chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took an antibody test and was negative; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Took an antibody test and was negative) 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 January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Took an antibody test and was negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Took an antibody test and was negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.  No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Upon internal review on 26-May-2022, significant correction was performed. Updated the report type from Invalid case to Spontaneous. Added lab data, reporter and patient details. The country of incidence, reporter and event country was updated from unknown to United States. Suspect product coding, event coding and narrative was updated.
Tired; His ear towards the upper tip felt little warm; Heart palpitations; Odd feeling in chest; Throat discomfort; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EAR DISCOMFORT (His ear towards the upper tip felt little warm), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Odd feeling in chest), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and HEADACHE (Headache) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced EAR DISCOMFORT (His ear towards the upper tip felt little warm), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Odd feeling in chest), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and HEADACHE (Headache). On 07-Jan-2021, the patient experienced FATIGUE (Tired). On 08-Jan-2021, EAR DISCOMFORT (His ear towards the upper tip felt little warm), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (Odd feeling in chest), OROPHARYNGEAL DISCOMFORT (Throat discomfort), HEADACHE (Headache) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Heart rate: The beats per minute were starting at 122 jumped to 133 then 150 then 170 and then to 179. The heart rate decreased to 95 beats per minute. After 5 minutes the bpm was 170 for 1-2 minutes and then dropped to 90 bpm. Then went to 120-130 bpm at ER. Turned to 75bpm after sitting. After getting home HR increased to 122 bpm then lowered to 85-115. At home range went to 75-80 bpm.. On 07-Jan-2021, Heart rate: Resting Heart rate Normal..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment received at the ER.  Patient was transferred to the ER.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Developed nodule and pruritic patch under injected arm which still had large local reaction. Likely reactive inflammation from large local rx. 1 week following this she developed pruritic scattered patches on extremities and face. Likely unrelated, re-enactment of childhood atopic dermatitis, perhaps due to immune stimulation of vaccination.
This is a spontaneous report from a contactable consumer or other non-HCP. An 80-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6203, expiration date: unknown), at the vaccination age of 80, via an unspecified route of administration, in left arm, on Mar 5, 2021, single dose, for COVID-19 immunization. The patient's medical history included neck pain; pain in the back of her neck, head, forehead and jaw. She reported she had mild pain in these areas before the vaccine. No concomitant medications reported. On Mar 5, 2021 (30 minutes) after receiving the vaccine, patient experienced pain in the back of her neck; pain in back of jaw, head and forehead. The pain got worse after the vaccine and lasted for a few hours. She felt bad. Patient mentioned she had mild pain in these areas before, but just did not pay attention at first. Then the pain got worse and lasted a few hours. Then stopped and went away completely. It did not occur to her it was from the shot as she had no side effects from shots before. She cannot take pain medicine. The outcome of  had pain in the back of neck, jaw, head and forehead; had mild pain in these areas before the vaccine; pain got worse after the vaccine and lasted for a few hours; and felt bad recovered on Mar 5, 2021. No follow-up attempts possible. No further information expected.
Information has been received from a physician concerning a female who was vaccinated with one dose of zoster vaccine (Oka/Merck). Subsequently the patient developed tingling and pain in the nerves on one side of her face that went away a couple of days after vaccination. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 95-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 30th January 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and experienced pain at the injection site that lasted for one week. The reporter consented to follow up.
Vaccinated 01/15/2021, by 9pm I was in severe distress. Both my arms felt like dead weight and I had extreme physical pain, body pain, joint pain, muscular pain, bone pain. It hurt to move. I ended up in the ER. Received narcotics. Went home shortly after because vitals looked good, at home I had diarrhea and severe stomach pain. the next two days it hurt to move a muscle.
No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 20-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1660112 and expiration date 18-OCT-2020, orally, for prophylaxis (dose, strength and frequency were not reported).    No adverse effects were reported. It was reported that rotavirus vaccine, live, oral, pentavalent(ROTATEQ) suffered multiple excursions of below 2°C (1.28C) for 2 hours and 30 hours. No previous temperature excursions were reported. Digital data logger was involved.
vomitting, stomach pain, extreme headache, extreme body and joint pain, 102.8 fever
Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Body ache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 milligram. At the time of the report, PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown. Not Provided
Administration of an expired PNEUMOVAX 23 vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.  On 30-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 injection form, lot # R034248, expiration date on 07-AUG-2020 (Expired vaccine used) for prophylaxis (strength, frequency, route of administration, and anatomical location were not reported).  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R034248; expirationdate: 07-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
high blood pressure; This is a spontaneous report from a Pfizer sponsored program, via a contactable consumer (patient).  A 60-year-old female consumer patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 12Mar2021 (age at the time of vaccination 60-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date, for COVID-19 immunization. On an unspecified date 2021, the patient experienced high blood pressure. Patient received medication as a treatment of adverse event. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Not sleeping; disoriented; Incontinence; Cough; pain; weakness; fever 102F; chills and aches; chills and aches; This is a spontaneous report from a contactable consumer or other non hcp.   An 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 11Feb2021 (at the age of 88 years), (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2. Callers parents received the second dose of the Pfizer covid19 vaccine on 11Feb2021. Her dad (male, age 92) had no reactions. Her mom (female, age 88) had delayed reactions. On 14Feb2021 she started to have a fever of 101F chills and aches. On 15Feb2021 cough and weakness, fever 102F, chills, pain, stronger cough. It seems to be happened in the evening/night. It was better during the day. At night it got worse. Did they report these side effects after 7 days? Did it go away after 7 days?" The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 14Feb2021, body temperature: 102 Fahrenheit on 15Feb2021. The clinical outcome of the events fever 102F was not recovered, chills and aches, Cough, pain, weakness was recovering, Not sleeping, disoriented, Incontinence was unknown.  Information on lot/batch number has been requested. Follow-up attempts completed. No further information expected.  Follow-up (11May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient stated day after receiving vaccine her middle toe swelled and whole foot was stiff. Her rheumatologist said that the vaccine triggered an auto-immune relapse (psoriatic arthritis).
Headache, huge stomach ache, vomiting whole meal and this occurred 5 times over 3 days, temperature between 99 and 101, wheezing and very pale, around the injection site (3 inches in diameter) was red, raised and hot, during the course of events she blacked out 2x, injection site was also extremely itchy.
On October 16, 2018, I received the flu vaccine at Hospital as required by employer. That evening around 10:00pm I developed body aches. From October 17, 2018 to October 22, 2018, I developed severe body aches, rib pain, jaw pain, facial edema, shortness of breath, and night sweats. There was no irritation, swelling, or redness at the injection site. On October 19, 2018, I presented to Express Care Clinic and no definitive diagnosis was given. Symptoms worsened and on October 21, 2018, I presented to Express Care Clinic again. A chest XR was obtained and found to have innumerable pulmonary nodules scattered throughout all four lobes. I was sent to ER. While at ER, many labs were ordered along with chest CT and head CT. Chest CT confirmed innumerable pulmonary nodules indicating sarcoidosis, Wegener's granulmatosis, metastatic disease, or atypical bacterial/fungal infection. While in ER, I was seen by pulmonologist and recommended follow up with rheumatologist and pulmonologist. I followed up with rheumatologist on October 23, 2018, and was not found to have an autoimmune disorder. I followed up with the ER pulmonologist on October 24, 2018, and he ordered a bronchoscopy. On October 31, 2018, I had  bronchoscopy and per Dr., was found to have a influenza vaccine reaction.
I had my first Moderna shot at the end of February and have not gotten my second shot yet; 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 PRODUCT DOSE OMISSION ISSUE (I had my first Moderna shot at the end of February and have not gotten my second shot yet) 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.    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 PRODUCT DOSE OMISSION ISSUE (I had my first Moderna shot at the end of February and have not gotten my second shot yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had my first Moderna shot at the end of February and have not gotten my second shot yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants are included. No Treatment included.
Patient's mother reported RUE hives, redness, raised rash developing post-vaccination same arm.  Vitals stable: 110/72; 80; 18; 95% RA; no SOB per mother; lungs clear.  Mother report patient fine otherwise.  applied Benadryl cream topically to RUE rash.  Redness and hives were resolving/getting much better and mother stated she would notify PCP.  Patient went home with mother.
I got the 2 Pfizer shots; I have thyroid and I am obese; I got the 2 Pfizer shots; I have thyroid and I am obese; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1,  I got the 2 Pfizer shots), for Covid-19 immunization. The following information was reported: THYROID DISORDER (non-serious), OBESITY (non-serious), outcome "unknown" and all described as "I got the 2 Pfizer shots; I have thyroid and I am obese". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter reported that I have thyroid and I am obese, like I am 200 something. I'm considered obese like I'm overweight. I am 62 years old, and I got the 2 Pfizer shots, I was okay with it. Now, I want to go for the booster shot. How many months after the 2nd shot, I need to go get the booster? I have been hearing like from people who ever got this shot the booster, they have been experiencing like numbness in their fingertip's hands and the feet, they've been experiencing that is that normal? Like I am afraid to have booster shot.  Follow-up attempts are completed. No further information is expected.
Basically, these started occurring - I have been using a CPAP machine and it was due to have the tubes and mask replaced. I have been using for 6 months. I may have caught a cold from that. I have been swimming in a swimming pool to take my weight down. I had a blood pressure med that I was taking before this one - and side affect is that a cough can be developed from that. My doctor said it could be even allergies. I have been taking Claritin and Flonase  - started that four days ago - and that has helped me a great deal. Claritin helps me not to cough.. I still have a cough. It seems to affect me after I wake up  after being a prone and late at night (after certain foods) it flares us again. If it continues I am to see my doctor in person and maybe she'll do a physical exam (had a phone visit so far).  No sinus pressure. It's pretty much just a cough. It's not a dry cough.
Patient states symptoms of general malaise began 3/8/15. By morning of 4/9/15 patient was experiencing severe abdominal pain and diarrhea, which lasted five days. Patient also reports experiencing muscle aches, fatigue, and loss of appetite during this time.
My COVID-19 onset symptoms were headache, sore throat, sinus congestion, runny nose, diarehea . I also have a rash on my trunk below both armpits on sides and below the waist in the front. I did have a sharp pain above my stomach below my ribcage but I think its related to my stomach being distended from diarrhea, and it has since gone. I took Advil, Dayquil and Nyquil, water as well as sleeping to help with treatment. I contacted telehealth doctor to see if there were any treatments to be given, they mentioned FDA approved emergency use drugs but the doctor did not think I was a candidate. Since then my symptoms have eased. The diarehea has persisted as well as headache. I still have stuffy nose, but that clears up after a shower.
Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (Arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
8/31/2023 developed right sided lower extremity weakness, numbness to bilateral lower extremities, muscle contractions, and inability to walk dragging right leg and left leg feeling heavy- admitted to hospital for evaluation and treatment . Took Medrol dose pack, Ibuprofen and started Baclofen 10 mg for muscle spasms.  9/7/2023- fasciculation's and tremors began in bilateral lower and upper extremities with intentional movement, difficulty with gait, right leg locking out. .  9/8/2023- follow up with neurology for symptoms, Dr- more extensive lab testing ordered at this time 9/10/2023- numbness and tingling in ascending fashion, extended to right side up body up to the scapular on the back- went back to ER for evaluation and neurological consultation started with tremors. Home on motrin and baclofen and no explanation still.  09/13/2023 1700- lost ability to speak clearly- difficulty getting words out although thoughts were clear, EMS called to my house transported to ED and stroke code activated for speech and gait changes Scans negative but extensive nerve pain and burning in bilateral feet began making it hard to ambulate with shocking and shooting fashion. Only lab abnormality low potassium- supplemented  09/17/2023- speech normalized bilateral lower extremity weakness and activity intolerance persisted.  09/18/2023- EMG completed showed no sign of large skeletal muscle disease but did not exclude a small fiber neuropathy. physical therapy consultation for neurological rehabilitation 09/25/2023- symptoms improving aside from shocks remaining in left foot and occasional twitching of muscles in back arms and legs.
I received my 2nd shot on 4/7/21 and the first booster on 11/20/21. In late February 2022 I got what was diagnosed as a "bad cold" with a cough. Covid tests were negative. I've had the cough since although it is slowly getting better. The adverse event is just me wondering if this could be from having Covid in August 2021.
Prepared vaccine by drawing up from single dose vial. Went to administer vaccination into the right arm of the patient. Needle went into arm, upon pressing on the plunger to administer vaccine, needle/syringe became un-attached causing needle to fall out of arm and flu vaccine to squirt out of the syringe onto patients arm.
No symptoms other than just a mild injection site pain. Didn't last long. On 5th of April I began to get: I had rigors (shaking, chills), sweats at night 3 or 4 times of night changes of bedding, acute Prostatitis and pain upon urination and pain from prostrate itself. fever spike as high as 102.2 and my blood cultures were positive for Staphauereus in my blood stream. Sepsis diagnosis.  I was admitted to hospital on 7th  April  of Hospital I had a fever of 102. My prostate was enlarged to 131 grams and I was having difficulty urinating. The infection was Staphaureus Staphlicottis. I was initially treated at a walk-in clinic and they did a direct admit to the hospital  for UT .and I stayed there for 7 days. They installed a PICC line for IV upper arm to vena cava up into my heart. I still have that in - for intravenous home infusions of antibiotic. Peripheral Inserted central Catheter. Up until Sunday, May 16,  of this past week, I had extreme fatigue to the point of not being able to walk a normal amount for me - maybe 1/3 of the amount. I haven't been able to get back to my regular exercise. I was having headaches and brain fog and a lot of aches and pains throughout the body up until Sunday. Since then I have felt quite a bit better.