chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received late 2nd dose of shingrix. DOSE 1:AUG 2019, DOSE 2: 06/25/2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On 25th June 2021, the patient received the 2nd dose of Shingrix. On 25th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix late than the recommended time interval which led to lengthening of vaccination schedule. No other detail of patient or vaccine available The reporter consented to follow up.
Patient was given vaccine in each arm. Shortly after vaccine was given patient started coughing and complaining of difficulty breating. EMS was called and Epi pen administered. Patient was taken to hospital via ambulance.
I noticed about one week after getting the vaccine that my upper right arm was red and rash-like. It was warm, and the tissue in the area was harder and less pliable than the surrounding tissue when it was palpated.  There appeared to be some swelling. There was a little itching, but otherwise no discomfort with noting.  The site extended about 6" on and below the injection spot and was about 4" wide.  Twelve days after the vaccine, symptoms have lessened but are still there.  The event may have started sooner, but I didn't notice it until about a week after getting the vaccine.  (Also maybe worth noting: 18 months prior to the vaccine I had a total shoulder replacement and now have an implant in my right shoulder near where the vaccine was done.) I never sought treatment for this as information I found online said this sometimes happens and it is not something to have checked by a doctor.
Patient received Pfizer COVID-19 vaccine dose 1 (3/26/2021) and dose 2 (4/16/2021). Patient qualified for 3rd dose in primary series due to immunocompromised state. Patient received Moderna booster dose of 0.25ml on 1/25/2022. Provider notified and provider contacted Moderna to receive  clinical clarification regarding volume of dose to be admitted to equal a primary series 3rd dose.  Instructed to administer an additional 0.25 mL dose of Moderna to bring patient total volume to 0.5ml. Additional 0.25ml of Moderna administered on 1/27/2022. Patient made aware and tolerated well.
Shoulder pain after 5 months of receiving the COVID-19 vaccine. I still have the pain and it is getting worst.
Administered vaccine to patient. After returning to pharmacy mother stated that child needed to throw up.  I took trash can to parent and patient threw up twice.  He stated that he was sleepy and that his arm was tingly at injection site.  I continued to monitor the child but he seemed like he was going to faint.  He was complaining about having headache and needing to go to the restroom.  I called 911. They came to the store and took all necessary vitals of patient.  His blood pressure and pulse oxygen were normal.  No reaction at injection site.  No rash developed.  No swelling of the tongue.  The EMS stated possible hyperventilation and nerves.  After they left mother waited in store another 10 minutes then left.  When I called later in day, mother stated he ate meal and was fine.
Routine TYLENOL prior to shots Temp 103 - inactive 11-29-10 red crusty eye c/o. Mom plans to see MD over eye "today" or "tomorrow" she will call MD & discuss.
5 days after my shot,  I broke out with a rash (from my elbow down to my wrist) on the arm in which I received the vaccine.   I took some "Benadryl" yesterday and put a cream called "Betamethasone Dipropionate" on the rash area.   It looks about the same today.   The Benadryl makes me drowsy, so I didn't take it, but I put the cream on today.  What do you recommend?
Initial misuse report received from a health care professional on 01 October 2013.  The 62 year old female patient had received FLUZONE HD. Patient had chemo and radiation 5 years ago so she gave her the vaccine. No adverse event was reported. List of documents held by sender: none
Recently, my daughter was given three incorrect (double dose) vaccinations at her eighteen month appointment by Dr.  Dr. administered a second dose of those three vaccinations on Sunday, March 6, 2022  that she received at her fifteen month appointment on December 18, 2021 (less then three months ago) and was not supposed to receive them again until she was four years old.  This is negligence.   My daughter was supposed to receive DTap and Hepatitis A on March 6, 2022.  Dr. injected her with the wrong vaccines.
Joint pain needed cruches to walk. Sweating, cold, body overheating and joints were hot. lost of appatite
Information has been received from a licensed practical nurse concerning an 11 year old female with asthma who on 06/15/1995 was vaccinated with the first dose of varicella vaccine SC in the left thigh. There was no illness at the time of vaccination. On 11/07/2001, the pt developed a fever and an itchy rash. The pt sought unspecified medical attention. Follow-up info reported that the pt had chicken pox and recovered on 11/12/2001. No further info is expected.
improperly stored vaccine administered to patient on 10/7/2020; This spontaneous report has been received from a registered nurse referring to a 13 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.     On 07-OCT-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S010729, expiration date 01-DEC-2021; strength and route unknown) ; unspecified dose in series for prophylaxis (incorrect product storage).   The storage temperature of the vaccine was above 9 degrees Celsius (11.3 degrees Celsius) for a time frame of 55 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse event was reported. No product quality complaint was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
on 3/16 client had fever to 100.4 with severs shakes. Ambulance called next morning 3/17. Patient had confirmed diagnosis of EColi infection and was treated and discharged 4 days later
Non-cancerous lymphoma; Back pain; Swollen abdomen; Swollen lymph nodes in her stomach; This spontaneous case was reported by a patient and describes the occurrence of PSEUDOLYMPHOMA (Non-cancerous lymphoma), BACK PAIN (Back pain), ABDOMINAL DISTENSION (Swollen abdomen) and LYMPHADENOPATHY (Swollen lymph nodes in her stomach) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 004M20A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in her stomach). On an unknown date, the patient experienced PSEUDOLYMPHOMA (Non-cancerous lymphoma), BACK PAIN (Back pain) and ABDOMINAL DISTENSION (Swollen abdomen). At the time of the report, PSEUDOLYMPHOMA (Non-cancerous lymphoma) had not resolved and BACK PAIN (Back pain), ABDOMINAL DISTENSION (Swollen abdomen) and LYMPHADENOPATHY (Swollen lymph nodes in her stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Biopsy: non-cancerous lymphoma.         No concomitant medications were reported. Before, 04-Jul-2022, patient went to the hospital and a biopsy was performed. Patient stated that her physician told her that the antibody for the Covid-19 vaccine may reverse the lymph nodes (resolve). She was also told during her yearly mammogram that the vaccine can produce swollen lymph nodes in her breasts. No treatment details were reported.
Got my first shot on February 11th,2021 later that evening I had some soreness on injection site then on February 12th around 8pm I got really hot so I took my temp and it was 101.3. I then proceeded to take tynenol for fever and it lasted until the 13th. A week later on Wednesday 17th I started to feel very lethargic. I then proceeded then next day to take my temp with it reaching to 102.9. I then took acetaminophen every 4-6hours for my fever. I had a fever lasting until Saturday with it reaching as high as 103.5. I then proceeded to get covid tested on Thursday the 18th which came back negative and on Saturday the 20th. I went to urgent care, they tested me two more times for covid which came back negative and the flu. The nurse practitioner suggested my symptoms were due to the covid 19 vaccine.
Fingers and Toes went numb and tingling. Legs went weak. SOB. Chest Pain. Stomach upset but not nauseas.  Temperature.
Started getting hives then on 11/6/2017 hot a 102.5 fever. 11/7/2017 became hard to console and would not sleep, stayed up all night.
Extreme Headache, body aches, extreme fatigue, increased  joint pain, swollen lymph nodes in armpits, neck and breasts,  brain fog, left breast pain, increased heart rate.
Pt first started developing a rash on ankle, thought it was a bug bite because of intense itching.  Rash began to quickly spread all over body. Realized it was hives.  Pt was itching all over body.  took 50 mg of benadryl at 6:15 and again at midnight.
I also received the flu shot, but not sure which one. After receiving both vaccines on November 2, 2020 that evening I began to feel chills, fatigue and had a fever of 101.  I have never had a bad reaction to any vaccine in my 64 years of age, this was a first. Within 3 days of the Shingrix vaccine I began to feel a strong burning sensation in my upper back.  I had a couple of what I thought were two little pimples and when I touched them it was very painful, however there was no redness anywhere. The burning was inside the skin. I also began to have itching inside my skin at night which later became a prickly stinging unbearable sensation which I still have as I write this. I feel like I am covered in sandpaper at all times. The doctor has prescribed Gapapetin but no results.
Patient also did not get some side effects that patient got after previous doses; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient also did not get some side effects that patient got after previous doses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient also did not get some side effects that patient got after previous doses). At the time of the report, IMMUNISATION REACTION (Patient also did not get some side effects that patient got after previous doses) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-659177 (Patient Link).
Pain at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at injection site". Additional information: Patient preferred pfizer because all 4 of patient's shots were pfizer and had no reaction other than soreness at injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Parent's report on 2/21/09 at 1 pm pt fever 102 degrees axillary. Gave acetaminophen and "fever went down". Crying most of the time. Temp did not go below 100 degrees with medication every 4 hours until 2/22/09 at 4 pm. Rash developed on2/21/09 at 9pm. Rash began on thighs and arms. Then noticed on trunk area then on face. Stated rash was red and flat. Today 2/23/09 red, raised, corn meal feel rash over face, trunks and extremities. Temp is 97 degrees at 10:00am. Visit, playing and has taken juice and 1/2 bottle this am.
On 10/2/21 I started having dizziness and vomiting along with nystagmus of my eyes, ringing and moderate hearing loss left ear.  I went to ER they diagnosed me with vestibular neuritis/labrynthitis on my left side. I continued to vomit for 7 days straight, unable to get out of bed, care for my kids or work.  I had double vision with my eyes open. I had 100% loss of balance, could no longer walk without falling down.  I started physical therapy at week 2 and have continue to do this weekly.  This has helped me recover enough balance to be able to walk again, though I still cannot run or do the sporting activities that I previously enjoyed.   I have 100% loss of function of the vestibular system in my ear on the left /side leaving me with permanent dizziness. I am unable to ride a bike, play sports, go up and down stairs unassisted and unable to perform my job of assisting in surgery.  I am dizzy every day all day and even walking is difficult.  I have 3 children that I now have difficulty caring for.  My adverse event was approximately 4 weeks after my injection.  I am now starting to receive the bills from this and now it is affecting me financially.
Very sore left arm; body aches; headache; chills; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 20Feb2021 at 16:30 (at the age of 78-years-old) as dose 2, single for COVID-19 immunisation. Medical history included arthritis, high blood pressure, and high cholesterol. The patient previously took codeine and experienced allergy. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number: EL9262, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 30Jan2021 at 16:30 (at the age of 78-years-old) for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 20Feb2021 at 20:00, the patient experienced very sore left arm, body aches, headache, and chills. Therapeutic measures were taken as a result of the events which included paracetamol (TYLENOL). Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Feb2021.   No follow-up attempts are possible. No further information is expected.
Within 24 hours, post vax, pt developed a fever of 102F for 3 days. He had local site edema and soreness. Symptoms were gone by the 4th day.
body was sore; little chills; low fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body was sore), CHILLS (little chills) and PYREXIA (low fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body was sore), CHILLS (little chills) and PYREXIA (low fever). At the time of the report, PAIN (body was sore), CHILLS (little chills) and PYREXIA (low fever) outcome was unknown.            Patient took Tylenol to treat symptoms. No concomitant medication was reported   Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Chills and pyrexia are consistent with the known safety profile of the vaccine.
This was my 2nd vaccine dose.   The first dose was on 1/15/21 at 12:30pm and my side effects that  started in the evening were much milder:  very sore arm, nausea, body aches, fatigue which resolved after 48 hours.    The 2nd dose on 2/5/21 was at 2:30pm, but the side effects started in the evening were more concerning:  same sore arm, nausea, body aches, fatigue, but I also started having chest pain at 9:00pm.   This was frightening to me so I took aspirin because it was heart related.   When the pain lessened, I went to bed.  I awake the next morning to chest pain and now tachycardia.  My normal heart rate is 68-70,  but now it was up to 98-100.  I took more aspirin, went back to bed, and tried to slow my heart rate with deep breathing.  I called my nurse expert friend who told me to go to the ER if my heart rate went to 140.  I  stayed in bed most of the day, trying to slow my heart rate, hydrating, eating slow portions of food and taking aspirin.  My chest pain & heart rate starting lessening by the evening into the next morning.  Thank God it was mostly gone by Sunday evening.   My biggest concern that I would appreciate an answer to from you is :  will the next COVID vaccine that I take be even more dangerous to me?  Am I allergic to this vaccine or would I be okay with a lower dose?  Should I not take a COVID booster if it becomes recommended?
Has not received second dose; Vertigo; Could not get up; Sore spine; Dizziness/light headedness; Injection site is sore; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizziness/light headedness), MOBILITY DECREASED (Could not get up), SPINAL PAIN (Sore spine) and PRODUCT DOSE OMISSION ISSUE (Has not received second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Dizziness/light headedness) and VACCINATION SITE PAIN (Injection site is sore). On 14-Mar-2021, the patient experienced VERTIGO (Vertigo), MOBILITY DECREASED (Could not get up) and SPINAL PAIN (Sore spine). On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received second dose). On 05-May-2021, PRODUCT DOSE OMISSION ISSUE (Has not received second dose) had resolved. At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness/light headedness), MOBILITY DECREASED (Could not get up), SPINAL PAIN (Sore spine) and VACCINATION SITE PAIN (Injection site is sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Significant follow up received on 5-May-2021.Updated reporter information, patient demographics. Added new event .The outcome of the events updated.
Patient had appointment with Dr on 12/19/2005 at 11:22 am with hx of rash on body for the last 3-4 days. He got VZV on 11/28/05. No fever.
pt was here to get his Covid-19 vaccination. He fainted about 2 minutes after administration. Pt notified associate, associate and pharmacist moved pt from the seat to the floor. He then sat on floor for a few moments until he was feeling better. He was given water and then was waiting for his fiance to come drive him home
My period is a week late, yet two home pregnancy tests I took were negative. First dose did not affect my period at all. I have always been regular, give or take a few days. I am in the process of switching doctors, so I could not go to a doctor yet, and I did not have medical info to list.
The family and I had gone out for lunch, I was sneezing a bit but didn't think anything of it. I woke up on December 23, 22 not feeling a really well and had a slight fever. I took a home COVID-19 test that came back positive immediately. I moved upstairs to quarantine, I developed a headache, my fever was getting worse. We called the doctor and had a telehealth visit, I was prescribed PAXLOVID. I wasn't sure about taking it until the next day. That day I woke up with a really sore throat, so I started the PAXLOVID. Within twelve hours of taking the pills I felt like I wasn't getting worse, but it did take three or four days before I started feeling better. It took three weeks before I felt like myself.
Pt called clinic 5 days after receiving imm to report infection symptoms. Pt seen in clinic that day for cellulitis, given bactrim. Pt called next day saying cellulitis was spreading. Advised to go to ER. Prescribed clindamycin in ER.
fever over 103 F, migrating tremor uncontrollable for 3 hours with no sweating, burning joint pain, exhaustion, long term pain for >2 weeks
employee noticed a swelling hot red spot about 3 inches in diameter on shot site. Her throat had soreness, and eyes were itchy. she put ice on site, swelling went down a little. came to work to be seen and nurses noticed a swollen 2 inch in diameter red hot area where the immunization was given.
WEAK, COUGH... DIFFICULTY BREATHING AND TONS OF MUCUS.  Patient states she is feeling better after taking abx - ciproflaxin 500 mg, Motrin 600mg every 8 hrs, Benzonatato 100 mg every 8 hours.  She also states she is a Dentist, so she prescribed all of the above medications for herself.  Lastly, she states she has been resting and her breathing has not been laborous any longer, overall she is improving.
I felt extremely hot, headache and dizziness - pressure on left temple and top pf head - next day had diarrhea.
pt w/apnea/brachycardia assoc w/gastroesophageal reflux had an arrest (like many prev) w/in 24 hr of receiving vax;
Pt dev red itchy raised rash 2-3 days post AVA #1 and meningococcal vaccines. Pt had one episode of  rash in 1996 prior to AVA. He reports that he had acute facial/lip swelling 12 hrs after AVA #2. Sought med attention and was placed on steroids. No assoc symptoms. Has recurrent rashes.