chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An episode of angioedema; Hives; A spontaneous report was on 05 Mar 2021 received from a consumer concerning, a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives and a second episode of angioedema.   The patient's medical history, as provided by the reporter, included an episode of angioedema after receiving first dose of mRNA-1273. Concomitant products included sertraline hydrochloride 100 milligrams once daily, and zolpidem tartrate 10 milligrams in the evening, diphenhydramine hydrochloride, and cetirizine hydrochloride.   The patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in left arm for prophylaxis of COVID-19 infection on 10 Jan 2021.  On 07 Feb 2021, approximately 13 days prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 20 Feb 2021, approximately 13 days after receiving the second dose of vaccine, the patient experienced hives and a second episode of angioedema. Treatment for the reported events was self-administration of an EpiPen as a treatment.   The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, hives and a second episode of angioedema, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
tinnitus in ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus in ear) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced TINNITUS (tinnitus in ear). At the time of the report, TINNITUS (tinnitus in ear) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided
8pm - that night restless. 10pm - hurting/grunting. 11pm - vomiting, shaking, Lg temp rash small red bumps.
Patient drove to clinic at 1400 and received vaccine at 1410. Patient was instructed to wait in her vehicle for 15 minutes and to honk if she needed medical care. At 1420, patient comes out of car and walks to vaccine table to alert nurses that she felt ?like her heart was racing and I feel spacey?. Patient was sat down and vitals were taken. Vitals appeared within normal limits. Patient?s cheeks and chest were red and splotchy. Patient given cold water and was instructed to wait with nurse for an additional 30 minutes. Patient continued to have complaints of racing heart and lightheadedness. Vitals taken again and pulse increased from 100s to 120s. EMS called and arrived at 1450. EMS took vitals and patient?s heart rate was increasing to 130s. EMS took patient by ambulance.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 29-APR-2014, the patient inadvertently administered PROQUAD (merck), subcutaneous after the labeled expiration date. The lot number was H019441 and expiration date was 25-APR-2014. No adverse effects reported by nurse. Additional information is not expected.
VACCINE EXPIRED ON 05/31/23; ADMINISTERED ON 06/02/23. NO ADVERSE EFFECTS TO PATIENT.
Patient got flu vaccine at 12:30pm. Called pharmacy at 3:00pm. He stated both hands are swelling. Pharmacist told him to come in but patient stated he was busy. Pharmacist stated he may need to go to ER. Called patient at 3:30 to check and patient said swelling went down.
Pain in L forehead and face, superficial.  Started 2/2/2021, called MD 2/6/2021. MD diagnosed likely shingles reactivation (have had once before).  Prescribed valcyclovir.
After receiving the vaccine I was experiencing fatigue and tiredness. I went to bed that evening and experienced tachycardia for several hours. I went to the doctor the next morning as soon as possible and was given an EKG. The EKG came back normal, as did my blood pressure, but my doctor put me on a cardiac event monitor a few days later for two weeks to continue monitoring my heart. I had ongoing symptoms and went to the ER a few days later and had another EKG, blood tests, and a chest x-ray done, all of which came back clear. However, I am still wearing the heart monitor and will follow up with my doctor in a week when it is removed and the results come back to see if there is a reason for the tachycardia.
Report A0372355A describes Lyme disease in a 48 year old female who was vaccinated with Lyme disease vaccine recombinant OspA for prophylaxis. This report was received from the subject and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were unknown. In July 2000, the subject reportedly received her third injection of LYMErix. The subject stated that during the last six months she has been having vision problems "losing vision, equilibrium is terrible, have tendency to fall." She stated that she was "disoriented" and "living in a fog." She stated that she had MRI performed which indicated "11 or more brain lesions." She stated that her physician has "ruled out multiple sclerosis." She stated that her physician stated that her tests NOS indicated that she had "Lyme disease." As of 6/20/02, the events were ongoing.
papular rash, initially appearing on the face and then spreading to the legs. tele-visit only secondary to COVID19 limitations (so entire visit obtained via audio history only) will treat as atopic dermatitis - emollient use recommended.  recommend photo-documentation from parent monitor -- if worsening, recommend in-person or video visit to review rash. FH of eczema.
I received the shot and went home. My arm got a little sore that evening. The next day I got a large hard knot at the injection site. It was so big I showed my daughter who is a nurse. I was having more pain in the arm starting the next day. It was the weekend as I had my shot on a Friday so I didn't call anyone until the next week. I sent my primary care Dr a note stating I was having pain still a week later. They said to give it more time. I also reported the pain and knot to the Clinic number.. I continued with the pain for awhile thinking it would just take time to go away. But it hasn't.  So I went in to see my PCP and she examined me and suggested ice and exercises pushing against the wall. After several weeks it didn't feel improved at all. So she did an X-ray and that only showed the bone so she sent me for an MRI. I'm waiting for the results done 2 days ago.  I've lost my range of motion. It's difficult to drive and turn the wheel on the left.  I can't sleep on my left side. I can't dry my back after a shower or fasten my bra in the back. I can't dry my hair easily lifting my arms up and dressing myself with clothes going over my head is difficult. It has changed my life unfortunately.
very painful arm; chills; extreme fatigue; Moderate prefrontal headaches; mild nausea; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 26-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, via an unspecified route of administration, on 31Jan2021 12:00 pm at single dose for COVID-19 immunization. Medical history was reported as none. The patient has no allergies. There are no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number: EL3248) on 10Jan2021 at 08:00 am on the left arm for COVID 19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications taken with 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date, 48 hours after the second dose, it was reported that the patient had very painful arm, chills, and extreme fatigue. On an unspecified date, 8 days after the second dose, the patient had moderate prefrontal headaches and mild nausea. No treatment was received for the events. The events were considered as non-serious and the events did not result in death, life-threatening condition, hospitalization, disability or congenital anomaly. The patient was tested for COVID-19 since the vaccination on 02Feb2021 via nasal swab with a negative result. The patient was vaccinated in a hospital. The outcome of the events was reported as recovering.
Significant Upper Body Itching experienced within 5 minutes after the injection Sent to Emergency Department immediately Administered 25mg Benadryl (Diphenhydramine), which reduced the itching Left Emergency Department after 2 hours Itching continued intermittently for approximately 10 days Primary Care Physician was notified and referred me to an Allergist  Saw Allergist on 3/3/21 who recommended that I do not receive the second dose of the Moderna vaccine Follow-Up contact with Allergist scheduled for 4-6 weeks
After getting J&J covid vaccines the patient was having allergy reaction, difficulty breathing and warm.  I gave the pt epipen and called 911, he had  seizure For 3 minutes as well
Seizure; Patient unable to drive for at least 6 mons to avoid repeat episode of seizure; This case was reported by a physician via sales rep and described the occurrence of seizure in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced seizure (serious criteria GSK medically significant) and activities of daily living impaired. On an unknown date, the outcome of the seizure and activities of daily living impaired were unknown.   It was unknown if the reporter considered the seizure and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced seizure post Shingrix dose. The patient would unable to drive for at least 6 months to avoid repeat episode of seizure. The reporter stated the patient was a fellow provider and not his patient and he had no further details. The reporter consented to follow-up.
Redness, the size of a softball, under the site of injection to right arm. Pain and stiffness to upper right arm.
Patient did not have any symptoms or adverse effects; Product origin unknown; Caller is a medical assistant who reports that GARDASIL 9 was given to a pregnant patient.; extra dose administered; This spontaneous prospective pregnancy report was received from a medical assistant referring to a 26-year-old female patient. the patient's concurrent conditions included gestational diabetes and hypothyroidism. The patient's concomitant therapies included acetylsalicylic acid(ASPIRINE), prenatal vitaminis and metformin. The patient's medical history and historical medications were not reported.       On 15-MAY-2007, 17-JUL-2007 and 03-APR-2008, the patient was vaccinated with the 3 doses of an unknown brand of a HPV vaccine (dose, route of administration, lotnubmer and expiration date not reported) for prophylaxis (product origin unknown), and on 11-APR-2022, was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, intramuscular, lot number U032676, expiration date 26-OCT-2023 for immunisation (exposure during pregnancy). This dose was administered as the patient did not recall to have been given and HPV vaccine before (the dates were looked into the patient's chart) (extra dose administered). No adverse event was reported.  The patient became pregnant with LMP of 19-JUL-2021 and EDD of 25-APR-2022. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 38 week(s). The pregnancy outcome was outcome pending.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at a health center as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2014, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
I was told to report I tested positive for COVID-19 after being vaccinated/boosted. But, I don't believe this is an adverse event related to the booster shot.
red dots on the whole arm  and there is some yellow in the middle; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EW0153, Expiration date not reported), via an unspecified route of administration on 18Apr2021 (at the age of 52-year-old), as first dose, single dose for COVID-19 immunisation. The patient has reported he doesn't have any medical conditions and is not allergic to anything. The patient has not received any other products. There were no other vaccines administered on the same date of the administration of BNT162B2. The patient experienced red dots on the whole arm and there is some yellow in the middle on 18Apr2021. He called for the reaction he had on his arm. He had a lot of little dots. Patient stated they were not pimples. They were dots on the whole arm. They are red dots and there is some yellow in the middle. He mentioned it to the person that gave him the second injection and they said it was normal. The outcome of event was not recovered.
Fever, body aches, headache, exhaustion. Started ~11 hours after the dose and lasted for a total of ~ 36 hours. Pain in location of previous shingles infection.
Raised pimple-like area with small amt of drainage developed 1 day after receiving flu vaccine. Drainage subsided after cleansing site. A day or so later area scabbed and skin sloughed off. No redness or swelling noted to area surrounding injection site only a pimple-like area at injection site.
SHORTNESS OF BREATH; DIZZINESS; CHILLS; WEAKNESS; HEADACHE; This spontaneous report received from a parent concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 15:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced shortness of breath. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced weakness. On 31-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, weakness, chills, headache and shortness of breath was not reported. This report was non-serious.
Dec. 30 received first Moderna COVID 19 vaccine.   Had sore arm for seven days.  Fatigue x 2 days.   On evening of day 6 (Jan 2)  back of neck  and upper back started itching.  Day 7 (Jan 3) noted itchy, red diffuse rash along with some raised red areas up to 1/4" oval shaped on legs, arms, back, head, neck .   Few on abdomen.    Seen by HCP who felt it was probably an allergic rash and advised that I not get the second vaccine.   I pursued seeing an allergist as I really wanted to get the second vaccine shot.  Saw Dr. on Jan 21.  She advised to go ahead and get vaccine as it was more likely a side effect.   The rash slowly disappeared over a couple of weeks.   I took an anti-histamine for a couple of days.   Was able to continue to work despite prickly, itchy feeling.
Headache, Arthralgia, Fever, Rash & NauseaVomiting Narrative:  The employee c/o fever of 100.0 F, chills, body aches, headache, and N/V with no emesis. Intermittent neck pain radiates to left scapula and spine. The symptoms started after 8 hours of receiving the second dose.
Severe rash/open wound on left elbow.; Severe rash/open wound on left elbow.; Dose received: 3/ Dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 04Oct2021 at 10:00 (Lot number: FF8839) at the age of 65 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing) and "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient took unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3249, Anatomical site: Right arm, Administration time: 10:00), administration date: 13Jan2021, when the patient was 65 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN5318, Administration time: 10:00), administration date: 03Feb2021, when the patient was 65 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021 at 10:00, outcome "unknown", described as "Dose received: 3/ Dose number=3"; RASH (non-serious), WOUND (non-serious) all with onset 08Oct2021, outcome "recovering", and both described as "Severe rash/open wound on left elbow". The event "Severe rash/open wound on left elbow." was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash and wound.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Events lasted weeks and still healing, needed medical attention twice. After reading several articles provided to the patient by a J&J COVID team member, in which similar adverse reactions were pictured and detailed, she was confident this rash/outbreak was a result of the booster. Treatment included medications and injection for severe rash/open wound on left elbow.
Information has been received from a 74 year old male consumer with no known allergies. Type II diabetes mellitus and a history of shingles who on approximately 21 Oct 2006 was vaccinated with a dose of Zostavax. Concomitant therapy included Actos. Subsequently, the patient got a rash. The patient reported I had shingles just before I got the shot. Unspecified medical attention was sought, no labs were performed. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information is available.
Gave booster too early.  Second dose Pfizer on 11/10/21. Given booster 1/19/2022
pt recv vax 929AM & 1004AM pt c/o itchy arm & devel hives @ site of inj was given DPH;1020AM pt feels better rash gone, arm less itchy;
Death Narrative:  Patient received the first dose of Moderna COVID-19 vaccination on 3/11/2021. He had not received any vaccines within 4 weeks prior and did not have any contraindications to the vaccine listed in his chart. He did not have a positive COVID-19 test within the facility system. Cause of death: Patient was transported to facility on 4/3/21 after complaining of shortness of breath. It was noted that he had some GI bleeding and was hypertensive. The documentation from facility indicates that death was of natural causes.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 010M20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Chest wall pain, Bronchitis (Acute), Abdominal pain (Left lower quadrant), Urine analysis abnormal, Cardiac disorder (high risk) and Anticoagulant therapy. Previously administered products included for Product used for unknown indication: Influenza (Series 1) on 19-Oct-2018 and Influenza (Series 2) on 09-Nov-2020. Past adverse reactions to the above products included No adverse event with Influenza and Influenza. Concurrent medical conditions included Lung nodule, Lumbar strain (Left), Vitamin D deficiency, Liver cirrhosis (Nodules along the contour of the liver query.), Hematuria (Unspecified.), Nodule (Pulmonary Nodule, Right upper lobe 8mm.), Mitral insufficiency, Dysphagia (Intermittent), Atrial fibrillation (Paroxysmal), Impaired fasting glucose, Constipation, Reactive airways disease, Hearing loss, Supraventricular premature beats, Lung cancer, Gastroenteritis, Gastritis, Cellulitis, Sebaceous cyst, Colitis, Anal spasm, Anal fissure, External thrombosed hemorrhoids, Hyperlipidaemia, Cough, Sinusitis, Erectile dysfunction, Melanoma and Drug allergy (Mucinex(GUAIFENESIN)(Moderate)). Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Chest wall pain, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Pain, METOPROLOL SUCCINATE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy colon: results not reported Screen colon cancer. On an unknown date, Biopsy skin: results not reported Screen Skin cancer. On an unknown date, Computerised tomogram thorax: results not reported screen lung cancer. On an unknown date, Physical examination: normal (normal) routine. On an unknown date, Rectal examination: results not reported Screening for prostate cancer. On an unknown date, Urine analysis: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported  Date the vial was initially stored in the refrigerator 09-Nov-2021. The vial did not undergo any temperature excursions
Strong Numbness and tingling entire body.   Stronger on the left side, then the right side.   Still able to move around.