chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received dose 1 / Dec 12th 2016 / 2nd dose was not yet administered.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th December 2016).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient called on the day of reporting to received 2nd dose. It was clarified that 2nd dose was not yet administered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No Batch number or Expiration Date provided for 1st dose, as other health professional stated the 1st dose was administered at different facility. The VAERS details were reported for 1st dose. The reporter consented to follow up.
Large redness (significant reactions); Swelling (significant reactions); This case was reported by a nurse via sales rep and described the occurrence of erythema in a patient who received Men ACWY-CRM NVS (Menveo) (batch number amva723z, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Menveo.     Additional Information: GSK Receipt Date: 12-SEP-2022  Reporter's Comment:  Nurse reported that event is related to product, reported several patients had significant reactions with large redness and swelling to dose 2.
Alopecia Areata - started losing hair on scalp, chest, back, legs, buttocks ... both general loss and typical circular patterns
fever to 102.5, morbilliform rash (pink, macular, round spots, truncal-centrifugal) began 7 days p/vax;
Severe headaches, diarrhea interfering with function, b/w pain T 98.1 degrees.
pt was given his 2nd moderna booster this morning. (08/02/22 @ 9:15)...vial had been opened on 08/01/22 @ 9:30)
Severe  swelling and pain  along with a bruise on and below injection size about 2 inches wide by 4 inches long, sever bruising of arm
This spontaneous prospective pregnancy report was received from a consumer (patient's mother) via nurse practitioner refers to a 16 year old female patient. The patient's current condition included Allergy to dogs, dust-mites, roaches, and some grass. The patient takes allergy shots. Concomitant therapies included ALLEGRA, ZYRTEC and daily vitamins and allergy shots. On an unknown date in July 2017 (reported as last year), the patient was vaccinated with the first dose of GARDASIL 9 (route, expiration date and lot number not specified) in the right arm for human papilloma virus prophylaxis. On an unknown date in July 2017, the patient developed swollen, painful, puffy eyes and a red face after receiving her first shot of GARDASIL 9. The patient became pregnant. The last menstrual period (LMP) and estimate date of delivery (EDD) were not known. The pregnancy outcome was pending. On 18-APR-2018 at 9 AM (reported as this morning), the patient was vaccinated with second dose of GARDASIL 9 one injection (1DF) (expiration date and lot number not specified) in the right deltoid by intramuscular route for human papilloma virus prophylaxis (vaccine exposure during pregnancy) and a few hours later noticed her eyes were hurting and swollen and her face was turning red. It was reported that the patient was having an allergic reaction to GARDASIL 9. The patient's one of the eyes appears more swollen than the other and was almost swollen shut. The event did not cause hospitalization to the patient. The patient called a doctor who recommended the patient take 25mg of BENADRYL, and PEPCID AC. The patient already had taken ALLEGRA for seasonal allergies. The patient didn't seek medical attention and the swelling seemed less severe last year than this day. Lab diagnostics/studies were not performed. The reporter wants to know whether the patient's need to get third shot. The outcome of the events eye pain, erythema, eye swelling and allergy to vaccine was unknown. Causality assessment was not provided. Product quality complaint was not involved.
Nausea, vomiting, whole body muscle aches, headache, 94.4 temperature.  Took ibuprofen and upped fluid intake.  Symptomss lessened gradually over the course of a few hours.  Nausea improved after vomiting.  Headache persisted.
Arm became red, swelling, feverish redness continued to spread over 5 days.
Sweat & Fever Headache Sharp Pain & Tightness in chest on heart left side  Tightness in lungs - couldn?t breathe and very sharp pain in lower lungs  Overall pain in whole body  Went to ER around 2:00
Fever 103, rash.  Seen in ER, and follow up at PCP clinic.  Treated symptomatically with tylenol and benadryl.
Yesterday early in the morning, she started with high fever; Nausea; Headache; She also started vomiting; She started with diarrhea yesterday afternoon; Patient started with sore arm in afternoon after receiving 2nd dose; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Patient started with sore arm in afternoon after receiving 2nd dose), PYREXIA (Yesterday early in the morning, she started with high fever), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (She also started vomiting) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM (ATIVAN) and COPD inhaler for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Patient started with sore arm in afternoon after receiving 2nd dose). On 21-Apr-2021, the patient experienced PYREXIA (Yesterday early in the morning, she started with high fever), NAUSEA (Nausea), HEADACHE (Headache), VOMITING (She also started vomiting) and DIARRHOEA (She started with diarrhea yesterday afternoon). The patient was treated with NUTRIENTS NOS (ENSURE [NUTRIENTS NOS]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Patient started with sore arm in afternoon after receiving 2nd dose), PYREXIA (Yesterday early in the morning, she started with high fever), NAUSEA (Nausea), HEADACHE (Headache), VOMITING (She also started vomiting) and DIARRHOEA (She started with diarrhea yesterday afternoon) outcome was unknown. Not Provided
Patient had standard side effects (fever, fatigue, muscle soreness) day 1 and 2 after vaccination. Starting approx. 3 days after vaccination, patient started noticing altered smell and taste, which has gotten worse in the 14 days since vaccination. Patient also has fatigue and has been experiencing weakness since vaccination. These symptoms are identical to the symptoms the patient had with COVID (starting ~3 weeks after contracting COVID and lasting over a month). The patient contracted COVID in December 2020 and had fully recovered prior to vaccination. Recrudescence of symptoms appears to be due to immunological response to the vaccine.
Patient reported redness that traveled from the injection site down to her elbow and around her arm. She stated that it was painful and sore and remained for approximately four days. She said that after four days the redness as well as the pain disappeared and she has had no other issues since.
beginning approximately 48 hours after dose 1, insulin requirements increased to more than 200% of usual doses administered by insulin pump.  There were multiple occasions the patient needed to supplement coverage by insulin pen/syringe to maintain usual 'time in range'.  This situation continued until approximately 15 July 2021.
New onset Plaque Psoriasis in index finger and middle finger of right hand, controlled through BID application of compound Dithranol ointment (a compound product consisting of Dithranol IP 1.15% w/w, Salicylic Acid IP 1.15% w/w, Solution of Coal Tar 5.3% w/w, white soft paraffin IP q.s.). I have mentioned recovered from adverse event cause the exacerbation has been treated with the ointment.
Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again; feels faint each time she stands; chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again) (seriousness criterion medically significant), PRESYNCOPE (feels faint each time she stands) and CHILLS (chills). On 01-Apr-2021, LOSS OF CONSCIOUSNESS (Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again) had resolved. At the time of the report, PRESYNCOPE (feels faint each time she stands) and CHILLS (chills) outcome was unknown.            No concomitant medications reported by patient.  Treatment of these events included Zyrtec and Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sore throat; Glands were swollen; Looked uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Looked uncomfortable), OROPHARYNGEAL PAIN (Sore throat) and LYMPHADENOPATHY (Glands were swollen) in a 54-year-old male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced DISCOMFORT (Looked uncomfortable). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and LYMPHADENOPATHY (Glands were swollen). At the time of the report, DISCOMFORT (Looked uncomfortable) had not resolved and OROPHARYNGEAL PAIN (Sore throat) and LYMPHADENOPATHY (Glands were swollen) outcome was unknown.            No concomitant medications were reported.   No treatment medication was reported.
Hundreds of extremely itchy hives from scalp to ankles.  Almost 2 months and they are still present.
Heart palpitations increased. Hair loss.  Dramatic increase in hair falling out by the roots. Have no idea is this is related to vaccine or not.
Initial report was received on 29 September 2011 from a health care professional. A three month-old female patient had received on 27 August 2011 a first dose of IPOL (lot number, route and site of administration not reported) and an unspecified amount of time later on vaccination date, experienced vomiting once, a puffy face, tenderness at the injection site, irritability, tiredness and one time "jerk movement". No further information was available at the time of the report. Patient's outcome was reported as recovered. Documents held by sender: none.
The vial was exposed to room temperature for 27 hours; Vaccine administered to 2 patients greater than 12 hours post puncture/Expired vaccine doses adminitered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients greater than 12 hours post puncture/Expired vaccine doses adminitered) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 27 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2022 at 2:36 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2022 at 2:36 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients greater than 12 hours post puncture/Expired vaccine doses adminitered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 27 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients greater than 12 hours post puncture/Expired vaccine doses adminitered) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 27 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in refrigerator on 08-Mar-2022 and was first punctured on 12-Mar-2022 at 11:08 am and the Vial was stored in room temperature. Vial did not undergo any temperature excursions.  The vial was exposed to room temperature for range (8° to 25°C= 46° to 77°F) for 27 hours. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2022-511737 (Patient Link).
After this vaccine, I cought COVID for the first time.  Since, I have been sick four times each lasting more then a week with lingering coughs and tiredness.  Prior to the vaccine it would be unsual for me to get sick once a year and have any sickness last more.then a few days.  I never had lingering coughs prior to this vaccine.
After administration of vaccine, within 10 min site became red, inflamed, hot and itchy. Reported to ED, reaction spread up arm and to (L) ear. IV started and as BENADRYL being administered reaction spread to throat and face causing difficulty breathing (1350). Epi given in (R) deltoid. Given steroids and ZANTAC IV. Watched for 2 hrs in ED and discharged home. 4 days of oral steroids and ZANTAC. Symptoms of redness inflammation and itchiness waxed and waned for 2 days.
Rash, hardness on Left Upper Arm Body chills for 12 hours Fatique Slight Headache Nausea
passing out; almost like I was deaf for a second; couldn't talk; couldn't get off the couch; red spots over it; arm was swollen; low grade fever; A spontaneous report was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hearing decreased, speech impairment, NOS, loss of consciousness, gait inability, vaccination site erythema, vaccination site swelling and pyrexia.   The patient's medical history was not provided by the reporter. Concomitant medications were not reported.  On 09 Feb 2021, about 10 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 027L20A) through unknown route in the right arm for prophylaxis of COVID-19 infection. Nine days after the shot (18 Feb 2021) she had the following symptoms: arm was swollen, red spots over it, low grade fever, passing out, couldn't talk, couldn't get up off the couch and hearing decreased for a second. She had ibuprofen 2 tablets on 18 Feb 2021 and 19 Feb 2021.  Action taken with mRNA-1273 in response to the events was not applicable  The events, hearing decreased, speech impairment NOS, passing out, couldn't get off the couch, vaccination site erythema, vaccination site swelling, low grade fever,and were considered recovered on 19 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Low grade Fever; Inappropriate schedule of vaccine administration; Injection site swollen; Injection site pain/tender; High Fever; Injection site red; Headaches; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE PAIN (Injection site pain/tender), PYREXIA (High Fever), VACCINATION SITE ERYTHEMA (Injection site red) and HEADACHE (Headaches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included LEVOTHYROXINE, ESCITALOPRAM OXALATE (LEXAPRO) and TRAZODONE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE PAIN (Injection site pain/tender), PYREXIA (High Fever), VACCINATION SITE ERYTHEMA (Injection site red), HEADACHE (Headaches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). On 30-Apr-2021, the patient experienced PYREXIA (Low grade Fever). The patient was treated with SUMATRIPTAN ongoing since an unknown date for Migraine, at a dose of 1 dosage form; BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) ongoing since an unknown date for Migraine, at a dose of 1 dosage form and ACETAMINOPHEN at a dose of 1 dosage form. On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved. On 29-Apr-2021, PYREXIA (High Fever) had resolved. On 04-May-2021, VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE PAIN (Injection site pain/tender) and VACCINATION SITE ERYTHEMA (Injection site red) had resolved. On 06-May-2021, HEADACHE (Headaches) and PYREXIA (Low grade Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 103.8 (High) High fever of 103.8.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medications included Sumatriptan and Fioricet.    This case was linked to MOD21-090108 (E2B Linked Report).; Sender's Comments:  MOD21-090108:
Injection site 4" x 2" oblong reddened area. Swollen hand and warm to touch. -7/18/19 Area was the size of a quarter on 7/17/19, much worse on 7/18/19 Applying ice, Ibuprofen et Benadryl every 6'
Initial reactoin of bluish color around injection site that went away after a few days; "knotted" feeling with soreness around injection site that has gotten worse.
Sores in mouth; dry throat; This is a spontaneous report from a non-contactable consumer (Patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021, as dose number unknown, single for COVID-19 immunisation at hospital. The patient medical history, concomitant medications were not reported and had no allergies. The patient did not receive other Vaccine in four weeks. On 16Feb2021, 14 days after vaccination, the patient had sores in mouth and experienced dry throat. The patient was not Covid prior vaccination and was not tested Covid post vaccination. The patient did not receive any treatment for the events. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A little over an hour after vaccine my arm went numb from my shoulder blade down my entire arm, no pain just numbness, it also itches
Swelling at injection site - white lump with redness swelling going down my arm; Swelling at injection site - white lump with redness swelling going down my arm; Swelling at injection site - white lump with redness swelling going down my arm; Fatigue; Muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old-non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not reported) via an unspecified route of administration, administered in left arm on 14May2021 at 14:30 (at the age of 54-year-old) as a DOSE 2, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included known Sulfa drugs allergy. The patient's concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration in left arm on 20Apr2021 at 13: 30, (at the age of 54-year-old) as DOSE 1, SINGLE, for COVID-19 immunisation. 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 and not tested for COVID-19 since vaccination. The patient experienced swelling at injection site, white lump with redness swelling going down my arm; fatigue, muscle aches and chills on 17May2021 at 06:00. The patient was not received any treatment for events. Outcome of the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pt reports about 20 minutes after receiving H1N1 vaccine. Became nauseous and started vomiting. Also got HA, hot and cold chills with dizziness. Pt rested, the returned to clinic 3 hours post vaccination. Recommended MD, evaluation. Pt went to local ER.
about 10 minutes after administration of vaccine, pt started complaining of blurred vision and nausea
The pt experienced mild to severe pain in neck and shoulders. Continued achiness in joints, stiffness in muscles to this day. Feels 75 years old.
GUARDIAN REPORTS THAT AFTER THE SHOTS PATIENT WAS FINE. THEY STOPPED TO GET LUNCH THROUGH A DRIVE THRU AND WHEN SHE ARRIVED AT HOME (1 HOUR LATER), SHE TURNED TO GET PATIENT OUT OF THE CAR AND NOTICED HIS FACE WAS "BEET RED" AND HIS BODY WAS RED WITH HIVES ON HIS BELLY AND BACK. SHE DECRIBED HIS ARM, INJECTION SITE AS RED AND SWOLLEN. SHE ALSO MENTIONED HIS FACE WAS SWOLLEN. SHE IMMEDIATLY GAVE HIM BENADRYL AT HOME AND TOOK HIM TO THE MEDICAL CENTER ER. ACCORDING TO HER: THERE HE WAS TREATED WITH STEROIDS, MONITORED AND WAS SENT HOME WITH A SCRIPT FOR BENADRYL. SHE REPORTS HE WAS NEVER APPPEARED IN DISTRESS OR SHORT OF BREATH. When he was RELEASED FROM THE ER. GUARDIAN CALLED THE HEALTH DEPARTMENT TO REPORT THE INCIDENT. (ABOUT 2:50 PM) AT THAT TIME, SHE REPORTED PATIENT WAS FINE. NO REDNESS VISIBLE, NO SOB, NO DISTRESS, AND APPEARED BACK TO HIS NORMAL SELF. 7/14/23 9:30 AM ON A FOLLOW UP CALL TO PATIENT'S GUARDIAN. SHE REPORTS PATIENT DOING FINE NO OTHER INCIDENCES OCCURRED.-RN