chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received dose of Fluzone HD on 20Sep2019 in which there was a needle malfunction and some of the dose leaked out, no AE; the leakage was not from the tip of the needle, but further up the syringe and some of the dose leaked out, no AE; Initial information received on 23-Sep-2019 and additional information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old female patient who received a 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ242AA, expiry date: 04-May-2020) via intramuscular route in the right deltoid on 20-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and syringe leak.   Pharmacist reported that patient received dose of Fluzone HD in which there was a needle malfunction and some of the dose leaked out. It was reported that the leakage was not from the tip of the needle, but further up the syringe. Leakage did occur during administration and it was believed the needle might not have been attached properly/screwed in tight.  At the time of reporting, no adverse event was reported.  List of documents held by sender: none.
Fever or Chills  Cough  Shortness of Breath  Fatigue  Muscle or body aches  Headache  Sore throat  Congestion or running nose
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K011800, exp date 21-AUG-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Fatigue, exhaustion, headache within five hours of vaccination. Severe abdominal cramps, diarrhea, sweating, chills, and nausea 34 hours later (03-03-21) ? lasting one hour.  Another bout of diarrhea mid morning on 03-4-21.  Did not seek medical help.
Patient said on the second day after the vaccine she had fever, dizziness, blotches, nausea, and racing heart.  Her face and arm were swollen.  She used ice packs on her arm and took Tylenol.
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medicine were reported. No treatment medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non-significant follow-up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Diarrhea, loose watery stools. >5 times in a 12 hour period
Vaccine was 1/25/2021, fine until 1/27/2021 a little sore in arm with injection. This morning about 4am, burning in the injection area, sore and red.  Blister filled with puss formed and is growing.
1/3/03- anthrax vaccine #1- minor reactions- slight redness, swelling, and tenderness around the injection site x 1week  2/25/03-anthrax vaccine #2- 48 hours after she received her anthrax vaccine, she developed a small "knot" under her tricep area.  The lesion felt soft at first then became firm within a day.  Pain was relieved by OTC Motrin and the lesion slowly dissipated on its own within the next 2 weeks.  The patient denies having any numbness or paresthesias of her hand.  No systemic complaints  3/17/03- anthrax vaccine #3- same as above.  "It was bigger and more painful."  It slowly dissipated on its own within 3-4 weeks.  No other systemic complaints  8/19/03- anthrax vaccine #4- same as above.  It was "now a baseball-sized" lesion and the pain was worse.  The patient also noticed that because of the swelling and pain of the upper arm, she had a limited range of motion in her affected arm.  The lesion lasted 7 weeks.  No other systemic complaints  2/18/04- anthrax vaccine #5- same as above.  "Much bigger and more painful" than the lesion noted above.  This lesion lasted about 2 ½ months.  The pain from the lesion hindered this patient from participating in any activities that involved her affected arm.  "I couldn't do any push-ups, heavy lifting, running, and participate in PT because of the pain."  No other systemic complaints  9/1/04- the patient presented herself to FBRVHC.  She is being asked by her commander to receive her sixth anthrax vaccine at this time.  This patient works as a physician.  She feels apprehensive and concerned that she would develop another lesion that would be "worse" as to hinder her from providing affective patient care.  This patient is requesting an exemption from the anthrax vaccine.  There is no deployment scheduled at this time.
fever; feel bad; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION COMPLICATION (feel bad) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (fever) and VACCINATION COMPLICATION (feel bad). At the time of the report, PYREXIA (fever) and VACCINATION COMPLICATION (feel bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient is fully vaccinated and boosted. 75-year-old male that presented to hospital with dizziness. Patient was found to be in atrial fibrillation with rapid ventricular response. Patient stated that he has also recently been diagnosed with COVID-19. He is however asymptomatic from this without fevers, chills, shortness of breath, or cough. Labs PLT 147, Patient was seen by cardiology. He was recommended to follow-up for a repeat sleep study. Patient was started on metoprolol and apixaban. Patient doing well on discharge and wanting to go home. Patient discharged home.
Ten days later woke up in severe pain in neck and shoulders; spread to other joints over the next few days -- some days so painful can hardly walk (hips, knees, elbow, ankle; most recently big toe...which joints varies from day to day but always in neck, hips and knees).  Major fatigue; daytime sleepiness; unexplained and random diarrhea.
Experienced shortness of breath, lightheadedness, irregular and rapid heartbeat, diagnosed by my physician as Afib
to er and admitted with shortness of breath , covid pneumonia, became septic hypoxic  admitted to icu  , had acute kidney injury, AECHF, lower extremity ischemia,   had gi bleed.  Was  made DNR and to be given comfort measures as he continued to decline and he was  transferred to hospice 10-17   and passed away  on 10-18
PATIENT COMPLAINS OF HANDS FREEZING, TIRED/ FATIGUE (FELT LIKE SHE COULD NOT MOVE), MUSCLE ACHES IN LEFT ARM, SHOULD AND NECK, HEADACHE, NAUSEA
Patient awoke in the middle of the night with a swollen throat, but had no difficulty breathing.  Her father, who is a physician, said that her tonsils and uvula looked swollen.  Mom felt her neck looked swollen.  She had not had any other exposures such as to insects.  The child went to school the next day and did not worsen.  Mom went to the school and gave otc benadryl 50mg to the child, which caused the symptoms to resolve completely in 20 minutes .  The child was never seen in our office for the reaction.  All information was supplied to us by the mother of the patient.  The child has no residual problems.
Information has been received from a claims administrator, concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (LOT # J001700, expiration date 18MAY2014) (dose and route not reported). The patient had an adverse reaction (not further specified) to the ZOSTAVAX (Merck) vaccine. It was unknown if the patient sought medical attention. Treatment and outcome of the adverse reaction was unknown. Additional information requested.
After receiving the vaccination the patient presented about 10 to 15 minutes later with a spotted purple-red rash on the inner aspect of the forearms.  This was the only symptom reported at this time.  The patient was monitored for about 45 minutes.  During this time the patient reported having a racing heart and some mild dizziness.  As time passed no worsening of the rash was seen or reported.  After sitting calmly for a period anxiety symptoms also subsided.  After making sure the patient was able to walk and function normally she was instructed to get immediate medical attention if there was any worsening of symptoms or if there was no improvement.
information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071154, 2019SA071155 and 2019SA071156, same reporter. This case involves an 8 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringes during the 2018- 2019 Flu Season, lot UJ043AB, expiry date 22-May-2019 via unknown route in unknown administration site instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was reported that 8 years child patient was given accidentally the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT. 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. List of documents held by sender- none.
Breakthrough Case. Patient also received Moderna Booster vaccine on 08/30/2021. Lot #088D21A Rite Aid Pharmacy #4339.
Bruising on my legs and arms (mostly on my legs). Headache that never goes away.
Patient called the pharmacy back on 11-12-20 at approx. 515pm to state she was experiencing adverse reactions after receiving her Shingrix  immunization on 11-11-20.  She related that at approx. 630pm on 11-11-20 she started experiencing  chills, aches, and itching at the immunization site.  She said she had no rash or redness at the injection site.  She stated the chills and aches had worsened as of 11-12-20 at 515pm.  She had tired to reach her prescriber about her adverse reactions.  She was taking Aleve (otc) for her aches.  We spoke again on 11-13-20 at approx. 330pm and she said her symptoms had started to improve.  She plans to follow up with her prescriber on Monday if she is still experiencing symptoms.
Assessment and Plan Patient is a 80 y.o. male patient of, MD with history of bladder cancer, LBBB, cardiomyopathy, COPD, chronic respiratory failure, HTN, HLD, non-Hodgkin's lymphoma, prostate cancer, presented to Hospital with leg edema, shortness of breath.   Multifocal pneumonia, POA COVID-19 infection Seen in the ED 1 day prior to admission, diagnosed with pneumonia CTPA (12/27) showed new consolidation within bilateral lower lobes, GGO infiltrates CT also showed stable lung mass and nodules On baseline oxygen requirements Suspect most of patient's respiratory complaints are multifactorial from pneumonia and CHF Continue rocephin and azithromycin, completed course of azithromycin during hospitalization Transition to cefdinir at discharge Tested positive for COVID via home test 12/19/2022 and completed 5-day course of Paxlovid prescribed by pulmonology   Chronic HFrEF, now recovered Chronic respiratory failure with hypoxia Cardiomyopathy Suspect secondary to recent medication changes, (Lasix dose cut in half approximately 2 weeks prior, now taking 20 mg daily instead of BID) Last EF 47% on Echo in January 2021, repeat echo (12/29) showing EF 55%.  Presents with bilateral lower extremity edema as well as orthopnea BNP of 437 on admission Baseline O2 requirement of 2.5 to 3 L/min Currently on O2 at 3 L/min Continued on home ACE inhibitor, Beta-blocker, Aldosterone antagonist, and High dose statin.   Strict I's and O's, daily weights Cardiology consult- suspect presentation more consistent with pneumonia more than heart failure.  Lasix changed back to 20 mg BID (12/30) As above, patient has had improvement in ejection fraction Continue current medications     Essential hypertension Well-controlled Resume home Norvasc, Coreg, lisinopril, spironolactone, Outpatient follow up
Pt was a healthy young woman who had just been seen for her annual on 12/6/22 with no issues, abnormalities, or complaints. She received her first vaccine on 12/28/2021 and on 1/24/22, she suddenly developed abdominal ascites, abdominal pain, constipation. The pt was extremely bloated. A full work up with U/S and CT scan found a large mass in her uterine/cervix area growing along the peritoneal wall likely demonstrating a gynecologic malignancy with  metastatic disease. She had routine screenings and bloodwork for years that never indicated any kind cancer and there is no family hx of gynecologic cancers. This was a very sudden onset of symptoms of what is typically a slow growing cancer that occured within a month after her first COVID vaccine.
Cough Shortness of Breath DOE Decrease in ADL's due to aforementioned symptoms
Left lower ventricular bleed; Low blood pressure; Severe headache; This spontaneous case was reported by a nurse and describes the occurrence of INTRAVENTRICULAR HAEMORRHAGE (Left lower ventricular bleed), HYPOTENSION (Low blood pressure) and HEADACHE (Severe headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced INTRAVENTRICULAR HAEMORRHAGE (Left lower ventricular bleed) (seriousness criteria hospitalization and medically significant), HYPOTENSION (Low blood pressure) (seriousness criterion hospitalization) and HEADACHE (Severe headache) (seriousness criterion hospitalization). The patient was hospitalized on sometime in April 2021 due to HEADACHE, HYPOTENSION and INTRAVENTRICULAR HAEMORRHAGE. At the time of the report, INTRAVENTRICULAR HAEMORRHAGE (Left lower ventricular bleed), HYPOTENSION (Low blood pressure) and HEADACHE (Severe headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded   This case was linked to 1st 3rd and 4th patient reports. Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded 1st patient case report 3rd patient case report 4th patient case report
bil hand grip weakness & paresthesia begn 48 hrs post vax; resolved w/o rx w/in 2 wks;
pt recv vax 21MAR97 & 5APR97 pt exp stiffness & swelling of the fingers, hands, & knees;
Patient presented to my office on 3/15/2019 with painful rash to right mid back and right abdomen. He had received the SHINGRIX vaccine on 3/5/19 and developed the rash beginning 3/13/19.
came down with the flu; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated came down with the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date in Aug-2022, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu vaccination.  On an unknown date in Dec-2022, the patient had a non-serious event of came down with the flu (influenza) (approximately 4 months latency) following the administration of influenza vaccine.  It was reported: First of all nothing is guaranteed I took my flu shot in August I came down with the flu Christmas week end and still sick I been getting my flu shots for many many years   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
This spontaneous report was received from a registered nurse, via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On unspecified date in 2014, the patient was vaccinated with the first dose of GARDASIL (Lot #, expiration date and route of administration were not reported), the second dose was administered on unspecified date in 2015 (Lot #, expiration date and route of administration were not reported) and the third on unspecified date in 2016 (Lot #, expiration date and route of administration were not reported). The adverse event reported was that the vaccination was given other than prescribed in the prescribing information. The patient sought medical attention as there was an office visit. Additional information is not expected as the reporter did not wish further contact.
Woke up 11/16/16 (the next morning) with every joint in body hurting and very tired so went back to sleep which is very unusual. Woke up about 11:00 am and made breakfast.  Felt awful when sat down to eat, so just sat there looking at the food feeling awful.  Passed out and fell off chair hitting head (now sore around left temple).  Family woke me up, had to go to the bathroom immediately to relieve bowels, and immediately began to sweat profusely for 5 or 10 minutes.  Went back to bed and slept until 2:00 pm.  Around 9 pm, by right ring finger joint began to swell and it was very difficult to close and up hand.  That lasted all day 11/17/16 (the next day), but was better by Saturday 11/18/16.  I feel like I am back to "square 1" trying to rid my body of things my antibodies are attacking.  I really don't know what the long term effect of this Pneumococcal polysaccharide vaccine #23 will be.
No adverse Event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
temp excursion/beyond use date excursion; temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment information was not reported.