chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately one minute after receiving the shot, patient had a seizure. She fell, hit her head (repeatedly), and was unresponsive for less than a minute.  Pharmacy staff offered an ice-pack and water, but then proceeded to walk her out of the store.  They did not file a report at the time. They did not offer to call an ambulance. They did not offer to call someone to pick her up. Just walked her out.  She got back to her vehicle, and proceeded to call her mother (who is a nurse). Her mom arrived to pick her up, and went in to ensure that a report would be filed.  Her mother states that the staff had been unaware that there was a form to fill out, and that there had been a few other patients who had seizures (we assume these were not reported as they had not been aware of the proper forms).  Initially, patient had a cut and swelling on her forehead from hitting her head. The swelling has reduced, but as of 8/3/21, patient has had discoloration around her eyes. This is indicated by what appears to be blood collecting in corner of her right eye socket on the bridge of the nose, bruising under the eyes, and yelling of the skin along her nose and center forehead, which may be indicative of a basal skull fracture.  Patient has a doctor's appointment scheduled for 8/5/21, and has stated that she will wait until her doctor's appointment if the symptoms do not worsen for a proper diagnosis.
Pt received vaccines 1/25/08.  Had tactile fever that evening and area of swelling/redness developed at site 1/26.  Positive pruritic.  Seen in clinic 1/28/08 & noted to have 1 inch x 2 inch erythematous/indurated area on L upper arm (back) with about 8-10 overlying clear blisters (some coalesced).  Called 1/28 department of health who recommended pt stay out of school until lesions are dry/scabbed.
Pt received MMR and Hepatitis B on 1/26/01. By evening pt reported fever (?amt), muscle aching - 1/27/01, continues with aches. 1/28/01 whelps reported by mother to face and neck - Treated in ER with Benadryl and antibiotics. Improvement 1/28 now returning.
No adverse event; vaccinated 7 patients after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated 7 patients after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated 7 patients after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated 7 patients after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccinated 7 patients after the expiration date).    Concomitant medications details were not reported by the reporter.   At the time of an unannounced visit by a health department bureau representative on 28-Sep-2022, 50 doses of Moderna vaccines were left in the office which were looked well after but they were uncompliant since that lot of Moderna vaccines had expired on 07-Jul-2022.  Additionally it was mentioned that the expiration code on the packaging slip was not the expiration code, instead they had to scan the QR code to determine the actual expiration code, which they failed, by not reading carefully the packing slip.  The patient had received the expired vaccine on 15-Jul-2022.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2022: Significant live follow-up added. Patient identifiers added.
Information has been received from a nurse at physician's office concerning a female patient who on 31-DEC-2008, was vaccinated with the third dose of GARDASIL, intramuscularly.  The nurse reported that on approximately 14-JAN-2009, the patient experienced redness and swelling around injection site about two and half weeks post vaccination.  The nurse reported that the patient did not have any reaction after the first or second dose of GARDASIL.  No lot number was provided.  The patient sought unspecified medical attention.  Additional information has been requested.
Pain in right arm moving down toward hand. Very severe. Considered going to the emergency room. Resolved within an hour but still has some pain about a week later.
tested Covid positive; tested Covid positive; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Dec2020 at 18:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jan2021 at 18:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Nov2022, outcome "not recovered" and all described as "tested Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Nov2022) positive; (22Nov2022) negative; (27Nov2022) positive. Therapeutic measures were taken as a result of covid-19. The patient tested COVID positive on 17Nov2022 in the afternoon with a sore throat, nasal congestion, cough, fever, and body aches. Although, the patient's Urgent Care physician did not think of her as a high-risk patient and did not initially plan to order Paxlovid for the patient, after her request, the physician ordered Paxlovid. The patient finished the 5 days of paxlovid treatment on 22Nov2022 morning. The Covid test on the 22Nov2022 afternoon was negative. The patient's symptoms seemed to be better at that moment. 3 days after finishing Paxlovid treatment, she gradually felt the nasal congestion got more severe, and the body aches got worse. The symptoms do not match the Covid negative result on 22Nov2022. Then on 27Nov2022, she did a Covid test again, then realized she turned back Covid positive again. She then started isolation again. She would like to find out why she got Covid rebound even though she was fully vaccinated, healthy, and even did paxlovid treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, the reported serious events vaccination Failure and covid-19 cannot be excluded for the suspect product(s).
Initial report received from a health care professional on 28 October 2011. A 61-year-old female patient received an intramuscular injection (site not reported) of FLUZONE SV, sanofi pasteur lot number not reported, on 11 October 2011. The patient had an allergy to ZANTAC and penicillin. The patient's concomitant medications were reported as unknown. The patient had no illness at the time of vaccination. The patient reported redness and swelling at the injection site and was diagnosed with cellulitis. The next day after these symptoms appeared, the patient was itchy all over her body. The outcome was reported as unknown. Documents held by sender: None.
dizziness; Elevated blood pressure at 148/93 mmHg; Heart rate normal; Temperature normal; This is a spontaneous report from a contactable pharmacist. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via intramuscular route of administration in the left arm on 03Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021, the patient experienced dizziness. Elevated blood pressure at 148/93 mmHg. Heart rate and temp were within normal limits. 5 minutes after vaccine administration, patient reported feeling better. She denied numbness, tingling, pain, and headache. Blood pressure was 148/84 mmHg. The patient did not receive any treatment for the events. The clinical outcome of the events dizziness, blood pressure high, heart rate normal, body temperature normal was recovered on 03Mar2021.  No follow-up attempts are needed. No further information is expected.
Within 2 hours, weakness, dizziness, nausea, inability to articulate words, fever, heat behind ears, inability to lift arm the remainder of the day (opposite of injection) sore throat day two, continued waves of dizziness through days 3. Pain in opposite arm day 4.
Patient was given 0.5ml as his booster dose after a complete  2 dose Moderna series instead of the correct 0.25ml dose. Pt does not report any adverse events.
Patient fainted and seized for approximately 30 seconds and regained consciousness about a minute after. Patient felt dizzy and lightheaded.
101.5 fever 24 hours later with lethargy. 48 hours later noticed redness and swelling on entire shoulder.
PT WAS GIVEN VARIVAX ON 6/10/2008 THEN BEGAN HAVING FEVER THAT SAME EVENING MOM CALLED OFFICE ON 6/11/2008 TO STAT THAT PT FEVER WOULD NOT BREAK ADVISED MOM TO ALTERNATE TYLENOL AND MOTRIN EVERY 6HRS. MOM CALLED AGAIN ON 6/12/2008 STATING THAT THE PT WAS NOT EATING AND WAS STILL HAVING FEVER. MOM WAS ADVISED TO BRING IN PT FOR DOCTOR TO SEE. PT WAS STARTED ON ANTIBOTIC. 6/13/2008 PT FEVER WAS GREATER THAN 103.4 AX. MOM THEN TOOK PT TO HOSPITAL. PT WAS ADMITTED FOR NEUTROPENIA AND HIGH FEVER. PT WAS GIVEN IV ROCEPHIN AND WAS HOSPITALIZED FOR 5 DAYS NEUTROPHIL COUNT WAS 1285 UPON ADMISSION. AFTER DISCHARGE PT IS STILL BEING FOLLOWED TO MONITOR NEUTROPIL COUNT 7/9/08-records received for DOS 6/13-6/18/08-DC DX: acute neutropenia with high fever. Possible viral syndrome. Admitted through ED with fever of 104.5, two days after vaccination presented with temperature of 103, confusion and pulling at ears. Nasal congestion, erythema of tympanic membranes. Irritable.
17-year old M with history of recurrent ear infections requiring PE tube placement who was in his usual state of health until 5/5 when he noticed a new itchy hive-like rash. He was short of breath 5/6, and developed fevers that night along with vomiting. He was seen 5/6 with negative COVID19 PCR and documented fever to 104. Fevers continued, and he was admitted the evening of 5/10 with concern for myocarditis. See below for hospital course. Additional information for Item 18: ...Screening labs were notable for mild lymphopenia, hyperbilirubinemia, hepatitis, and elevated inflammatory markers.  Given prior COVID infection, rash, and systemic inflammation, additional studies including troponin, D-dimer, BNP, and EKG were obtained.  EKG was reassuringly normal, however the D-dimer (2.48), troponin (1.27), and BNP (469) were elevated.  Other work-up included chest x-ray which was unremarkable, and right upper quadrant ultrasound with incidental cavernous hemangioma of the liver.  He was started on milrinone (5/11-5/12) after initial TTE was concerning for severely diminished LV function. Follow-up TTE 12 hours later was normal (on milrinone), and remained so after milrinone was discontinued 5/12. Follow-up TTE after discontinuation remained normal. Cardiac MRI was completed 5/14, although read remains pending. He received IVIG on 5/11, and was started on methylpred 50 mg IV BID, Anakinra 100 mg SQ BID 5/14,  and transitioned to prednisone 30 mg PO BID with clinical improvement, down-trending troponin and systemic inflammatory labs.  Subsequent CBCs have been notable for rising leukocytosis (5/16 WBC 56.3) and thrombocytosis (5/16 plts 690) and 4+ spherocytes (with no known personal or prior history of spherocytosis). He will likely be discharged 5/17.   Infectious evaluation was unrevealing including cultures and viral studies. COVID spike and nucleocapsid antibodies were sent, but remain pending. Pt. initial COVID-19 infection was diagnosed October 2020, with positive saliva PCR testing.  He was symptomatic for 3-5 days.  He received his second dose of the Pfizer COVID19 vaccine 4/27 in his left arm; denies any significant reactions (arm swelling, injection site redness, lymphadenopathy, myalgias, fatigue, or fever). He has had passing contact with school classmates who have recently been diagnosed with COVID19.
Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and NAUSEA (Nausea) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
10 min after shot pt started complain about stomach pain and perspiring BP 60/40 pulse 70 oxygen saturation 86% pt was given oxygen by mask 4L. EMT came pt was feeling much better but was taken to ER.
Localized hive that got as large as 3 inches and was warm to the touch.  Resolved within 48 hours.
Ok so after the vaccine on 3/25/2021 on 3/26/2021 I got achy and fever. on 3/27 fever and headaches. on 3/28 sore and facial rash and groove in my face like part of my muscle had gotten removed. on 3/29 my temp went back up to 106, dizzy, nauseas, diarrhea, coughing. That is when I called the DR. I just did a telehealth conference with the DR and got no tests. My DR said it was an unusual reaction to the shot.
Excessive sweating especially at nighttime; blurry vision; headaches; increased depression and anxiety; increased depression and anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 11:00 (Lot number: EN6208) at the age of 51 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "GERD" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, reaction(s): "allergy". The following information was reported: HYPERHIDROSIS (non-serious) with onset 16Mar2021 13:00, outcome "not recovered", described as "Excessive sweating especially at nighttime"; VISION BLURRED (non-serious) with onset 16Mar2021 13:00, outcome "not recovered", described as "blurry vision"; HEADACHE (non-serious) with onset 16Mar2021 13:00, outcome "not recovered", described as "headaches"; DEPRESSION (non-serious), ANXIETY (non-serious) all with onset 16Mar2021 13:00, outcome "not recovered" and all described as "increased depression and anxiety". The events "excessive sweating especially at nighttime", "blurry vision", "headaches", "increased depression and anxiety" and "increased depression and anxiety" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hyperhidrosis, vision blurred, headache, depression, anxiety. Additional information: Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. Patient had administered in arm right, administration date 06Apr2021 13:00 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Patient underwent treatment as Medication and instruction. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, patient had covid test post vaccination via nasal swab and result as Negative. No follow-up attempts are possible. No further information is expected.
Around 8 pm on the date of my vaccine, I went to bed and woke up around 7 pm the following day. I woke up maybe three times for a duration of 15 minutes each time during this period. When I got up, I felt really dehydrated. I drank water and ate a meal.  Event that was reported to me but that I do not recall: Afterward, I got in the shower, where I felt lightheaded and experienced darkening vision. I tried to exit the shower but fainted. I did not lose consciousness. A family member heard me fall and came to help. As I was exiting the showering, I couldn't stand and got down on my hands and knees. Then I lost consciousness while my eyes remained fully open and very wide. I was holding my head up and staring straight forward. I made a grunting noise and shook a little before vomiting. Shortly after, my eyes rolled to the back of my head before closing and then I lowered my head. I regained consciousness shortly thereafter and was not aware of what occurred. Though, I do remember vomiting. I am told that I was unconscious for 2-3 minutes. I didn't experience any issues after this.
I had muscle aches in the left upper arm that started a couple of days after vaccination. They occurred early morning and late afternoon. About two days later, I had muscle aches in my leg and right arm, but they went away after about 24 hours. The muscle aches in my left arm came and went for about two weeks. I told my doctor about it, but she didn't do any treatment. I rotated the arm to try to ease the pain. It finally went away on its own.
Patient was waiting in the waiting area for 6 minutes after getting the pfizer covid vaccine when she started to feel like she was going to faint. Her mom was with her. Her mom had already given her a snack when I was notified. Pt stated her vision was blurry and her hearing was "like she was in a tunnel". She was feeling cold and was feeling scared of that feeling. I asked if I could apply a cold pack and asked her to rest the back of her head against the wall and to close her eyes. I applied the cold pack to her forehead and observed her. She started to sweat and was calmer. She was feeling better and her hearing and vision was back to normal. I had her wait for a total of 30 minutes and had my technician stay with her at that time. She was feeling better and I asked her mom to hang on to her while walking to their car. I followed up with the patient 4 hours later and she was doing well. She said she was feeling well and her arm was not even sore just some fatigue.
THE PATIENT EXPERIENCED BLEEDING AND SWELLING IMMEDIATELY AFTER INJECTION, WHICH WAS NOT COMMON FOR THE PATIENT. THE PATIENT AND HIS DOCTOR WERE WORRIED ABOUT HAVING THE PRODUCT LEAKED INTO THE SUBCUTANEOUS TISSUE AND WANTED AND ADDITIONAL DOSE. BOTH THE PHARMACIST AND THE PATIENT SPOKE WITH THE CLINICAL SPECIALIST OF THE PHARMACY AND  ADDITIONAL BOOSTER WAS GIVEN
Severe head pain in temporal region, posterior neck pain, light side more than right; left sided facial flushing;  chronic migraine with nausea on/off for seven days straight. Unable to do normal daily activities.
Developed chickenpox 3-4 years after exposure to sibling who also had varicella vaccine.
I started having fever, loss of taste and smell, chills. I got tested for COVID on 08/31/2021 and it came back positive. I took some medications to help with the symptoms.
Chills, fever, muscle soreness, and stiffness, fatigue, difficulty sleeping, lack of appetite, headache between 2/7/2020 at 1800-1200 on 02/28/2020. Took Ibuprofen every 4hr and increased liquid intake.
Patient had been feeling dyspneic for 1.5 weeks to 1 month prior to his death on 2/28/21.  He received vaccine on 2/25/21.  On his family found him leaning on the couch with eyes rolled back and foaming at the mouth. He was making noises  (like grunting sounds?). EMS was called. He had cardiac arrest while in ambulance enroute to EMS. Resuscitation efforts continued in ED. Family was informed about his status and resuscitation efforts were stopped.
I received the johnson and johnson vaccine. I had an abscess tooth and I had taken 4 days of antibiotics. The johnson and johnson shot made me feel dizzy and I got so stiff that I could not walk. I was shuffling my feet to get anywhere. I would fall all on my bad and then gradually move my self by holding onto the head bead to actually get in the bed. This lasted 2 days and I had stopped taking the antibiotic because I felt so ill from the shot. I then began vomiting. My entire body hurt it felt like every cell in my body was transforming and the pain was unreal I was so weak I couldn?t open a water bottle
Approximately 1 and 1/2 hours after the injection, her tongue became thick, lips swelled, chest pain, short of breath and headache. Injections site was red and swollen. She was traveling out of town  and called an urgent care and was advised to take  50 mg of Benadryl q 4 hours till swelling was gone. She took it for 4 days. She saw here PCP on 12/21/2020.
Headache, Myalgia, fatigue Narrative: missed work following second dose due to fatigue
no adverse event; expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 56-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    Patient 's age was reported as 56 year 1 month. ID was reported as 80777027399. No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2022: Live Significant Follow up completion date and patient age month updated.
Pt recvd vax & exp hypotension, lightheadedness, & tachycardia 2 1/2 hrs p/vax;