chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little bit itching, little bit of rash on face, both arms and legs; Itching in face; Tingling in mouth and tounge and worked its way down to legs; Tingling down the legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in face), PARAESTHESIA ORAL (Tingling in mouth and tounge and worked its way down to legs), PARAESTHESIA (Tingling down the legs) and RASH PRURITIC (little bit itching, little bit of rash on face, both arms and legs) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Itching in face), PARAESTHESIA ORAL (Tingling in mouth and tounge and worked its way down to legs) and PARAESTHESIA (Tingling down the legs). On 19-Mar-2021, the patient experienced RASH PRURITIC (little bit itching, little bit of rash on face, both arms and legs). At the time of the report, PRURITUS (Itching in face), PARAESTHESIA ORAL (Tingling in mouth and tounge and worked its way down to legs), PARAESTHESIA (Tingling down the legs) and RASH PRURITIC (little bit itching, little bit of rash on face, both arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: New events were updated.
expiration date=9/19/21 later that evening--left arm swelled, left shoulder pain, left axilla nodes swelled,were tender,had persistent pain, eventually days later the lymphnodes decreased in size, pain in the axilla,left shoulder persisted, problems with ROM saw doctor-11/1/2021--stated post -injection synovitis from the Covid vaccine  and I am  being treated.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 14-JUN-2013, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
NAUSEATED AND  SLIGHT PAIN AT INJECTION SIGHT WITHIN 20 MIN ...HEADACHE WITHIN 30 MIN LASTED ALL DAY.......LESSENED UP ON 2ND DAY      ..LATER THAT EVENING FACE FLUSHING.....GOT VERY SLEEPY WITHIN 2 HRS........ITCHING AT INJECTION SIGHT...  DID NOT SEEK TREATMENT JUST USED TYLENOL  AND ICE PACK ON INJECTION SIGHT..  NOTIFIED MY DR OF THE SIDE EFFECTS I HAD..
Cellulitis; Injection site swelling; This case was received via website (Reference number: 0977305) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.  This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, CELLULITIS (Cellulitis) and INJECTION SITE SWELLING (Injection site swelling) outcome was unknown.   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.  No concomitant medications were provided.  Company comment: 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.  Reporter did not allow further contact; 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.
7/30 PM left thigh big red welt at site size of softball & 7/31 looks smaller.  Mom advised to give BENADRYL & to call us back if redness worsens or spreads.  Swelling, fever. - (AM)  7/31 (pm) swelling down to 50 cent piece.  She is acting fine.
Hives all over his body after booster/Hives inside the throat on & off after booster; Itchiness after booster; Rash all over his body after booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over his body after booster/Hives inside the throat on & off after booster), PRURITUS (Itchiness after booster) and RASH (Rash all over his body after booster) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 001C21A and 024C21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy.On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced URTICARIA (Hives all over his body after booster/Hives inside the throat on & off after booster), PRURITUS (Itchiness after booster) and RASH (Rash all over his body after booster). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency; CETIRIZINE for Hives, at an unspecified dose and frequency and LORATADINE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over his body after booster/Hives inside the throat on & off after booster) outcome was unknown, PRURITUS (Itchiness after booster) was resolving and RASH (Rash all over his body after booster) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. About 10 days after the booster, he started having Hives and Rash all over his body. Cortisone cream, did not work. He was prescribed Prednisone tablets for 2 weeks which helped to decrease frequency of rash and itchiness. When the Prednisone ran out, the rash came back. He also has Hives inside the throat on & off. He tried taking Cetirizine, and Loratadine which did not help. All Blood test were normal.No concomitant medication was provided by the reporter.This case was linked to MOD-2022-457608 (Patient Link).
3/5/21 Restlessness, fatigue & arm soreness.  3/6/21 Arm fevered, inflamed and bruising at and around  injection area 3/7/21 Arm worsen with the bruising and redness  3/8/21 & 3/9/21 No improvement in arm Took Benadryl- no change
Day 1 swelling and redness to elbow given Benadryl (no fever, no pain) Day 2 swelling and redness to wrist Day 6 swelling  receded Tx was Benadryl (right arm)
Patient stated she had previous passed out following vaccination. EMS on site in case pt passed out again. Patient passed out following vaccination and EMS was able to catch her and lower her to ground. She regained consciousness quickly and was monitored afterward. Refused any further treatment/transport as she was feeling fine upon leaving.
I received the Moderna COVID-19 vaccine - 1st dose.  My arm (site of injection) was sore right away and through Friday and Saturday during the day.  The soreness ended at the same time the other symptoms (reported before) started and lasted about 24 hours.
She broke out in hives. Mom called our medical call center and was told she could treat this at home with BENADRYL. Mom did so and hives have subsided as of 10-3-13.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/25/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD)
Mother states child came home from school yesterday c/o itch and breaking out. Mother brings child by for evaluation to see if r/t the vaccines. On exam, noted wheals, raised and red with a prominent puncture mark in the center. Wheals are localized to the back, hip, and gluteal areas, beginning at the thoracic region of the spine down to the gluteus maximus. There are 9 wheals on her back, 3 on right hip, 1 on left hip, and 6 on right gm, ranging in size from 1/2"-1" in diameter. Each one has a distinct center such as a bug bite would. Denies any other symptoms. Mother states child was in the woods the evening before her shots playing hide and seek with 3 other friends, but none of those 3 have similar s/s. Mom has been using OTC cortisone cream on areas, which helps temporarily but comes back. No other treatments attempted. Mother thinks it might actually be chiggers from the woods, but wanted to make sure. All 3 injection sites are free of any symptoms, skin is pink, nontender to touch, normal temperature to touch. No redness or reaction of any kind at the injection sites.
Redness at injection site; Swelling at injection site; Pain at the injection site; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who was participating in the mRNA-1273 Emergency Use Program and who experienced redness/vaccination site erythema, welling at the injection site/vaccination site swelling, and pain at the injection site/vaccination site pain.  The patient's medical history was not provided.  Products known to have been used by the patient, withing two weeks prior to the event, included Vascepa, Tribenzor, Rosuvastatin Calcium, Levothyroxine Sodium, Allopurinol, Xigduo, Omeprazole and Multivitamin.    On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT: 011J20A) intramuscularly in the left shoulder for prophylaxis of COVID -19 infection.      On 24 Dec 2020, the patient experienced persistent redness, swelling at the injection site and pain in the arm for last two weeks.    Treatment for the events included taking Naproxen, keeping the injection site very clean and application of antibiotic ointment.   Action taken with the mRNA-1272 in response to the events, redness, swelling at the injection site and pain in the arm was not provided.   The events redness, swelling at the injection site and pain in arm were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
I experienced two colds back-to-back. One shortly after the other. When the second cold came along, I developed a deep hacking cough which turned into pneumonia. I went to my local urgent care clinic who performed an x-ray and advised that I go to the emergency room due to hyper inflated lungs. I went to the emergency room and 8 hours later, I saw a doctor who could not confirm any cause for an emergency. I then had a virtual visit with my primary care physician but I could not be seen in office due to my cough. After my cough improved, I was able to go in office to be seen where they prescribed medication and ordered a CT scan. The CT scan confirmed pneumonia and also found potential artery issue that I will be seen for in the next few weeks. I am currently taking prescription medication to treat the pneumonia. I am also participating in a vaccine study.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 51 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Certain antibiotics" (unspecified if ongoing). Concomitant medication included: ADVAIR, start date: 24Dec2010, stop date: 14Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: COVID 19 treatment included Paxlovid from 14Feb2023 to 19Feb2023.
Pt had been in inpatient rehab since 4/5 where she tested negative for COVID on admission. Pt was retested for COVID on 4/17 and had complaints of mild shortness of breath and increased secretions. She also had family with COVID.
PT'S SPOUSE CALLED STATING THAT PT WAS STILL EXPERIENCING ARM PAIN AND DECREASED RANGE OF MOTION FROM TDAP VACCINE GIVEN IN JANUARY HERE. INFORMED PT THAT ARM SORENESS IS A COMMON SIDE EFFECT OF ANY VACCINATION; HOWEVER, IF PAIN WAS EXPERIENCED LONGER THAN 2 WEEKS THEN IT IS ADVISED THAT PT SEEK MEDICAL ATTENTION FROM PCP. INFORMED PT THAT I WILL REPORT THIS TO VAERS BUT IN THE MEANTIME PT SHOULD VISIT PCP FOR POSSIBLE IMAGING TO MAKE SURE THERE IS NOT ANY OTHER UNDERLYING CONDITION
This spontaneous report received from a health care professional concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 05-FEB-2022 for prophylactic vaccination. Age at time of vaccination 37 years old. No concomitant medications were reported.  On 05-FEB-2022, the patient experienced vaccine was administered to patient without being stored at recommended storage conditions of 2 to 8 celsius. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and vaccine was administered to patient without being stored at recommended storage conditions of 2 to 8 celsius was not reported. This report was non-serious. This case, from the same reporter is linked to 20220504995, 20220505593, 20220505044, 20220505162, 20220505192, 20220505340 and 20220505373.
Needle hit bone and patient reported pain not usually felt with vaccine. Patient arm was very small and not much muscle. Patient was responsive and alert when leaving vaccination area, but became distressed and overheated by the time she reached her husband outside. (it was quite warm in the store today ).  Called patient later to check on her and she felt fine but felt like the vaccine was too high on her arm. I apologized and told her about possibilty of shoulder impingement and she had no side effects at the time.
PROQUAD was administered to a 1 year old patient along with VARIVAX insted of MMR.; PROQUAD was administered to a 1 year old patient along with VARIVAX insted of MMR.; This spontaneous report was received from a registered nurse and refers to a 1-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.    On 20-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, once, lot # T018279 was confirmed to be valid, expiration date 23-NOV-2021 (route and site of administration were not provided), which was reconstituted with sterile diluent (STERILE DILUENT) lot # T001190 was confirmed to be valid, expiration date was not provided but upon internal validation was established as 29-AUG-2022, and varicella virus vaccine live (oka/merck)(VARIVAX) (dose, lot#, expiration date, route and site of administration were not provided), both for prophylaxis. Other suspect vaccines included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# and expiration date were not provided).   On that day, the patient experienced overdose and wrong product administered. The patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) with varicella virus vaccine live (oka/merck)(VARIVAX) but was supposed to received varicella virus vaccine live (oka/merck)(VARIVAX) with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The outcome of overdose and wrong product administered were unknown.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient has received  booster shot on 12/26/2021. Patient called on 12/29/21 stating that he expereinced severe swelling and itch of his whole body and face on morning of 12/27/2021. Pt stated that he has been using cortisone and eczema creams to help with the itch and swelling since that time and symtoms did get better by 12/29/21, but there still was moderate swelling and onstatnt itch. I did advise patient to see a dr and go to the ER if symtoms get worse. Symptoms are better on 12/30/21.
COLD; COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED; COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (COLD), VACCINATION SITE PAPULE (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED) and VACCINATION SITE PAIN (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On 30-Nov-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) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 in 1 wk. On an unknown date, the patient experienced NASOPHARYNGITIS (COLD), VACCINATION SITE PAPULE (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED) and VACCINATION SITE PAIN (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED). At the time of the report, NASOPHARYNGITIS (COLD) outcome was unknown and VACCINATION SITE PAPULE (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED) and VACCINATION SITE PAIN (COVID VACCINE INJECTION SITE WAS VERY SORE AND RAISED) was resolving.            Concomitant medication was not reported.  On an unknown date patient had lack of effect with Humira.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (each time soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient had no allergies to medications, food, and other products. The patient never had COVID + test or diagnosis. The patient didn't reported receiving any other vaccines within 1 month prior to Moderna COVID-19 vaccine. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (each time soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (each time soreness at the injection site) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant product use was reported. The patient stated that after receiving the Moderna primacy series doses (1st and 2nd) each time patient experienced soreness at the injection site. The patient reported they didn't had any other side effects from any of these doses. No treatment information was provided. This case was linked to MOD-2022-545276, MOD-2022-545265, MOD-2022-545278 (Patient Link).
redness; swollen; tender; warm area; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 4th December 2019, 2 days after receiving Shingrix, the patient experienced erythema, swelling, tenderness and skin warm. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the swelling, tenderness and skin warm were unknown.   It was unknown if the reporter considered the erythema, swelling, tenderness and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient stated that, after vaccination with dose of Shingrix, had red, swollen, tender, warm  area 2 to 3 inches belowthe injection site. The patient received vaccine at reported pharmacy. The patient consented to follow up with health care professional.
Hypersensitivity and burning sensation located on right side forehead, right eyebrow, surrounding right eye, radiating to temple. Started 2 days after vaccination and has been constant since then as of 5/13/2021
RECEIVED THE SHOT ON 10/2/21,  THREE DAYS LATER FACIAL NUMBNESS OCCURRED. NOT SWOLLEN, JUST NUMB. THIS DISAPPEARED AFTER A DAY AND THEN MY LIPS BECAME NUMB FOR THREE DAYS BEFORE SUBSIDING THEN LOWER LIP CONTINUED TO BE NUMB UNTIL THIS AFTERNOON.  I HAVE ALSO EXPERIENCED OCCASSIONAL RAPID HEARTBEATS THAT CAUSE MY HANDS TO SHAKE/TREMBLE BUT IT HAS SUBSIDED.
Blood clots at time of periods that have been abnormally large.  Much heavier bleeding than last 20 years.
Around 5 days after shot, rash appeared and was very warm to the touch and very itchy, rash looked like a target
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Fever-Severe