chrisvoncsefalvay/vaers-outcomes huggingface dataset:
During the observation period the patient lost consciousness for a short period. The patient was sitting in a chair and dropped her phone. She exhibited a mild fencing response and her hand trembled until she regained consciousness. Patient stated she has passed out from needles in the past.
transient blurring of peripheral visual fields with tightness in temporal region.  Fundoscopic exam and CT WNL local neurologist dx'd as migraine headache.  Resolved without sequellae.  No evidence that condition was vaccine related.
Upper right arm was achy sore immediately after injection on 11/26/29.  Morning of 11/27/29 arm still was achy and the area of the injection site was painful to touch pressure.  The area of the injection site was intermittently mild itchy.  I iced my upper arm one time for 10 minutes.  By the morning of 11/28/2021, my upper arm was less achy, but the injection site was mildly painful to touch pressure; my skin was faintly pink in the area of the injection and was still intermittently itchy.  I put some Jergens lotion on the itchy area.  In the morning of 11/29/2021, the injection site was less painful to touch pressure; my arm had a more noticeable pink area about 2-1/2 inches in diameter around the injection area and was more itchy.  Thinking this was similar to an allergy, I  took 1/2 of an over the counter Benadryl tablet (1/2 x 15 mg =  12.5 mg).  Alarmed that the area had become more pink at the upper edge of the pink area, I called a pharmacy and talked with a pharmacist who suggested applying over the counter 1% cortisone cream.  In the afternoon and at bedtime of 11/29/2021, I took 12.5 Benadryl, and applied the 1% cortisone cream.  In the morning of 11/30 21, the area was less pink and less itchy. I applied the 1% cortisone cream in the morning and at bedtime, and took 12.5 mg Benadryl  in the morning, mid-day and at bedtime.  In the morning of 12/1/2021, the pinkness and itchiness were gone.
11 days after receiving the Moderna Covid booster, I woke with intense itching across the back of my scalp and armpits. I saw no visible rash. But as the day progressed, the itching continued and evolved into a widespread pink bumpy rash. When I would scratch, large welts would appear. The rash progressed and intensified over the next day until it was so uncomfortable and widespread, I scheduled a telemed with my PCP. He suspected it was caused by the vaccine. I also took a home Covid test which was negative. I had no fever or other symptoms, but the itching, rash, welts and swelling were significant. My ear canals even swelled. PCP prescribed multiple antihistamines to treat the itching which has helped significantly but not taken it away completely. I am now on day 6 of the rash.   In retrospect, I had a terrible headache on Thu 12/16, felt intermittently queasy Sat 12/18 and Sun 12/19, and shaky like my blood sugar was low on Mon 12/20 and Tue 12/21. I also had my teeth cleaned Wed 12/15 and my gums bled a lot which only typically happens when my body is fighting a bug or my immune system is working. I also had a herpetic whitlow decades ago that only comes out every several years and on Fri 12/17 I felt the area it erupts twinge, but it never materialized. It was clear that my body just wasn't quite right in the days preceding the rasy.
Fainting, possible seizure - child fell back and started shaking, eyes rolled back. Lasted 10-15 seconds. Child layed down for 20 minutes and was fine, seen by doctor.
Chest tightness, neck pain (headache), joint pain, shoulders, knees, hips, back pain, nausea.
Developed nose bleed approx. 4 hours after receiving LAIV NASAL H1N1 Vaccine. Mother reports lasted approx. 30 mins. No other symptoms. No prior hx nose bleeds.
This dose was administered as dose #5 (3rd booster). #3 booster was not authorized at the time administration.  I called the patient on 8/6/22. no side effects/symptoms to report.
I tested positive for Covid-19 on 11DEC2022. Around 25FEB2023 I started to get a really bad sore throat and loosing a lot of hair. On 08MAR2023 I noticed my neck swelling on 10MAR2023 the left side of my neck blew up the swelling went from left side of the Thyroid and the swelling continued below the sternal notch past the midline and a little bit tot the right with no fever and no problems breathing. 11MAR2023 I went to a local urgent care and CT Scan of the chest and neck with blood work was performed. An Ultrasound was performed on 28MAR2023 and on 03APR2023 fine needle aspirate was performed and the biopsy was benign.
Three inch lesion/rash at location of injection, eight days after injection.  Area is itchy, firm and red eight days after injection.   Location was intially very tender and sore, especially the second and third day after injection.
4 patients 16-17 years of age were administered from the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported as 4 doses were given to 4 patients (ages 16-17 years).  No AEs were reported by patient.  No treatment medications were reported   This case was linked to MOD-2022-554595, MOD-2022-554700, MOD-2022-554702 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up received contains no new information.
VACCINATION ERROR ONLY - NO ADVERSE EVENT REPORTED BY PATIENT. PATIENT GIVEN PFIZER BIVALENT BOOSTER FOR PATIENTS 12 YEARS AND UP WHEN PATIENT WAS 9 YEARS OLD. LOCAL REGULATOR HAS REQUESTED THAT WE REPORT THIS INCIDENCE ONCE THEY REALIZED THE ERROR.
Edema in hands and the back of her knees and thighs us; on nipple of right breast was a piece of hard crust/looked like a clear scab; she noticed a dark brown spot on the nipple; rash; swollen; warm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), FEELING HOT (warm), SCAB (on nipple of right breast was a piece of hard crust/looked like a clear scab), RASH MACULAR (she noticed a dark brown spot on the nipple) and OEDEMA (Edema in hands and the back of her knees and thighs) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cyst. Concurrent medical conditions included Contrast media allergy.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced SWELLING (swollen), FEELING HOT (warm) and RASH (rash). On 09-Mar-2021, the patient experienced SCAB (on nipple of right breast was a piece of hard crust/looked like a clear scab) and RASH MACULAR (she noticed a dark brown spot on the nipple). On an unknown date, the patient experienced OEDEMA (Edema in hands and the back of her knees and thighs). At the time of the report, SWELLING (swollen), FEELING HOT (warm), SCAB (on nipple of right breast was a piece of hard crust/looked like a clear scab), RASH MACULAR (she noticed a dark brown spot on the nipple), OEDEMA (Edema in hands and the back of her knees and thighs) and RASH (rash) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received on 07-JUL-2021 contains Significant information- added a new event Edema
My appointment was on time, 4pm on 4/3 at the Pharmacy.  The young girl that gave me the shot told me she was certified, and she gave me the shot in the presence of her manager.  I have given  myself shots for years with diabetes, plus many flu shots, and have never felt pain like that.  I expressed this to her, how painful it was, and she just said "I know, I know..." as if it was normal for the shot to be so painful. I knew instantly something was wrong.  They were more worried, it seemed, about a potential adverse reaction such as an allergy shock, since I'm allergic to a few things, but I did not experience that.  I waited 15 minutes, my arm hurting the whole time, and they suggested I go buy Tylenol for the pain, which I did.  My left arm has hurt since then. I got a horrible bruise from this shot (will send picture) that took weeks to heal.  Since then I've continued to feel pain and don't have full mobility of my left arm. I can type, but not lifting anything heavy and have to go easy with anything on the left side.  I thought at first it might be what people were calling "covid arm" but I discovered that was more about soreness, not pain.  I tried ibuprofin, but after three weeks I'd had enough and made a doctors appointment.  Since I was also noticing my left shoulder was very tense and tight, and I was starting to get neck stiffness in same area, I started googling before my appointment.  When I entered my symptoms, SIRVA kept popping up, so I wondered if that was what I now had because of the improper vaccine administration.  I asked my doctor for an MRI order to find out, but she said we needed to do an Xray first (which only showed mild issues related to osteo).  She offered a prescription of taking Advil 400 mg three times and day and to use a muscle relaxer when I needed it, such as at night (Cyclobenzaprine).  She said to try that for a week, and if it wasn't better, that another Dr could order MRI.  Since then I've also added a pain spot under my left shoulder blade. Insurance called and said the order was "under review" so that's where things stand now. If they don't approve, I guess I will go next to an orthopedist for guidance?  This has cost me health, due to lack of sleep also - I wake up with pain in the middle of the night, even when I take the meds. Praying for a diagnosis, and solution, soon.
HCP is reporting that 1 dose was administered after exposure to room temperature and gt, 24 hours; no adverse event; 1 dose was administered after exposure to room temperature >24 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was administered after exposure to room temperature >24 hours), PRODUCT STORAGE ERROR (HCP is reporting that 1 dose was administered after exposure to room temperature and gt, 24 hours) and NO ADVERSE EVENT (no adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7646C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose was administered after exposure to room temperature >24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (HCP is reporting that 1 dose was administered after exposure to room temperature and gt, 24 hours) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose was administered after exposure to room temperature >24 hours), PRODUCT STORAGE ERROR (HCP is reporting that 1 dose was administered after exposure to room temperature and gt, 24 hours) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 dose was administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (HCP is reporting that 1 dose was administered after exposure to room temperature and gt, 24 hours).    No concomitant medication was reported.  The vial was initially stored in the refrigerator at 10:06 AM on 28-AUG-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
Hard time walking; problems with mobility; 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 GAIT DISTURBANCE (Hard time walking) and MOBILITY DECREASED (problems with mobility) 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) (unknown route) 1. On an unknown date, the patient experienced GAIT DISTURBANCE (Hard time walking) and MOBILITY DECREASED (problems with mobility). At the time of the report, GAIT DISTURBANCE (Hard time walking) and MOBILITY DECREASED (problems with mobility) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided.  Concomitant medications was not given.
Chills, loss of hearing of left ear Narrative: Patient reports of loss of hearing of left ear 50%, blood pressure 250/130 for the first two days after receiving the vaccine.
inappropriate schedule of vaccine; shingles; UTI; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 2nd dose of Shingrix. In September 2019, the patient received the 1st dose of Shingrix. In July 2020, not applicable after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced shingles and urinary tract infection. In September 2020, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the shingles, urinary tract infection and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles and urinary tract infection to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient received her first dose in September 2019 and developed shingles and a UTI (urinary tract infection) in July 2020. The patient received 2 dose later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
4/16/07 3:05 Felt flushed, body hot, dizzy, headache - chest pain that night. 4/18/07 Left arm hurt and nerves in left hand and fingers felt numb. Lymph node in front of left ear swollen and painful - as day progressed neck, swollen ear canal and throat, swollen arm, swollen  / hot went to PA. Given Atarax, Z-pak and ear drops.
This spontaneous report as received from a medical assistant refers to 5 year old child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014.  There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
shoulder aches; severe headaches; pain in arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder aches), HEADACHE (severe headaches) and VACCINATION SITE PAIN (pain in arm of injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain in arm of injection). On 28-Jan-2021, the patient experienced ARTHRALGIA (shoulder aches) and HEADACHE (severe headaches). On 28-Jan-2021, ARTHRALGIA (shoulder aches), HEADACHE (severe headaches) and VACCINATION SITE PAIN (pain in arm of injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Relevant concomitant medications was provided      This case was linked to MOD-2021-062310 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: TCR added, three NS events added from 2nd dose.
Patients wife stated that the patient became disoriented. He could not walk or talk. The patient could not sit up and lost control of his bladder. Push food out of his mouth. Patient is also drooling. Patient does not understand what you are saying. VA has order home health for three hours a day. The patient has a plan to have speech and physical therapy.
*Headache *body aches *taste is not working properly *nose and head is congested *left arm pit lymph node is swollen and sore *sore injection site, warm and hard
Tested positive for COVID19 3/5/2021. Test: coronavirus antigen IA Rapid Test, SARS-CoV-2 nucleocapsid protein antigen.  I am asymptomatic but got tested because we were going to be around family members for a funeral.  I am a healthcare worker.  I have not received results of the confirmatory PCR test also collected 3/5/21. 1st dose vaccine 12/29/20 2nd dose vaccine 1/25/21
Severe vertigo with nausea about 1 1/2 days following vaccine injection on Friday, Oct. 6.  Had to stay in bed for 2 full days - Sunday, Oct. 8 and Monday, Oct. 9.  Able to resume normal activities on Wednesday, Oct. 11.
1 day p/vax pt devel an inj site rxn characterized by redness, warmth, & swelling;this is one of three employees from this site to devel an inj site rxn p/flu vax;
2 cm itchy erythematous spot on left deltoid first noticed 8 days after the vaccine was administered, mildly tender.
Pt had an allergic skin reaction to that required treatment from a physician. Physician had told pt that it was most likely due to the ZOSTAVAX vaccine or a component in the vaccine.
Soeness in the arm, fatigue,  muscle pain, headache,  sweating at night.
I had no reactions after my first Pfizer injection.  2 Days after my second injection my right calve started to hurt.  This grew increasingly worse each day to where walking was painful.   A week later on Monday,  March 15 my left knee started to hurt and then my left calf.  On Tuesday, March 16 I went to the Hospital Emergency room.  They did a number of tests and one of them was ultrasound of both of my legs.  They found DVTs in both legs and started me on Lovenox injections.   About 5 years ago I had a DVT in my right leg but never had any pain or other adverse symptoms from this DVT.  Also I was taking Xarelto to prevent any further DVTs.  On Saturday, March 20 I went back to the ER because my leg pain was still bad.  They did new leg ultrasounds and the DVTs were gone.  My left knee still hurts and my doctor is trying to find out why.   Anyway none of this may be related to the vaccine, but everyone is curious of why I would get these new DVTs when I was taking Xarelto daily and I had never had a problem for 5 years.  The other odd thing is that i had so much pain when my prevous DVT had no pain symptoms.  So now I am continuing the Lovenox injections and we are trying to determine why my left knee is still in so much pain.  It might be something like arthritis in that knee but it seems like such a coincedence that it happened at the same I got these DVTs and I have no history of joint pain anywhere in my body, not even any back pain.
Initial report received on 09 October 2009 from a health care professional. A 16 year old female patient, with no medical conditions or allergies, received a right arm 0.5 ml intramuscular injection of MENACTRA (lot number U2908AA) on 16 September 2009 as part as part of routine immunization. The patient was pregnant at the time of vaccination. Concomitant medications included FERROUS SULFATE 325mg. Her last menstrual period was either 15 or 19 August 2009 and her expected date of confinement is 26 May 2010. Prenatal testing was not reported. The patient had no previous pregnancies. No adverse event was reported. The patient had no previous pregnancies. No adverse event was reported. Follow up information received on 28 December 2009 from a health care professional. The patient had a questionable history of high blood pressure and no known use of recreational drugs or alcohol. The patient's last date of her menstrual period was 19 August 2009 and estimated date of delivery was 26 May 2010. In addition to receiving MENACTRA, the patient also received a first dose of Tdap (manufacturer not provided, lot number AC52B036BA) and a third dose of GARDASIL (manufacturer Merck, lot number 0100X) on 16 September 2009. The patient was reported as having an iron deficiency during the pregnancy (onset date not provided) and was being treated with iron. The reporter stated that at the time of the last attempt in contacting the patient, the patient had still not received prenatal care at that time.
On 10/25, body aches, difficulty breathing, nasal/head congestion. On 10/26 all of the above mention plus a fever reaching 102.7.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date approximately in 1995 (reported as "20 years ago"), the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route and site of the administration, lot#, expiry date were not reported) and with a dose of influenza virus vaccine (manufacturer unknown) (dose, route and site of the administration, lot#, expiry date were not reported). On an unknown date approximately in 1995 (reported as "20 years ago"), the patient experienced swelling and a rash at the injection site. The outcome of the events was unknown. The relatedness between the pneumococcal vaccine (manufacturer unknown) and the events was not reported. Additional information has been requested.
No adverse event.  COVID-19 vaccine administration errors? Dose administered past the expiration/ beyond-use date. Expiration date for Pfizer BioNTech vaccine Lot number FK5127 is 04/30/2022. Vaccine was administered 05/04/2022. 4 days past expiration date.  As per CDC guidelines dose is not valid and should be re-administered.
Patient reported fever of 100.3F upon waking up the next day. Took Tylenol OTC for fever. She also reported fatigue, chills, all over body ache the day after the vaccination; Symptoms resolved after 23 hours; These symptoms did not occur after her first vaccine of the series.