chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experiencing prolonged arm pain at injection site post administration; complained of difficulty lifting her arm because of the pain; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 27 years old female patient who had prolonged arm pain at injection site post administration and complained of difficulty lifting her arm because of the pain after receiving influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or other vaccines: NO  On 03-Oct-2023, the patient received a standard dose of suspect influenza quadrival A-B vaccine Suspension for injection at a dose of 0.5 ml total (lot UT8076NA, expiry date- 30-JUN-2024) via intramuscular route in the right deltoid for Immunization.  On an unknown date in OCT-2023, (unknown latency), the patient developed prolonged arm pain at injection site post administration (vaccination site pain) and complained of difficulty lifting her arm because of the pain (injected limb mobility decreased) following the administration of influenza quadrival A-B vaccine.  Action taken was not applicable.  Treatment: Patient went to Urgent Care last week, prescribed steroids  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.; Sender's Comments:  US-SA-2023SA322148:Patient #2: US-SA-2023SA322445:Patient #4:
Two months after second dose,I started getting Crawling feeling in my left arm in injection site,then it went to a warm feeling,then to a cold  feeling then a sharp pain.this is thru out the day,every day.Here it is September and in still experiencing the same thing.In may I was able to put a fork,and a nickel battery.on my arer they couldn't find anything.m and walk around with out it falling. I went to the
Immediate onset of "huge swings" in heart rate. Rate would vary from over 200 to mid-thirties in a matter of seconds. It continued without improvement to date. He cannot exercise. Too much instability in heart rate. He is scheduled for a heart electrical ablation in a month.
Woke up with fever of 103.3 vomiting cold chills and body aches called an ambulance to transport me to ER after they evaluated my symptoms and found out that I had the shot a few days prior they said it was more than likely a reaction to the shot and that I should just alternate tylenol and ibuprofen until the fever stopped and if by morning i wasnt feeling better to get seen. My fever broke by morning all I had was extreme fatigue I slept until 5 pm Monday. by Tuesday morning I felt back to my normal self. I never went in to get tested. since the EMT seemed to think my vitals were fine. my lungs were clear my ears were fine, my throat was clear and my nose was clear. I had never heard of anyone having reactions after 4 days from getting the shot but he said he had heard of people getting it up to 7 days!
reported fatigue/general malaise;non specific discomfort in knee, back & lower extremities;3wk p/vax 23OCT96;reported same sx 2-3 wk in 12OCT94
unknown - pt has been given 2 nd dose of moderna vaccine at less than 28 day interval
Developed Arm pain at injection site, fever  100.2 F 48 hours post vaccine, and HA
Patient has not experienced any adverse affects at this point however patient received 2 booster pfizer vaccines in 2 months (10/5 and 12/2)
Vaccine dose 3 and 4 was Moderna Booster; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 60 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EN6206), in left arm and on 06May2021 as dose 2, single (Lot number: EW0173), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 3 (booster), single (Lot number: 05H21A), in right arm and on 30Apr2022 as dose 4 (booster), single (Lot number: 056M21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; METOPROLOL SUCCINATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine dose 3 and 4 was Moderna Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2022) Positive, notes: tested positive 20Dec2022; (31Dec2022) Positive, notes: Experience Paxlovid Rebound on 31Dec2022 with a positive COVID test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested positive on 20Dec2022, started Paxlovid on 21Dec2022-26Dec2022. Experience Paxlovid Rebound on 31Dec2022 with a positive COVID test.
Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more; Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more; Stuff comes from her nose (up to her eyes) then goes into her throat; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more), CONDITION AGGRAVATED (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more) and UPPER-AIRWAY COUGH SYNDROME (Stuff comes from her nose (up to her eyes) then goes into her throat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection. Concomitant products included MONTELUKAST and LEVOCETIRIZINE for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more), CONDITION AGGRAVATED (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more) and UPPER-AIRWAY COUGH SYNDROME (Stuff comes from her nose (up to her eyes) then goes into her throat). At the time of the report, SINUS DISORDER (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more), CONDITION AGGRAVATED (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more) and UPPER-AIRWAY COUGH SYNDROME (Stuff comes from her nose (up to her eyes) then goes into her throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.
blood sugar increased to 308; Pain at the injection site; Dizziness; Shivering, so bad; Headaches; fever,; cracked a molar; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (SHINGRIX) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included diabetes.   On 20th February 2023, the patient received the 1st dose of SHINGRIX (intramuscular) and Flu vaccine. In February 2023, unknown after receiving SHINGRIX and Flu vaccine, the patient experienced injection site pain, dizziness, shivering, headache, fever and tooth fracture. On 22nd February 2023, the patient experienced blood sugar increased. On an unknown date, the outcome of the injection site pain, dizziness, shivering, headache, fever, tooth fracture and blood sugar increased were unknown.   It was unknown if the reporter considered the injection site pain, dizziness, shivering, headache, fever, tooth fracture and blood sugar increased to be related to SHINGRIX and Flu vaccine.     Additional Information: GSK Receipt date: 23-FEB-2023 reporter comment: The reporter was the patient The reporter stated that  she received her first dose of SHINGRIX vaccine in her right arm and has been with headaches, dizziness , pain at the injection site and shivering at night since then.  The patient also received a flu shot on her left arm. she did not know the name of the flu shot received.  The patient stated that she has been experiencing fever, headache, dizziness, soreness and injection site, and shivering after receiving her dose. The patient stated that her shivering is so bad that  she cracked a molar while she was sleeping.  The patient also stated that she is diabetic and her blood sugar increased to 308. Education provided on SHINGRIX side effects per content. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023030470:same reporter
3rd morning after she had an isolated episode of vertigo.; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (3rd morning after she had an isolated episode of vertigo.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient did not had vertigo for the past 15 years.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (3rd morning after she had an isolated episode of vertigo.). At the time of the report, VERTIGO (3rd morning after she had an isolated episode of vertigo.) had resolved.            Concomitant medications were not reported.  The vertigo passed after a day.  Treatment information was not reported.   This case was linked to MOD-2022-534964 (Patient Link).   Reporter did not allow further contact
Itching over entire body, beginning to have blotching/rash on arms and legs. MD notified. Diphenhydramine 50 mg po given with some relief. Sent to urgent care, given Pepcid 20mg po, released to return to work on 10/4/14.
Dizziness spells worse (hinders or prevents normal daily activities), more persistent (a few days at a time), and more frequent [1-4 days between spells) since the vaccine. (Previous dizziness was almost exclusively during or immediately after respiratory illnesses, more of a discomfort than a genuine hindrance, and usually resolved within a day or two.)  Chiropractor did ___ (Epley? or similar) maneuver to treat vertigo approximately May 3.  I went to ENT on May 5. He did a thorough check-up history (he had treated sinus issue in 2016), looked in ears, camera in nose, prescribed course of Cefnidir for mild sinus infection, scheduled allergy testing (to be done May 27)?. I have been able to treat with heat and positioning at home, or chiropractor help, but it keep coming back.
This spontaneous case reported by a consumer, describes the occurrence of pain (sore to the touch), erythema (noticed it was red) and erythema (got red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011A21A) for COVID-19 vaccination. No medical history reported. On Mar 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 2, 2021, patient experienced erythema (noticed it was red). On Mar 9, 2021, patient experienced erythema (got red). On Mar 18, 2021, patient experienced pain (sore to the touch). The patient was treated with diphenhydramine hydrochloride), at an unspecified dose and frequency; and antibiotics, at an unspecified dose and frequency. At the time of the report, pain (sore to the touch), erythema (noticed it was red) and erythema (got red) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Blood pressure medicines were taken as concomitant medication.
Abdominal Cramping and vaginal bleeding after going through menopause 5 years earlier. Hot flashes
I had a very bad headache, and I was very congested. I started taking PAXLOVID when I reached out to my doctor. I felt been within 48 hours. Then a week later I tested positive for COVID for 5 days and felt bad for about 36 hours.
NONE No adverse reaction First dose given on 3/9/2021 and second dose given on 3/29/2021 given to soon. No signs and symptoms
Patient received covid Moderna vaccine 1st does at Health Department on 1/12/21 (lot number unknown).  Due to hx of anaphylaxis observed for 30min. After 15-20 minutes, patient experienced mouth and tongue swelling. Also c/o dry mouth. 911 was called and patient was given epinephrine 0.3mg IM and 25mg diphenhydramine per EMS without improvement in symptoms. The sensation included the upper portion of her throat. Pt has known allergies to Shellfish and iodine. Patient was referred for allergy follow up. Per review with allergy - second dose is not recommended.  In ED - patient received additional diphenhydramine 50mg IV, famotidine 20mg IV, methylprednisolone 125mg IV. Was already given epinephrine by EMS Discharged home in good condition after approximately 3+ hour observation in ED.  Seen by allergy on 1/15/21 who recommended not to administer 2nd vaccine.
R09.02 HYPOXIA 4/19/2023 DM 2 WO COMPLICATIONS R09.02 HYPOXIA 4/19/2023 GERD COUNSELING
Felt a  spark in my left elbow the same day. Severe left side and body pain the next day. Felt my heart pumping faster than usual for about 3 hours. Almost all the symptoms subsided by the next day but lymph nodes in the left arm pit and elbow got enlarged. Don't feel the lymph nodes now but severe elbow pain now. Can't lift heavy  things. It's even painful when I bend and straighten the elbow.
Feeling faint, heavy arms, sweaty, and pale.  Recovered after about 20 min of observation, drinking some water, and eating small crackers.
pt recv vax & devel a fever of 103 & on 8/2/98 fever was reduced to 101;pt also devel elongated nodule on lt lower inguinal region 1inch x 1 inch nodule, firm, non painful, not discolored;
Information has been received from a physician concerning an "over 80" year old female consumer who on an unspecified date was vaccinated with a single dose vial of 0.65 mL of zoster vaccine live (Oka/Merck). It was not noted whether or not the patient had a history of shingles prior to the vaccination. Subsequently, about a month after receiving the vaccine the patient developed a rash. It was noted that upon visual examination by the physician that the patient developed a mild case of shingles. There was no pain associated with it. The patient was treated with VALTREX. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
The patient started with a Headache shortly after the vaccines, for which she took a tylenol.   The patient started with nausea, and then vomiting aroun 11:30pm to midnight on 10/06/2023.   the patient continued with vomiting throughout the night, and still continues with a headache at 6 pm on 11/07/2023.
Injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash). At the time of the report, VACCINATION SITE RASH (Injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment medication not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Febrile seizure, lasting less than 5 minutes, transported to local ER by ambulance, seen and observed, lac normal, CXR normal sent home with fever control measures.
About 3 weeks after vaccination with Pfizer COVID-19 patient experienced severe fatigue and SOB. In April and May symptoms worsened and she experienced lower extremity edema. She went to the Urgent care early May (Best approximate time) Patient has been on Colchicine prescribed by her PCP and remains on it to this day. Patient was told her condition would improve in about 6 weeks.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The patient had no pre-existing medical conditions.  On 03/02/2005, the patient received the fifth dose of Infanrix in the right thigh.  On the same day, the patient also received the second dose of measles, mumps and rubella virus vaccine, the fourth dose of inactivated poliomyelitis virus vaccine at unspecified sites of administration.  At an unspecified time following the fifth dose of Infanrix, on 03/02/2005, the patient experienced an injection site reaction at the site of the Infanrix administration characterized as swollen, hard, red, warm, and painful.  The outcome of the injection site reaction was not reported.
Information has been received from a pharmacist concerning an unknown age female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 24-SEP-2018, the patient received a dose of improperly stored VARIVAX (0.5 ml, once, lot # N027627, expiration date 04-OCT-2019) subcutaneously for prophylaxis (incorrect product storage). Sterile diluent used for reconstitution of VARIVAX was properly stored. The vaccine was exposed to temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degree for 18 hours. Data logger was not involved. There was no previous temperature excursion. No adverse effects were reported.
Patient received vaccine and within 1 min of administration fainted. Patient also convulsed upon fainting due to quick drop in blood pressure.  Patient was taken to hospital and received IV hydration only.  He was able to return home after.
lightheaded and dizzy; Severe motion sickness; loss of appetite; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient was allergic to sulfa (sulfonamide allergy). Concomitant medications included ethinylestradiol and norethisterone acetate (JUNEL), desvenlafaxine succinate monohydrate (PRISTIQ) and buspirone hydrochloride (BUSPAR). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced sore arm. On 23Mar2021 at 12:00, the patient was very lightheaded and dizzy and also experienced severe motion sickness and loss of appetite. Next day after that, the patient felt fine and ok. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore arm, lightheaded, severe motion sickness and loss of appetite was resolved on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Incident Description: On 2/24/21 at about 10am, a family of 5 (2 parents and their 3 kids) approached me asking for COVID-19 vaccinations. The parents provided signed, informed consent forms and paperwork for all 5 individuals. Against the parent's initial request, I denied the COVID-19 vaccination to the 13 year old patient. In accordance with the parents? initial request, I administered the vaccine to the other 4 family members, including the 4 year old patient. Active clinical trials and articles with data to support the use of the COVID-19 vaccination in children are below. During my years working at acute care facilities where successful use of medications were often supported by primary literature and clinical trials, I made a judgment decision to administer the vaccination to the 4 year old citing previous success from previous experiences and the below references. References: 1. https://clinicaltrials.gov/ct2/show/record/NCT04581148 2. https://clinicaltrials.gov/ct2/show/NCT04330261 3. https://abcnews.go.com/Health/holiday-covid-19-surge-blame-rising-mis-cases/story?id=75928794 4. https://pubmed.ncbi.nlm.nih.gov/33278108/
12 hours after Prevnar #1, pt developed fever of 102 and it was on and off x 3 days with increased lethargy, decreased tone and gross motor strength and esotropia (both eyes). Pt was somnolent but arousable with pain and refusing to sit up, not social.60 day follow-up dated 09/27/00 provided no additional data.  Diagnosed with acute disseminated encephalomyelitis.
Telephone call from employee, stating she was diagnosed with Guillian-Barre Syndrome. Unclear if related to Influenza Vaccine or not. States prior to vaccine c/o sore throat and earache on 10/26/04- Saw PMD, temp 99-100F. Started on Amoxicillan. 10/28/04 c/o hands and toes tingling. Received Influenza vaccine on 11/2/04. Admits to only telling administering nurse that she was on an antibiotic for cold s/s but denied an elevated temp. Did not tell nurse about neurological symptoms. 11/3 stated rt side of face "paralyzed". 11/4 c/o "feet slapping". Saw neurologist. States had MRI 11/5- reported no stroke or tumors. 11/8 Saw neuro again- c/o falling with ambulation. States had "no ankle reflexes" and admitted to hospital. Had spinal tap and dx with GBS. Currently at home, slowly improving with home PT.   01/12/05 Discharge summary 0f 11/8-11/15/2004 gives final diagnosis as Guillain-Barre syndrome, CMV (+), Depression. Treated with IVIG, antivirals for CMV(+) & PT resulting with ability to walk w/walker on d/c.  H&P states sore throat 'two weeks ago' (about 10/25/04) went home from office visit to Dr and 'had tingling in her face and hands'.  The tingling continured thru 11/02 when she got the flu shot. Next morning she had rt side of face numbness and drooping and  weakness in feet and legs, worse on the rt than left.' Neuro consult obtained. 01/26/05 From nursing supervisor that patient had at least one previous flu vax in 02.
heart  palpitations ,followed by  vision problems, followed by headache - total time lapse approximately half hour, then goes away. Happens intermittently throughout day. No occurrences after going to bed
Projectile vomitting, headache, chills Sore throat from the intensity of the vomitting.  I usually cannot and do not vomit