chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The reporter stated that on 12-AUG-2014 the patient was inadvertently administered expired (Oka/Merck) VARIVAX (lot # 0186AE expiration date: 18-JAN-2014, dose, units, route of administration, anatomical location were not reported. No adverse effects reported. Additional information has been requested.
11 hours after receiving influenza, pt. experienced generalized itching, hives, facial redness, SOB, facial swelling, tongue and lip swelling. Received BENADRYL, epinephrine, and prednisone. Recovering. Discharged from ED.
Information has been received from a physician concerning a 41 month old male with autism, speech delay and encopresis who on 02-SEP-2005 was vaccinated subcutaneous in left with a first dose of VARIVAX (Merck) (LOT# 647535/0824P) and was vaccinated intramuscular in right with the fourth dose of RECOMBIVAX HB (+) Hib conj vaccine (OMPC) (LOT# 648809/0145P). Patient was also vaccinated intramucular in deltoid with the fourth dose of INFANRIX  (unspecified) (GSK - LOT# AC14A056BA) and was vaccinated subcutaneous in right with the third dose of IPOL (unspecified) (Aventis - LOT# X12313-2). At the time of vaccination, the patient had a slight fever. On 31-JUL-2007 the patient developed zoster on right hip and diarrhea. Acyclovir 200 per 5 was prescribed. The patient sought medical attention in physician's office. At the time of the report, it was unknown if patient had recovered or not Additional information has been requested.
almost every symptom except for loss of taste and smell; nasal congestion; back aches; runny nose; sore throat; extreme fatigue; chills; Fever; joint pain/the pain was even in my knuckles; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell), NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), FATIGUE (extreme fatigue), CHILLS (chills), PYREXIA (Fever), ARTHRALGIA (joint pain/the pain was even in my knuckles) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event NOS, at a dose of 800 mg; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; VITAMIN D NOS for Adverse event, at a dose of 5000 unit; HYDROXYCHLOROQUINE for Adverse event, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) for Sinusitis, at an unspecified dose and frequency. On 25-Aug-2021, NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), FATIGUE (extreme fatigue), CHILLS (chills), PYREXIA (Fever), ARTHRALGIA (joint pain/the pain was even in my knuckles) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4f (High) Increased. On an unknown date, SARS-CoV-2 test: neagtive (Negative) Negative.     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.   Concomitant product use was not provided by the reporter. Patient reported that her doctor prescribed antibiotics. And also patient stated that she had using mucinex and something for her sinuses.
Symptoms- TERRIBLE body aches, especially back, legs, and feet.   Extreme fatigue- Exhausted walking 10 steps Chills- Could not get warm even after dressed in sweatpants, hoodie, electric blanket and down comforter.
After pt receiving the vaccine fainted from exam table and has (?) convulsion x few seconds was complete pale pt fell forward.
My heart is hurting me right now; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (My heart is hurting me right now) in a female patient of an unknown age 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 ANGINA PECTORIS (My heart is hurting me right now) (seriousness criterion medically significant). At the time of the report, ANGINA PECTORIS (My heart is hurting me right now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Patient reported that she took the vaccine over a week ago and her heart was hurting her.  Company Comment : This case concerns a female patient of age with no reported medical history of who experienced the expected event of Cardiac pain (Angina pectoris).  The event occurred on an unknown date after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as dosing detail was not disclosed. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Angina pectoris is an important medical event and an adverse event of special interest.; Sender's Comments: This case concerns a female patient of age with no reported medical history of who experienced the expected event of Cardiac pain (Angina pectoris).  The event occurred on an unknown date after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as dosing detail was not disclosed. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Angina pectoris is an important medical event and an adverse event of special interest.
Patient was vaccinated at approximately 1130 AM;  at 1650 PM she reported diffuse rash on both arms, neck and trunk with itching.   She reported to the Emergency Room.  She was released with prednisone, Benadryl,  epi-pen and instructed not to receive any further COVID vaccination.  As of today (12 Nov 2021) patient reports no further issues and is completing her prednisone taper as instructed
Two days after vaccine was administered, parent noticed warm red rash on patient's arm.  Patient was taken to urgent care center.  Doctor prescribed Augmentin and ice compress.  Rash resolving after 24 hours on antibiotic.
Received shingles vaccine Jan 26, 2007. First shingles rash 08/07/07. Visited doctor 08/13 received Zovirax cream prescription. Severe spasms in area and pain. Acupuncture treatments seemed to ease pain. Still have some rash and numbness, burning, itching 6 weeks later.
barely hurt(when received injection); Feels like a permanent bruise; Big, hardened knot; Arm was sore to touch; Ring of discoloration around the knot; Itching sensation; Swelling arm; Arm was red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Arm was red), PRURITUS (Itching sensation), AXILLARY MASS (Big, hardened knot) and PAIN IN EXTREMITY (Arm was sore to touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) and ERYTHEMA (Arm was red). On 15-Apr-2021, the patient experienced PRURITUS (Itching sensation). On 16-Apr-2021, the patient experienced AXILLARY MASS (Big, hardened knot), PAIN IN EXTREMITY (Arm was sore to touch) and SKIN DISCOLOURATION (Ring of discoloration around the knot). On 18-Apr-2021, the patient experienced CONTUSION (Feels like a permanent bruise). On an unknown date, the patient experienced VACCINATION SITE PAIN (barely hurt(when received injection)). At the time of the report, PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Arm was red), PRURITUS (Itching sensation), AXILLARY MASS (Big, hardened knot), PAIN IN EXTREMITY (Arm was sore to touch), SKIN DISCOLOURATION (Ring of discoloration around the knot), CONTUSION (Feels like a permanent bruise) and VACCINATION SITE PAIN (barely hurt(when received injection)) outcome was unknown. Not Provided      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Cough, Shortness of breath, Non-intractable vomiting with nausea, unspecified vomiting type.  ED to Hospital Admission Current 8/22/2021 to present for 5 days. Pneumonia due to COVID-19 virus a Principal problem.  Patient presents with Vomiting.  History of Present Illness     A 73 y.o. male who presented to the ED with chief complaint of nausea and vomiting and decreased po intake for 5 days. Patient reported there is tested positive for Covid on Tuesday. Patient symptoms are getting worse which made him come to the ER for further evaluation and treatment. He reports fever, chills, myalgias, and shortness of breath associated with nausea and vomiting. He denied chest pain and palpitations. Patient was vaccinated for Covid in March with Pfizer.   Patient past medical history significant for hypertension uncontrolled diabetes mellitus coronary artery disease, hyperlipidemia atrial fibrillation, and CHF. Patient appears to be comfortable not in acute distress requiring 2 L of oxygen to keep saturations above 90.  White count is 3.2 with a low lymphocytes, potassium is 3.3 chloride, 96 AST is mildly elevated to 53, BUN and creatinine are within normal limits. Chest x-ray is consistent with atypical pneumonia.
I received FLUVIRIN on 10/6/14 and was feeling well at time, no symptoms. Woke up during night of 10/7/14 with bad headache. Felt bad 10/7, 10/8 and still feeling bad 10/9/14. Symptoms include chills, diarrhea, general body discomfort, headache and congestion. I am reporting this because I've been getting flu shot for over 10 years without any side effects. This year was different for me. I am 59 years old male in good general health.
Within 5 minutes of vaccine I experienced dizziness and started to get a headache. I have chronic conditions so I didn't think too much of it. I got home and about an hour later I proceeded to have throat tightness, throat/face/inner ear itching, severe abdominal cramping, and headache. I got the vaccine 16 days ago and have continued to have issues with allergy symptoms, but now issues with bronchospasms and airway issues. This has worsened my mast cell activation syndrome symptoms significantly
R/arm tenderness and erythema on site of vaccine injection, which developed the next day. Erythema increased day after. No fever. Size 18cm x 10cm. Tx:Benadryl.
I received the updated Pfizer (comirnaty) mono booster 10/6/23 and had general malaise, moderate to severe body aches, elevated body temp and extreme tiredness. In addition I had severe soreness at the injection site. As the day went on, I had increasing blood pressure and heart rate, neither of which I have a problem with normally. (My metoprolol is prescribed off label for another reason, not hypertension and I have no cardiac issues). I always have a normal BP and by the time I was at my worst feeling I was stage 2 hypertensive at 134/83 with a general heart rate of around 80-85. Normal resting rate is around 60-65. I woke up feeling less sick today, 10/8 but throughout the day I have a large red bump, and moderate to severe itchiness at injection site. I also have lymph pain in my upper body on that side. I have had a couple abnormal BP readings today but not consistently and my heart rate has been largely normal but has also spiked a few times. I do still have joint pain today.
36 y/o male with possible adverse reaction to Smallpox Vaccine. 2/10/09 Office note received from reporting MD. Pt seen 10/6/08 with c/o L arm pain and increased redness at SP vax site. Some malaise and flu-like sx. PE WNL except oval shaped smallpox lesion with central scarring. Assessment: Robust reaction from SPV-likely etiology for pt sx constellation. Tx-Motrin PRN.
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. On 06-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unspecified date in October 2014 afterwards vaccination, the patient experienced fine rash at the injection site which was hot to the touch and a burning sensation in the inside of her rash. The injection site was very pink and was about the size of a silver dollar. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
vesicular rash to trunk of body 4 days after immunizations.  No fever or URI symptoms
Started wheezing 3 or 4 hours after 2nd shot and have not stopped wheezing.
Checking out at front desk, while standing up, passed out, fell and hit back of head on floor. Observed by mother. Had several seconds of seizure like activity, flexed one arm, extended other arm, eyes rolled back. Unresponsive for approx. 30 seconds. Staring and slow to respond with glazed look. No loss of continence. No change in respirations; no tachycardia. Pale. 911 called and transported to ER.
Initial report received on 23 August 2010: The patient was enrolled in a randomized, open label, single center, dose- and regimen-ranging study to evaluate immunogenicity, safety and tolerability of different formulations of S-OIV FLUVIRIN in healthy children and adults ages 3 to 64 years. Study vaccine was commenced on 29 Aug 2010 (7.5cmg with MF59). On 23 Aug 2010, the patient (see mother case PHHO2010CR12865) underwent prenatal control and an abdominal ultrasound revealed a presumptive cerebral congenital malformation due to agenesis of the corpus callosum and dilatation of the third ventricle. Another abdominal ultrasound was scheduled to define the diagnosis. At the time of reporting, the event was persisting. The investigator did suspect a possible relationship between the event and the study vaccine. Follow-up received on 24 Aug 2010 (prior to initial circulation): Study vaccine was commenced on 29 Aug 2009 (not 23 August 2010). On 13 Sep 2009, the mother received the second dose of study vaccine. Follow up received on 30 Aug 2010: The neonate's mother did not have any previous children born with congenital abnormalities or any previous spontaneous abortions. The neonates' mother's last menstrual period was on 08 Apr 2010. The pregnancy was confirmed on 20 May 2010. The estimated date of delivery was reported as 15 Jan 2011.
generalized seizure, prolonged course, paramedics called, treated with Lorazepam
This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Increased joint pain in knees/Arthralgia) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis. Concurrent medical conditions included Arthralgia. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) UNK dosage form. On an unknown date, the patient experienced ARTHRALGIA (Increased joint pain in knees/Arthralgia). At the time of the report, ARTHRALGIA (Increased joint pain in knees/Arthralgia) outcome was unknown. 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. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Swelling, heat + site, then over 24 hours, increased bilat ankle edema and heat, increased redness noted thigh. No urticaria, no signs of anaphylaxis.
Initial information received on 14-Sep-2018 regarding an unsolicited valid serious case received from pharmacist via phone. This case involves a 67 years old female patient who experienced skin hard, redness from the elbow to the shoulder, temp of 101 Fahrenheit and painful and cellulitis, while she received vaccines PNEUMOVAX 23 and FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2018, the patient received 0.5 mL dose of suspect FLUZONE HIGH DOSE lot UJ004AA, expiry date 09-MAR-2019 and PNEUMOVAX 23 not produced by Sanofi Pasteur lot number not reported via intramuscular route in the left deltoid. On 14-Sep-2018, 2 days post-vaccination patient reported a serious skin hard (Skin induration), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (Extensive swelling of vaccinated limb), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (Fever), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (PAin), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (Inflammation) and later it was diagnosed as Cellulitis. These events were assessed as medically significant. Relevant tests were not reported. Final diagnosis was redness from  the elbow to the shoulder, temp of 101 Fahrenheit and painful, skin hard and cellulitis. The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Product used for unknown indication and CLINDAMYCIN (CLINDAMYCIN) for Product used for unknown indication. The outcome of the events was reported as unknown. Documents held by sender: none.; Sender's Comments: This case involves an elderly female patient who presented with cellulitis after vaccination with FLUZONE HIGH DOSE vaccine. Time to onset is compatible. There is, however, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
The adverse reaction began on the morning of 8/13/23. Patient started with a red, itchy rash and swelling to her cheeks. Benadryl was given throughout the day and rash remained the same. The following morning, the patient woke with her entire face red, itchy, and swollen, and she had a rash on other areas of her body including her chest, back, arms, legs, and hands. A dose of Benadryl was given and she was brought to the ER. In the ER, they gave her a dose of Claritin without improvement in symptoms and was then started on a 5 day course of prednisone. At the time of her office visit on 8/16/23, three doses of prednisone had been given and the rash was beginning to improve but was not fully resolved.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 11-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter
Presented with SOB, afib; dx bilat covid PNA; CXR with pulm edema; D-dimer 2.40; CRP 1.46 Ferritin 179; Tx: Maxipime, decadron, cardizem (afib), singulair, zinc 1/4 pt with poor intake 1/5 pt with continued afib 130's at times, increasing oxygen demand; placed on 100% NRB; pulmonary consult; pt with hypotension during HD; Family decided on comfort care;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old male patient received BNT162b2 (BNT162B2), on 12Aug2021 as dose 2 (booster), single (Batch/Lot number: unknown), in right arm and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "allergic sinusitis" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "fatty liver" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: May2022, stop date: Jun2022; XYZAL, start date: Mar2022, stop date: Jun2022; FLUTICASONE PROPIONATE, start date: 18May2022, stop date: 09Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive, notes: Original test pos. 23May; (30May2022) Negative, notes: Negative RAT 30May; (01Jun2022) Negative, notes: Negative RAT 01Jun; (02Jun2022) Positive, notes: Positive RAT 02Jun; (10Jun2022) Positive, notes: RAT continues positive thru 10Jun. Therapeutic measures were taken as a result of drug ineffective, Covid-19.Clinical course: Rapid Antigen Test positive after negative for 3 days after completion of Paxlovid. Original test pos. 23May, Paxlovid ended 29May. Negative RAT 30May & 01Jun. Positive RAT 02Jun & returned milder symptoms end 09Jun. RAT continues positive through 10Jun.If treatment ae: Yes AE treatment: Azithromycin. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2nd dose of SHINGRIX given 5/21/18. On 5/24/18, pt reports loss of appetite, extreme tiredness (slept all day next day), fever approximately 100.5 F. Follow up w/pt 5/25/18, pt is still sick w/fever approximately 100.5-101 F w/cough and sore throat.
2.8 cm area of erythema & induration left upper arm 2 days after VARIVAX administration.
From an initial report received on 01/04/2001, it was reported an 18 year old male was given a Menomune vaccination on 11/08/2000. Reportedly after receiving the Menomune vaccine the pt passed out, diaphoretic less than or equal to 10 seconds. Pt reclined supine position. Pt identified states "I have not eaten" orange juice provided, cool packs applied to face and neck. Pt instructed to  take slow deep breaths. Improvement noted. Pt stated "I feel good." From additional corespondence received on 10/24/2001 no further info was provided.
Acute on chronic diastolic heart failure. ED Visit and hospitalization. This visit was within 6 weeks of receiving the COVID vaccine.