chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient admitted due to shortness of breath.  Per patient she had just received COVID-19 vaccine on 11/10/2021, subsequently 2 days after she tested positive to COVID-19 infection with shortness of breath and cough with chest discomfort.  CTA of the chest was negative for PE.  Patient was exhausted from severe weakness from COVID-19 infection.  Of note, patient has a history of dizziness vital ago and has been on meclizine for symptomatic management.  Suspect had similar episode at the ER  During this entire hospitalization she had no chest pain no shortness of breath no dizziness did not feel faint.  Recommend outpatient follow-up family doctor regarding syncope.  She received Decadron, Remdesivir and Baricitiinib during this hospitalization responded well to treatment and was discharged in stable condition
Patient states that 4 hours after her influenza vaccination on 10/05/2020 she began having a stabbing pain, with difficulty lifting her left arm over her hand, with occasional numbness in her left hand. NSAID's have helped with the patient's swelling very little. Patient is still currently having all the listed symptoms.
Her arm at the site of injection became red, swollen and minimally painful a few hours after her injection. Daughter described about a 3 inch diameter are of mild pinkness that feels slightly rubbery to her.  Patient stopped by the doctors office the following day to have it looked at. The injection site was looked at by the provider and described it as less swollen and less painful than yesterday. No temperature. Patient was advised to continue to monitor and it the redness expands or becomes firmer or more tender she was to let us know.
Headache, Myalgia, FATIGUE, RED SWOLLEN SORE ARM  Narrative:
Second dose is outside of recommended interval from first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose is outside of recommended interval from first dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose is outside of recommended interval from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose is outside of recommended interval from first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported  Treatment information was not reported.   Reporter did not allow further contact
Narrative:  Vaccinated, not boosted pt admitted for symptomatic COVID, discharged after 2 day admission.
Felt fine during the 15 minute waiting period.  Later in the afternoon I became very sleepy.  Napped for 2 hours, awoke feeling feverish with a headache, no appetite.  Took Advil Friday night around 7, then 2 a.m. Saturday, 7 a.m. , 2 p.m. but it didn't alleviate the headache.  Slept almost all day Saturday and Sunday.  My left arm still is red, swollen and itchy.
Chills; Fatigue; Nausea; Fever; Pain in arm; 1st dose 09-FEB-2021 2nd dose 19-MAR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 09-FEB-2021 2nd dose 19-MAR-2021), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 09-FEB-2021 2nd dose 19-MAR-2021). On an unknown date, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 09-FEB-2021 2nd dose 19-MAR-2021), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.            No concomitant medication was reported by reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter contact for lot number information was unsuccessful.  Co-suspect Humira was given by Solution for injection in pre-filled pen.   The reporter's causality for the event(s) of CHILLS, FATIGUE, NAUSEA, FEVER and ARM PAIN was not provided.  No treatment medication was reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recvd DTP/HIB vax on 23JUN92 4PM; 645 pt was fussy & felt very cool, very pale, diaphoretic & t103 ax; pt taken to ER t103.2, p120, resp 32; also had pharyngitis;
C/O dizziness, vasovagal symptoms, nausea, almost fainting episodes, did not faint, headache, muscle aches, weakness, joint pain, no joint swelling.
HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. The batch number was not reported and has been requested.  This report was non-serious.
My arm is moderately painful, which interfered with sleeping. I feel fatigued, my neck aches, I have a headache, and at times I feel nauseated.
Hot flashes. After the 2nd Pfizer shot, I get hot flashes. It is the same as when I went through menopause, but it started up again right after the 2nd dose. My face gets very red and flushed and my body gets hot, then it goes away. It especially happens when I feel stress  or at night. It happens at once a day or several times a day. Within an hour of getting the 2nd Pfizer shot, my skin was very red and itchy. The hot flashes occur regularly since February after the shot.
Complaints of stomach ache began to occur off and on during this time. Add to this, as later determined after a period of 4 months of observation, that my child would be playing and running then all of a sudden have to stop and sit down and complain of being entirely exhausted, HAVING TO SIT DOWN TO REST. Also FREQUENT ANGER OUTBURSTS which could or could not be attributed to the child coming home from foster care after 70 days. THIS DRUG WAS ADMINISTERED TO MY CHILD AGAINST MY WISHES WHILE SHE WAS IN THE CUSTODY OF THE STATE.
had a similar reaction/numbness and tingling/felt prickliness; had a similar reaction/numbness and tingling/felt prickliness; After the second shot the symptoms got worse; Received her 1st dose of the Moderna vaccine 2 weeks before she got her 1st dose of the Pfizer-BioNTech Covid-19 Vaccine; This is a spontaneous report from a contactable consumer (patient's parent). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from an unspecified date (Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that her daughter (patient) received her 1st dose of the Moderna vaccine 2 weeks before she got her 1st dose of the Pfizer-BioNTech COVID-19 Vaccine. She further reported that at the 1-week mark after receiving the 1st dose, the patient had a similar reaction/numbness and tingling/felt prickliness, as she had. The patient's doctor still told  her to receive the second shot. After the second shot, the symptoms got worse and continued. The consumer stated that there must be something the vaccines have in common that she and the patient reacted to. The outcome of all the events was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Pt called on 4/20/21 at 10:20am complaining of face swelling on the left side only mostly under the eyes and part of the cheek since Saturday after getting 1st dose Pfizer Vaccine on 4/16/21. Pt stated using warm and cold compression but swelling did not go away. Advised pt to go to the ED
sore arm; fatigue; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK-9231) via an unspecified route of administration into the left arm on 30Dec2020 07:30 at a single dose for covid-19 immunization. Medical history included hypertension, hypercholesterolaemia and psoriasis. Concomitant medication included amlodipine (AMLODIPINE), atorvastatin (ATORVASTATIN), acetylsalicylic acid (BABY ASPIRIN), ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient experienced sore arm and fatigue on 31Dec2020 06:30. The patient did not receive treatment for the events reported. Outcome of events recovered on an unspecified date.
ITP (immune-mediated thrombocytopenia); This is a spontaneous report from a contactable other HCP (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included premature menopause. Patient not diagnosed with COVID-19 Prior to vaccination. The patient previously took penicilline and sulfa drugs and experienced allergy. Concomitant medications within 2 weeks of vaccination include Multivitamin and paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID. The patient experienced ITP (immune-mediated thrombocytopenia) on 23Apr2021. Patient received immunosuppression with steroids for the event. The outcome of event was not recovered. Patient received dose 2 administered in left arm on 06May2021 13:15 (Batch/Lot Number: EW0175). Patient has not been tested for COVID-19 Since the vaccination.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Immune-mediated thrombocytopenia cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available.
Information has been received from a registered nurse concerning a 4 year old female with no known drug allergies, who on 06/17/1997 was vaccinated with varicella virus vaccine. On 03/20/2001, the pt presented with "chicken pox fifty plus varicella-like lesion." In follow-up, the nurse reported the pt presented with varicella 50-100 lesions. The nurse reported that the onset of the varicella was 03/18/2001. There was no relevant diagnostic tests and lab data. The nurse reported the pt may also have been given varicella immunoglobulin (VZIG) at one year of age, and that the reason was not known. The pt recovered from the varicella. No further info is expected.
Information has been received from a consumer concerning her grandson who on an unknown date was vaccinated with MMR II. It was reported that after having gotten MMR II vaccine when the patient was between 18 months to 2 years old, he developed autism. The patient's outcome was not reported. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Pt. recieved vaccine past 12 hours expiration. MD contacted pt. No adverse event. Pt. declined revaccination.
Patient was a healthy 75 year old male when he got the shot.  Within  5 hours, he began to feel TIRED, which was an expected side effect. He felt tired for several days. Nine days later he went to Memorial Hermann ER in Kingwood, and they said he had pneumonia. They also said he had a "small mass" at the bottom of his lung and might want to get it checked out. On March 20, he developed a cough. On March 21 we went to a different ER and a CT scan showed he had plureal effusion.  On the next day he was short winded. He went back to the ER and they admitted him and transferred him to hospital by ambulance.  On March 23, 1.7 liters of fluid was drained from his lung and sent to be tested. On March 26 he was diagnosed with malignant plureal effusion. He passed out at the doctor office and tranferred to to another facility by ambulance. He remained there for 4 days for tests, and a port was put in to drain the fluid. On March 29 he was transferred .  They repeated many tests and did a bronchoscopy.  On April 1 they told him he had squamous cell carcinoma.  He came home on April 2. The doctor called and said they made a mistake he had small cell carcinoma.  He remained home until April 11, when he was taken back to  by ambulance.  He had gone from a healthy appearing individual on March 17 to a critically ill individual and he died on April 15.  Doctors had never seen cancer overtake a man in 28 days. 28 days!!!!  On March 22, he had a small mass at the bottom of his lung, and one week later, it was a mass so large, his lung could not be seen and his lung had collapsed.  Doctors assumed that the cancer was dormant and that the vaccine did something to wake it. It attacked my husband with a vengeance.  He never smoked.
After the first shot, I had a slight ear ringing which went away about 5 days prior to my second shot. I then received the second shot three weeks after and the next day developed severe swollen lymph nodes. Went to the doctor to discuss. Around that time, the ear ringing came back. Went to a ENT yesterday who has now given me a steroid to make it go away.
I was vaccinated with J and J for COVID-19 I developed Pneumonia, Blood Clot on right calf (hospital diagnosis- acute deep vein thrombosis (DVT) of lower extremity), lower back pain
Injection site pain and redness x 3 days Headache x 2 days Fatigue x 2 days Chills x 2 days Joint pain on day 2 only  Day 3 minor swelling/redness at ink site but not other affects
Nausea, shakes, cold, vomiting lasted 1 day - next day was some nausea gone by 4pm.
1st set immuns given 9MAY94; pt died of SIDS 12MAY94;
Pt developed a red, swollen, warm to the touch area @ the inject site; has a knot size of a 50 cent piece;
Received the injection (painless) prior to deployment to airport to make a 08:30 departure. While standing in line about 07:20, at the ticket counter. I began to have chills that began the check-in process. When I stooped to get my tickets and passport and my carryon, I had a near syncope episode when I stood. I then developed diaphoresis which continued for a few more minutes and ///.
I woke up on morning of January 23 with severe left sided pain in left arm and shoulder.  4 days later developed gradual onset left hand weakness.   EMG revealed pattern consistent with either Parsons Turner Syndrome of C8/T1 Radiculopathy.   Hand strength has slowly returned over subsequent 10 months.  My left hand is still slightly weaker than I believe it once was, though it is almost normal.
One day after shot: body aches, pain In both legs. Three days after shot: pain in shoulder and upper chest, particularly when inhaling Five days after shot: loss of voice, sharp shooting/crushing pain in left chest cavity, increased pain when breathing Six days after shot: diagnosed with Pulmonary embolisms in left lung, pleurisy, and inflamed lymph nodes near left lung.
COLLAPSED TWICE; OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a patient via a company representative via media concerned a 12 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number was not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. 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 collapsed twice, off label use, and product administered to patient of inappropriate age. "Reporters cousin 12 year old had collapsed twice after the vaccine. Reporters husband had changed sense getting vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the collapsed twice, off label use and product administered to patient of inappropriate age was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220224963.; Sender's Comments: V0:20220224739-covid-19 vaccine ad26.cov2.s-collapsed twice. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
p/vax pt was febrile; became cyanosis & stiff; paramedics called; tx: o2 & pulmonary resuscitation; in ER, sz was over, alert/active; hosp for observation;stay was uneventful;fever subsided in 3 days;broke out in rash; Dx: roseola
arm soreness; 100.6 F fever; slight headache; A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness, 100.6 f fever, slight headache.  The patient's medical history was not provided. Concomitant medications reported were Losartan for hypertension, Triamterene-Hctz diuretic, Vitamin B Complex supplemental, Vitamin D supplemental, Zinc supplemental, Vitamin C supplemental for drug use for unknown indication.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) arm soreness, 100.6 f fever, slight headache.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm soreness, 100, 6 f fever, slight headache was unknown.
Patient received his 2nd dose of moderna 22 days after his first dose (05/17/2021)
Syncope, dizziness, fainted. Crackers, water, apple juice given. Vitals wnl.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX. Co-suspect products included Pneumococcal vaccine. On 31st January 2018, the patient received SHINGRIX. On an unknown date, the patient received Pneumococcal at an unknown dose. On 1st February 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm and headache. In February 2018, the patient experienced vomiting, diarrhea and bedridden. On an unknown date, the outcome of the pain in arm, headache, vomiting, diarrhea and bedridden were unknown. It was unknown if the reporter considered the pain in arm, headache, vomiting, diarrhea and bedridden to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient received Pneumococcal vaccine at different site on body. In 2018, less than a week after vaccination, the patient experienced vomiting, diarrhea and was ended up being bedridden. The patient was fine at the time of reporting, but was concerned whether to received the 2nd dose. All the events were lasted for about 5 days. The reporter did not agree to follow up from GlaxoSmithKline.
Initial report was received 09 April 2008 from a health care professional.  An 11-year-old female patient with no pre-existing medical conditions, had received an intramuscular left arm injection of Menactra, lot number U2429AA and an intramuscular right arm injection of Havrix, lot number AHAVB214AA (manufactured by GSK) on 08 April 2008 and within 24 hours, experienced tingling in both arms, vomiting and a fever of 100 degrees Fahrenheit.  The patient had no illness at the time of vaccination.  At the time of the report, the patient's recovery status was unknown.
Acute lower back pain with no known cause.  Two months after onset, pain is almost completely resolved.
p/vax pt rt arm (pneumonia vax) puffy & swollen, hot, hard & very red;
Shot #1: 3/11/21 - symptom: mid back pain Shot #2: 4/2/21  - symptom: mid back pain; DVT symptoms early 05/21; DVT diagnosis  05/07/21 BRCA diagnosis 09/21 Shot #3: 11/18/21 - symptom: mid back pain
PT states he got the j&j vaccine at 0930 today. He states he experienced chills, body aches, head ache and numbness in his hands. PT denies taking any medication.
Fever, NauseaVomiting, arm pain, body aches (unspecified) Narrative:
Patient had a signed consent form. Staff gave us the signed consent form. When we went to report it in system it said the patient received the vaccine a month before. We don't know if its in error or not.
feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; the tip of the tongue tingling and sore.; the tip of the tongue tingling and sore.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 27Jan2021 (age at vaccination 79-year-old) as 1st dose, single for covid-19 immunisation. Medical history included allergy related with sinusitis from an unknown date and its ongoing. Concomitant medication included prednisone (PREDNISONE) taken for sinusitis, start and stop date were not reported. The patient reported that she was administered with the first dose of the Pfizer's COVID-19 vaccine on 27Jan2021 (Wednesday) and a few hours after the administration of the vaccine she started feeling the half of her face swollen, thick and numb and the tip of the tongue tingling and sore. The patient reported that she took Prednisone that she had in her house and was previously indicated for the management of an allergy related with sinusitis. The patient reported that she has taken 3 doses of Prednisone, one each 24 hours. Patient asked for information about if her symptoms could be related with the administration of the Pfizer's COVID-19 vaccine. The outcome of the events was reported as unknown. Information on the Batch/Lot number has been requested Follow-up attempts are completed. No further information is expected.