chrisvoncsefalvay/vaers-outcomes huggingface dataset:
multiple heart arrhythmias; increased sense of pressure in his chest; shortness of breath; light headed feeling; weakness; welt that was red, sore, and very hot; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (multiple heart arrhythmias) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertrophic cardiomyopathy (experiencing flare ups which he says he has had before).  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (multiple heart arrhythmias) (seriousness criterion medically significant), CHEST DISCOMFORT (increased sense of pressure in his chest), DYSPNOEA (shortness of breath), DIZZINESS (light headed feeling), ASTHENIA (weakness), URTICARIA (welt that was red, sore, and very hot) and FATIGUE (tiredness). At the time of the report, ARRHYTHMIA (multiple heart arrhythmias), CHEST DISCOMFORT (increased sense of pressure in his chest), DYSPNOEA (shortness of breath), DIZZINESS (light headed feeling), ASTHENIA (weakness), URTICARIA (welt that was red, sore, and very hot) and FATIGUE (tiredness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Company comment: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Employee reports on 12/30/10 to clinic. States on 12/24/10 she noticed LUA red, tender and aching. Self treated with ice and BENADRYL.
On 07/11/2001 the parents reported the patient developed a red swollen grapefruit size area on his left leg. Instructed by RN to administer warm compresses and monitor for increased swelling or streaking. On the evening of 07/11/2001 the patient developed a softball size, blistering center.  On 07/12/2001 the patient had a 2x1/2 cm central small blistered area in the left thigh with a 16x10 area of erythema. Doctor advised application of heat to the area and take ibuprofen.
Almost immediately following the DT shot, patient began profusely bleeding from the nose and  subsequently had several nosebleeds over the next 8 hours.  (Patient has only had 1 very minor nosebleed in her life prior from hitting her nose on a toy).
Sore arm; Fatigue; Light headed within 6 h; Cold hands; Mild chill 12h after injection severe chill started 18h after injection & lasted about 5 hours; Muscle aches; Sore and swelling armpit and breast same site as the injection site; Sore and swelling armpit and breast same site as the injection site; Sore and swelling armpit and breast same site as the injection site; Sore and swelling armpit and breast same site as the injection site; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33026BD) via an unspecified route of administration in left arm on 10Nov2021 at 19:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included perimenopause. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) and norethisterone acetate (NORETHINDRONE ACETATE); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 53-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the patient experienced sore arm, fatigue, light headed within 6 hours, cold hands and mild chill approximately 12 hours after injection, muscle aches and severe chill started approximately 18h after injection & lasted approximately 5 hours, sore & swelling armpit and breast same site as the injection arm started approximately 18h after injection and persist at the time of submitting this report. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event mild chill approximately 12hours after injection, severe chill started approximately 18h after injection & lasted approximately 5 hours was resolved on 11Nov2021 and sore arm, fatigue, light headed within 6 hours, cold hands, muscle aches, sore & swelling armpit and breast same site as the injection arm started approximately 18h after injection was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
fever, nausea, myalgia, vomiting, local redness & swelling, lt deltoid;
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. Of patients exposed, 602 patients experienced pneumonia. Age: 1 was 17; 49 were age 18; 484 were age group 19-24; 60 were age group 25-29; 6 were age group 30-34; 2 were age group 35-39. Sex: 68 female; 534 male. Of the unexposed 1,468 patients experienced pneumonia. Age group: 110 age 18; 1,222 age group 19-24; 114 age group 25-29; 16 age group 30-34; 2 age group 35-39; 4 age group 40-50. Sex: 58 female; 1,410 male.
AE's: extreme pain within seconds of needle insertion, and sense of needle being forced through some structure within the arm; bleeding upon needle removal; bruising and ongoing significant arm pain; within days the pain increased and range of motion became substantially limited due to this pain;  some ongoing pain at rest;  extreme throbbing and radiating pain down the arm into the back of the hand when range of motion attempted;  Treatment: examined by primary doctor on 9/17/2021 & X-Ray taken; referred to Ortho P.A. 9/29/21;physical therapy prescribed; patient started physical therapy 11/08/2021, ongoing; Outcomes: extreme pain with attempted range of motion unresolved to date; concern damage could be permanent;
lost sense of smell; This spontaneous case was reported by a health care professional and describes the occurrence of ANOSMIA (lost sense of smell) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (lost sense of smell). At the time of the report, ANOSMIA (lost sense of smell) 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.   No relevant concomitant medications were provided.  No treatment information was provided.
Fever 100.8 (PO), general Malaise, dull headed, stuffy nose lasting 2.5 days. No appetite. Rx symptomatic with Ibuprofen.
Increase in volume of the already existing high pitched tinnitus ringing in my left ear. The noise has definitely gotten much louder, which I noticed approximately 48 hours after receiving the shot.
Itchy painful Rash on arm about 3 inches wide around injection site. Blotchy in appearance with an irregular border
Feel pain in my heart; I have had trouble moving or moving my left arm due to the pain; Feels like heart inflammation; This is a spontaneous report from a contactable consumer (patient).    This 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Jun2021 08:30 (Lot Number: 59267-1000-02) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 19Jun2021, the patient experienced feel pain in my heart , I have had trouble moving or moving my left arm due to the pain, feels like heart inflammation. The outcome of the events was unknown. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sore arm; Uterine Cramping; moderate to severe menstrual cramping without bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 13:30 (Lot number: FL3198) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Endotrimosis" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "EDS" (unspecified if ongoing); "hormone replacement therapy" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "AS" (unspecified if ongoing); "chronic migraines" (unspecified if ongoing); "degenerative disc disease" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE; GABAPENTIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0217, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 26Jun2021, when the patient was 25 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0127, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 03Jun2021, when the patient was 25 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Jan2022 22:00, outcome "recovered" (Jan2022), described as "Sore arm"; UTERINE SPASM (non-serious) with onset 20Jan2022 22:00, outcome "recovered" (Jan2022), described as "Uterine Cramping"; DYSMENORRHOEA (non-serious) with onset 20Jan2022 22:00, outcome "recovered" (Jan2022), described as "moderate to severe menstrual cramping without bleeding". Therapeutic measures were not taken as a result of pain in extremity, uterine spasm, dysmenorrhoea. Additional Information: The patient stated that, she had the normal Sore arm, but 30 hours after the covid shot she have begun to have Uterine Cramping, she had not gotten my menstrual cramping in years due to being on Testosterone, however after this shot she had moderate to severe menstrual cramping without bleeding. Prior vaccination within 4 weeks was reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. No follow-up attempts are possible. No further information is expected.
Received immunization on 12/20/11. States arm became red, warm and swollen that evening. The next day site became more painful, and swelling and redness increased. Went to the doctor the next day and was dx with secondary staph infection. Was given antibiotic IM and orally for 10 days.
HIGH HEART BEAT / TACHYCARDIA; ALLERGIC REACTION (SWOLLEN FACE UNDER EYES, ITCHINESS IN MOUTH, ITCHINESS IN PALMS / FEET); SHAKINESS; TINGLING; FEVER; HEADACHE; WEAKNESS; MUSCLE PAIN IN BACK AND LEGS; DROWSINESS / SLEEPINESS; BACK PAIN; BODY ACHES; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced back pain. On MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced drowsiness / sleepiness. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced muscle pain in back and legs. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced tingling. On 02-APR-2021, the subject experienced high heart beat / tachycardia. On 02-APR-2021, the subject experienced allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet). On 02-APR-2021, the subject experienced shakiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high heart beat / tachycardia, and muscle pain in back and legs on 02-APR-2021, drowsiness / sleepiness, and weakness on 16-MAR-2021, tingling on 28-MAR-2021, fever on 18-MAR-2021, and headache on 19-MAR-2021, had not recovered from shakiness, and allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet), and the outcome of back pain and body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
LOCALIZED RED IRRATATED AREA AT INJECTION SITE THAT FLARED A WEEK POST INJECTION  - 24 HOURS AFTER HAVING HAD A TETANUS SHOT IN OTHER ARM.
hives devel face, arms, & back approx 3 1/2hr p/vax seen 28OCT by MD will not take next dose to complete series;
pt recvd MMR vax on 28AUG91 & following vax pt devel measles; no further details were provided;
Pruritic rash lower extremities and distal upper extremities.  Not raised.  Started 1 day after 1st HPV shot.
Started with itching on my neck, then head. The next 2 weeks they would flare up on different parts of my body. Would only last 10-15 minutes and go away , then it would appear in a different spot. Primary said it was Spontaneous Urticaria. Gave me Prednasone  for 3 days. It help calm them down, but they are still continuing. I went to the Dermatologist, started taking Claritin every morning and Benadryl at night. The are milder as I am in the 4th week, but they are still appearing throughout the day, no triggers associated with food, working, etc. It is sporadic. I am a healthy person and not allergic to anything.
Patient had facial pressure and some throat tightness.  His VS were normal and he was transported to the ER.
1st 24 hours, lethargic, confused, weak, shaky, pale, hallucination. Intermittent headaches and tiredness persists.
t105 devel 6-8 hrs p/vax administration; pt went on to become lethargic & have several generalized sz;
My ear started ringing really badly and the outside went numb on the outer structure and about 1-2 inches around that. It lasted for about an hour and then went back to normal. I haven't experienced it since.
Itchiness started on same side of body, on side of torso, back and chest area on the right side, near arm injected, but no rash immediately.  At first I thought it was clothing that was pinching me but my skin, because it was a pretty small area (especially the right side of torso/back/chest), but it has progressively gotten more itchy, with more surface area itchy and sensitive to contact with clothing or air/breeze. Today, woke up with a possible  tiny goosebump like rash on area that itches, including part of arm, but seems to be fading since waking up. Itching is more intense than yesterday though. This reminds me of an allergic response that I had to sunscreen s few years ago. Sometimes I get localized rashes if I use a new sunscreen, but that incident was not localized and was similar general itching all over. In comparison to that general sunscreen response, this sensation is more like hypersensitivity (eg any acne or skin imperfections itch and sting when they usually don?t, and contact with clothing and air/breeze makes it itch and sting/hurt also.)
Initial unsolicited report received from a healthcare professional on 22 September 2014. An 80-year-old female patient, had received first dose of ADACEL, (batch number U4965AA, route of vaccination was not reported) in left deltoid on 18 September 2014. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions include sulfa and codeine allergy. The patient did not receive any concomitant medications. On 19 September 2014, the patient experienced pain in left arm, itching and burning. No laboratory tests were performed. The patient was treated with Benadryl. The patient was taken to emergency room visit for doctor visit. At the time of this report, the outcome of event was unknown. Documents held by sender: none. Follow up information received from healthcare professional on 07 January 2015. It was reported that ADACEL was administered intramuscularly. Documents held by sender: none. Follow up information received from healthcare professional on 8 June 2015. At the time of this report, the patient was recovered from the events. Documents held by sender: none.
Muscle ache, fever,  headache, chills, nausea.  loss of taste and smell, nightmares nightly.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021 at 1:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 1:49 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 71.55 years. No concomitant medications were reported. Batch number 016M20A underwent temperature excursion on 08-Feb-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and at 11:00 AM with temperature 35 degrees Fahrenheit. The vial was initially moved to the fridge on 02-Feb-2021 and proposed beyond use date was 04-Mar-2021. Product moved to clinic on 08-Feb-2021. 3 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Shortly after receiving his first HPV vaccine,  patient fainted twice within 30 minutes.  Patient came around both times within 30  seconds.
no other symptoms or other AE reported; doses of VARIVAX were given following temperature excursion; This spontaneous report as received from a office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, or concomitant therapies were not provided.   A temperature excursion of varicella virus vaccine live (oka/merck)(VARIVAX)  was registered as 7.4 °F for 10 minutes on 01-MAR-2022. On 23-MAR-2022, the patient was vaccinated with the improperly storage dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route were not provided) with lot # U022732 and expiration date of 20-JUL-2023 for prophylaxis. There was no previous temperature excursion. No adverse events were reported.   This is one of several cases received from  the same reporter.      ?; Sender's Comments:  US-009507513-2203USA010197:
Sore left upper arm; Rash red; This is a spontaneous report from a contactable consumer (patient). This 72-year-old patient reported.  A 72-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via intramuscular route, administered in left arm 02Mar2021 11:00 (72-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history included ongoing hypertension (since 33years old. pertinent details: Just constant Dr. visits), gallbladder operation from 1992 to an unknown date (pertinent details: Surgery-1992 Was 29 years old), Hip replacement right hip from 1994 to an unknown date (was 46 years old Pertinent details: 1994), hysterectomy from 1994 to an unknown date (was 46 years old pertinent details: surgery 1994) and Heart condition (Father and Mother-deceased). Concomitant medication(s) included atenolol (ATENOLOL) taken for blood pressure measurement from an unspecified start date and ongoing; citalopram (CITALOPRAM) taken for anxiety from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastroesophageal reflux disease from an unspecified start date and ongoing; amiloride (AMILORIDE) taken for Heart-blood pressure from an unspecified start date and ongoing; chlorthalidon (CHLORTHALIDON) taken for blood pressure measurement from an unspecified start date and ongoing. Patient did not receive any vaccine prior to vaccination. On 02Mar2021 at 13:00, the patient experienced sore left upper arm and rash red. On an unspecified date patient underwent lab tests and procedures which included angiogram: normal (No problem with heart. All problems from very high blood pressure). The patient did not want to go hospital. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included, blood test: normal (on Mar2021 No problems), electrocardiogram: Problem with heart (Dr. found that problem was usually from high blood pressure) and sars-cov-2 test: negative. The patient did not receive any treatment for the events. On an unspecified date on 2021, the patient recovered from the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021493855 Same patient/vaccine, different dose