chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; extremely thirsty; Fatigue, little tired; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), THIRST (extremely thirsty), FATIGUE (Fatigue, little tired), HEADACHE (Headache) and NAUSEA (Nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 001C21A) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Not clear if allergic reaction to amoxicillin is historical or related to recent tooth extraction) since an unknown date and Tooth extraction on 16-Apr-2021. Concomitant products included AMOXICILLIN, CLINDAMYCIN, VALACYCLOVIR [VALACICLOVIR], IBUPROFEN and TRAMADOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Dizziness), THIRST (extremely thirsty), FATIGUE (Fatigue, little tired), HEADACHE (Headache) and NAUSEA (Nausea). On 27-Mar-2021, DIZZINESS (Dizziness), THIRST (extremely thirsty), FATIGUE (Fatigue, little tired), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Specific treatment information was not reported.
onset of tinnitus day of dose one of Moderna vaccine; after the second dose I had fatigue and body aches for a day, then half a day of vertigo; 3 months later I had a 10 day period of mild fever, body aches, fatigue, that would clear up with ibuprofen, then return when it would wear off; I always wore a mask around others and had very little exposure to people so I doubt I had COVID - I have recovered from the symptoms except for tinnitus.
fever started 12/30 after vaccine and resolved. returned around 1/3/2021 with mild cough and decreased appetite and loose stools, went to ED and tested positive for SARS-CoV-2 PCR on 1/4/2021. Received bamlanivimab on 1/9/21. Symptoms worsened with worsening SOB and went to ED on 1/11/21 and was admitted. While here received remdesivir and required max O2 4 liters on nasal cannula. Discharged on 1/20/21 on home oxygen 2Liters.  2/3/21 readmitted for complaint of 3 days of persistent SOB, headache, weakness and poor appetite.
Patient was given pediatric dose of Hepatitis A instead of an adult dose. Verified with pharmacy to give another pediatric dose (0.5mL) of Hepatitis A to equal one adult dose (1mL). So patient was given two pediatric doses (0.5mL each) in total.
his other brother required blood transfusion after getting the Moderna Covid-19 vaccine because his white blood cells were attacking his red blood cells; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WHITE BLOOD CELL DISORDER (his other brother required blood transfusion after getting the Moderna Covid-19 vaccine because his white blood cells were attacking his red blood cells) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL DISORDER (his other brother required blood transfusion after getting the Moderna Covid-19 vaccine because his white blood cells were attacking his red blood cells). The patient was treated with Manual therapy (blood transfusion) for White blood cell disorder. At the time of the report, WHITE BLOOD CELL DISORDER (his other brother required blood transfusion after getting the Moderna Covid-19 vaccine because his white blood cells were attacking his red blood cells) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  Caller states that his other brother required blood transfusion after getting the Moderna Covid-19 vaccine because his white blood cells were attacking his red blood cells.   No treatment medications were provided.
First dose is considered invalid by CDC; pain on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on the site of injection) and PRODUCT USE ISSUE (First dose is considered invalid by CDC) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain on the site of injection). On 21-Apr-2021, the patient experienced PRODUCT USE ISSUE (First dose is considered invalid by CDC). At the time of the report, VACCINATION SITE PAIN (pain on the site of injection) and PRODUCT USE ISSUE (First dose is considered invalid by CDC) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on the site of injection) and PRODUCT USE ISSUE (First dose is considered invalid by CDC) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain on the site of injection). On 21-Apr-2021, the patient experienced PRODUCT USE ISSUE (First dose is considered invalid by CDC). At the time of the report, VACCINATION SITE PAIN (pain on the site of injection) and PRODUCT USE ISSUE (First dose is considered invalid by CDC) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 15APR2021, post vaccination, the patient reported that he experienced flu-like symptoms and pain at the site of his injection.   No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-101207 (E2B Linked Report).   This case was linked to US-MODERNATX, INC.-MOD-2021-101207 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101207:
I had my second dose of shingrix on 6/12/19. About 12 hours later I developed burning muscle and joint pain as well as shivering - shaking and nausea. The injection site is red and very painful. I have a terrible headache and it literally hurts to walk. My heart races sporadically. I didn't have any reaction to the first shot. Even my fingers are throbbing. I hope this is a "normal" reaction. I'm just concerned about how long this will last.
Was fine until after I had the fever on Saturday.  After that I had a brain fog.  I had trouble with memory and articulating my thoughts verbally.  I forgot my name when introducing myself on a conference call.  Lose focus more when stressed.  Was isolating before injection.  It seemed to get better as the week progressed but not yet 100%.
Patient presenting to ED that received her flu shot and booster at the same time on Friday. She states that she needs it for school in July and was trying to get it done beforehand. It was done on the same arm and she states that she found a lump so she put an ice pack on it. That night of the booster and flu shot she started to have diarrhea for the past 3 days and she has been super nauseous. She also has had a low-grade fever which would progress over time. The highest it has been is 101.8 and she has been taking Tylenol to help break the fever which comes and goes. She also says that her face feels like it is on fire and her eyes are constantly burning.
45 minutes post vax, the patient complained of itching and swollen eyes. The patient's mother reported being able to see his glands. Motrin and Benadryl were given.
No additional AE information; a temperature excursion for PROQUAD/-10C; This spontaneous report was received from a office manager and refers to a 4 years old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 22-FEB-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) dose: 0.5 ml, lot # T027111, expiration date 07-FEB-2022, for prophylaxis (route of administration was not reported).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of minus 10 degree Celsius for 1 hour 15 minutes on 16-FEB-2021. No previous temperature excursions were reported.  No digital data logger was involved. No additional adverse events were reported.
Headache; Sore neck; Extreme muscle weakness; Patient fell a couple of times; Incontinence; redness around injection site; Swelling around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, neck pain, muscle weakness, fall, incontinence, injection site erythema and injection site swelling. On an unknown date, the outcome of the headache, neck pain, muscle weakness, fall, incontinence, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the headache, neck pain, muscle weakness, fall, incontinence, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient experienced headache, sore neck, extreme muscle weakness, fell a couple times, incontinence, redness and swelling around injection site after 1st dose of Shingrix. The reporter asked how to proceed with 2nd dose of vaccine. The reporter did not consent to follow up.
Velamentous cord insertion; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Nov-2019, concerning a 23-year-old, pregnant, female subject of body weight: 125 lbs, height: 66 inches and body mass index (BMI): 20.2, enrolled in, a prospective observational safety study.  The subject's obstetrical history included one previous full-term live birth. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The concomitant medications of the subject included Prenatal Vitamin (minerals nos, vitamins nos) for neonatal care.   The subject's last menstrual period (LMP) date was 19-Feb-2019, the estimated date of delivery (EDD) was reported as 26-Nov-2019 and corrected estimated date of delivery (CEDD) was reported as 22-Nov-2019. The type of pregnancy was singleton.   On 22-Apr-2019, the subject underwent ultrasound scan and no MCM was noted.   On 23-May-2019, the subject underwent First trimester screen and no MCM was noted.  On 17-Jul-2019, the subject underwent ultrasound scan and no MCM was noted.   On 10-Oct-2019, approximately at 33 weeks of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261207, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as 'Vaccine exposure during pregnancy').  On 20-Nov-2019, when pregnancy status was collected it was noted that pregnancy was complicated with velamentous cord insertion.   At the time of initial reporting, the outcome was not reported.   The case was assessed as serious (medically significant). The reporter did not provide causality assessment to Flucelvax (QIV).  Company Comment: The subject experienced velamentous cord insertion after vaccination with the suspect Flucelvax QIV at third pregnancy trimester (at 33 weeks of gestation). Chronology is implausible because placenta with cord insertion site is fully formed by the end of first trimester. Considering all the above mentioned, causal relationship between the suspect product and the event velamentous cord insertion is assessed not related. Exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: The subject experienced velamentous cord insertion after vaccination with the suspect Flucelvax QIV at third pregnancy trimester (at 33 weeks of gestation). Chronology is implausible because placenta with cord insertion site is fully formed by the end of first trimester. Considering all the above mentioned, causal relationship between the suspect product and the event velamentous cord insertion is assessed not related. Exposure during pregnancy is assessed as not related per company's conventions.
Patient got the 2nd dose of Moderna Vaccine on June 17th, she started noticing stingling on her palms the next day and after 2 days, she started having swellings and itching on both hands, left hip, lower back and both thighs, by Sunday the 20th her face lips and tongue was swollen, she went to the Emergency Room, she was told to wait for the reactions to phase out, she then self medicate by taking Benadyl tablets and tylenol, this has greatly reduced the itching and swelling as at today June 22nd 2021
This spontaneous report was received from a physician via company representative refers to two patients of unknown age. On an unknown date in SEP-2013 (reported as in last 2 weeks), the patients were vaccinated with a dose of ROTATEQ, (lot number, expiry date and route was not reported). On an unknown date in SEP-2013, 24 hours after vaccination the patients experienced diarrhea. The outcome of diarrhea was unknown. Additional information has been requested.
Raised Rash on left arm at administration site, fatigue, flushed feeling 2 days following administration
No adverse reaction to report. Patient given the COVID-19 vaccine (purple cap) after the use-by date.
This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a patient who received SHINGRIX. On 25th March 2018, the patient received the 1st dose of SHINGRIX. On 26th March 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site warmth, tiredness, erythema and chills. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site warmth, tiredness, erythema and chills were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site warmth, tiredness, erythema and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the Office Manager. Next day after vaccination, the patient felt very tired and had chills, redness, also experienced a 4 inch diameter hot swelling at the injection site and injection site was not specified. The patient also reported that the soreness at the injection site was not as sore as it was before.
Fever, chills, rash. I developed a rash, fever and chills starting the evening after receiving my second shingrix vaccine on Friday, 1/3/2020. Symptoms developed approx. 12 hours after receiving the shot. The rash was a 3" diameter red spot around the injection site (left arm). The fever measured around 99.8F, and I developed chills requiring blankets all over me. I took aspirin, the fever came down, and the next day I was better but sore all over. I was much better on Sunday. I received the shot at Pharmacy.
Discharge Provider:  DO Primary Care Provider at Discharge:  MD  Admission Date: 5/12/2022 Discharge Date: 05/14/2022  PRESENTING PROBLEM: Hyponatremia  Weakness  COVID-19    HOSPITAL COURSE: Patient is an 85-year-old female who presented to the emergency department with generalized weakness.  In the emergency department, vital signs were stable.  She was found to be COVID-19 positive.  She was also found to have a sodium of 124. She was also noted to have some elevated troponins.  She was admitted to the Internal Medicine service with a Cardiology consult.  Cardiology felt elevated troponin likely was secondary to myocardial injury in the setting of COVID-19 and hyponatremia.  Echo was obtained and revealed EF 69% with normal LV function. They did not recommend any further testing.  Patient's sodium did improve with some IV fluids.  She was evaluated by therapy who recommended home with assist.  Patient was recommended to follow up with her primary care physician.  She was discharged home in stable condition.
After receiving the flu vaccine at work, I started coughing about 2 hrs afterward. At approximately 6 hrs after the vaccine my left hand and especially my left thumb started aching badly and the strength in my left hand, left thumb and left fingers was diminished. This symptom has continued ever since the day of the vaccination with no improvement. I reported this to my supervisor on the morning after the vaccine and was instructed to see the POC. I went to the area where I received the vaccine and the POC was not available so I was instructed to speak with someone else. After describing my symptoms to her, she stated it was not related to the vaccine and if I had further problems or questions I should consult my physician. I attempted to work for approximately one hour but was in too much pain to perform my job so I went home on sick leave. I saw a physician that afternoon and he stated the pain and symptoms could be related to the injection if it had hit a nerve. He stated it could take several weeks or longer for the pain and strength to return if in fact a nerve was damaged. I am in pain and cannot use my left hand fully due to the diminished strength and pain. I plan to make an appointment with a specialist/orthopedist as soon as possible.
Initial report was received from a health care professional on 18 Dec 2009: This patient (15 month old) was inadvertently given S-OIV FLUVIRIN batch no: 101329ZP, 0.5 ml, intramuscular on 17 Dec 2009. No adverse events were reported.
This spontaneous report was received from a patient's mother, referring to his 10 year old male son. The patient did not have pertinent medical history, concurrent conditions, allergies, drug reactions or concomitant medications reported. On 14-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 and on 23-NOV-2016, he received the second dose (0.5 ml in each dose, route was not provided). The patient did not experience any adverse event after the first two doses. On 27-MAR-2017, the patient was vaccinated with the third dose of GARDASIL 9 injection, at 0.5 ml (lot #, expiration date, route and anatomical location of administration were not reported) given to prevent HPV. On 10-APR-2017, reported as "about two weeks after the third dose'', the patient experienced started to experience "very high fevers'', terrible headaches, and achiness. Subsequently, he also experienced fatigue on an unspecified Friday (exact date not provided) after the third dose was given, and approximatelly in April 2017 by (the following) monday, he developed a rash on his torso and back that was raised, red and itchy. Afterwards, the patient was diagnosed with idiopathic urticaria, and he was prescribed with an unspecified medication to treat the rash; it was unknown if the treatment was effective. On an unknown date, the patient recovered from the fever, however the rash, as reported ''comes and goes''. On an unmentioned date, the patient underwent an unspecified test reported as ''marker type things'' and a bloodwork but results were not provided. The patient had been on unknown antibiotics and "several other things" but none of these treatments were effective. At the reporting time, he was still experiencing headaches and fatigue and the patient's mother referred that this was ''unusual for an active kid''. Additionally, it was stated that he had missed a lot of school due to the events. The outcome of idiopathic urticaria was reported as recovering. The causal relationship between vaccination with GARDASIL 9 and the events was not mentioned. The idiopathic urticaria was considered serious due to disability.
Migraine headaches; Headaches; Elevated blood pressure for 3 weeks; This is a spontaneous report from a non-contactable nurse, the patient. A 52-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Aug2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Jul2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Aug2021, the patient experienced migraine headaches/ headaches every day since the second dose as well as elevated blood pressure for 3 weeks. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department, or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event elevated blood pressure was resolved on an unknown date in 2021; while that of migraine headaches/ headaches was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extremely sick; Joint pain; Fever; Chills; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ILLNESS (Extremely sick), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue). On 01-Apr-2021, ILLNESS (Extremely sick), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.            No concomitant products were reported.  No treatment information was provided.    This case was linked to MOD-2021-066829 (Patient Link).