chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Executive dysfunction; symptoms were back; Scatter brain; Mood swings; Inflammation; Angry; Anxiety; Pain; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of EXECUTIVE DYSFUNCTION (Executive dysfunction), GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings) and INFLAMMATION (Inflammation) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Drug allergy (Manifested to hives and lip swelling.), Fibromyalgia, GERD, Tobacco user (VAPE) since 2007, Alcohol use (One Wine once a month.) since 2009, Neuropathy and Rheumatoid arthritis.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced EXECUTIVE DYSFUNCTION (Executive dysfunction), GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings), INFLAMMATION (Inflammation), ANGER (Angry), ANXIETY (Anxiety), PAIN (Pain) and TREMOR (Shaking). At the time of the report, EXECUTIVE DYSFUNCTION (Executive dysfunction) had resolved and GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings), INFLAMMATION (Inflammation), ANGER (Angry), ANXIETY (Anxiety), PAIN (Pain) and TREMOR (Shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Laboratory test: results not reported Results not reported. On an unknown date, X-ray: inflammed Inflammed.         Concomitant medication information was not provided by the reporter.  The de-challenge results for event Executive dysfunction (Humira) was reported as Yes. The reporter's causality for the events of executive dysfunction, scatter brain, mood swings, angry, anxiety and shaking with Humira 40mg/0.4 mL (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of symptoms were back was not provided. The reporter's causality for the events of inflammation and pain with Humira 40mg/0.4 mL (ADALIMUMAB) was a no reasonable possibility. It was reported that it was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided by the reporter.
HOT, SWOLLEN ARM UP TO SHOULDER. FEEL BLISTERS COMING ON.
Patient was awoken early in the morning by pain in her upper back/chest area on the left side between her collar bone and scapula (same side as the injection). She said it was 6/10 on a pain scale and was running up the left side of her neck and down her arm. It felt like nerve pain. She was able to continue with her day but it was bothering her. By evening the pain had increased to 7/10. She took 2 Advil/Ibuprofen before bed which she said took the pain down very little. She was able to sleep and the next morning the pain was down to 1/10 and was more concentrated behind her scapula. By that evening the pain had completely disappeared and hasn't returned. She had no other side effects, other than soreness at the injection site.
Breakthrough case admission after 2 vaccines Pfizer 3/30/21  lot# ER8730;  04/20/21 Pfizer lot# Ew0162
Booster dose given 3 days post 30 day refrigerator storage shelf life. Refrigerator shelf life was to end at end of day on 10/20/22. Vaccine given on 10/24/22.
Broke out w/mild hives on left inner arm approximately 10 hours after injection.  Hives spread to torso and both arms.  Took Q-Dryl antihistamine 25 mg and hour after the hives started.  Relieved the situation but hives returned about 10 hours later.  Hives were present on arms. torso, buttocks.    Took another antihistamine a few hours later; hives returned on arms, left hand and torso; also felt nauseous  Have had no hives since  Monday, Jan 18th about 8:00 PM.
Temperature today which was102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature today which was102 degrees) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN and VITAMINS NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Temperature today which was102 degrees). At the time of the report, PYREXIA (Temperature today which was102 degrees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medicine.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Tinnitus presented approximately 3 days after 2nd dose.  High pitch ringing that was constant for 4 month, after which it started to diminish in frequency and duration.   Received booster, moderna (lot # 027H21B) on 11/21/21.  Tinnitus presented 1 day after 3rd dose, currently much louder and higher pitched than the first time with no breaks.
shingles; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. In 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: all symptoms resolved after 20 minutes
Paralysis affecting left arm, leg and facial features. Hospitalized after Dr's office visit on 11/11/02. Parents told two blood clots in brain. Treatment-physical therapy one baby aspirin daily. Diagnosed with opening between atria of heart. Being treated for mitochondrial defect and blood clotting disorders. In process of recovery. On 60-day followup report received 04/25/2003, reporter states, "Patient was tested at facility after Vx and they found a hole in his heart and said it was not Vx-related. Pt is going back to facility in 5 months to see if hole in heart has closed."  Annual follow up on 04/21/04: "Pt has recovered from adverse event."
5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16-Dec-2021 vial was initially stored in the refrigerator. 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15-Jan-2022.  The vial did not undergone any temperature excursions.  Concomitant medication was not provided.  Treatment information was not provided.
moderate intensity myalgias and arthralgias; moderate intensity myalgias and arthralgias; fatigue; headache; I have been having difficulty with routine activities due to pain; I have been having difficulty with routine activities due to pain; pain at the lumbosacral area; ESR elevated; ANA is positive; This is a spontaneous report from a contactable physician (patient).  A 41-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EL1283), on 05Jan2021 at single dose in left arm for COVID-19 immunisation at hospital. Medical history included rhinitis allergic and eczema. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and ethinylestradiol, norgestimate (TRINESSA). The patient previously took ciprofloxacin hydrochloride (SPECTRA) and experienced drug hypersensitivity. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EH9899) on 16Dec2020 at 09:00 for COVID-19 immunisation in the left arm and experienced myalgia, arthralgia, fatigue and headache. After the second dose on unspecified date in Jan2021 the patient developed moderate intensity myalgias and arthralgias, also significant fatigue and headache. The patient waited the 2-3 days after vaccination to see if adverse reaction improved, and it improved at the third day, but unfortunately the same symptoms started again one week after second dose of vaccine and have no improved. The patient had symmetric polyarthralgias affecting her hands, wrist, knees, ankles. She had been having difficulty with routine activities due to pain. Also pain at the lumbosacral area. Also have myalgias and fatigue affecting her work and routine activities. The patient also had a mild HA. The patient underwent laboratories after symptoms began again and CBC, CMP, CK, RF, Anti-CCP and TSH are WNL. But, ANA was positive which in the past was negative and have a ESR borderline elevated for her age. The patient was going to see a rheumatologist, but all this that she was feeling coincides with the vaccination for COVID 19. The outcome of the events was not recovered, no treatment was performed.
R arm pain w/in 1 hour of immunization. Several hours later developed sever headache, located behind her eyes.  Able to sleep overnight, but awoke w/ more severe headache, neck & occipital pain, described as "the worst headache I've ever had."  Was dizzy & disoriented, and described that her vision didn't seem normal.  Was taken to the ER at Hospital, where she received a "migraine cocktail" of IV fluids, Toradol, Benadryl, & Compazine.  She was eventually able to sleep, slept x 15 hours, then was better the following day.
This spontaneous case reported by an other healthcare professional, describes the occurrence of headache (slight headache that went away) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. In January 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In January 2021, patient experienced headache (slight headache that went away). At the time of the report, headache (slight headache that went away): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient received the 1st dose of Moderna COVID-19 vaccine on last week of Jan 2021. She had experienced slight headache that went away. Patient's dose given at a local healthcare facility. This case linked to MOD-2022-440584 (patient link).
0955-Tdap and MCV administered as below in #13. 1000 - Patient began to look pale, became cold and clammy, weak, and upper extremities began to jerk involuntarily. B/P-60/46, HR-52, RR-16. Placed head down between legs. 1015 - B/P-90/60, HR-62, RR-17. "Feeling better."
Reddened area approx. 3 inches in diameter, hot to touch, very firm to touch.  Pt. c/o "hurts" but no itching.
pt states after she received 2nd vaccine of gardasil she continues with a rash on her body.Saw  PCP doctor was then referred to dermatologist were contact dermitis was discussed with pt.
Headache, numbness in feet and toes. Sweating, diarrhea, nausea. Dizziness. anxiety. Insomnia.
Site: Pain at Injection Site-Severe, Additional Details: patient called stating he has severe pain at site of injection. discovered that patient received a 2nd flu shot a week after his 1st flu shot. counseled patient to take tylenol and apply cold compress to site of injection.
Pt had IMMOVAX and Yellow Fever vaccine 1-23-2004. Next morning had episode of dizziness, difficulty walking. Over next 10 days had episode of dizziness 1-2x/day. Now resolved.
Had breakthrough covid July 11,2021. Spent three days in hospital, no vent. About a month later after assumed recovery, had severe shortness of breath. Cardiologist performed ultrasound on heart - heart was good; he upped my doage of lasix, seemingly improving the shortness of breath.  A few weeks later, I noticed the shortness of breath was still in existence after light exertion. Covid booster - 9/21/2021 - felt bad after the covid booster.  Took to bed the next day.  Felt better day after that.
09/03/2019 at 1430pm-swelling at injection site, numbness, tingling, threw up x4 on night of 09/03/2019. intense body aches, pain to shoulder, lats, and ribs. stiffness to shoulder, lats and right arm. limited mobilities for right arm.
This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 17-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Approx 2 yrs ago pt began series of 3 Engerix-B vax on a regular dosing schedule (exact dates unk); pt waited for 2 yrs for a titer to be performed & when it was performed results were neg; pt will get booster;
Mental confusion, exhaustion, aggression, forgetfulness, constant daytime sleepiness, foggy brain  and heart palpitations
Rash noticed 12 days after vaccination. Urticaria on face, maculopapular rash on trunk and upper arms. No other symptoms.
Abnormal lymph glands under my arm; Initial information received on 25-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported abnormal lymph glands under my arm while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "abnormal lymph glands under my arm" (biopsy lymph gland abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I have abnormal lymph glands under my armfound 3 days after flu shot. Have to go in for another scan. Radiologist said they see this a lot with Covid vaccinations. As it is, I hope the lymph gland condition is temporary".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Abnormal lymph glands under my arm).  At time of reporting, the outcome was Unknown for the event abnormal lymph glands under my arm.
Felt like Novocaine was injected in lips and tongue, difficulty swallowing, racing heart. The racing heart lasted for approximately 60 minutes while the numbness and swallowing issues lasted for approximately three hours.
Tough, red, itchy, warm circle around the area of the injection sight.  The area continues to increase by the day.  It has now been 10 days since the vaccine and the area is the size of a small apple.
Hard swelling; Painful; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Hard swelling) and PAIN (Painful) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs), Allergy to antibiotic (Ciprofloxacin), Allergy to antibiotic (Celebrex), Allergy to antibiotic (Betadyne), Soy allergy, Contrast media allergy (Contrast dye), Food allergy (Wheat), Fish allergy, Shellfish allergy and Bee sting.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced SWELLING (Hard swelling) and PAIN (Painful). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency; NAPROXEN (NAPROSYN E) for Adverse reaction, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency. On 10-Sep-2021, SWELLING (Hard swelling) was resolving. At the time of the report, PAIN (Painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant were provided.
Information has been received from a registered nurse concerning her 13 year old daughter with no pertinent medical history and no known drug allergies, who was vaccinated with the first dose of GARDASIL (0.5ml, IM, lot # unknown) on 31-JUL-2008, the second dose (0.5ml, IM, lot # unknown) on 24-NOV-2008 and the third dose (0.5ml, IM, lot # unknown) on 12-MAR-2009. There was no concomitant medication. On 16-AUG-2009 the patient experienced a headache above her left eye. About 30 to 45 minutes after the start of headache she experienced numbness on the right side of her tongue and face which lasted 1 to 3 hours. Prior to the onset of headache she felt a "little out of it". She was examined in the emergency department on 16-AUG-2009. She was treated with ibuprofen. On 17-AUG-2009 she was examined by a neurologist. Labs and diagnostic tests included CT scan and lab work (results not reported). The patient recovered on 18-AUG-2009. Additional information has been requested.
pt had previous positive COVID test on 8/18/21; to hosp ED on 8/22/21 due to SOB; O2 sats 80% on RA; placed on 100% NRB; chest x-ray  showed bilateral pneumonia; transferred to ICU; acute hypoxemia due to COVID pneumonia; Decadron, Remdesivir, baricitinib, Lovenox; eventually required intubation with mechanical ventilation; MRSA bacterium found in sputum; antibiotic changed; pt's condition worsened; hypotensive; family decided to make pt DNR/DNI, comfort care; pt passed away in the hospital
Very tired for three days. Difficulty thinking for three days.  Fever and chills the next day.
Pt recvd 3 doses of Engerix-B vax & titers were checkked 6 months p/last dose & titer result was neg;
pain in his eye sockets that is ongoing; nausea; feeling yucky for a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Mar2021 13:00 (Lot number: EN6208) at the age of 70 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EYE PAIN (non-serious) with onset 23Mar2021, outcome "recovering", described as "pain in his eye sockets that is ongoing"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (26Mar2021), described as "nausea"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "feeling yucky for a few days". Additional information: The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
More pain than usual for vaccinations at injection site noticed about six hours after injection. Minor to moderate fatigue and malaise, along with minor body aches noticed about eight hours after injection. Those symptoms decreased overnight and, except for injection-site pain, were mild for the first few hours of the morning, but increased again later in the morning, about 22 hours after injection. The symptoms at this point were moderate fatigue and malaise, minor to moderate body aches (especially in lower back), and slight headache. Injection site pain remained moderate, feeling like a bad muscle bruise, but without swelling or discoloration. Symptoms persisted at this level until sometime after bed, about 35 hours after injection. Aside from injection site pain (now minor), Symptoms largely resolved by morning, about 46 hours after injection. Slight injection site pain remaining about 72 hours after injection, but no other symptoms.
Stomach cramps; Gas; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Er8737) via an unspecified route of administration on 17Apr2021 at 10:00 (at the age of 61-years-old) in left arm as a single dose for covid-19 immunization. Medical history included anxiety, hypertension, and penicillin allergy all from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications included lisinopril (LISINOPRIL) and propranolol (PROPRANOLOL) both taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number=Ep6955) on 27Mar2021 at 10:00 in left arm for covid-19 immunization. The patient experienced stomach cramps, gas, and diarrhoea on 17Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated, and he was seeking treatment appt next Thursday. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.