chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very shakey; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (very shakey) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NERVOUSNESS (very shakey). At the time of the report, NERVOUSNESS (very shakey) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-033929 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033929:1ST DOSE CASE for patient
Report diarrhea, sore throat, congestion, nausea, and cough. Treatment: Nothing, Outcome: EE advised to self isolate and scheduled for COVID testing.
Narrative:  PATIENT REPORTS SEVERE JOINT PAIN, STARTED A FEW DAYS AFTER SHOT. AFTER 2 WEEKS CAN STILL HARDLY WALK. PT DOES HAVE ARTHRIRIS. BEEN TO ER 2 TIMES FOR PAIN. FELL OUT OF BED AND NOW CAN'T OPEN JAW.
Began with stiff neck.  Had trouble speaking, could not say words also was drooling.  Gradually better over hours to days.
Patient fainted about 5 minutes after receiving the vaccine.  She was in the monitoring area and fell over and hit her head on the ground. I went to her aid and monitored her until the paramedics showed up.  She was unconscious for a 10-15 seconds with her eyes open before regaining consciousness.  IShe was not having breathing problems or other symptoms of anaphylaxis so i did not administer an epi-pen or benadryl to her.  I rolled her on her side in case she became nauseas.  Then the paramedics arrived and attended to her.
the vial was initially stored in the refrigerator on 1Jun2022; administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 1Jun2022) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 041C21A and 005C21a) for COVID-19 prophylaxis.     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 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 1Jun2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 1Jun2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies. It was unknown if patient ever had COVID + test or diagnosis. No other vaccines were taken within 1 month prior to Moderna COVID-19 vaccine No concomitant medication were reported.  The vial was initially stored in the refrigerator on 1-Jun-2022. The vial did not undergo any temperature excursions.       No treatment information was provided by the reporter.
The patient came in on 11-15-07 with his left arm all swollen and red from the shoulder bone all the way down to his elbow. It was also hot and Mom said that his elbow started to swell on 11-14-07 at night.
Diarrhea, racing heartbeat, heart palpitations, headache, nausea all started at 1.5 hours post injection.
Sore arm at injection site. Sore muscles, aching joints, fatigue, decreased appetite
1 HR AFTER RECEIVING THE J&J COVID-19 VACCINE PATIENT STARTED FEELING TINGLING IN LIPS. IT PROGRESSED THROUGH THE DAT TO TINGLING DOWN THE ARMS, LIP AND TONGUE SWELLING AND ABDOMINAL PAIN. PATIENT CALLED TO REPORT THE ADVERSE EVENT AT 10AM ON 18/18/2021 AND INDICATED HE DID NOT TAKE ANYHTING AND REMAINED AT HOMW, HE INDICATED HE THOUGHT THE SWELLING WAS GOING DOWN BUT COULD STILL FEEL HE WAS NOT BACK TO NORMAL. PATIENT WAS INSTRUCTED TO NOTIFY HIS PCP, TAKE BENADRYL AND CALL EMS IF EMERGENT SYMPTOMS PRESENTED (SOB, CHEST PAIN, SEVERE SWELLING). PATIENT WAS ALSO INSTRUCTED TO GO TO URGENT CARE IF SYMPTOMS DO NOT GET BETTER OR THEY GET WORSE BY THE AFTERNOON.
A report has been received from a Health Professional according a subject of unknown gender, who had been receiving FLUMIST (INTRANASAL).FLUMIST (INTRANASAL) started on an unknown date. The patient experienced CROUP. The outcome of the event of CROUP is unknown. The report was considered to be non-serious.
Patient visited us at the store on 11/22/19 and talked to the Pharmacist on duty to discuss what he experienced after a flu shot administration on 11/8/19. He said right after receiving the vaccine two weeks ago, he had felt moderate to severe pain and muscle stiffness on his left arm where he had been vaccinated, causing him limited mobility on that arm and having pain moving and reaching across the opposite shoulder. He said there were nights that he can't sleep or wake up in the middle of the night because of the pain. He hasn't seen a doctor yet for these symptoms. Pharmacist suggested if he want to take NSAIDS like Advil or Aleve to help with the pain but he said he would only take NSAIDS if he feels it to be necessary. A Quality Assurance and Safety Report was already submitted on 11/22/19 about the patient's concerns and symptoms. He had been getting his yearly flu shot and this was the first time that he had experienced this shoulder pain. He understands this occurrence is usually expected after a vaccine administration but his symptoms still persist over two weeks after. He just wanted an assurance that these symptoms are just temporary and will be resolved soon. Pharmacy Risk Management Team had started working on this case and they will be reaching out to the patient to help him on this situation and fully address his concerns.
urticaria and rash started on back, bil elbow and bil knee/lower region on 4/21, 12 days post vaccine. Also noted significant bil upper eye lid swollen(angioedema). Pt was treated aith Prednosone 10 mg dose pack x 6 days and triamcinalone cream for itching. All sx resovled after day #2 of steroid PO.
Dizzy, weak, nausea, tired, pain and swelling at injection site down to elbow with burning and itchy
Patient had normal side effects (vaccine on 4/7/2021) Wednesday and Thursday with fever and aches. Woke up Friday morning with fatigue and over the course of the next days developed shortness of breath, severe fatigue, and palpitations. Came into the ER a week later (4/14/2021) found to have significant anemia. Coombs test positive. Seen by hematology suspect autoimmune hemolytic anemia. Started on prednisone 1mg/kg. Will need at least  weeks of treatment then tapering of steroids. Outpatient follow-up with hematology.
I developed a cough on May 26th. That cough got worse over a 10-day period. It got so bad that I started to throw up. On June 9th, I saw an urgent care physician via health visit. He prescribed Venotone and cough syrup. It began to get better and then got worse again. I saw my PCP and she refilled the cough syrup and Venotone medication.  After taking that round I started to feel better.
Patient was sitting for the immunizations, felt fine afterwards, got up and left. Patient was seated for approximately 5 min. Patient then proceeded to the restroom, where he finished utilizing and then as he was drying his hands felt lightheaded. Patient then fell backwards hitting his head on the floor. Patient was found by a coworker, who then ran to get help. Patient sustained a minor laceration and a skull fracture. Patient is currently being treated for this event.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from an nurse. This case involves an eight year old male patient who received 0.5 ml expired dose of FLUBLOK QIV (batch number QFAA1813, expiry date, 30 June 2018) right deltoid on 08 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration as 8 year old boy received FLUBLOK QUADRIVALENT and expired vaccine used. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Information has been received from a 25 year old male pt who on 7/28/99 and 9/18/99 was vaccinated with a first and second dose of Hep B. Following both doses, the pt became sweaty and things started to spin. The pt reported that he then postured and had a real rapid heart rate followed by a headache. Unspecified medical attention was sought. Additional information has been requested.
DIZZINESS; PAIN AT INJECTION SITE; VACCINE ADMINISTERED IN PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a parent concerned a 17 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced pain at injection site. On 10-APR-2021, the subject experienced vaccine administered in subject of inappropriate age. On 10-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and pain at injection site, and the outcome of vaccine administered in patient of inappropriate age and off label use was not reported. This report was non-serious.
6 days after the shot swollen nodule appeared on injection side above the clavicle below the carotid artery. Nodule is about a nickel size, discomfort when palpated.
LOST MORE TO THE VAX; This spontaneous report received from a consumer via a company representative via social media (J&J corporate social media account) concerned multiple patients. The patients weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, multiple people were lost due to vaccine and died from an unknown cause. It was unknown whether an autopsy was performed or not. The reporter reported that, "I've lost some to the flu and lost more to the vax..check your news sources". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220752266 and 20220749737.; Sender's Comments: V0: 20220749758 -covid-19 vaccine ad26.cov2.s -LOST MORE TO THE VAX. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Prolonged sinus burning and burning in neck and lower back 24 hours after first covid vaccine Moderna
p/vax pt exp shingles (less than 10 lesions) on rt upper forehead & rt side of nose;
THE PATIENT HAD NUMBNESS AND TINGLING IN THE LEFT HAND (SPECIFICALLY PROMINENT IN THE #4 DIGIT) THAT RADIATED UP THE LEFT ARM INTO THE RIGHT SIDE OF THE NECK.
pt states that the site of inject turned red & spread over most part of upper lt arm & pt said that the site of inject felt hot;
On April 6, 2021, patient stated on COVID vaccine consent form she had never received a dose of COVID vaccine.  Janssen dose was given. on April 6, 2021.  Upon entering the dose into the electronic vaccine documentation system, it was discovered that patient had received a dose of Pfizer in January, 2021.  No adverse effects have been reported by patient.
Sick; This is a spontaneous report from a non-contactable healthcare professional reporting similar events for 6 patients. This is the 5th of 6 patients. A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 20Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient was sick. The outcome of the event sick was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076652 same drug and event, different patient
rash that covered from shoulder to elbow; intense itches in the left arm; pain at the injection site; A spontaneous report was received from a 73-year-old male physician who was participating in the mRNA-1273 Emergency Use Program and experienced tenderness and pain at the injection site, intense itchiness on left arm and rash that covered from the shoulder to elbow.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient reports he experienced tenderness and pain at the injection site that lasted one day. On 5 Jan 2021, the patient experienced intense itches in the left arm and on 6 Jan 2021, he woke up with a rash that covered from the shoulder to the elbow. Treatment for the event included liquid loratadine and corticosteroids.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, tenderness and pain at the injection site were considered resolved on 31 Dec 2020. The outcome of the events, intense itchiness on left arm and rash that covered from the shoulder to elbow, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Stiffness in my neck on my right side; Unusual sensation start up through my neck/ below my ear in my gland area and into my jaw line/ slightly numb but not totally numb; This is a spontaneous report from a contactable pharmacist, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 27Apr2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid lobectomy on May 2019 as a result of a follicular neoplasm which was identified post op as malignant. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), levonorgestrel (MIRENA) and beta glucan (WELLMUNE); all from an unknown date for unknown indication and unknown if ongoing. On 27Apr2021 at 10:45 (also reported approximately 6 minutes post vaccine), the patient started to notice stiffness in neck on right side, same side as vaccine shot. At first, patient thought it was just from a workout the day previous but then had an unusual sensation start up through her neck, below her ear in her gland area and into her jaw line. The patient reported that she would describe it similar to the sensation post being to the dentist as an anesthetic was wearing off and she experienced slightly numb but not totally numb. The patient stated that, it never got worse over the course of the day and wasn't bad enough to warrant to seek medical treatment. The patient further stated that, it took 48-72 hours to fully clear. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event stiffness in my neck on my right side and unusual sensation start up through my neck, below the ear in the gland area and into my line, slightly numb but not totally numb were resolved on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
I received my second COVID vaccine March 30th, 2021 and then started experiencing poking sensations in my legs April 2nd. Which then turned into zapping sensations, warm/itching all over my body, huge rash on my left leg. That continues to flare up and go away randomly to this day. The cause is unknown for when it flares up. Once the rash progressed and got worse, I went to the Urgent care the second week of April. They looked at it, and they sent me home. So the following week I went to a dermatologist, they took some tests but they came our inconclusive on what the rash was caused by. I went back to Health clinic to try and figure out what was going on. I have been going in ever since then, almost once a month I would go in. I've seen an allergist, dermatologist,  and the people at Health clinic and no one can confirm what is going on. They put me on antihistamines and that has helped some, as well gabapentin for the muscle pains. Hopefully they can figure out more soon.
I had a reaction about 3 or 4 hrs later and was very itchy. I had hives on trunk and arms. I was itching in my throat and ears. I took a couple doses of Benadryl and Pepcid. I also felt like I was experiencing SOB. I went to the doctor the next day and was prescribed steroids. I continued taking everything for the next few days and was unable to work.
Pericarditis. Awful. Started feeling some slight chest pain on 12/22. Felt it more or less continuously for a few days, but nothing severe, until the evening of 12/24. I woke up at 11 pm with severe pain and difficulty lying down and taking a deep breath. Severe chest pains and pain throughout my neck and throat. Went to the ER. They did an EKG and ran some blood tests. My CRP was at a 5, leading them to think I had some sort of infection. EKG was normal, didn't show that I had or was having a heart attack or anything, thank God. They sent me home.  Next day, I saw a cardiologist who performed an ultrasound and that showed pericardial effusion around the heart and some fluid buildup around the lungs. Diagnosed it as pericarditis. Prescribed ibuprofen -- 3 pills 3 x a day -- with food. Went back on 12/28 and the fluid around my heart was gone and the fluid around my lungs had diminished from 20 mm to 16 mm. On 12/28, Cardiologist, along with pulmonologist, reduced my ibuprofen to 2 (400 mg tablets) 2x a day. Feeling much better than on 12/24, when I thought I might be having a heart attack despite no history of heart problems in my family at such a young age.
body ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-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 15-Apr-2021, the patient experienced MYALGIA (body ache). At the time of the report, MYALGIA (body ache) had resolved. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: telephone contact report received on 10-JUN-2021 .Outcome of the event Myalgia updated from unknown to recovered.
Moderna covid -19 vaccine eua  fever, aches, fatigue, congestion, cough, sore throat, head ache, sneezing
Frequent, harsh, dry cough with mild wheezing.  He reports it has happened after every flu shot he has received in past.  Lasts about 6 weeks.  Starts within 24 hours of shot.  Happened again with this administration.  All were inactivated vaccines.
Pt developed arthralgias and myalgias 1-2 weeks after injection. Symptoms persisted for 4 months. By the time he was seen at the clinic, he was asymptomatic.
Two hours after administration I encountered headache, shivering, fever, muscle pain, and nausea.