chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Booster Vaccine administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster Vaccine administered >12 hours post puncture) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 37C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022 at 8:10 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022 at 8:10 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster Vaccine administered >12 hours post puncture). On 28-Jan-2022 at 8:10 AM, EXPIRED PRODUCT ADMINISTERED (Expired Booster Vaccine administered >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 stated that a 46-year-old patient received an expired booster dose of Moderna COVID-19 vaccine more than 12 hours after puncture on 28-Jan-2022. The date the vial was initially stored in the refrigerator was unknown, but it was less than 30 days.   The date and time the vial first punctured was 27-Jan-2022 at 8 AM and the date and time of administration of vaccine was 28-Jan-2022 at 8:10 AM. The vial was stored in the refrigerator post puncture. It was also reported that the vial didn't undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was N/A because it was kept in the refrigerator post puncture.  No treatment information was provided.
Patient is on immunosuppression for kidney transplant and qualified for the 3rd moderna dose to complete the primary vaccination series, which should have been 0.5 mL. He received the booster dose, which was 0.25 mL.
Lymph node, on my left side which is where I got the vaccine were swollen, only the ones on my left side like one under my arm and the other one is above my clavicle; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via unspecified route of administration as a single dose for COVID-19 immunization in right arm on an unspecified date. Concomitant medications included, Atomoxetine, the brand name for that is Strattera. (further clarification unknown if consumer was taking brand or generic, hence both captured in tab). patient take more medicine but think that was fine and did not really think they have interaction, the other one was just birth control (not clarified further). Medical history included Irritable bowel syndrome. It was reported that, I got a blood test the other day, last week on Friday, that was my lab test. I went to my doctor because of my swollen lymph nodes, so they sent me for an ultrasound and the ultrasound showed that the lymph node was swollen. So, they sent me some blood test to do and I did them on Friday and I got the result for that and every thing in the result was normal. It was reported that, I did not know if this has already been recorded or not. After about two or week and a half after I had my first Pfizer Covid vaccine, my lymph node, on my left side which was where I got the vaccine were swollen, only the ones on my left side like one under my arm and the other one was above my clavicle. Therapeutic measures were not taken and stated, no, I have not. It still had not changed, it had been two weeks and it did not come down. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 11-May-2022; administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 11-May-2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 11-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the patient had received expired dose after the 30 days use by date. The date the vial initially stored in the refrigerator was 11-Jan-2022 and was administered on 11-May-2022  The vaccine did not experience any temperature excursions. There were no adverse reactions reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Follow up was received: Updated the primary reporter's additional contact information. On 17-May-2022: Significant follow-up was received: Report type updated into a valid case, patient details updated added patient's identifier, Suspect product dosages added batch number added, event verbatim updated and I-narrative updated.
This spontaneous report as received from a Nurse Practitioner refers to a female patient of unknown age. Medical history and concurrent condition were not reported. The patient stated that "she received VARIVAX at birth and at 10 years old". Dose, route, lot number and expiration date were not provided. No other suspect or concomitant therapy was reported. Recently, the patient developed a "herpes outbreak". For this Herpes outbreak the patient was prescribed Valacyclovir, 500 mg daily, by her physician. The patient stated that she was entering to nursing school and received serologic testing (date unspecified) that included varicella titers; results came back as "low" (viral test positive). The outcome of herpes virus infection and a "low" results for serologic testing was reported as unknown ("I am working through it"). The causality between the events and the therapy with VARIVAX was unknown. Additional information has been requested.
Anaphylaxis; A spontaneous report was received from a physician assistant concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis.  The patient's medical history was not provided. No relevant Concomitant medications were reported.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, after receiving vaccine, the patient died due to anaphylaxis. No further details were available at the time of this report. Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event anaphylaxis was fatal .The patient died on an unspecified due to anaphylaxis. Autopsy details were not provided.; Reporter's Comments: Very limited information regarding the event of anaphylaxis has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Anaphylaxis
Information has been received from an RN concerning a 38 year old female with no past medical hx who on 31OCT2003 at 9:00 AM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine IM in the right deltoid. There was no illness at the time of vaccination. On 31OCT2003 at 3:00 PM the pt complained of "hot, red, swollen arm after pneumococcal 23v polysaccharide vaccine. The pt also reportedly had a painful arm. The pt was told to use Tylenol. The pt recovered 02NOV2003. There were no relevant diagnostic testes or lab data. It was noted that the pt received the first dose of pneumococcal 23v polysaccharide vaccine in 1998. It was also noted that the pt did not have any adverse events following previous vaccinations. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  It was also reported that four other pt had a similar rxn. Additional info is not expected.
Hearing loss; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEAFNESS (Hearing loss) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Hearing loss) outcome was unknown.            No concomitant medications were reported. It was reported that patient had got second dose of moderna vaccine and lost hearing a couple of days after that in his left ear. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a patient friend, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Deafness, which occurred a couple of days after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Patient lost hearing in his left ear. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a Spontaneous case reported by a patient friend, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Deafness, which occurred a couple of days after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Patient lost hearing in his left ear. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Report A0363826A describes flu-like symptoms in a male of unspecified age who received Lyme disease vaccine recombinant. This report was received from the vaccinee's wife and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions and concurrent medications were "unknown." On unspecified dates, the vaccinee received his first and second injections of LYMErix. It was reported that subsequent to an unspecified injection of LYMErix, the vaccinee experienced flu-like symptoms, injection site redness, and injection site pain. As of 3/20/02, the outcomes of the events were reportedly unknown.
pt recvd vax & devel soreness in lt arm around the beginning of November; pt has seen MD; recvd 2nd dose w/no sx & intends to complete the series;
BREAKTHROUGH COVID: PT FULLY VACCINATED. 85-year-old female admitted to intensive care unit during a septic shock, necessitating mechanical ventilation and vasopressors for the 1st 48 hours of the hospitalization, when she was extubated successfully and vasopressors were able to be discontinued,  antibiotic therapy with fosfomycin and doxycycline.  Subsequent blood cultures follow-up were negative. Patient diagnosed with COVID 19 infection, possible the triggered the acute respiratory failure necessitating mechanical ventilation at the time of admission.  Patient was treated with Decadron, as well as with 5 days of remdesivir, which she completed both treatments here in the hospital. On June 16th patient was considered non infectious and will be able to transition to the skilled nurse facility. Primary Discharge Diagnosis: Acute Hypoxemic Respiratory Failure, requiring intubation. Extubated 6/7, COVID-19 Positive, Bilateral Pleural Effusions,Severe sepsis with shock, Acute encephalopathy secondary to sepsis, Senile Dementia, Nonspecific radiographic changes on pancreas, Chronic kidney disease, Essential hypertension, Hypotension upon admission, Hyperlipidemia, AND Constipation.
I was having difficulty breathing, and dr during a regular check up on my back, suggested I go immediately to the ER. I had a blood clot on my lungs and my right leg. I was admitted for 3 days. This was in January. I started to feel this way, with the shortness of breath after the vaccine, but I thought it was related to age.  I now take Eliquis and where a compression hose most of the time.
Chest pain like squeezing first on the left side then succeeding pain on the right chest. Last about a minute or less.  Several times this in an hour this morning.
Myalgia, pain, swelling at site for 3 days, fever, fatigue, myalgia day 2.  Narrative:
Patient received first dose of Pfizer on 3/30/2021 despite only being 14 y.o at time of vaccination (<16 y.o.). Error was discovered by registration staff when patient presented for her 2nd dose of pfizer. 2nd dose of pfizer was not administered. Patient instructed to wait for second dose until they expand age requirements for Pfizer to 12+ y.o.
Spontaneous Pain in inside left foot just above heel, pain radiates all over back of foot when standing or walking. Feels like blood clot / ruptured blood vessel. Not sure if this is attributable to vaccine
PAIN IN INJECTION SITE FOR 6 DAYS. A LARGE PART OF UPPER ARM SWOLLEN AND HOT ONSET 24 HOURS, CONTINUING FOR 4 DAYS. APPROXIMATELY 24 HOURS AFTER INJECTION CHILLS, FEVER, NAUSEA, HEADACHE, LETHARGIC, FUZZY HEADED, COULD NOT CONCENTRATE. REACTION CONTINUED FOR 72 HOURS. I MISSED 1.5 DAYS WORK BEFORE FEELING BETTER. I PUT ICE ON MY UPPER ARM, TOOK IBUPROFEN, DRANK LOTS OF WATER, DID NOT EAT FOOD, SLEPT A LOT.  I TRIED NEOSPORIN AND LAVENDER OIL ON MY ARM BUT IT STILL HAS A LARGE RED PATCH ALMOST A WEEK LATER BUT SWELLING IS GONE.
extra Engerix-B adult dose administered by error instead of Menveo (5th dose); extra Engerix-B adult dose administered by error instead of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 333M4, expiry date 07-APR-2024) for prophylaxis.   On 23-SEP-2022, the patient received the 5th dose of Engerix B adult. On 23-SEP-2022, an unknown time after receiving Engerix B adult, the patient experienced extra dose administered (Verbatim: extra Engerix-B adult dose administered by error instead of Menveo (5th dose)) and wrong vaccine administered (Verbatim: extra Engerix-B adult dose administered by error instead of Menveo). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: Receipt date: 10-AUG-2023 Physician was looking for information of an extra Engerix-B adult dose administered by error instead of Menveo, which led to wrong vaccine administered and extra dose administered. This last dose was administered as a 5th dose. The reporter consented to follow up. Fax: preferred
Swelling of the throat--trouble breathing--went to doctor and was then instructed to go to emergency room for care.
Pt had shots 3MAY89 that evening pt was very cranky & irritable; pt didn't want to be touched that noc pt kept getting up; crying had a fever; wasn't hungry next day died;
RNs responded to a knock on the door of immunization clinic.  Client was recognized as had received first dose of Jynneos vaccine a few minutes prior. Client verbalized feeling swelling of the throat, was directed into clinic vaccination area chair, Station #1, to sit. Vitals were taken at 10.09 am as RN prepared 1mL diphenhydramine for client administration.  Vitals at 10.09 am 147/88, HR 71. O2 Sat. 99%. Diphenhydramine administered on opposite arm of vaccination, right arm, at 10.11 am.  Client denied difficulty breathing or speaking at the time.  RN called to assist.  Vitals taken again at 5 minutes, 121/72, HR 60, O2 Sat 98%.  10.29 am client verbalized feeling better, denied c/o throat swelling.  10.35 am vitals 119/61, HR 61, 98%.   10.40 am client verbalized needing to go to the restroom, accompanied by RN, gait and symmetry of stride within normal range and no difficult upon standing or sitting.  Client verbalized feeling better and no longer feeling swelling of the throat and wanting to go home.    Client refused further care and left the clinic with no further complaints or concerns, agreed to self-monitor and when to seek medical care if symptoms re-occur.  Client left clinic at 10.45 am.
Hair falling out. Elevated body temp (not a fever). Bright red tongue. Because of the increased publicity being given to the desirability of widespread meningococcal vaccinations, I send along the enclosed information. My son's reaction, while not life-threatening, nor, apparently, common (he would have noticed other balding students), was serious enough, in my estimation, to put the vaccine in a category with, for example, pertussis-i.e. riskier, for certain individuals, than other common childhood vaccines. Although my child went back to the student health services clinic for the symptoms, which appeared within days of the vaccination, he was told, by a curtly dismissive physician, that there was no connection to the vaccine, that he was simply going bald. (Baldness does not occur in either his father's or mother's family and the suddenness of the onset seemed peculiar to him). He did see several other doctors for the problem, one of whom had seen this before as a reaction to vaccination (but not the same vaccine). Years after the vaccine, he still seems to have that same revved up immune reaction that started right after the vaccination: his tongue is still a very bright red, his temperature is slightly elevated, and he continues to lose hair. In every other way, he appears to be healthy. This year when my daughter's university sent me the info packet for the meningococcal vaccine, my decision was easy: she will not receive the vaccine. In my estimation, the vaccine can be dangerous. I do not want my child's identification in the report. I do hope this information may help someone.
This 68 year old  female received the Pfizer Covid shot on 2/1/21    and went to the ED on  2/21/21     and was admitted  on 2/21/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) R29.810 - Facial weakness
Employee states left deltoid started to swell with redness noted, c/o slight headache persisting for 12 hours. Donor denies any pain at injection site donors temperature at time of notification 98.3.
Individual's mother contacted health authority to request a record update. Initial information from health authority chat indicated the individual's mother falsified the individual's age to obtain a COVID-19 vaccine. At the time of the vaccine, she listed the individual's age as 12 years, but review of the record for which she requested update shows the individual is 10 years of age. The names and birthdates on the two records are different. The individual received two adult doses of Pfizer vaccine (0.3 ml).
Information has been received from a physician concerning a 2 month old female who on 23-JAN-2008 was vaccinated PO with her first 2.0 ml dose of ROTATEQ (lot# not available).  On 25-JAN-2008 the patient experienced severe vomiting and diarrhea that led to dehydration.  Per physician, the patient was brought to the Emergency Room to seek rehydration therapy on that same day, but was not admitted to the hospital.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
the patient was administered improperly stored VARlVAX; This spontaneous report has been received from a physician referring to a 2 years old patient of unknown gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 11-AUG-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX); lot # S032355, expiration date 14-OCT-2021 (strength and dose were not reported) subcutaneously for prophylaxis (reported as routine vaccination) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S032591, expiration date 16-AUG-2022).  The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.6 Fahrenheit degrees) for a time frame of 12 hours (multiple excursions) and in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees (16 Fahrenheit degrees) for a time frame of 30 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved.
On 10-23-14, patient stated she had allergic rxn to the FLUZONE-HD shot she received on 10-20-14. She said she got chills (got really cold and started shaking), got a bad cough, and a fever. The symptoms lasted just that day and into the night... She "thought she was going to die." She felt better the next day.
Covid rash, 5x6 inch rash shape of a bean on left arm around injection site. Rash was treated with benadryl cream and aloe Vera gel daily as suggested via telemedicine appointment with pcp. Lasted about a week and a half.
PATIENT RECEIVED VACCINE 1/12/2021. STATES SHE WOKE AT 0500 ON 1/21/2021 WITH SEVERE BURNING AND ITCHING AT INJECTION SITE, STATES ARM SWOLLEN TO GRAPEFRUIT SIZE. WENT TO PCP WHERE SHE WAS ADMINISTERED A STERIOD INJECTION AND PUT ON BENADRYL PO. RESOLVED ON 1/25/2021.
about 1.5 weeks after receiving the first dose of the Comirnaty/pfizer-bioNTech COVID-19 Vaccine I have been experiencing deep soreness/pain in my arm which received the shot. I have limited mobility in this arm as a result of the vaccine.
Immediately after receiving vaccine, patient began to panic. Patient stated she has a fear of needles. Patient given gatorade water and encouraged to do deep breathing relaxation techniques.