chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a Physician on 05 January 2015. A male patient had received a dose of Influenza vaccine (manufacturer unknown, batch number, dose number, route and site of vaccination not reported) on an unspecified date. The patient had a history of multiple sclerosis and had received medications like REBIF and Copaxone from 01 January 2002 to 05 January 2002. Patient stated he was on REBIF again from 05 January 2002 to 05 January 2009 and then SOLUMEDROL was added to REBIF from 05 January 2009 to 05 January 2012. Patient was on Clinical Trial from 05 January 2012 to 09 January 2012, for Tcelna, and wasn't sure if he received Med or Placebo. Patient stated he then was put on SOLUMEDROL again from 03 January 2013 to 04 January 2013. The patient had a history of sinus problems. The patient was concomitantly treated with Tecfidera and Lemtrada. On an unspecified date, after vaccination, the patient experienced cold and laryngitis for last 3 weeks. Patient stated he has tested positive for JC Virus. The patient took Z-Pak for 3 days and was doing better. At the time of this report, the patient was recovering from the symptoms. Documents held by sender: none.
This spontaneous report was received from a pharmacy technician who was the patient's mother, referring to her 29 year old daughter. The patient's historical drugs and medical history were not reported. The patient's concurrent conditions included diaphragmatic hernia. The patient's concomitant therapies included unspecified birth control, PROZAC and multivitamins. The patient did not have any drug reactions or allergies. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL for prevention (strength, dose, route, frequency, lot#, expiration date and indication were not reported) (extra dose administered). On an unknown date, after the fourth dose, the patient began to have some nerve problems, described as lost all feeling in her feet, hands and arms, her fingers were always numb (hypoaesthesia), loss of grip, fell down steps from this during college, had so many different issues (adverse event) and she was getting more debilitating (asthenia). On an unknown date (reported as "years ago"), an unspecified test of Lyme's (results not provided), chronic fatigue (results not provided) and Guillain-Barre syndrome were performed from an unspecified healthcare worker; the results for Guillain-Barre syndrome were that some markers came up positive, but not all markers that were needed to be diagnosed. On an unknown date, a neurologist did an unspecified nerve study on an unspecified date (results not provided). On an unknown date, the patient saw an unknown physician to manage her pain. On an unknown date in May 2018 (reported as "in the last month"), the patient had a rheumatoid arthritis (RA) blood test blood work for autoimmune disorder performed by an unspecified healthcare worker, which resulted in very high levels of C-Reactive Protein (CRP) (reported as "went up another 10") and the multibiomarker Disease Activity (VECTRA) test was very high too (blood test abnormal). The patient sought medical attention and received treatment. At the time of reporting, the outcome of hypoaesthesia, blood test abnormal, C-reactive protein increased, pain management, fall, grip strength decreased, asthenia and adverse event, Lyme disease and chronic fatigue was reported as not recovered. Additionally, the reporter was unsure if she attributes these events to GARDASIL. Hypoaesthesia, blood test abnormal, C-reactive protein increased, pain management, fall, grip strength decreased, asthenia, adverse event, Lyme disease and chronic fatigue were considered disabling events. Upon internal review, Lyme disease was determined to be a medically significant event. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA009284.
Sore throte, headache, body aches, wet couph, glands are swollen, and runny nose
Woke up early day after receiving vaccine with a tingling sensation all over my body and feeling groggy. I thought my walk to work would help, but part way there I became so weak I could barely make it. When I got to work I was confused and couldn't figure out what to do. I became diaphoretic and shaky (not rigoring). Admin staff called employee health who advised she call 911. I declined and another staff member provided Benadryl and Advil which I took around 0830. Went to urgent care: labs drawn, ECG performed (WNL so troponin and CXR not obtained). Having visual disturbances at urgent care and mild SOB. Received 4mg dexamethasone (I'm very sensitive to meds) and was sent home. Awake all  night w/heart palpitations (from dex??) and for the following several weeks experienced intermittent chest pain, SOB, and dizziness. Missed 1 day of work d/t AEs. I am an avid hiker and have experienced wheezing and chest tightening shortly after starting every hike I've been on since receiving the 2nd dose of the COVID vaccine; no prior hx of anything similar.
felt like she had been hit by a two by four in her lumbar; dizzy; Nauseous; Burping; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6205 and Expire Date: unknown) via unspecified route of administration in left arm on 04Mar2021 as 1st dose, single (at the age of 49-years-old) for COVID-19 immunisation. Vaccination was not administered at a facility. There was no prior vaccination taken and adverse events taking place within 4 weeks of Covid-19 vaccination. There was no illness at time of vaccination. Medical history included ongoing asthma and anaphylactic food allergies from an unspecified date. Concomitant medications were none. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. After vaccination, patient had a strange reaction. On the same day of vaccination, 04Mar2021, she felt dizzy and nauseous which all of this happened a half hour after the shot since the facility made her wait a half hour after because of her history with food allergies. Then she started burping after the first shot and the burping went on for 1 hour or 2 hours. She got the shot in the afternoon and it went on until 8 o'clock at night and it was not one burp it was a lot of burps. It was reported that she does not have a history champion burper in the family. On 25Mar2021, Patient felt like she had been hit by a two by four in her lumbar and stated this stopped 2 or 3 days after. Patient took Advil for her back pain. Patient did not visit emergency room and physician's office. The patient did not undergo any relevant tests. No Investigation Assessment. The outcome of event for dizziness and nausea was recovered on 04Mar2021, and burping and back pain on an unspecified date in Mar2021.
c/o red, swollen lt leg p/vax for 2 days beginning 3-5hr p/vax;afeb, 5cm x 9cm circular erythematous macular on lt thigh, mild edema @ site;tx observation;
monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster).    No concomitant medications was reported. No treatment medications was reported.  The reporter states that she has a situation. She found out that they could not give the Moderna as a booster starting 31Aug2022, but she administered 15 monovalent doses as boosters.
Patient developed a pretty intense cough one week post vaccine around bedtime. She was able to sleep through the night fine, but when she woke up the next morning she was experiencing rapid, shallow breathing. She did not have a fever and was acting normal. When being seen by the pediatrician later that morning she was determined to have extremely tight lungs with below average O2 saturation levels and elevated heart rate. She was given back to back nebulizer treatments as well as two doses of an oral steroid at the office. She remained monitored there at the clinic for 2 hours before pediatrician determined she was safe to come home. She continued with nebulizer treatments every 4 hours for the next day and a half, then reduced to every 6 hours, then every 8 hours. She also received 4 more single doses of oral steroid daily.
headache; Case reference number MOD-2021-012188 is a spontaneous case report sent by a Non-Health Professional on 22-JAN-2021 .   On 20-JAN-2021,  the patient received Moderna COVID-19 Vaccine for COVID-19 vaccination and developed headache. Also patient Patient asked if is there a difference on the Moderna COVID-19 Vaccine in patients who are on a blood thinner  No concomitant medicines were reported.  No treatment information was provided.
First dose end of Mar-2021, second dose end of Jun-2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose end of Mar-2021, second dose end of Jun-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose end of Mar-2021, second dose end of Jun-2021). In June 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose end of Mar-2021, second dose end of Jun-2021) had resolved.            The patient took first dose of vaccine in end of Mar-2021 and second dose in end of Jun-2021. No concomitant medication reported. No treatment information was provided.
BLOOD CLOTS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots (Dose number in series 1). It was reported as "I got the blood clots too after one of the shots". The patient also received dose 2 with covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221244261- blood clots . Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
On day 7 following vaccination  I developed swelling, redness, heat, and itching at site of vaccination. Swelling got worse over next 24 hours until it was approximately four inches in diameter. Swelling is gradually diminishing at this time (1/22/2021 @1430
Developed chronic Tinnitus in April 2021 after 2nd completed COVID-19 vaccine dose. It is in both ears. Also have some hearing loss.
flushing - sweating - tightness in chest - severe pain and back and arms and legs - shaking and elevated blood pressure
No adverse event; Excursion occurred on 10-Feb-2023 and vaccine administered on 27-Mar-2023; Patient was received expired vaccine on 27-Mar-2023; Excursion occurred on 10-Feb-2023, 10.2 F for 1 hour and 11 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was received expired vaccine on 27-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10-Feb-2023, 10.2 F for 1 hour and 11 minutes), POOR QUALITY PRODUCT ADMINISTERED (Excursion occurred on 10-Feb-2023 and vaccine administered on 27-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 071B22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 27-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Feb-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10-Feb-2023, 10.2 F for 1 hour and 11 minutes). On 27-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was received expired vaccine on 27-Mar-2023) and POOR QUALITY PRODUCT ADMINISTERED (Excursion occurred on 10-Feb-2023 and vaccine administered on 27-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was received expired vaccine on 27-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10-Feb-2023, 10.2 F for 1 hour and 11 minutes), POOR QUALITY PRODUCT ADMINISTERED (Excursion occurred on 10-Feb-2023 and vaccine administered on 27-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was received expired vaccine on 27-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10-Feb-2023, 10.2 F for 1 hour and 11 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Excursion occurred on 10-Feb-2023 and vaccine administered on 27-Mar-2023).    No concomitant medications were reported.  The vial was initially stored in the refrigerator on 26-Mar-2023.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-718070 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718070:Master case- 1st adult patient vaccine administer on 27Mar2023.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided
Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on March 4 woke up after a very deep sleep tired the next day the same thing March 5 woke up extremely fatigued March 6 same thing woke up extremely fatigued and after going for a short bike ride started getting an intense headache, set up got very dizzy, then proceeded to throw up harder than I ever have and so debilitatingly that I had to call the paramedics and they took me to the emergency room. The ER doc at first said that this could not be an adverse effect 14 days later of the first Covid shot, but then he said he didn?t know, for the next nine days I did not leave my house I was so exhausted. I am an athlete and exercise every day have tons of energy all day long and have never felt this way before.  I then met with my regular Doctor Who ordered tests of different varieties everything came back normal and to this day which is now March 25 I have extreme fatigue and I can barely work. Like I said above I am an athlete I run five days a week ride my bike two days a week and swim generally two or three days a week and work as a teacher and I can barely do any of that.
Patient left after first vaccine with no known issues, did not call or complain about any issues. Was called to get second vaccine, as was prepping vaccine and asked which arm he would like, patient stated that in his left arm around where he thinks is the injection site he gets shooting nerve pain that lasts about 5 seconds and goes away. He states these happen one to two times weekly over the past 2 months. Asked when he started noticing the pain and he couldn't recall exact date.
Took unrefrigerated Vivotif; Spontaneous report received on 16DEC2019.  A pharmacist reported that a female consumer who "took unrefrigerated Vivotif" (PT: Product storage error), while being on Vivotif for immunisation. The consumer took the first dose of Vivotif and then left the rest of the doses unrefrigerated before taking them. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took unrefrigerated Vivotif doses (Product storage error). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A consumer took unrefrigerated Vivotif doses (Product storage error). Considering the nature of the event, the causality of the event is assessed as not related.
I am unable to lift my arm above my shoulder without severe muscle pain in my upper arm.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the arm left on 10Feb2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient received unspecified medication within two weeks of vaccination. The patient previously took diclofenac (VOLTAREN) on unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021, the patient experienced inability to lift her arm above shoulder without severe muscle pain in the upper arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and included treatment with prednisone for 7 days. The clinical outcome of the event inability to lift arm above shoulder without severe muscle pain in the upper arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
30 patients received FLUZONE HIGH DOSE QIV after the vaccine experienced a temperature excursion with no reported adverse event; vaccine experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event; Initial information on 19-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA435111(CLUSTER).  This case involves 30 unknown age and unknown gender patients who received fluzone high dose qiv after the vaccine experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event (product storage error).  On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, dose, route not reported; lot UT7714AA) for prophylactic vaccination.  On an unknown date, the 30 patients received fluzone high dose qiv after the vaccine experienced a temperature excursion with no reported adverse event (poor quality product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 the 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.
Urticarial hives over entire body. Started within 1/2 hr of immunization. Benadryl given.
The morning of April 3, staff at the Vaccination Clinic discovered a discrepancy in the preparation of Pfizer vaccine doses. It was discovered that several undiluted vaccine doses were administered. Staff accounted for all unused undiluted vaccine doses. Unfortunately, 10 undiluted vaccine doses had been administered to patients and were not able to be retrieved. This patient received one of the undiluted doses.   The medical team contacted the CDC to determine the potential side effects and observation requirements of receiving an undiluted vaccine. The CDC confirmed that the recipients of the undiluted doses may experience stronger side effects and symptoms than someone who received the diluted dose (sore arm, flu-like symptoms, etc.).  The site public health officer spoke with suspected recipients of the undiluted vaccine to explain potential medical side effects. The  will follow up to monitor their status.