
pt recv vax 10MAR97 & & devel lethargy;11MAR97 pt devel irritability & anorexia;all the sx were mild & pt mom thought they might have been secondary to teething;
05/14/05- developed a raised, red, non-itchy, non tender rash on face spread to neck, chest and back. Abdomen and arms. TX with Allegra and Aveeno bath.
Swelling, redness at injection site. Difficulty walking/moving. Muscle pain in upper extremities (bilateral). Muscle pain/weakness in lower extremities (bilateral). Fatigue and loss of appetite. Immobility.
Chills, body ache, headache, slight nausea. ..all except nausea was severe btwn 11pm-8am (got the shot around 4pm) with difficulty sleeping; had to take off work the next day (Tues) and slept on and off until 3pm. Felt like the flu but without respiratory issues. Fatigue and headache after that (that evening), more mild. Wednesday worked from home, but developed runny nose, sneezing, and scratchy throat, ears feel clogged; feels like oncoming regular cold (current state, reporting now).
The provider ordered Dtap, IPV, Hib, Hep B and MMRV but did not specify what brand (combination) to give. The medical assistant confirmed the order and asked if Kinirix (Dtap-IPV) could be used. The provider confirmed the use of Kinirix. The MA gave the vaccine. The MA reported the error on 7/14/23 and the case was reviewed by the lead physician with the provider and MA. Corrective action was taken to ensure the provider writes/documents the specific brand of vaccine or combination of vaccine to be given when writing vaccine orders. The MA was re-educated on the requirement not proceed with any order that is not written with the brand or combination identified, to follow the manufacturer instruction and limitations on age printed on the vaccine box and to contact the lead doctor if she has any question about a vaccine.  The patient's mother was notified of the error on 7/17/23. The mother has not reported the patient having any symptoms or signs of any consequence from the vaccine.
Became extremely weak and sick for 3 days after the shot. Had a grand mall seizure 19 days after vaccine. Also had a really bad headache and lost vision in my left eye for nearly 8 hours about 2 weeks after the seizure. Have had dizziness and been feeling week for nearly 2 months after vaccine and still cannot manage to get rid of the constant headaches and loss of thought due to these side effects.
Patient was given DAPTACEL at 3 years and 11 months instead of at 4 years-old, with no reported adverse event); Initial information received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male who was given diphtheria -15/tetanus/5 AC pertussis vaccine [Daptacel] at 3 years and 11 months instead of at 4 years-old, with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown (dose 4) of suspect diphtheria -15/tetanus/5 AC pertussis vaccine, Suspension for injection (strength, lot number and expiry date - not reported) at 3 years and 11 months instead of at 4 years-old, with no reported adverse event) (inappropriate schedule of product administration) (unknown latency) via unknown route in unknown administration site for prophylactic vaccination.  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 guidelines. 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.
Received 1st dose of moderna and 2ns dose of J&J vaccine; She felt fatigue; muscle soreness, whole body ache; Arm hurts bad; Severe anxiety; Neck pain; Couldn't really getup; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts bad), ANXIETY (Severe anxiety), NECK PAIN (Neck pain) and ASTHENIA (Couldn't really getup) in a 55-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 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts bad) (seriousness criterion medically significant), ANXIETY (Severe anxiety) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), ASTHENIA (Couldn't really getup) (seriousness criterion medically significant), FATIGUE (She felt fatigue) and MYALGIA (muscle soreness, whole body ache). On 14-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received 1st dose of moderna and 2ns dose of J&J vaccine). On 14-May-2021, WRONG PRODUCT ADMINISTERED (Received 1st dose of moderna and 2ns dose of J&J vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts bad), ANXIETY (Severe anxiety), NECK PAIN (Neck pain), ASTHENIA (Couldn't really getup), FATIGUE (She felt fatigue) and MYALGIA (muscle soreness, whole body ache) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient took vaccine on deltoid muscle. On 14May2021 patient received J&J shot.  Concomitant product use was not provided/unknown by the reporter.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Treatment for events included pain killer.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Intense rash on back of thighs. Starting 2nd round of Prednisone. Rash came back 5 days after 1st course.
redness in oval shape/ patch on left arm; swelling at injection site; stiffness around his left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (stiffness around his left arm), VACCINATION SITE ERYTHEMA (redness in oval shape/ patch on left arm) and VACCINATION SITE SWELLING (swelling at injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Condition reported).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (stiffness around his left arm). On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in oval shape/ patch on left arm) and VACCINATION SITE SWELLING (swelling at injection site). On 28-Jan-2021, VACCINATION SITE SWELLING (swelling at injection site) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (stiffness around his left arm) outcome was unknown and VACCINATION SITE ERYTHEMA (redness in oval shape/ patch on left arm) had not resolved. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included ice(which was put on and off the site of events)
Head to toe rash morning after immunization. Cleared within 12 hours, Pruritis. Used "Itch Eraser" on spots (contains 5% baking soda).
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment medication information provided.   This case was linked to MOD-2021-392458 (Patient Link).
Began having hives & itching on 06/15/2007, 15 days after vaccination.
Patient developed acute bilateral pleural effusions within 12-24 hours of vaccine administration requiring hospitalization and treatment with lasix.  CT scan did not show PE or pneumonia, only pleural effusions.  ECHOCARDIOGRAM normal EF-no evidence of myocarditis. She was discharged roughly 24 hours after admission and evaluation.
Patient admitted to Hospital on 5/14 for portal vein occlusion/thrombosis with unknown etiology.    Pt receive Moderna COVID vaccine (1st dose in 3/5 and 2nd dose on 4/12.   Hem/Onc consulted, managed with lovenox with follow up at Hem/Onc clinic.   Discharged on 5/19/2021
pt with end stage renal disease, on hemodialysis; presents to ED with SOB; positive for COVID, COVID pneumonia; during the pt's stay, required ventilation support; condition worsened; multi-organ failure; expired in the hospital
taste in mouth Narrative: He notes having developed a "funny taste" almost immediately after the first vaccination, which spontaneously resolved after 30 minutes. He was unable to further describe the taste other than it was like "I ate something I was not used to" and denied metallic quality. He denied increased salivation, swelling, and issues swallowing + any other s/sx concerning for angioedema or immediate allergic reaction.
Given rotavirus then soon after pt became unresponsive/lethargic decreased HR, NMI resp. no rash. EPI Jr given pt with increased responsiveness. Sent ER for evaluation.