chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a very sore arm) 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 20-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 VACCINATION SITE PAIN (a very sore arm). At the time of the report, VACCINATION SITE PAIN (a very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were not reported. Treatment information was not provided.    This case was linked to MOD-2021-011083 (Patient Link).
Tdap vaccination date due 11-21-14. Given 11-12-14. Pt had no adverse reaction no treatment needed.
The covid vaccine was fine. I received my FLU SHOT at the same time but in right arm which is my dominant side.  The injection hurt at time she gave it and within just a few hours got worse. Within 2 days my entire shoulder and all muscles in my arm were severely painful. Although I iced and heated the affected arm, ended up at my doctor on 10/25/2022 at which time she said it was all inflamed. Gave me trigger point injections around scapula and said she suspected deltoid bursitis. It has only gotten worse. I will be getting an MRI of my shoulder 11/23 and depending on what that shows, will either see an orthopedist on 12/6 or see my pain management physician.
Had low grade fever, night sweats, headache and fatigue for 1 month and am still having night sweats and fatigue on 03/26/2021.  Had blood work done several times and nothing came up except low vitamin D which is being treated but nor relevant to all of these symptoms
Symptoms started the day following the vaccine on 4/17/2022; Upon getting up from the couch, the room went dark, the room was spinning and she fell; She tried to get up but couldn't due to dizziness, feeling unsteady; Had to crawl to the bathroom, was nauseated; Couldn't see to work the phone to call 911; She laid down and her symptoms resolved after some time, unsure how long this was. Was able to get up a couple of hours later; Has some difficulty describing her symptoms.
Immediately after dose 2 of the Moderna vaccine I felt fatigued and slightly congested. At approximately 3 am (14 hours after vaccination due to daylight savings), I woke up with severe body aches, headache, skin tenderness, and chills indicating a fever. The following morning, these symptoms were joined by lack of appetite, weakness, and nausea upon attempting to eat. Symptoms lasted at full intensity for approximately 24 hours. At some point in the early hours of 3/15, my fever started to break and left me sweating on and off all night. By the morning of 3/15, symptoms were still present, but had greatly lessened in intensity. After approximately 36 hours, (3/15 at 3 pm) symptoms had mostly ended, though I still had a headache and felt weak. Today (3/16), feelings of weakness persist and I feel very 'foggy'; slow to think and slow in movement. I did not take any NSAIDs or medicines of any kind to deal with symptoms, as I feared it would lessen the efficacy of the vaccine.
Information has been received from a 48 year old female with penicillin allergy, sulfa allergy, an allergy to Ludiomil, dust allergy, dairy allergy, dog allergy and allergy to some cats and a history of hysterectomy 1996, biopsy 1993, and hospitalization 2000 for bleeding ulcers in colon and lower intestine who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included rofecoxib 25mg and Prozac. Subsequently, the pt's upper arm became swollen and she ran a fever of 101.5 degs. F. Her doctor feels that it was an allergic reaction. Unspecified medical attention was sought. Further info received from a physician indicated that the pt was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent on 12/7/01. On 12/7/01, the pt developed a fever of 101 F, redness at injection site and soreness. The outcome of the events was unknown. Additional info has been requested.
Convulsions; In and out of consciousness; extreme pain throughout the body; Vomiting; Inability to speak; Couldn't walk; Couldn't raise limbs; Sustained premature ventricular tachycardia; Heart collapsed to 20 BPM; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition reported).    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia) (seriousness criteria hospitalization, medically significant and life threatening), BRADYCARDIA (Heart collapsed to 20 BPM) (seriousness criteria hospitalization, medically significant and life threatening), SEIZURE (Convulsions) (seriousness criteria hospitalization prolonged and medically significant), SEIZURE (In and out of consciousness) (seriousness criterion hospitalization prolonged), PAIN (extreme pain throughout the body) (seriousness criterion hospitalization prolonged) and VOMITING (Vomiting) (seriousness criterion hospitalization prolonged). 23-Mar-2021, the patient experienced GAIT INABILITY (Couldn't walk) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs) (seriousness criterion hospitalization) and APHASIA (Inability to speak) (seriousness criterion hospitalization). The patient was hospitalized on 23-Mar-2021 due to APHASIA, BRADYCARDIA, GAIT INABILITY, MUSCULOSKELETAL STIFFNESS and VENTRICULAR TACHYCARDIA. At the time of the report, VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Heart rate: 20 (Low) 20 BPM.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) to be related.
Information has been received from a nurse practitioner concerning a 31 year old female with an allergy to codeine and no illness at the time of vaccination who on 15Jun04 was vaccinated SC in the left tricep with a dose of rubella virus vaccine live (Wistar RA 27/3) (lot 6470370796N). Concomitant therapy included rofecoxib (MSD). Immediately post vaccination on 15Jun04, the pt complained of a headache. On 16Jun04, the pt developed redness and swelling at the injection site, fatigue, and nausea. On 25Jun04, the pt developed joint pain and fever. On 26Jun04, the pt developed a generalized rash. The pt sought unspecified medical attention. The pt subsequently recovered. No additional information is expected.
Left sided hearing loss; This is a spontaneous report from a contactable physician who was also the patient. A 42-year-old non-pregnant female patient received bnt162b2, lot number and expiration date were unknown, via an unspecified route of administration on 16Dec2020 , 8:30 at a single dose for covid-19 immunization. The patient's medical history included antiphospholipid antibody from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Dec2020, the patient experienced left sided hearing loss. It was unknown if patient received treatment for the event. The outcome of the event was not recovered. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID-19 since vaccination. Patient has no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Information on the lot/batch number has been requested.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment.  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.
Pt recvd 1st dose of vax on 11MAY92 & pt devel mild hives on lt wrist & lt hand; treated w/DPH & sx resolved; recvd 2nd dose w/no noted problem; No further details were provided;
February 14--fever, body aches, headache, fatigue February 22/23/24--headache, fatigue February 27/28 & March 1--headache, fatigue
bREAKTHROUGH case admission after 4 vaccines Moderna 3/18/21 lot# 044A21A;  Moderna 4/15/21 lot# 017B21A;  Moderna 10/27/21 lot# 939905;  MOderna 4/9/22 lot# 066K21A
Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild
Headache, Myalgia, Arthralgia, chills Narrative:  Other Relevant History:
Mom reported that on Wedns. 6/16 approx. 24 hrs after receiving shots she noticed redness and hard, hot swelling (about size of half dollar) and welts around shot site (left thigh) after complaints from child of itching and pain at site (per dad on f/u case). No respiratory symptoms or anything indicative of systemic involvement. Dad reports they gave BENADRYL per PCP x1 and child has been fine since (call dated 6-21-10 for f/u).
Severe headache starting about 24 hours after vaccine, building up through the evening. Ultimately, 500mg of Acetaminophen was taken to manage this symptom in the evening. Low grad headache next morning.
This spontaneous report as received from a Medical Assistant refers to a 16 year old male patient. On 17-JUL-2013 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # not provided), (dose and frequency unspecified), injection. The patient had received MMR (manufacturer unknown) and VARIVAX (Merck) in the past on an unspecified date and was to receive the second dose of both the VARIVAX (Merck) and MMR (manufacturer unknown). No adverse effect reported. Additional information has been requested.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 101 degree f High. On 14-Apr-2021, Body temperature: 102 degree f High.         No relevant concomitant medications were reported. Treatment information included paracetamol 500 mg. Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a nurse referring to a 1 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 20-AUG-2018 the patient was inadvertently administered one dose of PROQUAD (strength and route were not reported; lot # N019249 and expiration date 20-DEC-2018) and one dose of VARIVAX (strength, route, batch/ lot # and expiration date were not reported) for prophylaxis(overdose). No adverse effects were reported.
This case was reported by a physician and described the occurrence of injection site irritation in a adult female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site irritation, injection site mass, mass, eye swelling, nausea, and pruritus. On an unknown date, the outcome of the injection site irritation, injection site mass, mass, eyes swelling, nausea and pruritus were unknown. It was unknown if the reporter considered the injection site irritation, injection site mass, mass, eye swelling, nausea and pruritus to be related to BEXSERO. Additional details were reported as follows: The reporter stated that, the patient was a friend of the family. The patient who was going to college to receive the BEXSERO and was believed that, the patient had an adverse reaction. The patient had an irritant a knot below the injection site also has another knot at a remote location. The events seem like a minor reaction. The reporter stated that, she was not his patient but a family friend. The reporter asked to give him a call.
adverse reaction that was not noted on your site; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction that was not noted on your site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   Concomitant product used was not provided by the reporter. No treatment information was reported. On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction that was not noted on your site).   At the time of the report, ADVERSE REACTION (adverse reaction that was not noted on your site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt developed tinnitus (ringing in the ear) 3 months after receiving janseen covid19 vaccine
Info has been received from a registered nurse concerning a 44 year old female who on 10/16/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641115/1159L). Concomitant therapy that day included a dose of an influenza virus vaccine and interferon beta-la (AVONEX). Subsequently, the pt developed severe swelling above elbow, and entire posterior left arm was red and hot. The pt was also reportedly "short of breath, light headed." The reporter considered this as an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt sought medical attention and was treated with cetirizine (Zyrtec). Additional info has been requested.
My son was administered the Hep B vaccination at one day old and died at 18 days old almost to the minute of original vaccination date and time. I was told by VAERS if your gonna have a deadly reaction it will happen w/n 18 days.
Patient c/o Throat tightness "My throat is closing up, and I also took Benadryl 50 mg 30 mins before I got the vaccine".  Patient for extra 15 mins,  vital signs checked,  water offered.  Patient vital signs remain within normal limit,  symptoms improved and patient left at 1257.
Patient received 3rd full dose in September 2021, should not have received booster until March 2022
CRAMPS ON MY PELVIS/CRAMPS ON LOWER BACK; INDUCED PERIODS; This spontaneous report received from a consumer concerned multiple patients. 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: unk) dose, start therapy date were not reported for prophylactic vaccination The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced cramps on my pelvis/cramps on lower back, and induced periods. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps on my pelvis/cramps on lower back, and induced periods. This report was non-serious. This case is a duplicate of 20210424112. This case, from the same reporter is linked to 20210412152.  It was determined that this case is a duplicate of Manufacture Case number (20210428669). This case, Manufacturer Report Number (20210424112), will be nullified and deleted. All relevant information will be submitted under a Manufacturer Case Number (20210428669).
Became nauseated evening of 10-12-16. On 10-13-16 patient went to ER with tachycardia and erythematous of trunk. Pain bil arms and legs. Pt states smoking TAC prior to ER visit. Mother stated body swollen and body bright red. Was given ATIVAN in ER. Prob resolved.
Information has been received from a physician concerning a female who was vaccinated with GARDASIL. Subsequently the patient developed redness at the injection site. No additional information was provided. This is one several reports received from the same source. Additional information has been requested.
Pt states she broke out in hives all over body and slight temp3 days after receiving the Covid Vax and has never had hives before. Pt states she is itchy and has nausea, body aches, headache and not feeling well.  Pt had a tele visit w/ PCP  which advised her to take Benadryl and Pepcid.
Patient called 911 for difficulty breathing and chest pressure approximately 30 minutes after vaccination. During evaluation, patient began hyperventilating which resulted in additional symptoms which were managed once the breathing was controlled. Patient was administered Diphenhydramine 50mg IM with improvement of symptoms.
During mass Immunization Clinic H1N1 approx 1:30pm post vaccination client c/o itching while sitting waiting area. Client assessed per EMS and BENADRYL 50mg IM administered per EMS @ 1:51pm. BP 132/100 P = 66, O2 Sat 99%. Alert and oriented x 3. Itching resolved. BP retaken 120/88 @ 2:11pm. Client declined transport. Client instructed go to ER, if recurs or any problems.
Case number PHEH2014US019170 is a initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 57 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly on 18 Sep 2014. It was reported that he was vaccinated with 1.0 ml of vaccine instead of 0.5 ml. No adverse events reported after the maladministration.
Patient awakened with a feeling of fever, chills which then progressed to lethargy, headache, nausea and vomiting in the am.  Then about 24 hours post vaccine she developed enlarged lymph nodes on the same side of her body as the injection.  This swelling and painful enlargement lasted for 2-3 days post emergence.  She was able to return to work on the 4th day but reported neck pain and still feeling tired.
Patient died with the cause of death being reported as Acute Myocarditis. Due to: Neisseria Meningitis Septicemia. Isolate tested as Group Y. Being reported as a breakthrough case.
Felt a little achy; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt a little achy) and FATIGUE (Extremely tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (Felt a little achy) and FATIGUE (Extremely tired). On 15-Feb-2021, PAIN (Felt a little achy) and FATIGUE (Extremely tired) had resolved.        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.   Treatment information was not provided.   This case was linked to MOD-2021-390033, MOD-2021-390040 (Patient Link).
**THIS IS AN ERROR, NOT AN ADVERSE EVENT** Patient received multiple doses of the Pfizer vaccine. The vial was not diluted with 1.8mL of normal saline and 0.3mL of the undiluted vaccine was accidentally sent up the floor and administered to the patient. No adverse effects have occurred to the patient since administration.
Chest pain dx as viral myocarditis Elevation of cardiac enzymes- CK & Troponin to 6.4 Received anti-inflammatory meds ECHO exam normal
chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of chills (1st dose received on an unknown date, refer case US2021AMR204564).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced chills. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt severe chills. The event severe chills was lasted for four hours. The follow-up would not possible as no contact details were available. This case has been linked with case US2021AMR204564, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR204564:same patient
had a generalized seizure that lasted about two minutes on February 16th.  This was preceded by 5-10 minutes of intense shivering. has a pre-existing seizure disorder, but the shivering was not typical.  In addition, he had another generalized seizure on March 11th.  In 2019 and 2020, averaged three seizures per year.
Developed right arm pain, swelling in arm and hives. Seen at own personal primary care clinic. Given Benadryl and Tylenol.