chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 74 years old male patient who was administered 2 doses of each 0.5 ml of FLUZONE HIGH DOSE (lot UJ022AA, expiry date: 18 Apr 2019) via intramuscular route in each arm on 17-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to extra dose administered. Patient had not reported any side effects. 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.
Patient came in on 5/29/19 with hives on his body and itching. He showed me pictures. I recommended hydrocortisone cream and zyrtec, but he said he would try the cream. I said if it persists, to go to the doctor.
Left arm pain, fatigue, chest tightness. Nausea, abdominal pain and left armpit pain.
Gave Two Patients who are Under 18 Years Old; Initial Report Received on 13-Dec-2021  A registered medical assistant reported that a 14 year-old female patient (race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. The patient had no known drug allergies.  No relevant concomitant medications were reported.    On 13-Dec-2021, the patient, who was under 18 years-old, received a dose of HEPLISAV-B (Lot # 935843, expiration date 08-Oct-2022, and NDC # 43528-003-01) in the left deltoid from the registered medical assistant. The wrong vaccine was chosen instead of the pediatric vaccine. It was a "human error." The patient had no adverse reactions at the time of the injection and there were no other adverse events associated with this event.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Narrative:  72 y/o M with PMHx of Alzheimer's dementia, depression, HLD, and GERD admitted for generalized weakness, anorexia, ataxia, and productive cough . Pt was found to be COVID positive on admission. Symptoms were likely secondary to poor oral intake and COVID-19 infection. Pt was started on 5-day course of Azithromycin to help combat inflammatory changes typically seen with COVID-19 and cover any common bacterial sources of pneumonia. Pt had good oral intake and was given a total of 2L LR over 24 hours which resolved lactic acidosis and stabilized all signs of severe sepsis. Additionally, pt never experienced any respiratory symptoms of SOB or dyspnea. He complained of productive cough with white sputum but mentioned that this is chronic for him. Did not require any oxygen requirements during hospitalization and saturated between 93-95% on room air. On neuro exam, pt never had any focal deficits or motor strength weakness (5/5 strength in all extremities) but did show a little unsteadiness while walking to and from the bathroom. PT and OT evaluated the pt and had no concerns with current condition and equipment/support at home.
pt recv vax 10OCT97 & on 20OCT97 pt devel a severe abscess @ the inj site which was larger than the size of a quarter;
joints are "popping"/ joints are "cracking"; a lot of pain in the hip joint/problems with his hip joint; This spontaneous case was reported by a consumer and describes the occurrence of JOINT NOISE (joints are "popping"/ joints are "cracking") and ARTHRALGIA (a lot of pain in the hip joint/problems with his hip joint) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT NOISE (joints are "popping"/ joints are "cracking") and ARTHRALGIA (a lot of pain in the hip joint/problems with his hip joint). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, JOINT NOISE (joints are "popping"/ joints are "cracking") and ARTHRALGIA (a lot of pain in the hip joint/problems with his hip joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Itchy red rash started forming under arms and on the side of her left breast in splotches, patient took pediatric Zyrtec and applied sarna lotion and rash went away, it came back the following night worse covering torso (worst on left side) and took pediatric Zyrtec and applied sarna lotion, rash cleared up and patient has been symptom free since.
Pt awoke on morning of admission (11/25/09) with jerking movements of head and ataxic gait of abrupt onset, which slowly resolved through 48 hour hospitalization.  12/2/2009 hospital records and discharge summary received. Service dates 11/25/09 to 11/26/09. Assessment: Acute ataxia, movement disorder. Patient presents with an acute onset of unsteady gait with multiple episodes of back/head extension. Fussy. Tympanic membrane bulging. Nonfocal neurologic exam. No evidence of infection. To follow-up as outpatient. Discharged.
dose 1 3/15/2018, did not receive dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th March 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. After receiving 1st dose of Shingrix, the patient had no reaction. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter plan on administering the 2nd dose per CDC (Centers for Disease Control and Prevention) recommendations but did not state the exact date The reporter consented to follow up via Email.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019084035:same reporter
November 19th at 10:00 a.m. whole body aches, chills, fever of 100.1, substantial pain as injection site.   11:00 p.m. 2 inch red, welt, hot  November 20th 9:00 a.m.  Welt  had increased by a quarter of an inch. Still very red & hot  November 20th 8:00 p.m. whilst head increased by an additional quarter of an inch. Still red and hot and now itchy
11/28/22  My family had been all feeling sick. In that evening I began to feel bad. I had sneezing, felt tired  and sore throat.   I tested positive with a home COVID test on 11/29/22.  On 11/30/22, I saw a physician at the clinic, and they prescribed Paxlovid which I began taking  that day.  I felt better right away, within 24 hours.  I still feel a slight sore throat and less energy.
Longer than Recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Longer than Recommended Interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 19-JUL-2023 The patient received a dose of Engerix B later than the recommended interval, which led to lengthening of the vaccine schedule. The reporter consented to follow up.
Reported to employee health days after event that she'd experienced immediate pins/needles sensation over face. Had itching that lasted 5-6 days. Benadryl helped. No rash. In addition, reported GI symptoms within the day of receipt, unknown duration.   No history of adverse events to flu vaccines in the past.
given the pfizer maroon cap vaccine without diluent; 0.2ml (undiluted); high fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2022 as dose 2 (maroon cap), 0.2 ml single (Lot number: FT9142, Expiration Date: 31Dec2022) at the age of 3 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1; Manufacturer unknown), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious) with onset 02Dec2022, outcome "unknown", described as "0.2ml (undiluted)"; PRODUCT PREPARATION ERROR (non-serious) with onset 02Dec2022, outcome "unknown", described as "given the pfizer maroon cap vaccine without diluent"; PYREXIA (non-serious) with onset 02Dec2022, outcome "unknown", described as "high fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: States there was an incident in which a toddler was given the pfizer maroon cap vaccine without diluent. States she needs information on how much the dosage would have been. States she followed up with the mom, so far the child had a high fever one day after the vaccine was administered. States the child was given Motrin which brought it back down and seems to be ok right now. Confirms dose volume that was administered to the 3 yr old male patient was 0.2ml. NDC number of Pfizer Covid vaccine: 59267007801. The Pfizer covid vaccine that was administered for toddlers age 3-4 and she had made a report with interaction; they had a 2nd dose administered on a toddler and it was given without the diluent at the dose of 0.2mL and she did file this information in an initial report but did not know if there was any other information as far as what to look for and side effects and this happened on the 02Dec.It was said they had a toddler that received his second dose without the dose being diluted. Caller asking what they need to do. It was mentioned that they had a toddler that received his second dose without the dose being diluted. Reported that they do have a patient who received the second dose of Pfizer covid-19 maroon cap without diluent.
This spontaneous report was received from a nurse and refers to a 63 year old patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The reporter stated that a dose of ZOSTAVAX was reconstituted previously and stored for 2 months in a refrigerator, subsequently, on 05-JAN-2017 (also reported as "today"), the patient was vaccinated with that dose of ZOSTAVAX (concentration, dose number, dose and route were not reported) which had a lot # of L031272, an expiration date for prophylaxis. No adverse effects were reported. Additional information has been requested.
Pain at shot site Extreme tiredness Slight pain in joints Headache All lasting a full day
The day after my second shot I went into Atrial Fibrillation.  This lasted for 6 days. I have never been diagnosed  with this, but have had infrequent bouts with PVC's. Diagnosis was made at  Hospital ER a few days after onset of symptoms. Visited my Cardiologist about a week after that, but by then my symptoms had disappeared. It is now about 3 months after this episode and I have had no irregular heartbeats since.
Patient came in for a  second shingle but a covid booster that was not due until 12/2/2021 was administered 11/24/2021. Patient realized he received wrong vaccine. Patient alerted PCP and patient is being monitored by PCP. No symptoms or reactions reported as of 12/01/2021
got the Omicron, tested positive for COVID about 4 months ago; got the Omicron, tested positive for COVID about 4 months ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "got the Omicron, tested positive for COVID about 4 months ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive.  Clinical course: Patient got the Omicron, tested positive (later clarified as tested positive for COVID) about 4 months ago and has these ongoing symptoms. Patient got the common side effects like the chest congestion and little bit of brain 'falled' (later clarified as the symptoms of COVID). Patient stated, that it's not from the vaccine, it's from the Omicron. When probed to clarify if patient took the Pfizer COVID-19 Vaccine: Consumer stated, "Right, I took all the shots." (unspecified doses). Patient has not had any side effects from the vaccine. Patient has just had only side effects from the COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 08-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 08-Nov-2021) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 08-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 08-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. There was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator was 29-Oct-2021. Patient did not experience temperature excursion and any adverse event. No treatment medication information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
pt recv vax & exp inj site swelling;swelling progressed to involve the lt upper arm, the area was warm to touch, pt exp numbness in the fingers;
No adverse event occured. We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given
POSSIBLE NAUSEA; MALAISE; LOW GRADE TEMPERATURE (99.2 F); This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cold, and other pre-existing medical conditions included she stated she runs cold and that her regular temperature was usually 97.8 f. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced malaise. On 09-MAR-2021, the subject experienced low grade temperature (99.2 f). Laboratory data included: Body temperature (NR: not provided) 99.2 F. On an unspecified date, the subject experienced possible nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from malaise, and low grade temperature (99.2 f), and the outcome of possible nausea was not reported. This report was non-serious.
Patient received 3rd dose instead of booster dose/Was administered a 3rd dose (0.5mL dose) to the patient instead of a booster dose of 0.25mL; the doctor stated that the patient was not immunocompromised.; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (Patient received 3rd dose instead of booster dose/Was administered a 3rd dose (0.5mL dose) to the patient instead of a booster dose of 0.25mL) and OFF LABEL USE (the doctor stated that the patient was not immunocompromised.) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Nov-2021, the patient experienced OVERDOSE (Patient received 3rd dose instead of booster dose/Was administered a 3rd dose (0.5mL dose) to the patient instead of a booster dose of 0.25mL) and OFF LABEL USE (the doctor stated that the patient was not immunocompromised.). On 04-Nov-2021, OVERDOSE (Patient received 3rd dose instead of booster dose/Was administered a 3rd dose (0.5mL dose) to the patient instead of a booster dose of 0.25mL) and OFF LABEL USE (the doctor stated that the patient was not immunocompromised.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was administered a 3rd dose (0.5mL dose) instead of a booster dose (0.25 mL). The pharmacist stated that, the doctor stated that the patient was not immunocompromised.  The pharmacist stated that the patient had late stage Alzheimer's. The pharmacist stated that the vaccine was administered to the patient at their house by the pharmacy.   No concomitant medications or treatment details were reported.
Approx. 1 hr. & 20 min. post injection, severe reaction: Severe upper abdominal pains, multiple, uncontrollable formed to diarrheal bm's triggered vagal response, passed out, severe diaphoresis, violent chilling loss of control of bowel movements. Lasted approx. 30-35 minutes. crawled with head hanging to floor to keep from passing out, to locate a phone for help. after several of agonizing attempts to try and climb up to couch to elevate legs high above head and laying there for  approx. 20 or more min. blood pressure came up some. (Did not call emergency services) afraid of hospitalization due to  all chronic health problems, (forgot to report earlier that I am Hypothyroid as well)  previously hospitalized for a Thyroid Storm. This is day 10 from injection and still have nausea, dizziness & fatigue, (also have couple episodes of abdominal pain). (I want to add that I felt completely fine prior to receiving 2nd Pfizer Covid dose).  I am contacting my  doctor today to receive some IV fluids.
No known adverse event. Patient was administered these vaccines with vials that were mixed with Lidocaine.
Two days before I tested positive, I felt an infection in my throat. There was phlegm, but I didn't whether I was getting sick or not. At 4 PM on 1/11/2023, I began sneezing. I took a home antigen test and got a positive result.  I got Paxlovid the same day and began taking it around 6 PM. I isolated from my husband and took the Paxlovid according to the instructions. I consumed plenty of fluids and kept eating. I mainly had nasal congestion, cough, and phlegm in the throat. I had no difficulty breathing or a fever, and my blood oxygen level was normal. On 1/16/2023, I tested negative. On the afternoon of 1/11/2023, I noticed that I had welts on my hips, thighs, and abdomen. They were flat and raised a little bit. Some were small, and some were larger. They did not itch, though. The welts were gone within 12 hours, though. About a week before I tested positive, I had similar welts appear on my legs, belly, and thighs. They also lasted maybe 12 hours.
Wheezing, tightness in the chest , tightness in the throat, trouble breathing, trouble swallowing, hoarse voice, swelling of the roof of the mouth, swelling of the tongue. Heart racing, dizziness, falling down, weakness, headache, muscle and joint pain, upset stomach, throwing up, diarrhea, extremely tired from July 23, 2021  until Aug 27, 2021  I rushed my husband to the hospital on Aug 26, 2021 he was severely dehydrated and heart rate at 156, BP 158/109, and pulse 123 and had lost 30 lbs. My husband had no illness before he got the Covid-19 vaccine shot .
Patient is a 60 year old male who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: tingling and numbness around lips area, left arm and bilateral lower extremities 30 minutes after  Janssen/J&J COVID-19 vaccine# 1 in series administered.   Action(s) taken: Vital sign at 1626 blood pressure ; 153/95, heart rate: 70, respiration ; 16, Spo2: 98 % Repeat Vital sign at 1635: blood pressure ;148/101, heart rate:69, respiration ; 16, Spo2: 98 % - Patient  denies chest pain ,shortness of breath, nausea vomiting, diarrhea, abdominal pain, difficulty swallow, headache, dizziness, or vision changes.  Action(s) taken: Transferred to higher level of care/urgent care,  report given to doctor. Doctor states that he is going to prescribed benadryl and will observed for 30 minutes.   Patient advised to follow up with Primary Care Physician
12hr p/vax t104 (taking APAP q4hr) red spots on chest/stomach & arms;flu for 48hr;2 1/2" round hot, read area @ inj site;
painful, red 4x6 oval area @ inj site; reaction occurred 48 hr p/inj; Ibuprofen prescribed;