chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Extreme chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction NOS and Hypertension.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (Extreme chills). At the time of the report, CHILLS (Extreme chills) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter
My right arm pit and breast feel extremely warm to the touch. Both arm pit and breast feel like they are stuck in a cramp/charlie horse.
Very weak. Lose energy very quickly doing very simple things. Legs try to "buckle" or fold up underneath me as I try to walk.
Lump at the injection site, Initially the size of a golf ball with redness and itching .  Swelling has decreased as well as the itching.
5/15/2021 passed out  while taking shower, and passed out 2nd time  outside bathroom ( witnessed) , hit head on side of door ,was seen in ER for head injury/ concussion Labs , EKG, Blood sugar , and Head CT scan done - normal results , referred to concussion doctor within 3-5 days
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received expired FLUMIST. The product expired on 11-Dec-2011. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 03-Apr-2012 and incorporated into the narrative. No late occurring adverse event.
I had achy muscles, especially legs and back. I felt bloated and had little appetite. I felt bad enough to stay home from work 1 day. This has happened each year for over 5 years, and seems to be getting more severe each year.
Dose administered to 10 patients after more than 30 days of storage in the fridge; Dose administered to 10 patients after more than 30 days of storage in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30 days of storage in the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2022, the patient experienced PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30 days of storage in the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge). At the time of the report, PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30 days of storage in the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vials were stored in the fridge since 22Dec2021. Not know if patients are under any concomitant or regular medication.  No treatment medication was reported.   This case was linked to MOD-2022-483999 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Follow up received  contains Lot number, patient details update
The patient received an intramuscular dose of prefilled FLUZONE at around 3:45 PM. She waited about minutes while her brother received his dose. She appeared fine and left. A few minutes later she reported feeling unwell with dizziness, unable to walk and cloudy eyes. The EMT was called and she was seen by them. They left about 15 mins later with the patient walking.
JANSSEN COVID-19 Vaccine EUA -  I started to experience tinnitus on day 5 after being fully vaccinated. ( I noticed a persistent ringing in my ear since Sept 8th) I reached out to my primary care doctor who suggested I try Flonase for a week, I did and this unfortunately did not help. I went to an ENT specialist who noted that she had been seeing more patients come i. Describing tinnitus recently after the vaccines had been rolled out and she prescribed me a steroid (methyl prednisone) to take to clear up any fluid behind my ear, I took this and this also did not help, I have seen another specialist who told me the common denominator in females my age who have had Covid in the past, and were vaccinated, that the common denominator was a history of migraines. He had given me a list of foods as well as alcohol to avoid which I have for a week and I am still experiencing the tinnitus now for 6 weeks straight.
Pfizer on 3/20 and 4/17. Positive on 9/29
Pt. received a flu shot on 11/13/2008 at approx. 1:40pm and then at about between the hours of 2:30pm to 4pm he broke out in dime size hives, very red and itchy. The hives would migrate from front of chest to neck as well as, some on his back. He made an after hrs. phone call to a doctor and was advised to take Benadryl. He was seen by the doctor the next day which advised him to continue with the Benadryl prn-and that he looked like he had a mild rash. Patient still had migrating hives as of 8pm on 11/14 and some light colored hives as of 9am 11/15.
no reaction - Pt state on screening form that she was 65. 65+ Fluad administered. Pt is actually only 64 and will be 65 on 10/7/2022
Pt stated she was feeling dizzy and lightheaded.  VS 120/82 85HR   Pt stated she didnt hae lunch and being dehydrated. Going through a lot of stress due to covid and epilepsy.  Given Gatorade and water, kept in Observation for 40 minutes.  Pt stated "feeling much better and feeling safe to drive".  Pt was released without dizziness, instructed to hydrate and rest at home.
Information has been received from a physician concerning a 15 year old female who on 16-JUL-2007 was vaccinated with Gardasil (Lot no. 658094/0524U).  Concomitant therapy included Menactra.  On 24-JUL-2007 the patient experienced "erythrocythemia nodosum"  The patient sought medical attention.  Additional information has been requested.
Two weeks after vaccination, injection site was raised(about size of dime), itchy and red around area. Lasted 2 days, so far, but better. Similar looking to a horsefly bite
COVID-19; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and IMMUNISATION REACTION (Vaccination adverse reaction) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, COVID-19 (COVID-19) and IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Has gotten her blood work back and it was almost in the range that it should be.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. Daily dose of Humira was reported as citrate free and Moderna as 1 in 1 once.   Company Comment: This spontaneous case concerns an adult female patient (age not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. On an unknown date, Blood test reported as: was almost in the range that it should be. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient (age not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. On an unknown date, Blood test reported as: was almost in the range that it should be. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Initially slight headache which went away with Tylenol. However,  about 4:30 that morning awoke with severe stomach cramps and diarrhea. Intestinal cramps and diarrhea continued intermittently for 4 days total.
Immunization done 9/25/09 (PENTACEL). Onset sudden hives (moderate) 9/30/09, no resp sx only skin; oral steroid ordered (of note did have new melon today). 10/1/09 back today rash much worse, erythema multiforme. Admitted to hospital.
Pt recvd 3 doses of Engerix-B vax 17JUL91, 15SEP91, & 12NOV91 & 12NOV91 immed p/3rd inject pt exp burning while inject was being given which continued for a few hrs;
Pharmacy mailed Shingrix, No refrigeration used; This case was reported by a nurse via sales rep and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: The reporter reported that, a patient that had a e-prescription sent to pharmacy. The pharmacy mailed the Shingrix to their home for the patient to bring in office to be administered.  No refrigeration was used by pharmacy.  In one case the Shingrix vials were put in a pill bottle and mailed.  The dose was spoiled and patient sent back to pharmacy.  The reporter was checking with patients to see if got the vaccination after that. The reporter agreed to follow up from GlaxoSmithKline. Additional Supportive Information: The reporter reported that Shingrix was not refrigerated, which led to intercepted product storage error. This was 1 of 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR136884:Same reporter - Patient 2 US-GSK-US2022AMR136866:Same reporter - Patient 4 US-GSK-US2022AMR136883:Same reporter - Patient 1
Shortly after injection area is raised, warm and red. Pt said he felt like toxins were running through his body. By the next morning he was experiencing abdominal, intestinal and rectal pains. He made a number of visits and complaints to his primary care doctor. He now has hard to control Bowel Dysfunctions-IBD & IBS  and colitits, colon inflammation. Tests and scans have been performed with no cure or resolutions. Primary care says we may not figure out what exactly happened and pt may have to deal with the continuous pains and bowel disorders as best as possible through medications, diet etc
pt was administered Moderna Monovalent instead of Moderna Bivalent vaccine for booster dose
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with GARDASIL for her second dose. Subsequently the patient experienced "seizure-like and fainting-like symptoms, including weakness". When on therapy the adverse effect improved. Subsequently, the patient recovered from seizure-like symptoms, fainting-like symptoms and weakness on unspecified date. The patient saw doctor for medical attention. Upon internal review, seizure like symptoms was considered an other important medical event. Additional information has been requested.
Rn went to administer vaccinations. Orders reviewed and mistakenly thought Menquadfi was ordered. Pulled form vaccine fridge and prepared by this RN. Administered to child after verifying name and date of birth as well as vaccines receiving. Aunt in room with child. Child tolerated well. Patient left. RN charting vaccines approximately 30 minutes later when downtime available. RN switched to vaccinations tab to chart vaccines. Noticed Menquadfi not ordered. Verified error by viewing vaccination record. Notified promptly.
fever; muscle and body aches; muscle and body aches; cannot smell; tastebuds going haywire; described as "flu-y"; This is a spontaneous report from a contactable consumer(patient). A 65 years-old male patient received first dose BNT162B2, via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization.  The medical history included the patient had Covid 5-6 weeks ago in 2020. The patient received first dose of the vaccine yesterday on 08Jan2021. He had Covid 5-6 weeks ago in 2020 and after getting vaccine experienced similar symptoms. In Jan2021 the patient specified fever, muscle and body aches, cannot smell, taste buds going haywire, and described as "flu-y". He wanted to know how long these symptoms would last. The outcome of the events was unknown.   Information about lot/batch number has been requested.
4/18/06, pt. developed sudden fever 101.9F, irritability, poor eye contact, dehydration.  He was admitted to the hospital for observation and iv fluid rehydration.  Blood, urine, chest x-ray, flu A/B and RSV tests all done searching for source of infection (all negative).  Physical exam nonfocal.
Right thigh induration approx 5x5cm with raised papular rash over thigh, this happened with last vaccines too mom stated. She said both legs reacted last visit. Last visit patient had PEDIARIX and PCV, no Hib. Patient is happy and well, bearing weight on leg. No redness. No pain at sight.
1011 Immediately after receiving vaccination patient had c/o itching to chest and head.  Patient reports that after the 1st dose of the vaccine she have itching after making it home. Patient also stated that she has had reaction of itching with influenza vaccine.  Patient has Allergy to penicillin and is not taking any medications currently. 1016 Patient given Benadryl 25mg Oral liquid.   1020 patient taken to First aid area where patient was assessed by nurse, paramedics and provider on duty.  Patient was A & O x3 and all VSS. Patient refused ER transport and signed release and VSS remained stable.  Patient advised of the following action plan: repeat dose of Benadryl in 4-6 hours after initial dose.  Patient advised to seek immediate medical attention by calling 911 for worsening or persistent symptoms: SOB, swelling to tongue/throat.  Pt verbalized understanding of information provided and was discharged home after patient had returned to baseline.
PATIENT RECEIVED A PFIZER VACCINE AS BOOSTER WHEN HER FIRST TWO DOSES WERE MODERNA. PATIENT DID NOT HAVE ANY SIDE EFFECTS AT ALL THAT SHE REPORTED AND NO ADVERSE EFFECTS, JUST WRONG VACCINE ADMINISTERED.
sz x 2; seen in ER admitted for observation; EEG-WNL;
vaccine administration to 17 year old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration to 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration to 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration to 17 year old) outcome was unknown. Not Provided      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.
mom states w/in an hr of vax pt had convuls & was seen in ER;pt OK now but mom told should not have recv vax because has ear infect;by history not seen;
Extreme fatigue (falling asleep sitting still), headache, sore arm. Fatigue was equivalent to that when actually having the flu. Extreme difficulty staying awake, ended up falling asleep mid-sentence while sitting on the couch. After nap, low-level fatigue and sleepiness remained. Would not consider self safe to drive. Mild headache, responded well to over the counter medication (ibuprofen and acetaminophen). Arm soreness began earlier (immediately after vaccination) and increased in stiffness and soreness with reducing range of motion over time. Pain medication helps but still very sore. Pain seems to be affecting a nerve, as tingling radiates down the arm to the little finger in the hand, and all along the side of the arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Became red on Mon evening. Wakes up and c/o pain-Redness progressed and now down to elbow.
This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number and Expiry Date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Reporter stated she was still experiencing a lump under her right armpit on an unspecified date, and she did not know if it was her gland that was swollen. Reporter queried that if the lump would go away on its own, or did she need to be concerned, and see her doctor. Reporter clarified that she received both doses of the COVID-19 Vaccine, and the vaccine was administered in her right arm. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained.
Fever 100.5, myalgias, with redness / swelling upper arm X 2 wks; skin subseq sloughed off. Tx with Prednisone X 7 days.
FATIGUE, DIZZINESS, BRAIN FOG, HEAT INTOLERANCE, DEHYDRATION, TACHYCARDIA, WEIGHT LOSS, BLOOD POOLING IN FEET, WEAKNESS. POTS- POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME.
Pt. woke up ard. 100am with her whole (L) arm and shoulder hurting. The pain increased to the point of her crying and being unable to move her arm. Pain extended from the top of her shoulder to her elbow. No swelling or redness ard. injection site but redness over (L) shoulder. She experienced some diarrhea and stomach hurting. Pain has decreased with increased mobility.
Chills, shivering, temperature elevated 1.5 degrees, tender skin, extreme fatigue, loss of appetite all beginning about 12 hours (4:30 AM) after booster shot. Symptoms subsided around 9 PM the same day.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Exhaustion / Lethargy-Mild, Additional Details: She came into the pharmacy on 9/10/22 and she still had brusing and swelling was better.  She is allergic to latex but has had the vaccine before
26 y/o F who presents to the ED with complaints of an allergic reaction to her 1st Pfizer COVID-19 vaccine that she received on 04/01/2021. Pt reports generalized urticaria with pruritis and an itchy throat. Pt says she does not have a history of reactions to vaccines. Pt denies SOB, lip edema or throat swelling. Pt says she has taken benadryl for her symptoms with some alleviation.   Pfizer Vaccine Lot #: ER8733 EXP date: 07/31/2021.