chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 86 y.o. female patient of MD with history of multiple sclerosis with neurogenic bladder, who presented to the hospital from the resident facility with dyspnea on 2/26/2023/   Covid-19 Pneumonia  Acute hypoxemic Respiratory Failure, POA Possible superimposed bacterial pneumonia Mucous plugging Date of onset of symptoms: 2/25/23 Symptoms present on admission: Hypoxia Date of covid positive test: 2/26/2023 Vaccination status: vaccinated Imaging: CT PE study on admission with bilateral left greater than right groundglass opacities on my interpretation.  Repeat chest x-ray 3/2/2023 showing right hemithorax Oxygen requirements on admission: 2 L Current oxygen requirements: High flow, 90% FiO2 Medical therapy: Dexamethasone.  Status post remdesivir Consultants following: ID following Continue cefepime and vancomycin for possible superimposed bacterial pneumonia Management of secretions/mucous plugging with Mucomyst, vibratory pep, and chest physiotherapy Diuresis as able Limited echo reviewed with normal EF, dextrocardia, small to moderate inferolateral pericardial effusion, indeterminate diastolic function.   Goals of care discussions repeatedly addressed throughout hospitalization with patient and adult children (2 daughters and son).  Ultimately CODE STATUS transition to DNR CC on 3/4/2023.   Discussed with patient and daughters at bedside today, referred to hospice per patient and family wishes. Comfort medications ordered.   Hospice meeting at 1 PM today.   Hyponatremia, worsening Likely hypovolemic in the setting of decreased p.o. and diuresis Trend sodium Hold diuresis today Hold off on fluid resuscitation given her tenuous respiratory status   Possible underlying heart failure with preserved ejection fraction On oral Lasix at home and BNP elevated on admission Unclear if has underlying heart failure.  Chest x-ray not consistent with cardiogenic pulmonary edema and exam not consistent with decompensated heart failure.   Chest x-ray 3/4 reviewed with near complete opacification of right hemithorax with minimal improvement from few days ago.  Consistent with lung airspace disease possible pulm edema bilaterally. Diurese as able, on hold for now due to hyponatremia Echocardiogram with normal LV function
side effects that she had from the 1st booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (side effects that she had from the 1st booster dose of the Moderna Covid-19 vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (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 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (side effects that she had from the 1st booster dose of the Moderna Covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (side effects that she had from the 1st booster dose of the Moderna Covid-19 vaccine) outcome was unknown.            No concomitant product use was reported.  Reporter stated that while looking for Evushield, the medication that was prescribed to reporter to counteract the side effects that reporter had from the 1st booster dose of the Moderna Covid-19 vaccine (monovalent), reporter met 2 patients (no identifiers except their gender and age group) who was also had the same side effects as reporter had. There was no parental vaccine exposure.  No treatment information was provided for patient.  This report is for the 1st patient of 02.   This case was linked to US-MODERNATX, INC.-MOD-2022-687442 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687442:Same reporter
A pediatric Hepatitis B vaccine was given by nurse instead of an adult vaccine. Trying to correct error, nurse gave another pediatric Hep B thinking 2 pediatric would equal an adult. The patient still didn't get the equivalent of an adult dose with 2 of the pediatric doses. The patient has been notified and instructed that the 2nd dose that was given incorrectly would need to be repeated to fully complete the Hepatitis B series.
This spontaneous report was received from a healthcare worker and refers to a 61 year old female patient with no drug reactions or allergies. On 07-JUL-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L003227, expiration date 13-OCT-2016), 0.5 ml, intramuscular. There was no concomitant medication provided. On an unspecified date in July 2015, the patient experienced difficulty breathing and an unspecified local injection site reaction. On 10-JUL-2015, the patient was admitted to an unspecified hospital critical care unit for the treatment of the reactions. The unspecified threatening physician at the hospital stated that the symptoms were either due to an allergic reaction to PNEUMOVAX 23 or the vaccine was unsterile. The reporter stated that they have 22 remaining doses of PNEUMOVAX 23 lot L003227, that they did not want to use anymore, therefore they requested that a lot check be completed. At the reporting time, the outcome of dyspnoea, injection site reaction and allergy to vaccine was unknown. The reporter considered the dyspnoea to be a life threatening condition. Additional information has been requested.
pt recvd vax SEP92 & on 5NOV92 devel pain in lt arm; No further details were provided;
Initially had localized redness, tenderness and swelling at injection site.  This resolved and came back 7 days later, although with less pain and increased warmth to the injection site.
Initial report was received 29 November 2010 from a health care professional. A 24-year-old pregnant woman received an intramuscular injection of ADACEL, lot number C3490AA (site not reported) on 11 October 2010. The patient was reported to have been one week gestation at the time of vaccination. Her date of last menstrual period was reported as unknown and her estimated date of delivery was not reported. According to the reporter, the patient had not experienced any adverse event following receipt of ADACEL. Follow-up information received from a health care professional on 09 March 2011. The identifier of name of patient was provided. The outcome remained unknown. Follow-up information was received from the healthcare professional on 29 August 2011, which update the event to serious. This case now pertains to the mother; information for the baby is captured in case number 2011-07925. The patient smoked during pregnancy, but was otherwise healthy. The father of the baby was 47 years old, and was also healthy. Estimated date of delivery was July 2011. The patient was reported to have had one prior pregnancy. On 01 April 2011 she experienced early fetal death (20-27 weeks gestation) of a male fetus. Documents held by sender: None.
Breakthrough case admission after 3 vaccines  Moderna 1/12/21  lot# 025J20A;  MOderna 2/9/21 lot# 004M20A; Moderna 11/24/21 lot# 012h21B
Deep fatigue 7th day after vaccination. Then extreme fatigue (unable to do anything but sit or lay down) 9 days after vaccination. Gradually improved over the following 4 days.
p/vax s/s erythema, pain, edema;tx compresses, analgesics, DPH;
This spontaneous report as received from a nurse concerning a 38 year old male patient with hypothyroidism. It was reported that the patient did not experienced drug reactions or allergies. The nurse reported that the patient who on an unknown date, started prednisone (manufacturer unknown) tablet, orally (strength, dose, frequency, route of administration, lot number and expiration date were not provided) an immunosuppressive therapy for asthma, on 20-JUN-2017, inadvertently received a first dose of M-M-R II, lot # M048368, expiration date: 08-DEC-2017, (strength, frequency, route of administration were not provided) for prophylaxis. Concomitant therapies included zolpidem, fluticasone propionate, ADVAIR and albuterol. According with the nurse the patient received the first dose of the vaccine, in this date. However there were records from childhood was received and it was also mentioned that the nurse stated prior to vaccination, patient had titers drawn (Measles antibody negative) and did not show immunity to Measles, Mumps, Rubella. Per nurse, patient experienced no adverse effects. No treatment was given for the adverse event. It was reported that the patient was doing fine. The patient did not seek the medical attention. There was no product quality complaint (PQC) involved.
2 weeks following second dose of COVID vaccine he began to experience daily headaches complicated by vomiting and eventually spent 2 weeks hospitalized for intravenous medication to control the migraine. He was released with multiple oral medication and to this date has not been able to stop the medication due to return of migraine
12:30 a.m. Chills/sweating back and forth, began to hurt all over.....shoulders, back, hips, hip bursa, knee, ankles, and injection site began to ache.  Increased during night, with NO sleep!  Headache and fever arrived.  Entire day aching increased (Extra Strength Tylenol really didn't help).  Appetite minimal.  Plenty of water!  Aching  injection site so bad could barely lift the arm.  Fever 100.6 gone by following morning and felt stiff all over.  Day 5, still feel light-headed and unsettled.  Notified doctor by Portal message of reaction (knowing it wasn't life-threatening and common).  Doc's reply it was common.  But this took a healthy, active old lady with NO conditions to a general very ill level.
Per Dr: Patient complained of lip and tongue swelling at 13:!6 after receiving Moderna vaccine. BP 167/102 and HR 94, O2 98%. No SOB, no pruritus, no rash. Given Benadryl 25mg at 13:19 with prompt improvement. Symptoms started to recur and second dose of Benadryl 25mg given at 13:29. Patient comfortable until 13:35 when she looked less comfortable, complained of difficulty swallowing, looked anxious and uncomfortable.  Continued to progress but denied SOB.  BP 214/116 HR 109. Epi-pen given x 1 at 13:43 - concern that episode pen did not deploy. Epi given again at 13:45. BP 187/95, HR 121, O2 sat 100%. Patient subsequently improved with less anxiousness, less difficulty swallowing.  Patient transported to UTC at 14:05.  Lot 042L20A
It was reported that a female pt received a Fluzone SV "99-'00 vaccination on 10/7/99. Reportedly, that same day, the pt experienced soreness of the arm, radiating to neck and also experienced a headache.
Information has been received from a consumer concerning her 13 year old daughter with no pertinent medical history or any known drug allergy, who on an unspecified date was vaccinated with the first and only dose of GARDASIL (Lot number not reported). There was no concomitant medication. In May 2009 (reported as for 3 months), the reporter's daughter had been having dizziness. The patient's dizziness persisted. At the time of reporting the patient was not recovered. Additional information has been requested.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from Other health professional (Medical assistant). This case involves a 41 years old patient who experienced received vaccine TYPHIM VI. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE). On 15-May-2018, the patient received a 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number N1K911M, expiry date 27-Oct-2019 via intramuscular route in the right deltoid. It was a case of actual medication error due to syringe issue and vaccine underdose. It was reported that there were no problems with the needle going on. Medical assistant stated that she tightened the needle down tight. The vaccine came out as it was being injected where the needle joins the syringe. MA stated that when she tightened the needle the little area where you put the needle on seemed a little loose. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Follow up information was received from  Other health professional (Medical assistant) and Quality department regarding PTC on 08-Oct-2018. Lot number and expiry date updated. PTC investigation was in process. List of documents held by sender- none
Runny nose, headache,exhaustion, chills, cough, body aches, congestion
This spontaneous report as received from a physician refers to a 13 year old male patient. No medical history or concurrent conditions were reported. The patient was vaccinated with the first, the second and the third dose of GARDASIL (indication, dose, lot# and expiration date were not provided) on 29-JUL-2013, 02-APR-2014 and on 04-AUG-2014, respectively. On 16-DEC-2015, the patient was vaccinated with GARDASIL 9 (indication not provided, 0.5 ml, lot# L007560, expiration date 15-JUN-2017), intramuscularly. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Death Narrative:  Patient received dose 1 of COVID vaccine on  1/27/21. Was observed x15 minutes, no reactions noted. Later that day patient's spouse reports patient has been acting out (reports behaviors the night before) and that she cannot care for him any longer. Patient falls sometime in the 48 hours after vaccine and is admitted to the hospital with an unknown diagnosis. Not certain of patient's history after this hospitalization until 2/9 when patient is admitted again to the hospital with hepatic encephalopathy. Patient is switched to hospice status by 2/12, and passes on 2/21/21.
PATIENT CALLED ON 10/15/2020 TO REPORT THAT SHE DEVELOPED A RASH AND  PAIN ON HER RIGHT ARM AT SITE OF INJECTION. SHE REPORTED FEELING BETTER TODAY, BUT IS NOT FULLY RECOVERED YET
SWELLING AND REDNESS AROUND INJECTION SITE ON BACK OF LEFT ARM. COVERING LARGE PORTION OF UPPER ARM.
3/9/2021--1 day after 2nd dose--had chills, body aches, slight headache, fatigue, nausea--lasted 2 days 3/19/2021--13 days after 2nd dose--had fatigue, body aches, chills, nausea--lasted 1 day 4/15/2021--40 days after 2nd dose--have body aches, chills, slight fever, nausea--don't know how long this will last It seems every 15 to 20 days after the 2nd dosage I get sick
not feeling well; weakness; tiredness; Achy; Dilation of eyes; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), ASTHENIA (weakness), MYDRIASIS (Dilation of eyes), FATIGUE (tiredness) and MYALGIA (Achy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced MYDRIASIS (Dilation of eyes). On 18-Jun-2021, the patient experienced ASTHENIA (weakness), FATIGUE (tiredness) and MYALGIA (Achy). On an unknown date, the patient experienced MALAISE (not feeling well). In June 2021, ASTHENIA (weakness), MYDRIASIS (Dilation of eyes), FATIGUE (tiredness) and MYALGIA (Achy) had resolved. At the time of the report, MALAISE (not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications include Thyroid medications. Treatment information was not provided.
Chills, body aches and fever (101.6 F) for 18 hours.  Low grade fever (99 F) and fatigue symptoms remain (4 days and counting).
Developed rash within 12 hours of vaccine, talked with Dr. after hours, Dr. triaged call recommended Tylenol and Motrin, call if worsens. Patients mother called 07-16-2008, was seen in the morning, patient was cranky through the night, had fever. Patients mother had to pick child up from daycare with fever up to 103.8, vomiting, diarrhea, canker sores in oral mucosa. Child is alert, no seizure or meningal signs noticed. After seeing Dr. and recieving treatment patients mother took her to local ER, on her own with increasing vomiting, and higher fever. ER DR. contacted Dr. with the patient having a fever of 104, by the time ER Dr. talked with DR. temp was down to 98.
Pt. developed mild cellulitis - mild red erythema & pain - pt. being treated w/ KEFLEX 500mg twice daily.
Hep B IM (R) deltoid - after developed cold sensation (R) arm and shoulder - also "like chicken bone stuck in throat" - no hives no rash no SOB - just "uncomfortable when swallow" called PHN - told if SOB -> to ER. As day progressed cold sensation subsided. Left some discomfort (R) shoulder blade increased with movement. F/U call 4/18/14 states still some discomfort (R) scapula increased with movement. N/C at injection site - feeling in throat gone. Client has not contacted physician. PHN advised to call with any change and seek medical eval. if discomfort persists.
UTI; Bacterial vaginosis; had arrhythmia kicking off; heart rate was 110-120 and had arrhythmia and it would calm down and she is still fighting that and it is not as frequent as much; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: ER2612) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of Covid Vaccine on 02Mar2021 (also reported as Start: 01Mar2021). The patient experienced had arrhythmia kicking off  (medically significant) on 23Mar2021 with outcome of unknown, UTI (non-serious) on an unspecified date with outcome of unknown, bacterial vaginosis (non-serious) on an unspecified date with outcome of unknown, heart rate was 110-120 and had arrhythmia and it would calm down and she is still fighting that and it is not as frequent as much (non-serious) on Mar2021 with outcome of not recovered. Patient stated she got the shot 23Mar2021 and as soon as she got it she had arrhythmia kicking off. States her heart rate was 110-120 and had arrhythmia and it would calm down and she is still fighting that and it was not as frequent as much. Stated she had another problem she can't get rid of, she had a UTI and BV. Caller clarified BV as bacterial vaginosis. Stated she was finding she can't get rid of the UTI since she got the shot it keeps coming back and that she has never had that problem before. Patient stated she was wondering what do we suggest that she do because no matter what there was no winning the battle and keep going on antibiotics. Patient stated she got the shot on the 1st or 2nd day of antibiotics and she continued to finish the 7 days and didn't have a UTI and then she got the UTI. Patient stated it was screwing with her body. Stated she was diagnosed with the UTI, it was like 23Mar2021 and she did a week and it was a couple days ago, she did 7 days and was finishing the 5 days and so it was a couple days ago. Patient stated she was unable to complete a report at this time. No further information provided or clarified. Patient stated she got the 2nd dose of the Pfizer Covid vaccine on 23Mar2021 and the 1st dose 2Mar2021.  The patient underwent lab tests which included heart rate: 110-120 on unknown date.
tenderness that was in the upper left arm deltoid muscle; soreness on injection site upper deltoid muscle; weakness on injection site upper deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MUSCLE WEAKNESS (weakness on injection site upper deltoid muscle), TENDERNESS (tenderness that was in the upper left arm deltoid muscle) and INJECTION SITE PAIN (soreness on injection site upper deltoid muscle) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. NDC# 80777027315) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced INJECTION SITE MUSCLE WEAKNESS (weakness on injection site upper deltoid muscle). On 11-Jul-2021, the patient experienced INJECTION SITE PAIN (soreness on injection site upper deltoid muscle). On 12-Jul-2021, the patient experienced TENDERNESS (tenderness that was in the upper left arm deltoid muscle). On 13-Jul-2021, INJECTION SITE MUSCLE WEAKNESS (weakness on injection site upper deltoid muscle), TENDERNESS (tenderness that was in the upper left arm deltoid muscle) and INJECTION SITE PAIN (soreness on injection site upper deltoid muscle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up contains no new information but added secondary contact details in general tab that were missed to capture initially and also updated Batch number that was not fully captured.
Patient complains of red area around vaccine site, no where else. States the area about 1 inch around where the vaccine was given 2 days ago is still very red. Concerned with redness not going away. Hurts if she touches it, otherwise does not cause her any discomfort through daily routine.
Rash beginning under both arms and spreading over most of body.  Taking Diphengydramine HCI, still awaiting outcome.
p/vax pt c/o lt stiff neck; pain/swelling lt arm; pain lt arm to finger tips