chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covered with sweat; muscle weakness in legs; nerve pain in legs, shooting pain in the legs; joint pain, mostly in right wrist; felt very fatigued; 101 degrees F temperature/ fever lasted all day and night/ max temperature 102 Fahrenheit/ struggled with her temperature (fever)/ fever resolved (morning); ongoing headache; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), HYPERHIDROSIS (covered with sweat), MUSCULAR WEAKNESS (muscle weakness in legs), NEURALGIA (nerve pain in legs, shooting pain in the legs) and ARTHRALGIA (joint pain, mostly in right wrist) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nerve pain. Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (first dose 24-FEB-2021 with lot number  EN6202 and second dose 22-MAR-2021 with lot number  ER8782) from 24-Feb-2021 to 22-Mar-2021.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore right arm) and HEADACHE (ongoing headache). On 28-Oct-2021, the patient experienced HYPERHIDROSIS (covered with sweat), MUSCULAR WEAKNESS (muscle weakness in legs), NEURALGIA (nerve pain in legs, shooting pain in the legs), ARTHRALGIA (joint pain, mostly in right wrist), FATIGUE (felt very fatigued) and PYREXIA (101 degrees F temperature/ fever lasted all day and night/ max temperature 102 Fahrenheit/ struggled with her temperature (fever)/ fever resolved (morning)). On 29-Oct-2021, PYREXIA (101 degrees F temperature/ fever lasted all day and night/ max temperature 102 Fahrenheit/ struggled with her temperature (fever)/ fever resolved (morning)) had resolved. At the time of the report, PAIN IN EXTREMITY (sore right arm), HYPERHIDROSIS (covered with sweat), MUSCULAR WEAKNESS (muscle weakness in legs), NEURALGIA (nerve pain in legs, shooting pain in the legs), ARTHRALGIA (joint pain, mostly in right wrist) and FATIGUE (felt very fatigued) outcome was unknown and HEADACHE (ongoing headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Body temperature: 101 fahrenheit (High) 101 degrees Fahrenheit and max temperature 102 Fahrenheit.         Reporter had reported that she had no known drug or food allergies. She did not take any medications daily. No treatment medications were reported.
loosing too much blood,spotting; just beeing so tired,is just tired; pain in her heel fasciitis with the heel spur; muscle pain in general; pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (loosing too much blood,spotting), FATIGUE (just beeing so tired,is just tired), ARTHRALGIA (pain in her heel fasciitis with the heel spur), MYALGIA (muscle pain in general) and VACCINATION SITE PAIN (pain in her arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE (HCTZ) for an unknown indication.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (loosing too much blood,spotting), FATIGUE (just beeing so tired,is just tired), ARTHRALGIA (pain in her heel fasciitis with the heel spur), MYALGIA (muscle pain in general) and VACCINATION SITE PAIN (pain in her arm). At the time of the report, HEAVY MENSTRUAL BLEEDING (loosing too much blood,spotting), FATIGUE (just beeing so tired,is just tired), ARTHRALGIA (pain in her heel fasciitis with the heel spur), MYALGIA (muscle pain in general) and VACCINATION SITE PAIN (pain in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not reported.
Patient called over nurse and stated she felt like her heart was racing.  Vitals taken and pulse 64-72  and regular.  Patient states she is feeling very emotional and she states she thinks this is anxiety.  Patient reassured and monitored until 2 :20.  All symptoms resolved and patient states she felt fine prior to discharge
severe pain and stiffness left arm and around travelling down to forearm, cannot comfortably position left arm in any position, cannot type, cannot sleep   due to pain .
Patient was given outdated vaccine. Flu Mist was outdated on 12/25/2011.
Patient reported history of adverse reaction to Flu Vaccine in the past and now reporting Shortness of Breath post 15 mins after vaccine administration.  Patient transported to local ER for further evaluation.
I received my booster vaccine on Monday, 11/1/2021. On Tuesday morning, 11/2/2021, I woke up with full body hives, as well as on Wednesday, Thursday and Friday. Each day got progressively worse. I take Xyzal and it seemed to subside but the red marks remain. Today, 11/5/2021, I woke at 3 am and took a Xyzal 5mg. I had to take another at 6 am because I started to swell - my hands are so swollen I can leave dents in them. I have hives all over my entire body including my palms, my ears and scalp. The lower half of my face is swollen including my lower lip. I am thinking about going to the emergency room.
headaches; not fell good; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 16:45 (Batch/Lot number: unknown) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "ADHD and asthma" (unspecified if ongoing), notes: Known allergies: No; The patient's concomitant medications were not reported. The following information was reported: HEADACHE (medically significant) with onset 21Jan2022 18:30, outcome "not recovered", described as "headaches"; MALAISE (medically significant) with onset 21Jan2022 18:30, outcome "not recovered", described as "not fell good". Therapeutic measures were taken as a result of headache, malaise including Tylenol for children.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination,  the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
day following vax pt exp swelling, redness to elbow, extending up to the inj site; pt advised to apply warm epsom-salt compresses by MD; 10/20/98 pt presented again to MD w/swelling underneath neck on lt side lasted week; neck pain;
Approximately 3 hours of vaccination, patient started to feel that his throat was swollen, tongue was swollen, airway was restricted. Patient felt very tired and lethargic. Patient was flushed. Patient felt this way for several hours. Patient did not take anything to relieve symptoms. Awoke feeling fine.
Cellulitis of arm. Extensive but not beyond sholder or elbow joints. Began 24 + hours after immunization. Responded slowly to antibiotics.
pt recv vax 16OCT97;pt states a couple of hr p/lt arm blew up like a balloon, fever 101, chills, pain in lt arm;went to hosp a few hr later;woke up next day was better;tx @ hosp;
Pt: passed out and became hypotensive and observation RN thought the Pt might have displayed seizure like activity after passing out. 911 called and Pt take to ED via ambulance.
4 hours after injection I felt itchy all over (fairly mild) with no rash.  Got covid arm rash on day 8 and lasted 3 days.
Shortly after the injection the site became very hot and sore. My arm swelled to twice its size. The pain was so horrible I could not lift my arm. I had to hold it down with my forearm folded along my waste. A large patch of bright red welted rash appeared. I could not sleep for two nights. I couldn't move the rest of Saturday, all of Sunday, and most of Monday. Benadryl and Tylenol were of no help. I went to work on Monday and told my boss I was ill and may have to leave. The symptoms lingered until Wednesday. I will never get a pneumonia shot ever again. This was an excruciating experience. I felt the flu shot in my left arm was also agitated by this event. I did not feel good at all.
Felt a burning sensation when vaccine was injected into left arm.  The next day, noticed increased erythema, swelling and tenderness at the injection site.  Now eight days later has 5mm wide "sore" looking lesion, no circular erythema or swelling present.
Patient developed chills, body aches, mild fever (didn't take actual temp) and local redness & swelling at site of injection, left deltoid. Pt said he felt incoherent for awhile. He also received Tdap same day.
passed out within minutes of administration.  Woke up once prone. Passed out again when Paramedics sat him up.  Paramedics treated him and took him to hospital.
Patient was re-vaccinated during office visit as per staff patient administered FLUZONE QUADRIVALENT; vaccine leaked from syringe as the stopper was difficult to pull from  syringe upon preparation of vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case received from an other health professional via call center and transmitted to Sanofi on 06-Nov-2020.  This case involves patient unknown age was re-vaccinated during office visit, as per staff the patient administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number UT7058JA) via unknown route in unknown administration site for prophylactic vaccination (incorrect dose administered) because the vaccine leaked from syringe as the stopper was difficult to pull from syringe upon preparation of vaccine (syringe issue).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  This is a true medication error case since incorrect dose administered since there was a syringe issue (latency unknown).   At the time of this event there was no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
vision got worse/ almost lost of all vision; Condition aggravated; pressure problems in eye; infected eye; This case was reported by a consumer via call center representative and described the occurrence of vision decreased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had in his eye in 2016.). Concurrent medical conditions included ophthalmic herpes zoster and vision decreased.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced vision decreased, condition aggravated, sensation of pressure in eye and eye infection. On an unknown date, the outcome of the vision decreased, condition aggravated and sensation of pressure in eye were not recovered/not resolved and the outcome of the eye infection was unknown.   It was unknown if the reporter considered the vision decreased, condition aggravated, sensation of pressure in eye and eye infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her son in law got shingles in 2016 in his eye. The virus was still active 2 years later. The reporter stated that when the virus went into remission, his physician gave him a Shingrix injection. The patient vision got worse after the Shingrix injection but he had already almost lost all vision in the infected eye anyway. Now the patient was having pressure problems in the same eye and sees a specialist and was having a hard time of it. The reporter did not provide any specific information regarding the patient. This was all the information that was reported. The reporter did not consent to follow-up.
Oth complications following immunization, NEC, init on 2016-12-08.
Information has been received from a physician and a registered nurse concerning an active infant female who in March 2008, was vaccinated PO with a dose of ROTATEQ (no lot# available). In 2008, the patient experienced diarrhea. The physician added that the patient had non-bloody diarrhea, no vomiting and no fever. The patient sought unspecified medical attention. subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source.
Report 2001003270-1 describes knee joint pain in a 68 year old male who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health care professional. Allergies, medical history, and concomitant medications are not specified. In 1999, and in early 2000, the vaccinee received his first and second doses of Lymerix, respectively. "Shortly" after dose 2 of Lymerix, the vaccinee developed such severe pain in his joint that he was unable to work. He subsequently under went exploratory surgery in July, 2000, and reportedly was told that he will need knee replacement. This report is considered serious due to the need for hospitalization and the inability of the vaccinee to work. As of 02/01/01, the out come of the event is unknown. The serious adverse event of "knee joint pain" is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Pt given an adult dose (20mcg) of Hep B and also child dose (10mg) of Hep B at same visit. Poison control called.
Right arm almost twice as large as left (shots given in the right arm). Red, warm to touch, afebrile. Feels ill. Referred to doctor. Arm hurts
Passed out & blood pressure dropped low 5 minutes after getting vaccine. Started having various medical issues following this event, mostly started in July: vertigo, tinutis, anxiety, sudden adrenaline rushes, panic attacks, head pressure in temples & back of head,sudden racing heart, heart palpitations, sudden blood pressure drops that cause lightheadness/dizziness where I feel I?m going to pass out.
We received on 24 JAN 2008 from a healthcare professional the following information: A female patient, born on 16 SEP 1936, was vaccinated, two years ago with an influenza virus vaccine (batch no. and manufacturer unknown) on an unknown date. The patient experienced idiopathic thrombocytopenic purpura. The outcome is unknown. It was also reported, that she experienced adverse events in the following two years (see cases MA2008-0091 and MA2008-0092).
Narrative:  Moderna COVID-19 Vaccine EUA. The patient received bamlanivimab at an outside facility on 12/9/20 and received his first dose of the COVID vaccine 1/26/21 which is less than 90 days apart.
Patient reports that she took the Johnson and Johnson Covid vaccine in May 2021. Patient reports that shortly after she began struggling with allergies. Reports she experiences itchiness and swelling to her lips and eyes. Patient denies difficulties breathing. Denies runny nose or frequent sneezing. Patient denies changes to her routine. She reports that antihistamines do help but that her symptoms always return. .
Received HPV #2 on 05/9/23, Seen in office 05/15/23 for  swelling started 2 days later at the injection site, Tylenol given shortly after swelling started, swelling has formed into hard mass that is tender to touch, no increase in size of swelling since onset, seems to be shrinking but pain persists, area of soreness and pain is radiating into his arm affection muscles and armpit, hurts when moving his right shoulder or lifting his arm. Given prescription for Naproxen, recommended supportive care with warm compresses and epsom salt baths, to follow up in office in 1 week if swelling persists or signs of infection develop
Approximately one day post vax, pt developed a circular erythematous mark at the injection site with a clear center.  Pt applied an herbal salve and noted slight improvement. On an unspecified date the pt recovered.
mom went to clinic 21FEB & stated that pt had broken out in rash (gen) w/whelps w/in 10min p/leaving the unit on 18FEB p/shots;
On April 1, 2021 the symptoms presented with right shoulder pain. Over the course of several days bilateral paralysis presented in the lower extremities.  On April 6, paralysis occurred in both hands/forearms. Then on April 7, bilateral facial paralysis was noted and was instructed to go to the local ER by PCP. A MRI of the brain and cervical region W/WO Contrast was performed along with spinal tap. On April 8, after a repeat MRI of the brain and cervical region, a diagnoses of Guillan Barre Syndrome was provided. April 8- April 12, 2021 IVIG therapy was administered while staying in the hospital. After the infusions were completed, I was moved to inpatient rehabilitation center on April 13. During my stay in the rehab unit I completed extensive therapy with OT/PT/SP along with neurophysiologist. I was discharged from hospital Rehab unit on April 22, 2021 (am). After discharge I was sent home and advised to continue outpatient therapy. I currently have paralysis in both legs, lower arms/hands, and right side of my face. I have been seeing a neruoopthamologist for my right eye as it can not close and is at risk for going blind. Currently I have not been given any sort of outcomes or time line as to when my condition should improve.
Hives, intense reflux/indigestion followed by tendon/joint pain in right shoulder, moving to right wrist, moving to right hand/fingers, followed by the same in left arm, low grade fever, loss of appetite, exhaustion, facial swelling on right side of face (site of prior cosmetic filler) but no other facial swelling at other sites of filler injections)
Site has not healed in 6 weeks, it looks like a mosquito bite as it itches all the time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 61 years, in right arm for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Moderna COVID-19 vaccine (Dose: 01, Batch/Lot number: 016B21A), administration date: 05Mar2021, when the patient was 59-year-old, for COVID-19 Immunization; Moderna COVID-19 vaccine (Dose: 02, Batch/Lot number: 006C21A), administration date: 22Apr2021, when the patient was 59-year-old, for COVID-19 Immunization; BNT162b2 (Dose:03, Batch/Lot number: FL3197), administration date: 27Dec2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Interchange of vaccine products"; BNT162b2 (Dose: 04, Batch/Lot number: FM9992), administration date: 27Apr2022, when the patient was 60-year-old, for COVID-19 Immunization.  The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 03Oct2022, outcome "not recovered", described as "Site has not healed in 6 weeks, it looks like a mosquito bite as it itches all the time".
About twelve hours after the vaccination, I was unable to sleep and felt so nauseous I almost vomited. In the months following the vaccination, I have experienced increased IBS symptoms and joint pain and back/neck spasms. I have also felt just general malaise.
Two blood samples taken about 5 to 10 minutes after I was given flu vaccine. Within a few seconds after taking the 2nd blood sample, I momentarily fainted. From 11 AM to 8:30 PM 08/24/2010, I experienced nausea and about six episodes of vomiting throughout the day and evening. Evening became mainly dry heaves. Pretty much a full recovery by the following morning.
Localized reaction (3 1/2 x 3") at injection site Benadryl PO X 1.
delayed reaction arm red spot; delayed reaction severe itching; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (delayed reaction arm red spot), INJECTION SITE PRURITUS (delayed reaction severe itching) and PAIN IN EXTREMITY (arm pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    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 VACCINATION SITE ERYTHEMA (delayed reaction arm red spot), INJECTION SITE PRURITUS (delayed reaction severe itching) and PAIN IN EXTREMITY (arm pain). At the time of the report, VACCINATION SITE ERYTHEMA (delayed reaction arm red spot), INJECTION SITE PRURITUS (delayed reaction severe itching) and PAIN IN EXTREMITY (arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information 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 events, a causal relationship cannot be excluded.
NDC # 0006-4837-03 local reaction of erythema, edema, warmth expanded well beyond the immediate injection site from the top of the lt. shoulder down to the elbow area, into my Lt. axilla & Lt pectoral area. It was extremely swollen and painful. I was concerned it could be cellulitis. I also had fatigue, headache, knee joint pain. The reaction resolved by date.
Stomach pain Vomiting From initial information received on 03/Dec/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a three-year-old male patient received his first dose of Fluzone SV 2003-2004 USP, lot number U1092AA, administered intra-muscularly (site not reported) on the afternoon of 02/dec/2003.  That evening, the child developed severe stomach pain and vomiting.  At the time of this report, the symptoms were still persisting.  The patient's pas medical history is significant for asthma and egg allergy.
Post vax the patient had a seizure that lasted approximately 1 minute. No known temperature recorded.
Covid diagnosis 6/30/2022, within 6 months of booster Initial symptoms evening of 6/27, increasing over 48 hr period until fever evening of 6/29 Negative home test 6/28 Positive rapid test at urgent care facility 6/30 6/30 was the worst symptoms, decreasing over time thereafter (started Paxlovid evening of 6/30)
Pt. started with fuss, fever and continued to bc irritable thru the night. Woke with fever 101.4 and projectile vomiting. So mom brought child to be seen. MD ordered CBC, UA, Abd XRay.
Patient reports that 24-48 hours after injection she developed redness, a 4x5 inch area of swelling and heat.  She went to MD and was diagnosed with cellulitis.
I got the vaccine in March, I had a mammogram in late April but my lymph nodes were swollen.  The doctor asked me to come back to check in 3 months and said that this was likely a reaction to the vaccine.  When I went back in three months I had metastatic breast cancer.  I don't know how this can be if my mammogram looked ok.