chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had my vaccines last year and caught shingles in June/ Suspected vaccination failure; caught shingles; painful; burning feeling; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In June 2022, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and burning sensation were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-July-2022 Reporter's comment: The case received from the patient via interactive digital media. The patient had the vaccines last year and still caught shingles in June. The patient was painful and burning feeling but the patient was told that it could had been worse and only lasted a week too. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Based upon the reported verbatim, 'only lasted a week too', outcome was captured as recovered for all the symptoms.
Sore and tightness in left side of neck, running nose, running eyes, tingling in side of mouth, having trouble walking, unbalanced
mild tingling of lips after injection - within 1st hour. Fever-   up to 101.6 degrees- noticable after 15 hours of the vaccine Chills- off and on after about 15 hours of vaccine Body aches and pains/ fatigue Headache- severe
Fever, coughing, paleness of skin, difficulty breathing. Went to the ER and was diagnosed with Pneumonia.
Woke up at 3 am. Was hard to turn over in bed due to low back and hip pain. Had a dull headache. Also had generalized aches and pains.Both arms aching. Left hurt worse and was itching.  Started running fever 100.3 about 10 am . I ran fever most of the day. Felt real bad. Started feeling better about 5 pm. I have not had fever since about 4:30 pm
pt recvd vax & became limp @ 9AM when care taker was dressing pt; called 911 taken to ER-mom was called about 10AM on 27SEP95 reported that pt had died; pt was a little fussy-autopsy done did not find any trauma according to mom;
Patient developed mucosal wart inside lower lip 5 days after receiving second HPV vaccine.
Pregnant (received vaccine); This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live full time birth) on 19-Nov-2019 and Complication of pregnancy (High Blood Pressure).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Dec-2020 and the estimated date of delivery was 26-Sep-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2020, Pregnancy test: Positive.     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.   Estimated date conception was reported on an unknown date in unknown month of 2020. Concomitant medications were not reported. Treatment medications were not reported.
Pt had fever of 103.7 F, a bulging fontanel, irritable, and inconsolable.
Left collar bone has build up of fluid between neck and shoulder on the left side; Slight fever; Soreness at the injection site; Really bad headache; Tired; Chills; Swelling at the injection site; Aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Aches), LOCALISED OEDEMA (Left collar bone has build up of fluid between neck and shoulder on the left side), PYREXIA (Slight fever), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Really bad headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (Aches), PYREXIA (Slight fever), VACCINATION SITE PAIN (Soreness at the injection site), HEADACHE (Really bad headache), FATIGUE (Tired), CHILLS (Chills) and VACCINATION SITE SWELLING (Swelling at the injection site). On 09-Apr-2021, the patient experienced LOCALISED OEDEMA (Left collar bone has build up of fluid between neck and shoulder on the left side). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 09-Apr-2021, PAIN (Aches), PYREXIA (Slight fever), HEADACHE (Really bad headache), FATIGUE (Tired) and CHILLS (Chills) had resolved. At the time of the report, LOCALISED OEDEMA (Left collar bone has build up of fluid between neck and shoulder on the left side), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter contact detail was updated.
Narrative: Report of diplopia related to this event may be disabling to some degree- possible that is resolves over time as well which would indicate less severe event. This report done based on incomplete medical record and results at this time.
HYPOTENSION ACUTE RESPIRATORY FAILURE ATRIAL SEPTAL DEFECT POST ACUTE MI 12/30/2022 &  2/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Mild varicella from Grandmother's shingles. Had 2 doses of VARIVAX.
Swelling of left arm with redness and tenderness and increase by 7/1/15; patient was leaving out-of-town; photos forwarded to mom who showed photos to MD; patient had no fever, only local tenderness and swelling at site of Tdap to left arm; Tx:  ice, Benadryl.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date, the unspecified number of patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot#, dose, route and frequency were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit; Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 3:36 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021 at 3:36 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month.  On 19-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.   This case was linked to MOD-2021-402935 (Patient Link).
Chills; Muscle ache; This is a spontaneous report from a Pfizer Sponsored Program via contactable pharmacist. A 38-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown) via an unspecified route of administration on 04Feb2021 as dose 1, single (at the age of 38-years-old) for COVID-19 immunisation. Patient had no medical history and received no concomitant medications. On Feb2021, after the first dose, patient had a reaction included chills and muscle ache. Therapeutic measures were taken as a result of the events and treatment included took some Tylenol. On 25Feb2021 (today), patient was scheduled for her second vaccine and questioned that if she should receive that second vaccine because of the reaction she had with the first one. The outcome of the events was unknown.  Pharmacist stated there was a definite causality of BNT162b2 with the events.  Follow-up attempts completed. No further information expected.
No adverse reaction.  Hep B Vaccine dose 3 but administered with a 2 dose series.
MOM STATES THAT ABOUT 2 HOURS AFTER DAUGHTER RECEIVED THE VACCINE, SHE REPORTED A SPLITTING HEADACHE. DIARRHEA AND VOMITING SOON STARTED BETWEN 4/10/21 AND 4/12/21.
Hospital Course and Significant Findings: Patient is a 93 Y male with PMH coronary artery disease with ischemic cardiomyopathy s/p CABG, hyperlipidemia, HFrEF, LVEF 40%, hypothyroidism, urinary retention due to BPH presented with complaint of shortness of breath for 3-4 days. Patient was seen in urology clinic day of admission to hospital for placement of foley catheter due to urinary retention, earlier foley wsa obstructed and seen in clinic for replacement and sent to ED for evaluation of shortness of breath. Patient admitted with acute hypoxemic respiratory failure 2/2 COVID-19 and heart failure exacerbation.
This spontaneous case reported by a consumer, describes the occurrence of pruritic rash (itchy, red rashes all over body) and erythematous rash (itchy, red rashes all over body) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pruritic rash (itchy, red rashes all over body) and erythematous rash (itchy, red rashes all over body). At the time of the report, pruritic rash (itchy, red rashes all over body) and erythematous rash (itchy, red rashes all over body) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Received undiluted vaccine.  About 24 hours after dose patient experienced a sore injection site, back pain, chills.  About 48 hours later all adverse effects were gone.
Pentacel at 4 months, 6 months and 15 months, with no adverse event; Initial information received on 02-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 15-month-old (gender unknown) patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] at the age of 4 months, 6 months and 15 months (inappropriate schedule of product administration).  The patient's past vaccination(s) included VAXELIS at the age of 2 months. The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.  On unknown dates, the patient received the first, second and third doses of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via unknown routes in unknown administration sites for prophylactic vaccination (inappropriate schedule of product administration).  It was a case of actual medication error due to inappropriate schedule of vaccine administered (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
Initially tasted metal, numb mouth, flushing, later resulting in all flu like symptoms (severe chilling, fever, body aches, headaches and GI issues.) GI issues persisted for the next 3 weeks and on Thursday evening, 2/25/2021 at about 6:30 pm. I was sitting on floor with children and almost passed out. I felt very faint, dizzy, and instantly started chilling. I had a fever of 102.8 and could not get warm. My husband was going to call paramedics, but I encouraged him not to. Discovered my right breast was red and inflamed/ swollen as well as all of my lymph nodes in my right arm pit. I could not reach my right arm forward. I noticed around 12:06 AM after not being able to get warm or break fever. I messaged my primary care clinic when I noticed the breast swelling, redness, pain, and lymph node swelling. I continually felt like I was going to faint/pass out and was very dizzy all night long. I was also extremely fatigued. The did a telemedicine appointment the next morning and diagnosed me with mastitis and prescribed me antibiotics. I am a breastfeeding mother and all of these symptoms came on suddenly and severely on the same side that I got the vaccine shot. I have been breastfeeding for over 7 months and my supply has been dwindling to nothing so I have no problems with engorgement or blocked milk ducts. Before this baby I had just got done breastfeeding a baby for 11 months with no issues of the like.
PATIENT REPORTS THAT A FEW DAYS AFTER DOSE 1 HER RIGHT KNEE STARTED HURTING HER. SHE HAD TROUBLE WALKING. SHE STILL HAS PAIN BUT CAN WALK. SHE REPORTS THAT SHE HAS NEVER HAD ANY PROBLEM WITH EITHER OF HER KNEES IN THE PAST. THE PAIN FEELS LIKE BONE PAIN SHE REPORTS. SHE SAW HER DOCTOR AND HAD AN MRI OF THE KNEE. THERE WAS NOTHING FOUND FROM THE DOCTOR'S EXAM OR FROM THE MRI TO EXPLAIN THE KNEE PAIN.
POST DONATION, IMMEDIATLY FOLLOWING TDAP WENT TO DONOR FLOOR TO BEGIN WORKING. GOT FAINT LOC X 20 SECONDS STAFF MEMBERS EASED HER TO FLOOR, PALLOR, CLAMMY- RAPIDLY RECOVERED ALERT/ORIENTED X3 BP AT START 84/55-85, 101/69,AT TIME OF DISCHARGE 101/81-85 STATED THAT WAS HER NORM, CONSUMED 20ML'S OF POWERADE. SHE FELT BETTER. STRONG STEADY GAIT.
At injection side, large red circular patch. The site itches and is inflamed. Inflammation is bad enough you can see the difference between the right and left arm.
Had my covid booster in conjunction with the annual flu shot (first time I've ever received the flu vac).  Approximately 12 hours after receiving the shots I experienced over the next 24 hours the usual fever, muscle aches, nausea, etc. but all went away except for a mild headache for the next 12 hours.  A week later and now 6 day later from initial occurrence I am experiencing dizziness that I've not had before mostly when moving around in and out of bed or even just turning in bed, fairly severe spinning. The first time it happened I was riding my horse and had to stop and grab onto his neck in order not to fall.
Left shoulder pain began after second dose ~2/2021. Other joint pains also noticed but post menopausal. August 2021 placed on hormone replacement therapy, all other joint pain ceased (ankles, hips, wrists, fingers) but left shoulder pain has persisted.   On 9/28/2021 saw Orthopedic surgeon who has ordered MRI left shoulder (scheduled for 10/4/2021).
Symptoms began with fatigue. Developed right side Trigeminal Neuralgia quickly progressing to several neurological symptoms including brain fog, headaches incontinence, left sided weakness, extreme fatigue, balance and gait issues. I have been out from work since June 11, 2021 Symptoms appear to be improving with PT and time.  I am still having increased symptoms with temperature increases.
Monday morning 8/23/21 woke up at 6:00AM not feeling well.  By 7:15 Acute onset of intense chest pain and pressure along with neck pain, severe headache, and labored breathing.  I could not lay down because the pressure and pain were so intense.  I got Covid tested around 4PM, negative.  I went to ER with chest pain and discomfort around 6PM.
Thrombocytopenia and severe abdominal pain concerning for thrombotic thrombocytopenic purpura.
after patient left pharmacy ( after receiving the shot) she called complaining of chest pains and shortness of breathe.She stated she  was feeling better but she was sitting outside the emergency room ( she had not entered or been admitted as of the call) She would wait to see how she feels and if the condition would worsen. she wanted to verify it was the flu shot she received and not MMR when she called
Swelling in face, eyes, nausea, tachycardia, erythema, no SOB
During time of COVID-19 Moderna vaccination, was taking Allegra Allergy medicine daily. On 2/15/2021, the vaccine was given and in the following 2 days afterwards, there was pain at the injection site and Tylenol was taken, then later a little Ibuprofen. In addition, experienced mild fatigue. At Day 11, on 2/26/2021 after 1st Moderna COVID-19 Vaccine administration, had a fist-sized red, inflamed rash appear on upper left arm. This included both the area of vaccine intramuscular shot was administered, as well as the area directly underneath on the upper left arm. There was some hardness spots noted, as well. However, did not experience itchiness, but the reddened arm area did hurt when it was brushed up against a wall by accident. It reddened and was warm to the touch,  over the next 1.5 days before medication of Zyrtec allergy 24-hour tablet taken and a cold press placed externally on the arm site. The plan is to continue Zyrtec for 5 days.  Allegra tablet was stopped at Medical Primary Care's direction, as she does not recommend it during adminstration of the COVID-19 vaccine. Upcoming 2nd dose is due 2/12/2021 and is expecting to take it; but, in the right arm instead.
Diffuse hives starting about 24 hrs after injection, initially started at injection site and then spread diffusely within 12 hours; also with some bruising at injection site.
Began coughing and wheezing. Stated she felt like her throat was sore and was swelling.
Patient noticed quarter sized red dots (4 of them) on left arm and chest upon awakening. Dots are slightly raised but not itching or bothersome.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 16-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K011083 with expiration date: 08-AUG-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
loss of weight; inability to eat; have to move their bowels immediately; decreased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (loss of weight), FEEDING DISORDER (inability to eat), BOWEL MOVEMENT IRREGULARITY (have to move their bowels immediately) and BLOOD PRESSURE DECREASED (decreased blood pressure) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third 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 WEIGHT DECREASED (loss of weight), FEEDING DISORDER (inability to eat), BOWEL MOVEMENT IRREGULARITY (have to move their bowels immediately) and BLOOD PRESSURE DECREASED (decreased blood pressure). The patient was treated with CILGAVIMAB, TIXAGEVIMAB (EVUSHELD) at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (loss of weight), FEEDING DISORDER (inability to eat), BOWEL MOVEMENT IRREGULARITY (have to move their bowels immediately) and BLOOD PRESSURE DECREASED (decreased blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Decreased. On an unknown date, Weight: loss of weight.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient was prescribed with Evushield for the symptoms. Reporter reported that while she was looking for Evushield, the medication which was prescribed for the symptoms that she experienced after getting the 1st booster dose of the Moderna Covid vaccine, she met 2 patients (no identifiers except for gender and age group) who were also looking for the same medication due to the same symptoms (inability to eat because they have to move their bowels immediately, loss of weight and decreased blood pressure) she had post Moderna vaccination.   Reporter did not allow further contact