chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On December 17, 2021 at 10:40 am, I received a Moderna booster. By 10:00pm that same night I started having intense chest pain, like someone was placing a branding iron on my heart and searing pain would radiate out to my arms. My rhr (resting heart rate) maintained at 90-114 bpm. I felt like my heart was pounding and beating irregularly, with shortness of breath and I was unable to calm either. I vomited. ALL of these symptoms mentioned above lasted from 10:00 pm until 8:00 am the following morning, December 18, 2021.
My son received the MMR vaccination on 1/14/2019  on 4/28/2019 he was diagnosed with Type1 Diabetes which clearly states on the MMR insert that type 1 diabetes mellitus is an adverse reaction.   he now has to be monitored hourly and given insulin injections at every meal, carb count for each meal, check ketones through finger prick.   the "handout" the pediatrician gave me did not include the adverse reactions that are on the actual insert we noticed he was   urinating a lot, and drinking a lot - we didnt think anything of it , just thought he was a growing 1.5 yr old.
Fast Heart Beat; Dose Number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 12:30 (Lot number: FH8027) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ep7533, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 02Apr2021, when the patient was 22 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 12Mar2021, when the patient was 22 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose Number 3"; HEART RATE INCREASED (non-serious) with onset 04Dec2021 07:00, outcome "recovering", described as "Fast Heart Beat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, heart rate increased.  Additional information: Patient was administered with most recent COVID-19 vaccine in Hospital. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as yes Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. known allergies and other medical history were reported as yes  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 20-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included Leg edema (Leg edema, left), Dizziness, Sick sinus syndrome, Osteoarthritis (erosive osteoarthritis, osteoarthritis of right foot), Pain in joint (Pain in joint involving foot, right foot), Headache, Effects of radiation, unspecified, Sacroiliitis, Carpal tunnel syndrome, Migraine, Plantar fasciitis (plantar fasciitis, right), GERD, Pain in hip (Hip pain, right), Renal insufficiency, Microscopic hematuria, Preoperative care (Preoperative examination) and Hip replacement (right artificial hip joint). Previously administered products included for Product used for unknown indication: Influenza on 10-Oct-2018, Pfizer (1st dose of PFIZER batch no.-ER8737) on 12-Apr-2021 and PFIZER (2nd dose of PFIZER batch no. - ER8736) on 03-May-2021. Past adverse reactions to the above products included No adverse event with Influenza, PFIZER and Pfizer. Concurrent medical conditions included Drug allergy (Allergy to Bactrim (sulfamethoxazole-trimethoprim)), Iodine allergy, Drug allergy (Allergy to Codeine sulfate (moderate)), Drug allergy (Allergy to Tramadol HCL (moderate)), Drug allergy (Allergy to hydrocodone bitartrate (moderate)), Drug allergy (Allergy to Oxycodone HCL (moderate)), Drug allergy (Allergy to Morphine sulfate (moderate)), Seasonal allergy and Hyperlipidemia. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ESTROGENS CONJUGATED (PREMARIN), MAGNESIUM, ZINC GLUCONATE and VITAMIN D3 for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-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 treatment information was provided by the reporter.  Services due included, Hemoccult or Sigmoid, TD Booster, PAP Smear, Mammogram and Breast Exam. concomitant drug Vitamin b12 last refill was on 24-Jan-2018.  screen colon cancer, screen lung cancer, screen skin cancer , osteoporosis, screen, ovarian cancer, Screening cervical cancer, Screening for breast cancer-no results provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 09-JUN-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # reported as M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Pt called today b/c she was scheduled for her 2nd shot tom. The reason she called was to inform us that she is covid + and needs to reschedule her second shot.
Pt. states that around 4 pm on day of vaccine, her right arm became very sore. It is still sore, and the muscle near deltoid has pain when she raises arm above head. She also felt "achey" for 2 1/2 days following vaccination.
Rash developed at school. Sparse hives on trunk and back - no angioedema. Possible hypersensitivity to components of FLUMIST - Rxn 24 hrs later and is isolated hives. No concern of anaphylaxis. Given BENADRYL PRN. Advised to f/u with allergy.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting chills and fatigue. pain, redness and swelling at the injection site. Narrative:
Hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for hearing loss. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of hearing loss was unknown. The reporter considered hearing loss to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, hearing loss was considered medically significant.
Unsure why pt. was tested on 04/20; on 05/01/21 tested for surgical procedure; pt. admitted for a scheduled transfemoral aortic valve replacement.
Immediately after felt like a ounch to the arm. After a day it started swelling, now has a large knot like area the size of a golf ball or larger that is painful, raised, warm to the touch and occasionally itchy.
Injection site seemed high, person administering vaccine commented on how she had to use a lot of pressure to inject it.  Had shoulder pain immediately. Still having dull pain at rest and sharp pain with certain movements.
Covid arm: slight rash on site of injection.  Minor swelling and itching. Used cortisone cream for relief.  This stopped the itching and swelling.  2 hours later no sign of rash.
pt presented w/fine rash on face, trunk & extremities 6OCT97 which reportedly 1st appeared on 4OCT97;denies any other sx-afeb @ time of visit +posterior lymphadenopathy also noted;
This spontaneous report as received from a registered nurse refers to a patient of unspecified age and gender. On 05-JUL-2016, the patient was vaccinated with MMR II, (lot# unspecified) dose 0.5 ml (one time vaccination), via subcutaneous route for prophylaxis that had an expiration date of 26-JUN-2016 (also reported as 27-JUN-2016). The nurse reported no untoward effects observed in this patient. No product quality complaint was involved. No further information provided. Additional information has been requested.
Patient stated she was experiencing joint pain in left arm (where she got vaccine), and severe muscular pain - pain has lasted from 10-13-10 thru 11-4-10. Pain is still not relieved from ibuprofen ER gave to her.
swelling on left side on check and eye; wasn't feeling good in general; heart rate went back up again, in the morning; nausea; Both my legs felt like I had glue on; sunburn rash on my face and chest; sore arm; tingling in my tongue; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Both my legs felt like I had glue on), RASH ERYTHEMATOUS (sunburn rash on my face and chest), PAIN IN EXTREMITY (sore arm), PARAESTHESIA ORAL (tingling in my tongue) and SWELLING FACE (swelling on left side on check and eye) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Both my legs felt like I had glue on), RASH ERYTHEMATOUS (sunburn rash on my face and chest), PAIN IN EXTREMITY (sore arm), PARAESTHESIA ORAL (tingling in my tongue) and NAUSEA (nausea). On 05-Mar-2021, the patient experienced SWELLING FACE (swelling on left side on check and eye), FEELING ABNORMAL (wasn't feeling good in general) and HEART RATE ABNORMAL (heart rate went back up again, in the morning). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. On 05-Mar-2021, SWELLING FACE (swelling on left side on check and eye) had resolved. At the time of the report, FEELING ABNORMAL (Both my legs felt like I had glue on), RASH ERYTHEMATOUS (sunburn rash on my face and chest), PAIN IN EXTREMITY (sore arm), PARAESTHESIA ORAL (tingling in my tongue), FEELING ABNORMAL (wasn't feeling good in general), HEART RATE ABNORMAL (heart rate went back up again, in the morning) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: 110 (abnormal) 110 heart rate 30 minutes after the shot..     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.
HCP calling to report vaccine was administered after experiencing a temperature excursion. Product was supported. Case filed. Permission to contact HCP was granted. No additional information. No AE/PQC reported.; No addtional AE reported; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.     On 05-SEP-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # X010525, expiration date: 11-APR-2025) (dose, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion (product storage error). Product was supported, no additional adverse event (AE) reported.
Fever; Whole body aches; Head is splitting; Chills; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: Ew0150) via an unspecified route of administration in the arm left on 06Apr2021 at 15:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EM6950 ) via unspecified route of administration on 13Mar2021 at 10:00 as a single dose for COVID-19 immunisation. On 07Apr2021 at 02:00, the patient felt head was splitting, fever, chills, whole body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for the events occurred. The clinical outcome of the events head was splitting, fever, chills, whole body aches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: RMH (Age and units added for Historical Vaccine), Suspect drug detail (Vaccination Facility Country added), event detail (event coding updated for event Head is splitting).
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 15-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient had a large 3 inch by 3 inch welt at vaccination site that was hot and tender and lasted for a week.  Patient had a 101 degree fever that lasted 3 days.
Apnea and Bradycardia, seizure, Hypoxic brain injury, Death. Full Resuscitation. Ventilator support. Epinephrine, Dopamine, Insulin, hydrocortisone, Antibiotics. VERSED x1 dose, Phenobarbital Loading dose.
Patient received second Moderna vaccine on April 5, next day redness swelling L thigh (inj site) now spreading, erthematous sunburn like rash 14 cm in diameter on 4/8
This spontaneous report was received from a medical assistant concerning a 24-year-old patient of an unknown gender. The patient's medical  history, concurrent conditions and concomitant therapies were not reported. On 26-APR-2016 (reported as 26-APR-20106), the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
I had difficulty breathing, dizziness, weakness shortness of breath of standing, felt like I wanted to vomit. I went to.
Case previously recorded as MA2009-4799. Case report received from a nurse, via Novartis, on 18 NOV 2009. 2 year-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 102126P1A, FEB 2010) i.m. on 15 NOV 2009, an off-label indication. No adverse event was reported. Reference no.: NA09-008489.
Not sure of time of onset-only date--patient reports sore arm which she cannot raise, welt on arm but not at immunization site, cold symptoms, hoarse throat, feels sick.
Now, the weakness has gone to the other leg and both of her arms; The feeling in her left leg is unusual; she starts feeling tired and weak and she needs to sit down and rest; she could barely walk; On Sunday, her left leg started hurting really bad; the arm started hurting/2 days later, her left arm started hurting more; Felt numb; She had little temperature about 10-12 hours later.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the arm started hurting/2 days later, her left arm started hurting more), HYPOAESTHESIA (Felt numb), BODY TEMPERATURE INCREASED (She had little temperature about 10-12 hours later.), PAIN IN EXTREMITY (On Sunday, her left leg started hurting really bad) and GAIT DISTURBANCE (she could barely walk) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included GABAPENTIN, LEVOTHYROXINE, MONTELUKAST SODIUM (SINGULAIR), CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]), HYDROCHLOROTHIAZIDE, LOSARTAN and ROSUVASTATIN for an unknown indication.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (the arm started hurting/2 days later, her left arm started hurting more), HYPOAESTHESIA (Felt numb) and BODY TEMPERATURE INCREASED (She had little temperature about 10-12 hours later.). On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (On Sunday, her left leg started hurting really bad). On 12-Apr-2021, the patient experienced GAIT DISTURBANCE (she could barely walk). On 12-May-2021, the patient experienced ASTHENIA (Now, the weakness has gone to the other leg and both of her arms), FEELING ABNORMAL (The feeling in her left leg is unusual ) and FATIGUE (she starts feeling tired and weak and she needs to sit down and rest). The patient was treated with CYCLOBENZAPRINE at a dose of UNK dosage form; TIZANIDINE at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (the arm started hurting/2 days later, her left arm started hurting more), HYPOAESTHESIA (Felt numb), BODY TEMPERATURE INCREASED (She had little temperature about 10-12 hours later.), PAIN IN EXTREMITY (On Sunday, her left leg started hurting really bad), GAIT DISTURBANCE (she could barely walk), ASTHENIA (Now, the weakness has gone to the other leg and both of her arms), FEELING ABNORMAL (The feeling in her left leg is unusual ) and FATIGUE (she starts feeling tired and weak and she needs to sit down and rest) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not applicable.
since then with the Shot I've had them 3 more times /suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had the shingles several years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had shingles several years ago before the shot and since then with the shot had them 3 more times, the shot did not work. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
on august 14th i tested positive for Covid/I recieved my first shot on 8/7/21 then tested positive  for COVID on 8/14/21; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (on august 14th i tested positive for Covid/I recieved my first shot on 8/7/21 then tested positive  for COVID on 8/14/21) 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 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced COVID-19 (on august 14th i tested positive for Covid/I recieved my first shot on 8/7/21 then tested positive  for COVID on 8/14/21). At the time of the report, COVID-19 (on august 14th i tested positive for Covid/I recieved my first shot on 8/7/21 then tested positive  for COVID on 8/14/21) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up information received Contains No New Information.