chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 03/24/2021 and 04/21/2021. They became symptomatic for COVID-19 disease on 08/10/2021 and tested COVID-19 positive on 08/15/2021. They were admitted to hospital on 08/15/2021. They experienced complications of acute hypoxic respiratory failure, COVID-19 pneumonia, pulmonary edema, and pulmonary hypertension. The individual died on 08/20/2021.
Chills, switches between hot and cold, high fever, body soreness, headache, dry eyes from tiredness.
Possible seizure. Prior history of seizures reported.  Diagnosed with syncopal episode. Pt described feeling dizzy. Patient was clammy and pale in color before syncopal episode occurred. Patient was unconscious for about 45 seconds, and confused after regaining consciousness for 15 seconds. Patient was fully alert and oriented afterwards.
The day after I had low grade fever, chills headache. then on 2/14/21 started with a bad headache, and then on 2/15-2/17/21 running Low grade fever (100) chills, nausea, headache, achy feeling sick. Not sure when on 2/14 started to feel sick if it is related to vaccine or not.
on April 1st, 2023, I got loose stools. i thought it was food poisoning from the restuarant i just ate at but it lasted a week. A few days later i got a sore throat. I thought it was because i left the window open overnight. then on april 7, i started coughing, sneezing and my temperature was 100.7. the next morning i tested for covid and it showed positive. I went to the urgent care.
Red spots with what looks almost like scab in center    Started about a week after 2nd injection, itched for several days...Now just there, but no itching
vaccine administered 2 days after 1st punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 2 days after 1st punctured) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 2 days after 1st punctured). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 2 days after 1st punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine was administered after 2 days of first puncture of vial No concomitant medication was provided Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up contains  NNI
Child took 3 hr. nap about 1 hr. after visit, woke up late then grabbed left arm and left check like he was hurting. Child was fussy and rolling around on ground, not himself. Behavior lasted 3 hrs. then he was fine, no seizure activity.
No adverse events whatsoever, Moderna was given beyond 12 hours at room temperature. Contacting manufacturer to see if stability information would support redosing or not.
12JAN mom noted fussiness, dec appetite, t102, 2-3 min episode of generalized tonic/clonic sz activity; arrival in ER t105.8; postictal in ER not follwoing commands; dx febrile sz;
Had 1st dose of  pfizer "felt bad" . He said he feels weak & hot.  got him in medical tent placed in supine position spoke to his wife regarding him allergies. "Horse Serum" After few minutes he felt better.  Refused OJ & water.   Hx. of covid 19 seven months ago.
c/o headache scale of 1-10 it is a 5-6 and tingling of lips.  no diff. breathing at this time.  Resp-20. 4:00pm states breathing better, but lightheadedness remains.  Called husband to pick her up. 4:11pm Husband at scene, ambulance called. 4:20pm HR 108, BP 149/84, Glucose 74.  Transported to Hospital via Fire Rescue.  Continues to complain of light headedness.
Swollen nodes under armpit and above clavicle. Feels hot  and burning pain under armpit and arm.
I had swelling of lymph nodes in neck, arm pits and hives in back and arms.
an unspecified patient received a dose of improperly stored PNEUMOVAX23; No adverse effect reported.; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient received a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S027047, expiration date 20-MAY-2021; dose, strength and route were unknown), which was exposed to an temperature excursions prior to being administered above 47 degrees Fahrenheit (48.13 degrees Fahrenheit) for 65 hours 30 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported.   This is a non-valid case due to lack of patients' identifier.
THE EVENING THE PATIENT RECEIVED THE VACCINE THEY BEGAN EXPERIENCING PAIN, STIFFNESS, AND NUMBNESS THROUGHOUT THE RIGHT ARM FROM THE SHOULDER TO THE HAND. THE PATIENT DESCRIBES THE PAIN AS THROBBING AND RADIATING FROM THE SHOULDER TO THE HAND. THE PATIENT ALSO REPORTS NUMBNESS AND LOSS OF COORDINATION WITH THE RIGHT ARM INCLUDING THE HAND. THE PATIENT DESCRIBES THE PAIN AS "BAD ALL THE TIME BUT WORSE AT NIGHT AND UPON AWAKENING IN THE MORNING." THE PATIENT DID NOT REPORT ANY VISUAL ADVERSE EFFECTS SUCH AS REDNESS.
Myalgia & CoughWheeze Narrative: Positive COVID-19 antigen test 01/12/2021
Fever, headache, body ache,  congestion, shortness of breath,  fluid in lungs. Was given antibiotics and then put in the hospital for 9 days for further examination band treatment and also experienced some hearing loss in left ear
Arm swollen; Redness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Redness) and PRURITUS (Itchiness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, AMLODIPINE, MIRABEGRON (MYRBETRIQ), TRAMADOL, ROSUVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) and DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Redness) and PRURITUS (Itchiness). At the time of the report, PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Redness) and PRURITUS (Itchiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided also include Omega. Treatment information was not provided. The patient reports that she is completely fine now.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received 09 May 2021 included events outcome.
Moderate pain and inflammation in left armpit area starting 12 hours after 2nd injection. Pain and sensitivity in area continued for 3 days. Also mild fatigue and general achy feeling for 2 days after shot.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K003408, expiration date 16-MAR-2016; dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Lichenoid dermatitis; This spontaneous case was reported by a consumer and describes the occurrence of LICHENOID KERATOSIS (Lichenoid dermatitis) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced LICHENOID KERATOSIS (Lichenoid dermatitis). At the time of the report, LICHENOID KERATOSIS (Lichenoid dermatitis) outcome was unknown.        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.   Relevant concomitant medications were not reported.  Patient received second dose of Moderna COVID-19 vaccine on 03 -Feb-2021. Patient reported today his Lichenoid dermatitis was not too bad but other times it got very intense. Patient's doctor reported that "the process was not consistent with urticaria". Patient also reported that his dermatologist had another patient (female) who received the Moderna COVID-19 vaccine and early on had the same conditions that he had (itchy and scratching) and she had lichenoid dermatitis.  Patient reported he received various treatments from his dermatologist, not specified.   This case was linked to MOD-2021-251557 (Patient Link).
Slight swelling in face within 5-10 minutes of shot. Swelling of throat within 15-20 minutes of shot. Epinephrine, Benadryl, methoprednisone, and Pepcid given 30 minutes after shot. Symptoms decreased over 20-30 minutes
Starting on 04/13/2021 noticed very easy bruising  seems to be improving. Starting 04/16/2021 backache right side near kidney area, still on-going. Starting 04/18/2021 sore on tongue and right inside of mouth.
10 CM ERYTHEMA. AREA WAS SLIGHTLY RAISED. MALAISE. DECREASED ROM OF RIGHT ARM. On 9/27/11 erythema measured 8 inches by 4 3/4 inches. Pt no longer had malaise. Area was warm, burning and painful.
Continued to feel worse and worse.  Temperature up to 105.  Violent shaking.  Complained of chills.  Took him to Urgent Care.  There he experienced nausea, pulse varies from 40 - 90.  Started to lose consciousness.  Given Zofran, oxygen, and NS IV started as paramedics were called.  Started to improve in route to the Emergency Department.
Crankiness began 7/28/07. Vomiting episodes began night of 7/29/07. Rash developed also - still blotchy here and there. Fever continues. Vomiting and diarrhea continue. 8/1/07 pt again seen for vomiting
The next day my joints were completely swollen in my left fingers, wrist and hand, as well as my right, this lasted for over three months.
The syringe that was used had a needle that had a auto retractor. The needle was retracted into the syringe before dose could be fully administered thus squirting some dose on patient's shoulder.
pt recv vax MAR96 & DEC96 pt exp gen chickenpox;It was noted that a sibling subsequently devel chickenpox;another pt was reported as well WAES97020805;
Immediate (very much unwanted) menstruation following both first and second dose; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 12Feb2021 17:30 (lot number: EL3249), as 1st dose, single; and via an unspecified route of administration, administered in the left arm, on 05Mar2021 13:30 (lot number: EL9265), as 2nd dose, single, for COVID-19 immunisation, at a clinic. Medical history included bleeding. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included medroxyprogesterone acetate (DEPO-PROVERA) taken to prevent bleeding; buspirone hydrochloride (BUSPAR); omeprazole; cyclobenzaprine hydrochloride (FLEXERIL); and naproxen, start and stop dates were not reported. The patient previously took ciprofloxacin (CIPRO) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 12Feb2021, the patient experienced immediate (very much unwanted) menstruation despite Depo-Provera to prevent bleeding. This was following both the first and second doses of COVID-19 vaccine. No treatment was given for the event. The outcome of the event was not recovered.
Pt. had localized swallow on the (R) deltoid IM. Give the second HPV.
injection site (varicella vaccine) posterior upper arm became very swollen and tender. Resolved without treatment after 2 days.
Extremely heavy periods (heavier than ever experienced in lifetime), breakthrough periods (after an extended time without having had a period), extended periods (lasting twice as long as normal), backpain, fatigue.  This lasted for 8 months.
This spontaneous report as received from a registered nurse regarding a patient of unknown age and gender. Patient's medical history or concurrent conditions were not reported. On an unknown date, the patient received improperly stored dose of GARDASIL lot #K010574, expiration date 08-APR-2017 (dose, strength and route were unknown). There was no concomitant therapies reported and also received an improperly stored dose of VAQTA lot # L008665, expiration date 10-FEB-2017 (dose, strength and route were unknown). At the time of the report, no adverse effects were reported. Additional information has been requested. This is one of several reports received from the same reporter.
I experienced chills, which caused me to shake and tremble. I woke up in the middle of the night and my eyes were sensitive to the light and I have a bad headache that was throbbing. As I got up I noticed that my steps felt heavy.  When I finally woke up in the morning I was covered in sweat with a headache, so I called into work and went back to sleep and then woke up covered in sweat again.
Tuesday evening I was tired and sore. Chills  and my entire body started aching late Tuesday night about 11pm and continued throughout all day Wednesday. I was also light headed. On Thursday I was better but not 100% same as today Friday 4/30/2021
A mother reported that her 18 month old daughter received Prevnar, poliomyelitis and DTP vaccines on 2/27/01. On 3/4/01, she developed a fever of 103F and severe diarrhea. On 3/5/01, she developed vomiting. She was treated with ibuprofen. As of 3/6/01, her symptoms persisted.
inflammation of the muscles muscle spasms fatigue tiredness general discomfort muscle cramps insomnia
Client had a breakthrough covid-19 infection.  Symptom onset 4/21/21. Client was fully vaccinated with J&J on  3/30/21.
patient received adacel after it experienced a temperature excursion, with no reported adverse event; Initial information received on 10-May-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old female patient who received vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] after it experienced a temperature excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine A/C/Y/W CONJ (Crm197) (Menveo) and Tozinameran (Pfizer Biontech Covid-19 Vaccine) for Immunisation.  On an unknown date temperature excursion happened, on 05-May-2023, the patient received ADACEL was after temperature excursion that was not supported at a dose 0.5 ml (1x) total of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine suspension for injection (lot: U76658A, Expiry date:  04-Mar-2025) via unknown route in unknown administration site for Immunisation (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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.
Uncontrollable chills, body pain(not aches, headache so intense felt like head was exploding, nausea,  joint pain, fatigue/weakness
Patient describes a rash that tracked from the injection site to he whole back.  It presented 24 hours after injection.  No signs or irritation at the site of injection.  No fevers or other symptoms.  Rash was not hives and was decribed as a lacy type rash on back.  At time of evaluation --- 4 days later -- no rash
Information has been received from a licensed practical nurse concerning a 12 month old patient of unknown gender. On 20-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and route not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Patient reported that he has received 2 doses of Pfizer Covid-19 vaccines in the Fall of 2021 and that within 1-2 weeks post vaccine #2 he developed chest pain. He underwent a cardiac MRI and it revealed a myocarditis. He was referred to an off-base cardiologist who told him that his myocarditis was due to the COVID-19 vaccine and that he should not receive another one. Patient reported he did have COVID infection in July 2021 and was evaluated by cardiology for chest pain following his COVID infection. The pain would occur only with exertion. He had EKG and enzymes and was told it was normal. The pain following his second vaccine was more severe and would occur at rest. He did not seek immediate medical evaluation because he thought his heart was okay. He waited to see his PCM a couple of weeks later where myocarditis was confirmed by MRI. Symptoms: CHEST PAIN, UNSPECIFIED (R079).
Parent called to report patient has rash on face, neck, chest, back, arms, and legs. Rask is raised, itchy, no fluid/drainage, no redness. Parent reported she asked her mom to look at rash and stated rash looked like measles. Parent reported she has not used any OTC meds (topical or oral) for rash and has only bathed child with DOVE body wash. Advised parent to take child to Urgent Care for evaluation of rash, and she may use mild OTC treatment for itching (e.g., calamine lotion, Benadryl topical cream/ointment, Aveeno bath). Also explained to parent that a VAERS report would be filed to report the reaction she has reported patient had to the vaccines.
This spontaneous report as received from a nurse practitioner refers to a 9 months old patient. On 01-APR-2013 the patient was vaccinated with an unspecified hepatitis a vaccine, either HAVRIX or VAQTA (lot # not reported) 0.5 ml, route not reported. No adverse effect reported.  Additional information has been requested.
Pulmonary embolism; Shortness of breath; Fever; This is a spontaneous report from a non-contactable pharmacist. A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 30130BA), intramuscularly in the arm left on 03Sep2021 (at the age of 61-years-old) at dose 2, single for COVID-19 immunisation. The patient was not pregnant. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162b2 (lot number: ew0185) intramuscularly in the arm left on 13Aug2021 for COVID-19 immunisation. The patient experienced shortness of breath, fever and pulmonary embolism on 10Sep2021. The events were reported as non-serious. The adverse events resulted in emergency room/department or urgent care visit. A treatment was received for the adverse events and included ELIQUIS. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Pulmonary embolism, dyspnea and pyrexia cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient developed myalgias and chills the day after vaccination.  Three days after vaccination, awoke from sleep wtih burning upper chest and neck pain lasting several hours.  Came to the ED.  ECG notable for lateral ST elevation.  Troponin I elevated.  CRP elevated.  COVID PCR negative x2.  Treated with aspirin and intravenous heparin infusion.  Echocardiogram revealed left ventricular systolic dysfunction (EF 48%).  Cardiac catheterzation revealed no coronary obstruction or thrombosis.  Cardiac MRI revealed late gadolinium enhancement and myocardial edema consistent with acute myocarditis.  Max temperature during hospitalization 37.4C.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 29-Apr-2022) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. No Medical History information was reported. On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 29-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient received booster dose. Date the vial was initially stored in the refrigerator on 29-Apr-2022. The vial did not undergo any temperature excursion. No treatment medications were provided.
The patient had a red mark on the arm about an inch under the administration site that was warm to the touch. I advised her to seek medical attention. Her MD diagnosed her with cellulitis and began treatment with Bactrim DS twice a day for 10 days
no adverse event after waiting 15 minutes. But patient was under age of 18.  Parents came up to the site and requested Moderna. medic was overwhelmed at the time and did not check patients age before administering shot
Patient developed a rash on his neck about 3 to 4 days after. He went to his doctor, who diagnosed it as Shingles. He was started on anti-viral therapy right away. His symptoms are mild.