chrisvoncsefalvay/vaers-outcomes huggingface dataset:
" I received the dose in my left arm and immediately after I was escorted from the treatment room to the waiting area I noticed a metallic taste in my mouth. I sat down to wait for my 15 minutes to be up as requested by the pharmacist. Within a minute of waiting my tongue started feeling numb on my left side and the left side of my face started tingling (cheek and region just below my eye). I also felt like my throat was tight and felt like I needed to clear my throat. I started researching "face tingling moderna" as I was getting concerned. I waited in the chairs for 20 minutes or so and no one came out of the pharmacy. My symptoms had not worsened but were not all the way gone with the face tingling remaining the longest. I decided to do some shopping as planned and would report my symptoms to the pharmacy if they didn't go away. All in all my symptoms lasted 25-30 minutes with the most intensity in the first 15 minutes."
She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume.  A 70-years-old female patient  received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation .  Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing  She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections.   The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting,  swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.
Saturday evening the day of the shot I become extremely fatigued, Sunday morning woke up with extreme muscle aches, Sunday after noon developed the chills and fever. When fever reached 101.1 started taking Advil but fever continued to rise  started alternating every 2 hours with Tylenol fever finally stopped increasing around 1 am on Monday highest it went was 102.3. Monday and Tuesday continued to have a fever ranging from 99.5 to 100.9 did not take anything to treat this. Felt fine otherwise. Today feel fine and fever free
Right deltoid IM injection. Crying, fussy, immediate 2" diameter redness with swelling around injection site. 4 drops of blood wiped away.
ANXIOUS; RAPID HEART BEAT; HIVES; This spontaneous report received from a health care professional concerned a 20 year old female. 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced anxious. On MAR-2021, the patient experienced rapid heart beat. On MAR-2021, the patient experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives, anxious and rapid heart beat was not reported. This report was non-serious.
Tested COVID positive, symptoms include  shortness of breath, abdominal pain, and diarrhea.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Shellfish" (unspecified if ongoing). There were no concomitant medications or other medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Jun2022 to 03Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event covid 19 and Drug ineffective and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Shoulder pain is no longer there/don't feel the pain anymore/haven't touched the Tylenol since the shot/ pain has substantially decreased, and some movement has improved; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Shoulder pain is no longer there/don't feel the pain anymore/haven't touched the Tylenol since the shot/ pain has substantially decreased, and some movement has improved) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement in 2020. Concurrent medical conditions included Penicillin allergy, Blood pressure high, Arthritis (Related to shoulder) and Arthritis (Related to Knee). Concomitant products included AMLODIPINE for Blood pressure, LISINOPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS], MAGNESIUM and TAMSULOSIN for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Shoulder pain is no longer there/don't feel the pain anymore/haven't touched the Tylenol since the shot/ pain has substantially decreased, and some movement has improved). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, qd and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Shoulder pain is no longer there/don't feel the pain anymore/haven't touched the Tylenol since the shot/ pain has substantially decreased, and some movement has improved) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up SD received on 13-MAY-2021 updated the Additional information about treatment drug and patient information On 12-Jun-2021: Follow-up SD received on 12-MAY-2021 updated the about additional information.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-OCT-2017, the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, therapy type lot # and expiration date were not reported) for prophylaxis. On the same date, the patient was also vaccinated with the first dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). 27 days later on 02-NOV-2017, the patient was vaccinated with her second doses of M-M-R II and VARIVAX. No adverse effect was reported.
Breakthrough case admission after four vaccines: Moderna 2/5/2021 batch/lot# 010M20A; Moderna 3/5/2021 batch/lot# 010M20A; Moderna 8/9/2021 batch/lot#040C21A; Moderna 4/5/2022 batch/lot# 066K21A.
Pt inadvertently received Hepatitis B vaccine along with scheduled Moderna 6mo-5yr and flu vaccines.
Expired Havrix Administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 39-year-old male patient who received HAV (Havrix 1440 adult) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 21-MAR-2023, the patient received Havrix 1440 adult. On 21-MAR-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced expired vaccine used (Verbatim: Expired Havrix Administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 The reporter was physician assistant. The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up. The patient received expired dose of Havrix adult, which led to expired vaccine used.
pt recv vax 15DEC97 130PM by the evening had a rash on upper body & flu like sx;the next morning 19DEC had rash, flu like sx & sore throat & h/a;also dec grade fever since evening of 15DEC;still has a severe h/a;went to MD 19DEC;
Headache, Myalgia, Fever, Fatigue,chills Narrative:
Vaccine expired on 01Apr2022, vaccine placed in refigerator on 04Apr2022, vaccine administered on 11Apr2022; Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01Apr2022, vaccine placed in refigerator on 04Apr2022, vaccine administered on 11Apr2022) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01Apr2022, vaccine placed in refigerator on 04Apr2022, vaccine administered on 11Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01Apr2022, vaccine placed in refigerator on 04Apr2022, vaccine administered on 11Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The vials were initially stored in refrigerator on 04Apr2022. The vial has not undergone temperature excursion. It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01Apr2022. No treatment medication was provided.
My arm hurts. Sometimes I get spasms. I could only raise it to a certain level and it begins to hurt. I saw a doctor and they gave me a shot for the pain. The shot helped a little bit but my arm still hurts a little bit and that bothers me. Tiredness; fatigue all the time. General body aches-especially on my left-side.
SWOLLEN AT THE SITE OF INJECTION; FEVER; PAIN AT THE SITE OF INJECTION; ITCHING; LITTLE DIZZY; FELT WEAK; REDNESS AT THE SITE OF INJECTION; FEELING SICK; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced little dizzy. On MAR-2021, the subject experienced felt weak. On MAR-2021, the subject experienced redness at the site of injection. On MAR-2021, the subject experienced feeling sick. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced pain at the site of injection. On 09-MAR-2021, the subject experienced swollen at the site of injection. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching, swollen at the site of injection, and redness at the site of injection, fever on 08-MAR-2021, and pain at the site of injection on 13-MAR-2021, had not recovered from little dizzy, and felt weak, and the outcome of feeling sick was not reported. This report was non-serious.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the reporting healthcare professional on 02-JUL-2015, who informed that a patient was vaccinated on 09-JUN-2015 with a dose of ROTATEQ lot # K016313, expiration date not reported, (administration route was not provided). According to the reporter the vaccine dose that was administered underwent a temperature excursion for 87 hours. This is one of several reports from the same reporter. Additional information has been requested.
1ST DOSE PFIZER VACCINE ADMINISTERED AT 6AM, EMS CALLED AT 12P DUE TO DIZZINESS AND CHILLS. PATIENT SEEMED ANXIOUS PRIOR TO VACCINE ADMINISTRATION
This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 05-FEB-2019, the patient received improperly stored dose of VARIVAX (lot # N017394, expiration date 07-JUN-2019) subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of VARIVAX was exposed to a temperature excursion of 11.9 Farenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter.; Sender's Comments: US-009507513-1903USA001826: US-009507513-1903USA002595: US-009507513-1903USA002596: US-009507513-1903USA002597: US-009507513-1903USA002598: US-009507513-1903USA002600:
On 10/31/2021 I began experiencing uterine cramping and spotting on 11/1/2021 until 11/6/2021. I have been on nexplanon since June 2021 and haven?t had a period or any period symptoms since  being on nexplanon.
1st shot on Oct2019, did not receive 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had 1st shot of shingles vaccine in October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-SEP-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient apparently did not have a second shot of shingles vaccine.  The reporter wanted to know if he/she should get one now. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.
Red at injection site with warmth and a hard knot.  Arm pain all of the day and kept me up all night. I woke to go to the bathroom about 0100 and found that I had a rash from my elbow up to my shoulder. I had some raised areas like i was trying to get hives. My lymph nodes under my armpit are swollen and hurt.  I did take benadryl before bed last night because my seasonal allergies have been so bad.
Heart Palpitations, no treatment. Excessive, continuous treatment.  Excessive menstrual cramping
she was real "swimmy" headed, like a fog; sinus infection with fever; sinus infection with fever; arm sore; felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), DIZZINESS (she was real "swimmy" headed, like a fog), SINUSITIS (sinus infection with fever), NAUSEA (felt nauseated) and PYREXIA (sinus infection with fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot 013L20A) for COVID-19 vaccination.     Concomitant products included MESALAMINE, HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN HCTZ), GABAPENTIN, VITAMIN D2, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FISH OIL, MONASCUS PURPUREUS, NICOTINAMIDE, PHYTOSTEROLS NOS (RED YEAST RICE WITH PLANT STEROLS) and CENTRUM SILVER +50 for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and NAUSEA (felt nauseated). On an unknown date, the patient experienced DIZZINESS (she was real "swimmy" headed, like a fog), SINUSITIS (sinus infection with fever) and PYREXIA (sinus infection with fever). On 27-Jan-2021, NAUSEA (felt nauseated) had resolved. On 29-Jan-2021, PAIN IN EXTREMITY (arm sore) had resolved. At the time of the report, DIZZINESS (she was real "swimmy" headed, like a fog), SINUSITIS (sinus infection with fever) and PYREXIA (sinus infection with fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 7.8 or 7/8 (Inconclusive) 7.8, or 7/8?.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information provided.
Client received a dose of Janssen COVID19 vaccine on 03/16/2021. Patient received a 2nd dose of Janssen COVID19 vaccine on 09/27/2021.  Client completed vaccine consent questionnaire and marked "no" to the question as to whether he had received a COVID19 vaccine previously.
PATIENT REPORTS HAVING SWELLING, REDNESS, SORENESS AND SKIN BEING WARM TO THE TOUCH BENEATH THE INJECTION SITE 24 HOURS AFTER INJECTION. SHE ALSO REPORTED BEING FAITGUED AND EXPERIENCING MUSCLE PAIN. PATIENT WILL CONTINUE TO MONITOR REACTION AND SEEK IMMEDIATE MEDICAL HELP IF SYMPTOMS PERSIST OR WORSEN.
Severe headache, severe muscle pain, loss of taste, severe skin sensitivity on whole body, sleepiness, lethargic, sharp eye pains
Fever-101.8  sleepiness for14 hours  no energy and headache with pain in arm. Treatment was acetaminophen 1300mg and rest, within 48 hrs after the shot I as feeling a bit stronger and awake.
Tired.  Chill with multiple temperature readings between 96.5 and 96.8F
Information has been received from a nurse concerning an  approximately 83 year old female patient. The patient's concurrent conditions included hypertension, thyroid issue, Atrial fibrillation (AFIB) and allergy to quinapril hydrochloride. No pertinent medical history was reported. Concomitant therapies included an unspecified thyroid medicine and an unspecified  high blood pressure medicine. On 10-OCT-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX23 (lot # M026317 with an expiration date of 11-JAN-2018) (dose, route, anatomical location of administration and expiration date were not  reported). Other suspect medications were not reported. On an unspecified date in 2016, after receiving PNEUMOVAX23, the patient experienced redness and swelling around the injection site and was diagnosed with cellulitis. The patient sought medical attention by visiting the physician's office and she was treated with an unspecified antibiotic. No laboratory studies were performed nor product quality complaint was involved. On unknown date in 2016, the patient recovered from  the cellulitis. The relatedness between the event and therapy with PNEUMOVAX23 was not reported. Upon internal review, cellulitis was determined to be a medically significant event. This is a Corrected report. The field Potential Lot Check was marked as Yes, as the case meets the criteria for Adverse Event Quality Investigation Process. Follow up information has been received from the reporting nurse on 20-DEC-2016, concerning a 83 year old female patient. On 10-OCT-2016 at 10:38, the patient was vaccinated with a dose of PNEUMOVAX23 via intramuscular in the left deltoid. On 11-OCT-2016 at 16:45, the patient experienced cellulitis on the left arm. The patient received AUGMENTIN 125 mg tablet, 875 mg bid for 10 days as treatment. On 21-OCT-2016, the patient recovered from cellulitis. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information had been sent and received. Sender's Comments: US-009507513-1611USA007073: US-009507513-1611USA007077: US-009507513-1611USA007088:US-009507513-1611USA007096: MERCK 1611USA007131: Mfr number.
48 hours after 2nd COVID injection, severe shortness of breath. Unable to perform any activity, including getting dressed , walking from room to room any physical activity without sitting or lying down to catch a breath. Also during this time experienced chills, body aches, muscle weakness.
Pt had a headache later in the day which has continued until today (2/16/13) and has a red, hot, itchy patch of skin at the injection site about 3 in x 4 in.