chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sinus infection; stuffy head; I do have tinnitus, and noticed that both injections made that worse; This is a spontaneous report from a contactable nurse (patient).  A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), intramuscular on the left arm, on 18Dec2020 at 11:30 at a single dose for Covid-19 immunization.  Medical history included at one time a severe allergic reaction to pecans have since eaten small amts without problems and tinnitus.  The patient has no Covid prior to vaccination. The patient is not pregnant. The patient's concomitant medications were not reported. No other vaccines in four weeks and no other medication in two weeks. In Dec2020, the patient stated that she does have tinnitus, and noticed that both injections made that worse, it is not yet subsiding since last injection the only other signs and symptoms (s/s) she had from the 1st injection, second day after, about 2 hrs of feeling like she had a sinus infection, stuffy head, wanted to go to bed and rest. The patient was treated with naproxen sodium (ALEVE), paracetamol (TYLENOL), and diphenhydramine hydrochloride (BENADRYL) for the events. The patient was not Covid tested post vaccination. The outcome of the event of tinnitus was not recovered, while other events were unknown.   Information on lot/batch number has been requested.
Constant dizziness and pressure in head, giving a lightheaded or high feeling. Occasional nausea. Trouble concentrating and foggy thinking. Not going away as of 1 week after the shot.
Burning sensation in injection side shoulder, Swollen/painful lymph node along collar bone 6 days following vaccine
No additional adverse effects reported; was administered an improperly stored dose of RECOMBIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 01-MAY-2020, the patient was administered an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # reported as S000961 and expiration date 19-OCT-2020; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was 47.6 Fahrenheit degrees for 2 hours 42 minutes. There was no previous temperature excursion. No additional adverse effects were reported.
Pt was sitting in the monitoring area when she began complaining of "difficulty swallowing" with a sensation of a "lump in my throat". Pt brought back to AR monitoring area and placed on monitors. She is speaking full and clear sentences. LSCTA, RR even and unlabored. -stridor and no oral or submucosal swelling/redness. Pt is swallowing her own saliva well. Pt reports that 8 mins post her 3rd Pfizer vaccine (Lot # FF2593) she developed the above symptoms. Vital signs as charted below. Pt also indicates that with her second dose of the Pfizer vaccine, approximately 30mins afterwards she developed bilateral eye swelling in which she took Benadryl 100mg po which provided relief. She indicates that after several hours her symptoms resolved without incident. Upon further assessment, pt with no other symptoms. She is free from any rash or redness and remains calm and cooperative. At approximately 0840 pt began coughing with increased sensation of difficulty swallowing. Call out to ER MD Dr. who advises for pt to be evaluated in the ED. He opted for no premedication prior to pt leaving the Covid Vaccine Clinic. Pt verbalizes understanding of ER MD recommendations and Covid Vaccine RN drove pt to the ED. Pt ambulated with very steady gait, continued to deny any SOB, Chest Pain, palpitations, dizziness or rash.
3 days after FLUMIST developed fever, myalgias, pharyngitis (strep negative) cough, rhinorrhea.  Ended up with clinical diagnosis of sinusitis on 11/3/08 (11 days post FLUMIST).  Started on AMOXICILLIN.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really Sick), NAUSEA (Nausea after booster dose) and CHILLS (Chills after booster dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 040321A- "N4CAC/MC" and 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Really Sick), NAUSEA (Nausea after booster dose) and CHILLS (Chills after booster dose). At the time of the report, ILLNESS (Really Sick), NAUSEA (Nausea after booster dose) and CHILLS (Chills after booster dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient took pills for some nausea. Concomitant information was not provided. This case was linked to MOD-2022-451798 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2022: Follow-up information includes updated consent information.
Immunization given 8/29/18. Per ED note pain started 9-1-18. Went to ED 9-5-18 3cm abscess. I and D with follow up 9-7-18.
A not-serious spontaneous report of sore throat, runny nose and fever has been received from a consumer/mother concerning her ten-year-old female, subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST at her school on 08-Oct-2009. On 10-Oct-2009, the patient's mother reporter that her daughter was not feeling well with a sore throat and runny nose. On 11-Oct-2009, the patient developed a fever of 100 degrees Fahrenheit. The outcome of the events was unknown at the time of the report.
Initial report received from non-healthcare professional (patient) on 07 January 2014. Almost 80-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that on an unspecified date, 12 days after receiving FLUZONE HD vaccine, the patient experienced ongoing have and urticaria. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Expired vaccine used; Cough; Fever; bodyache; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Cough), PYREXIA (Fever), MYALGIA (bodyache) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COUGH (Cough), PYREXIA (Fever) and MYALGIA (bodyache). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, COUGH (Cough), PYREXIA (Fever) and MYALGIA (bodyache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  It was reported that the vial didn't undergo any temperature excursions and the vials were received at the HCP office on 20-Aug-2021 and were stored in refrigerator till dates administered as indicated on the list 10 vials were used.  The patient received the booster dose.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Added reporter details and patient initials. New events were added. On 24-Nov-2021: Dose number for the suspect drug has been updated.
pt recvd 2 doses of Engerix-B & about 2 wks p/2nd shot devel a rash on chest, abdo, back & arms;
Patient received HPV and MENACTRA vaccines at the same time. Patient's body stiffened and eyes rolled back, for 5 seconds. Patient then felt dizzy. She was asked to lay down and vitals were taken.
On 10/17/2022, I woke up with some abdominal pain. Through the course of the day, it progressed into diarrhea. By the afternoon, I was passing a lot of blood. I called my internist who advised that I go to the emergency room, which I did. They put me on an I.V. did a CAT scan, blood work, and a stool analysis. They told me to contact a gastroenterologist to have a colonoscopy done. I had that performed on 11/01/2022. This all gradually got a little better and then on 12/07/2022, I had a recurrence of the pain and diarrhea, but not the bleeding. That continued until around 12/11/2022. I was prescribed VIBERZI. The medication seemed to help the first day I took it, on 12/07/2022. The next day, I called my doctor because it was no longer helping, and I stopped taking it. I was prescribed something else, a little bit later, but have not taken it because I have not had another outbreak.
High Blood Pressure, Bounding Heart Rate, Rapid Resting Heart Rate, Neck Pain, Back Pain, Right Knee Pain, Chronic Headaches, Weakness, and easily fatigued.  The blood pressure and heart issues have somewhat gone away, but the pain, headaches, and weakness have gotten worse.  I am not able to do my career to the full extent. I went to the doctor and they told me I was having an adverse reaction to the shot.
red patch on lower back sized 3" x 5" - hot & itchy & raised (waffled);saw NP who prescribed med;a second small area devel later & is still evident;
Itching body, swollen eyelids and lips rash head to toe. Itching throat/tongue tachycardic, no murmur. BENADRYL susp. 7.5 cc Prednisone 17 mg PO Allergy referral. Tx: IV saline, EPI Jr, PEPCID 8 mg IV.
Patient was sick for 2 days, and bounced back up.; Patient was exposed to someone who was sick and caught covid; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Patient was sick for 2 days, and bounced back up.) and COVID-19 (Patient was exposed to someone who was sick and caught covid) in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In October 2022, the patient experienced ILLNESS (Patient was sick for 2 days, and bounced back up.) and COVID-19 (Patient was exposed to someone who was sick and caught covid). At the time of the report, ILLNESS (Patient was sick for 2 days, and bounced back up.) had resolved and COVID-19 (Patient was exposed to someone who was sick and caught covid) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered ILLNESS (Patient was sick for 2 days, and bounced back up.) to be not related. No further causality assessment was provided for COVID-19 (Patient was exposed to someone who was sick and caught covid).    It was unknown patient did have previous COVID-19 vaccinations. No concomitant medication was reported.    Patient stated his doctor, allergist, and every person he knew, including nurses told him to take Moderna, because it does well with ethnic people. Patient stated its a superior product. Patient informed that he received his first and second primary doses and was good and didn't have any problems. Patient wasn't sick because of the vaccine. No treatment information was reported.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, in a range from 01-APR-2015 through 30-APR-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J013394, expiration date 25-AUG-2015) (Strength, dose and route were not provided). Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
the night of the injection flu-like symptoms, body aches, slight nausea, chills, loss of appetite, headache, very sore at injection sight include red spot approximately 1" in diameter around the injection sight. Symptoms  continued all day on Sunday (took two 500mg acetaminophen around 12 noon on Sunday - gave some relief of symptoms for about 8 hours). Today, Monday 9/14 feeling a lot better, a little sweaty at times but almost back to normal after 48 hours.
pt received pneumo 13 injection in clinic. Had allergic reaction, hives. Given 50mg Benadryl(IM), and 40mg Depo Medrol. Pt advised to stay in clinic for one hour post injections. (Will let her go at 1130). Addendum by provider on February 20, 2020 11:31 CST (Verified) Pt departed clinic @ 1130a. Pt reported feeling okay.
The first thing that happened was my lip started tingling and the nurse that gave me the shot was still standing there. It felt like ants crawling all over my lips. I started having a headache it was at a low rate and progressively got worse. Before I even got home, I was already running a temp. I was having chills and shaking. The temp was reading 103 when I got home. It felt like a light switch had been flipped and I was sick with what it felt like was the flu. I am not sure of the order, but I had no appetite, diarrhea. The next day I made an appointment to see my PCP. The doctor gave me promethazine and ZOFRAN and was told to take TYLENOL and get plenty of rest. This lasted for two weeks, and it felt like I had the flu but I had headache as well. I was also having joint pain that started a few days later. The joint pain was very strange and all over. I also had lots of fatigue.
20OCT95 pt came in for eval of local rxn to lt arm had flu shot yesterday) area appeared approx fifty cents piece size red & somewhat swollen;no itching or fever noted;
Patient had a Stroke, acute, thrombotic on 4/10/21 (10 days after receiving the Moderna vaccine) Patient was given Tylonol 325mg, Zyloprim 100mg, Atorvastatin 40mg, Colchicine 0.6mg, Docusate Sosium 100mg. Patient was released to a Physical Therapy facility to begin therapy to try and walk again and patient needs speech therapy as well. Note: While in hospital, patient also developed gout in left hand. Patient ended up falling and breaking her hip at the Rehabilitation Facility in which she was released to and had to come back to Hospital for a full hip replacement. After the hip replacement surgery, patient had several more strokes and developed pneumonia. It was noted on her chart also that she seems to have Linear Nodular Thickening within the lung apices as well as small pulmonary nodules. There are some scattered areas of groundglass density which are nonspecific, possibly related to atelectasis infectious/inflammatory process.
Rt lower face swelling-no pain. No redness occurred 8 hrs after vaccine.
Substantial swelling at injection site with mild discoloration. Fever >101F, mild nausea, and fatigue. Fever off and on still ongoing 48 hours later. Treated with Tylenol and Advil.
Extremely heavy and long periods; Along with worst cramps "I" have ever experienced.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 11May2021 at 08:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 of vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 20Apr2021 at 08:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient had extremely heavy and long periods along with worst cramps that patient had ever experienced. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely heavy and long periods along with worst cramps was unknown at the time of this report.
Patients mother consented patient was 12 years of age at time of vaccination. Mother states pediatrician strongly recommended vaccination due to daughter almost being 12 years of age.
At 8:00 AM 10/13/10 client was congested; she was achy in her arms & legs. No fever; no rash, no redness at site. Is still congested but much less achy.
This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (muscles feeling weird), MUSCLE TWITCHING (arm was twitching) and VACCINATION SITE DISCOMFORT (muscles in her arm were she had the injection jumping) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced MUSCLE DISCOMFORT (muscles feeling weird), MUSCLE TWITCHING (arm was twitching) and VACCINATION SITE DISCOMFORT (muscles in her arm were she had the injection jumping). In October 2021, MUSCLE DISCOMFORT (muscles feeling weird), MUSCLE TWITCHING (arm was twitching) and VACCINATION SITE DISCOMFORT (muscles in her arm were she had the injection jumping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
This case was reported by a consumer via call center representative and described the occurrence of swelling in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown. It was unknown if the reporter considered the swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter contacted through live chat and did not provide any additional information.
Weakness all over the body; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weakness all over the body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ASTHENIA (Weakness all over the body). At the time of the report, ASTHENIA (Weakness all over the body) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and the temporal relationship between the product use and the start date of the event a causal relationship cannot be excluded.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.; Sender's Comments: Based on the current available information and the temporal relationship between the product use and the start date of the event a causal relationship cannot be excluded.
Patient  reported to recovery area for about 4 minutes before EMS was notified that the patient needed an ice pack for a "hematoma" at her injection site. Upon visual inspection patient was noted to have a rash on her arm surrounding the injection site. Patient was brought back to EMS treatment area where upon physical assessment patient was noted to have systemic rash across abdomen, chest, bilateral arms (upper and lower). Vital signs were obtained. Patient was treated for allergic reaction without airway compromise. 50mg of Benadryl given in right deltoid. 20g IV access placed in the left AC without infiltration noted. Site secured with tegaderm and tape. EKG obtained. Patient remained alert and oriented w/o respiratory distress or oropharyngeal swelling. Withheld epinephrine and Decadron. Outside EMS requested for transport to local hospital. No further care noted
Swelling and redness of upper left arm, surrounding injection site. Site also warm to touch.
Patient called Pharmacy to report the adverse reaction on 8/3/19.  He reported a 5 to 6 inches long and about 2 inches wide of red spot.  He had no fever.  He feels a little weak but was fine after lunch.  He believed it is now getting a little better
pt recv vax & devel ascites, 2 plus edema & esophageal reflux of bile; lab testing on 23JUN94 was pos for hepatitis C; pt was concerned about the possibility of the initial course of hep B vax causing Hep C;
the patient already had tinnitus and very shortly after injection it got much worse.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):   A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "tinnitus" (unspecified if ongoing), notes: It was reported the patient already had tinnitus. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "the patient already had tinnitus and very shortly after injection it got much worse.".  Additional information: On 01Sep2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose and indication. It was reported the patient already had tinnitus and very shortly after injection it got much worse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received my second shot 4/7/21 at 10:30am woke up 6:30am 4/8/21 fever, chills, sweats achy and tired. Slept the entire day when I woke up at 5:0pm I felt better had some sweats again that night but much better today. Yesterday was terrible.
Face felt prickly and noticed face red and warm lasted about 30 minutes. Resolved on own, No treatment necessary No further problems.
I was itching like crazy for two days, I was shaking I almost passed out, had low grade fever, felt like I was going to pass out, had a severe headache. symptoms lasted for around 4 days.  Worst headache of my like.
Experiencing red rash around vaccine area. Also experiencing itching around the area, particularly when exercising. High level of fatigue despite sleeping normal hours.