chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warmth at the injection site; Itchiness at the injection site; Swelling and redness that is present from Left deltoid (Injection site); Swelling and redness that is present from Left deltoid (Injection site); This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Warmth at the injection site), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE SWELLING (Swelling and redness that is present from Left deltoid (Injection site)) and INJECTION SITE ERYTHEMA (Swelling and redness that is present from Left deltoid (Injection site)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MOD012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warmth at the injection site), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE SWELLING (Swelling and redness that is present from Left deltoid (Injection site)) and INJECTION SITE ERYTHEMA (Swelling and redness that is present from Left deltoid (Injection site)). At the time of the report, INJECTION SITE WARMTH (Warmth at the injection site), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE SWELLING (Swelling and redness that is present from Left deltoid (Injection site)) and INJECTION SITE ERYTHEMA (Swelling and redness that is present from Left deltoid (Injection site)) 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 Treatment information was provided. No concomitant medications were included.    Reporter did not allow further contact
Vaccine was taken out from freezer and stored initially in refrigerator on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022; Patient was given expired (4 days expired) Moderna vaccine on 24-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine on 24-May-2022) and PRODUCT STORAGE ERROR (Vaccine was taken out from freezer and stored initially in refrigerator on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K212A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose number-1, dose and unit-0.3 milliliter, Batch number (EN6207), Route of administration- Intramuscular, Anatomical location-Right deltoid) on 22-Mar-2021, Pfizer (Dose number-2, dose and unit-0.3 milliliter, Batch number (EW0151), Route of administration- Intramuscular, Anatomical location-Left deltoid) on 12-Apr-2021, Pfizer (Dose number-3, dose and unit-0.3 milliliter, Batch number (FF2593), Route of administration- Intramuscular and Anatomical location-Left deltoid) on 30-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 24-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine on 24-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was taken out from freezer and stored initially in refrigerator on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine on 24-May-2022) and PRODUCT STORAGE ERROR (Vaccine was taken out from freezer and stored initially in refrigerator on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  On 24-May-2022, the patient was given expired (4 days expired) Moderna vaccine lot 033K21-2A (manufacturer expiration date 20-May-2022) Intramuscular 0.25mL as a fourth dose. Vial was taken out of freezer and was initially stored in the refrigerator on 20-Apr-2022. Out of freezer expiration date was 20-May-2022. The vial did not undergo any temperature excursion.  No treatment medications were provided.   This case was linked to MOD-2022-575471 (Patient Link).
This spontaneous report was received from a doctor of pharmacy concerning a 6 month old male patient with Down's syndrome and congenital heart disease. There were no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose (reported as at least one dose) of ROTATEQ (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient was hospitalized. At the time of report, the patient was an in-patient in a hospital and had a Nasojejunal tube (NJ-tube) inserted approximately on an unknown date in October 2013 (reported as about a week and half ago) for an unspecified reason. It was unspecified if any treatment was given or if any lab tests were performed. The patient was not recovered. The relatedness for the event was unknown for ROTATEQ. Additional information has been requested.
Patient was initially showing sings of vasovagal syncope, then started t feel dizzy and stated that she could not breath well. Patient's vitals were taken: BP:86/54 HR: 82 Spo2: 97% RR:16  Provider was consulted and noticed that patient's lip was swelling, then administered an Epi pen.
Developed hives torso area on 9/14/18. Hives spread to bilateral axilla's, face, ears, arms, legs, back with severe itching, continued to worsen even with BENADRYL and CLARITIN. I followed up with RN at clinic and reported adverse reaction. Dr. prescribed MEDROL dose pack which resolved severe itching, and hives.
mouth ulcer; Roof of mouth pain and tenderness; Low grade fever; body aches; no energy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 27Mar2021 at 13:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included that the patient was a smoker. The patient had no known allergies to food, medications, or other products. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 06Mar2021 at 13:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. On 27Mar2021, first day of vaccination, the patient had low grade fever of 99.7 (unspecified units), body aches and no energy.  On 28Mar2021 at 12:00, second day of vaccination, the patient experienced ulcer in roof of the mouth, with pain and tenderness. On 29Mar2021, third day of vaccination, the mouth pain was worse. The patient reported that she was feeling better at the time of report except for mouth pain. The patient did not receive any treatment for the reported events. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the events mouth ulcer with pain and tenderness was not resolved, while that of low grade fever, body aches and no energy was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
leaking of the vaccine, and an incomplete dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 35AD3) for prophylaxis.   On 26-SEP-2023, the patient received Arexvy. On 26-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: leaking of the vaccine, and an incomplete dose administered).The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The reporter called to inform that earlier that day, a patient moved their arm during the administration of a dose of Arexvy and this resulted in the leaking of the vaccine and an incomplete dose administered, which led to incomplete dose administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
immune response related to renal failure w/no other known risk factors; did not feel well for month s/p vaccine; nephrologist felt vax may have caused this due to immune markers present prior to vax that were not known to pt;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EK9231), in right arm, on 16Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 08Oct2021 as dose 3 (booster),single (Lot number: FE3590) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; METFORMIN. Past drug history included: Topamax, reaction(s): "Known allergies: Topamax". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (25Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti viral details:  product=COVID 19 Treatment, brand=Paxlovid  Treatment start date=16Jul2022, Treatment stop date=20Jul2022, Lot number=GA2851, Indication=Treatment of COVID-19.  No follow-up attempts are Possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.   This case was linked to MOD-2021-193834 (Patient Link).
Redness, pain and swelling at injection site, joint and muscle pain, burning eyes, feverish.
After 1st dose: fatigue, arm soreness, and slight chills (waited 10-15 minutes before leaving) After 2nd dose: almost immediately was a sharp pain in my left neck and migraine, as well as rapid heart rate. Because I am allergic to Dexamethasone, there were two nurses watching me and I had to wait for 30minutes prior to leaving. Within a few hours, I had extreme fatigue, worsening migraines, rapid heart rate and difficulty breathing, fever, chills, and nausea. I was in bed for about 48hours with a fever over 102F before taking tylenol to reduce symptoms. I had lingering migraines for a week post 2nd dose, and rapid heart rate for about 2-3 weeks before it subsided. I also had a bladder infection that wasn't diagnosed until about a month later
The patient came to the clinic on 10/21/2021 to receive the 2nd dose of Pfizer COVID-19 vaccine. With her first shot, she had 3 episodes of racing heart at night for about 15-30 minutes (each time resolved on its own). She has not had any since that time. It began 2-3 days after her first immunization and occurred 3 out of 10 nights that they were out hunting. She denied any chest pain, fever or other symptoms.
Headache, muscle aches, chills, high fever, rash,, swollen joints, fatigue, minor chest congestion lasting 9 days.  Administered Tylenol, Ibuprofen,  Mucous DM. Tested negative for Covid 19 on rapid and lab test.
no adverse event from the vaccine itself, but patient presented to ED late on 9/23/23 with chills and fever.  He tested positive for COVID and was admitted to the Adult Care Unit early on 9/24/23 to rule out UTI as the cause of his symptoms.
10 X 15 redness and swelling over entire anterior thigh. Walks with difficulty, doesn't appear to hurt and is not scratching.
Urticaria/erythema multiforme. Progressive despite stopping Amoxicillin; swelling of hands and feet - started on po steroids with resolution.
t104+ fever; no sz or neurological side effects; no prolonged high pitched crying; advised by MD to clinic;
Redness on arm at the injection site (approx. 3 inch diameter); tenderness; swelling
SWELLING (patient described as softball size swelling at site of injection), REDNESS, HEAT, SEVERE IRITATION (patient reported could not have anything in contact with site), OCCASIONAL SHOOTING PAIN.  SWELLING, PAIN, HEAT AND SEVERE IRRITAION SUBSIDED BY 7-22-15 ALTHOUGH REDNESS AND SOME PAIN WITH PRESSURE REPORTED.
Tingling in hands , flush in face, itching on skin and hives all over face and body
Patient stood up approximately 5 minutes after receiving her last vaccine (flu shot) and stated she was "feeling hot and ready to go".Her mother observed a shift in her mood which she described as child gets mean prior to having a seizure. I asked patient to have a seat in the chair and she fainted. Her skin was clammy and sweaty. I called her name 3 times and she responded partially and closed her eyes. a Whiff of ammonia inhalant was given approx. at 10:04 A.M., Applied cool cloth to forehead was given 4oz. water. FS-123 and repeat BP 88/61 P-80. Parent declined 911 ambulance and agreed to take child to ER at Hospital. Repeated BP at 10:15 A.M. 86/60 P-83. Patient continued to be responsive. I explained Importance of child being evaluated today and parent agreed to give RN an update. Last vitals were done at 10:40 A.M. BP 89/60 P-65. Patient reported feeling better. Patient left clinic with her mom and was being transported to Hospital Emergency Room by her parent. 11/8/2019 Telephone call to parent today. Mother states child was evaluated at Hospital ER on 11/7/19. Was told by ER physician that child had a syncope episode after receiving vaccinations. Child was discharged on 11/7/19. Went home and rested. Mother stated "child is fine" and went to school today. - RN
Information has been received from an unspecified reporter referring to a 21 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Skin around injection site began to get red and swell.  Swelling and area of skin/tissue involved has increased over the last few days since injection was administered.  Pain, itching, hot to the touch, and beginning to look bruised in addition to the redness.
Donor received Tdap immunization on 6/13/22. Did not have any reaction after 20 minutes of immunization, donor left the building. Roughly 2 hours after immunization was given donor started to have pain/tenderness, redness, hardening and nodule formation at the immunization site. Donor reported these symptoms to the center today, 6/16/16. Symptoms still remain. Donor has been putting ice on the site daily. Given ice pack today for site, informed not to leave on for more than 20 minutes in an hour
The patient had a large red area just under where the immunization was given, the area was warm to the touch, but did not itch or burn.
Patient reported a sore/painful arm and felt feverish for 24 to 48 hours following vaccination. After initial reaction subsided, she continued to have pain in her left arm and it was warm to the touch. Patient presented to the pharmacy 12/3/21 and said her arm was hot and hard to the touch. Her cardiologist she saw earlier in the day directed her to see her primary MD which she did and was given prescriptions for Augmentin 875mg every 12 hours for 10 days and Fluconazole 150mg as a one time dose. Outcome currently unknown.
Severe soreness, could barely move my arm 12-hours after injection. Redness at injection site. Warmth at injection site.
Hospitalization; Some type of cancer; This serious case was reported by a pharmacist via call center representative and described the occurrence of hospitalization in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dementia.   On 17-MAR-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hospitalization (Verbatim: Hospitalization) (serious criteria hospitalization) and cancer (Verbatim: Some type of cancer) (serious criteria GSK medically significant). The outcome of the hospitalization was unknown and the outcome of the cancer was not reported.   It was unknown if the reporter considered the hospitalization and cancer to be related to Shingrix.     It was unknown if the company considered the hospitalization and cancer to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-SEP-2023 The reporter mentioned that the patient might had been in the hospital around the time she was supposed to get the 2nd dose.  The reporter stated that he believed she had some type of cancer and slight dementia.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Patient came in with ~24 hr history of rash, starting at L abd, then increased and spread central to extremities. Pt : multiple vesicles (>200), primarily on torso.
This spontaneous report as received from a registered nurse refers to a 4 year old patient (unknown gender). On 23-JUN-2010, the patient was vaccinated with the first dose of M-M-R (dose, route and lot # not reported) and VARIVAX (Merck) (dose, route and lot # not reported). On 15-AUG-2013, the patient should receive the second dose of M-M-R and VARIVAX (Merck), however received the second dose of PROQUAD (Merck) (dose, route and lot # not reported) and VARIVAX (Merck) (dose, route and lot # not reported) instead. No adverse effect reported. Additional information has been requested.
High fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Respiratory disorder NOS (she is on oxygen 24 hours per day.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever) and VOMITING (Throwing up). At the time of the report, PYREXIA (High fever) and VOMITING (Throwing up) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-403374 (Patient Link).
Patient recieved vaccine at 1312 and by 1315 patient started to complain of burning in the chest. Patient denied shortness of breathe at that time. vitals were taken and were within normal ranges. RN contacted provider and antacids were ordered for patient. Medication was administered by 1323 and patient verbalized relief at 1333. Patient was assessed for 15 minutes and was released to return home.
Went for yearly exam. To a booster Pneumonia shot. I asked what was in it or side effect. I mention my Wegner's granulomatosis. Shot was itchy, swollen, red, hard, hot, grew to 5" x 7". 6 day later saw doctor. Next week went away.
Patient received 2 flu shots, not reporting any adverse effects but did receive both within a 10-day time period.
he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse.; he woke up this morning with sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), CHILLS (non-serious), ABDOMINAL DISCOMFORT (non-serious), HYPERTENSION (non-serious), HEART RATE INCREASED (non-serious), outcome "unknown" and all described as "he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse."; HYPERHIDROSIS (non-serious), outcome "unknown", described as "he woke up this morning with sweats". Additional information: the patient received the first dose of the Pfizer COVID-19 vaccine 12 days before. During the first week he experienced arm pain at the injection site, chills, extra bowel movements, elevated blood pressure and elevated pulse. He also woke up with sweats.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.