chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jynneos was administered intramuscularly; Case reference number US-BN-2022-001864 is a spontaneous case report initially received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (fifth out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (5/8'' needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  Additional information was received from Bavarian Nordic on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients and information about needle.  Additional information was received from the Bavarian Nordic on 15-Aug-2022, included local BN case ID.  Follow up information received from a healthcare professional via Bavarian Nordic on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.  This case is linked to cases no. US-BN-2022-001860, US-BN-2022-001861, US-BN-2022-001862, US-BN-2022-001863, and US-BN-2022-001865 concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. It was confirmed that the patient did not experience any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. It was confirmed that the patient did not experience any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Had syncopal episode a week later, followed by weakness, fatigue, fogginess and balance impairment for three days.
My son had bruising from the injection and an initial site reaction. The site reaction (redness) resolved and then a red rash appeared on his left thigh and continued to get larger until it covered most of his thigh, area was red, warm to the touch (warmer than surrounding skin), and was hard to the touch.
On 11/14/2009 I developed a sore throat. On 11/15/2009 I developed a constant runny nose along with a sore throat. On 11/16/2009 same symptoms, and on 11/17/2009 fever 100.4 body aches and chills. I went to my physician who examined me and stated I had congestion in both lungs also and had swine flu symptoms. I did not wear a respirator while giving the flumist and my physican state I innoculated my self over and over again giving the flumist to the public. I am taking a z-pak, cough medication and vitamin C and D.
loss of smell; unanticipated cycle menstruation; lost of taste; sinusitis; cough; green sputum; myalgia; arthralgia; headache; extreme fatigue; low grade fever; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (myalgia), ARTHRALGIA (arthralgia), HEADACHE (headache), FATIGUE (extreme fatigue) and PYREXIA (low grade fever) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Ulcerative colitis. Concomitant products included Remicade infusions for Ulcerative colitis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced MYALGIA (myalgia), ARTHRALGIA (arthralgia), HEADACHE (headache), FATIGUE (extreme fatigue) and PYREXIA (low grade fever). On 08-Jul-2021, the patient experienced AGEUSIA (lost of taste), SINUSITIS (sinusitis), COUGH (cough) and PRODUCTIVE COUGH (green sputum). On an unknown date, the patient experienced ANOSMIA (loss of smell) and MENSTRUATION NORMAL (unanticipated cycle menstruation). On 17-Jan-2021, MYALGIA (myalgia), ARTHRALGIA (arthralgia), HEADACHE (headache), FATIGUE (extreme fatigue) and PYREXIA (low grade fever) had resolved. At the time of the report, AGEUSIA (lost of taste), ANOSMIA (loss of smell), SINUSITIS (sinusitis), COUGH (cough), PRODUCTIVE COUGH (green sputum) and MENSTRUATION NORMAL (unanticipated cycle menstruation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5 °f High. On an unknown date, SARS-CoV-2 antibody test: positive (Inconclusive) Patient was tested via PCR (nasal swab) in the hospital..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include monoclonal antibody therapy due to the severe Covid-19.  No treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-257954 (Patient Link).
After the first shot, 2-3 hours later, she lost sensitivity in her fingers; This case is considered invalid other- duplicate case as it was found to be a duplicate to AER 202200498883. Serious: No  Originating AE Request: withheld  Attachments: 2 Patient Age: Unknown  Reporter Subtype: Caregiver AE Present: Yes  Product: COMIRNATY  Question: Customer Verbatim: My daughter cannot feel her arms, hands and feet. We need help as you can draw a straight line to you vaccine. Not looking for dollar. Just help. Please, I am begging at this point.  Made an outbound call on 30Mar2022 at 9:22AM.   Caller clarified that he is asking for treatment recommendations for his daughter. His daughter had the first shot of the Pfizer COVID-19 vaccine in her left arm. After the first shot, 2-3 hours later, she lost sensitivity in her fingers. The next morning, it went away. Two weeks later or something like 28 days after (caller said whichever the interval was, he believes it is 28 days), immediately after the second shot, she lost feeling in her hand then her arm. After a couple days she could not feel her right arm and hands. Subsequently, she lost feeling on the left side of her hip. Eventually, couple of months later, she lost feeling in her feet.  They had MRIs which were clean. They had EMG in which needles were poked through the muscles in her daughter's arm, in which her daughter couldn't feel the needles going in. The test was normal. They have went to neurologists and to a chiropractor in which nothing worked. The psychologist thinks it is in her head. Caller believes it isn't a psychological issue. He firmly believes it is from the shot.  Caller hung up before he was offered to be transferred. E-transmitting AE.  Question: "My daughter was injected with your vaccine. Perfectly healthy kid. And now she is in a situation with her whole life ahead of her and nobody wants to help me. And you're just deflecting. I don't know what to do. I hope somebody is listening to this recording. Thanks for your time."
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter mentioned that there was incident because of miscommunication that the expirations date had been extended. The patient received expired dose and it was patient's second booster dose of Moderna COVID-19 Vaccine.  No treatment information was provided.
Breakthrough case admission after 5 vaccines Pfizer 2/24/21 Lot# EN6200; Pfizer 3/17/21 Lot# ER2613;  Pfizer 10/4/21 Lot# 30145BA;  Pfizer 4/23/22 Lot# FM9992;  Pfizer 10/6/22 LOt# GJ6739
chills; bones were sore; soreness; Sore throat; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old female patient received bnt162b2 (Solution for injection), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills, bones were sore, soreness, sore throat on an unspecified date. Patient had chills soreness and bones were sore, that went away after she took Tylenol. She noticed a slight sore throat and she did not see that on the list of side effects on the paper she was given. Patient asked that "Is sore throat one of the side effects of thehe vaccine?". Therapeutic measures were taken as a result of chills, bones were sore (bone pain), soreness (pain), sore throat (oropharyngeal pain). Outcome of the event Sore throat was unknown and other events were recovered.  No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
slight tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight tenderness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ubknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (slight tenderness). At the time of the report, VACCINATION SITE PAIN (slight tenderness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.
Pt became nauseated and vomitted 4-5 mins after receiving the vaccine.  Pt. begin to feel weak then loss conciousness and slumped over in chair.  Pt. regained consciousness in less than 30 seconds and was able to respond to the nurse.  Pt. was monitored until symptoms completely resolved.  Pt. was stable and ambulatory with a gaurdian upon leaving the health department.
That evening after getting 2nd shot I was rushed to ER because I has slurred speech- I went to ER and they initially thought I had bells palsy, but after a CT to confirm they found a brain bleed and I was rushed to hospital and put in the ICU and after two MRI's they also found a stroke - I had several tests and stayed in ICU for 5 days they could never determine the cause of the brain bleed or stroke - all tests were negative for autoimmune diseases.
pt states took usual oral meds 12noon, Premarin, Synthroid, ASA; 1210 began to perspire profusely, chills & SOB; took to clinic, BP was elevated; 02 applied; kept @ clinic for 2 hrs;
vaccine was administered outside of Facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 11/23/2021 DM 2 W HYPERGLYCEMIA J96.00 ACUTE RESPIRATORY FAILURE 11/23/2021 IDIOPATHIC PULMONARY FIBROSIS J96.00 ACUTE RESPIRATORY FAILURE 11/23/2021 PRESSURE ULCER OF BUTTOCK, UNSPECIFIED SIDE AND STAGE J96.00 ACUTE RESPIRATORY FAILURE 11/23/2021 DM 2 W HYPERGLYCEMIA
Patient experienced a diffuse, flat, red rash on his face, chest, abdomen and legs; This spontaneous report was received from an osteopathic physician, via company representative, and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (administration route, anatomical location, lot number and expiration date were not reported).   On an unknown date, the patient experienced a diffuse, flat, red rash on his face, chest, abdomen and legs. It was unknown if the patient sought medical attention, if he received treatment for the event or if laboratory tests were conducted.  By the time of the report it was unknown if the event had resolved.  The reporting physician did not assess the causal relationship between the event and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Large swollen lymph node on left side of neck above collarbone. Started the morning of 3/18/21. Still swollen. Very bad nasal drainage and sneezing from 3/15 to 3/16. Felt like i had developed severe allergies all of a sudden, but i don't have any allergies that i know of. The drainage cleared and i felt fine on 3/17, then woke up for work with the swollen lymph node, only on the left side.
flu like symptoms; Initial information regarding an unsolicited valid non-serious social media case through agency received from a consumer/non-health care professional (HCP) (patient's wife)  on 27-Nov-2020 .  This case is linked to case 2020SA344119.  This case involves Adult male patient who experienced flu like symptoms (influenza like illness), while he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.   On an unknown date in 1998, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site as a prophylactic vaccination.  On an unspecified date in 1998, (latency unknown) after the administration of vaccine, the patient got flu like symptoms (influenza like illness) for a week. It was reported that patient will not take the flu shots anymore.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information regarding the batch number of the case.
Headache, Myalgia, Fever,  chills Narrative:  Other Relevant History:
This 84 y.o. male was admitted on 1/7/2022 to the Hospital.  The following is from the admission history and physical: "HPI: The patient is a 84 y.o.  male who presents to the emergency department  for evaluation of COVID exacerbation, weakness, and confusion. Notably, the patient tested positive for COVID-19 on 1/4/22.  Per chart review he is vaccinated for COVID-19 but has not had his booster.  Patient states his symptoms started on approximately 1/3.  Patient complained of weakness and some confusion.  He states he has chronic diarrhea due to Metformin.  He denies chest pain, coughing or dyspnea.  He also denies nausea vomiting, dysuria, dizziness or headaches per chart review patient  a low grade fever of 100.7 in the emergency department.  Patient states he lived independently.    O2 sats were 88% on room air, and was placed on 2L nasal cannula.  Patient was treated with dexamethasone as listed below"   Acute hypoxic respiratory failure due to COVID-19 pneumonia. Patient was hypoxic on room air.  Patient subsequently placed on 2 L.  Patient was treated with supplemental oxygen and was started on dexamethasone 6 mg po daily.  The procalcitonin level was 0.22 which makes the bacteria infection unlikely The proning protocol will be initiated, every other day D-dimers were ordered, daily CRP levels were ordered, and the patient was placed on full barrier precautions.  Given the fact the patient has mild symptoms and is only on 2 L.   Today the patient was weaned to room air and screened by respiratory therapy.  Patient did well and did not qualify for home oxygen.  Patient agrees with the plan to discharge home today.  Patient does not require outpatient prescription for Decadron since he is on room air and doing well   Mild confusion due to suspected mild metabolic encephalopathy due to Covid 19 pneumonia.    Patient's confusion appears to have resolved   Weakness.  This is probably due to COVID-19.  Patient was evaluated by PT and it was recommended that he discharge home with support and someone with him initially to make sure he was able to care for himself.  Per RN report the patient's family agreed to be with the patient initially as he returns home.   Diabetes type 2.  This will probably be exacerbated by the dexamethasone.  Continue Metformin.  The patient is currently on the extended release and hopefully this will decrease his diarrhea.  Will have low-dose Imodium available if needed.    Patient was treated with low intensity sliding scale.  Patient's blood sugar should return to normal since he will not require dexamethasone after discharge.  I recommended that the patient follow-up with his primary care provider to discuss other options to treat his diabetes that do not produce diarrhea.   Hypertension.  Continue amlodipine and metoprolol but hold losartan due to mild renal insufficiency.  The patient's repeat creatinine was normal and the patient can resume his normal blood pressure medications at home   Mild acute renal insufficiency.  Admission creatinine 1.33.  The repeat creatinine was normal.   Prophylaxis: Lovenox daily dosing dosing and may adjust based on D-dimer result
Information has been received from a licensed practical nurse concerning a female (age not reported) who on 11-OCT-2007 was vaccinated intramuscularly in the right deltoid with the first 0.5 mL dose of PNEUMOVAX 23 (lot # 657529/0993U).  After receiving the first dose of PNEUMOVAX 23 the patient on an unspecified date developed an adverse reaction.  It was reported that it was not known if the reaction was localized or generalized.  There was no product quality complaint involved.  Follow up information obtained on 29-JAN-2008.  The licensed practical nurse reported that the 65 year old female weighing 158 pounds and height of 65 inches and with no known drug allergies and a history of epistaxis, fatigue, menopause and diverticular bleed, developed on approximately 11-OCT-2007 a "red and inflamed around the site of injection".  The patient was treated with BENADRYL and ice pack.  On an unspecified date the patient recovered.  Additional information is not expected.
Information has been received from a registered nurse (RN) concerning a 13-week-old male who was vaccinated with the first dose of Rotateq. It was unknown if medical attention was sought. Additional information has been requested.
Patient complained of a rheumatoid arthritis flare up the day after receiving her high-dose flu shot.
nurse gave some injections from a vial that was pierced the day before (19 hours after first punctured); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (nurse gave some injections from a vial that was pierced the day before (19 hours after first punctured)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (nurse gave some injections from a vial that was pierced the day before (19 hours after first punctured)). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (nurse gave some injections from a vial that was pierced the day before (19 hours after first punctured)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided by the reporter.  02-Sep-2021, The vial was initially stored in the refrigerator  09-Sep-2021, The vial was first punctured at 13.30 hs and then was left in the refrigerator.   10-Sep-2021, This morning a nurse came in and administer the vaccine to 3 patients from this vial.   the vial was not undergo any temperature excursions and total amount of time the vial was exposed to room temperature range was 8° to 25°C equal to 46° to 77°F: 7 times was out of the fridge just to withdraw doses  and never sat at room temperature.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up include dose number added.
Headache, lymphedema between clavicle and shoulder on right side, swollen lymph nodes on right side of body in neck, under arm and groin. Dizziness, generalized fatigue and head feeling ?foggy? or ?spacey?. Hard time concentrating and irregular heartbeat, feels like heart is skipping a beat.
administered expired doses of ACTHIB with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- US-SANOFI-00341596) and transmitted to Sanofi on 02-Nov-2020.  This case involves a 1 years old male patient who received first 0.5 ml expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ112AAB, expiry date: 21-Jun-2020) via intramuscular route in the left outer thigh on 02-Nov-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  Concomitant medications included INFLUENZA VACCINE.  It was an actual medication error due to the expired vaccine used (latency-same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Pt. reports diarrhea since Tuesday 03/09/21 and denies any further diarrhea today.