chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 10 minutes after receiving their 1st COVID shot, patient reported to pharmacy staff that they felt like their tongue was numb and tingling. Patient then spoke to the pharmacist and they stated they also felt like their throat was swollen and were given Benadryl 25mg. Staff called 911 and pharmacist administered an Epi-pen after patient stated they had difficulty breathing, felt like their throat, and tongue was swelling. Pharmacist waited with patient until EMTs arrived where they then took the patient under their care. EMTs did not indicate they were sending patient to nearby Emergency Room to pharmacy staff. (Continued on continuation page) Patient was apprehensive about going to the ED; EMTs said they would first monitor patient and decide if they'd go to ED or not. Pharmacist called local ED to see if patient was admitted around 5:30pm that day. Per ED staff, patient was not admitted. Tried calling patient later that day and the next day as well but no answer
A very red rash / the size of my hand; A very red rash /and was very itchy; Could not sleep; Fever / were better after 24 hours; Aches / like when you have a cold / were better after 24 hours; This case was reported by a contact via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia, sleep disorder, nervous system disorder and pain.   On 15th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fever, flu-like aching, red rash, itchy rash and insomnia. The patient was treated with paracetamol (Tylenol) and sleep medication (nos) (Sleep Medication). On an unknown date, the outcome of the fever, flu-like aching, red rash, itchy rash and insomnia were recovered/resolved.   It was unknown if the reporter considered the fever, flu-like aching, red rash, itchy rash and insomnia to be related to Shingrix.  Additional details were provided as follows: The age at event onset was not reported but it could be 74 or 75 years. The case was reported by the patient for herself. The patient had a bad reaction with the 1st dose of Shingrix. After 1st dose the patient experienced fever, aches like when she had a cold, a very red rash the size of hand her and was very itchy.  The patient could not sleep and had to take Tylenol and a medication to sleep. Patient stated because she had fibromyalgia it maybe made it worse because of this. Fever and aches were better after 24 hours but it took almost 5 to 7 days for rash to go away and the other symptoms for about 2 to 3 days. The patient also had 2nd Shingrix shot on 8th January, 2021 she took 650 mg of Tylenol and 25 mg of Benadryl one hour before the shot. The reporter consented to follow up.
I have a red half-circle on my neck opposite the side of the Covid Vac. Not itchy not raised didn't even know it was there.. headache comes and leaves in 2 seconds.  Didn't sleep well.  Arm is sore
desquamating rash, peeling rash with large pieces of skin coming off, on the palms, soles, and feet to the calves bilaterally. spares the face and abdomen. also present on the mid back. occurred ~5 days after receiving her second covid vaccine (moderna)- out of 3/28/21.
After 5 minutes of the shot I got up to walk around while I waited out the rest of the 15 minutes. While walking I immediately had paralyzing pain from right under my left hip area shooting straight down the front outer part of my leg. It has continued since then. No swelling though. They had me stay an additional 15 minutes to check for swelling and to see if the pain would go away; it did not. Doesn't hurt much when I sit, just when I put pressure on my leg to walk. My left butt cheek did begin hurting 35 minutes later when we left. They didnt know how to respond so they just gave me ibuprofen for the pain so I am letting that kick in now to hopefully help. If it doesn't then I will either see my regular physician or go to the ER
Cold sores in mouth that are painful and only presented after receiving the vaccine, still persist A minor headache for the rest of the day after receiving the vaccine Lethargy for the rest of the day after receiving the vaccine Muscle soreness at injection site Itchiness at injection site and on chest briefly after injection then subsided
Tinnitus (ringing in ear); This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 18Mar2021 at 11:00 (at the age of 57-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Apr2021 at 11:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, after the first dose, the patient experienced tinnitus (ringing in ear). It was reported that the event did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event tinnitus (ringing in ear) was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
She had some problems; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had some problems) and VOMITING (Threw up) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She had some problems) and VOMITING (Threw up). The patient was treated with PREDNISONE for Adverse event, at a dose of 10 and AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (She had some problems) and VOMITING (Threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
PATIENT PASSED OUT  AND WAS  SHAKY.  HER EYES ROLLED BACK FOR 2 SECONDS THEN UNRESPONSIVE FOR 10 SECONDS WHILE RUBBING CHEST COMPLAINED OF LEFT SIDE NUMBNESS AND TINGLING.  PUT COLD WHATER ON PATIENTS HEAD AND HAD HER DRINK COLD WATER.  TRANSPORTED TO ER.
Develop appendicitis after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Develop appendicitis after the first dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced APPENDICITIS (Develop appendicitis after the first dose) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (Develop appendicitis after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. No treatment product information was provided.  Company comment: This case concerns a 52-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Appendicitis. The event occurred on an unknown date after the first dose of Spikevax. The rechallenge was not applicable although the outcome of appendicitis is unknown, it could be interpreted that appendicitis should have recovered before the second dose is received. The benefit-risk relationship of Spikevax in not affected by this report. Query is added to send the patient Adverse Event Follow up Form, provide notes from a clinic and further details of the date of the first dose of vaccination and date of the event, outcome of the event.   This case was linked to MOD-2021-332183 (Patient Link).; Sender's Comments: This case concerns a 52-year-old, female patient with no relevant medical history, who experienced the serious unexpected event of Appendicitis. The event occurred on an unknown date after the first dose of Spikevax. The rechallenge was not applicable although the outcome of appendicitis is unknown, it could be interpreted that appendicitis should have recovered before the second dose is received. The benefit-risk relationship of Spikevax in not affected by this report. Query is added to send the patient Adverse Event Follow up Form, provide notes from a clinic and further details of the date of the first dose of vaccination and date of the event, outcome of the event.
Rash developed entire body. Swollen glands. 3/4-ER treated with Amoxicillin-Otitis Media. 4/8- Developed Rash over face, upper extremity torso, lower extremity palms, not soles (diffuse fine Morbilliform).
Patient received moderna shot (first dose in series) on 5/2/21. Patient  then received Pfizer shot on 5/30/21. No reactions or adverse outcomes, patient was observed for 30 minutes.
Cellulitis to left upper arm, hot to touch. Patient presenting with wheezing and sob. Prescribed KEFLEX and PROAIR inhaler.
A moderna vaccine for age group age 6-11 year old was given 3 days past expiration date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A moderna vaccine for age group age 6-11 year old was given 3 days past expiration date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A moderna vaccine for age group age 6-11 year old was given 3 days past expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A moderna vaccine for age group age 6-11 year old was given 3 days past expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A moderna vaccine for age group age 6-11 year old was given 3 days past expiration date).    No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. 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.  Company Comment: This spontaneous case concerns a 49-year-old, female patient with a concurrent condition of psoriatic arthritis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 after receiving a 2-dose primary series of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 relative to vaccination cannot be determined with an unknown event's onset date. Interval between doses 1 and 2 was 34 days apart. Outcome of the event was reported as not resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying condition of psoriatic arthritis and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 49-year-old, female patient with a concurrent condition of psoriatic arthritis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 after receiving a 2-dose primary series of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 relative to vaccination cannot be determined with an unknown event's onset date. Interval between doses 1 and 2 was 34 days apart. Outcome of the event was reported as not resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying condition of psoriatic arthritis and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.
Abdominal pain, joints and muscles ache, acid reflux, anxiety, vertigo and dizziness, high cholesterol, chills. Concentration-trouble, difficulty, loss of. Depression. Dermatitis. Diarrhea, digestive problems, low energy. Gastritis. Headache. Ringing in ears. Inflammation inject site. Short term memory loss. Neck rigid. Numbness and tingling in arms and down one side of body. Pain legs, lower back, back, knees and hips. Stiffness. Pain in feet, inject site, neck. Rash. Itchy skin. Cellulitis. Skin discoloration. Stomach problems. Weight gain. Walking difficulty. Struggle for words.
Vaccinated with Pfizer COVID vaccine on 1/21/21 and 2/12/21. Unknown facility, lot number  Hospital course 2/24 ? 2/26/21 2/24 Chief complaint: Chest Pain. Per EMS - CP and SOB started 1220. Mid CP radiating to left arm. semi-relief with nitro x 2. Reports N. Denies V and no other symptoms. Hx cardiac stents, MI.  HPI: Patient is a 77-year-old female who presents to the ER for evaluation of chest pain.  Patient states that her chest pain started this afternoon around 1230 when she was cooking lunch.  She says it lasted for about 10 minutes and was a intense substernal chest pressure sensation with radiation down her left arm.  She had associated shortness of breath and diaphoresis and also endorsed nausea without vomiting.  Patient also states she is had some occasional dizziness which she described as a room spinning sensation is made worse when she is in positions and standing or moves her head.  She has a history of 2 heart attacks and 2 stents placed which were done.  She has no local cardiology follow-up and she lives at an apartment and follows with pace.  EMS gave her 4 aspirin prior to arrival she takes no blood thinners but she does take Plavix.  Patient has a history of COPD and also endorses some wheezing, she says they took her nebulizer away from her for fear of spreading coronavirus and she is oxygen dependent at nighttime.  COVID positive 2/24/21 (this assay amplifies and detects The target rna using real-time pcr. Testing performed on cepheid genexpert) Patient states she tested negative for COVID 19 last week at her PCP and got her 2nd COVID 19 vaccine on 2/11/2021. She reports having dinner with a friend 3 weeks ago who just passed away from COVID 19.  EKG shows normal sinus rhythm with incomplete right bundle branch block and no obvious ST segment elevations or acute ischemic intervals Troponin negative  Patient admitted to the COVID unit.  Home (baseline) O2 requirement 2.5L at night  2/25: 3L O2 nasal cannula continuously, reduced to 2L within 12 hours No fever COPD with acute exacerbation: Diffusely wheezing bilaterally and in tripod position on exam.  Start IV Solu-Medrol  COVID-19 viral infection: Start IV Remdesivir as she is now requiring supplemental oxygen.  IV steroids as above.   Chest pain, history of CAD with previous stenting --Denies any chest pain on exam.  EKG negative for ischemic changes.  Troponin negative x1.  Continue to trend troponin x2 more occurrences. --Continue Aspirin, Plavix, statin, Imdur.   Anxiety disorder: Continue Prozac.  Add Xanax 0.25 mg 3 times daily as needed.   2/26: medically ready for discharge to SNF COVID unit.  Augmentin 875/125 x 7 days dexamethasone 6mg daily x 8 days
approx 1 hr p/vax, crying non-stop 3hrs & drooling more than usual, appeared sapcey a/falling asleep
temperature excursion; No adverse event; Patient adminsitered with vaccine that had undergone temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient adminsitered with vaccine that had undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient adminsitered with vaccine that had undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient adminsitered with vaccine that had undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient adminsitered with vaccine that had undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion).    Concomitant medication was not provided.   It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that lost power the next day in the middle of the day at 12:00 PM and placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 patients. No symptoms were reported.  Treatment information was not provided.  This case contains information for the 24th patient out of 26 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
I had a friend who had something similar that's growing underneath her one arm/she had a lump on her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM SKIN (non-serious), outcome "unknown", described as "I had a friend who had something similar that's growing underneath her one arm/she had a lump on her arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A week or two after receiving vacine I noticed I was having mild chest pains off and on. Sometimes when laying down or laughing I would have shortness of breath and the pains in my chest would come 2 - 3 days out of a week lasting 3-5 mins off and on
I had a household member that tested positive so I got tested immediately and it was Positive for Covid-19. I got a headache fever and nasal congestion. On the third day I developed a cough and chest congestion. The fever lasted for one week. I was fatigued for about 2 months. At the start I was sleeping 10-12 hours a day. I got my Booster one month after I tested Positive. Six weeks after getting my Booster which was 3 months after getting Covid-19 I started to experienced numbness and pain in my hands. I could not feel my index finger and thumb on my right hand for 3 weeks. I have no strength in my hands and it is very hard to grasp anything or rotate my wrist. I wear braces on my hands when I sleep. I was Prescribed Gabapentin twice daily and I received Steroid shots in my wrists which did not help. In the beginning my finger tips were numb but it subsided. The pain continues in my hands and it varies from which hand and which area of my hands that hurts and it has been two months.
Patient fainted 15 minutes after getting his first dose of covid-19 vaccine. He fainted for about 15-20 seconds and came back saying his vision decreased and thought he was dreaming. He was breathing normal upon wakening and didn't complain of anything else. he was lying flat until EMS arrived on site after approximately 10 minutes.  He was able to get up and leave the facility by himself and didn't get transported to any medical facility.
Post vax, the pt developed severe left arm pain and tenderness at injection site on left deltoid.
DIZZINESS AND NAUSEATED TREATMENT ONDANSETRON 4MG ODT 1 TID