chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a red spot and wheel developed just to the side of the injection site. Wheel about 1cm in diameter. Skin warm to touch and red. Pt. was given 25mg Benadryl PO and an ice pack applied to the site. He remained in clinic for an additional 30 mins for monitoring.  Symptoms did not increase during that time.  There rxn remained localized; no shortness of breath, no generalized hives or other complaints from the patient.
Dad calls our office to have us enter a report. He said that pt. was having myalgia and also injection site redness and swelling.
p/vax pt later had swollen glands, fever of 102.6;APAP given for fever last dose given 2/24/99 T98.7 on 2/25/99;pt seen by MD dx poss mumps;took pt long time to get strength back;
Patient contacted the pharmacy today reporting a perceived ADR following her first dose of the Moderna Covid19 vaccine which she received on 5/12/21.  The patient said that she is now experiencing an irregular menstrual cycle.  She began bleeding within days of the vaccine, which is 2 weeks earlier than her expected menstrual cycle, which is typically very regular.  She sates that she is still bleeding today lightly.  I suggested that she contact her physician or OBGYN and would report perceived ADR.
Information has been received from a consumer concerning her daughter (age not given) with no past medical history or allergies, who was vaccinated on an unknown date with the first dose of MMR II (lot not given). There were no concomitant medications. The reporter stated that her daughter "had a very bad reaction to the shot." She developed a high fever, hives, was screaming for hours and hours at a high pitched voice and started showing some behavioral problems. The pt was taken to the local hospital and was admitted overnight. She was treated with unspecified medications" to get rid of the hives and to take the fever down." The reporter noted that her daughter was fine after receiving her second and third shots of MMR II (lot not given). Additional info has been requested.
Patient had 15 month vaccines on 5/10/17. Mom noticed redness on his thigh where he got the Hep A. The site was swollen, warm to the touch and the size of baseball.
My mouth has developed swollen, red, tender gums and also some areas of roof of mouth. Behind front upper teeth is the worst. Also on  inside of right premolars area is very tender and sore. A slight bit of tenderness and swelling on inside of right cheek where premolars are also sore. Inside upper lip in top most center area is also red and swollen and extends down front to teeth. I took some ibuprofen but it did nothing. I just now took two Benadryl and it might be feeling a slight bit of improvement. First symptoms started yesterday evening around 5pm.  This morning symptoms became more pronounced. And now at 8:30pm it feels much higher level of discomfort.  My left lymph node under mandible is a bit swollen too. And around 3pm I felt like I had a slight fever but didn?t take temp. I Otherwise feel fine and have no other medical issues occurring.   When I was 10 I was diagnosed as having PCN allergy. I recall something like this happening about five days after I was prescribed. Something like this also happened after taking Sulfa antibiotic but it was at back of throat about 4 days after first administration. That was in 2015.
low grade fever (99.0F-99.8F); This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EN 5318), via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:45 as single dose for covid-19 immunisation at Workplace clinic. Historical vaccination included at age of 41 years first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Manufacturer: Pfizer/BioNTech; Lot: EN 5318) via an unspecified route of administration, administered in Arm Left on 26Jan2021 09:45 AM as single dose for covid-19 immunisation at Workplace clinic. The patient medical history and concomitant medications were not reported. On 16Feb2021, the patient experienced low grade fever (99.0f-99.8f). Approximately 12 hours following the injection on 16Feb2021, I had a low grade fever (99.0F-99.8F) which lasted for approximately 12 hours. The patient underwent lab tests and procedures which included body temperature: (99.0f-99.8f) fahrenheit on 16Feb2021. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was recovered.
Abnormally high temp @ 102.9 with severe chills, fatigue, and injection site soreness.  Effect lasting approx 24-30 hours
not able to walk without support; sore arm; Not felling 100 percent since vaccine; dizzy; Feeling terrible; nausea; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (not able to walk without support), PAIN IN EXTREMITY (sore arm), ASTHENIA (Not felling 100 percent since vaccine), DIZZINESS (dizzy) and MALAISE (Feeling terrible) in a 70-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.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (not able to walk without support), PAIN IN EXTREMITY (sore arm), ASTHENIA (Not felling 100 percent since vaccine), DIZZINESS (dizzy), MALAISE (Feeling terrible), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache). At the time of the report, GAIT DISTURBANCE (not able to walk without support), PAIN IN EXTREMITY (sore arm), ASTHENIA (Not felling 100 percent since vaccine), DIZZINESS (dizzy), MALAISE (Feeling terrible), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Tested Covid positive after being full vaccinated; Tested Covid positive after being full vaccinated; Had Fever; I do now have my taste, smell back; I do now have my taste, smell back; Have slight bit of congestion; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), dose 2 intramuscular, administered in Deltoid Right (On right shoulder) on 28Apr2021 10:00 AM morning (at the age of 33-years-old) as dose 2, single and dose 1 received on an unspecified date for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported and no other products. The patient had no other Prior Vaccination. The patient got Covid positive result this morning on 10Jul2021 after being fully vaccinated. He did two different type of tests, he got a rapid test and PCR test. He does know there was possibility that he can still get Covid. He was not calling to complaint or being rude or whatever he just didn't know he guess who to reach out regarding that just because he does know that this was all new, he didn't know if you guys are collecting data on this type of test or anything, but he also wanted to let you know that he personally feel that your vaccine did helped a lot regarding the symptoms. He was like in and out the fever and all of that within a day and he do now have his taste and smell back. He would clarify if he needs to report that or what. He was not taking any right now, at first onset of symptoms he did take Allegra 24 to help with the decongestion and it did help and once he developed a slight fever (on 28Apr2021) he did take Tylenol and that also helped the symptoms and then he was symptom free other than slight bit of congestion (in 2021), just normal. He also had taste and smell loss (on 28Apr2021) and stated his taste and smell came back today (on 10Jul2021) and he don't have any other symptoms. He just wants to figure out that do you know the difference between the ongoing things, he just wanted to make sure that he would be followed up with you guys. The outcome of vaccination failure and Covid 19 was unknown. The outcome of the events smell loss, taste loss was recovered on 10Jul2021 and fever in 2021. The outcome of congestion nasal was recovering.   Follow-up attempts are completed. No further information is expected.
minor symptoms with first dose w soreness of L arm. Approximately 4 days later experienced a numbness of tongue and gums somewhat like novacaine wearing off. This effect has continued until the present time and effects taste causing most foods to have a bitter taste. Tip and sides  of tongue still have a numbness.
Injection site itching; Injection site rash; Injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), the first episode of VACCINATION SITE RASH (Injection site rash) and the second episode of VACCINATION SITE RASH (Injection site rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a week. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), the first episode of VACCINATION SITE RASH (Injection site rash) and the second episode of VACCINATION SITE RASH (Injection site rash). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) had not resolved and last episode of VACCINATION SITE RASH (Injection site rash) was resolving.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Aches, fever, chills, and severe insomnia that has persisted for 28 hours after the shot. I don?t normally suffer from insomnia, but I can?t sleep at all.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 10:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 10:21 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 86.19.  Concomitant products were not provided.  On 27-Mar-2021 Excursion time was reported at 9 am and 10 am with  temperature as 35 and 35 degrees Fahrenheit respectively , total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  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.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 53 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, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1143015) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On MAY-2021, the subject experienced suspected immunological vaccine failure.  Laboratory data included: COVID-19 antibody test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from suspected immunological vaccine failure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210618322-COVID-19 VACCINE AD26.COV2.S-Suspected immunological vaccine failure.This event(s) is  considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and  has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a healthcare worker (certified medical assistant) refers to patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L011846 with expiry date 16-JUN-2017, lot # L017407 with expiry date 15-AUG-2017, lot # L020200 with expiry date 16-AUG-2017 (dose, strength, route, dose numbers, vaccination site unspecified). The previous temperature excursion for lots (# L011846, L017407) was reported at a temperature of 34 degrees F for 15 hours. The first excursion for the new lot # L020200 was reported at a temperature of 34 degrees F for 24 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Week (3/26/21) after vaccine I received a rash it lasted 9 days.  First day size of quarter next day size of a soft ball.
This spontaneous report as received from a nurse refers to a 59 year old patient. On 17-JUL-2014, the patient was vaccinated with PNEUMOVAX23 lot# H022280 expiration date on 16-JUL-2014 0.5 ml, once, intramuscular. No adverse effects reported. Additional information has been requested.
Vaccine administered 6-13-14, pt's arm turned bright red (size of circular coffee cup), next day. 2nd day out he got progressively redder and seems to be getting bigger - moving toward elbow.
Redness, pain, swelling itching at injection site, lasting at least 2 days so far, treated with ice, benadryl and ibuprofen with minimal effect
G47.33 OBSTRUCTIVE SLEEP APNEA 3/6/2023 HODGKIN NODULAR LYMPHOCYTE PREDOMINANT LYMPHOMA, UNSPECIFIED SITE
Primary Care Physician at Discharge: MD  Admission Date: 7/23/2022 Discharge Date: 7/23/2022  PRESENTING PROBLEM: COVID [U07.1]   HOSPITAL COURSE: Miracle is a 9 year old female with history significant for HLHS s/p Norwood with BT shunt on 7/10/2013, s/p bidirectional Glenn on 12/18/2013, most recently s/p extracardiac fenestrated Fontan on 6/6/2018; she went for cardiac catheterization on 10/22/2020 and underwent device closure of fenestration. She also has history significant for seizures and multiple thromboses secondary to being homozygous for MTFHR.  Miracle presented to ED on 7/22 with concerns for desaturations while sleeping into the upper 80s, patient's family positive for COVID and Miracle also had positive COVID test in the ED. Upon arrival to the ED she remained in RA with appropriate saturations >90%, she was hemodynamically stable, CXR did not demonstrate consolidation, effusions or pneumo. Following discussion with cardiology team she was admitted for observation following COVID diagnosis in the setting of complex congenital heart disease. Overnight she remained in RA with no increased WOB or shortness of breath, no chest pain, she rested comfortably, low grade temperature was responsive to Tylenol, she continued to take in adequate fluids with no changes to appetite. Discussed patient with ID regarding possibility of antiviral medications, however, due to her reassuring clinical status she was not deemed candidate for this treatment.  She was discharged to home the following morning and will continue supportive care at home. Parents instructed to contact cardiology with any changes in respiratory status or if clinical status changes.   Discharge instructions reviewed with dad at bedside who verbalized understanding.
Hoarse, weakness but not faint. Headache, tingling around outer edge of her neck. No marking, redness or reaction around SC injection sight. Tingling & numbness aroung the mouth. O2 stats @ 97%, & BPM 73, B/P 126/92
Client received the 1st dose Sinovac vaccine on 07/27/2021 and 2nd dose Sinovac vaccine on 08/25/2021. Client reported to Lead RN that she would like to receive the Janssen Booster. Client reported no adverse reaction to the Sinovac vaccine series. Lead RN provided medical consult to RN Supervisor.  RN Supervisor received approval for the Janssen vaccine booster dose from County. Client received the Janssen Booster  (lot#1855194) at 1025 in the L deltoid. No adverse reaction was observed during clients observation period of 15 minutes.
sore throat; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in an 81-year-old patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
I developed chills on Friday, February 19, 2021 in the afternoon. Chills continued through Saturday, February 20, 2021.  Did not feel well on Sunday, February 22nd and today, February 22nd, I woke up with a nice dose of shingles on my face.  Went to see the nurse practitioner at Dr office.   Not sure if this is a coincidence or a result of the vaccine.
Period on 2/18 was only 4 days, 3 days short. Period on 3/10 was 9 days, 2 days longer.  Period on 4/14, was a week early and 2 days short. Currently period on 5/2 is a week early. Since Feb. I am unable to eat pork. There is a difference I'm taste. Also certain smells, smell the same like what pork would smell like. Just recently had a papsmear and tested positive for HPV. I have tested positive for HPV since 2007. All papsmears prior to this one has been clear. I am also premenopausal at age 38, this wasn't so prior to thr vaccine.
Initial report received from a consumer (the patient) on 10 December 2013. A 80-year-old female patient, had received intramuscular dose of FLUZONE HD (lot number: unknown) in left deltoid on 29 October 2013. The patient had no illness at time of vaccination and was allergic to penicillin and sulfa. Concomitant medications were not reported. On 19 November 2013, the patient's blood pressure was increase 160/90, electrocardiogram abnormal and passed out for less than 1 minute. Relevant diagnostic tests/laboratory data: Normal blood work and electrocardiogram was abnormal corrective treatments was not reported. The outcome of the event was recovered on unspecified date. List of documents held by sender: none.
the area was very itchy; lump like thing on her arm; hard like bruise; like hematoma; little bit of chill; arm was very sore; tender; very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore), TENDERNESS (tender), SOMNOLENCE (very sleepy), PRURITUS (the area was very itchy) and MASS (lump like thing on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was very sore), TENDERNESS (tender), SOMNOLENCE (very sleepy) and CHILLS (little bit of chill). On 26-Mar-2021, the patient experienced PRURITUS (the area was very itchy), MASS (lump like thing on her arm), CONTUSION (hard like bruise) and HAEMATOMA (like hematoma). The patient was treated with CORTISONE at an unspecified dose and frequency and IBUPROFEN at a dose of 2 Tab. At the time of the report, PAIN IN EXTREMITY (arm was very sore), TENDERNESS (tender), SOMNOLENCE (very sleepy), PRURITUS (the area was very itchy), MASS (lump like thing on her arm), CONTUSION (hard like bruise), HAEMATOMA (like hematoma) and CHILLS (little bit of chill) outcome was unknown.        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.   Concomitant product was not provided by the reporter..
The day following my first dose of Covid-19 vaccine I experienced increased menstrual bleeding with large, noticeable clots which is not normal for me. This also occurred at a time where I was just ending a period cycle, yet bleeding resumed and increased for approximately two days following the injection, coupled with the clotting.
according to reporting pharmacist, MD states that more rxns (unspecified) have been noted w/this particular lot 426148 than w/prev lots;no clinical details provided;