chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details; Temperature excusion occurred on 23-MAR-2022; This spontaneous report has been received from a medical assistant, concerning a 5-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 30-MAR-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) first dose, subcutaneously (valid lot number U025790 [expiration date 19-AUG-2023]) for prophylaxis, after a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec. The time frame of 3 h, 0 min, 0 sec; 1 h, 30, min 0 sec (product storage error) and a device component malfunction was reported (dose, vaccination scheme frequency, and anatomical location of vaccination were not provided). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008006: US-009507513-2205USA008105: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007852: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA007957: US-009507513-2205USA008000: US-009507513-2205USA008002: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA008066: US-009507513-2205USA008069: US-009507513-2205USA008100: US-009507513-2205USA008189: US-009507513-2205USA008064: US-009507513-2205USA008795: US-009507513-2205USA008800: US-009507513-2205USA008830: US-009507513-2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007739: US-009507513-2205USA007748: US-009507513-2205USA007749: US-009507513-2205USA007861:
Arm sore for a week. Back very sore for 4 days.  No prior muscle issues in back and could not even lay down without medication and a heat pad. Cycle disrupted, so far missed one period even though ALWAYS regular prior.
Patient felt dizzy, lightheaded and nauseous about 5 minutes after vaccination. Provided him with a bottle of water and sat with him for about 15 minutes more (20 minutes wait time total) until he felt well enough to leave.
Eyelids irritation; A spontaneous report was received from a 72-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced eyelids irritation.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, approximately three days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (latch number: 013L20A) for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient experienced eyelids irritation. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of event eyelids irritation was not reported.; Reporter'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.
1. non-arteritic anterior ischemic uptic neruropathy (NAION) in right eye - an eye stroke- permanent loss of most of vision in right eye. 2.  had same issue  with left eye (Moderna Vaccine booster in November of 2021 and NAION in left eye in Februrary of 2022 - permanent loss of about half of vision in left eye
MD visit at 1 week - healthy baby. 6 lbs 9 oz born at 39 weeks. ? SIDS death.
Woke up just after midnight with chills, and a racing heart. Unable to sleep and symptoms progressed to headache, chills, fever, fatigue, weakness throughout the night and day, coming up to the 24 hour mark.
her arm pain was more so with the first dose but felt arm pain with the second dose as well; pain in groin; the top of her right leg was in pain; This is a spontaneous report from a Pfizer sponsored program.  A 63-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Right on 15Apr2021 15:30 (Batch/Lot Number: EL9265) as 1ST DOSE, SINGLE DOSE, dose 2 intramuscular on 06May2021 (Batch/Lot Number: EL3247) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Age at vaccination was 63 years. The patient medical history and concomitant medications were not reported. It took a day after the second vaccine, she understands arm pain is normal. She accepts the pain in arm as territory when getting a shot, she heard her arm will hurt. Clarifies her arm pain was more so with the first dose but felt arm pain with the second dose as well. She wants to jump to the major issue. She explains that last Saturday evening, which was almost a month to the day after her second dose, she got a severe pain in her right groin, very intense to the point she can no longer walk that well and cannot do too many things. She has been on extra strength Tylenol since Saturday. She has tried to do everything she can to alleviate the pain and it is wearing her out, she is tired and at one point she felt really cold, the top of her right leg was in pain and now it went back to the groin. It is very severe and she is trying not to take Tylenol. Tylenol helps but she does not like being on Tylenol. Therapeutic measures were taken as a result of her arm pain was more so with the first dose but felt arm pain with the second dose as well (pain in extremity). The outcome of the events was unknown.
Saturday March 6th ~6:00am - Severe vomiting, sweats, chills lasting the whole day... Sunday March 7th ~ 3:00 - 4:00am  - drenching sweat and dizziness  preventing  him from getting up. This is ongoing at this time. Sunday March 7th @ 1pm.  Any movement of the head brings the dizziness back .
Woke up the day after my shot with achy muscles and felt very slow.  Went to work and after a long day was spent. Achy muscles, shivering, night sweats, abdominal pain, diarrhea,  vomiting and mid level to high fever...the highest at 103.9. I haven?t had all the symptoms every day. I have experienced achy muscles, shivering and fever daily. Have been taking acetaminophen, 1000 mg every 6 hours. Pushing water and tea, only able to eat soup or vegetable smoothies.
Allergic reaction; Experiencing shortness of breath and indicates can barely breathe; Swelling/tightness and mucous in the face and throat.; Swelling/tightness and mucous in the face and throat.; Sore throat; Chest is getting tighter and tighter; Could not keep her eyes open; First dose Thursday shortly after a pain went down the other arm; Burning down her other arm; Headache; Nausea; Whole body aching; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Jun2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported first dose Thursday (22Jun2021) shortly after a pain went down the other arm. Reporter experiencing shortness of breath and indicated she could barely breathe. She reached out to her doctor for prednisone on recommendations of Pharmacist. She asked if she did just kill herself. Health care professional (HCP) declined prednisone and hung up on reporter. Caller (patient) also indicated swelling/tightness and mucous in the face and throat. She described it as a sore throat. She asked if she was going to die. The caller was calling about the Pfizer COVID shot. The caller got the first shot and shortly after she got burning down her other arm and shortness of breath. The caller woke up in the middle of the night with a headache, nausea, her whole body aching, and she could not keep her eyes open. The caller was still having the allergic reaction. The caller's chest was getting tighter and tighter and she could barely breathe. The caller's pharmacist said to get some prednisone but the health center that the caller went to said no and left the caller with nothing. The caller was freaking out and can barely breathe. The caller thought she was going to die. The caller felt like she just killed herself with the shot. She asked if there was any help out there. It was asked if the caller was really going to die. The case was reported as non-serious. The outcome of the events was unknown.  Information about lot/batch number has been requested.
c/o blistering @ site where rabies given;has been in sun 3 or more hr that day;states very itchy w/blistering-partly dry skin for 1wk;dry patchy whitish area;pharmacist stated was dermatological rxn;
Admission Information:  35-year-old female no primary care provider who has past medical history of seizures with coil procedure to a brain aneurysm in 2016 and history of tobacco use who presented with heaviness in her legs and knees down, unable to walk, fell and caught herself at home.  Was brought into the outside hospital emergency department via EMS and then transferred to Medical Center.  Patient was diagnosed with mild case of Gillian Barré and treated with IVIG for 5 days.  Patient was discharged, she returned to our ED when her symptoms worsened.  Vital signs stable.  Difficulty walking and admitted to hospitalist service.  Hospital Course:     Neurology was consulted and physical and Occupational Therapy consulted as well.  Neurology recommended MRI of her spine.  They agreed her clinical symptoms definitely suggestive of Guillain-Barré syndrome.  MRI results as below.Patient started on nicotine patch as she does has a history of smoking almost a pack a day.  Per neurology no evidence of transverse myelitis on repeat MRIs of the spine.  She will be transferred to acute rehab for strengthening and mobility.  Gabapentin dose has been increased for better pain control.  Continue Xanax as needed for sleep.  Transfer to acute rehab.  Rapid Covid testing is pending
Pt experienced red rash on upper arm approximately 4-5 inches away from the injection site on the posterior upper arm (injection more so on anterior deltiod of same arm). Came to pharmacy on 10/04 notifying us about possible injection site reaction. Rash slightly warm to touch. I took pt name and phone number down and told her i would follow up next day (today) with a courtsey call to check status of rash. I called pt and she said rash was about the same as yesterday, no better; a few hours later she came to the pharmacy to show status of rash. I told her rash will hopefully subside over the next few days but that i will complete a adverse drug reaction form to fda.
Second dose received after 18 days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received after 18 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received after 18 days). On 15-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received after 18 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Heavy post-menopausal bleeding. Started 08/30/2021. Still bleeding today 09/11/2021. Had normal pelvic ultrasound with Doppler done 2 weeks prior to immunization. EVERYTHING was NORMAL.
Pt had red, raised rash around site of injection on left deltoid that spread across entirety of upper left, outer arm. Rash started the morning after administration (2/5/2020). It was warm to the touch. No swelling of lips, tongue, or throat. Pt reported that the rash has reduced in redness and size on 2/6/2020. Pt has not used any topical or oral medications to treat. Recommended diphenhydramine 25mg every six hours and to apply ice to affected area. Follow-up with PCP if not resolved in 48 hours (2/8/2020 15:00)
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live.  Subsequently the patient experienced a mild breakthrough of varicella.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Information has been received from a pharmacist concerning a 68 year old female with high blood pressure, depression, hypothyroidism and no drug reactions/allergies who on 07-MAR-2011 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot # 667610/1355Z; exp date: 26-OCT-2011). Concomitant therapy included atenolol, citalopram, meloxicam, metformin, and levothyroxine. On 08-MAR-2011, the patient developed redness at the injection site. On 08-MAR-2011, the patient developed redness at the injection site. The treatment of cold compress and BENADRYL were given to the adverse event. There was no lab diagnostics studies performed. At the time of the report, the patient was recovering from her adverse event. The patient sought an unspecified medical attention. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 57-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) and in Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: PRINZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Hives developed 24hrs after vaccines given.  56 hrs later hives are progressively worse. Now there are multiple hives with bruise like areas along abdomen and upper thighs.  Hives are itchy and causing irritability.
On 9/20/11 - a lump located in the left arm appeared and along with some aching.
Pt states upper (L) arm swollen starting day after TDAP vaccination has continued for almost 1 week. Redness swelling has not gotten worse. Advised ice/warm pack alternate and Ibuprofen for swelling. Discomfort has subsided. Still a bit itchy. Advised to monitor see MD if redness/swelling increases.
On 7/16/00, the infant developed a rash described as "diffuse fine sandpaper". The infant recovered.
Muscular power was significantly reduced; Before was able to stand up with walker and move to another chair, her ability to do this has decreased by 50% to 75%; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Before was able to stand up with walker and move to another chair, her ability to do this has decreased by 50% to 75%) and MUSCULAR WEAKNESS (Muscular power was significantly reduced) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Muscular dystrophy and Walker user.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MOBILITY DECREASED (Before was able to stand up with walker and move to another chair, her ability to do this has decreased by 50% to 75%). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscular power was significantly reduced). At the time of the report, MOBILITY DECREASED (Before was able to stand up with walker and move to another chair, her ability to do this has decreased by 50% to 75%) and MUSCULAR WEAKNESS (Muscular power was significantly reduced) had resolved with sequelae.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.  No treatment medications were reported.  Follow-up update: Patient is reported to have regained some of her ability back, but is still not as good as before the Moderna shot. She is now able to transfer, but with the help of another person. Second shot administration was discontinued to minimize risk of her losing all ability to transfer.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant follow-up appended: changed outcome from unknown to recovered/resolved with sequalae
PATIENT COMPLAINED OF NUMBNESS AND TINGLING IN LIPS AND TONGUE AFTER MODERNA COVID19 VACCINATION.  12:25 BP 130/88, HR 102, RR 18 12:35 BP 122/90, HR 96, RR 16 12:40 BP 122/87, HR 94, RR 16  PATIENT RELEASED IN STABLE CONDITION AFTER OBSERVATION.
treat pain after vaccination; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received dose of Shingrix and experienced pain. The patient asked, how to treat pain after vaccination.
24 hours later developed raised erythematous hot indurated nodule at vaccination site right thigh. No fever. Seen 7/30 and 5cm diameter induration. Parent reports similar reaction to vaccine last year.
Infant with increased pallor, sudden onset lethargy, apnea.  Blood culture and urine cath done, LP done, labs sent and abnormal, antibiotics started, started on 1 L NC, given PRBCs. Labs remain abnormal.  12/14/09 DC summary received for DOS 09/01/09-12/03/09. Pt was hospitalized from birth until 3 months later. Pt was preterm neonate, small for gestational age and had multiple conditions. Pt was treated with multiple medications.  Pt discharged home.
On 7/25/02, mother stated the pt complained of pain in both arms and was given Advil by mother. On 7/27/02, mother stated the pt complained of severe pain in right arm and purplish spots in upper (proximal) and distal extremity. Right arm was placed in a sling; Vicoprofen prescribed for pain. Mother was instructed to f/u with PCP in 1 week.
Immediately after the vaccination, I felt dizzy, slightly nauseous, and like a rush of adrenaline. That lasted about 30 minutes.   A little later I started to feel sick and it lasted for about 30 hours. Symptoms included headache, lethargy, aches and pains. Then for about three days I seemed normal.   However, starting about mid-week I noticed that I smelled smoke all of the time. I kept searching for sources of smoke or trying to find something that might smell similar to smoke. It has now been about five days since the phantosmia started and I am still smelling smoke. It hasn't gotten any worse, but it hasn't gotten any better either. It is starting to drive me crazy.  I know that smell and taste issues can be a symptom of Covid and this made me realize that perhaps the vaccine could also cause such symptoms. That's when I decided I should probably file this report in case others were having a similar side effect. I'd also love to know when it will go away and if the second dose is going to make it worse.
Question:   I received the Moderna Covid-19 vaccine first shot on February 26, 2021, then I got the second shot on March 28.  Then on May 5 I developed shingles on the left side of my fact from my left teeth gums, left jaw, with shooting pain up to my left ear.  I never had chicken pox.    I went to a Doctor on May 8.  He gave me an Rx for the shingles pills and an anti-biotic pill.  I must take them 3 times per day.  I also received the Shingrix first shot  and will get the second shot in July.  I still have pain in my lower left jaw, left face up to ear and my left ear feels as if it is full of water like after swimming my ears fill with water and then shaking my head it drains out.  But not there is no water in the ear and no drainage.  I want to know if you have medical evidence that the MODERNA vaccine can cause my Shingles?  Is this one of the side effects?  Will I get more shingles in the future and will Shingrix vaccine prevent getting the shingles?  Did MODERNA cause the Shingles as a side effect?  Please answer these questions and email me any medical journals or articles or studies which show that the Covid-19 pandemic can Shingles or did the Moderna vaccine cause the Shingles.  Thank you for your consideration and diligent work on the research for the vaccines to stop the Covid-19 pandemic.
Sore throat, fever and achiness starting 3/1/2003 with productive cough. Chills 3/2 and 3/3/2003 lasting for 1/2 hour. Temp 3/4/03 PM 101.7 F. Temp today 99.5 F.