chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection was administered in appropriate area of left deltoid muscle.  Day of injection some arm pain, day after injection bruising at injection site was noticeable by patient.  With time, pain became more severe with swelling at injection site.  Peak of pain occurred approximately 1 week after injection and continues today on day 22, especially when arm is raised in certain positions.  Pain will radiate to shoulder and neck at times.  Pain is described as 9/10 for about 15 minutes when this occurs and is relieved with pressure to injection site where swelling is.
After the vaccine was administered he passed  out about 5 seconds after. He did  not hit his head or report any effects of falling to the ground from  a seated position.
Sore arm around injection site (2 days following vaccinations).  Chills, runny nose, muscle/joint aches, fatigue.  Began 4 days post vaccination and lasting < 24 hours.
p/recv flu vax & pt was dx w/ transverse myelitis; sx did not appear until spring. pt has extreme fatigue, feels nothing below the waist, gait significantly impaired; slight urine & bowel difficulties
My stomach started hurting I got nauseous next day I was lethargic sick and elevated temperature
This spontaneous report was received from a nurse and refers to a 3 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 18-SEP-2017, the patient was vaccinated with improperly stored RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) for prophylaxis. No adverse effects were reported. The administered vaccine underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
company administered a 2nd Bivalent Booster 20DEC2022; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (company administered a 2nd Bivalent Booster 20DEC2022) and NO ADVERSE EVENT (No Adverse event) in an 83-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (company administered a 2nd Bivalent Booster 20DEC2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (company administered a 2nd Bivalent Booster 20DEC2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (company administered a 2nd Bivalent Booster 20DEC2022).    No concomitant medication details was reported. No other vaccines received in the 4 weeks prior to COVID-19 vaccine. No treatment medication details was reported.
Patient was given the 2nd Moderna Vaccine 7 days before the recommended time between the 1st and 2nd dose.
No additional AE reported; An improperly stored dose of M-M-R II and VAQTA were administered to the patient on 24MAY2022 after experiencing a temperautre excursion.; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-MAY-2022, the patient was vaccinated with an improperly stored of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot # U033212 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported as 28-OCT-2022 and establish as 07-NOV-2022) and M-M-R II (lot # T033814 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 05-OCT-2022)  (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 54.4° Fahrenheit (F) for 11 hours respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.
Severe fatigue (unable to get out of bed for 15 hours), myalgia (ongoing pain in chest, shoulder blades, arms), brain fog/confusion, dizziness, shortness of breath, injection site swelling/tenderness
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment: brand: Paxlovid from 06Aug2023 to 10Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
didn't feel great at all; very weak; chills; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel great at all), ASTHENIA (very weak), CHILLS (chills) and PYREXIA (slight fever) in a female 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 second 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. On an unknown date, the patient experienced MALAISE (didn't feel great at all), ASTHENIA (very weak), CHILLS (chills) and PYREXIA (slight fever). At the time of the report, MALAISE (didn't feel great at all), ASTHENIA (very weak), CHILLS (chills) and PYREXIA (slight fever) outcome was unknown.            No concomitant medications reported by reporter. No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-101483 , MOD-2021-101494 (Patient Link).
doses given after temperature excursion; Product storage error; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported. patient states that SARSCOV2 VAC 50MCG/0.5ML IM, Moderna 3rd dose.
24 hours after receiving the vaccine I developed severe weakness in bilateral upper extremities with difficulty raising them which lasted approximately 36 hours. 48 hours after given the vaccine I developed severe vertigo with vomiting and while ambulating I was going to the left and could not walk in a straight line. The severe vertigo with vomiting lasted 48 hours and since that time I continue to have vertigo on a daily basis. Within the 48 hour time period I also was experiencing twinges of intermittent shooting pain from my left temple to the top of my head and now have a daily headache. I do not have any health insurance so did not seek medical evaluation and am very concerned about the lasting effects I am experiencing. I did not have any health issues prior to being given the vaccine.
Palpitations and tachycardia at rest, dyspnea on minimal exertion. No specific treatment. Improving on own
Time: 6 pm; Feb 4 1. Patient HR: 120. BP 131/109 2. Patient complains of neck tightening  - My team immediately lowered from sitting position to lying down with legs bended.   Patient feels very unease, confused, disoriented Patient complained of flickering eyes and yellow lights (was staring at overhead ceiling lights yellowish in color) Patient complained of hot chest  after 10 minutes
I had the shot at 9 am on 2/9/2021.  On 2/10/2021, I had a slight headache and had body aches. I took ibuprofen and laid down for a short while and it subsided before bed on 2/10/2021.   I woke up at 12am on 2/11/2021 with bilateral hands numbness and tingling in bilateral feet.  Within a few minutes of walking around, the numbness subsided and became very strong pins and needles in my hands.  Around 3 am, the pins and needles intensity had decreased but tingling had come up from fingertips to armpits and from toes to mid thigh but the intensity of the paresthesia was decreasing.  Around 8 am, I noticed that my coordination (could be weakness, I couldn't determine what it was) in my upper extremities was off when I was unloading the dishwasher.  I was able to unload without dropping anything but I was definitely off.  I called employee health when they opened (I was given the shot at the hospital where I work) and they said to call PCP immediately.  I called an MD office who said I needed to go to the ER but I could feel it improving so I didn't want to go to the ER.  Around 10am on 2/11/2021, the temperature sensation in my arms was off.  One felt very hot and the other was cold sensation and freezing to the touch and the bottom of my feet felt like I was standing on ice.  I ended up calling MDlive because I did feel like it was getting better and didn't want to go to the ER.  Telehealth MD said to go to the ER to rule out Guillian Barre.  I called another doc who said they would see me.  I went to new PCP at 1330.  At this time, I tingling was in the bottom of my feet and some in the hands and sporadically throughout the arms and legs but again with less intensity.  MD ran bloodwork to rule out another cause.  Bloodwork came back normal so they said that they after talking with MD, NP and MD thought the that this is a reaction to vaccine and I had no progressing weakness so they ruled out Gullian Barre but instructed me to go to ER if worsened.  The paresthia was only in my big toe and fingers in left hand when I went to bed on 2/12/2021.  I did wake up around 0300 on 2/13/2021 with  numbness in my left pinky finger and half of my ring finger was eventually subsided. I have had sporadic tingling sensation in my feet and in my hands today but with very little intensity.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 11:30 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date Sep2021. Past drug history included: Yes, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. can't get to the info, Location of injection: Arm Right, Vaccine Administration Time: 08:00 PM), administration date: 31Jan2021, when the patient was 73 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. can't get to the info, Location of injection: Arm Right, Vaccine Administration Time: 04:45 AM), administration date: 23Feb2021, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Oct2021 11:30, outcome "unknown", described as "Booster"; MYALGIA (non-serious) with onset 14Oct2021, outcome "recovered" (Oct2021), described as "Extensive muscle pain"; DIZZINESS (non-serious) with onset 14Oct2021, outcome "recovered" (Oct2021), described as "One day was very dizzy for about 4 hours". Therapeutic measures were taken as a result of myalgia. Therapeutic measures were not taken as a result of dizziness.  Additional information: Extensive muscle pain. Had to take Tylenol for 5 weeks.  One day was very dizzy for about 4 hours patient was not Prior to vaccination, was the patient diagnosed with COVID-19, Since the vaccination, patient was not patient been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received first dose of Pfizer COVID-19 vaccine.  Approximately 15 minutes post vaccination, patient had full blown tardive dyskinesia episode.  Patient states she was diagnosed with TD 7 years ago when taking seroquel.  Patient monitored for safety, husband arrived and drove patient home.  No meds administered via clinic staff.
SOB and dizziness with exertion 2-3 days following Pfizer COVID-19 booster on 10/28/2021. Had 1st two Pfizer vaccines on 3/18/2021 and 4/9/2021 without issue. No known history of COVID-19 infection.
Red rash on left arm, below where injection was. Rash has grown in size since first appearing.
Redness-trial of ZYRTEC, and if worsening then antibiotics.
no temp;marked local rxn rt deltoid;18x16cm erythematous, warm, induration lasted approx 4-5 days;tx ice, APAP;
Patient is a 68 y.o. male patient of Physician No with history of CLL, COPD and tobacco abuse who presented to the ED on 3/16 who presented with shortness of breath and malaise for the past week.  On arrival to the hospital, patient was hypoxic at 82% requiring 6 L nasal cannula.  Other vital signs include temperature 100.1, heart rate 113 and respiratory rate of 22.  Lab work was significant for sodium of 130, potassium 3.2, creatinine 2.33, CRP 110, BNP 1400, lactic acid 2.3, white blood cell count of 30, hemoglobin 11.2, platelets 50 and positive COVID test.  CTA of the chest was performed and negative for pulmonary embolism.  Also showed prominent patchy areas of groundglass and alveolar opacities in the lower lobes bilaterally.  Background changes of COPD are also present.  Patient was admitted to the hospital for hypoxia and suspected COVID/bacterial pneumonia. He received judicious fluids in the setting of COVID with progressive improvement in his renal function to baseline. Oncology was consulted and hydroxyurea continued during his stay. Broad spectrum abx started on admission with reduction to ceftriaxone due to neg mrsa swab and positive strep antigen. Also, sputum came back positive for H. Influ which was also sensitive to rocephin.  Oxygen require was de-escalated to 2L NC but could not be titrated further. Ultimately, he was hemodynamically stable and discharged home on 2L NC on 3/10. Six minute walk test was performed demonstrating need for home oxygen due to COPD and COVID pneumonia. A script for Omnicef was sent to his pharmacy to complete a 10 day treatment. A script for decadron 6 mg daily for 5 days and albuterol was also sent to his pharmacy. He was instructed to wear his oxygen until re-evaluation by a PCP for which info was provided to establish.    Discharge diagnosis   Sepsis (tachypnea, tachycardia and pna) Acute hypoxic respiratory failure COVID Pneumonia H. Influenza Pneumonia Acute COPD exacerbation Concern for Pulm HTN, on CTA Acute Kidney Injury, resolved Chronic Bladder Outlet Obstruction, per note Hypokalemia Hyponatremia Elevated Lactic Acid MPD Anemia and thrombocytopenia, due to above Chronic Splenomegaly Hx of Gout Severe Protein Calorie Malnutrition
Finished vaccine went to sit in holding area and 7 mins later passed out fell to floor on carpet.  Immediately came too. Superficil abrasions to forehead hands knees
Immediate reaction - asthma attack. Pt also endorsed "I couldn't see" - had spots in her vision/blurry vision lasting for a few minutes.
Peripheral, digital neuropathy: Dysaethesia in fingers Dig 4 and 3, first occurence in the left Hand. The dysaesthesia was self limting (at least to date  and lasted ca 5 days), now I have it on the right hand on Dig 4. No motor function issues observed, purely dysaethetic in nature. Tactililty altered and reduced. Whole finger is affected, albeit distal lateral portion most. No other issues, left hand , Dig 4 is almost back to normal sensation (80%). No neurological history personal or in the family- ever. No treatment attempted, resp what would help anyway?
Diffuse erythema right upper arm 8cm x7cm. Rx. Keflex 2 BID x 2 days
The vaccine administered box expiration was 11/25/2022 and the vaccine was used on 12/01/22-- pt has not experienced any adverse effects
Breakthrough case admission after 3 vaccines Pfizer 1/30/21 Lot# EL9261;  PFizer 2/20/21 Lot# EM9810;  Pfizer 10/11/21 Lot# FE3590
Patient was sitting in chair for a few minutes after vaccination, and then got light headed and collapsed onto floor.
Patient experienced sever migraine headache 10 minutes after vaccination which caused her to have shortness of breath for few minutes. EMT arrived at the scene and patient refused to go hospital once she was feeling better after 20 minutes. Patient went home by herself and was feeling better.
swelling area approx 4x4, redness, soreness and hot to touch of upper rt arm. Anthrax #2 given 11/29/99.
Severe shoulder pain. Pain was "shooting" down arm. Was not able to move shoulder that night or entire next day. Pain started a few hours after administration. Today 9/1/16 patient is able to move arm again with mild pain still very sore and uncomfortable. Patient did take naproxen for pain as directed by pharmacist.
Initial report received from a patient who is also a health care professional on 06 September 2007. A female patient (age, date of birth not reported and a medical history of asthma and 1 functioning kidney) developed a large, local reaction at the injection site - left deltoid of redness, swelling, and knot formation, after she received ADACEL (lot number C2775AA, route of administration not reported) in the left deltoid on 04 September 2007 for a 10 year booster. She self-medicated herself with ibuprofen. She did not have any illness at the time of the vaccination. At the time of the report, the symptoms were resolving.
Sore arm at injection site; shaking; migraine headache; aura; Sore arm at injection site; muscle aches all over; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), MIGRAINE (migraine headache), AURA (aura), INJECTION SITE PAIN (Sore arm at injection site) and MYALGIA (muscle aches all over) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 08-Oct-2023, the patient experienced TREMOR (shaking), MIGRAINE (migraine headache), AURA (aura), INJECTION SITE PAIN (Sore arm at injection site), MYALGIA (muscle aches all over) and CHILLS (chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm at injection site). At the time of the report, TREMOR (shaking), MIGRAINE (migraine headache), AURA (aura), INJECTION SITE PAIN (Sore arm at injection site), MYALGIA (muscle aches all over) and CHILLS (chills) was resolving and PAIN IN EXTREMITY (Sore arm at injection site) outcome was unknown.            Concomitant medication not reported.   Treatment medication not reported.  The patient experienced sore arm at injection site, 8 hours later muscle aches all over, chills, shaking, migraine headache with aura It was unknown if the patient experienced any additional symptoms/events.
Headache, Myalgia, NauseaVomiting, SEVER PAIN AND SWELLING IN AXILLA Narrative:
This spontaneous report as received from a 65 year old female consumer regarding herself as a patient with asthma. There were no drug reactions or allergies. In June or July 2013, the patient was vaccinated with ZOSTAVAX (one time vaccine, route reported as injection (lot and does not reported). Concomitant medication included an inhaler for asthma. On 23-JUL-2014, the patient experienced shingles. It started on the patient's face on whole right side of face and right ear. The patient sought for medical attention and was prescribed VALTREX and gabapentin (manufacturer unknown) for pain on face and ears. No lab diagnostics performed. The outcome of shingles was not reported.  Additional information has been requested.
Since the vaccine was given to the patient the patient has had fevers on & off, diarrhea, non itchy hives, bumps on her body, vomiting, loss of appetite, not as active or happy as usual, crying/moaning/screaming which is not her normal, lack of sleep, dehydration. Before the vacation she had none of these symptoms. None of these are Covid related- we have negative test results.
Onset of pain in mid/lower right quadrant of abdomen, fever, nausea, fatigue roughly 60 hours after injection.  Vomiting began 75 hours after injection.  Symptoms lasted 96 hours.
Normal ZOSTAVAX rash occurred on Friday & Saturday. On Sunday, patient noticed it feeling hot, burning, & itching. When using ZYRTEC & Hydrocortisone Crm. didn't make it feel better, she phoned the pharmacy Monday. We instructed her to go to her MD. MD gave her prednisone taper & Cephalexin 500 mg QID.
seconds after administration patient started losing consciousness. he stated he previously experienced vasovagal syncope after flu shots. he went in and out consciousness several  times over the next 5 minutes. he lost color in face and eyes closed when head dropped. his body was stabilized and kept alert with verbal and physical tests. cold compress was applied behind neck and BP monitor placed on arm. he had normal BP/pulse. skin color gradually improved as well as mental acuity. patient could stand after approx 10m and was observed for additional 30m. his phone was used to call his wife and someone came to assist getting home. said felt fine after full observation time and seemed to have made full recovery.