chrisvoncsefalvay/vaers-outcomes huggingface dataset:
40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored; No adverse event; 40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021.  Best Used Date was reported as 30-Jul-2021.  The patient did not report any side effects.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case ID
I had four shots and Then I received my last vsafe visit and I talked to a person. I had a 5th shot, and I did get a phone call. I had hospitalization but it had nothing to do with the vaccinations. I had COVID-19 in January. I thought it was little coughing and Bronchitis. I went to urgent care and was not given a COVID-19 test it was positive. We followed the guidelines of isolation and then I retested and negative. The coughing and lost my taste and smell for a few days. And this was after the 5th dose. I did develop Sepsis recently in July 2022 and had to go to rehab, due to the effects causing issues with the muscle function in my leg.
Vasovagal event with syncope and seizure activity fir 15 to 20 seconds  Client stated he always responds this way to shots.  Hx of TBI at age 4 years.  Blood pressure 106/68 pulse 84 and  02 saturation 100%.  EMS and Dr on site and client released when symptoms resolved.  Advised to seek medical attention later if needed.  Client verbalized understanding.
Around 10-15 minutes after injection, patient experienced increase heart rate. Her blood pressure kept increasing (over 180/103). Called her relatives and sent her to emergency room. Called her daughter this morning (8.15), her daughter said she is ok. She got home around 5 am from ER. They will follow up with primary care.
Vaccine had been punctured for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.
Fatigue, congestion, short of breath, rattling, wheezing, high heart rate (100), 180/130BP. he was admitted to the hospital for 24 hours and diagnosed with viral pneumonia and sent home with an oxygen generator that he only used at night.  after the second dose of the vaccine his symptoms were the same but escalated. he now has headache and nausea and fever and uses the oxygen generator daily. he had a swollen cigarette box shaped hard spot on the injection site.
Pain in arm; Trouble in sleeping at nights; Very very foggy; Headache/Headache type of symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), INSOMNIA (Trouble in sleeping at nights), FEELING ABNORMAL (Very very foggy) and HEADACHE (Headache/Headache type of symptoms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced INSOMNIA (Trouble in sleeping at nights), FEELING ABNORMAL (Very very foggy) and HEADACHE (Headache/Headache type of symptoms). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm), INSOMNIA (Trouble in sleeping at nights), FEELING ABNORMAL (Very very foggy) and HEADACHE (Headache/Headache type of symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  After the first dose of vaccination patient just had pain in her arm which lasted for couple of days and no other side effects. On 24 May 2021 patient experienced headache, trouble in sleeping at nights, headache type of symptoms, very very foggy which was effecting her work.   Treatment activities for event was done with over the counter sleeping pill.  Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
6.2 cm  x 4.5 cm erythematous, indurated, warm to touch area at injection site.
Approximately 48 hours after the Hepatitis A vaccination I started feeling flu-like symptoms.  Achy joints, high fever (102), swollen glands.  This has been persisting for over 24 hours.
Numbness on the left side of body. Mostly on the arm, leg and slightly on the left side of the face.
Of course I had side effects like aches, bone pain (mainly spine and sternum), kidney pain, abdominal pain, sweating with no fever, etc. But none of that is an adverse effect.  The adverse effect happened when I was taking a shower 45 hours after my second vaccine. I was starting to feel better at this point. I started to feel like I was going to pass out. I quickly turned off my shower and sat down. I would have passed out had I not focused to not. I felt nauseous, lost my hearing and started to lose my sight. After I was ok, my lips were blue/Gray. I don't pass out. I've passed out twice in my life when I was much younger. That's how I knew what was happening. I'm scared this will happen again and I don't know what this means.
Arm that received pneumonia shot became red, swollen, painful and warm to touch the evening after the shot was given. The area of inflammation extended from deltoid to wrist. This lasted 3-4 days then resided. nurse recommended cold compress, elevation, Advil.
On 04/25/13 in Dr office after immunology blood work determined an immunodeficiency he required re-booster of two vaccines. Per child mother advised 6 hours after administration of vaccines he was tired headache, dizziness, "worn out" and right arm pain was 100% better 24hr after vaccines given.
Difficulty swallowing and rash and itching in throat and neck/chest. Vs were taken bp was 208/110, hr 100, resp 20, spo2 100% ra. Epi 1:1000 was given 0.3 mg IM to RT deltoid.  911 was called anc iv access was established in RT forearm via 20g cath. Vs were improved after epi.
pt received second dose 3/19/22, pt stated her arm was sore afterwards. pt notified us 3-21-22 stating her arm was red, sore, and warm to the touch. pt was advised to seek medical attention. pt stated she contacted md and stated that she was having a hypersensitivity to the immunization and looks like a normal reaction to vaccine.  i spoke with the pt later in the day and she stated her arm is looking better and no longer warm to the touch.
headache, malaise, myalgia, poor appetite x 24 hours - I was flat on my back on 3/6/21, but fully recovered on 3/7/21
erythema, induration/swelling, pain, warmth to R upper arm in area where vaccines were given
First I got a headache, then I felt extra mucus in my throat. Then I started feeling compression, pressure, and pain in my diaphragm; and then the middle of my chest. Finally, I started coughing, and I wasn't able to breathe.   I had told all of the nursing staff that I had anaphylaxis to the first shot, but they acted like they didn't believe me. Also, there was no EMS staff on hand this time, unlike the first time, where they were on site. I think that made the difference in my medical care, because my husband heard the nurses at the facility say they were treating me for anxiety, not anaphylaxis, despite the fact that I was getting worse.   The nurses on staff didn't seem to understand or believe that a person could have anaphylaxis from the Covid injection, even though it's on record at the hospital that that's what happened the first time. It wasn't the same staff as last time, which also contributed to the problem. Once the ambulance staff got there, he took me seriously, and finally administered an EpiPen, and also put me on oxygen, which helped a little bit.  that was the most comprehensive care I got that day, from someone who was actually listening to me he also took an EKG, which which was normal.  When I got to Facility, the treatment wasn't as good as last time, either. Apparently they've been really busy the day before, and all of the staff seemed fatigued because of it. Nobody really checked on me, offered me even ice chips to moisten my mouth, and didn't offer me any assistance in getting to the bathroom, either. a respiratory therapist came in to give me a couple puffs on an albuterol inhaler, and I got a Benadryl shot, but nothing else. I think if I had not taken my coterie of prescriptions to stave off anaphylaxis, it would have been worse.   20 minutes before the shot I took: two aspirin, a CBD capsule, and one each of the following pills -cetirizine, benadryl, famotidine, 20 mg of prednisone, hydroxyzine. I think that's what enabled me to recover with only one EpiPen, instead of two, like last time. if there's a third Moderna shot for the varients, or a booster, I'll try to take all those pills an hour beforehand, and see if having them in my system for a longer period of time we'll make the difference. It will be nice to have *no* anaphylaxis, and skip the hospital trip . Since then, it's taken me about a week to recover fully, the same as after the first shot. I've had problems breathing, fatigue, muscle aches and pains, flushing, fever/chills, and in general just felt like I had the flu.
Dizziness, tingling and numbness in hands and feet immediately following vaccination. Onset of surface-level numbness head-to-toe within several hours, which has not subsided to date. Dizziness comes and goes to date. Vital signs remained stable; no paralysis; no loss of consciousness; preliminary neurological exams were normal. Reflexes in knees and elbows remain intact.
Patient called on 04/02/2021 stating that she was itching after receiving the Moderna Covid vaccine.  Stated the itching started at approximately 6:30 PM and she was itching all over.  Patient stated that the itching was even on her scalp.  Asked the patient if she had any kind of rash or difficulty breathing and patient denied.  Patient stated that she took a Benadryl approx. 2 hours before the call.  Instructed patient to continue taking Benadryl as needed and as directed, to go to ER if any difficulty breathing and to let us know if there is any further problems.  Let the patient know that this report would be made.
5-10 minutes post vax, the pt experienced tingling sensation in two fingers on his injection arm. Additionally, two hours post vax, he experienced more severe pain at the injection site. He was seen by a physician on 5/13/00. No treatment was given.
I had small reaction after the vaccine - low grade fever and body ache. 30 October 2021 with COVID-19 I had a cough, muscle fatigue, chills, ran out of breath walking, my chest hurts. Urgent Treatment Clinic to get COVID-19 test because I failed the health screening because of my cough on 1 November 2021.
tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) 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 Delivery (just gave birth) and Heart murmur.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The reporter thinks that the patient got COVID-19 from the patient's unvaccinated son who was not quite 2 years old and was in day care. No concomitant medication information was provided.  No treatment medication information was provided.  The patient tested positive for COVID after receiving the primary series of Moderna vaccine and the booster dose.   This case was linked to MOD-2022-450601 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient (age not provided) with no relevant medical history, who experienced the unexpected Non-serious event of COVID-19 (SARS-COV-2 test positive). The event occurred at unspecified interval after a booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after a booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Redness hive plus or minus 3 1/2 x 2 inch (R) upper arm. Itchy - not painful given ice packs & BENADRYL & MOTRIN.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's current condition and medical history was not provided. On 17-FEB-2016 the patient was vaccinated with ZOSTAVAX (vial, dosing regimen unspecified) lot #K020801, expiry date 31-JAN-2016 (expired product administered). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. This is one of the two reports from the same reporter. Additional information is not expected as the reporter did not wish any further contact.
Patient received Menactra and varivax injection.  Patient fainted 3-5 minutes after injection was given while in the elevator.
KINRIX DTaP+IPV should be administered to children 4 through 6 years of age. The patient was 3 years of age at time of vaccination.
sore arm; This is a spontaneous report from a contactable consumer (Patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 26Jul2021 15:00 (at the age of 62-year-old) as single dose for covid-19 immunisation. The patient medical and concomitant medications was reported as none. Family history was reported as none. No additional vaccines administered on same date of the Pfizer suspect. On 26 Jul2021, the patient experienced sore arm. She stated she got her first dose and the only thing she had was a sore arm but they said that was to be expected. Sore arm began the same day of vaccination. She stated that they go back on the 16Aug 2021 to get her second dose. Sore arm was gone away, only lasted a half of day. Any event did not require a visit to emergency Room or physician office. No relevant test was performed. The event was recovered on an unspecified date in Jul2021.   Follow-up attempts are completed. No further information is expected.
Patient admitted with UTI who had incidental positive for COVID upon discharge to facility.  No respiratory or GI symptoms during stay.  Provider d/c note:  "81 year-old male with a history of Alzheimer's dementia and T2DM who initially presented with altered mental status, multiple falls, and failure to thrive. CT Head, CXR, and BLE ultrasound were negative. UA was suggestive of UTI, urine culture grew proteus mirabilis, for which he completed a 5-day course of ceftriaxone. He had improvement of his mentation to what is likely his baseline given his known dementia. His medical regimen was also adjusted as listed below to accommodate his change to comfort measures per family's wishes. In preparation for initial discharge, he was found to be COVID positive from screening, for which he was kept in isolation here for 10 days. He exhibited no respiratory or GI symptoms from COVID. He completed isolation without complication and was otherwise medically optimized for outpatient comfort measures and discharged to facility in stable condition. "
Patient was in the passenger seat complaining of lightheadedness and dizziness.  Vehicle was directed to the ambulance on standy and an ALS crew assessed the patient and took vitals.  Vitals were all within normal limits and after 5 minutes, the patient's condition improved.  Since all symptoms were resolved, patient signed a refusal for Superior ambulance transport and exited the facility without issue.  End of report SG.
pt rt thigh was red & swollen w/a raised bump on the top inj site;mom said pt vomited twice & had diarrhea the same day;thigh is still sl swollen today but all other sx have ceased;
Pain, swelling and redness in left leg later diagnosed as blood clot at Hospital emergency room on 12/09/2021
Vertigo; Dizziness; Fatigue; Eyes move side to side rapidly; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 16:15 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, since midnight, the patient experienced vertigo, dizziness, fatigue and with the vertigo the patient's eyes move side to side rapidly. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vertigo, dizziness, fatigue and eyes move side to side rapidly was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via a market research program project number ADVAIR00165, and described the occurrence of pink around injection site in a female subject of unspecified age who was vaccinated with influenza (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medications included albuterol (unknown manufacturer). On 11 September 2013 the subject received a dose of influenza (details unknown). On 12 September 2013, 1 day after vaccination with influenza, the subject experienced pink around injection site and injection site hives and less than a week after vaccination with influenza, the subject experienced headache. The subject reported that she received her flu shot on Wednesday [11 September 2013] and for the "first time event had a reaction". She informed that she asked her mother to check if it was okay yesterday [12 September 2013] and her mother said it was 'a bit pink' (pink around injection site). She reported that she looked at it last night [12 September 2013] and "had a silver dollar size hive with a smaller one above it" (injection site hives). She noted, "Obviously, it didn't bother me, but sure startled me when I did look. Might explain my headache too!" At the time of reporting the outcome of the events was unspecified. Follow-up information received from a consumer via a market research program project number ADVAIR00165. The subject noted online the following: "I checked several times a day. If it goes below 90, I deep breathe and some sort of exercise (mild) in order to speed up the heart as my PVC's [premature ventricular contraction] happen when my pulse drops below 90 also. Seems to be the magic number. Still waiting on heart scans to try to pinpoint problem." (decreased heart rate, PVC) Follow-up information was received on 2 January 2014 from the patient. On 24 December 2013, the subject experienced lumbar compression fracture, back fracture (broke my back) and fell. This case was upgraded to medically serious by GSK. The subject stated that on 24 December 2013, she was trying to help her mother up, which caused the subject to fall and fracture her back. On 30 December 2013, the subject went to the doctor to have x-rays performed. The x-rays revealed a compression fracture of at least L1 (lumbar compression fracture). The subject had plans to return to the doctor's office on 6 January 2014. At the time of reporting, the outcome of lumbar compression fracture, back fracture and fell was unknown.