chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VOMITING; DIARRHEA; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the patient experienced vomiting, diarrhea, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, diarrhea, and nausea on 2021. This report was non-serious.
Sore arm at 13:00- ongoing Headache and body aches at 15:00- ongoing Loss of voice and cough 17:00- ongoing Fever at 05:00 on 10/29 off and on
a little stomach ache; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on 21May2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a little stomach ache on 23May2021. The patient received treatment with TYLENOL (Paracetamol). The outcome of event was not recovered as the patient had this event at the time of report.  Information on the lot/batch number has been requested.
Per patient following day had joint aches, malaise, low grade fevers, nausea, and headache
pain on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EN6208) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2009 (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Mar2021, outcome "recovered" (2021), described as "pain on the injection site".  Additional information: No prior Vaccinations within four weeks of the suspect vaccine. Reported that, Patient had the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE last on 15Mar2021, Developed pain on the injection site of left arm starting 15Mar2021 and it was resolved which only lasted about a day or two. Outcome of that event unable to be clarified as if recovered completely or with lasting effects, when queried patient, he reported that he did not notice any problems after that, did not have the pain at the injection site of left arm after that day or two. Time the Vaccination was given was reported as about 17:00. Event not resulted to Emergency Room and Physician Office. Patient was not hospitalized. Regarding concomitant products and other medical conditions caller reported that there is no relevant information to provide for this report. He reported being told that the medications he takes do not effect anything, not relevant.   No follow-up attempts are possible. No further information is expected.
Flu-like symptoms - body aches, fatigue,  diarrhea for several days
Patient received first Moderna COVID vaccine.  While waiting in the observation area, patient complained of itching at the injection site, hives on chest and mild SOB approx 5-10 minutes post vaccine.   Paramedic present in vaccine clinic responded ASAP and called a Rapid Response overhead, which was cancelled when patient stated that she was comfortable to walk to the Emergency Dept.  She was escorted to ED by a paramedic.   ED physician assistant evaluated patient and noted the following:  mild redness on her upper chest, upper left upper arm and back.  Patient denied chest discomfort, throat discomfort, no SOB, no n/v.     Physical exam documentation: Physical Exam General:  Alert, no acute distress, Not ill-appearing,   Skin:  Warm, dry, intact, mild redness to the anterior chest and back.  No urticarial rash noted., - edema .   Head:  Normocephalic.  Neck:  Supple.  Ears, nose, mouth and throat:  throat clear; -edema able to swallow saliva -stridor -tongue edema -hoarse voice -hot potato voice.  Cardiovascular:  Regular rate and rhythm.  Respiratory:  Lungs are clear to auscultation, respirations are non-labored, breath sounds are equal,  no retractions.   Gastrointestinal:  Soft, Nontender, Non distended.   Musculoskeletal:  Normal ROM.  Neurological:  Alert and oriented to person, place, time, and situation.  Psychiatric:  Cooperative.  Patient prescribed diphenhydramine 50 mg IM x1 dose and observed in ED for approx 1 hour afterward.  Noted that itching and redness was resolved.  Pt denied SOB, chest/throat discomfort.  Pt was discharged and asked to follow-up with PMD.
pt recv vax 19MAY97 & 29MAY97 pt devel one lesion on inner aspect of rt arm;then devel lesions on back & neck;arms & legs felt itchy & exp pain in neck;
severe headache; chills; tired; cold; This is a spontaneous report from a contactable consumer (patient). A 25-Year-Old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot no. EL3248) via unspecified route of administration in left arm on 09Feb2021 at 01:30 PM as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. She was not pregnant at that time. Previously patient received first single dose of BNT162B2 (lot no. EL3248) via unspecified route in left arm on 20Jan2021 01:15 PM for covid-19 immunisation. Patient experienced severe headache, chills, tired on 10Feb2021 at 06:00 AM and cold on feb2021. she felt great the remainder of my vaccination day. The next morning (10Feb2021). she woke up with a severe headache and chills. It should be noted that she only got around 2.5 hours of sleep, causing her to be extremely tired, which could be contributing to the headache. she also tends to be cold a lot of the time. Today seems to be worse than normal, but again, this could be independent of the vaccination. She did not receive treatment for adverse event. No covid prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Starting 3 days after vaccine, extreme fatigue made it difficult to get out of bed. I was so fatigued that I was unable to get up long enough to make food; I did not eat anything for 2 days.  I was unable to work and missed 4 days of work total and could only telework half days the next 2 weeks.  My muscles were sore, and I was physically weak for 2 weeks total.  During this time, I also experienced testicular pain and swelling which made it difficult to walk.  Muscle pain and weakness are still an issue 2 months after vaccination.
6 days after receiving vaccine, injection site became red (rash appearance) and warm to touch, which lasted 3 days. Site was also slightly itchy and swollen 6 days after injection, which lasted about 1 day . Erythema was about 4 inches in height and 2 inches in width around the injection site.
had a cold sore breakout; soreness in arm; had lymph node enlargement on mammogram; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ORAL HERPES (had a cold sore breakout), PAIN IN EXTREMITY (soreness in arm) and LYMPHADENOPATHY (had lymph node enlargement on mammogram) in a female patient of an unknown age 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 ORAL HERPES (had a cold sore breakout), PAIN IN EXTREMITY (soreness in arm) and LYMPHADENOPATHY (had lymph node enlargement on mammogram). At the time of the report, ORAL HERPES (had a cold sore breakout), PAIN IN EXTREMITY (soreness in arm) and LYMPHADENOPATHY (had lymph node enlargement on mammogram) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: had lymph node enlargement detected.         No concomitant information was reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-663907, US-MODERNATX, INC.-MOD-2022-664322 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663907:Reporter Case(Crosslink Case Number) US-MODERNATX, INC.-MOD-2022-664322:Same reporter(Crosslink Case Number)
Immediately about a week after my right hand in-between the ring finger and other finger I had a really bad itch like I never an itch like it. A couple of days later it started bleeding from so much scratching. It spread to both hands till up the top of my elbows completely around the arm and in-between my fingers. Now it is behind both of ears, all around my eyes. My groin and nut sack, it is red and inflamed. It's everywhere. If I scratch It starts cracking and bleeding. A living nightmare.
HAD SEVERE BODY ACHE, SORE THROAT AND COUGH AND FEELING MISERABLE AFTER RECEIVING FIRST DOSE OF MODERNA ABOUT 6 WEEKS AGO. STILL FEELING WEAK AND SICK OFF AND ON. PATIENT REPORTED HE NEVER WENT BACK FOR THE SENCOND DOSE OF VACCINE.
25 Minutes after the vaccine, patient came back to physician office complaining of burning, tingling and itching to face, arms and hands. Declines SOB, wheezing, tightness or swelling of throat.  No visible swelling or rash upon exam. BP 114/80, pulse 76 100% on room air.   Tingling and burning in arms/hands subsided.  sensation on face around nose and forehead was still present so patient give diphenhydramine 50 mg PO x 1.  Counseled on s/s of allergic reactions.
Hot flash while driving. Hot flash ended after a few minites but breathing was labored during hot flash. Took deep breaths with open car window for remainder of car ride (5 minutes). When home, lightheadedness to the point that I called my husband home. Drank water and sat for 2 hours until lightheadedness resolved.
minor headache; fever; chills/shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia and Shingrix with an associated reaction of chills (For the tolerability of 1st dose, refer case US2020AMR046605 reported for same patient.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache and 1 day after receiving Shingrix, the patient experienced fever and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that he  just had his 2nd Shingrix dose and he was wondering how long, on average, do the common side effects last? This dose he started with a minor headache last night but by this morning he was full on fever, chills, shivering etc. The patient was just curious as to how long this might last.
Adult patient received the pediatric dose of engerix-b; Adult received pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 57-year-old female patient who received HBV (Engerix B 10 mcg) (batch number YM444, expiry date 22nd May 2024) for prophylaxis.   On 24th August 2022, the patient received the 2nd dose of Engerix B 10 mcg. On 24th August 2022, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received the pediatric dose of Engerix-B in the right deltoid. The reporter consented to follow up. Additional supportive information: The adult patient was administered a pediatric dose of Engerix-B, which led to adult use of a child product and underdose.
I still have chest inflammation; I still have lung inflammation; I still feel very sick; Have some odd side effects/Inability to sneeze; Painful sensation in abdomen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (I still have chest inflammation), PNEUMONITIS (I still have lung inflammation), MALAISE (I still feel very sick), VACCINATION COMPLICATION (Have some odd side effects/Inability to sneeze) and ABDOMINAL PAIN (Painful sensation in abdomen) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (I still have chest inflammation), PNEUMONITIS (I still have lung inflammation), MALAISE (I still feel very sick), VACCINATION COMPLICATION (Have some odd side effects/Inability to sneeze) and ABDOMINAL PAIN (Painful sensation in abdomen). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 mg, every 8 hours. At the time of the report, CHEST DISCOMFORT (I still have chest inflammation), PNEUMONITIS (I still have lung inflammation), VACCINATION COMPLICATION (Have some odd side effects/Inability to sneeze) and ABDOMINAL PAIN (Painful sensation in abdomen) outcome was unknown and MALAISE (I still feel very sick) had not resolved.            No relevant concomitant medications were reported.
CONFIRMED COVID-19 INFECTION; SLIGHT ARM PAIN; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included no previous medical history and no known allergies. no drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced slight arm pain. On 09-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) PCR was positive on 10-APR-2021. On 10-APR-2021, the subject experienced confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight arm pain on 2021, and had not recovered from confirmed covid-19 infection. This report was non-serious. This case is associated with product quality complaint (PQC) number 90000176134.The suspected product quality complaint has been confirmed to be this report indicated a patient who received a positive covid-19 test result after vaccination, with 9 days elapsed between vaccine and test. Sufficient time was not elapsed for the patient to achieve immunity therefore, this report was not considered a lack of effect. case was approved for void, based on the pqc evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Red enduration around injection site; Itching around injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), VACCINATION SITE INDURATION (Red enduration around injection site) and VACCINATION SITE PRURITUS (Itching around injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMINS NOS (DAILY VITAMINS) and MELOXICAM for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 27-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Red enduration around injection site) and VACCINATION SITE PRURITUS (Itching around injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 01-Mar-2021, VACCINATION SITE PRURITUS (Itching around injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE INDURATION (Red enduration around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: AE outcome updated from unknown to recovered/resolved for the events of sore arm and red induration around injection site.
sore throat; fever; felt light headed; This is a spontaneous report received from non-contactable consumer, the patient. A 31-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left deltoid on 19Mar2021 at 11:15 (at the age of 31-years-old), as single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient experienced light headed. On 20Mar2021 at 04:00, the patient experienced fever and sore throat. The patient did not receive any treatment for the adverse events. The adverse events resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of light headed, fever and sore throat were not resolved at the time of report.  Information about lot/batch number cannot be obtained. No further information is expected.
Patient tested positive for COVID after receiving the 3rd dose of the vaccine; Patient tested positive for COVID after receiving the 3rd dose of the vaccine; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 28Nov2021 (Lot number: 320308D) at the age of 40 years as dose 3 (booster), single, administration date 23Apr2021 (Lot number: EW0161) as dose 2, single and administration date 31Mar2021 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 04Jan2022, outcome "recovering" and all described as "Patient tested positive for COVID after receiving the 3rd dose of the vaccine"; IMMUNISATION (medically significant) with onset 28Nov2021, outcome "unknown", described as "Booster". The event "patient tested positive for covid after receiving the 3rd dose of the vaccine" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: Inteliswab test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Product was stored for more than 30 days in the refrigerator; No adverse event; Dose was given after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after the 30 day BUD), PRODUCT STORAGE ERROR (Product was stored for more than 30 days in the refrigerator) 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Jan-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. On 23-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was stored for more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after the 30 day BUD), PRODUCT STORAGE ERROR (Product was stored for more than 30 days in the refrigerator) 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 EXPIRED PRODUCT ADMINISTERED (Dose was given after the 30 day BUD) and PRODUCT STORAGE ERROR (Product was stored for more than 30 days in the refrigerator).    No concomitant and treatment medications were reported.  The pharmacist reported that a dose administered after 30-day Use By Date. Vial size reported as 2.5 mL. Date the vial was initially stored in the refrigerator: 30-Nov-2022 Date of administration of vaccine: 23-Jan-2023 There was no temperature excursion.