chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Couldn't eat.; Back was sore; Nausea; Fever of 100.9F; Felt achy all over; sore arm at injection site for a day; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER SYMPTOM (Couldn't eat.), PAIN (Back was sore), INJECTION SITE PAIN (sore arm at injection site for a day), NAUSEA (Nausea) and PYREXIA (Fever of 100.9F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had mild form of Covid 19,not hospitalized.) in November 2020.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE PAIN (sore arm at injection site for a day). On 14-Mar-2021, the patient experienced EATING DISORDER SYMPTOM (Couldn't eat.), PAIN (Back was sore), NAUSEA (Nausea), PYREXIA (Fever of 100.9F) and MYALGIA (Felt achy all over). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, INJECTION SITE PAIN (sore arm at injection site for a day) had resolved. On 15-Mar-2021, EATING DISORDER SYMPTOM (Couldn't eat.), PAIN (Back was sore), NAUSEA (Nausea), PYREXIA (Fever of 100.9F) and MYALGIA (Felt achy all over) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 100.9 (High) Fever at 100.9 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided.
This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (No adverse reaction other than mild reaction) in a 60-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Concurrent medical conditions included Hypertension, Arterial calcification (arterial calcium buildup) and Drug allergy (unspecified drug). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 01-Aug-2021 to an unknown date and AMLODIPINE from 01-Sep-2021 to an unknown date for an unknown indication. On 22-Apr-2022 at 12:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Apr-2022, the patient experienced IMMUNISATION REACTION (No adverse reaction other than mild reaction). At the time of the report, IMMUNISATION REACTION (No adverse reaction other than mild reaction) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Pfizer was reported with indication of Treatment of COVID-19 used from 8-AUG-2022 to 12-AUG-2022. No treatment information was reported . Device Date was reported as 22-Aug-2022.
Pain in arm, elbow and rotator cuff of injection site (left arm),  progressive worsening to 01/12/2014  with intense pain such that I could not lift arm, grasp objects or find relief.  Have some relief now with lidoderm patch over injection site and across elbow.
PAINFUL ARM WITH NO SWELLING OR REDNESS MORE THAN A MONTH AFTER ADMINISTRATION
This spontaneous report as received from a nurse refers to a patient of unknown age. No infromation about medical history, concurrent conditions and concomitant were reported. The reporter stated that the patient was vaccinated with first dose of GARDASIL (dose strength, route not reproted) on 17-OCT-2013, the 2nd dose of GARDASIL on 07-JAN-2014. It was reproted that patient was seen in the office on 28-JUL-2014 and was getting 3rd dose of GARDASIL. No adverse effects reproted. The outcome of events reported is unknown. No product quality complaint was involved. Addtional information has been requested.
PFIZER 2nd dose. After waiting 15 minutes, started feeling dizzy, feeling a ringing sound in the ear and dots. Manager was told and I sat her down in the vaccination office with legs raised in another chair and with a cold pack in the back of her head. She said that her arm felt sleep and that she has a strong headache. White code was thrown, and the assistant arrived at the pharmacy. Patient was conscious, alert and would respond to all my questions all the time. We called her husband  to come and pick her up. Mean while she was not feeling better so I laid her down on the floor with legs elevated using a chair and a cold pack on the back of her head. She started to feel better (the ringing in the ear went away and vision dots). She did not have a numb arm anymore, only a strong headache but was able to sit and walk to the exit with the assistant, until her husband came (garden exit). All this happened between 5:50 and 6:40pm.
Patient experienced chills and fever for hours, Nausea with dry heaves, Diarrhea, severe Headache, Dizziness , staggering gait, myalgia causing difficulty in raising her or moving left arm---patient advised that she could treat signs and symptoms, which started 11pm the night before and continued at time of her call to the office to report adverse reactions at 10 am on 6/30/21
Guillain Barré syndrome-spinal tap. 3/3 weight loss, no appetite, pain in legs, inability to hold items in hand. 2/03 sore throat. 60 day follow up states pt has not recovered. Can not lift arms above shoulder level. Can not rise onto toes.
After 4th dose, I felt my heart beat differently. From the previous vaccines, I was okay. Starting in September I started my heart beat very high, blood pressure was high as well. In November 2022 I was admitted to the hospital I was a week in there. The doctors performed on me a catheterization. Again April 7th, 2023 the doctors performed an on me Ablation. I am feeling much better but very weak. Please guide me on what to do. Thank you. May God bless you.
MEDICAL HISTORY (Patient): The patient's past medical history included Alcoholic (1 drink/ week ,patient stop drinking on 01-Jul-2020) in 2011, Pregnancy (live full term birth) on 08-May-2016, Pregnancy (live full term birth) on 27-Feb-2018 and Miscarriage on 18-Jun-2020. Concomitant products included Colace for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, VITAMIN D NOS for Prevention, FAMOTIDINE (PEPCID AC) for Reflux esophagitis.   On 05-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 10:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 18-Jun-2020 and the estimated date of delivery was 31-Mar-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, Ultrasound antenatal screen normal: normal (normal) normal. On 16-Dec-2020, Glucose tolerance test: normal (normal) normal. On 03-Feb-2021, Ultrasound antenatal screen normal: normal (normal) normal.         Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: internal review on 21-JUL-2021 to update analysis and patient pregnancy details. On 25-Jun-2021: follow-up received on 25-Jun-2021 contains no new information
Information has been received from a physician concerning a patient with liver disease (unspecified) who was vaccinated IM with a dose of 0.5 ml PNEUMOVAX 23 in the left or right deltoid "within the last 2 months." The physician reported that the patient experienced a severe injection site reaction which impaired the use of the injection site arm (could not lift for 3 to 4 days). The patient sought medical attention and contacted the physician. At the time of the report, the patient recovered. The reporting physician considered injection site reaction and impaired use of injection site arm, (could not lift) to be disabling. This is one of several reports received from the same source. Additional information has been requested.
Patient reported a large, hard lump near bicep of vaccination arm that occurred the day following vaccination.
Report A0369656A described a 12 y.o. female who experienced an inject site reaction after receiving Hep B vaccine recombinant (Engerix-B). The medical history included juvenile rheumatoid arthritis. The PT was allergic to naproxen (Naprosyn). Concurrent medications included rofecoxib (Vioxx), minocycline, and ethinylestradiol/ noresthisterone (Necon). On 4/12/02, the vaccinee received her first injection of Engerix-B (lot ENG5167A2; expiry, 6/9/02). On approximately 5/3/02, she experienced inject site tenderness and "could not move her arm." She was seen by the rheumatologist (findings unknown). On 5/20/02, the vaccinee received her 2nd injection of Engerix-B (lot ENG5167A2; expiry 6/9/02). On 5/23/02, she again experienced tenderness at the inject site and "could not move arm." She returned to the pediatrician's office (findings unknown). The reporter stated that the events could have been associated w/the subject's juvenile rheumatoid arthritis. The events revolved on 5/24/02.
I had the flu; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (Patient) via global digital media through social media.  This case involves a patient (unknown age and gender) who felt like had the flu (influenza), while the patient received vaccine Influenza vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.   On an unknown date of 2019 (reported as one year ago) , the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient felt like had the flu (influenza) and  never again would the patient took the shot.  Additionally it was reported to the patient flu shot was the best way to help protect the virus  and the patient probably sniffles after a flu shot not the flu .  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
No adverse events, treatments, or adverse outcome occurred. This submission is being generated due to an administration error. Mr. received a booster dose prior to 6 months. First dose of the COVID-19 vaccine was on 06/18/2021 (Moderna) and the second dose was on 07/16/2021 (Moderna).  The booster dose of the COVID-19 vaccine was given on 12/02/2021 (Moderna).  Mr. had no adverse reactions, or outcomes. He had taken no additional treatments. Dr. was contacted direction was provided. Under the provider's direction, Mr. was counseled on the incident on 12/02/2021.
Patient was underage when vaccine was administered. Patient guardian was notified. Guardian reports patient is having no symptoms or negative reactions at this time.
URINARY TRACT INFECTION; SHORTNESS OF BREATH; CONSTANT HEADACHES; NAUSEA; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced urinary tract infection. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced constant headaches. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from constant headaches, nausea, shortness of breath, and urinary tract infection. This report as non-serious. This case, from the same reporter is linked to 20210505784.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
3 weeks following seasonal influenza vaccine, patient developed ataxia, headaches, and refused to walk. MRI and LP workup consistent with Guillian Barre Syndrome.
DAY AFTER, PT COMPLAINED OF PAIN IN LEFT COLLAR BONE.  PATIENT DECLINED IN FUNCTION OVER NEXT 11 DAYS.  HOSPICE WAS CONSULTED AND PT PASSED ON 2/23/21
pt recv vax 24MAR97 & 31MAR97 pt exp a fever & devel one lesion;
Headache and fever of 38.3 on 10/20/2017, then on 10/21/2017 developed intermittent numbness on right thigh, shin and calf lasting 10-20 seconds at a time, occurring about every 4 hours for 2 weeks, then became less frequent to 4x/day until present time. She will be referred to a neurologist for evaluation.
Relatively minor, but troubling.  The adverse effect was that my teeth sensitivity to cold became severe enough that I could not drink any fluids directly from the refrigerator or any drinks with ice.  I have never had cold sensitivity with the teeth before. This side effect  went away gradually and is mostly gone now, which is about 6 weeks after the first shot.  I had no additional side affects from the second shot.
pt recvd vax 17NOV92 approx 930AM; mom says pt started crying about 1 hr p/shot & would not stop; took pt to MD 4PM; was told was a reaction to the pertussis & should not be given anymore; pt given DPH & mom says pt stopped crying; indurati
No adverse event; Nurse administered 3rd monovalent vaccine to child that is not immunocompromised; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Nurse administered 3rd monovalent vaccine to child that is not immunocompromised) and NO ADVERSE EVENT (No adverse event) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     The patient's past medical history included Developmental delay.    On 28-Mar-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2023, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Nurse administered 3rd monovalent vaccine to child that is not immunocompromised). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Nurse administered 3rd monovalent vaccine to child that is not immunocompromised) 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 INCORRECT DOSE ADMINISTERED (Nurse administered 3rd monovalent vaccine to child that is not immunocompromised).    Concomitant medication details not reported by the reporter. Nurse reported that a pediatric patient (1-year & 1 month-old) received a 3rd Monovalent Moderna COVID-19 vaccine on 28-MAR-2023. Nurse states that this patient has a diagnosis of Delayed Milestones in Sacral Temple. After administering the 3rd dose for immunocompromised, they realized that they are not sure if the current diagnosis qualifies her for immunocompromised. Nurse was not sure if the patient was immunocompromised, but the 3rd primary dose for immunocompromised was administered on 28-MAR-2023. Treatment details was not reported by the reporter.
Patient experienced extreme fever, chills, nausea, loss of appetite, extreme dizziness and not able to walk.
Muscle Spasms, Nausea, Loss of Appetite (No interest in eating or drinking still to date and just received 2nd dose of vaccine), I have loss 7 pounds in 8 days, Headache, Extreme Fatigue and Sleepiness,  Worsening of Neuropathy Symptoms (Paresthesias return and Weakness in extremities).  Went to office visit and was written presciptions for Zofran and Baclofen. I am very concerned about how long the adverse effects are going to last. I took the second dose today(10-18-12) and already feel very ill.
5 days after vaccine experienced irregular heartbeat and fast heart rate.  Never had this before.  Went to hospital where HR and BP extremely elevated.   Observed overnight in hospital, placed on beta blocker and had Holter monitoring.
site soreness, headache, fatigue, chills, nausea Narrative:  Other Relevant History:
got vaccine at 9:45 , 5-6 minutes later on waiting room,  started having tingling on my face , got blurry vision , and felt weak, started having fine tremors , my hands became so cold . nurse was called , they took me back . my blood pressure got rose to 155 mmhg and o2 sat 99% . my blood pressure was up for 20 minutes . Then kept me there for one hour , then I had another episode of blurry vision , cold handed and fine tremor. They checked my blood pressure which was uyp again . then I took tylenol and a physicien over there recommended benadryl 25mg po  which  i took it. then around 1 pm i had another episode of coldness and  weakness which was not intense and severe as the first time and resolved on her own in 10 minutes . then they let me leave .  of fnote , My left arm got swollen  but no redness. swelling resolved in 2 days . meanwhile I continued to have weakness,fatigue and subjective fever for next 48 hours .
4/18/19 - 9:30 a.m. - Phone call received from mother, states armpit of left arm swollen and painful, not red, began evening of 4/15/19. Recommended follow-up with primary physician.   4/24/19 - Spoke with mother on phone, states saw Dr. and received antibiotic.  He felt better in 1-2 days.  Dr. Health Dept. Clinic Pediatrician notified. Spoke with Dr. patient's primary physician, localized cellulitis treated with antibiotic.
She developed a fever on 10/10/18; which has continued. She also developed a rash on the back of her neck that is radiating down to her back. She has some muscle aches.
This spontaneous report was received from unspecified reporter (clinical research coordinator) regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were unknown. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ (strength, dose, frequency, route not reported) lot # R016790 and expiry date 20-APR-2020 for prophylaxis (product storage error). The vaccine underwent temperature excursion of 2 degree Celsius (1.6 C) for 22 hours and 10 minutes and total time of temperature excursion of vaccine was 9 degree Celsius (10.6 C) for 2 days 14 hours 57 minutes. Previously no temperature excursion was reported. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.
Menstrual cycle has been off from normal. Period started 1 week after the 2nd dose and was very light, not a usual period, but lasted 8 days being very light/spotting. Cycle is normally ~35 days; however, period started again on day 18 and again was very light/spotting and lasted 11 days. Other side effects experienced (swollen lymph node under armpit, hives/rash near injection site, extreme arm pain, headache, fever) were reported already. Also still experiencing brain fog/slowness after vaccine.
Soreness in my Arm; Headaches; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (Soreness in my Arm) and HEADACHE (Headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness in my Arm) and HEADACHE (Headaches). At the time of the report, INJECTION SITE PAIN (Soreness in my Arm) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Patient complained of headaches, nausea, weakness, and hyperesthia of the right arm the day after receiving vaccine. Symptoms start approximately 12 hours after vaccine. Unable to lift arm due to pain. Axillary lymph nodes swollen and tender. No redness or swelling at the injection site. Patient given prescription for Medrol Dose Pack and tylenol.
During the day arm felt heavy. By evening arm was swollen and painful, was unable to fall sleep. Woke up at 4am to take aspirin for pain but fainted/unconscious, Felt hard. Dentist came over to examine missing teeth from fall called doctor in the morning but was unable to go due to bad weather was able to fall sleep after taking some Tylenol. Swelling in arm as decreased but still has pain under armpit. Has appointment with dentist today to fix teeth.
3 days p/vax pt devel inj site rxn of 16-cm by 23-cm area of induration & 10 blisters.Seen by MD tx w/Tylenol #3, Benadryl & prednisone. This is 1 of 2 pt from this site to have adverse rxn p/vax w/lot #4968281
Warm; Itchy; Red; Bumped; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Bumped) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Bumped). The patient was treated with Wound care (Ice therapy) for Vaccination site warmth; Wound care (Ice therapy) for Vaccination site pruritus; Wound care (Ice therapy) for Vaccination site erythema and Wound care (Ice therapy) for Vaccination site swelling. At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Bumped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Patient done ice therapy which made the itchiness better
pt devel fever 102 ax & became delirious; mom gave APAP & tepid sponge bath & fever dec;