chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Area of burning moved to upper arm, shoulder, neck, and scapula; Burning at the injection site; Area was hot to the touch; painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (Area of burning moved to upper arm, shoulder, neck, and scapula) and VACCINATION SITE PAIN (Burning at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No historical condition reported.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Area of burning moved to upper arm, shoulder, neck, and scapula) (seriousness criterion hospitalization prolonged), VACCINATION SITE PAIN (Burning at the injection site) (seriousness criterion hospitalization prolonged), SENSITIVE SKIN (Area was hot to the touch) and MYALGIA (painful). At the time of the report, SKIN BURNING SENSATION (Area of burning moved to upper arm, shoulder, neck, and scapula), VACCINATION SITE PAIN (Burning at the injection site), SENSITIVE SKIN (Area was hot to the touch) and MYALGIA (painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I discovered a raised red circle around the injection site, about 2 inches in diameter, two weeks after the injection. It is still very visible two days after the discovery. There is some soreness as well as itchiness related to the redness.
Main Complaint - Nasal Congestion, Sore throat & Headache, Fever (Temperature ranging from 99.8F to 98.8F) At the time of this report, pt. reports that both the headache and sore throat have improved. He has been taking Tylenol as needed and temperature is now down to 98.0F to 98.8F.  He visited Emergency Center (due to complaints listed above) and was prescribed Mupirocin Ointment to apply to his nose (for possible bacterial infection). However, pt. reports no improvement with nasal congestion.  Pt. has indicated that he will be visiting the Emergency Center (see above) to follow up on an alternative treatment - Clindamycin.
Soreness at injection site almost immediately and worsened over next 25 hours.  10-12 hours after shot joint and muscle aches (feels like flu without the fever), 8 hours after shot and continuing for remainder of day diarrhea, fatigue.
12/31/2021: Started off with sniffles and wheezing. I took COVID tests, and all came back negative. I did have nasal congestion, sore throat, coughing and headache. I took Ibuprofen, Decongestants, Sudafed, Allegra, Mucinex. I took these meds for about a month, and they didn't really help. I decided to see a doctor. I had a tele visit and I was told that I was having an extreme allergic episode. They prescribed a 7-day course of Steroids and Flonase. That seemed to work. I was fine for a couple days and then the symptoms came back. I scheduled an appointment to see the doctor again but by the time of the appointment the symptoms subsided again. It took over a month to get it under control. In 04/2022 the coughing and wheezing has returned. I am now taking Allegra and Flonase.
This is a spontaneous report from contactable healthcare professional (patient). A 32-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3246) intramuscularly in left arm on 27Jan2021 at 11:00 (at the age of 32 years) as 2nd dose single for COVID-19 immunization. The patient medical history included asthma. The patient previously took codeine and experienced allergy. Concomitant medication of the patient included amphetamine aspartate, amphetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 30 mg received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number:Unknown) intramuscularly in left arm on 04Jan2021 at 13:00 as 1st dose single for COVID-19 immunization. Patient did not receive any vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 27 Jan 2021 post vaccination, patient has been tested for COVID-19 test (Curative) and result was unknown. On 27Jan2021 at 15:00, patient experienced muscle stiffness, dizziness, fatigue, diarrhea, headache, fever, pain in arm, ringing in ears, confusion and nausea. Patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer from 18-Mar-2021 to 15-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
30 hours after the Vaccine I woke up and noticed my top lip swollen, red and warm to the touch. My left arm, and neck was hurting as well.
Expired dose was administered/received dose from vial punctured for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was administered/received dose from vial punctured for more than 12 hours) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022 at 1:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was administered/received dose from vial punctured for more than 12 hours). On 25-Jan-2022 at 1:30 PM, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered/received dose from vial punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on 13Jan2022. Date and time vial was first punctured was on 09:15 hrs on 24Jan2022. Post puncture the vial was refrigerated. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degrees C= 46 to 77 degrees F) was Less than 24 hours. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Follow up received includes Added patient details, Lot number of suspect, updated i narrative with product information. On 28-Jan-2022: Follow up received includes no new information.
Fever, chills, burning in the arm, Dizziness, sweating, palpitations and chest pain. It all happened within 5 minutes of giving me the vaccine.
92 year female admitted to hospital for fall on 5/24/2021. Unknown exposures in 14 days prior. Pfizer vaccine 2/25/2021 & 3/19/2021. PCR positive 5/24/2021. Transferred to hospice on 29th. Passed on 5/30/2021. Diagnosis at time of death: ARF on chronic with hypoxia, hematoma anterior chest wall left hip and upper thigh, suspected mild heart failure preserved ejection fraction, mechanical fall, delirium, bilateral PNA, pulmonary HTN, acute encephalopathy.
Reported redness on left arm, cheeks, ears, and small amount on chest at 2:23 pm, reported itchy left arm at 2:31, itching resolved at 2:34, redness decreased  by 2:55. Client left clinic with husband at 3:05 and called staff at 4:32 reporting redness had resolved without treatment.
Elevated heart rate; Tachycardia; Feeling so sick; Weight is like 85 lbs; lost weight from being so sick; weight loss; Vertigo; Really bad panic attacks; Blind spots; Dizziness; Very uneasy feeling; Haven't had an appetite; Sore arm; Swollen lymph nodes under armpit; Sick to stomach after eating; This serious, initial spontaneous safety report was received on 22-JUN-2023 from a consumer via the contact center.  A female of 30 years was vaccinated with intramuscular use Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 in the left arm on 28-APR-2023 at a pharmacy and dose 2 in the right arm on 26-MAY-2023 at a public health department.  Medical history included Influenza like illness after the influenza vaccine when the individual was younger, and COVID-19 in NOV-2021. She had no illnesses at the time of vaccination, and no allergies.  The individual was not taking any concomitant medications.  On an unspecified date in 2023, after dose 1, the individual had a sore arm (PT: Pain in extremity) and swollen lymph nodes under the armpit (PT: Lymphadenopathy). She reported the first vaccination was fine. On 27-MAY-2023, 1 day after dose 2, the individual started feeling sick (PT: Illness). On the same day, she woke up with tachycardia (PT: Tachycardia) (Serious: Hospitalization) and has been in and out of the hospital on unspecified dates in 2023. On an unspecified date in 2023, after dose 2, the individual lost weight from being so sick and was about 85 lbs (PT: Weight decreased). Additionally, she started having symptoms of vertigo (PT: Vertigo), really bad panic attacks (PT: Panic attack), elevated heart rate, blind spots (PT: Visual field defect), and dizziness (PT: Dizziness). It seemed like it started to go away and came back. The individual had a very uneasy feeling (PT: Feeling abnormal), hasn't had an appetite (PT: Decreased appetite), and has been sick to her stomach after eating (PT: Nausea).   Relevant lab tests included: Computerised tomogram (Result: Fine; 2023), Blood test (Result: Fine; 2023), Computerised tomogram head (Result: Fine; 2023) and Chest X-ray (Result: Fine; 2023).  At the time of reporting, the event outcomes of Pain in extremity and Lymphadenopathy were unknown, and the event outcomes of Illness, Tachycardia, Weight decreased, Vertigo, Panic attack, Visual field defect, Dizziness, Feeling abnormal, Decreased appetite, and Nausea were not recovered/not resolved.; Sender's Comments: This 30 year-old female experienced: Tachycardia, Illness, Decreased appetite, Dizziness, Feeling abnormal, Lymphadenopathy, Nausea, Pain in extremity, Panic attack, Vertigo, Visual field defect and Weight decreased after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Tachycardia was assessed as serious. The events Illness, Decreased appetite, Dizziness, Feeling abnormal, Lymphadenopathy, Nausea, Pain in extremity, Panic attack, Vertigo, Visual field defect and Weight decreased were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
12/16/04:mom called yesterday afternoon stating patient had red, swollen area that had a small knot. Instructed to use witch hazel and Tylenol. Call in AM to let us know how patient doing. Spoke with mom this am. Knot bigger, will see patient. When patient got to office knot 10 cm in length and 7 cm wide. Purplish red in color and blanches white. Hot to touch.
The patient called and reported that within 24 hours of getting vaccine she starting itching all over from the waist up. She did get relief from the itching by Benadryl so she had been taking Benadryl. She let her physician know and was being monitored. I followed up a couple days later and she reported that she was seeing some improvement but was still using Bendryl when needed.
Patient reported tinnitus which he feels may be attributed to vaccine. Onset over a month after second dose
About 10 minutes after receiving the Prizer shot, I began to feel dizzy. Nurses took my vitals and they came back normal. The dizziness gradually intensified within the next 45 minutes. I lost my balance and required assistance to get into my car. My husband drove me home.  Two days after receiving the shot, I visited a Urgent Care because the dizziness turned into a headache and a dull ringing persisted in both ears. The dizziness lasted 3 weeks. Today is 04/14/2021. The dizziness is mild and only comes up when turning too quickly or do strenuous work around the house.
I have a history of herpes infections on the sacrum and usually have about two episodes per year. Approx. 1 wk. after my vaccination I broke out and have had an almost continous episode since. Accompanying symptoms include nasal and chest congestion, difficulty sleeping.
Swelling around area of shot (in buttocks), deep aching in right hip side of buttocks and upper leg, some nausea and tiredness. 60 day follow-up dated 9/21/00 states that the pt has continuing rashes, burning itching skin, burning watery eyes, various aches in body, fatigue and tiredness. Symptoms aren't constant but seem to run in cycles.
adipose necrosis-1x1cm <less;pt exp dimpling of thigh p/vax;dimpling is a result of necrosis of fatty tissue;
This spontaneous report was received from a nurse referring to a adult male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was unknown. On 16-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # M032635, expiration date 05-MAY-2018) )(dose and route were not reported) for prophylaxis. In November 2016, at an unspecified time after that, the patient noticed redness, swelling, and some mild pain and itching at the injection site. On 18-NOV-2016, patient came to physician office to report the above symptoms. The nurse reported that patient stated that the redness, swelling, pain and itching had all diminished to "about 50% of what they were yesterday (17-NOV-2016)". An unnamed health care provider at office recommended supportive care with cold compresses and ibuprofen to improve comfort during recovery. The outcome of the events was recovering. The causality between the events and PNEUMOVAX 23 was not provided. Additional information is not expected as no consent to contact the HCP.
Patient apparently  was in the bathroom, shaving.  Patient's wife was in the kitchen.  He does  not recall exactly what happened other than he fell backwards.  His wife  heard a "thud."  She went into the bathroom and the patient was not  responding.  Eyes were open but he was not focusing.  He did have generalized  shaking of his extremities.  Nine-one-one was called at this time.  Patient  does complain of some mild back pain.  He denies any significant headache.  There has been no nausea or vomiting. He was diagnosed with syncope event and new onset bells palsy.
We are using the Drive thru method at Airport. Client received COVID-19 vaccine and afterwards drove to Recovery Room. Client states she had a metallic taste in her mouth. 76-20. Respirations Good. She says this happens to her when she has a CAT Scan with IVP dye. Put her in the 30 min line. She drank some water and felt better. When 30 min was done, she went home. Daughter was with her. Told client if any other problems, to call her Dr.
Patient given HPV vaccine on Friday 08/31/2018. Initially developed a localized reaction (nodule) in the injection site. Later he developed papular rashes on the right  upper eye lid, trunk, neck and chest, thighs and legs. No shortness of breathing. The rash was developed after one day after the shot was given.
Higher Hep B viral load (from being in 100-500 for years to over 2000 and 3000)/ virus reactivation
Left side upper tooth ache on crown tooth that lasted about 1 week after getting vaccination. Went to dentist for this event
Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 68 years old female patient who had bruising and itching, while she received vaccine FLUZONE HD. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 06-Sep-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI995AB and expiry date: 01-Apr-2019) via intramuscular route in the left arm. On an unknown date, following the vaccination the patient experienced bruising and itching. (Other relevant tests included no lab test.) Final diagnosis was itching and bruising. The patient was treated with TYLENOL and placed with Band Aid as a corrective treatment. The outcome of the event was unknown. List of documents held by sender: none.
Awoke 23JUl w/numbness in both hands; Numbness persists involving hands, arms, legs, shoulders; Pt is unable sleep thru night due to numbness & tingling from elbows down to fingers; sx appear to be transient but consistent throughout body
Fatigue, Migraine, Hot flashes and Chills, Muscle aches and pains
A mother reported that her 13 month old son received an injection of Prevnar. Three weeks, post vax, he developed erythema multiforme. He was hospitalized. No further information was available at the date of this report.
Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body aches for 24+ hours, abdominal pain for 2 hours.
Minor rash around collar bone. Noticed 3 days after vaccine. No other logical causes.
Runny nose, headache, swollen nasal passages, difficulty breathing, painful breathing, difficulty sleeping, watery eyes. Continuing through 11/1/2011, symptoms have not abated.
Patient presented to ED on 03/05/2022 with generalized weakness.  Patient was previously hospitalized at facility on 01/11/2022 to 02/09/2022 with failure to thrive and Covid-19, Right segmental PE.  Since discharge from the facility, the patient has became progressively worse, and unable to care for himself.  In ED chest xray revealed bibasilar airspace opacities, and UTI, started on antibiotics.  Patient was discharged on 03/14/2022 to hospice.  Patient expired on 04/02/2022.
(H/A) AFTER INJECTION/VACCINES HOT, SWEATY, Nauseated
Swelling and pain on left anterior thigh. Pt. had immunizations on 7/19/14. Left thigh displays redness and hot with touch.
Body aches, chills, fever, severe headache at the base of my skull, that required an emergency room visit. Pain was excruciating. This headache lasted most of the second day after getting the vaccination. ER was able to help with the pain and the next morning (3rd day after getting the SHINGRIX shot.) I felt better. I had also received a pneumonia vaccination (PNEUMOVAX) the same day as the Shingles vaccination. But, the ER felt it was from the SHINGRIX vaccine.
15 Mar 21 - 2000 Hrs CST - Started get chill throughout body 15 Mar 21 - 2030 Hrs CST - Fatigue 16 Mar 21 - 0400 Hrs CST - Body itchy all over, coughing up mucus 16 Mar 21 - 1000 Hrs CST - Fatigue 16 Mar 21 - 1300 Hrs CST - Vertigo with Cold Sweats
Left deltoid injection w/ erythema, itching and small raised bump at injection site. Patient treating at home.
Patient reports that later in the day after receiving the vaccine, she developed a "blood spot" below the injection site of her left arm.  She described it as a bruise, approximately the size of a nickel.  Denies pain or itching, resolved slowly over 1 week without treatment.
Pt was feeling lightheaded and could not stand up. She was set on the ground with her feet elevated and felt ok afterward.
One half hour after the injection she felt an almost anaphylactic reaction. She also experienced nausea, vomiting, felt itchy, wheezing and tightness in her chest. She treated herself with adrenalin, Benadryl, and cetirizine.
Roughly 48 hours after receiving the second dose of the Moderna Covid-19 vaccination I developed a bright red skin rash.  The rash appeared first in the Elbow joint (antecubital fossa) area of the right and left arm and then also appeared behind the right and left knee.  The rash presents as a bright red rash with raised bumps that almost appear as small blisters. The rash produces a significant itch.  Taking a OTC antihistamine (Benadryl) has relieved the itching and some of the raised bumps have subsided however the rash remains visible. As of this writing the rash has been present for 48+ hours.
Redness, swelling and induration after 48 hrs following the vaccine, warmth area, itch. Pt went to ED she is taking KEFLEX.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 35-year-old female patient 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, there was no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they needed to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the state at this time. It was also reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
Clusters of lesions with heads on them on the left anterior thigh only-evaluated on 2-8-10 and diagnosed with shingles.