chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had a lesion on spinal cord; tingling, widespread throughout the body; numbness, widespread throughout the body; Initial information regarding an unsolicited valid serious case was received from a consumer or an other non-professional (patient) via Global Medical Information (GMI) (Reference number- 00337905) and transmitted to Sanofi on 29-Oct-2020.   This case involves a 59-year-old female patient (age reported as: 60 year old) who experienced numbness (hypoaesthesia) and tingling (paraesthesia) which became widespread throughout the body and a lesion on spinal cord (spinal cord disorder), after patient received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On 18-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot UJ244AA, expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   It was reported that, patient was unsure that vaccine was not preserved (NP) or from Multi-dose vial (MDV).  On 18-Nov-2019, the patient had non-serious numbness (hypoaesthesia) and tingling (paraesthesia) which became widespread throughout the body, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.   On the same day patient had testing and found she had a lesion on spinal cord (spinal cord disorder) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant as per important medical event list.   Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was reported as unknown for the events.; Sender's Comments: This case involves a 59-year-old female patient (age reported as: 60 year old) who experienced hypoaesthesia, paraesthesia and was found to have spinal cord lesion (spinal cord disorder) after vaccination with FLUZONE QUADRIVALENT MULTIDOSE. The time to onset is compatible with role of vaccine. Patient had testing and found she had spinal cord lesion. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.
I run twice a week. One 6-8 mile and one 10-12 mile run.  I breathe through my nose mostly and I'm in very good pulmonary and cardiovascular condition.  I went for a run and 1 mile in I started drooling a lot! Spitting out mouthfuls every 15-30 seconds and I never spit.  Then my chest got tight and hurt and got irritated.  The feeling was identical to Bronchitis.  I started walking home and my breathing rate increased with wheezing. I got nauseous and was bent over with saliva poring out of my mouth.  Walking up one flight of stairs was difficult.  I have a finger pulse oximeter and it was at 84!  Breathing was very rapid and difficult. After 5 minutes it went up to 94 and then up to 98-99 after 1 more minute (when my pulse fell back under 100bpm.  Chest tightness continued for about 1 hour before I was back to normal for the most part. by today I feel 100% again.
Patient stated she developed severe itching on her hands and feet/between toes today. She stated there is not a physical rash on her body. Itching is confined to hands and feet. Denies any difficulty breathing. Reaction only started today.
Presented to ED with progressive shortness of breath, wheezing, cough. Was noted to be hypoxic requiring low flow oxygen (4 L at time of report) to maintain saturations > 90%.
This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the right arm on 04Nov2021 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received triamcinolone acetonide(AZMACORT) and tetryzoline hydrochloride (VISINE); both for unspecified indication from unknown date and experienced drug allergy and also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 12Jan2021 (at the age of 30-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 01Feb2021 (at the age of 30-year-old), both as single dose for COVID-19 immunisation. On 05Nov2021, the patient experienced nausea, muscle/joint aches, headache, soreness/redness around injection site and injection site had a red ring around it approximately 1 in diameter and still had sore/"firm" feeling days later. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nausea, muscle/joint aches, headache, soreness/redness around injection site and injection site had a red ring around it approximately 1 in diameter and was still sore/"firm" feeling days later was resolving at the time of this report.
Has not had a SZR since april of last year. He was not feeling well after vaccine, (body aches, subjective fever, tiredness) and wife found him having a seizure while lying in bed.
This spontaneous report was received from a licensed vocational nurse concerning a patient of unknown age and gender. On 08-OCT-2013, the patient was vaccinated with 0.5 milliliter (ml) of MMR II (lot number and expiry date unspecified), subcutaneously which was improperly stored in a syringe for 16 hours. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
got the vaccine and then got shingles, suspected vaccination failure; got the vaccine and then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and then got shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Within 15 minutes of receiving the injection I began to feel itching in my chest and tingling in my legs. I had my husband purchase a Benadryl from the store and I took that. My chest itchiness resolved but the tingling in my legs has continued without ceasing for the last 6 weeks.
Information has been received from a consumer about Gardasil therapy. The reporter was told by a pediatric neurologist who examined her daughter for syncopal episodes/seizure-like episodes (reported in WAES # 0803USA04544) that he had seen similar episodes related to Gardasil. The outcome was unknown. Upon internal review "seizure-like activities" was determined to be other important medical events. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Patient suddenly fainted and fell, striking and lacerating the back of her head on a table leg.  The laceration resulted in copious bleeding.  After regaining consciousness, patient telephoned for help, and was transported by ambulance to Emergency Dept.  After tests verifying no internal bleeding, the laceration was closed with four staples.  Patient had no prior history of fainting, nor subsequent fainting.  Fainting incident was sudden onset and not preceded by significant episode of faintness.  During this day after vaccination, patient also suffered more typical second-dose side effects, including soreness of shoulder, rash, malaise and low-grade fever (100.2°F).
Redness at site, warmth at site, inflammation at site, pain at site when moving arm.
My wife contracted COVID-19 first, so I got it from her. I had chills for a day. I was just lethargic. I don't remember anything else other than those symptoms. I may have had some cold symptoms but they were mild and I was just tired. I tested positive on 12/05/2022. I did get PAXLOVID and I tested negative on 12/10/2022. I went back to life as normal. I tested positive again on 12/16/2022. I tested negative again on 12/21/2022. I did get a rebound case while my wife did not.
itching on his arm and back of his scapula.; swollen in the arm like a welt in the injection site; allergic reaction; a welt on his arm; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 63 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose #4: , Date: 13May2022 , Lot: FP4554, NDC: unknown , Expiry: unknown), administration date: 13May2022, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose #3: , Date: 09OCt2021 , Lot: FF2590 , NDC: unknown , Expiry: unknown), administration date: 09Oct2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose #2: outside source, Date: 06Feb2021, Lot: EM9810, NDC: unknown , Expiry: unknown), administration date: 06Feb2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose #1: from an outside source, Date: 19Jan2021, Lot: EL3247 , NDC: unknown, Expiry: unknown), administration date: 19Jan2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching on his arm and back of his scapula."; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swollen in the arm like a welt in the injection site"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction"; URTICARIA (non-serious), outcome "unknown", described as "a welt on his arm".  Additional information: Caller was asking for the components of the vaccine. Agent also stated there was a complaint, caller said they usually get a list of components when they receive the boxes and for this vaccine nothing was in the boxes.  Follow-up attempts are completed. No further information is expected. Follow-up attempts are completed. No further information is expected.
delayed angioedema; This is a literature report.  A 33-year-old woman with a history of episodic idiopathic urticaria, asthma, venom hypersensitivity, and Cushing syndrome on long-term low-dose corticosteroids tolerated her first Pfizer-BioNTech COVID-19 mRNA vaccine without immediate complications. After 1 day, she developed a pruritic, erythematous rash on her chest, throat tightness, and dyspnea, and presented to the ED where she was noted to be normotensive, tachycardic, and mildly febrile. Physical examination revealed lip and tongue angioedema, urticaria involving arms and chest, muffled voice, and decreased breath sounds. Flexible laryngoscopy revealed edematous vocal cords. She was urgently intubated. Serum tryptase levels during symptoms were normal. She received 2 doses of 0.3-mg intramuscular epinephrine, 50-mg oral diphenhydramine, 125-mg intravenous methylprednisolone, and 20-mg oral famotidine. Owing to her symptom severity, she was started on a continuous intravenous epinephrine infusion, which was weaned after 8 hours, and her angioedema resolved by 14 hours. She was advised not to receive dose 2 of the Pfizer-BioNTech COVID-19 vaccine. She denied a previous history of angioedema and reported no further episodes in the subsequent 7 months.  Table 1: Overview of Cases of Delayed Angioedema After SARS-CoV-2 mRNA Vaccine Administration Age (y): 33; Sex: Female; Atopic history: Allergic rhinitis, intermittent asthma, venom hypersensitivity, chronic spontaneous urticaria, no previous history of angioedema; Miralax exposure: Unclear if ever taken; Vaccine administered: first dosage Pfizer-BioNTech COVID-19; Onset of symptoms: 26h post-vaccination; Symptoms: Urticaria, lip swelling, tongue swelling, vocal cord swelling, dysphonia, dysphagia, and dyspnea; Vitals on presentation to the emergency department: BP, 95/55; HR, 128; RR, 18; T, 100.6F; oxygen saturation 98% on RA; Treatment: IM epinephrine, IV epinephrine, corticosteroid, antihistamine; Serum tryptase (mcg/L) 2.2, normal; C4 level (mg/dL): 21.8, normal; Recurrence of angioedema to date: None.; Sender's Comments: Based on the available information in the case, the causal association between the event "angioedema" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200115083 Same drug/event and different patient.;US-PFIZER INC-202201343859 Same drug/event and different patient.;
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
patient got light-headed and heart racing, shivering about 15 minutes after vaccine.  could not relax her breathing
\    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore). On 20-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot arm), PYREXIA (fever of 99.7 degrees) and VACCINATION SITE RASH (rash on arm where shot was given about 3x5 inches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (hot arm), PYREXIA (fever of 99.7 degrees), VACCINATION SITE PAIN (sore) and VACCINATION SITE RASH (rash on arm where shot was given about 3x5 inches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: (High) 99.7 DEGREES.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated events outcome as recovered/resolved This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021. The most recent information was received on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot arm), PYREXIA (fever of 99.7 degrees), VACCINATION SITE PAIN (sore) and VACCINATION SITE RASH (rash on arm where shot was given about 3x5 inches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore). On 20-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot arm), PYREXIA (fever of 99.7 degrees) and VACCINATION SITE RASH (rash on arm where shot was given about 3x5 inches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (hot arm), PYREXIA (fever of 99.7 degrees), VACCINATION SITE PAIN (sore) and VACCINATION SITE RASH (rash on arm where shot was given about 3x5 inches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: (High) 99.7 DEGREES.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated events outcome as recovered/resolved
This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 5-6 hours post vaccination, patient began to feel light-headed. Symptoms further developed over the next few hours to include headache, significant chills (without fever), and muscle aches, followed by difficulty sleeping due to sweating.
This is an 89-year-old female patient with a known medical history of type 2 diabetes mellitus, hypertension, heart failure, Wolff-Parkinson-White on Eliquis, hard of hearing who presented to the ED after feeling nauseous, lightheaded, increasingly weak over the last couple days. She was found to be with symptomatic anemia with hemoglobin 6.9 and unknown source.  Patient states that over the last couple days she has had above symptoms as well as decreased appetite and minimal intake.  She lives at home with her husband who is COVID positive.  She does admit to mild fevers, intermittent shortness of breath especially with exertion and nonproductive cough.  She did test positive for COVID-19, does admit to receiving both of her vaccinations.  Denies any evidence of bleeding.  She does admit that she is on Eliquis for Wolff-Parkinson-White.  Last colonoscopy was roughly 2 years ago which was reportedly unremarkable.  Denies any recent NSAID use.  On presentation sodium 132, potassium 5.6, hypochloremia 92, glucose 165, creatinine 1.74, BUN 80, magnesium 2.7.  She does states that she is on some type of diuretic at home which does not recall the name, she states that she does intermittently have lower extremity edema which has improved over the last week.  Denies any diarrhea or black or bloody stools.  Denies any recent chills, chest pain, palpitations, abdominal pain, diarrhea or dysuria.  Patient will be admitted for symptomatic anemia workup as well as COVID-19.
nauseated/ nauseated again; threw up a little bit/ she threw up again/ second time I threw up; stomach started bothering me; pain off and on through the night; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach started bothering me), ABDOMINAL PAIN UPPER (pain off and on through the night), NAUSEA (nauseated/ nauseated again) and VOMITING (threw up a little bit/ she threw up again/ second time I threw up) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu vaccine (She took the flu vaccine around September or October of 2021.) in 2021. Past adverse reactions to the above products included No adverse event with flu vaccine.    On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced ABDOMINAL DISCOMFORT (stomach started bothering me) and ABDOMINAL PAIN UPPER (pain off and on through the night). On 26-Jan-2022, the patient experienced NAUSEA (nauseated/ nauseated again) and VOMITING (threw up a little bit/ she threw up again/ second time I threw up). At the time of the report, ABDOMINAL DISCOMFORT (stomach started bothering me), ABDOMINAL PAIN UPPER (pain off and on through the night), NAUSEA (nauseated/ nauseated again) and VOMITING (threw up a little bit/ she threw up again/ second time I threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient had a reaction to the Moderna vaccine. The patient stated she went to the restroom about 1 o'clock at night on 25-Jan-2022. After she used the bathroom, her stomach started bothering her. She had pain off and on through the night.  In morning on 26-Jan-2022, after she ate, she was nauseated and threw up a little bit. While she was on the phone with physician, she got nauseated again, so then she spoke with a nurse. While she was talking to the nurse, she threw up again, a lot more than she did this morning. That was the second time she threw up. She normally did not have a reaction to vaccines.  No treatment information was provided.