chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 7APR97 & exp inj site pain & swelling;19APR97 pt exp itching, lt side was unable to sleep;22APR97 pt exp lt side was hot;24APR97 pt exp dry skin;lab eval 26APR97 revealed pt vzv positive;
Moderna COVID?19 Vaccine EUA  Muscle aches Joint pain Chills  Fever
I was having irregular heartbeat that lasted for several hrs. & I was feeling very weak & very tired so I went to ER & they ran test & told me to f/up with my PCP.
Hypersensitivity reaction to flu vaccine.  Action: admit to ER, diphenkyloxima and cephalexin were prescribed.
Severe psoriasis symptoms. Itching. Rashes and hives on back, armpits, stomach, groin area, buttocks, wrist, legs, feet.  Symptoms subsided after taking a total of 4 Benadryl tablets. Milder symptoms mostly on legs started to come back on the next day.  Cleared up after taking 2 Benadryl tablets. No symptoms since. Typically suffer from mild psoriasis. Have never experience such a severe episode before.
Post vaccine pt became dizzy and felt lightheaded. Pt was instructed to lay supine on floor and was transferred to med obs via litter. Pt reported feeling better after laying on stretcher. Vitals obtained and monitored. Pt had no complaints of chest pain. Pt had no complaints of SOB. Pt released at 17:49. Vitals as follows: 1738 LYING BP 114/73 HR 86 RR 18 SpO2 100% 1747 SITTING BP 105/73 HR 80 RR 18 SpO2 98%
DIFFICULTY CONCENTRATING; SLIGHTLY ELEVATED HIGH BLOOD PRESSURE; MODERATE ASTHMA; MILD JOINT PAIN; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty concentrating, slightly elevated high blood pressure, moderate asthma, mild joint pain, and slight headache. The action taken with covid-19 vaccine was not applicable. The outcome of the slight headache, difficulty concentrating, slightly elevated high blood pressure, mild joint pain and moderate asthma was not reported. This report was non-serious.
patient lost her vaccination card and was not sure what vaccine she had. she mentioned of having moderna before to technician and was given modrna booster full dose since patient is categorized as immunocompromised due to kidney transplant. before injecting vaccine pharmacist verified that she is giving her full dose (0.5 ml) moderna and patient approved it. later reporting it to state registry , pharmacist came to know that patient had pfizer before for 2 doses. pharmacist made call to patient and notified her and patient understood the scenario and was fine getting moderna .
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:54 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 50.61.  Concomitant products were not provided.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-NOV-2015 23:50, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 10.8 and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Started with severe arm pain the day before. A fever of 101 spiked at 11:00 am. Hives developed on that arm at 8:00 pm that evening.
-Patient developing palor, sweating, tachycardia, blurry vision, Low BP, almost fainting 1-2 m after shots given -VS was checked q 5-10 minutes and self improved after changing position, given fluids. Last checked BP 105/70 HR 72/min SpO2 99% after 30 minutes  Rechecked on the next day, pt totally normal, no concerns.
Pt vax w/HIBV/HEP/DTP/on 28FEB91. Vax w/ OPV 2MAR91. Pt hospitalized on 28MAR91 w/meningitis. Recovered w/o sequelae & D/C on 9APR91.
Box 17 - Shingrix   When I started experienced broken skin. Looked like skin was flipped open with a small red dot in the center. Very painful, as if I was being bitten. Washed the areas with an antiseptic, then applied Neosporin. Eventually area disappeared.
This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 17Apr2021 at 16:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. On 25Mar2021, the patient underwent COVID-19 test (Rapid test) via nasal swab and the result was positive. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT), ibuprofen (ADVIL) and remdesivir (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. On 19Apr2021, the patient experienced lump on collarbone. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of event lump on collarbone was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
My child developed a fever of 102 degrees at about noon on Oct 10, 2016 and had it for the whole day and night following, and a slightly lower fever the following day and evening, tempered only by the administration of Infant TYLENOL every 4 hours (as described in the instructions on the bottle). On Oct. 12th, the fever was gone, but we had noticed that he had a rash all over his torso. I will be keeping my eye on this.
This spontaneous report as received from a registered nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with PEDVAXHIB (lot number not reported) and an unspecified Merck vaccine. No other concomitant medications were reported. Approximately on an unknown date in 2013 (reported as last year) the patient had an unspecified diagnosis which required a bone marrow transplant. The outcome of bone marrow transplant is unknown. The causality for bone marrow transplant was not reported. No Product quality complaint (PQC) filed. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a group of patients of unspecified number and demographics. On 16-FEB-2017, those patients were vaccinated with RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. It was reported that the vaccines were improperly stored for 30 minutes, in the temperature of 10 degrees Celsius (C). It was reported that there was no previous temperature excursion and that it was a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.; Sender's Comments: US-009507513-1702USA008447: US-009507513-1702USA011948: US-009507513-1702USA011949:
rash on face; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JUN-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received the dose of Shingles vaccine and had rash on face. Additional supportive information: The follow-up would not possible as no contact details were available.
This spontaneous report was received from a healthcare worker refers to a 4 years old patient of unknown gender. On 14-OCT-2014, patient was vaccinated with an improperly stored dose of MMR II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
seeing cloudy images; This spontaneous case was reported by a health care professional and describes the occurrence of VISION BLURRED (seeing cloudy images) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (seeing cloudy images). At the time of the report, VISION BLURRED (seeing cloudy images) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient recently received Moderna booster vaccine.
neuropathy; postherpetic neuralgia; vision problems; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 78-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 17-OCT-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for herpes zoster, postherpetic neuralgia, neuropathy and vision problems. The outcome of herpes zoster, postherpetic neuralgia, neuropathy and vision problems were not reported. The reporter considered aforementioned events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, neuropathy peripheral was determined to be a medically significant event.
There was no significant medical history, known allergy or concomitant medications. The pt received her third injection of Lymerix on approximately 22-JUL-2001. She was seen by an OB on 27-AUG-2001 and determined to be pregnant, at 11 weeks gestation. The pregnancy was, therefore, at 6 weeks gestation at the time of Lymerix administration. The pt's last menstrual period was on 09-JUN-2001. Estimated delivery date is 16-MAR-2002. The follow up states the vaccinee delivered a normal, full-term female on 3/5/02 (39 weeks gestation). Birth weight was 7 pounds 12 ounces.
Sore arm, fatigue, headache, aches and pain, low grade fever (99.8)
Received expired vaccine greater than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture). On 26-Jan-2022 at 9:30 AM, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter who was a Nurse called to report that 1 vial of Moderna COVID-19 vaccine was taken out of refrigerator on 25-Jan-2021 9:30AM punctured and left at room temperature overnight. The patient received expired booster of Moderna COVID-19 vaccine form the vial on 26-Jan-2021 at 9:30AM. The dose was administered more than 12 hours post puncture.  The date the vial was initially stored in the refrigerator was 21-Jan-2022 and the vial was stored post puncture in the room temperature. It was also reported that the vial didn't undergo any temperature excursions. Reportedly, the total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 24 hours.  No treatment information was provided.
stiffening & eye fluttering-brief; poss sz 4-6 hrs p/vax; also devel rash-poss roseola
Patient came back to clinic 5 days after receiving Tdap with localized redness, warmth around injection site. Pt also reported had pain for the 5 days after injection.
105 degrees temperature 1 week and 2 days after vaccine came down quickly with MORTIN.  Child still running low grade fever of 100.8 treating with MOTRIN.  Per doctor can last up to 5-7 days.
Information has been received from a specially trained medical technician for the Pregnancy Registry for GARDASIL vaccine, concerning a 26 year old female with diabetes and no drug reaction/allergies, who on 21-Jun-2007, 25-Aug-2007 and 28-May-2008 was vaccinated intramuscularly with 0.5 ml of first (lot# 660389/1968U), second (lot# 658100/0525U) and third (lot# 658556/1060U) doses, respectively, of GARDASIL vaccine and is pregnant. Concomitant therapy included NOVOLOG. On 07-Jun-2008 the patient took home pregnancy test that tested positive (LMP = 05-May-2008). Unspecified medical attention was sought, the patient was seen in office. No adverse event reported. At the time of this report the outcome is unknown. Follow-up information has been received from a person in the physician's office on 24-NOV-2009 who reported that on 21-JUL-2008 the patient had an ultrasound performed which identified a "missed AB", which was dated at 11 weeks gestation by LMP. The patient did "fine" after that, recovered. Upon internal review, "missed AB" was determined to be an other important medical event. This is one of two reports concerning the same patient (WAES#0911USA04901). A lot check has been initiated. No further information is available.
The pt experienced right arm swelling, pain too bad to move. The next day, the arm was red and a rash appeared from shoulder to the elbow.
I had five episodes of atrial fibrillation starting in early February 2021, then approximately one episode every two weeks, the last in April 2021. Prior to getting Covid vaccine, I had one or two episodes per year. Each episode lasted about 24 hours and stopped spontaneously.
itchy hives on the injection arm; itchy hives on the injection arm; Redness on the injection arm/Redness reappeared; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy hives on the injection arm), VACCINATION SITE URTICARIA (itchy hives on the injection arm) and VACCINATION SITE ERYTHEMA (Redness on the injection arm/Redness reappeared) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy hives on the injection arm), VACCINATION SITE URTICARIA (itchy hives on the injection arm) and VACCINATION SITE ERYTHEMA (Redness on the injection arm/Redness reappeared). At the time of the report, VACCINATION SITE PRURITUS (itchy hives on the injection arm) and VACCINATION SITE URTICARIA (itchy hives on the injection arm) had resolved and VACCINATION SITE ERYTHEMA (Redness on the injection arm/Redness reappeared) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.
Absence seizurez aggravated; This case was reported by a consumer via call center representative and described the occurrence of absence seizure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (receoved 1st dose on 31st August 2019 and experienced soreness at injection site, refer case US2019AMR203300). Concurrent medical conditions included epilepsy (experienced all her life) and seizure (experienced all her life).   On 4th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 5th November 2019, 1 days after receiving Shingrix, the patient experienced absence seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the absence seizure was recovered/resolved.   It was unknown if the reporter considered the absence seizure to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient experienced absence seizure in the afternoon and early evening the next day after receiving Shingrix. The absence seizure lasted for several minutes instead of seconds like she usually used to get.  The patient was advised to see her primary care physician as she experienced absence seizure. The reporter consented to follow up.
Broke out in rash on face, neck, chest, and arms.  Some swelling in the face.
Arm with red rash, numb and unable to move. She stated she felt drunk. She denied SOB, VS were stable, and by the time EMS arrived, she was unable to move her other arm, and stated she felt like she was going to faint and her lips were numb.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the Shingle shot and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report as received from a Healthcare Worker refers to a male patient of unknown age. On 14-APR-2010 the patient was vaccinated with GARDASIL dose 1 (route, dosage and lot number not reported). On 02-JUN-2010 the patient was vaccinated with GARDASIL dose 2 (route, dosage and lot number not reported). At the time of the report the patient did not get the third dose yet. No adverse effect reported. Additional information has been requested.
pt recvd vax 6OCT95 & 15NOV95 pt exp tingling in feet p/delivery of a child;No further details were provided;
13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains no new information.
Headache, Myalgia, Fever & HYPERglycemia Narrative:
Arm swelling; fever; pain in arm. MD called manufacturer and prescribed clindamycin accordingly. Pt ended up on IV antibiotics.