chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 14 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe  explosive Diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIARRHOEA (Severe  explosive Diarrhea). On 12-Jan-2021, DIARRHEA (Severe  explosive Diarrhea) had resolved. Patient stopped consuming Xeljanz XR for 5 days prior to 2nd dose of Moderna COVID vaccine and did not experienced any reactions after the 2nd dose of vaccine. Patient had severe exploding Diarrhea 12 hours after the administration of 1st dose of Moderna vaccine, which lasted for 2 hours then recovered.
The patient was given the Bivalent instead of the Monovalent COVID vaccine for the first dose.
10/21/05 Husband took patient to therapy in morning where she felt dizzy and nausea occurred. Patient experienced vomiting episode.
COVID-19 breakthrough case, resulting in multiple hospitalizations  Summary: 1) originally she was hospitalized 12/2 bc of UTI that was interacting with health conditions- discharged    12/6 2) daughter called ambulance and case went back to hospital 12/7 (for cough) and tested positive for    COVID-19- discharged 12/8 (3:30 am) 3)  case?s daughter took her back to ER yesterday 12/8 for low pulse-ox and chest pain- discharged 12/9  4) As of 12/13 - case had been re-admitted to the hospital  More details: 12/2- The case went to the hospital bc she has congestive heart failure and had a UTI that was interacting with it 12/5- Daughter noticed the cough start (symptom onset) 12/6- Came home from the hospital- daughter asked the doctor about the cough- he said that it would go away once she finished up the antibiotics for UTI - did not test her 12/6- when she was home she was loopy and hallucinating 12/7- cough got worse - a daughter called the ambulance 12/7- tested positive for covid-19- sent her home 12/8 at 3:30 am- said that they couldn't keep her overnight until 12/8 12/8- Case is home now: -daughter reported her pule-ox was 74 today 12/8; asked if she received monoclonal antibody treatment; dr at a HCF told her that there is a shortage and that she could not receive it; case is on oxygen 24/7  COVID-19 symptoms: runny nose/congestion, fatigue, cough, confusion, hypoxia, loopy- delusional; is on 2 liters of oxygen 24-7 ; O2 level was 74- check a few times a day  She let me know that she took her mom back to the ER yesterday for low pulse-ox and chest pains; the machine was pulse-ox inaccurate (said her O2 was 77); chest pains; chest X-ray; loopy for days; found out that the antibiotics for the UTI didn't work- put her on a different antibiotic
FLUSHED/REDNESS TO CHEEKS, NOSE, CHIN ~30 MIN POST VACCINE ADMINISTRATION
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced a positive COVID-19 test on an unknown date after the vaccine. The clinical outcome of the event COVID-19 was unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
explosive diarrhea for 3 days, no nausea, dizzy  weak.  lasted 7 days
- large rash covering entire area between elbow and shoulder (appeared 1 hour after immunization), continuing thru 2 days later (and currently at time of this report) - body aches starting next day - soar throat starting next day  prednisone to treat rash, body aches/soar throat has subsided.
The patient is a 82 y.o. female with history of cad, cardiomyopathy, dm2, ckd3 presented to the Hospital with exertional dyspnea .   Exertional dyspnea and hypoxia - resolved  Covid 19 virus infection Date of onset of symptoms: 1/3/23 Symptoms present on admission: Cough, nasal congestion, exertional dyspnea Date of covid positive test: 1/5/2023 Vaccination status: vaccinated Imaging: CTPA showed no acute PE, showed borderline aortic aneurysm and ascending aorta, stable mildly enlarged mediastinal and bilateral hilar lymph nodes.  Minimal scarring in RML.  Cholelithiasis also noted Oxygen requirements on admission: None at rest, 2 L with exertion Current oxygen requirements: Room air Medical therapy: steroids Consultants following: ID Anticipated special isolation end date: 1/13/2023   AKI on CKD 3 - resolved  Most likely due to diuresis Cr 1.9 on arrival Baseline Cr.  Around 1.4 Hold home diuretics and Entresto Avoid nephrotoxins Monitor renal function   Acute UTI UA with moderate leuk esterase, WBC 9500 bacteria Patient does endorse urinary frequency but is also on diuretic Given Keflex in ER Urine culture grew E-coli  Will discharge home with 2 more days of Keflex   Elevated troponin Troponin 27 and then 24 Likely related to CKD EKG without any acute ST changes Patient denies chest pain Continue telemetry monitoring   Chronic HFrEF Does not appear clinically fluid overloaded Hold home Lasix and Aldactone given AKI Monitor volume status BNP 509, near baseline of 500 Echo 12/12 with EF 45%  Hilar lymphadenopathy, chronic stable, likely benign.    DM type 2 with current long term insulin use and CKD 3 A1c 8.8 on 12/16/2022 Home regimen: levemir 50 units qpm and novlog 7-10 with meals Lantus 25 units nightly plus sliding scale ordered for now   Acquired hypothyroidism Continue levothroid   Depression Continue sertraline
Headache, scratchy throat, flushed face felt puffy and swollen and red. Pain down arm and up into shoulder. MOTRIN - event lasted 48 hours.
ALLERGIC REACTION SWELLING OF THE FACE ON LEFTSIDE, TROUBLE BREATHING, CHEST TIGHTEN UP, NECK AND BACK , SEVERE HEADACHES, DIZZINESS, EXTREME FATIGUE, MUSCLE ACHES AND PAINS.
I had no immediate symptoms. I had a normal eczema flare on my shin. As time went on it was itching beyond belief. As it progressed, it was like my shin was completely open and it was infected with a staph infection. I saw the doctor and she prescribed hydroxyzine and hydrochloride to treat it. I was also on prednisone and mupirocin antibiotic ointment. I have eczema already, but this has been insane. It usually goes away after treatment, but this did not go away. None of these works. I only started to see improvement when she started me on DUPIXENT injections in my abdomen or thigh. After a few weeks of taking it, I saw improvement. As symptoms progressed, I would get hives and my body turned red. I felt like I was being pricked by needles in my arms, palms, back of hands, and chest. The tops of both legs were also affected as well as any parts of my back that I can reach. I do still have the rash but most of itching has gone away except for in the arm I had the shot in. I have had these symptoms before, but it was not as severe. I had to go to the ER twice in September of 2021. The anemia was identified in November of 2021, so we thought this was. My iron count was 6.5 but that was fixed after I stopped taking EXCEDRIN. I do believe I have recovered from these symptoms. It took about a month.
This spontaneous report was received from a pharmacist via a company representative and refers to a unspecified patients of unknown gender who were less than 50 years. The patients medical history, concurrent conditions and concomitant therapies were not reported. The pharmacist reported that "he has heard" from unspecified physicians, that on unspecified dates, unspecified patients had received ZOSTAVAX (strength, dose, route and lot number were not reported) for prophylaxis. No adverse effects reported. Additional information has been requested.
Minor pain and swelling at injection site, mild fever responsive to tylenol, fatigue. Fully recovered from all side effects at 48 hrs.  Reporting only due to the fact that this is a new vaccine for tracking purposes.
Left arm rash lasting 4 days, then on 5th day rash became intensely red and spreading upward to clavicle and down left arm, with clear margin, soft tissue induration and pain. Took oral antibiotic AUGMENTIN and antihistamine cetirizine. 80% improved within 10 hours, but appears to be recurring 20 hours later.
Racing heart for up to 8 hours over 152 pulse started 30 min after injection
The patient who received the vaccine was a breastfeeding mother. Her 15-month-old developed an ear infection, requiring antibiotics for the first time ever, within 72 hours of the vaccine administration. Her 15-month-old developed a fever of 102.6 approximately 6 days after the vaccine was administered. He then was prescribed antibiotics 7 full days after the vaccine was administered to the mother.
Information has been received from a registered nurse RN concerning a 6 year old female who on 24SEP2002 was vaccinated SC with a dose of varicella virus vaccine live. The RN reported that on 07OCT2003, the patient developed a severe case of chickenpox characterized by a slight fever and a high number of lesions that started on her neck and soon spread to her whole body. At the time of this report, the patient had not sought medical attention and her chickenpox persisted. Additional information has been requested.
Started w/fever & rash on 1APR92; On 2APR92, had strange odor also had unusual drowsiness, fever, weakness of rt arm & rt leg, unable to turn head to the rt & did not know mom; adm to hosp x 2 days tx w/IV's; dx febrile seizure;
She felt like she was going to faint; She couldn't focus; Felt her throat closing; Fatigue; Her arm got red; Her arm got tender; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (She felt like she was going to faint), DISTURBANCE IN ATTENTION (She couldn't focus), THROAT TIGHTNESS (Felt her throat closing), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Her arm got red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (to antibiotics) and Sun sensitivity.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PRESYNCOPE (She felt like she was going to faint), DISTURBANCE IN ATTENTION (She couldn't focus), THROAT TIGHTNESS (Felt her throat closing), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Her arm got red) and VACCINATION SITE PAIN (Her arm got tender). On 06-Jan-2021, PRESYNCOPE (She felt like she was going to faint), DISTURBANCE IN ATTENTION (She couldn't focus) and THROAT TIGHTNESS (Felt her throat closing) had resolved. On 12-Jan-2021, FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Her arm got red) and VACCINATION SITE PAIN (Her arm got tender) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication use was not reported. She was in the medical area from 8 - 12 PM but she did not receive any treatment.
8 days after the vaccine I got a larger 2X4 inch raised hive on my arm at the injection site.
About 5 minutes after receiving  her shots, the patient told her mom present with her she was not feeling good and  having a little  a little shortness of breath.   The mom had her sit in the chairs and ask the tech to let me know.  When I got the the patient she was a little flushed in the face.   I gave her some water to drink.  She stated the feeling had started to pass. She no longer felt shortness of breath . She did state she had only had cereal at breakfast and had not eaten anything since. After about 15 minutes  the mom stated  she was feeling fine and they left.
Very high fever progressed by 4:00am 03/10/2015 to 105.2 degrees Fahrenheit pain and burning in upper right arm gave her 2 500 MG of Tylenol fever started coming down at around 6:00 am on 03/10/2015 at present time she is sleeping pain still on upper arm and lethargic.
Fever, fatigue, and achey after shot for 3 days. Chronic hives started several weeks after receiving vaccine.  Extreme facial swelling started 11/18/21. Was told by my allergist that it's caused my virus and immune system is attacking body.
Patient was light headed, dizzy and stomach hurt. Patient then fainted. We offered to call the ambulance but patient and girlfriend refused. After questioning the patient we found out the patient hadn't eaten or drink water in the past 12 hours. we gave the patient water and snacks and some ice to cool him down. we also found out the patient has a fear of needles. once the patent started to eat and drink more he started to look and feel better.
After the injection, I felt a little dizziness and stayed in my car for about 15 min.   Then I came home and around 10pm, I started with chills, then a headaches about 30 minutes after and that stayed until Feb. 14th around 3pm.  About 1pm, the muscle aches and body aches and soreness started to set in as I needed help going to the bathroom as I was urinating 1-2 times per hour. I felt pain and a sensation moving through my organs, one by one.  I was sensitive to anyone touching me as it hurt as my daughter helped me to the bathroom.  At 4pm when I check for my temp, it was 100.9 and it remains that now.    On 2/15, I still have  a mild headache and a fever of 100.9 all day.  Slow moving and definitely fatigue, foggy brain and now some nasal stuffiness.
Red, swollen, hot, itchy. Treatment-warm, compresses, Motrin.
Patient presented to our ED on 11/05 with complaints of recent nausea, vomiting, diarrhea and abdominal pain. All symptoms started shortly after receiving influenza vaccination. Patient reports no regular use of alcohol, tobacco or recreational medications. Initial lab results are significant for creatinine of 4.07, BUN of 52, calcium of 14.7, alkaline phosphate of 730, lipase of >3,000, amylase of 861, platelet count of 510,000, blood iron of 253 with other labs largely within normal limits. Upon CT scan patient is found to have a diffusely enlarged, edematous pancreas, hepatic cirrhosis, splenomegaly, portal hypertension. Patient is diagnosed with acute pancreatic of unknown origin (possibly related to influenza vaccine, possibly related to underlying sarcoidosis/hypercalcemia). Patient was admitted to intensive care unit. On day two of hospitalization patient displayed altered mental status, a head CT was negative and change was thought to be due to metabolic encephalopathy. Patient was electively intubated evening of day 2 and would remain on the ventilator for 7 days. While in the ICU patient received 7 bags of TPN and 3 dialysis sessions. Also while in ICU patient spiked temperatures and was subsequently started on meropenem. Patient also experienced anemia with her lowest hemoglobin at 6.5 (blood transfusions refused). Gradually patient improved and was downgraded from ICU status on 11/14 and subsequently moved to a medical floor on 11/16 and discharged on 11/18.
First dose was on 01/12/2021 at 9:30 am. No reaction until Feb.7. 2021, when left leg began to swell, but not seriously.  Feb.8, 2021 leg was continuing to swell.  went to doctor's office where he prescribed an ultrasound.  Was told there was a clot behind my left knee and in some of the smaller veins.  I had the chills, joint pains all over, which lasted about the three weeks, but was slightly different every day.  When I began the 20 mg dose of Xarelto, every symptom cleared up and I felt great.  I am continuing on the 20 mg Xarelto.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.  ; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
"The next couple of days i was extremely tired, slept for several hours in a row and was not even aware of it.  12/23 I started feeling light headed and shakey and couldnt get my heart rate down when attempting a light work out. I felt so bad i took the rest of the week off.  12/30 it hit me again with really bad stomach cramps, fever, light headed and shakey again.  i took  covid and flu tests and it was all negative.  it was so bad i was in bed from new years eve at 9p till 1/1/21 4p and i missed another week of work"
within 30 minutes couldn't swallow, tongue swollen, numbness in face, burning in ears, light headed, dizzy  several days later severe diarrhea lasting weeks, another emergency room visit for gastrointestinal tests (see Dr. had same reaction to first vaccine on 3/25/21 Pfizer ER8727...WITHOUT antiphalactic reaction: first vaccine: pain in arm, dizzy, lightheaded, congested, head was heavy and foggy brain, diarrhea that lasted weeks, lethargy, pain in gut and head
Pt received vaccine 20Sept21, started having symptoms 21Sept21 vaccine including  substernal CP 3/10, HA, generally "feeling sick".  Denies SOB.  Pt went to ER 22Sept21 for ongoing CP,  dx with Pericarditis.  Pt prescribed Ibuprofen and Colchicine, has not yet picked up medications as of this writing.  Pt only ongoing symptoms is still CP, 3/10, substernal, has not changed in nature.
Information has been received from a registered pharmacist (R. Ph) concerning a 62 year old male with no medical history and no drug reaction/allergies and no recent exposure to chickenpox who on 08-MAR-2011 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669408/1384Z) in left deltoid. On 25-MAR-2011 the patient noted "three pox marks that were red and raised, 1/4 inch apart in a row (line formation) and each about 1/8 inch high, there was no pain or itching", it included chickenpox . There was no shingles. No treatment was given for the event. No lab diagnostics studies performed. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain." According to the VZVIP guide on 30-MAR-2011 the lesion sample was collected from skin. Follow-up information was received from the lab. The specimen was collected from lesion of left upper arm. The specimen arrived in lab on 01-APR-2011. The final PCR (polymerase chain reaction) result was inadequate specimen. No further information is available.
Nurse administered H1N1 Flumist vaccine. Nurse was then going to administer SEASONAL FLU injection vaccine. She inadvertently administered H1N1 injectable instead. Follow up done with patient's mom no known side effects or adverse reactions.
LETHARGY, NAUSEA, HEADACHE, SHORTNESS OF BREATH, FATIGUE, FEVER>100, SLEPT FOR 36 HOURS
COVID-19 PFIZER with an extended expiration date was given on 07/31/2022
Constant nausea, fatigue, heavy periods, abdominal pain, pelvic pain, left side weakness, numbness, flu-like symptoms, sore throat, nasal congestion, anxiety, heartburn, chest pain, bloating, mouth sores, constipation, seizures, brain fog, dyspareunia, vision loss, left side paralysis, hemiplegic migraines, neuropathy, pressure in head, gait disturbances, light and sound sensitivity, dizziness, tremors, temp intolerance.