chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bit more tired than usual; Running a temp of 100.7; Sick to my stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to my stomach), FATIGUE (Bit more tired than usual) and PYREXIA (Running a temp of 100.7) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 15-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to my stomach) and PYREXIA (Running a temp of 100.7 F). On an unknown date, the patient experienced FATIGUE (Bit more tired than usual). At the time of the report, ABDOMINAL DISCOMFORT (Sick to my stomach) and PYREXIA (Running a temp of 100.7F ) had resolved and FATIGUE (Bit more tired than usual) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 F (High) High.         No concomitant products were reported. No treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: The outcome of event (sick to my stomach and running a temp of 100.7 F) updated to recovered/resolved and newevent (bit more tired than usual) added.
Developed cellulitis at the injection site. treated with Keflex. redness and swelling at injection site
Burning feeling in the left wrist. Throbbing from left wrist moving down to left hand.  Lasted 30-45 minutes. Started within one hour after the vaccine administration. Sensations subsided afterwards.
Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Vial moved from freezer to refrigerator on 3-MAR-2022. The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022. Treatment information was not reported.
Red indurated warm painful (R) deltoid. Doxycycline 2 x 1 day x 7 d. BENADRYL 25 mg 2 x day x 2 days.
Vaccine administered after more than 30 days in the refrigerator; Vaccine administered after more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.   This case was linked to MOD-2021-279679 (Patient Link).   Reporter did not allow further contact
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 16-year-old female patient who received BEXSERO (batch number 153701A, expiry date 20th APRIL 2017). Concomitant products included MENACTRA. On 8th JUNE 2016, the patient received the 1st dose of BEXSERO (intramuscular). In June 2016, less that a month after receiving BEXSERO, the patient experienced injection site pain, injected limb mobility decreased, vaccine administered at inappropriate site and labeled drug-drug interaction medication error. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved and the outcome of the vaccine administered at inappropriate site and labeled drug-drug interaction medication error were unknown.  The reporter considered the injection site paint and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was reported by a licensed practical nurse. On 8th JUNE 2016, the patient received BEXSERO and MENACTRA in left arm, which led vaccine administered at inappropriate site and labeled drug-drug interaction medication error. The reporter stated that, the patient experienced sore arm and unable to lift arm after receiving BEXSERO at 18:30 in left arm. The patient advised the physician's office of the reported events but still received her second injection in this series on 8th AUGUST 2016. IT was reported that no events were associated with 2nd dose of vaccine. The case is one of the three cases reported by the same reporter.
Was vaccinated on 3-11-2019. Woke up the next morning with a temperature 101.3 and a sore throat.  Negative strep test. Unable to rule out fever being an adverse reaction of vaccine. Was told to take Tylenol and Motrin to control the fever.
There was some blood at the injection site; Fluzone Quadrivalent prefilled syringe that leaked from where the needle attaches; the patient did not get the full dose; Initial information regarding an unsolicited valid non-serious case received from a pharmacist and transmitted to Sanofi on 09-Oct-2019.  This case involves a male patient of unknown age for whom it was reported that Fluzone Quadrivalent prefilled syringe that leaked (Preferred term: Syringe issue) from where the needle attaches so that the patient did not get the full dose (Preferred term: Underdose), and some of the vaccine ran down the patient's arm and there was some blood at the injection site (Preferred term: Vaccination site haemorrhage), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment, vaccination and family history were not provided.   No concomitant medication was reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6681LA and expiration date: 30-Jun-2020) via unknown route in unknown administration site.  On an unknown date (latency unknown) after vaccination it was reported that Fluzone Quadrivalent prefilled syringe that leaked (Preferred term: Syringe issue) from where the needle attaches so that the patient did not get the full dose (Preferred term: underdose), and some of the vaccine ran down the patient's arm and there was some blood at the injection site (Preferred term: Vaccination site haemorrhage).  Final diagnosis was Not Applicable the patient did not get the full dose, Not Applicable fluzone quadrivalent prefilled syringe that leaked from where the needle attaches and there was some blood at the injection site.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for Vaccination site haemorrhage and as not applicable for rest of the events.
pt recv vax 23MAR98 & 24MAR98 pt devel itchy diffuse red rash over arms, trunk, & feet;
The pt developed a large area from shoulder to elbow that was swollen to 2 X normal, erythematous and tender; blotchy with large local reaction. No distant hives or systemic symptoms. Recovery pending.
discontinue GARDASIL-9 after receiving one dose in order for him to receive surgery.; This spontaneous report as received from a patient's mother refers to a 22 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (1 dosage form [reported as one dose], 3 dosage schedule, route, strength, batch/lot # and expiration date were not reported) for prophylaxis.         On an unknown date, the patient had to discontinue hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) after receiving one dose in order for him to receive surgery (Surgery). The reporter inquired if her son would experience any adverse effects, aside from the common side effects, if he started taking hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) again.   Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued. The outcome of surgery was unknown.   The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and surgery was not reported.
Pt received dose 2 of HPV. RN asked screening questions no contraindications noted. 0905 am Administered HPV while client was sitting in chair. After vaccine administered client stood up so sibling could receive vaccines. Nurse asked father if he would like children to receive fluoride treatment for children and he stated yes. Nurse asked client if she would like to sit while she did fluoride she stated no she would stand. Nurse asked client to smile , client had blank stare. Nurse asked if she was okay, client stated her head, her arms stiffened and started to fall to floor. Nurse grabbed client in arms hug like position and lowered her to the floor. Client had seizure like activity for approx. 30-45 seconds. Client was pale and disoriented. RN came into room and had clerk call for ambulance, she  got BP cuff and RN took BP, 142/84. Police and EMS arrived client was transported to hospital.
"I" have a consistent 30 day menses cycle which is now four days late, and may be a missed cycle; This is a spontaneous report from a contactable consumer, the patient. A 32-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 left arm on 16Apr2021 at 07:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The medical history included Irregular menstrual cycle (an interrupted cycle before as a result of receiving other powerful vaccines in the past). 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. The patient did not receive any concomitant medications. On 22Apr2021, the patient had a consistent 30-day menses cycle which was now four days late, and may be a missed cycle. Because the patient was extremely consistent in tracking her menses, she noticed the change this month. The patient reported that she was not pregnant and had not been sexually active. She had not received any treatments or medications since her last cycle except the Pfizer vaccine and when she had to face a missed cycle. The patient reported that she always looked at medications or physical illness as a cause. The patient experienced an interrupted cycle before as a result of receiving other powerful vaccines in the past and she believe women need to be told that they could have an unexpected interruption in their cycles as a result of the vaccine. As the patient was going to receive her second dose soon, this could mean at least two months of irregularities or longer. 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 events consistent 30-day menses cycle which was now four days late, and may be a missed cycle was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient presents today with a several day history of increasing SOB and non productive cough. She reports recently taking doxycycline and prednisone for bronchitis and subsequently being treated for thrush yesterday. She has known COPD and monitors her 02 sats at home. Over the past couple of days her sats have been in the low 80's (83% on admission), usually in the low to mid 90's. No fever or chills. Her oral intake has been poor the last couple of days. No nausea, vomiting or other abdominal symptoms. In TEC her Ddimer was elevated at 2086, CTA negative for PE however chronic emphysematous changes and lower opacities consistent with COVID.
On the left side of my body I have a giant lump under my arm that I received my vaccine in. I am also having some issues with my retina on my left side. I am still going through this at this time.
Chills for two days after the first vaccine.  rash on right foot and right arm after the second vaccine which lasted several days and then dried up.  At that point I had cold sweats and chills which started today about 10 AM.  I texted Dr. who advised me that the rash should disappear in a few days.  She was correct and a couple of days later texted that she had no concerns about the cold sweat and chills.
Information has been received from an Optometrist concerning an approximately 11 year old female patient with no known drug reactions/allergies or pertinent medical history who "about 2-3 weeks ago", on approximately 17-SEP-2009, was vaccinated with her second dose of GARDASIL. There was no concomitant medication. The Optometrist reported that on an unspecified date during the examination she observed the patient optic nerve swelling. A recent magnetic resonance imaging was negative. It was noted that the patient was seen due to a request of contact lenses. During the examination the Optometrist observed the optic nerve swelling. The patient had not received any treatment for the optic nerve swelling. At the time of the report the patient had not had any symptoms and her vision had not been impaired in any way but the optic nerve swelling persisted. The Optometrist did not know the cause of the swelling and would continue to monitor the patient. The Optometrist contacted during telephone follow-up could not supply the following information: dates of vaccination and lot numbers. Additional information has been requested.
Tinnitus constant loud buzzing; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL9265), via an unspecified route of administration in the left arm on 12Feb2021 at 20:00 (at the age of 67-year-old) as first dose, single for COVID-19 immunization. On 12Mar2021, Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot no: EN6206; Dose number: 2nd dose), via an unspecified route of administration in the left arm. The patient was not pregnant at the time of report. The Patient's Medical history included diabetes, polymyalgia rheumatica, giant cell arteritis, thyroid. The patient did not have any allergies to medications, food or other products. Concomitant medications included methotrexate Injection (manufacturer unknown), dulaglutide (Trulicity), levothyroxine (manufacturer unknown). 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 12Feb2021, patient experienced Tinnitus constant loud buzzing. The event assessed as non-serious. No treatment was received for the event. The clinical outcome of the Tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality checked of reporter, correspondence contact in slide#2, Occupation was updated from Other HCP to physician; Health care professional leave blank; "MD" was added as suffix, Patient's demographics updated (name, age/unit, Country), RMH: "giant cell arteritis" was added, RMH# 01 verbatim was updated as Thyroid, Second dose was removed from suspect product tab and was keep in narrative, Best doctor/Health care professional information added in vaccince administration tab, Vaccination facility information added, treatment information added, Concomitant therapy leave blank since the concomitant drugs were coded in product tab, event onset date/time was updated from "12FEB2021 00:00" to 12FEB2021 20:00.
I had the Moderna booster and got hives the following day. About a week later, a rash began on my ankles. It has spread through my entire body. Dermatologist said it is granuloma annulare. I am treating with cream but new lesions surface and do not see much improvement after months of treatment.
Patient is complaining of left arm achiness and soreness and decreased range of motion since getting her flu shot. Pain upon lifting arm over should height, difficulty in carrying heavier items in left hand due to pain radiating in the arm at injection site.
This case was reported by a nurse and described the occurrence of fever in a 6 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 07/28/2004, the patient received the third dose of Infanrix.  At an unspecified time following the administration of Infanrix, on 07/28/2004, the patient experienced fever and fussiness.  The patient was treated with acetaminophen.  The outcome of the events is unknown.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046D21A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis C in 2015. Previously administered products included for Hepatitis C: Harvoni. Past adverse reactions to the above products included No adverse event with Harvoni. Concurrent medical conditions included Arthritis.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient never had positive COVID-19 test or diagnosis. No Concomitant information was reported. No Treatment information was reported.   This case was linked to MOD-2022-498505 (Patient Link).
On 12/30/2020, I experienced extreme abdominal pain and cramping, diarrhea that resulted in syncope, severe fatigue, injection site pain and swelling, nausea, dizziness, lethargy, apathy.  These symptoms lasted for over a week. The only syncope episode was the morning after the vaccine.
Mild but very high pitched tinnitus in the right ear - new symptom.  Lasted for 36 hours so far (on and off but mostly on).
The day after the vaccination, I was very sick with flu-like symptoms including exhaustion, chills, and a headache.  At the date of my vaccination, my ulcerative colitis was in remission. A few weeks after the vaccination, I had severe inflammation in my body which triggered an episode of ulcerative colitis. I was limited on my ability to leave my house. I went to to bi-weekly acupuncture appointments which helped reduce the inflammation. I also, went to a holistic doctor that put me on a special diet. My symptoms included severe stomach problems, chills, joint pain, mouth ulcers, weight loss, and exhaustion.
Headache first day. 2nd day headache nausea,  vomiting, headache, full body aches, fatigue, soreness at injection site. 3rd day no headache, buy still pain in Lower back and neck, soreness/ burning pain at injection site. In total headache lasted about  24 hours.
Passed out; Broke a tooth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and TOOTH INJURY (Broke a tooth). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) and TOOTH INJURY (Broke a tooth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned   no treatment medication information was mentioned   Additional information mentioned that the patient had a reaction to the vaccine where she passed out and broke a tooth.  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.; 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.
Sore muscles , 3rd day being very dizzy and falling, 4 th day can?t stand without my body wanting to go back or forth like I want to fall down. Getting ready to go checked by a doctor