chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Feels weak; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (Feels weak) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A20A and 007M20A) 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 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Feels weak). At the time of the report, HEADACHE (Headache) and FATIGUE (Feels weak) outcome was unknown.            Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-027742 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027742:
pt recv vax  10OCT96 woke up AM 11OCT96 w/severe h/a & unable to get out of bed d/t the pain;pain was all over head & cont;h/a was so bad that it affected pt hearing some & made pt eyes sore;seen by MD who gave med which made h/a wors
Fever, chills, headache starting at 11pm on 2/2. Same On 2/3 with addition of  severe body aches and inability to lift arm of injection due to pain.
Approximately 4 hours post vaccine, parent reports c/o sore throat. Fever (101-102F) developed, persisting to next day (none in early am, then recurrence around 10am 11/6), treated with Tylenol by family. h/o family illnesses earlier in the week.
Itching arms legs progressed 11/17/06 arms cleared, to left scapula and down hands. Prednisone.
CELLUSLITUS VS SMALLPOX VACCINE REACTION. PATIENT PRESENTED WITH HA AND LOCALIZED ERYTHEMA. PATIENT TREATED WITH HYDROXYZINE HCL 25 MG AND DICLOXACILLIN 250 MG #80.
chills, slight temp, bad body aches throughout body, swelling and redness and itchy at injection site
sore arm/severe arm pain; Fatigue; Appetite absent/No appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite absent/No appetite), PAIN IN EXTREMITY (sore arm/severe arm pain) and FATIGUE (Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) UNK, Citrate free. In October 2021, the patient experienced DECREASED APPETITE (Appetite absent/No appetite) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm/severe arm pain). At the time of the report, DECREASED APPETITE (Appetite absent/No appetite) and FATIGUE (Fatigue) outcome was unknown and PAIN IN EXTREMITY (sore arm/severe arm pain) had resolved.            On unknown dates, the patient experienced dispensing error/pharmacy mistakenly dispensed original humira/when injected calf burned and the injection left marks up and down on leg and very painful for about a week. on an unknown date, very painful for about a week resolved.  The outcome of the events Drug dispensing error, Injection site burning and Injection site reaction was unknown.  The causality for Humira(adalimumab) for all the events w not provided. The other Mft. opinion is that there is no reasonable possibility that the events of back surgery, sore arm with first and third injection of covid vaccine/severe arm pain after the booster, no appetite, fatigue and dispensing error/pharmacy mistakenly dispensed original humira/when injected calf burned and the injection left marks up and down on leg unknown onset are related to humira(adalimumab). Mft opinion is that there is a  reasonable possibility that the events of dispensing error/pharmacy mistakenly dispensed original humira/when injected calf burned and the injection left marks up and down on leg unknown onset, very painful for about a week and dispensing error/pharmacy mistakenly dispensed original humira/when injected calf burned and the injection left marks up and down on leg unknown onset are related to humira(adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient had spinal operation on unknown date.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621645 (Patient Link).   Reporter did not allow further contact
Patient developed numbness in the arm where Td was administered, one week after Td administration. Couple of weeks later numbness spread to patient's legs and feet. Subsequently, the reaction subsided, although patient is still experiencing numbness in her arm, hand and elbow. Patient did not experienced adverse reactions to previous Td vaccinations. Follow up obtained on 10/31/06: Patient received the vaccine as a booster shot. Patient had no other symptoms besides numbness: specifically no pain nor weakness. The doctor did not associate the numbness with the immunization given its onset one week post immunization and given the nature of the event. The doctor had no explanation for the numbness and referred the patient to a neurologist. Patient had no recovered at the time of the follow up. Follow up obtained on 04/27/07: Patient did not go see a neurologist. The pain and numbness went away couple of days after the visit to the doctor's office. The patient had no other complaints.
Swelling; red at the injection site; flu like symptoms; This is a spontaneous report from a contactable Physician via Pfizer Sales Representative.  A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced swelling, red at the injection site and flu like symptoms. The events were non-serious with outcome of unknown.  The information on the batch number has been requested
swelling and pain at injection site. Axillary lymph node: Narrative:  Per nursing report: "took the 2nd dose of Moderna vaccine yesterday morning [2/1]. C/o back of right leg popped when getting into her truck yesterday. States has a lump on left arm at site of injection and feels like a lump underneath armpit. C/o swelling to right knee with stiffness and aching." Note that the R knee strain is almost certainly unrelated to the vaccine.
Patient had out break of rash on face, with swelling, itching. Swelling and rash on scrotal area, Prednisone p.o. BENADRYL p.o. initial injection.
Approximately 14-15 minutes after receiving vaccine patient complained of heart beating fast.  A few minutes later, while being assessed she also stated she felt that she was going to wheeze and had emesis.  Noted to be hypertensive at that time with )2 saturation of 100%.  Immediately, transferred to onsite Urgent Care, where received albuterol and solumedrol.  )2 sat remained at 100% but patient had episodes of HR up to 140s and decision made to transfer her to an outside ED after about 3 hours.
Tested Postive for Covid on May 3, 2022.  Had running nose and cough.  SLight symptoms have persisted.  Retested positive, May 24, 2022.
Patient administered booster dose of Pfizer vaccine at the age of 16 years. Current guidelines only allow 18 years and older.
Blood in urine, protein in urine. Doctors cannot identify why. I've had a CT scan, bladder scope, and even 3 months later I still have significant blood and protein in my urine
Flare-up of her colitis; A spontaneous report was received from a consumer who was a female patient that received Moderna's (mRNA-1273) Covid-19 vaccine and experienced flare-up of her colitis.  The patient's medical history included Colitis (type unspecified). No concomitant medications were reported.  On 03-Feb-2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly for prophylaxis of Covid-19 infection .   On an unknown date, the patient experienced a flare up of her Colitis.  Lab data was not provided.  Treatment for the event included Prednisone.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, flare up of her Colitis, was considered to be unknown.  The primary reporter believed that the adverse event was not related to the vaccine.; Reporter's Comments: Based on reporter's causality, the event is assessed as unlikely related to mRNA-1273.
I feel issue is more related to injection error, Injection site was above the deltoid. I have had steroid injections in other shoulder and this is the sensation I felt during injection. The rn also told me " You have tough skin" after the intense pressure started. I worked the night before injection. I went home to sleep. woke around 2pm with intense pain in my left arm, I could not shift position or move my arm. with out excruciating pain. I used heat, aleve,  tylenol & biofreeze. By saturday,  i could easily move left arm from elbow down, but extremely limited from shoulder. today i have most of my range of motion, but still have dull ache and pain restrictions. This pain is in my shoulder, not my arm or deltoid. . On thursday, pain was constant, roaring throb 7/10  shoulder to shoulder blade, almost to spine in back and down to elbow , then 9/10 with any movement.   Today is ache 2/10 just in my shoulder, with 5/10 with some movement. I had to call into work 1/7. I am scheduled tonight. I am an ICU RN.
pressure in head; heaviness in her chest,chest area hard and felt similar to when a steering wheel went into chest; Slow speech; tired; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (pressure in head), CHEST DISCOMFORT (heaviness in her chest,chest area hard and felt similar to when a steering wheel went into chest), SLOW SPEECH (Slow speech) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HEAD DISCOMFORT (pressure in head), CHEST DISCOMFORT (heaviness in her chest,chest area hard and felt similar to when a steering wheel went into chest), SLOW SPEECH (Slow speech) and FATIGUE (tired). At the time of the report, HEAD DISCOMFORT (pressure in head), CHEST DISCOMFORT (heaviness in her chest,chest area hard and felt similar to when a steering wheel went into chest), SLOW SPEECH (Slow speech) and FATIGUE (tired) outcome was unknown. Not Provided          No concomitant medication was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-092350 (Patient Link).
Covid-19 treatment: Paxlovid; Covid-19 treatment: Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment: Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 16Sep2023 to 20Sep2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Started feeling hot all over and jittery with cold sweat and nausea. Soon after then vomited. She still feels jittery and headache.
Initially, only mild pain at injection site. At 1:30 am - the morning after I'd received the vaccine - I woke up with a fever of 101.4.  I had body wide aches in my joints, muscle soreness in my whole body, intense fatigue, and a loss of appetite. I could not work that day. I took Advil and went to sleep for several hours. The next morning, however, I felt much better. The muscle soreness was still there, but greatly reduced-. Advil enabled me to work that next day - March 16th, 2021.
Pt presented with bilateral rashes to arms, tachycardia 110, Respiratory rate 18, BP 130/90,  denied pain, felt hot flush, lungs clear bilaterally. History of stroke in 2012, denies hypertension or other comorbidities. Had pt lay down, given sips of water and an antihistamine, 15 minutes later her redness was dissipating,  30 minutes later the redness turned pink. Advised a primary care visit before the second dosage
Vertigo.  Onset was sudden.  Head movement out of the vertical intensified the symptom.  Lasted remainder of day.  At bedtime it had subsided to the point that laying down did not aggrevate the vertigo.  The next day, I just felt out of sorts but did not have the vertigo.  By Oct 7th I was feeling better.  I did not have any treatment, nor did I see a doctor.  I've received flu vaccines the last 32 years and this is the first time vertigo was an issue.
10 year old female paient was administered an adult dose of Pfizer covid 19 vaccine. No adverse affects present at this time.
Full body pain in joints and muscles to the point of not being able to move without pain. The injection site is swollen red, hot to touch and hard 5inches around site.  My fingers and feet feel numb like they are cold but arent cold.
C/O numbness and edema in both legs and inability to walk since Wednesday night. States"I'm crawling around because it feels all mushy when I try to walk"  Pt states he got the 2nd Covid vaccine on Tuesday morning. States I had something like this when I took Hepatitis C medication" Pt states he had nausea and body aches on Tuesday. The patient called nurse triage 4/1/21 and was sent to the Emergency room 4/1/21 for a possible allergic reaction to the vaccine. DIAGNOSIS at time of disposition:   1. Renal insufficiency  2. Elevated liver enzymes  3. Leukocytosis, unspecified type  4. Vaccine reaction, initial encounter  5. COVID-19 ruled out by laboratory testing  1721   Arrived 1739   Sodium Chloride 200 mL/hr 1814   Complete Blood Count w/Differential  1839   COVID-19 PCR, Rapid 1913   Sodium Chloride 1000 mL 1937   Comprehensive Metabolic Panel (CMP)    Lactic Acid, Blood Level   Lipase, Blood Level   Magnesium, Blood Level   NT - Pro BNP (B Natriuretic Peptide) Blood Level 2052   Discharged
I did not have an adverse reaction to the vaccine. I started feeling sick on 11/22/2022 with a sore throat, chills and body aches. I tested positive for COVID-19 on 11/23/2022. I went to an urgent care, and I was given a prescription for PAXLOVID but I did not get it filled. I took over the counter medication for my symptom. I had a fever, extreme fatigue, cough and headaches. As of today, I am still feeling fatigue. I have had stomach issues since having COVID-19.
** Within minutes of administering 2mo vaccines, infant broke out in raised, urticarial rash on legs only.  No distress or breathing difficulty.  1.25ml of Benadryl was given and infant was monitored in office for about 30 mins.  Rash started resolving prior to Benadryl and was almost completely gone at D/C. **
This literature marketed report has been received from authors of a published article, referring to 46 adolescent patients of unknown gender. The patients' medical history, concurrent condition and concomitant therapy were unknown. The purpose of this longitudinal study was to identify individual and interpersonal factors associated with human papillomavirus (HPV) vaccine series completion in a sample of low-income adolescent girls and boys. On an unknown date patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose, frequency, route, batch/lot number and expiration date were not provided) for prophylaxis (product origin unknown). Within 1 year of initiation, patients received only the initial dose or two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (inappropriate schedule of product administration). Findings highlight important opportunities for improving completion of the HPV vaccine series among adolescents. Intervention efforts should involve health care providers and parent-adolescent dyads and prioritize evidence-based strategies for reducing missed opportunities for series completion. This is one of three reports regarding the same literature (linked case# 1902USA011603 and 1903USA008996). Sender's Comments: US-009507513-1902USA011603: US-009507513-1903USA008996.
This spontaneous report was received from a unspecified first year pediatric resident via a field representative and refers to a 2 month old patient on an unknown gender. No information regarding the patient's cconcurrent conditions, medical history and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with a dose of ROTATEQ oral liquid, vial, orally (lot #, expiration date were not reported) for prophylaxis. On an unknown date, the patient was hospitalized due to unknown reason. The outcome of adverse event was reported as not recovered/not resolved. The treatment was received for adverse event. Product quality complaint was not reported. The causality between the event and suspect therapy was not reported.
Fever, chills, headache, body aches, nausea, stomach cramps, sore throat, thick sputum.  Event came on very suddenly.  It lasted about 8 hours until approx. 1 AM and then all symptoms disappeared as suddenly as they came on.
Presents to the emergency department with complaints of swelling on the roof of her mouth which has progressively increased since receiving the Johnson & Johnson COVID-19 vaccine 10 hours prior to arrival.   Mass on the roof of the mouth which is firm and hard like bone.  Treated with IV fluids and medications.
Symptoms included swelling at the site, arm warm to touch, felt tired, extremely painful. Went to emergency room on 10/5/14. Patient stated she had a cellulitis.
back ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder infection.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced BACK PAIN (back ache). At the time of the report, BACK PAIN (back ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use included blood pressure pill (not specified).  No treatment medications were reported.  It was reported that the patient developed a back ache which she thought was related to a bladder infection, however, her physician did not see an infection.  Consent was given for safety follow up.   This case was linked to MOD-2021-022622.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 at 16:45 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 07Feb2021 as dose 1, single (Lot number: 011M20A), in right arm, on 09Mar2021 as dose 2, single (Lot number: 001B21A), in right arm and on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Pt. started to complain of flu like symptoms, dizziness, body tingling, weakness where he complained he could not grip his pencil in school, temp of 100.2. He was seen in our office where his exam was normal, full strength 5/5 to all extremities, no cerebellar signs. The following day he continued to complain of weakness, numbness and tingling to all extremities, with temp of 101, the symptoms continued and on 5/19/16 and patient was seen by neurology.  He was complaining of weakness, numbness and tingling to his hands and feet, and lower extremities, with headaches, as well as neck and back pain. His exam was normal and a head MRI was ordered at that time. His headaches continued and he was being treated by neurology with Nortriptyline for headaches.  On 5/30/17 patient again c/o muscle weakness, sensory disturbance to his arms and legs and around his waist with headaches at which time he went to Hospital and was transferred to Medical Center to rule out possible GBS, GBS was not diagnosed and patient was discharged.
This spontaneous report was received from a physician referring to unspecified number of patient of unknown ages and genders. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M042322, expiration date 21-FEB-2019, for prophylaxis. On 29-AUG-2017, the physician reported that she had no further information to share. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA005530.
injection site is sore; injection site is red; hot to the touch; injection site is raised; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE ERYTHEMA (injection site is red), FEELING HOT (hot to the touch) and VACCINATION SITE SWELLING (injection site is raised) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No Adverse Events.    On 31-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE ERYTHEMA (injection site is red), FEELING HOT (hot to the touch) and VACCINATION SITE SWELLING (injection site is raised). At the time of the report, VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE ERYTHEMA (injection site is red), FEELING HOT (hot to the touch) and VACCINATION SITE SWELLING (injection site is raised) outcome was unknown.            There is no lab data provided by the reporter.