chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm stiffness/ Legs are stiff and heavy/ muscle stiffness; Joint pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021. The most recent information was received on 13-May-2021 and was forwarded to Moderna on 13-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Patient's medical history is not provided by the reporter.  The patient's past medical history included COVID-19 in November 2019.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-127485 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant follow up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127485:husband case
I had vaccination on 09/16/2022. On 03/03/2023 I started to experience a stuffy nose fever chills coughs a stabbing headache and my eyes were bothering me. On 03/04/2023 I tested COVID-19 positive. I contacted urgent care as I am obese and have Asthma. On 03/05/2023 had an O2 of 80. I called urgent care back and started PAXLOVID on 03/06/2023. I was vomiting over the night with PAXLOVID and stopped after my third dose. I ended up in the emergency room with dehydration and diarrhea. I was provided anti-nausea meds and fluids. I tested COVID-19 negative 03/06/2023. I still have stuffy nose on 03/22/2023.
I reported an inner ear infection when the last text arrived.  I don't know if it is related or not, but someone called and wanted me to fill this out.  I am on a second course of antibiotics to try and clear the infection.  I go back to my allergist in two days to check.
On 10/30 patient developed R arm swelling, hives to her back, hoarse voice.  Went to ER 11/1/15 and given Benadryl with resolution.
Systemic: After patient was directed to sit down for 15 min to be observed. A few min after patient sat down in chair he passed out and fell off his chair. Nurse gave epipen called 911. Had scrape on R front scalp and some blood on nostril.-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported that he had a phobia of needles prior to vaccination. Vaccine was given at approximately 2:50pm. After he fell, the nurse noted he was face down. The nurse asked him to roll on his back and he responded after a few moments. His skin was red, blotchy, and sweaty. Patient said that he was ok and didn't want to get sent to ER. Epipen was administered at 3:02pm on 3/17/21 and ambulance arrived 3:07pm. The nurse noted some improvement but pt was complaining of hand and arm pain.
Patient stated that she felt dizzy within about 10 minutes of receiving injection. She stated that she has never had an adverse reastion to the flu shot and that the dizziness was comng in waves.  I gave her water to drink and after about 45 minutes she asked for the store manager to drive her home,
Soreness in her left arm of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in her left arm of the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness in her left arm of the injection site). At the time of the report, INJECTION SITE PAIN (Soreness in her left arm of the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.  No treatment information provided.
Recurrence of episcleritis that had occurred after the second dose of the vaccine.  Symptoms started approximately one week after the third dose of the vaccine and have persisted despite steroid eye drops for over 6 weeks.
That evening after the vaccine around 06:30PM ET I told my husband I felt cold, then I felt hot. I took my temperature and it was 104F. I got in the floor because the bed was soaking wet because I was sweating so bad. That whole week I felt extremely tired and had extreme brain fog and confusion, a dry hacking cough a heaviness in my chest that made me feel like I could not get my breath. I called the doctor on Monday to make an appointment. I went in on Tuesday, the doctor did a complete check up. He ran an EKG, had a complete CBC blood panel work up done. Everything came back negative. My doctor feels that I had an adverse reaction to the second booster shot and that it may take a couple weeks for me to get over this. To this day I am still experiencing some brain fog and I still have times that I cannot get enough air in my lungs. I have fatigue now and that is not me.
This spontaneous report was received from a patient's mother concerning a 2 year old male patient. Patient's concurrent conditions and relevant medical history was not reported. The reporter stated that there was history of other family members having unspecified adverse effects. On 02-FEB-2015 the patient was vaccinated with M-M-R II (1 single shot, route unspecified) (lot number: K009956 with expiry date 14-JUL-2016). Concomitant medications were not reported. On unknown date in February 2015 the patient experienced sore throat, lack of appetite, sweats, irritability, fever of 102.8 Fahrenheit, muscle twitching and keeps rubbing his eye. No treatment was given for the adverse events. The patient sought medical attention by speaking with the physician. The outcome of the events was reported as not recovered/not resolved. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. Additional information has been requested.
Information has been received from a medical assistant concerning a 19 year old female with no pertinent medical history and a penicillin allergy who on 15-AUG-2007 was vaccinated with Gardasil (lot# 657872/0515U) 0.5 mL in the left deltoid IM.  There was no concomitant medication.  On an unspecified date the patient developed a rash.  Medical attention was sought.  Specific information about the rash was unknown.  At the time of reporting the outcome of the event was not specified.  No further information was available.  Additional information has been requested.
I received the 2nd shot wed afternoon, 2 days later Saturday early morning woke with sudden onset acute hearing loss B ears  and tinnitus. Worsened Sunday . Monday I went to ENT doctor 130 pm he confirmed I have SSHL left ear significant. We discussed treatments of steroid injection  due to my intolerance of  oral steroids we discussed getting the approval from (other doctor) if steroid injection to L ear would be a good treatment . MRI of brain  also ordered . Later that day symptoms of severe dizziness, nausea and headaches , fuzzy head , and high blood pressure , feeling like I would faint , went to the ER all night , BP came down, fluids given , labs stable still dizziness told to follow up With outpatient doctors . Called ENT he said for the approval for steroid injection and wants to wait for MRI .  Next day nausea and dizziness and hearing loss worsens , horrible vomiting Tuesday night for 2 hours , horrible dizziness and hearing loss continues wed ENT prescribed anti nausea medicine to help . Wed went to Chiropractor clinic For consult and X-rays of the cervical spine to prepare for neck adjustment to relive some pressure and reduce dizziness and nausea . Thursay am went to get MRI of brain with contrast , results ordered stat - results came back no mass no bleed normal study . ENT calls with results and plan for steroid injection Tuesday 6/15 315 pm .  I continue to go to chiropractic doctor for care to help reduce the dizziness and fuzzy head / headaches feeling . I present as Very weak and 9 lb on wt loss in 1 week due to dizziness and weakness . Unable to drive , work , barely can provide self care , or take care of my children .  Still dizzy and not better
chills; achy back; low fever; injection site pain; This is a spontaneous report from a contactable other health care professional. A 59-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el 3248 and expiration date not provided), intramuscular (right arm) first dose on 12Jan2021 12:00 at single dose for covid-19 immunisation. The patient's medical history included psoriasis, seasonal allergies, and If COVID prior vaccination: Yes. The patient's concomitant medication included oxymetazoline hydrochloride (CLARITIN EYE ALLERGY RELIEF), ergocalciferol (VIT D), vitamin c [ascorbic acid], and zinc. On 13Jan2021 07:00, the patient experienced chills, achy back, low fever, injection site pain. No treatment was given to the events. The outcome of the events was not recovered. No other vaccine was taken within four weeks and not tested for Covid post vaccination.
I felt a strange thing in with my heart, it was beating so so strong. It woke me up. It was like a drum beating in my chest. Every 5 minutes, I felt the same beating. Then 3 days later, when I noticed it was not stopping. I went to ER. Doctor said that I would feel like this for 2 weeks, and then go back to normal. However, 48 days later, I called my doctor because I was still feeling it. She said to go to ER again, gave me something for controlling the heartbeat, metoprolol 25 mg twice daily. I am still taking this. Sometimes I still feel my heart going back to the crazy beating. The pain in my chest, it feels like I have something open in my chest. It feels like my chest is opening and there is pain in the middle. I had never had any heart problems before whatsoever. They gave me some medicine. Most of the time I feel tired and I continue to get short of breath. I exercise or do something for about 45 minutes and then it feels like I've used my breath and need to rest. I have read that some women this got the same reaction.
Patient had flu shot in the LEFT arm on 9/28/17 in the morning, on the same day in the evening she started having problems. Pt reported the following side effects: Pain in both shoulder but mainly in the RIGHT shoulder, feels like a muscle ache (relieved by squeezing) and pain in the bone, pain also in the back of the neck, but not at the sides of the neck. Pt complains pain still continues as of today (10/2/17) when it was reported. Pt has been taking TYLENOL. I instructed her to take ibuprofen or naproxen and she cannot due to GI disturbances w/ NSAIDS. I instructed her to try and ice the area and continue TYLENOL. I contacted the md office and they will get in touch with pt with further direction. MD office instructed pt to contact the office in the morning if symptoms didn't improve.
Redness, erythema and induration 3 x 6 cm at site of MMRV, just below DaPT
I developed a headache about 1 hour after the vaccine. I developed a fever of 100.4 about three hours after my first dose of the COVID-19 shot.  Shortly after this I had moderate GI upset including diarrhea, cramping for about 24 hours.  Over the course of 48 hours after the vaccine I had swelling at the injection site, tenderness of the injection area to the point where I was not able to put pressure on the area or sleep on my left side and severe fatigue/malaise.    All symptoms resolved after 48 hours.  I am a person and wanted the reaction information to be part of the trial data.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 71-year-old female patient who received HAB (Twinrix adult) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2023, the patient received Twinrix adult (intramuscular) and Twinrix Pre-Filled Syringe Device. On 7th February 2023, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The patient received an expired Twinrix adult vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received an expired Twinrix adult vaccine, which led to expired vaccine used.
This spontaneous report was received from a nurse, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of PNEUMOVAX23 whit Lot # M022086 and an expiration date of 09-OCT-2017 and lot # M023460 and expiration date of 12-NOV-2017 (strength, dose and route were not reported) for prophylaxis. It was confirmed that all the vaccines were reconstituted with sterile diluent (lot # and expiration date were not reported) which was stored in correct temperature range. No adverse effects were reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit degrees (°F) to 77 °F range, for a time frame of 3 hours and 30 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000300: US-009507513-1705USA002378:
chest pain; missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and PRODUCT DOSE OMISSION ISSUE (missed second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced CHEST PAIN (chest pain) and PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, CHEST PAIN (chest pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
On 10-27-10 at 7pm pt received his second dose of FLUZONE flu vaccine on his RAT IM. Mom noted redness & swelling of area 24 hours later, then on morning of 10-29-10 much worse - red, swollen non tender area noted by Dr. 10 x 12cm - advised BENADRYL & cool compresses; mom states improved by next day, gone by 10-31-10.
First COVID vaccine in series.  Pt was nervous about the Immunization.  She told pharmacy she was allergic to bees (anaphylactic reaction), so she was instructed to wait 30 minutes post vaccination.  At around 20-25 minutes pt said she stood up and felt dizzy (room spinning ) for a few seconds and it immediately resolved.  Took per blood pressure and is was around 120/80 mmhg.  She said It is usually a lot lower but had been nervous about the shot.  After 30 minutes she was fine again and left.
dizzy, increased blood pressure and pulse, lightheaded, neck tight, throat tight  Narrative:  Presented to the ER following the second covid vaccine. She became dizzy, lightheaded, had neck pain and a sore throat. She was given normal saline in Solu-Medrol 125 mg IV and diphenhydramine 25 mg IV was given in the ER.
On 06/30/2021, I had excruciating chest pain for 3 days. On the 1st day, I went to the hospital to do a drive-up COVID-19 test-negative. On the 2nd day the symptoms were not getting better, so I called the doctor. The doctor told me to come in 1st thing in the morning. (I did not think I was having a heart attack because I figured I would be dead by then.)  On the 3rd day, the doctor sent me for a test, to get a EKG test. And I was supposed to have a chest x-ray, but the portable machine was broke down. When the EKG results came back they sent me to the ER-trauma. (the same hospital Dr. office is in) In the next couple of hours, I was life-flighted to Hospital. When I arrived they took me directly to the Catherization Lab. They prepped my arm and groin area. The next thing I knew I woke up and the doctor said I was fine. He diagnosed me with pericarditis.  I was on ibuprofen 200 mg ,2  tablets  2x day,  for 14 days and Colchine .6mg for 30 days.
raised knot at injection site; Redness; Swelling; itches constantly; This is a spontaneous report from a contactable consumer (patient).   A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6210), via an unspecified route of administration, administered in Left arm on 01Mar2021 16:00 (at the age of 34 year old) as dose 2, single for COVID-19 immunisation.  The patient medical history and family medical history was reported as none. Concomitant medication included sertraline taken for an unspecified indication. The patient has no known allergies, never had an allergic reaction to medication. Prior vaccination, patient did not receive other vaccines within four weeks. Historical vaccine included first dose of 0.3 ml BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261), via an unspecified route of administration on 23Jan2021 (at the age of 34 year old), as single dose for COVID-19 immunization and the patient experienced a little tired. On  01Mar2021 16:00, after received the vaccination, once she reached home, she felt tight like knot under the skin, at the injection site on her left arm, little more than half way down to the elbow. Next day, on 02Mar2021, by the evening time, the knot was raised and kept getting more red and swollen. The redness and swelling spreads, where size of a quarter (that was found on 03Mar2021) became size of a plum or little bigger than a half dollar at the time of report, (on 04Mar2021). At the time of report, it is red and swollen with a white line around it, where it itches constantly. It is super tender and been tender the whole time. It was reported that COVID vaccine was given, on top of her bicep, where she used to get injections towards the top of her shoulder. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected
Sweating during the night after his second shot; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Sweating during the night after his second shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NIGHT SWEATS (Sweating during the night after his second shot). On 09-Apr-2021, NIGHT SWEATS (Sweating during the night after his second shot) outcome was unknown.            No concomitant medications were reported.   No treatment medications were reported.   This case was linked to MOD-2021-060605 (Patient Link).
began to experience adrenal stress; fatigue; teeth chattering; confusion; nausea; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: 30155BA), dose 2 via an unspecified route of administration, administered in arm left on 29Sep2021 13:30 (at the age of 65-year-old) as dose 2, single for COVID-19 immunization. Medical history included Congenital Adrenal Hyperplasia and known allergies. Concomitant medication included dexamethasone 0.5 mg. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number: FD0809) administered in arm left on 01Sep2021 13:45 as single dose for COVID-19 immunization.  No Covid prior vaccination nor Covid tested post vaccination. The patient has a congenital Adrenal Hyperplasia and 4 hours after injection on 29Sep2021 at 17:30 began to experience adrenal stress including fatigue, teeth chattering, confusion, nausea. Initiated stress protocol of increased dexamethasone (1.0 mg) in addition to normal dose. Symptoms abated within the hour. The adverse events resulted in Life threatening illness (immediate risk of death from the event). The patient received treatment for the events which included dexamethasone 1.0 mg. The patient recovered from the events 29Sep2021.
Patient given expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine). On 05-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) had resolved.        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.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Additional information received on 10 -Jun-2021 had no new information.
Raised itchy rash, it was also painful in the area and the muscle was hard and warm.  I sent my cousin who is a md on Sunday evening and she showed it to her husband who is also a md, he said to ice it and hydrate.  I took a claratin Sat and Sun (13 and 14) and applied ice on 14th and took 2 advils and went to bed
During pt 15 minute wait after receiving vaccine, pt felt dizzy and light headed. Pt stayed an additional 15 minutes for a total of 30 minutes and was attended by the RN. Pt stated she was feeling better. RN said pt was fine to leave. pt left in stable condition.
Patient called stating she is having problems with the immunization from 10/27/20 stating the shot may have been administered too high on the arm.
2 inch x 2 1/2 inch red raised area with firmness noted on right thigh warm to touch.  At site indicated by Mom as injection site.
Headache, Myalgia, CHILLS Narrative:  EMPLOYEE REPORTS THAT HE WOKE UP 1/1/2021 WITH CHILLS, BODY ACHES, AND FATIGUE THAT RESOLVED WITHIN 24 HOURS. RECENTLY HAD COVID INFECTION.